The entrepreneur has now turned her attention to South San Francisco-based Calithera Biosciences, which earlier this month landed a $40 million Series A round to ramp up development work on a new group of cancer drugs discovered in the lab of Jim Wells, chair of the Department of Pharmaceutical Chemistry in the University of California, San Francisco School of Pharmacy. Wells was impressed by Proteolix’s ability to find the correct dosing, formulation and potency for its cancer drug–a challenge he suspects Calithera will face in its work. Wells’ compounds activate procaspases and trigger apoptosis (cell death) in cancer cells.

Wells and Chris Christoffersen, managing partner at Morgenthaler Ventures (one of Calithera’s VC backers), agreed that Molineaux was the right choice to head up Calithera. They were impressed with her ability to bridge the gap between science and business. During Molineaux’s interview for the CEO spot, “we talked serious science and candidly and openly with great strategic clarity about businesses she’s been involved with,” Christoffersen tells the San Francisco Business Times. “I walked out of the interview saying, ‘That’s impressive.’”

- here’s the San Francisco Business Times article

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Read the original here
Molineaux turns her attention to start-up Calithera

In early stage studies, GSK2251052 (GSK ’052) has shown robust activity against multi-resistant gram-negative bacteria with no cross resistance to existing classes of antibiotics. GSK ’052 is being looked at as a potential treatment for complicated urinary tract infection, complicated intra-abdominal infections and hospital/ventilator-associated pneumonia (HAP/VAP).

“GSK ’052 has an entirely novel mechanism of action with the potential to be the first new class antibacterial to treat serious hospital gram-negative infections in 30 years,” says David Payne, VP of GSK’s anti-bacterial drug discovery unit. “Our collaboration with Anacor has enabled the rapid progression of GSK ’052, and we are excited about the opportunity to address the growing need for new treatments for serious hospital acquired infections.”

GSK and Anacor entered into a worldwide strategic alliance for the discovery, development and commercialization of novel medicines for viral and bacterial diseases in October 2007. The alliance grants GSK access to Anacor’s proprietary boron-based chemistry for use in four target-based project areas. Contingent on achieving certain milestones, Anacor is eligible to receive development and regulatory milestone payments of up to $84 million as well as commercial milestones and tiered double-digit royalties up to the mid-teens, which are dependent on sales achieved.

- read the Anacor release

ALSO: Colgate-Palmolive hasasked a federal court to rule that its new “Triple Action” toothpaste doesn’t infringe trademarks of GSK’s competing product, Aquafresh. Report

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GSK willing to pay big for Anacor’s anti-infectives

Read more from the original source
Anacor gets $15M from GSK

In a May 20 warning letter, the agency found River’s Edge failed to establish standards, specs and testing procedures to assure its meds have the appropriate quality and purity; oversee contract manufacturers, implement proper manufacturing procedures and train employees. And as the FDA notes, outsourcing is not an excuse for a screw-up…

Read the original here

Rigel Pharmaceuticals

We continue to view RIGL shares as undervalued: the company finished 1Q 2010 with ~$210M in cash and with no debt, and at today’s market cap of $437M, has an enterprise value of approximately $227M. The company’s lead compound R788, a syk inhibitor, is an oral disease modifying anti-rheumatic drug (DMARD), that will enter Phase III testing this year and is partnered with AstraZeneca (NYSE: AZN, Not Rated). We believe that given that R788 is a) a Phase III asset, b) with the potential to address one of the largest and most lucrative therapeutic markets in rheumatoid arthiritis, and c) in development with the resources of a global pharma partner, this asset’s value alone is significantly higher than the company’s current market cap. We believe that as the market continues to digest and appreciate both the Phase II TASKi 1-3 trial data, and the value of the Astra Zeneca deal, RIGL shares should recover and provide significant upside from current levels.

Many investors have questioned the choice of AstraZeneca as a partner, the implication being that “if there was a lot of real interest in R788, Rigel could have signed on with a company with an established rheumatology franchise, and not one that is now trying to establish a presence in the space.” It is very difficult to really know how many interested parties were sitting across from Rigel during the negotiations for R788. However, regardless of the demand, we really like the outcome of this process, and we really like the choice of AZ as a partner for R788. Yes, AstraZeneca does not have a rheumatology tradition. However, they do have the desire to build one (no one can argue with the amount of capital they are investing), and we believe that R788 is better off being the centerpiece of a committed new effort in rheumatology, versus being one of a number of assets in an established rheumatology franchise. We believe that the choice of AZ was a strategic one and we believe that R788 can benefit from the increased attention and resources it will enjoy in the hands of a company looking to break into this space.

In addition, we believe that the terms of this deal compare very favorably to the two most recent deals done in RA. We’ve compared the terms of the Rigel/AZ deal with the two recently announced deals in the RA space: 1) the Alder (private company)/Bristol Myers Squibb (NYSE: BMY, Not Rated) deal for Alder’s injectable IL-6 mAb ALD518 announced November 10, 2009, and 2) the (INCY, Not Rated)/Eli Lilly (NYSE: LLY, Not Rated) deal for Incyte’s oral JAK1/JAK2 inhibitor INCB28050 announced December 21, 2009. Briefly, Rigel received $100M upfront and is eligible to receive up to $1.145B in milestones from AstraZeneca, while Incyte received $90M upfront and is eligible for up to $665M in milestones from Eli Lilly, and Alder received $85M upfront and is eligible for up to $964M in milestones. Of note, Rigel is eligible for $345M in pre-commercial milestones. Thus, we believe that the terms Rigel secured compare very favorably to the other two compounds that are now in the hands of US large pharma companies, with higher economics in terms of both upfront and future milestones.

OncoGenex Pharmaceuticals (NASDAQ: OXGI, Market Outperform)

We consider OGXI shares undervalued, since at a current market cap of $77M, and $47M in cash and no debt at the end of 1Q 2010, we believe that the market is heavily discounting the value of lead program OGX-011/TV-011. This second-generation antisense compound, is partnered with Teva (NASDAQ: TEVA, Not Rated), which is paying for three Phase III trials, two in CRPC (castration refractory prostate cancer) and one in NSCLC (non-small cell lung cancer). We like the OGX-011/TV-1011 data in the randomized Phase II trials in CRPC and NSCLC, which provided evidence of a significant survival benefit in two of the largest and among the most difficult oncology settings.

We believe the compound’s results are heavily discounted by the Street primarily because OGX-011/TV-1011 is an antisense compound, and this comes with a heavy discount, which we see as understandable, given the novelty of the class, yet too heavily applied in this case. We also like the company’s December 2009 deal with Teva, because A) it secures OGX-011/TV-1011′s development future with 3 Phase III trials fully funded by Teva, and B) because we like Teva as a partner. The choice of the Israeli generics giant was definitely unorthodox; however, we like Teva’s track record in the branded markets, with Copaxone, and we don’t see any reason why they could not replicate this success in the oncology space, too.

Infinity Pharmaceuticals (NASDAQ: INFI, Market Perform)

Infinity is an oncology-focused biotech whose lead compound IPI-504, an Hsp90 inhibitor failed in Phase III testing in GIST (Gastrointestinal stromal tumor) in 2009. Since then, the company has been evaluating the efficacy of this lead program in breast and lung cancer, while also advancing the remainder of its pipeline, which includes IPI-926, an oral Hedgehog inhibitor program heading towards Phase II in pancreatic cancer; IPI-493, an oral Hsp90 inhibitor in testing in both solid and liquid tumors; IPI-940, a Phase I oral selective inhibitor of the FAAH enzyme with potential applicability in neuropathic and other inflammatory pain conditions; and INK1197, a PI3K inhibitor licensed from private company Intellikine, and expected to enter the clinic for testing in inflammatory diseases in 2011.

Our current rating for Infinity is Market Perform, but we want to point investors to the fact that the company’s current cash position provides a floor to the stock with limited downside risk. With Infinity shares trading around the $6/share range and a market cap of around $155M, with another $150M in committed reimbursed R&D spending from Purdue/Mundipharma in 2010-2011, it is clear that the market is currently not assigning much/any value to the company aside from the cash position of $126M or $5/share. We acknowledge that it may be difficult for investors to assign significant value to the company’s pipeline (especially during periods of uncertainty in the market), since despite its promise, it is still in its early stages of development. However, we believe that the company’s current cash position and the low burn rate provide downside protection to Infinity investors, and we thus see very limited downside in INFI shares, with the possibility of significant upside with any good news on the Hsp90 (IV or oral) and the hedgehog Phase II trial in pancreatic cancer.

As we mentioned above, we expect Infinity shares to remain range bound, since we believe that investors will remain on the sidelines near- to medium-term on the company, until we have some clarity on what the future holds for IPI-504. However, and despite the setback with the Phase III RING trial, we continue to consider Infinity as a small cap oncology company worth paying close attention to, since we believe it has the potential for significant growth long-term, because it in addition to the possibility of positive data from the ongoing studies with IPI-504, it
combines: a) promising early programs in Hedgehog and the oral Hsp90 with strong biological rationale behind them, b) an all-star R&D team with an enviable record of success, and c) a seasoned senior management team, coupled with 4) financial stability due to strategic decisions in late ’08. We will continue to follow the developments on the IPI-504 front closely, and will continue to look for attractive entry points, especially when additional clarity becomes available on the future of the lead program

How’d we do last time? Check out this quick look at our theses from our “On the Radar: Five biotech companies to watch” piece last September. Next page >>

Read more from the original source
Five high-value biotech stocks to watch (Page 2)

In October 2009, Onyx (ONXX) paid $276 million up front to acquire the privately held Proteolix to get to its multiple myeloma drug carfilzomib. It promised $535 million in future payments largely contingent on carfilzomib’s approval. As usual, investors did not like Onyx paying money, because investors do not like any company to pay money to develop or acquire state-of-the-art products. When somebody hates something he sees everything in it with pessimism. Onyx put its hands on carfilzomib, which looked very promising for multiple myeloma cases resistant to current treatments. The breakthrough multiple myeloma drugs Velcade (bortezomib) and Revlimid (lenolidamide) could not prevent the cancer from recurring and failed to work at all on a large percentage of recurrent cancer.

Complete Story »

Idenix Pharmaceuticals, Inc. (IDIX)

Q2 2010 Earnings Call Transcript

Complete Story »

The decision contradicts a US Labor Department brief filed recently in a Novartis case supporting overtime payments (see here) and, moreover, continues a very confusing trend in which different federal courts have come down squarely on either side of the issue, prompting some lawyers to say the debate is increasingly likely to end up before the US Supreme Court, even as drugmakers accelerate plans to eliminate more sales reps.

A primer: the FLSA’s overtime compensation requirement doesn’t apply to employees who work as outside salespeople, but the law does require employers to pay overtime for hours worked beyond 40 hours a week, unless a FLSA exemption applies. What are those exemptions? If an employee’s primary duty is to obtain orders or contracts (as defined by the statute) and regularly does so away from the employer’s place of business

Drugmakers argue their sales reps are, indeed, outside salespeople who close sales because the primary customer is the physician. In the case involving Alpharma, US District Court Judge Garrett Brown Jr. cited a recent case involving a Johnson Johnson/Ortho-McNeil rep, who was denied overtime by the US Court of Appeals for the Third Circuit (see this). Interestingly, in his ruling, he doesn’t refer to the recent Labor Department brief, and acknowledges the case “lacks the direct testimony of the plaintiffs regarding their autonomy and independent nature, (but) the underlying facts differ little from the facts in (the J&J lawsuit).”

Brown goes on to explain that sales rep Tito Jackson met three conditions cited by the drugmaker: he was compensated on a salary or fee basis at a rate of not less than $455 per week; his primary duty is performance of office or non-manual work directly related to the management or general business operations of the employer or the employer’s customers; and his primary duty includes exercising discretion and independent judgment “with respect to matters of significance.”

Hat tip to Bnet

Read more from the original source
King Pharma Rep Denied Overtime By Federal Court

What drove Teva’s growth in the last 10 years?

Both of these areas are currently going through a period of profound change. It is possible that these changes have already affected the share price of Teva, which fell from about $63 a share to the current price of $49. The main question is this: Will these changes affect Teva’s ability to maintain its profitability and growth rate that characterized it in last few years?

Complete Story »

There are only two companies that will be up for FDA approval for their products in the second half of the year that have an SPA (special protocol assessment) with the FDA. Those companies are Avanir Pharmaceuticals (AVNR) and Vivus Pharmaceuticals (VVUS).

VVUS has a PDUFA date of October 28^th for Qnexa® which treats weight loss. Avanir has a PDUFA date of October 30^th for Zenvia™, which treats pseudobulbar affect. Key safety and tolerability data from the Vivus, Inc. special protocol assessment (SPA) that was not evident at the recent FDA Advisory Panel meeting is present for Avanir (AVNR) into their PDUFA date. VVUS has their SPA in a crowded but profitable market of weight loss and obesity. Avanir has their market in an often under-recognized and undertreated condition of uncontrollable laughing and crying known as PBA (pseudobulbar affect).The Avanir SPA has an emphasis on safety and tolerability to go along with the efficacy data that was clearly demonstrated in the recent STAR trial.

Complete Story »

Read the original here
NovaBay’s impetigo drug aces Phase II trial

The company’s lead product candidate is CTP-518, an HIV treatment covered by the GSK pact. Another compound, CTP-347, is in Phase I testing as a non-hormonal treatment for vasomotor symptoms. CEO Roger Tung tells the Boston Globe that his company is working on getting more clinical data on CTP-347 and other experimental compounds so Concert can attract additional pharma partners.

- here’s the article

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Read more from the original source
Concert pursues clinical data for drug delivery tech

F4Q10 (Qtr End 04/30/10) Earnings Call

June 14, 2010 4:30 pm ET

Complete Story »

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

BioSante Pharma (NASDAQ:BPAX)

Complete Story »

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news…

Shares of Cumberland Pharma (NASDAQ:CPIX) have shed approximately 65% of market value since its initial public offering (IPO) last August at $17 per share.

Complete Story »

In fact, Glenmark produced just three e-mails in response to discovery requests for an entire year’s worth of material and allegedly engaged in a “systematic document destruction policy,” in which documents and e-mails were retained on company servers for only one month. The ruling, which allows a jury to draw an adverse inference, comes less than a month after Sanofi and Abbott lost a bid to prevent Glenmark from launching its generic, The American Lawyer notes.

Glenmark argued it was entitled to “work product immunity,” but US District Court Judge Dennis Cavanaugh didn’t buy that reasoning. “The destroyed documents…were relevant to the claims and defenses in the present litigation and were the subject of reasonably foreseeable litigation,” he wrote in his ruling. Sanofi and Abbott sued Glenmark for patent infringement in 2007 and sought to prevent Glenmark from selling its generic during the litigation. However, Cavanaugh earlier this month allowed Glenmark to proceed because the generic drugmaker raised “a substantial question” about the validity of the brand-name patent.

On June 21, Affymax (AFFY) and their partner Takeda Pharmaceutricals (TKPHF.PK) announced phase 3 trial results for their investigational drug, Hematide (peginesatide), a novel peptide-based, long acting erythropoietin agonist. The trial examined the efficacy of hematide for the treatment of anemia in chronic renal failure, and met all of its primary efficacy and safety endpoints to demonstrate equivalency to recombinant erythropoietin (epoetin and darbepoetin). Normally, one would expect this to be interpreted as good news, but in the case of AFFY, it was interpreted as bad news due to the inclusion of this statement in the headline: “With Some Differences Noted in Secondary Analyses”.

Spooked investors quickly sold off AFFY stock giving it a 60% haircut from its prior trading of almost $22.50 to about $8.50 by market open. This type of market behavior is understandable, given that Hematide is Affymax’s sole clinical asset, and the failure of Hematide would leave Affymax without any clinical pipeline. Most traders expected a bounce from there as investors stop panicking and absorbed the significance of the news.

Complete Story »

“We were proactive on the size of the new fund,” Bryan Roberts, a Venrock partner, told the Wall Street Journal. “It fell out of who we had (at the firm). If we could find great people to hire, we would, but finding great new investors is hard.”

Eight partners will handle the investing work for this fund, down from 15 partners involved in the most recent round of work. But many venture capital firms are downsizing as the average size of new funds dwindles. The National Venture Capital Association says that the number of venture principals has shrunk from 8,892 in 2007 to 6,828 in late 2009.

So far this year Venrock has been able to benefit from three biotech IPOs; Alimera Sciences, AVEO Pharmaceuticals and Ironwood Pharmaceuticals. And it counts a number of drug developers in its portfolio. But IPOs overall have been few and far between over the last two years, and that trend has helped throttle the venture industry’s activities. This new fund will  concentrate on a broad slate of new technologies ranging from healthcare IT, biofuels, and energy systems to software.

- here’s the press release
- here’s the story from the Wall Street Journal

Read more from the original source
Venrock gets lean and mean with $350M venture fund

Lux Biosciences has named Dean Mitchell as president and CEO. Mitchell is the former president and CEO of Alpharma. Release

Jiangbo Pharmaceuticals has tapped Linxian Jin as the company’s CEO. Jin will take over the role of CEO from Chairman Wubo Cao, who resigned on June 29. Cao will continue his role as chairman of the company’s board. Release

James Connolly has been named president and CEO of the Aeras Global TB Vaccine Foundation. He joins Aeras after a career in the pharmaceutical industry, most recently as executive VP and GM of Wyeth Vaccines. Release

Novavax has named Gregory Glenn as its chief scientific officer. Release

Eliseo Oreste Salinas has joined Elan as executive VP and chief medical officer. Release

BioVex has named Steven Kelly as its chief commercial officer to help prepare for the potential launch of the company’s investigational product, OncoVEX GM-CSF. Release

Vanda Pharmaceuticals has announced that Steven Galson, former acting U.S. surgeon general, has joined the company’s board. Release

Margaret McGlynn, former president of Global Vaccines and Anti-infectives at Merck, is joining the board of the International AIDS Vaccine Initiative. Release

Probiodrug has appointed Christian Haass to the company’s scientific advisory board. Release

Read more here
AlloCure taps Brenner as president, CEO

Summary: The company continued its shopping spree with the consumer healthcare group Chattem. The deal strengthened Sanofi’s consumer business, perhaps the only area the company hadn’t yet bolstered via one buyout or another. Report

Alopexx
Date: Dec. 10, 2009
Estimated worth: $375M

Summary: This time around it was a $375 million deal to collaborate with Cambridge, MA-based Alopexx Pharmaceuticals on a preclinical antibody program that targets infectious diseases. Report

Regeneron
Date: Nov. 11, 2009
Estimated worth: $1B

Summary: The drug giant extended its two-year-old pact to develop new therapeutic antibodies with a commitment to pay more than a billion dollars to Regeneron over eight years. In the deal, Sanofi increased its support from $100 million a year to $160 million as it extended the pact an additional five years, to 2017. Report

Micromet
Date: Oct. 29, 2009
Estimated worth: $475M

Summary: The new pact made Micromet responsible for developing an antibody that targets an antigen on the surface of carcinoma cells, activating T cells that seek and destroy cancer cells. Micromet will develop the drug candidate through Phase I and then pass it along to Sanofi, which will then be responsible for the research program. Report

Wellstat Therapeutics
Date: Oct. 21, 2009
Estimated worth: $350M

Summary: Sanofi-Aventis brought out its well-worn checkbook to complete another deal–this time in-licensing a mid-stage diabetes therapy from Gaithersburg, MD-based Wellstat Therapeutics as it built a portfolio of experimental drugs around its blockbuster drug Lantus (insulin glargine). Report

Fovea Pharmaceuticals, Merrimack
Date: Oct. 1, 2009
Estimated worth: $1B

Summary: The acquisition of Fovea marked Sanofi’s first foray into ophthalmology. Merrimack is responsible for development of antibody MM-121 through Phase II proof of concept on each indication and Sanofi picked up the development work after that point. Merrimack also retained co-promotion rights in the U.S. Report

Shantha
Date: July 27, 2009
Estimated worth: $784M

Summary: Sanofi’s vaccine division Sanofi-Pasteur, acquired ShanH, French subsidiary of Merieux Alliance, which holds a majority stake in Hyderabad-based Shantha. Shantha Biotech developed, manufactured and marketed a recombinant human healthcare product in India. It’s also developing generic biologicals, therapeutic antibodies, proteins and vaccines in the fields of oncology, infectious diseases and platform technologies. Report

Exelixis
Date: May 28, 2009
Estimated worth: $140M

Summary: Exelixis licensed a pair of early-stage cancer drugs to Sanofi-Aventis in a pact that’s worth $140 million upfront and could eventually break the billion-dollar mark. Story

Read more from the original source
Sanofi-Aventis: A timeline of biopharma deals (Page 2)

On July 1 Arena Pharmaceuticals (ARNA) announced a US marketing partnership for its late-stage obesity drug candidate lorcaserin with the US arm of Japan’s Eisai, known for gastrointestinal drugs, among others. A well-attended conference call was held before market open, which will be archived on the company’s web site for 30 days.

Reasonable people may disagree whether this is the long hoped-for partnership with Big Pharma by one of the three small-pharma obesity drug developers, ARNA, Vivus Inc. (VVUS) and Orexigen Therapeutics (OREX), all of whom have drug candidates up for FDA review and approval within the next 6 months. While I personally would think of the top dozen or so companies by worldwide revenues when people say "Big Pharma" — Pfizer (PFE) , GlaxoSmithKline (GSK), Roche et al. — Eisai is certainly in or close to the top 20, depending on who’s counting and over what period, and a muscular partner.

Complete Story »

“He’s done some things that have generated controversy,” Michael G. King Jr., a biotechnology analyst at Wedbush Securities, tells the New York Times‘ Andrew Pollack. “But at the end of the day, (Abraxane) is a good product.”

AstraZeneca, of course, took a shot and failed at making a big success of the cancer drug. But Celgene has had considerable success with Revlimid, and clearly feels that it can do a better job at selling the solid-tumor drug than Abraxis has managed on its own. Soon-Shiong, in the meantime, can add one more successful deal to a blockbuster resume.

- here’s the story from the New York Times

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Read the original here
Abraxis’ billionaire chief is adding to his blockbuster bank account

There have been accusations that some whistleblowers are only in it for the money (see this), but life as a whistleblower has its challenges (see here). And so concerned that the pharmaceutical industry may not be doing enough to educate employees about whistleblowing protection, US Senator Chuck Grassley has written 16 big drugmakers to provide information about their programs.

The letters went to Abbott Labs, Amgen, AstraZeneca, Bristol-Myers Squibb, Eisai, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Hoffmann-La Roche, Johnson & Johnson, Merck, Novartis, Pfizer, Sanofi-Aventis, Takeda Pharmaceuticals and Boehringer Ingelheim.

The drug is designed to increase testosterone levels in women, which are typically reduced as they take traditional oral contraceptives now on the market. Changes in estrogen and progestogen levels attributed to contraceptive pills have been linked to reduced levels of sexual activity, arousability and a greater frequency of rejecting a partner’s initiation of sexual activity.

BioSante also is studying a testosterone gel to improve the female libido, an area of drug development that has been put in the spotlight as FDA experts reviewed, and rejected, the new drug flibanserin.

- here’s the story from Reuters

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Oral contraceptive a success in Phase II

Read the original here
BioSante shares surge on promising contraceptive drug data

Bind Biosciences has appointed Ed Schnipper as chief medical officer. Release

Michael Tremblay has been appointed president of the Canadian subsidiary of Astellas Pharma. His predecessor, Fumiaki Sakurai, will return to Japan to assume a new role in the company’s Asia International Division. Release

David Price, executive VP and CFO at Cornerstone Therapeutics, is leaving the company. He will assume the CFO position at another company.  Release

Cleveland BioLabs has appointed Michael Paterno as director of clinical operations. Release

Avrio Biopharmaceuticals has named David Gelber as the director of manufacturing. Release

Peter Strumph has joined Codexis as senior VP, commercial operations, a new position. Release

Clinuvel Pharmaceuticals has announced that Stan McLiesh will assume the role of non-executive chairman of Clinuvel. In addition, Brenda Shanahan will preside over the audit and risk committee. Release

PharmaGap has appointed Ian Malone to its board of directors. Malone has extensive finance and biotech industry experience and will bring key insights to the board of PharmaGap as it proceeds toward clinical trials and out-licensing of its lead cancer drug GAP-107B8. Release

Read more here
Noxxon’s Morich to leave in August

In reaching his decision, US District Court Judge Joseph Farnan ruled that the generic drugmakers, a group that included Apotex, Aurobindo Pharma, Cobalt Laboratories, Mylan Laboratories, Par Pharmaceuticals, Sandoz, Sun Pharmaceuticals and Teva Pharmaceuticals, failed to prove the AstraZeneca patent was invalid because it was an obvious invention. He also decided Apotex may be held liable for infringing the patent (read the ruling).

In an investor note, Sanford Bernstein analyst Tim Anderson writes that “most in the investment community felt AstraZeneca would very likely win, but given how devastating a loss would/could have been, actually securing a favorable ruling removes an overhang.” He adds that Crestor has benefited from the Vytorin debacle in 2008, but after Pfizer’ Lipitor loses patent protection in November 2011, “we think the product will likely slow.” AstraZeneca stock rose nearly 10 percent on the news.

Eli Lilly (LLY) discovers, develops, manufactures, and sells products in one business segment, pharmaceutical products. The Company also has an animal health business segment. It manufactures and distributes its products through facilities in the United States, Puerto Rico, and 17 other countries. Its products are sold in approximately 128 countries. The Company’s products include Neuroscience products, Endocrinology products, Oncology products, Cardiovascular products, Animal health products, and other pharmaceuticals. In the United States, Eli Lilly and Company distributes pharmaceutical products principally through independent wholesale distributors, with some sales directly to pharmacies.

Last Price – 34.02
52 Week High – 38.00
52 Week Low – 32.02

Complete Story »

Recent accomplishments for Avanir (AVNR) marked the most exciting quarter in the history of the company, and it is highly likely that big news is on the near-term horizon. Avanir’s share price closed at $2.67, a gross undervaluation, in Friday’s trading session. I expect Avanir’s share price to easily double prior to October when the FDA is expected to approve its key drug, Zenvia. And the stock price should easily reach $10 per share by early 2011, the expected launch time of Zenvia. The details of my analysis will be presented later in this article, but first, I will address the key drivers that make Avanir a compelling “buy and buy more” proposition:

1. Patent protection – The Company received long-term (15 year) patent protection on Zenvia, securing its monopoly on Zenvia for years to come.
2. Extremely Positive Data – Avanir provided extremely positive safety and efficacy data at the American Academy of Neurology meeting and American Psychiatric Association meeting. They also showed tolerability with common drugs Paroxetine (a common antidepressant) and Memantine, a drug Merz +Co and Forest Labs (FRX) market for ALS patients. Commenting on the AAN meeting, Keith Katkin, CEO of Avanir, states "…the physician interest level in PBA is significant and reinforces our belief there is a large unmet medical need". As a Merriman Analyst commented, "Avanir Pharmaceuticals is advancing its lead product, Zenvia, for the unique indication of pseudobulbar affect, a hitherto little-known neurological condition that may affect millions of individuals…In our view, the Phase III STAR trial data are compelling…” Evidence of the excitement about Zenvia is apparent when looking at the stock price action after the Jeffries & Company (JEF) Health Sciences presentation by Avanir on June 8. The stock price had greater than a 25% upward move in a matter of a few days. Also notable is the trading volume in the $5.00 December calls. And furthermore, Avanir boasts institutional holders such as Blackrock, which is one of the most respected hedge funds on the street.
3. Early start on marketing/awareness efforts- Awareness of PBA is growing and the management team is diligently preparing for commercial launch. Top talent Michael McFadden was hired. Mr. McFadden previously managed markets at Amylin Pharmaceuticals (AMLN). When asked by an analyst of upcoming events prior to approval, Keith Katkin responded, "…you’ll see PBA awareness advertorials within all of the medical journals. You’ll also see them in the patient-focused journals…"Also, Avanir will attend "a dozen" different neurology and psychiatry meetings. Also, quite noteworthy is that AVNR partnered with ITV and PBS and will be airing a series on PBS stations (estimated late-June to early July) about the impact of PBA on patients’ lives. Cannacord Adams analyst comments “AAN doctor opinion on Zenvia has been positive; we think that Zenvia will see good patient and doctor acceptance…”
4. Raised Capital – Debt-freeAvanir raised over $26 million through a recent stock offering such that Christine Ocampo, CFO of Avanir, stated "we expect our current cash on hand will be adequate to fund continuing operations and the clinical development of Zenvia through the anticipated FDA approval decision date…"
5. FDA Submission – The Company provided the FDA with all data needed to assess Zenvia in PBA. Approval is extremely likely as Zeniva’s two major components are not new molecular entities and the response letter submitted was solid. After reviewing the submission, Cannacord analyst commented “…any delay would be minor and not reflect negatively on Zenvia’s approvability or sales potential.” Investors will remember Dendreon’s (DNDN) situation after receiving an approvable letter from the FDA, its engagement in subsequent studies, and ultimately approval which turned a $4 stock into one that now trades above $37.

Let’s examine a price/sales multiple. Cantor Fitzgerald estimates $675 million in peak sales for Zenvia, ramping up and seeing those peak sales in 2015. Personally, I think the estimate is a bit conservative when one factors the indefinite prescribed period and the other applications of Zenvia that should be approved following the PBA approval. But, let’s go with Cantor’s sales estimate. Although there is wide variation in price/sales ratios, the average biotech trades at 3 times peak sales. Since Avanir has rights to the drug longer than most drug companies (15 years), it could reach much higher multiples. But, even using a more conservative estimate of half that figure (1.5 times price/sales), the market cap of Avanir should be over $1 billion. That’s approximately $10 per share, indeed compelling with a potential upside of over 400%! And for more short-minded investors, there are two near-term catalysts:

1. A Barron’s article this weekend mentions that 9 pharma companies (Pfizer: PFE, Merck: MRK, Eli Lilly: LLY, Bristol Myers: BMY, Novartis: NVS, Roche: RHHBY.PK, AstraZeneca: AZN, Sanofi-Aventis: SNY, and Glaxo Smith Kline: GSK) are undervalued and could rally 30%, and
2. There should be a nice run prior to FDA acceptance, easily pushing the stock to $6. I’ve taken a sizable position and am quite ready to enjoy the ride!

Disclosure: Long AVNR, DNDN, PFE

Complete Story »

Anthera’s market cap of $150 million reflects the risk embedded in its drug. If GSK’s darapladib does well, I would expect investors to warm up to Anthera’s A-002.

Disclosure: No Position

Complete Story »

The majority of Gilead’s $120 million will come as an upfront payment, with the remainder based on clinical development of drug targets. The deal is expected to close in the third quarter of the year. CGI will continue operations in Branford as a wholly-owned subsidiary of Gilead.

“The acquisition of CGI represents a unique opportunity to expand our research efforts in an interesting and promising area of drug discovery,” says Norbert Bischofberger, Gilead’s CSO, in a statement. “CGI has established itself in the area of protein kinase biology and small molecule discovery, and the company’s scientific leadership and expertise represents a strong strategic fit with Gilead’s existing research organization. We look forward to advancing compounds in CGI’s portfolio toward clinical development.”

- here’s Gilead’s release

ALSO: Gilead is closing R&D operations in Durham, NC, taking with it 150 local jobs. The drugmaker is consolidating its hepatitis research in Foster City, CA; that research is currently split between the two sites. In addition the layoffs, 30 Durham-based employees will be offered positions at the Foster City headquarters. Article

Related Aricles:
Gilead inks $1.4B buyout deal for CV Therapeutics
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Gilead doubles jobs, space to boost development
Safety concerns force Gilead to halt mid-stage hep C trial

Read the original here
Gilead to buy CGI Pharm for $120M

Nereus, which is developing therapies derived from marine microbes, recruited 170 patients for its international trial of plinabulin (NPI-2358), which it describes as a tumor selective vascular disrupting agent. “Preliminary data on the primary efficacy endpoint of survival are encouraging and continue to mature,” Nereus said in a release. Nereus’ second drug candidate, marizomib (NPI-0052), is a second-generation inhibitor of the 20S proteasome. Nereus reported a $45 million D-2 round in 2007.

“Nereus has made significant clinical progress with its anti-cancer agents, plinabulin and marizomib, two highly differentiated product candidates that are progressing nicely through mid-stage clinical trials towards pivotal studies,” said Matthew A. Spear, M.D., Chief Medical Officer of Nereus Pharmaceuticals, Inc.  ”There is significant momentum behind our programs, fueled by enthusiasm from some of the top cancer experts from around the world.”

- check out the Nereus release for more data

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Read more from the original source
Nereus attracts $20M round for cancer drug programs

Phytopharm has appointed Tim Sharpington as CEO and board director. Release

Jennerex has announced the appointment of Gregory Schafer as senior VP and CFO. Release

Farouk Dakhil has been named Xytos’ new chief scientific officer and the head of its scientific advisory board. Release

BrainStorm Cell Therapeutics has named Liat Sossover as its CFO. Release

Spectrum Pharmaceuticals has appointed James Shields to the position of senior VP and chief commercial officer. Release

Jessica Mann will resign as chief medical officer of Evolva and join Roche as head of translational medicine. Release

Spencer Pharmaceutical has announced that Max Arella will be president and chairman of the company. Release

Bausch + Lomb has appointed Rodney Unsworth as president, Asia-Pacific, effective July 1. Release

Ariad Pharmaceuticals has tapped Timothy Clackson as its first president of R&D. Release

NexMed has appointed Deirdre Gillespie, president and CEO of La Jolla Pharmaceutical Company, to its board. Release 

International Stem Cell Corporation has announced that Charles Casamento has been elected to the board of directors. Release

Jack Wyszomierski has been elected to Athersys’ board of directors. Jordan Davis and William Mulligan did not stand for re-election. Release

ZymoGenetics has announced that Novo Nordisk’s Lars Fruergaard Jørgensen was elected to the company’s board of directors. He replaces Lars Rebien Sørensen, a previous Novo Nordisk representative, who resigned from the board in March. Release

Idera Pharmaceuticals has elected Eve Slater to its board. Release

Read more from the original source
Claudio Albrecht to become Actavis CEO

We begin by reviewing background information about Watson and the business environment in which it is currently operating.

Complete Story »

Once the initial round of Phase III data arrives in the first half of next year, OMJ has the right to take over full control of the remaining trial work. Diamyd is hanging on to the commercialization rights in the Nordic countries.

“This agreement will allow Diamyd to expand and become a significant player as a specialty pharma company in the Nordic region, but most importantly it should make this transformational beta cell preserving therapy available to patients around the world,” says CEO Elisabeth Lindner.

Diamyd’s GAD65 antigen-based therapy is designed to prevent the autoimmune assault on beta cells, preventing the damage that causes Type 1 diabetes. A Phase II study of 70 children and adolescents with Type 1 diabetes demonstrated that the therapy significantly slowed the progression of the disease in newly-diagnosed subjects.

Hayward, CA-based Metabolex, meanwhile, signed on to a discovery deal with OMJ covering  the rights to several preclinical Type 2 diabetes programs. Metabolex gets an upfront and milestones that could total $330 million along with royalties on any approved drugs.

- see the release on the Diamyd deal
- check out the Metabolex release

Read more here
Ortho-McNeil inks twin diabetes pacts totaling $1B

Incline is developing Ionsys, a needle-free delivery device for opioid meds that was originally advanced by Johnson & Johnson. Approved by the FDA four years ago, Ionsys was never marketed and Incline is adding new patient safety features to the technology.

“We believe that this agreement provides Cadence with the opportunity to build our pipeline and strengthen our franchise in the hospital market, while effectively managing our cash,” said Ted Schroeder, the CEO of Cadence.  ”This transaction is consistent with our long-standing strategy to focus on products for use in the hospital that we believe have a clear clinical and regulatory path to approval.” Cadence also announced a $30 million secured loan facility with Oxford Finance Corporation, Silicon Valley Bank and GE Financial Services.

The startup is being bankrolled by a long list of venture groups: Frazier Healthcare, 5AM Ventures, Technology Partners, Adams Street Partners, Saints Capital Partners, and Emergent Medical Partners.

- check out the Cadence release
- here’s the story from the San Francisco Business Times

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Read more here
Pain startup lands $43M round, option to sell for up to $228M

Billed as the largest microRNA partnership yet formed, Sanofi and Regulus will collaborate on four microRNA targets, focusing on fibrosis. And the package includes Regulus’s lead microRNA program for fibrosis. Sanofi will also provide R&D support for the program.

“MicroRNAs are believed to be extremely important in human development and physiology,” said Sanofi R&D chief Marc Cluzel. “Together with Regulus we will develop therapeutics which could potentially open a new paradigm in the treatment of major diseases and could offer an attractive new therapeutic approach for patients.”

Regulus, a 2008 Fierce 15 company, came out of the gate with strong backing and an earnest desire to strike major pharma partnerships at a very early stage. Soon after it was launched in 2007, the developer inked a $600 million deal with GlaxoSmithKline. MicroRNA is believed to regulate the expression of about a third of all genes, offering a new approach to treating diseases.

- here’s the release from Regulus
- check out the Dow Jones story

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Regulus Therapeutics – 2008 Fierce 15

Read more from the original source
Regulus pairs with Sanofi in $750M microRNA pact

Today, however, the drugmaker has begun marketing yet another statin for controlling cholesterol, which it calls Livalo. This is a big market, of course, with statins ringing up some $13 billion in sales last year. But do patients really need another one? Lilly, which actually licensed the pill from Kowa Pharmaceuticals, hopes Livalo will be distinguished from the pack because it’s metabolized differently than most statins, which could reduce unwanted interactions with other drugs.

“While there are some very good medicines in this category today, based on the number of patients who are untreated and who fail to stay on therapy tells us there is a good opportunity here,” Lechleiter tells The Indianapolis Star in an advance interview.

Maybe so, but as Miller Tabak analyst Les Funtleyder tells the paper: “I think it’s going to take a lot of work to interest physicians in a new statin. It’s going to have to work much better, or be much cheaper, or have fewer side effects than anything else on the market.” Adds Hilliard Lyons analyst Steve O’Neill: “The space for cholesterol drugs is extremely crowded. That’s just a simple fact.” Lilly hopes pricing will help – at $3.30 a tablet wholesale, Livalo will be 15 percent cheaper than Crestor.

Like its rivals, Lilly faces a huge dropoff in revenue as big sellers lose patent protection, but its situation is more precarious than others. Matters are not helped by the poor performance of its new Effiant bloodthinner. So Lilly, which recently overhauled its R&D operation, can hardly be blamed for pursuing a tactic that may help weather the storm. In fact, while Lilly has never been known for cardiovascular drugs, Lechleiter says more cholesterol-fighting research may be pursued as a way out of its mess. Whatever works, as they say. It is ironic, though, that a drugmaker that regularly describes itself as an “innovation-driven company” and whose ceo harps on that theme is forced to rely on a variation of the ‘me-too’ approach to try to get by.

Read more here
GW prices Sativex for MS pain

This post describes our model of King Pharmaceuticals‘ (NYSE: KG) Income Statement for the second quarter of 2010, which will end on 30 June.

Complete Story »

GW had hoped to get an approval in Britain back in 2003 but faced a long series of regulatory hurdles in its quest. Up until now GW has had to content itself with a 2005 approval in Canada. But Europe appears to be opening up. GW says that Spain appears ready to hand out an approval soon and other European nations are likely to follow suit. GW and Bayer–which now owes GW a $15 million milestone payment–will market the drug in the UK with Almirall taking the reins in Spain. The approval helped buoy GW’s shares by about eight percent, according to Reuters, which broke the news.

An even bigger market could be opened up if GW wins an approval to use Sativex to treat cancer pain. Analysts say that a European approval for MS on top of the Canadian market would generate about 121 million pounds in annual sales while a cancer approval on the continent would be worth close to $500 million a year in sales.

GW has focused on the cancer pain indication for its application to the FDA. In March the developer announced positive Phase IIb cancer pain data with its U.S. partner Otsuka. Researchers are planning a Phase III trial for cancer pain.

- here’s the story from Reuters

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Bad trial design faulted for GW’s Phase III failure
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Read more here
GW Pharma’s cannabis drug Sativex wins landmark approval

The Redwood City, CA-based OncoMed also stands to earn double-digit royalties on any approved therapies, making this a foundation partnership to build a much bigger biotech company on–if it’s successful. For Bayer, which already markets Nexavar and has late-stage drugs in development, the OncoMed programs represent an early-stage generation of promising oncology drugs to feed into the pipeline.

“The development of anti-cancer stem cell therapeutics together with OncoMed is a highly innovative approach with the potential to perfectly complement our oncology portfolio,” said Prof. Andreas Busch, head of Global Drug Discovery at Bayer. “Anti-cancer stem cell research could turn out as one of the missing pieces in today’s cancer therapy.”

Bayer will take over the development of any therapy that it options from OncoMed. The agreement also contains “provisions under which OncoMed may co-develop biologic therapeutics with Bayer. The collaboration includes for example OncoMed’s lead Wnt pathway antibody, OMP-18R5, which is intended to enter clinical testing in 2011.”

- take a look at OncoMed’s release
- here’s the story from Bloomberg

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Read more from the original source
OncoMed scores big cancer development pact with Bayer

Recently Alkermes Inc. (ALKS), Amylin Pharmaceuticals Inc. (AMLN) and Eli Lilly & Co. (LLY), the co-developers of type II diabetes candidate Bydureon (exenatide once weekly), announced mixed results from one of several studies conducted to evaluate the superiority of the candidate over other type II diabetes therapies.

The 26-week study (n=820), known as DURATION-4, compared the efficacy of Bydureon, a glucagon-like peptide-1 (GLP-1) molecule, as a monotherapy treatment against Merck’s (MRK) Januvia (sitagliptin), Takeda’s Actos (pioglitazone hydrochloride) and metformin.

Complete Story »

In the study, patients taking Bydureon demonstrated a 1.5 percent drop in blood sugar, or A1C, slightly better than Januvia but only on par with the generic metformin and Takeda’s Actos. Analysts weren’t impressed, noting that the once-weekly version of Byetta has to distinguish itself in a crowded field in order to compete. Amylin’s shares slid about four percent on the news. A spokesperson for the company says that the trial results will not be submitted to the FDA as part of its application for approval.

“Our conclusion is that Duration-4 may do more to reinforce generic metformin as the front-line diabetes drug of choice than to support asking for broad front-line use of Bydureon,” noted Robert W. Baird analyst Thomas Russo. Some analysts, though, say they are waiting for upcoming data on the drug’s cardiovascular benefits before determining its true market potential.

“The real key to actual expanded use of Bydureon is and still remains the demonstration of a cardiovascular outcomes benefit,” Thomas Wei, an analyst with Jefferies & Co., told the San Diego Union-Tribune. “If positive, Bydureon could be the first drug to demonstrate a reduction in cardiovascular events in diabetics, which we suspect would change the way the GLP-1 class is used.”

- check out Amylin’s release
- read the story from the San Diego Union-Tribune
- here’s the report from Reuters

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Regulator notes potential cancer risk for weekly Byetta
Rival developers race to grab Type 2 diabetes market
FDA delays Amylin’s Byetta LAR

Read more here
Amylin’s Bydureon fails to impress in head-to-head trial

“Given the higher than usual placebo response, TRU-015 did not meet the internal hurdle for continued development,” said Scott C. Stromatt, M.D., senior vice president and chief medical officer at Trubion. “It is evident that the drug has significant biological and clinical activity with no significant safety concerns, but market dynamics dictate that we pursue a differentiated and best-in-class product to bring into Phase III development.” 

Pfizer hasn’t forsaken Trubion altogether though. The two will continue to collaborate on SBI-087, another CD20 drug which has been touted as an even better program that TRU-015. Trubion’s shares slid 11 percent yesterday afternoon.

- here’s the press release
- here’s the story from Reuters

Read the original here
Trubion slumps after Pfizer kills lead RA drug program

Titan Pharmaceuticals (TTNP.OB) is a company and a ‘Stock to Watch’ this week after shares closed over ten percent to the upside on Monday, most likely in anticipation of a decision by the United States Patent and Trademark Office that is expected to be rendered on Tuesday, June 15th regarding Titan’s Probuphine patent.

Any extended patent life for Probuphine would significantly boost the value and future potential of Titan Pharmaceuticals, a company already reaping the 8-10% royalty rewards from the Fanapt licensing agreement. Titan has also been awarded a grant from the National Institutes of Health to cover up to $8 million of the cost of the Probuphine confirmatory Phase III trial.

Complete Story »

Try as they might, Bayer (BAYRY.PK) and Onyx Pharmaceuticals (ONXX) have been struggling for some time to prove that Nexavar has a role beyond liver and kidney cancer. Therefore news that the drug has failed in a second phase III lung cancer study is hardly encouraging.

Despite these two failed trials, executives at Onyx Pharmaceuticals struck an upbeat note on a conference call Monday, pointing to upcoming data in breast cancer and another lung cancer trial in a different setting, and expressing confidence that additional tumor types are within the kinase inhibitor’s grasp. However, with Onyx having invested heavily in this quest, at the expense of profitability, good news is needed to restore some flagging confidence (Onyx needs to find Nexavar growth as another quarter disappoints, April 30, 2010).

Complete Story »

Regeneron’s (REGN) Phase 3 study in gout patients initiating allopurinol therapy to lower their uric acid levels showed that the company’s drug Arcalyst (rilonacept), known as IL-1 Trap, prevented gout attacks, as measured by the primary endpoint of the number of gout flares per patient over the 16 week treatment period.

Is this good or bad news?

Complete Story »

Igenica, a cancer antibody start-up based in Burlingame, CA, is reporting that it raised $24 million in a Series B. The new round was led by The Column Group, OrbiMed Advisors and 5AM Ventures.

Launched a little more than a year ago, Igenica says it uses two technology platforms to generate tumor antigens and antibody candidates for cancer. “Igenica’s technology is ideally positioned to develop cancer antibodies that will function as first-in-class and best-in-class therapeutics on their own or in combination with current treatments,” said David V. Goeddel, PhD, managing partner at The Column Group and chairman of the board of Igenica.

San Diego-based Otonomy tells Xconomy that Avalon Ventures has converted a $10.5 million loan into an equity stake in the biotech, which is focused on hearing loss treatments and other diseases related to the ear. Otonomy says the first round is likely to expand significantly as it brings in new investors. CEO Jay Lichter, a venture capitalist, was inspired to start the company after experiencing a bout of Meniere’s disease, which causes dizziness.

And Quark Pharmaceuticals in Fremont, CA says it raised $10 million from Japan’s SBI Holdings to back its work in RNAi. “We are pleased to close our latest financing round and remain well-capitalized to advance our promising siRNA drug candidates through the clinic,” says CEO Daniel Zurr.

- check out the release on Igenica
- here’s the story from Xconomy
- take a look at the Quark release

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Read the original here
Igenica leads a trio of new venture rounds

Immunovaccine has tapped Keith Abriel as acting CFO. Abriel will fulfill the role until a permanent appointment is made. Release

Ikaria has announced that Geoffrey Nichol has been appointed chief medical officer. Nichol will be responsible for activities related to late-stage drug development. Release

Laurent Audoly has joined Pieris as chief scientific officer, effective immediately. Release

Biocodex USA has announced that Rajesh Gupta has joined the company in the newly-created position of director of medical & scientific affairs. Release

Gilead Sciences has announced that John McHutchison will join the company as senior VP, Liver Disease Therapeutics. Release

Genzyme’s nominating and corporate governance committee of its board of directors has nominated Dennis Fenton for election to the board. He was executive VP of operations at Amgen when he retired from the company in 2008. Release

Jazz Pharmaceuticals has appointed Paul Berns to the company’s board of directors. Release

StemCells has named R. Scott Greer to its board of directors. Release

Rexahn Pharmaceuticals has hired Frederick Frank, the current vice-chairman of Peter J. Solomon Co (PJSC), to advise on a range of corporate activities. Release

Oragenics has announced that Frederick Telling and Charles Pope have formally joined the company’s board of directors. Release

Dr. Inder Kaul has joined Asiatic Clinical Research as an independent director. Release

Read more from the original source
Unigene names president, CEO

On March 18, 2010, Somaxon Pharmaxeuticals (SOMX) was granted FDA approval to sell Silenor 3 and 6 mg. tablets for the treatment of insomnia characterized by difficulty with sleep maintenance. This approval was met with a stock price move from 4 to 10 dollars. Shares were only 30 cents just one year earlier. The stock has lost half its value since the day after FDA approval to just above 5 dollars. Can the stock rebound or will the price continue to drop?

Silenor is a unique dose of the compound doxepin (Sinequan) which is available as a generic in 10, 25, 50, 75, 100 and 150 mg capsules and a 10 mg/ml concentrate liquid. Silenor’s mechanism of action is likely due to histamine blocking. This is a different mechanism from Ambien (Sanofi-Aventis (SNY)), Lunesta (Sepracor (SEPR)) and Sonata (King Pharmaceuticals (KG)) which work through the GABAalpha1 receptor or from Rozerem (Takeda Pharmaceuticals (TKPHF.PK)) that works through the melatonin receptor.

Complete Story »

Javelin Pharmaceuticals (JAV) is a specialty pharmaceutical company with a focus in the pain management market. Their primary technical innovations are improved formulations of existing drugs. Javelin has one marketed product – Dyloject – in the UK. In the US, it has submitted a New Drug Application (NDA) for Dyloject and has two drug candidates in Phase III clinical development: Ereska (intranasal ketamine) and Rylomine (intranasal morphine).

Its stock price has been in wild swings in the last several months because of its involvement in two M/A activities. Late last December, Myriad Pharmaceuticals (MYRX) entered into an agreement to merger with Javelin. But in April shortly before the closing date, Javelin struck a better deal with Hospira (HSP) for an all-cash acquisition of $2.20 per share (~$145M in value with a ~60% premium over its closing price). However, things are not all rosy from there for Javelin share holders. On May 19th, Hospira announced that it is extending the tender offer for another 2 weeks because certain conditions were not fully satisfied prior to the expiration of the initial offering period. Understandably, Javelin’s stock price dropped ~40% at the start of the day. But that’s not all; five days later, Javelin announced that its UK partner, Therabel Pharma which licensed the commercial rights to Dyloject in the European Union, is withdrawing the product from the UK market because of the presence of a white particulate matter in some vials of Dyloject in its supply chain. It appears to be a bigger blow to Javelin and its stock price dropped to as low as $1.15, but it soon bounced back to as high as $1.77 the day before the deadline of the extended tender offer.

Complete Story »

The new money arrived a day after the FDA announced that an expert panel will review Arena’s lorcaserin on September 16, a little more than a month before its October 22 PDUFA date. The same committee will gather on July 15 to review Qnexa, which was developed by VIVUS. And just on Tuesday the FDA accepted the NDA for Orexigen’s Contrave. So far, no review date has been set for Contrave.

Their race to gain an approval has been one of the most closely watched in the biotech industry, with analysts eager to see how the developers fare with regulators in one of the most perplexing fields in the industry. Weight drugs have been bedeviled by safety problems, which may be holding Big Pharma companies back from doing licensing pacts on late-stage drugs.

“We are committed to ensuring that Arena is well capitalized as it evaluates collaborative opportunities to commercialize lorcaserin,” commented James E. Flynn, a general partner for Deerfield Management. 

Without a pharma partner with deep marketing pockets, it’s hard to see how a weight drug could reach anything like its full market potential.

- check out Arena’s release on the Deerfield deal
- here’s a story from Reuters

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Read more here
Arena Pharma lands $35M investor as it jockeys obesity drug

As expected, and as management discussed as a possibility a few weeks ago on the Q1 conference call, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review Arena Pharmaceuticals (ARNA)’s weight-loss drug candidate lorcaserin at its already scheduled Sept. 16 meeting. We rate this news as good.

In the small-cap world, it is always especially reassuring when outside agencies behave as management expects them to. While lorcaserin’s cardiovascular safety has been extensively studied and independently reviewed, we still were never in the camp that believed that this might give lorcaserin some sort of free pass to FDA approval with no further review. The PDUFA (approval decision) date for lorcaserin is in late October.

Complete Story »

Alexion (ALXN) got some good news yesterday, receiving earlier than expected approval for its drug, Soliris (eculizumab), for the treatment of PNH in Japan – the world’s second largest pharmaceuticals market. Having received approval from the FDA and the European Commission only in 2007, Soliris has rocketed to expected 2010 sales of over $500 Million. Alexion has been profitable since the second quarter 2008; that speaks highly to a disciplined management team and quality of Alexion’s sales efforts.

What is Soliris?

Complete Story »

Teva’s (TEVA) at-risk launch of generic versions of the contraceptive Yaz is set to send the Israeli company to the US courts as Bayer seeks to preserve sales of its best-selling franchise. Whilst Teva is accustomed to spending time in the courts, what surprised some industry observers is that it had already signed a deal with the German company agreeing to hold off launch until July 1, 2011.

But Teva has its own sales to think of. A 30-month stay against Watson Pharmaceuticals’ (WPI) own application for its Yaz copycat (drospirenone and ethinyl estradiol) expired in May, and an at-risk launch was necessary for Teva to reach the market first with a low-cost generic. The early launch, not expected by some analysts, could see consensus sales forecasts coming down by €200m ($244.5m) in 2010 and 2011, according to analysts from JP Morgan Cazenove.

Complete Story »

Read the original here
Orexo inks $585M drug pact with J&J

Rigel Pharmaceuticals has named Raul Rodriguez as president and promoted Ryan Maynard and Dolly Vance to executive VPs. Release

Amylin Pharmaceuticals appoints Christian Weyer, senior VP, R&D and named Orville Kolterman as senior VP, chief medical officer.

Ikaria has tapped Douglas Greene as executive VP of R&D. Release

PharmaGap has announced the appointment of the appointment of Kenneth Sokoll,  to the company’s clinical development group.  Release

Alnylam Pharmaceuticals has named Laurence Reid as senior VP, chief business officer, and Kenneth Koblan, as VP, distinguished Alnylam Fellow. Release

Xytos has appointed John Trotter II as the company’s new chief medical officer. Release

Genstruct has appointed David de Graaf as its chief scientific officer. Release

Alexion Pharmaceuticals has announced the appointment of Ann Veneman to the company’s board of directors. Release

Read the original here
Theratechnologies’ Yves Rosconi to retire

Originally launched under the leadership of Third Rock Ventures’ Mark Levin with additional funds from The Column Group, Venrock, and Altitude Life Science Ventures, Constellation’s Series B was led by SR One, the high-profile venture arm of GlaxoSmithKline. And it brings their total venture haul to $54 million, says CEO Mark Goldsmith, M.D., Ph.D., who has shepherded the rapid buildup of the company’s sizable scientific staff.

Goldsmith isn’t laying out much by way of a development timeline. The Cambridge, MA-based developer expects to identify at least one clinical development candidate in 2011, Goldsmith tells FierceBiotech, and there’s enough money to significantly advance work on three lead programs. But any development timeline will be influenced by the compounds it chooses to focus on and the overall state of affairs at the company. And epigenetics can play a role in a broad range of diseases, including cancer, inflammation and immune ailments.

“We’re not focusing on a single class or a small number of targets,” explains Goldsmith, who’s focused on developing the company’s “broad-based capability” in fine tuning how DNA can influence disease. But with a staff of 50–large for a biotech still at the preclinical stage of development–Goldsmith has some definite ideas on pursuing collaborations sooner rather than later.

Partnering is “the next step,” he says. The extra money will help finance the company’s development and acts as “a way of demonstrating that others with expertise in drug discovery and development believe that what we have is special and high value.”

- here’s the Constellation release

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Read the original here
Constellation banks $22M for ambitious epigenetics play

Better than expected results were announced from a phase 3 randomized, double-blind, placebo-controlled ADVANCE study with Vertex’ (VRTX) hepatitis C drug telaprevir. Around 1,095 patients suffering from the genotype 1 chronic hepatitis C virus took telaprevir, which has tremendously increased the cure rate at record treatment duration. Many liver experts considered this news a historical advancement in the management of progressive disabling, life-threatening and sometimes deadly chronic hepatitis C viral infection. First, the drug deals directly with the virus and, second, it wipes it out in a short limited time. The good news will be hailed by 3 millions people infected with the virus in the U.S. and by 170 million worldwide if they hear the news.

Telaprevir’s trial results demonstrate that 75% of chronically infected patients with genotype 1 hepatitis C virus (HCV) who had not previously been treated achieved a sustained viral response (SVR or viral cure) after receiving a 12-week telaprevir-based combination regimen followed by the conventional drugs pegylated-interferon and ribavirin. A slightly smaller number, 69%, of patients, achieved the same results after an 8-week treatment with the same regimen. On the control arm, where the conventional treatments pegylated-interferon and ribavirin were given alone without telaprevir, only 44% achieved viral cure, but only after 48 weeks duration, i.e., four times the treatment duration with telaprevir. These results are better than scientists’ expectations, including those responsible for developing the drug.

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Due to activity on May 14th, 2010, Steven Cohen’s hedge fund firm SAC Capital has disclosed a new position in XenoPort (XNPT). As per a 13G filed with the SEC, SAC Capital shows a 6.0% ownership stake in the company with 1,819,228 shares. Again, this is a new position for the fund as it did not show ownership in its previous portfolio disclosure as of March 31st, 2010.

Please also keep in mind that SAC is a trading oriented firm and moves in and out of positions much quicker than the fundamental hedge funds we typically track. Of the prominent hedge funds we cover, we’ve only seen one other firm previously own shares of XNPT. Lee Ainslie’s firm had a position in XenoPort, but Maverick Capital just sold out in the first quarter. Regarding other recent portfolio activity from Steven Cohen’s firm, we saw that it raised its stake in Inspire Pharma (ISPH) and updated its position in The Talbots (TLB).

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After a safety scare last year, Anadys Pharmaceuticals’ (ANDS) trials of its hepatitis C candidate ANA598 appear to be back on track with a series of positive interim results in phase II trials (Anadys’ bubble burst by lack of partner, June 5, 2009). The burning issue for the California firm, however, is its urgent need to partner the drug before it runs out of cash.

With the aim of cutting its cash burn by $4m-$5m last summer, Anadys went through a restructuring that involved trimming its workforce by 40% and suspending work on a second hep C candidate, ANA773. But it remains a company with just $15.5m in cash at the end of March and a burn rate of $4m-$5m per quarter, meaning phase III will not happen without a partner or new investment.

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Watson Pharmaceuticals, Inc. (NYSE: WPI) earned $0.57 per share on a GAAP basis in 2010′s first quarter, which ended 31 March. Reported earnings were 36 percent more than the $0.42 per share Watson made in the same quarter of 2009.

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While the markets are crashing, it’s a good time to add to medium term catalyst trades. One name I am looking at is Avanir Pharmaceuticals (ticker: AVNR).

The company’s lead Phase III candidate, Zenvia, is a drug targeting Pseudobulbar Affect (PBA) and according to the company, targets an underserved market of up to 2 million patients where there is currently no approved therapies (i.e. “no competition”). In 2006, the FDA issued the company an Approvable Letter, and following discussions with the FDA, AVNR agreed to conduct a confirmatory Phase III trail under an SPA for Zenvia. In August 2009, the company finally reported solid top-line data to address these FDA concerns. AVNR recently stated that they expect an FDA decision on Zenvia by October 30, 2010.

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By Michael Fitzhugh

Astellas Pharma (ALPMF.PK), Japan’s second-largest drugmaker, is paying $4 billion for OSI Pharmecuticals (OSIP) and its profitable cancer medicine, Tarceva. The pricey victory is a triple-win for Astellas, likely to bolster its revenue, geographic base, and pipeline.

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King Pharmaceuticals, Inc. (NYSE: KG) earned $0.02 per diluted share on a GAAP basis in the 2010′s first quarter, which improved on a loss of $0.04 per share in the same quarter of 2009. Non-GAAP "adjusted" earnings fell from $0.26 to $0.14 per share.

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In its November 2009 complaint, Teva charged that Sanofi’s communications with doctors and pharmacists emphasized differences between Plavix and generics, including Teva’s 75mg version, without revealing the differences. However, Sanofi failed to say the differences have no therapeutic significance or effect on safety or efficacy (see the statement).

Sanofi’s communications with scientists and practitioners emphasised differences between Plavix and competing generics, including Teva’s clopidogrel 75 mg, without revealing that these differences have no impact on the therapeutic efficacy of the product or that the generic was tested and approved by medical authorities elsewhere in Europe. Plavix, which is jointly marketed by Bristol-Myers Squibb, generated $9.8 billion in sales last year, but faces US patent expiration in 2011 and in 2013 in Europe.

“The Authority’s decision to investigate Sanofi-Aventis’ behaviour underlines our view that such practices are likely to prevent access to competition and damage the long-term interests of patients,” Gerard van Odijk, Teva Europe’s ceo, says in a statement. Maurice Chagnaud, Teva Sante’s ceo, adds that brand-name companies “need to understand that they cannot use misleading practices to prevent competition from therapeutically equivalent and effective generic products.”

Enzon Pharmaceuticals, Inc. (ENZN) is a biopharmaceutical company dedicated to the discovery and development of medicines for patients with cancer and other life-threatening conditions. The Company’s drug development program utilizes several technologies, including its Customized Linker Technology and the Locked Nucleic Acid (LNA) technology.

It has three compounds in human clinical development: PEG-SN38, the HIF-1 alpha antagonist and the Survivin antagonist. PEGylation has been used on various pharmaceutical compounds (protein, peptides and antibody/antibody fragments) to improve their performance and deliverability. Through the customized attachment of polyethylene glycol (PEG) to a pharmaceutical compound using a spectrum of stable and releasable linkers, its Customized Linker Technology has the potential to overcome the pharmacologic limitations for a universe of molecules and generate compounds. On January 29, 2010, it completed the sale of its specialty pharmaceutical busines

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Yesterday, Discovery Labs (NASDAQ:DSCO) announced that the re-validation has been completed for the Biological Activity Test (BAT) for quality control and stability for SURFAXIN (lucinactant). DSCO has submitted a protocol to the FDA, outlining its plans for preclinical studies and expects feedback from the Agency in June. The company affirmed its prior guidance for a NDA resubmission to the FDA during 1Q11.

Hospira (NYSE:HSP) announced this morning that it is extending its $2.20 per share ($145 million) cash tender offer for Javelin Pharma (AMEX:JAV) until 2-June, referencing unsatisfied conditions. JAV disagreed with the statement by HSP and believes the latter is using a DYLOJECT supply chain issue in the UK as the basis for extending the tender offer.

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At issue in both cases is a deal in which Bayer paid Barr, now owed by Teva Pharmaceuticals, to drop its 1991 patent challenge to Cipro. In 1997, Barr struck a deal with Bayer just two weeks before a lawsuit was set to go to trial, delaying the entrance of a generic version. The US Second Circuirt Court of Appeals ruled the deal was kosher (see here), although the Federal Trade Commission continues to argue – mostly in vain – that these so-called pay-to-delay deals are anti-competitive (see this).

Due to procedural matters, the California plaintiffs were waiting for the outcome of the Second Circuit ruling before filing their appeal (here it is). Whether they will win is unclear, but the case may be closely watched, especially since the FTC continues to suffer setbacks in pressing its argument. “If our appeal succeeds, we would still have to prevail at trial, but it could send an important signal,” says Dan Drachler, an attorney who represents the plaintiffs. “Courts often look to see what other courts are doing and California is, of course, a big state with a large population that spends large amounts of money on medications.”

Meanwhile, the plaintiffs who were rejected by the Second Circuit have filed a motion for a full court review, since the court last month acknowledged the issue needed further review. In fact, the court invited entities that purchase drugs and had challenged the Cipro settlement to ask that the case be reviewed by the full circuit, citing the “exceptional importance” of the antitrust implications. Here is their filing.

EDITOR’S NOTE: If you’re wondering why portions of both filings are redacted, this is because the original lawsuit was filed prior to the 2004 expiration of the Cipro patent and Bayer was able to win the argument that certain information is proprietary, a decision that continues to reverberate to this day in court filings.

Astellas Pharma recently entered into a definitive agreement to acquire OSI Pharmaceuticals (OSIP) for $57.50 per share, which represents a premium of about 10.6% to Astellas’ earlier offer of $52 per share. The board of directors of both companies approved the all-cash transaction, which values OSI Pharmaceuticals at about $4 billion.

Astellas’ bid to acquire OSI Pharmaceuticals first hit headlines on March 2, 2010, when the company announced that its indirect subsidiary, Ruby Acquisition, had commenced a cash tender offer at $52 per share. Prior to expiration of that offer on March 31, 2010, Astellas extended the same through April 23, 2010. Subsequently, Astellas again extended its tender offer until May 17, 2010.

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To coin a L’Oréal phrase, in the eyes of Astellas Pharma (ALPMF.PK), OSI Pharmaceuticals (OSIP) is definitely ‘worth it’. Having conducted its due diligence of OSI’s private books, Astellas Sunday raised its original hostile offer of $52 cash per share to an accepted bid of $57.50 cash per share, valuing the deal at $4bn, the second biggest overseas acquisition by a Japanese pharma company.

Big sighs of relief all round then at Astellas, who failed to land CV Therapeutics last year and adopted a slightly risky approach to bidding for OSI. But it now looks set to increase its presence in the US market and gain a portfolio of marketed and pipeline cancer drugs, most notably lung cancer drug Tarceva. As for OSI, some ambitious shareholders will be disappointed with the price as the stock reached $59.80 on Friday, but given that the offer is a 55% premium overall and equivalent to a five-year high, they should be more than happy.

Complete Story »

By Michael Fitzhugh

Regeneron (REGN) delivered encouraging news to investors bullish on the company. One of its experimental drugs appeared to significantly lower cholesterol while another successfully reduced pain in osteorarthritis patients. However, that same experimental drug failed to show benefit in patients with acute sciatica. Both drugs are partnered with Sanofi (SNY) and are produced by mice engineered to generate fully human monoclonal antibodies.

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When Sanofi-Avantis (SNY) made a major endorsement of Regeneron’s (REGN) technology in 1997 and signed a drug-development partnership with the company, we asked why? And when the top class pharmaceutical firm has willingly decided to offer Regeneron $160 million a year to develop therapeutic antibodies that they can equally share their revenues, we, again, asked why? We also asked: What did the French giant drug maker expect to get from Regeneron, which it could not itself provide or get from other biotech firms?

We satisfied our built-in curiosity as early as a few days after the signature of the cooperative agreement between the two firms. We learned at the right time that Sanofi had fallen in love with Regeneron’s antibody technology and that it expected the small firm to be capable of advancing several antibodies into clinical trials each year through 2017. It was obvious that Sanofi-Aventis decided to pay the costs of developing Regeneron’s drugs because it wanted the small firm to focus on building the therapeutic molecules under no tension that would cause unnecessary delays.

Complete Story »

Q1 2010 Earnings Call Transcript

May 10, 2010 11:00 am ET

Complete Story »

By Michael Fitzhugh

Merck (MRK) will pay Ariad Pharmaceuticals (ARIA) about $69 million plus milestones for exclusive rights to the Cambridge, Massachusetts-based company’s late-stage soft tissue cancer drug ridaforolimus, replenishing Ariad’s waning cash reserves as it revs up a new trial on its next experimental drug, AP24534, a therapy for chronic myeloid leukemia and other cancers.

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A few weeks ago, Cramer touted Teva Pharmaceuticals (TEVA), the large generic and proprietary drug company. He couldn’t move the stock higher. Usually he gets something for his efforts. He made some great points (see here) but Cramer missed the two key reasons to buy TEVA.

First, starting now, TEVA no longer has to pay an onerous 25% royalty payments to Sanofi Aventis (SNY) for its blockbuster drug copaxone’s U.S. sales. Mark that. That is not a typo. 25% of sales, not earnings. And copaxone is gigantic for TEVA. Last quarter, U.S. sales were $513 million, for FY 2009 they were $1.9 billion.

Complete Story »

Q1 2010 Earnings Call Transcript

May 6, 2010 10:00 am ET

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King Pharmaceuticals, Inc. (NYSE: KG) earned $0.02 per diluted share on a GAAP basis in the first quarter of 2010, which ended 31 March. In the year-earlier quarter, various restructuring charges related to the Alpharma acquisition contributed to King losing $0.04 per share.

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Q1 2010 Earnings Call

May 6, 2010 8:30 am ET

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Rofe, one of the company’s biggest investors, launched his hostile takeover effort a month ago, putting a valuation of about $40 million on the company.

Q1 2010 Earnings Call Transcript

May 5, 2010 5:00 pm ET

Complete Story »

Marc Monseau, head of corporate communications at Johnson & Johnson (J&J or JNJ) and contributor to the JNJBTW Blog, often says that JNJ is not a pharmaceutical company. He likes to think of it as a healthcare company.

But I think of JNJ as a pharmaceutical holding company, by which I mean it holds several separate pharmaceutical companies under its corporate umbrella. Each one a “silo” of sorts.

The advantage of this type of organization is that the Johnson & Johnson name and brand remain untarnished among consumers even when one or more of its “units” breaks the law or fails to protect consumers from tainted products.

One such unit or division is McNeil. There’s Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, which markets and sells Rx products such as Topamax. And there’s McNeil Consumer Healthcare, which markets and sells over-the-counter products such as children’s Tylenol, Motrin, etc.

Both of these J&J/McNeil “units” are in the news these days. Ortho-McNeil Pharmaceutical and Ortho-McNeil-Janssen Pharmaceuticals were fined a total of $81.5 million for misbranding and illegally marketing Topamax (see “J&J to Pay $81 Million, End Federal Cases on Topamax”). Topamax is approved only for treating epilepsy, but BNet author Jim Edwards, points out that the J&J companies “promoted Topamax for such a wild range of conditions eg, weight loss, based on such thin evidence, that it was impossible not to notice that many of them were off-label” (see here).

Meanwhile, McNeil Consumer Healthcare has been cited AGAIN for bad manufacturing processes. I wrote about this in the past — see “Social Media Vs. Social Responsibility: J&J Fails Crisis Management 101.” McNeil apologized back in January, 2010 and is now apologizing again AFTER FDA issued a report (here and here).

Although news stories mention the J&J name in headlines, when all is said and done, the J&J brand image among consumers will remain unsullied for the most part, IMHO. Which suggests that “silos” works! Other drug companies may not have the same corporate structure as does J&J, but they are just as “siloed” — by brand! So, consumers remember Vioxx, but often forget that it was marketed by Merck, which lately gets a lot of kudos for Gardasil.

I’m not sure what the point of this is other than that drug company silos can be a useful strategy. Of course, siloing also can lead to failures to communicate (see “Is Your Brand a Digital Genius or a Feeble-Minded Idiot?“).

Read more here
Trouble in the House that McNeil Built: Why Drug Company Silos are Useful

Q1 2010 Earnings Conference Call

May 4, 2010 10:00 AM ET

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Q1 2010 Earnings Call Transcript

May 3, 2010 10:00 am ET

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1. Humira (arthritis) Abbott Labs/Eisai – $10.1b; 9 percent
2. Avastin (cancer) Roche – $8.9b; 6 percent
3. Enbrel (arthritis) Amgen/Pfizer/Takeda – $7.3b; 2 percent
4. Rituxan (cancer) Roche/Biogen – $6.8b; 3 percent
5. Crestor (cholesterol) AstraZeneca – $6.3b; 4 percent
6. Herceptin (cancer) Roche – $6.2b; 3 percent
7. Remicade (arthritis) J&J/Merck – $5.7b; 0 percent
8. Lantus (diabetes) Sanofi-Aventis – $5.3b; 3 percent
9. Advair (asthma) GlaxoSmithKline – $5.2b; -6 percent
10. Prolia (osteoporosis) Amgen/Daiichi – $5.2b -

Separately, EvaluatePharma also ranked drugmakers. The ranking below depicts annual sales, followed by the change in annual sales and the change in market share from 2009 to 2016. The listing reflects market rank in 2016. The most notable difference is that Teva Pharmaceuticals will have cracked the Top 10 by then, overtaking Bristol-Myers Squibb, Eli Lilly and Amgen…

1. Pfizer – $47.1b -2 percent; 6 percent
2. Merck – $46.3b +2 percent; 5.9 percent
3. Novartis – $46b +3 percent; 5.9 percent
4. Roche – $43.9b +3 percent; 5.6 percent
5. Sanofi-Aventis – $38.9b; 0 percent; 5 percent
6. GlaxoSmithKline – $38.7b; +1 percent; 4.9 percent
7. Abbott Labs – $26.1b; +7 percent; 3.3 percent
8. Johnson & Johnson – $24.8b; +2 percent; 3.2 percent
9. AstraZeneca – $22.1b; -5 percent; 2.8 percent
10. Teva – $20.8b; +7 percent; 2.7 percent

Despite the emergence of new biological treatments for cancer, chemotherapy is still essential, and indispensable as a major treatment for malignancies. The adverse events caused by these chemicals were found to be acceptable as a risk versus the great reward of using chemotherapy. Due to the technological evolution that took place in the past decade and the surfacing of state-of-the-art technologies such as nanotechnology, scientists believed possibilities exist now for improving the adverse effect profiles of these therapeutic molecules. Reformulating the existing products has become an increasingly common product lifecycle-management technique. We read that a 2004 report on the U.S. drug market from BCC, Inc. projected that reformulations would grow from 62% of the market in 2003 to 79% in 2008. Finding ways to modify and improve existing products’ side effect profiles has become feasible after being an essential but unreachable goal.
Among Wednesday’s news, Adventrix (ANX) announced that, based on information received from the FDA, it decided to resubmit its New Drug Application (NDA) for ANX-530 (vinorelbine injectable emulsion), or Exelbine, a novel emulsion formulation of the approved cancer chemotherapy drug vinorelbine for approval for the sake of improving its side effects of the marketed drug. From the same press release we understood that the firm has met with the FDA and clarified certain matters regarding stability data necessary to file the Exelbine NDA and that the studies are ongoing and the emerging data will enable the firm to resubmit the NDA in the fourth quarter of this year.

Background: Adventrix had submitted an NDA for ANX-530 to the FDA in December 2009. On March 1, 2010 it announced that it had received a refusal-to-file letter from the FDA regarding that submission. In the letter, the FDA indicated that the data included in the December 2009 NDA submission from the intended commercial manufacturing site was insufficient to support a commercially-viable expiration dating period. The FDA identified only this one chemistry, manufacturing and controls (CMC) reason for the refusal to file. No clinical or nonclinical issues were otherwise identified.

Complete Story »

Another weak quarter for kidney and liver cancer treatment Nexavar prompted a 5% drop in Onyx Pharmaceuticals’ (ONXX) shares Thursday and questions about what exactly is driving the disappointing figures.

The sales were reported by Onyx’s marketing partner Bayer and when the US biotech reports first quarter figures next week, no doubt the subject will take center stage; some financial analysts have already moved to significantly trim sales forecasts. Just how concerned followers of the US biotech should be remains to be seen, but with competition from newer agents biting in its biggest market, kidney cancer, Onyx needs to demonstrate that demand for Nexavar will pick up.

Complete Story »

Q1 2010 Earnings Call Transcript

April 30, 2010 10:00 am ET

Complete Story »

The ruling was made after reviewing a deal in which Bayer paid Barr Pharmaceuticals, which is now owed by Teva Pharmaceuticals, to drop its patent challenge to the Cipro antibiotic. Barr challenged the Cipro patent in October 1991 and struck a deal with Bayer in January 1997, about two weeks before the case was set to go to trial.

The ruling is yet another setback for the Federal Trade Commission, which has been pushing aggressively to end pay-to-delay deals (look here). Two months ago, a federal judge dismissed an antitrust lawsuit filed by the FTC against Abbott Labs’s Solvay unit for allegedly conspiring with several generic drug makers to delay competition for a testosterone-replacement med (see here). And the White House included what became a scuttled proposal to make these deals illegal as part of its health care reform package.

However, the three-judge panel, in an unusual move, invited entities purchase drugs and had challenged the settlement to ask that the case be reviewed by the full circuit, citing the “exceptional importance” of the antitrust implications.

And here is something we hope to make a regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that that Qforma, which traffics in analytics and predictive modeling, hired Judy Stein as director of client services. She most recently worked as a senior manager at GE Healthcare’s Performance Solutions unit, where she led service line growth and operational improvement analyses for hospitals and healthcare systems.

Celgene promoted Robert Hugin to ceo;
Transgenomic named Katherine Richardson as technical director for lab services;
Warnex added Richard Lacombe to its board;
Pennsylvania Bio named Christopher Molineaux as ceo;
Heritage Pharmaceuticals hired Michael Polito as cfo;
Orexigen Therapeutics added Wendy Dixon to its board;
Amgen named Robert Bradway as president and chief operating officer;
InteKrin Therapeutics named Roman Skowronski as vp, clinical development;
Tennessee Biotech Association added Joseph Cook to its board;
Quintiles named Tony van Bijleveld as biz dev vp for Global Commercial Solutions in Central and Eastern Europe, and the Russian Federation.

Ladder shot thx to Robert CB on Flickr Creative Commons

Titan Pharmaceuticals (TTNP.PK) announced on Tuesday that the SEC has completed the review of the company’s "Form 10 for the re-registration of the company’s securities and resumption of its reporting obligations under the Securities Exchange Act of 1934."

Titan intends to remain a reporting company from this point forward, according to recent releases from the company.

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Researchers said that BCX4208 demonstrated a statistically significant reduction in serum uric acid levels compared with a placebo for all three dosages used in the 21-day trial. Biocryst added that the drug appeared safe and well tolerated.

“This successful first clinical test of BCX4208 in patients with gout confirms this PNP inhibitor’s ability to reduce uric acid levels in the blood and supports its continued evaluation as a potential treatment for patients with gout,” said Dr. William P. Sheridan, the chief medical officer at BioCryst. “We have started part two of this study and we are finalizing plans for an additional Phase 2 trial of BCX4208 as a monotherapy and in combination with allopurinol, a commonly used urate-lowering treatment for gout. During 2010 we expect to complete these studies, which should define dosing suitable for further development of BCX4208 for gout.”

BioCryst also reported a $2.6 million loss in the first quarter, down from a $9.3 million loss a year ago.

- check out BioCryst’s press release
- here’s the story from Reuters

Related Articles:
BioCryst reaps $22.5M windfall on IV peramivir order
Feds hand BioCryst $77M for anti-viral trial

Nature has a paper from CalTech, UCLA, and several other groups with the first data on a human trial of siRNA delivered through targeted nanoparticles. This is only the second time siRNA has been tried systemically on humans at all. Most of the previous clinical work has been involved direct injection of various RNA therapies into the eye (which is a much less hostile environment than the bloodstream), but in 2007, a single Gleevec-resistant leukaemia patient was dosed in a nontargeted fashion.

In this study, metastatic melanoma patients, a population that is understandably often willing to put themselves out at the edge of clinical research, were injected with engineered nanoparticles from Calando Pharmaceuticals, containing siRNA against the ribonucleotide reductase M2 (RRM2) target, which is known to be involved in malignancy. The outside of the particles contained a protein ligand to target the transferrin receptor, an active transport system known to be upregulated in tumor cells. And this was to be the passport to deliver the RNA.

A highly engineered system like this addresses several problems at once: how do you keep the RNA you’re dosing from being degraded in vivo? (Wrap it up in a polymer – actually, two different ones in spherical layers). How do you deliver it selectively to the tissue of interest? (Coat the outside with something that tumor cells are more likely to recognize). How do you get the RNA into the cells once it’s arrived? (Make that recognition protein is something that gets actively imported across the cell membrane, dragging everything else along with it). This system had been tried out in models all the way up to monkeys, and in each case the nanoparticles could be seen inside the targeted cells.

And that was the case here. The authors report biopsies from three patients, pre- and post-dosing, that show uptake into the tumor cells (and not into the surrounding tissue) in two of the three cases. What’s more, they show that a tissue sample has decreased amounts of both the targeted messenger RNA and the subsequent RRM2 protein. Messenger RNA fragments showed that this reduction really does seem to be taking place through the desired siRNA pathway (there’s been a lot of argument over this point in the eye therapy clinical trials).

It should be noted, though, that this was only shown for one of the patients, in which the pre- and post-dosing samples were collected ten days apart. In the other responding patient, the two samples were separated by many months (making comparison difficult), and the patient that showed no evidence of nanoparticle uptake also showed, as you’d figure, no differences in their RRM2. Why Patient A didn’t take up the nanoparticles is as yet unknown, and since we only have these three patients’ biopsies, we don’t know how widespread this problem is. In the end, the really solid evidence is again down to a single human.

But that brings up another big question: is this therapy doing the patients any good? Unfortunately, the trial results themselves are not out yet, so we don’t know. That two-out-of-three uptake rate, although a pretty small sample, could well be a concern. The only between-the-lines inference I can get is this: the best data in this paper is from patient C, who was the only one to do two cycles of nanoparticle therapy. Patient A (who did not show uptake) and patient B (who did) had only one cycle of treatment, and there’s probably a very good reason why. These people are, of course, very sick indeed, so any improvement will be an advance. But I very much look forward to seeing the numbers.

SurModics gets $3.5 million upfront and up to $200 million in milestones and fees if the global developer is able to successfully advance several new eye drugs. The Eden Prairie, MN-based SurModics gets undisclosed royalties and Roche and Genentech have the right to gain manufacturing services.

“This agreement represents yet another major advancement toward realizing our strategic vision of developing technologies that address important clinical needs in the large and growing ophthalmology market,” said Bruce Barclay, president and CEO of SurModics. “The agreement, which includes Lucentis and potentially other products, addresses a wide range of ophthalmic diseases and leverages our expertise and technology platforms in ophthalmology, employs our proprietary biodegradable microparticles drug delivery system from SurModics Pharmaceuticals, and will utilize our new world-class cGMP manufacturing facility in Birmingham, Alabama.”

- check out the SurModics release

Related Articles:
Medicare code favors costly Lucentis use
Roche gets closer look at Genentech’s R&D secrets

And some days I truly wonder, am I talking to myself?? Sure, everyone at One Eleven has drunk the kool-aid, but does pharma buy it? Lately, I’ve been wondering.

Today my friends, a miracle happened! A potential client called about mobile optimizing web sites – and said, “You know, Janet, 65% of physicians are accessing information via smart phones*, so we need to be there.” I’ve repeated that statistic until I was hoarse and my fingers nearly fell off from writing, blogging and emailing – but apparently, the word has gotten around.

When I was a sales rep, my district manager used to say, “it takes at least 10 visits to a doctor to convince her of ONE point you are trying to make” – well, I have come to realize that it takes at least that many exposures to pharma folks to make a point.

Well, stubborn is good for something – so, now that I have made THAT point,  on to the next one…

*My thanks to Mark Bard of Manhattan Research, who kindly provides the latest statistics for HCPs and their use of mobile.

Read more from the original source
Am I Talking To Myself?

Kapidex works a second shift to help shut down acid pumps

Kapidex is the first and only PPI with a dual delayed release (DDR) formulation, which provides a second release of drug

Brand name: Kapidex
Generic name/category: Dexlansoprazole, proton pump inhibitor
Company: Takeda Pharmaceuticals North America
Country/Market: USA, North America
Indication(s)/use: erosive oesophagitis and non-erosive reflux disease, gastro-esophagi reflux disease (GERD or GORD)
Target: Healthcare Professionals (HCP)
Tagline: Two releases. One pill.
Medium: Print ad
Size/duration: single-page
Publication/Aired: Drug Topics – August 2009

To see all of this brand’s ads on AdPharm, click here