According to Ms Hewlett more than anything else, the things that distinguished women from men in 2008 was that they hated what happened to the reputation of Wall Street.

  It was pretty important for them to work with a company they could feel proud of. … Men are more likely to just tough it out, because in the end the paycheck and the comp package is tremendously important to a lot of men.

I have worked for women while I was at Lilly and frankly I found them to be more open and transparent then the men I had worked for.  I can’t think offhand of any big pharma company that is being led by a woman but maybe it’s time to give the keys to the CEO suite to a qualified woman who wants to feel proud about the company she represents.

Over time I have maintained contact with a lot of colleagues within the healthcare industry and for the most part woman are stuck in middle management while men get the senior management roles.  I have also found that when men come in from the field to take a marketing position they more times than not try and replace woman on their team with men they worked with.  There is a lot of talk within pharma about the “ol boys club”.

Of course no organization should turn over the keys to the executive suite to a person based on gender alone but I for one would like to see a woman in charge who wants to be proud of the company she works for rather than the size of her bonus.

Read more here
Women fleeing Wall Street. Does this apply to pharma as well ?

eMarketer just published a study which shows growth in use of online for pharmaceutical companies albeit slow growth.  Spending for drug companies online has been slower to take off than other industries. Most insiders attribute this to the uncertain regulatory environment. FDA is working under regulations drafted before the Internet when advertising was confined to broadcast, print and direct mail. They never contemplated millions of available pages of health information with easy links to millions of other pages worldwide.

FDA is under the regulatory yoke of ensuring consumers see risk and side effects displayed with the indication mention. They say that means without needing to click further to see it. That restriction makes no practical sense in the unlimited information age. Consumers do not need so much protection. Online allows consumers to investigate in infinite detail the risks and side effects of drugs with easy clicks. They can ask other consumers on social sites what they experienced with drugs under consideration. FDA says they are trying to deal with the new realities of web use but must comply with Congressional statutes. I do believe FDA knows the regulations are out of date, and unfair but of course will never say that.

Of course Henry Waxman likes to investigate whether Roger Clemens is a liar and has had no time to deal with less important issues like Internet use for drugs. One day Congress may get to these issues but for now we can expect more delay on practical regulations for drug company use of the net.

The common sense thing to do is to make sure drug companies have a blanket warning on all brand and indication web search or banner ads. I propose that anytime a brand mentions what it is for there is a bolded link that says “see side effects and risks”. Lipitor for high cholesterol, see side effects and risks. The idea that someone seeing “Lipitor for High Cholesterol” on a search or sidebar is somehow in danger without immediate visible full risk disclosure is absurd.

Our government needs to use common sense. The idea that consumers must see everything immediately as if they were reading a print ad is government regulation on over drive. I know FDA says that is the law and they must enforce it. So what does Congress say? Not much.  I know the web companies have lobbied Congress for reasonable regulation. I know FDA is trying to come up with something that allows use of more web vehicles. I am not optimistic that we will see true pragmatic rules in the near future.

The problem is why is it taking so long for the obvious to be addressed? Did the Internet just start in 2010? If anyone needs an example of why government is a problem not the solution, this is a prime example. I am afraid our regulatory system is always going to be a decade behind reality. I cannot wait to see how this 1980’s thinking government will deal with health reform.

We clearly are seeing a new D.C. regulatory mindset across most industries. While most government agencies are well-meaning, most do not understand how long it takes and how much it costs to follow their new rules. I know the desire for drug companies to use web search is not high on the list of societal needs. It is, however, a symptom of our lack of regulatory common sense. Add this issue to the thousands of other silly regulations and we can see why we are wasting time, money and limiting innovation and job growth.  Most Americans have common sense and want less government protection on unimportant things. FDA can and should protect us from real dangers like Salmonella in our eggs, counterfeit drugs, sham claims from wonder vitamins, and other real dangers. Debating the one click solution for web ads/search is just plain silly and should be able to be settled quickly using common sense principles in about 5 minutes.

Read more here
Online Moves Slowly

Anyway, today I record here the first leg of my my journey from obesity to normal weight. The following chart shows my progress to date:

This chart was created by an iPad app that I am using to record my meals, weight and exercise history. The app is called “FatSecret.” It syncs up with the FactSecret.com web site so that whenever I update data using the iPad, my Web account is also updated and vice versa. There’s also a community, buddy system, etc. on the Web site, but I haven’t used those social networking tools yet. That may change, however.

As you can see from this chart, I seem to be a bit stuck at my current weight of 191 lbs. My current body mass index (BMI) is 29.0. According to the National Heart Lung and Blood Institute’s BMI calculator, that puts me out of the obesity range (BMI greater than 30.0), but at the high end of the overweight range (BMI = 25 to 29.9). To get into the normal BMI range of 18.5 to 24.9, I will have to lose another 27 lbs!

Since I am halfway there, I can look at this as a glass half empty or half full. Right now I feel half full, I can tell you that!

My goal, however, is to reach 175 lbs by the New Year. I am using the Numbers app on my iPad to plot my goal each month against my actual weight:

I missed my “goal” this month by 1 lb! Actually, I have been resetting the goal based on past performance. In August I reset the goal for the beginning of September to be 190 lbs. That’s an 11 lb drop from the goal I set at the beginning of August (you can see the graph dropped steeply). I now have set my monthly weight loss goal to be about 4 lbs, which I hope is more realistic and attainable.

If you have any ideas how I can keep on schedule — including some good low calorie recipes/meals, etc. — let me know.

To those of you who have called me an “ass” or worse, thanks for not prefacing it with “fat”! When I lose that additional 27 lbs, nobody will be able to legitimately call me fat. I may, however, still be an ass!

Read the original here
My Journey From Obesity to Normal. First Stop: Stuck in Overweight!

Although Roche CEO Severin Schwan (photo) says in a statement that the company is launching the restructuring from a “position of strength,” Pharmalot notes that the Swiss drugmaker has been hit with a series of recent pipeline setbacks that have caused some concern. Roche has delayed development of its potential blockbuster Type 2 diabetes drug taspoglutide for up to 18 months due to hypersensitivity problems observed in trial subjects. In addition, the FDA handed Roche and Genentech a refuse-to-file letter for the developers’ BLA for trastuzumab-DM1. Trials of rheumatoid arthritis drug ocrelizumab were suspended, and the FDA is reviewing a breast cancer indication for blockbuster drug Avastin. “The net effect is that we have had to revise our revenue forecasts and must now adapt our business and manage our costs more carefully so as to safeguard our funding of innovation,” the company says in a memo.

Roche provided no further details on the cuts. “Cost savings could easily reach 2 billion Swiss francs ($1.9 billion) as of 2012 to 2013, which would boost our earnings per share forecast by some 10 percent,” Helvea analysts Odile Rundquist and Karl-Heinz Koch tell Reuters.

- here’s Roche’s release
- check out Pharmalot’s assessment
- read the Reuters report

Related Articles:
Paper: Roche mulls ‘massive’ worldwide job cuts
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Roche faces long delay for diabetes drug taspoglutide
Roche, Biogen shutter blockbuster ocrelizumab arthritis program
FDA panel votes to yank Avastin indication

Read more here
Roche plots layoffs as it focuses on R&D

His parents applied for compensation under the UK government’s Vaccine Damage Payment Scheme, but were rejected in 1997 on the grounds that it was impossible to prove beyond reasonable doubt what had caused their son’s illness, The Daily Mail reports. But she won on appeal, although she says the money isn’t the issue: “‘What matters is the recognition that (the measles, mumps and rubella vaccine) was the reason this happened.”

In a six-page judgment, the panel wrote: “Robert was a more or less fit boy who, within the period usually considered relevant to immunization, developed a severe convulsion…and he then went on to be epileptic and severely retarded. The seizure occurred ten days after the vaccination. In our view, this cannot be put down to coincidence. It is this temporal association that provides the link. It is this that has shown on the balance of probabilities that the vaccination triggered the epilepsy. On this basis, we find that Robert is severely disabled as a result of vaccination and this is why we allowed the appeal.”

The case does not involve autism which, of course, is a hugely controversial issue. Nonetheless, the decision is likely to further fuel the debate over childhood vaccines and links to various disorders. Polly Tommey, who edits the magazine The Autism File and believes her son Billy is autistic because of MMR, tells the paper that “This is fantastic news. Now doctors can’t tell me that the MMR is safe.”

Nadine Dorries, a member of the Commons Health Committee in the UK Parliament, adds that, “if an independent panel has reached the conclusion that there has been a link between the MMR vaccine and the brain damage suffered by this boy in this case, then it is fair to assume that there could be as many as thousands of children and parents in the same position.”

As an aside, last month, the US Court of Appeals for the Federal Circuit recently upheld lower court decisions that rejected a connection between childhood vaccines and autism that was made in a lawsuit, which was the first in a series of several test cases heard by special masters for the US Court of Federal Claims.

Read the original here
Family Wins Fight Linking MMR Vaccine To Epilepsy

According to Reuters, Forbion is considering an investment in Amsterdam Molecular Therapeutics, which is awaiting EMA approval of its lead product Glybera. Forbion Managing Partner Bart Bergstein also says his firm is mulling two stock listings of biotechs it had previously invested in.

“We are very pleased to have raised such a substantial amount as fundraising conditions have never been more challenging” notes Bergstein in a statement. “Given that only few venture players have active funds to commit from, we currently see many highly attractive assets from an increasingly rich deal flow. We are therefore confident that both new funds could be at least as successful as FCF I.”

- take a look at Forbion’s release
- see the report from Reuters

Related Articles:
AMT looks for funding while it waits for EMA approval
Top Venture Capital Firms

Read the original here
Forbion raises $240M investment fund

The move is the latest step in Sonderby’s quest to overthrow Martin, who he has accused of having various undisclosed conflicts of interest and simply being overpaid. Earlier this week, for instance, Sonderby alleged that Martin (that’s him in the photo) has also been a board member of Kinsale Capital Management, a hedge fund, at the same time that he was ceo of the biotech.

“Is Mr. Martin breaching his position of trust within industry by serving in such a conflicting role? Does he have an incentive to hide his involvement in Kinsale?” Sonderby wrote. “Did Kinsale trade in shares of Elan or its partners? Was it a short or long position or options related? Was trading short term or long term? How much does Kinsale invest in healthcare and biotech?…For lack of disclosure, we do not know the answers to a number of these important questions. Yet, from what we do know, it is clear that Mr. Martin’s dual roles represent an inappropriate and unacceptable combination of responsibilities of which shareholders should have been informed.

“Elan’s Board exists to serve the company’s shareholders and yet it allows this pattern of troubling behavior to continue unchecked among its members,” Sonderby continues, and then rattles off a few other examples he has cited previously as examples of undisclosed conflicts or ineptitude (background). “These unfortunate facts join a long series of poor business decisions and wasteful spending at the company. The board must recognize the severity of the situation it faces and the consequences of not addressing them. I will be recommending a list of board candidates that will restore oversight in the near future.”

Read more from the original source
Dissident Elan Shareholder To Propose New Board

In fact, one out of every five Americans was using five or more drugs by 2008, and one out of every five children used at least one prescription med compared with nine out of 10 adults aged 60 and over. Children up to age 11 were using penicillin and drugs for asthma and allergies, while adolescents were taking meds for asthma, depression and ADD.

Consequently, US spending for prescription drugs more than doubled between 1998 and 2008 to $234.1 billion. The CDC notes, however, that the increasing use of multiple drugs by older Americans “is a continuing challenge that may contribute to adverse drug events, medication-compliance issues and increased health-care costs.”

A few other nuggets: Women were more likely to use prescription drugs than men. People with a regular place to visit for health care were 2.7 times as likely to have used pescription drugs than those without a regular place for health care. And people with health insurance were almost twice as likely to have used at least one prescription med than those without health insurance coverage. Among people with health insurance, those having a prescription drug benefit were 22 more likely to use prescription drugs.

Read the original here
Half Of Americans Are Taking Prescription Meds

Under the terms of the agreement, Ipsen will acquire the rights to fipamezole outside the U.S., Canada and Japan for an upfront payment of €13 million ($16.7 million) and additional payments contingent to future development, regulatory and sales milestones of up to €128 million ($164.6 million). Santhera also is entitled to royalty payments on Ipsen’s future net sales.

Biovail is scheduled to start Phase III testing of the product next year. Santhera granted Biovail the development and commercial rights to fipamezole in the U.S. and Canada in August 2009.

“This agreement with Santhera will further enrich Ipsen’s pipeline with a new promising first-in-class compound thus complementing our fast-growing neurology franchise, in clear medical and operational synergy with our existing portfolio,” says Stéphane Thiroloix, Ipsen’s executive VP, corporate development, in a statement. ”We have been impressed with the scientific and development capabilities of both Santhera and Biovail. Ipsen will benefit from the Biovail development and collaborate fully to achieve regulatory filings excluding North America planned for 2015.”

 - check out Santhera’s release

Related Article:
Santhera grabs $192 million CNS licensing deal

Read the original here
Santhera, Ipsen ink fipamezole pact

Celldex will regain full worldwide rights to develop and commercialize rindopepimut. The company says it plans to move ahead with more trials of the drug. TheStreet notes that as of June 30, Celldex had $65.8 million in its coffers; it will have to draw upon that nest-egg to fund late-stage trials of rindopepimut.

The general prognosis for anyone diagnosed with malignant glioma is poor, and patients generally have up to three years to live following diagnosis. “There is a significant need for new therapies for GBM and we are fully committed to developing rindopepimut for the patients who suffer from this fatal disease,” says Celldex President and CEO Anthony Marucci. “The program has advanced significantly, including the completion of a multi-center Phase II study, the development of a diagnostic companion product, the manufacture of drug supply for clinical studies, and the execution of discussions with regulatory agencies on the design of a global controlled study.”

- check out Celldex release
- read TheStreet article for more

Related Articles:
New brain cancer vaccines target tumor cells
Celldex acquires CuraGen for $94.5M
Pfizer, Avant ink $440M cancer vax deal
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Read more here
Pfizer returns brain cancer vax rights to Celldex

A new paper may well have tracked down a mechanism for this effect, which adds to the sense that it’s real. Here’s a summary of the work – it looks like an mTOR-driven process, which is plausible. Specifically, it seems to inhibit the TORC1 pathway, though at least two different mechanisms. That’s an important player in nutrient sensing and cellular growth, among a bewildering variety of other things, and the whole mTOR area has been the subject of oncology research for quite a long time now.

Metformin (and related biguanides) might be acting on it in a very useful way. Mice exposed to a known lung-cancer agent were substantially protected by pretreatment with the drug. What’s not clear yet is if that direct TORC1 effect is the reason, or if it’s a more general downstream effect having to do with metformin’s effects on glucose levels and insulin signaling. If it’s the latter, there are tumor lines that should (unfortunately) be able to evade the problem, specifically ones that have their PI3K signaling cranked up already, so it’s going to be quite interesting to see how metformin does protecting against those. As has been noted many times, nutrient sensing, insulin signaling pathways, carcinogenesis, and mechanisms of aging are tangled together in ways that it’s very much in our interest to unravel. (mTOR specifically is right in the middle of it, apparently).

These results (both the new mechanistic study in mice and the retrospective clinical observations) would seem to strongly suggest trying metformin out in patients with a high risk of developing various sorts of cancer. It also suggests that, other things being equal, Type II diabetics might want to use metformin to take advantage of its apparent side benefits. A protective effect would be very welcome news indeed – it’s terribly difficult to do anything about most tumors once they’ve occurred, and the best thing would be for them not to appear in the first place.

Oh, and one more thing. If everyone had followed Sidney Wolfe’s advice when metformin first came out – not to use it – we wouldn’t have found out about these effects at all. Would we?

Read more from the original source
Metformin Against Cancer?

The company has orders to fill for the remainder of the year and has been looking to expand, Garner says. “We hope in the next couple of months to be adding to the work force as there is gained interest in this form of technology,” he adds.

Soluble is the second biotechnology company to spin off from UAB research and incorporate this year, the other being VIPAAR, the Birmingham Business Journal reports. In addition, it is one of about 40 entities to spin off from the school’s R&D since the UAB Research Foundation formed more than 20 years ago, according to the foundation’s website.

- get more from the Birmingham Business Journal

Related Articles:
Drug R&D spending surges
For tough 2010, pharma cuts billions from R&D

Read the original here
UAB spin-off’s tech could shorten drug dev to 6 weeks

There were scant details provided, other than that the entire organization will be reviewed in coming months and an announcement will be made by year’s end. One analyst tells Reuters the cuts could involve pu to $1.9 billion in cost savings and will likely target salespeople, particularly in the US, and R&D. Of course, Roche has already rejiggered R&D in the wake of the Genentech acquisition.

The move is hardly surprising, though, given recent setbacks Roche has endured: a delay with an experimental diabetes drug, another delay in winning FDA approval for a Genentech cancer drug (see here) and a recommendation from an FDA panel to rescind a breast cancer indication for the best-selling Avastin cancer med.

Nonetheless, Roche ceo Severin Schwan insists “we have launched this initiative from a position of strength.” How so? He notes that Roche doesn’t face a stiff patent cliff to the same extent as its rivals. But he then blames “mounting pressures to curb healthcare costs – especially in the US and Europe – together with recent developments in late-stage projects in the Roche pipeline.” This is a bit of a stretch. One could hardly call pipeline setbacks a position of strength.

Read the original here
Yes, Roche Is Planning Those Job Cuts

Allergan Steps Up Overseas Clinical Trials (CBS News)

Novartis Experimental Malaria Drug May Be First In 30 Years (Bloomberg News)

Abbott Cancels Sale Of Solvay Vaccines Unit (The Wall Street Journal)

Accenture And ICRI Partner On Indian Clinical Research Training (Outsourcing Pharma)

Read more here
Pharmalot… Pharmalittle… A Holiday Weekend

Few expected anything less than sterling phase III efficacy data for Genzyme (GENZ) and Isis Pharmaceuticals’ (ISIS) cholesterol-lowering candidate, mipomersen, at the European Society of Cardiology (ESC) congress in Stockholm (Preview – ESC to throw up more than just the hot topics, August 26, 2010). Gleaming rays of light though these results may be, they still failed to penetrate the dark cloud of uncertainty cast by some serious side effects in the liver.

Nearly half the study population of heterozygous familial hypercholesterolemia (heFH) patients reached LDL-C levels below the standard 100mg/dL threshold, recognized as a goal for patients at an extreme risk of a serious cardiovascular event. However, the issue of raised alanine liver transaminases ALT that has dogged the candidate is still giving cause for caution (Safety concerns continue to drag down mipomersen, August 04, 2010). Isis insists the effects are no different to those seen with Lipitor or any other statin-based approach, and that it is not an effect of toxicity, but of mechanism of action. Still, with the companies stating they wish to file as early as the beginning of next year, the outlook for approval remains uncertain. Indeed, the market too remains cautious, with only a meager share price increase for Isis Wednesday.

Complete Story »

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By Michael Fitzhugh

Pfizer (PFE) has agreed to by FoldRX, a privately held specialty drug developer targeting protein misfolding for an undisclosed initial payment plus milestones. The purchase builds on the drug giant’s growing interest in niche drugs, a category it has begun to develop as a potential source of new revenues capable of partially stemming the losses it will incur when Lipitor goes off-patent in 2011.

Complete Story »

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Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

U.S. employers push increase in cost of healthcare onto workers

A new survey shows an average worker with a family plan pays nearly $4,000 a year, up 14% from 2009. Meanwhile, the average employer contribution to a family plan hasn’t increased at all.  The average worker with a family plan was hit with 14% premium increase this year, pushing the bill to nearly $4,000 a year, according to a survey by the nonprofit Henry J. Kaiser Family Foundation and the Health Research and Educational Trust.

That is the largest annual increase since the survey began in 1999 and a marked change from previous years, when employers generally split the rise in the cost of premiums with their employees. The average employer contribution to a family plan did not go up at all this year, meaning the entire increase was borne by workers. At the same time, nearly a third of employers reported that they either reduced the scope of benefits they are offering this year or increased the amount that workers must pay out of pocket for their medical care.

Workers saw average copays for routine office visits increase 10% and deductibles continue their surge upward. In 2010, more than a quarter of American workers with employer-provided health coverage were in plans with deductibles of at least $1,000

Source: LA Times

Prescription Drug Use Rose to Include Half of Americans in 2008

Almost half of Americans took at least one prescription drug per month in 2008, an increase of 10 percent over the past decade, a U.S. study found.  One of every five children ages 11 or younger took at least one medication each month in 2008, led by asthma and allergy treatments, according to the survey released today by the U.S. Centers for Disease Control and Prevention. Among those ages 60 or older, 37 percent used five or more prescriptions per month.  U.S. spending for prescription drugs more than doubled to $234.1 billion over the 10 years covered by the report.

Source: Bloomberg Business Week

Allegan pays $600 million fine for illegal marketing of Botox

The government’s civil complaint said that Allergan had “illegally, vigorously and, without any thought to the possible negative health effects to which it subjected patients, promoted” Botox for uses that had not been deemed safe and effective by the F.D.A.

The company developed and put in place a wide-ranging marketing program, according to the complaint, that included paying kickbacks to doctors to induce them to prescribe Botox for conditions — like pain and severe spasms in the limbs of children with cerebral palsy — not included in the drug’s label.

Federal prosecutors also accused the company of teaching doctors how to get reimbursement from Medicare and Medicaid for off-label uses by putting in the codes for an approved treatment.

Source: NY Times

Meridia increases heart risks

Final data from the so-called SCOUT study, published on Wednesday, showed Meridia increases the risk of heart attacks and strokes in patients who already have heart disease. Patients taking the drug lost an average of 8.8 pounds (4 kg).

Patients given Meridia had a 16 percent increased risk of heart problems such as heart attack or stroke compared to those given a placebo, the study showed. There was no increased risk of death, although Meridia patients also saw an increase in blood pressure and heart rate, it said.

Source: Reuters

U.S. Food and Drug Administration rejected accelerated approval for a novel breast-cancer drug

Swiss-based Roche is developing trastuzumab-DM1, or T-DM1, in partnership with biotechnology company ImmunoGen Inc.  Roche said it will continue to work with the FDA on the drug, and expects to make a new submission by mid-2012.  ”We firmly believe in the potential of T-DM1 as a novel HER2 targeted option and remain fully committed to its ongoing development,” said Hal Barron, chief medical officer at Genentech, the Roche unit that is working on the treatment.

In HER2-positive breast cancer, increased quantities of the HER2 protein are present on the surface of the tumor cells. This form of cancer affects approximately 20% to 25% of women with the disease, which is the most common cancer among women world-wide, killing nearly 400,000 people each year.

Source: Wall Street Journal

Get erectile dysfunction ads out of prime time, nation’s pediatricians say

Parents, lawmakers and media executives are given plenty to think about in the American Academy of Pediatrics’ policy statement published Sunday. Kids today are bombarded with inappropriate sexual messages and images, the AAP committee said; everything from graphic sexual lyrics in songs to ubiquitous erectile dysfunction drug advertisements that air all hours of the day and night.

Source: LA Times

Novo Nordisk Creates “App” to Help Doctors Dose Insulin

Novo Nordisk announced today the availability of NovoDose^TM– the first-ever mobile insulin dosing guide for physicians to look up dosing guidelines and blood glucose goals for their patients with diabetes, a disease that affects nearly 24 million Americans. The guide is available as an application on iTunes and is specific to Novo Nordisk’s modern insulin analog portfolio.

This new technology is part of a trend of physicians using hand-held devices (i.e., PDAs or SmartPhones) when treating their patients. According to a survey conducted by Manhattan Research of nearly 2,000 physicians:

• 70 percent believe their PDA/SmartPhone is “essential” to their practice, and
• 81 percent want more apps related to their specialty.

Source: A Sweet Life

Cocktails Are Next For Cancer-Drug Makers

A diagnosis of AIDS was a death sentence until the advent of drug cocktails in the 1990s allowed patients to suppress the disease indefinitely. Now scientists say a similar combination strategy may change the course of cancer treatment.  For more than a decade, cancer researchers have been crafting drugs to disrupt the precise cellular processes that fuel cancer, creating a $51 billion market in 2009. So far, the survival benefits have been measured in months, not years. That’s because cancer, like the virus that causes AIDS, evolves rapidly to evade a single treatment. Rather than mixing and matching approved drugs, researchers are developing new, targeted combinations that work in tandem to block cancer.

“We’re looking to see a radical change in terms of stopping the disease in its tracks,” says Tal Zaks, head of global oncology drug development at Sanofi in Paris. “The return on investment here is not going to be just evolutionary; it has the potential to be revolutionary.”

Source: Business Week

FDA getting tough with certain drug trials

The U.S. Food and Drug Administration is cracking down on use of certain clinical trials that show a new drug is no worse than another already on the market, according to a government report released on Friday.

Such trials, known as non-inferiority trials, are used when drugmakers want to compare their experimental product to another one that is already FDA-approved. By showing that their new drug is no worse than another, it can also show some potential benefits such as fewer side effects.

Source: Reuters

FDA: Very concerned about Baxter continued violative promotion of their products

The FDA wants to know what Baxter is planning to do to ensure that they don’t continue to violate guidelines.

Source: FDA Website

About.com Health Study shows more people going online to manage their health

We are seeing a significant rise in people using online to take charge of their health and better educate themselves about conditions and treatment options; allowing them to make informed decisions and have knowledgeable discussions with their doctors.

Right after diagnosis with a new condition, respondents took the following actions:

• Used search engines to find more information about conditions (65% in 10 vs. 47% in 09)
• Used search engines to learn about different treatment options (47% in 10 vs. 16% in 09)
• Went to health websites to find more information about conditions (43% in 10 vs. 20% in 09)

Source: World of DTC Marketing

Read more here
Weekly health and health marketing news September 3rd, 2010

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Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Martek Biosciences Corporation’s (MATK) third-quarter fiscal 2010 earnings (excluding special items) of 38 cents per share surpassed the Zacks Consensus Estimate by 2 cents and the year-ago earnings by 11 cents.

On a reported basis (including special items), the company earned 35 cents per share in the reported quarter as against 27 cents in the year-ago quarter. The higher earnings in the reported quarter were driven by a surge in sales. Sales in the quarter benefited from the purchase of Amerifit Brands in February this year coupled with a rise in nutritional ingredient sales.

Complete Story »

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Submit your candidate for the Fierce 15

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Antibiotic gets positive FDA staff assessment

On 23 tries related to new chemical entities and major new indications, developers won 12 votes in favor of recommendation–a 52 percent rate of approval. “The percentage of ‘yes’ recommendations is down significantly compared to 2009 and 2008, when 75 percent and 80 percent of drugs received positive recommendations,” Ramsey Baghdadi, an analyst with Concept Capital, tells Adam Feuerstein at TheStreet, which has the full story.

What’s behind the new level of intensified criticism? New rules require a review now for most new therapies, which is triggering more votes. And the analysts insist that tougher conflict-of-interest rules are forcing the agency to pick less experienced people for the panel. That could be bitter news for anyone up for a review. A negative vote can torpedo a new drug’s chances at the agency.

- here’s the story from TheStreet

Related Articles:
Fitch projects 23 new drug filings for 2010
Biotech drug approvals spiked in 2009
Think tank: Let EMA-approved drugs onto U.S. market
FDA proposes controversial release of complete response letters

Read the original here
Analysts: New FDA rules inspire tougher drug reviews

Alzheimer’s has proved a vexing target for drug developers. Eli Lilly was bitterly disappointed to learn that its drug candidate actually appeared to make the disease worse in trial participants. And Medivation’s Dimebon was scuttled by a failed late-stage study.

As the New York Times explains in its feature on Greengard’s work, Lilly’s scientists had focused on shutting down gamma secretase, which is needed to make beta amyloid, a common marker for the disease. But gamma secretase does more than generate the brain plaque, and drug developers who block it entirely may well hurt patients.

Greengard, though, found a protein that is needed by gamma secretase to produce beta amyloid–and only beta amyloid. A variation of Gleevec that can remain in the brain–something the current formulation can’t accomplish–may be just what’s needed.

“You could use Gleevec as a starting molecule,” Harvard Alzheimer’s expert Rudolph Tanzi tells the Times. “You could change the structure a little bit and try analogs until you get one that does what Gleevec does and does not get kicked out of the brain. That’s possible.”

- read the NYT story

Related Articles:
Start-up biotech with Nobel founder, $8M lands in Florida
Lilly’s Alzheimer’s disaster spells trouble for entire class
Lilly halts Phase III Alzheimer’s program
Data-sharing breeds Alzheimer’s progress

Read the original here
Nobel Prize-winner finds new path for Alzheimer’s drug

At the time, the committee sent a wad of documents to the FDA that contained emails and drafts of different manuscripts. One appeared slated for the American Journal of Cardiology and the lead author was Baylor College’s Steve Haffner (see this). Also included was a draft manuscript of a study destined for Circulation (see attachments H and I).

Read more here

Genzyme already has the diagnostics business, along with its oncology genetics testing ops, up for sale. And it won’t wait for Sanofi’s next big move before choosing a buyer.

“The processes are continuing and we expect transactions to close by year end,” Genzyme CEO Henri Termeer told Reuters. “We are stopping no development at this stage.” Termeer has been on the press circuit this week to make clear he’d gladly sell Genzyme–for the right price. And $18.5 billion, he insists, is not the right price.

The two business units generate more than a half billion dollars in annual sales, but Genentech put them on the auction block after mounting a turnaround effort that includes a closer focus on its core business strategy. Reuters even found some interest for a deal at PerkinElmer. But analysts say they’re not looking for any fresh sales deals at Genzyme before the faceoff with Sanofi is completed.

“I would be very surprised to see Genzyme go off and sell that diagnostic testing business before they’ve teased out the Sanofi thing as far as they can go,” Jefferies analyst Arthur Henderson tells the wire service. “If they really wanted to disrupt the (Sanofi) discussions that might be a possibility.”

- here’s the report from Reuters

Related Articles:
Quiet panic at Genzyme as merger leaks dry up
Termeer insists Genzyme is worth much more than $18.5B
Genzyme rejects Sanofi’s $18.5B offer

Read more from the original source
Genzyme dickers over sales deals as Sanofi dangles

Allergan — the company that markets Botox legally for wrinkles and illegally for other things — agreed to pay $600 million in fines, including $375 million to the government as part of a Botox “misbranding” charge. Allergan admitted that its marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy. Read the media stories and press releases here.

Considering that Eli Lilly paid $1.41 billion to settle charges that it had improperly marketed  Zyprexa for elderly patients with dementia and that Pfizer paid $2.3 billion to settle charges that it had illegally marketed the painkiller Bextra, the $600 million Allergan has to pay seems “reasonable,” which is exactly how  Larry Biegelsen, an analyst at Wells Fargo Securities in New York, described it: “The $600 million settlement amount appears reasonable based on industry standards.”

Why such a “reasonable” settlement for a drug company that, IMHO, is an unethical marketer and the the drug industry poster boy for off-label promotion? Allergan, for example, has refused to abide by PhRMA’s DTC Guidelines as well as PhRMA’s Guidelines for Interactions with Healthcare Professionals (see “Allergan Doesn’t Comply with PhRMA Guidelines, Wins Kudos Anyway“). Allergan has also been cited by the FDA for other violations such as a misleading Latisse Web site (see “FDA Reads My Blog: Declares Latisse Web Site Misleading“).

You must read a bit further down in the media articles about this to learn that Allergan “is required as part of the agreement to drop the lawsuit it filed against the FDA in October challenging a government rule that prohibits marketing drugs for unapproved uses.”

There’s a lot to ponder when reading that statement.

I ponder, for example, whether Allergan got off much easier because it agreed to drop its suit? Which was probably frivolous to begin with!

BTW, I’ve written about Allergan’s off-label migraine shenanigans previously. See Allergan’s “Eye-popping” Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

Allergan is currently seeking FDA approval of Botox for the treatment of migraine. In the above post I reviewed a clinical study that Allergan is doing to support its case. The drug was so ineffectual that the researchers admitted they “have searched for patient characteristics that may predict a favorable treatment response.” Of course, they ultimately were successful in winnowing down the migraine population that is responsive to treatment: ie, those people who suffer from “imploding” or “eye-popping” headaches but NOT “exploding” headaches.

This would all be a joke if Botox was not such a dangerous drug, which includes a black box warning on its label. But I won’t get into that — you can read what other people have to say about the dangers of Botox here.

P.S. As part of the agreement with the Justice Department, Allergan also will be required to publish information about its payments to doctors. I am not anticipating that Allergan’s physician payment information will be easy to analyze considering that much more ethical drug companies have failed to be transparent in this regard (see “Transparency Vs. Translucency in Reporting Physician Payments“).

Read more from the original source
"Reasonable" $600 MILLION Fine for Misbranding BOTOX: I Guess Allergan’s Suit Against FDA Paid Off!

Merck decided recently to postpone a Phase III trial of oral vernakalant, a new drug to treat an irregular heartbeat, which analysts said would likely push back a commercial launch until 2016. News of the delay triggered a drop in Cardiome’s share price in August, but its stock was trading up 10 percent this morning. Merck handed over $60 million upfront for its pact covering vernakalant, along with $300 million in milestones.

“European approval and the milestone payment further strengthen Cardiome’s financial position, both in the near term and in the long term via royalties from product sales,” said Cardiome CEO Doug Janzen in a statement. “The teams at Merck and Cardiome have done an exemplary job in gaining European regulatory approval for Brinavess, and Cardiome is now part of a select group of biotechnology companies who have successfully shepherded a molecule from discovery through to product approval.”

- check out the Cardiome release for more info

Related Articles:
Cardiome shares soar on $700M Merck deal
EMA recommends Merck heart drug

Read more from the original source
Cardiome shares jump after vernakalant OK triggers $30M milestone

As far as I’m concerned, posters are quite a bit harder to work up than a talk. They really should stand by themselves, for one thing, so you can’t fill in any holes verbally. And narrative flow is harder: there’s no chance to go back and re-emphasize or contrast with later slides, because the whole thing is sitting out there, with no guarantee of what order people will use to see its parts. (I find that narrative is one of my main weapons in a presentation, so going without it is always tough).

I care about design, too, probably more than I should, so a poster also presents complications there. If visual cues wander a bit from slide to slide through a presentation, that’s not good, but it’s not fatal, either. But when everything’s up there on one sheet, the messages really have to be consistent: same fonts, same colors, same rotations, views, and angles, etc.

But at these times I try to remind myself of what happened to a friend of mine many years ago. She was working on a poster for an ACS meeting, and took it to her PI to look over. “Yes, yes, that looks good”, came the word, “but could you perhaps take this part over to here? And emphasize this a bit more? And. . .” So she went back and made the changes, and took the poster back for a re-check. “Much better! Yes. . .but I wonder if maybe this part should be bigger? And did you find a way to include those results where. . .” Back for another round.

After another iteration of this, she caught on. She started taking an unchanged version back to the PI, and after another couple of rounds of seeing the exact same poster, it was finally pronounced ready for viewing. Saves time, saves effort – try it when you can!

Read more here
Posters and Pickiness

Just a few weeks ago, Eisai paid $50 million for the rights to sell Arena Pharmaceuticals’ lorcaserin in the US; another $160 million based on development and approval milestones, and a $1.16 billion, one-time payment that may follow based on annual sales. Neither pill has been approved – an FDA advisory panel will review Arena’s lorcaserin on Sept. 16, while Orexigen’s Contrave is reviewed in December.

Read the original here

Allergan — the company that markets Botox legally for wrinkles and illegally for other things — agreed to pay $600 million in fines, including $375 million to the government as part of a Botox “misbranding” charge. Allergan admitted that its marketing of Botox from 2000 to 2005 led to intended use in treating headache, pain, muscle stiffness and juvenile cerebral palsy. Read the media stories and press releases here.

Considering that Eli Lilly paid $1.41 billion to settle charges that it had improperly marketed  Zyprexa for elderly patients with dementia and that Pfizer paid $2.3 billion to settle charges that it had illegally marketed the painkiller Bextra, the $600 million Allergan has to pay seems “reasonable,” which is exactly how  Larry Biegelsen, an analyst at Wells Fargo Securities in New York, described it: “The $600 million settlement amount appears reasonable based on industry standards.”

Why such a “reasonable” settlement for a drug company that, IMHO, is an unethical marketer and the the drug industry poster boy for off-label promotion? Allergan, for example, has refused to abide by PhRMA’s DTC Guidelines as well as PhRMA’s Guidelines for Interactions with Healthcare Professionals (see “Allergan Doesn’t Comply with PhRMA Guidelines, Wins Kudos Anyway“). Allergan has also been cited by the FDA for other violations such as a misleading Latisse Web site (see “FDA Reads My Blog: Declares Latisse Web Site Misleading“).

You must read a bit further down in the media articles about this to learn that Allergan “is required as part of the agreement to drop the lawsuit it filed against the FDA in October challenging a government rule that prohibits marketing drugs for unapproved uses.”

There’s a lot to ponder when reading that statement.

I ponder, for example, whether Allergan got off much easier because it agreed to drop its suit? Which was probably frivolous to begin with!

BTW, I’ve written about Allergan’s off-label migraine shenanigans previously. See Allergan’s “Eye-popping” Migraine Botox Study: Freedom of Expression or Off-Label Promo Tool?

Allergan is currently seeking FDA approval of Botox for the treatment of migraine. In the above post I reviewed a clinical study that Allergan is doing to support its case. The drug was so ineffectual that the researchers admitted they “have searched for patient characteristics that may predict a favorable treatment response.” Of course, they ultimately were successful in winnowing down the migraine population that is responsive to treatment: ie, those people who suffer from “imploding” or “eye-popping” headaches but NOT “exploding” headaches.

This would all be a joke if Botox was not such a dangerous drug, which includes a black box warning on its label. But I won’t get into that — you can read what other people have to say about the dangers of Botox here.

P.S. As part of the agreement with the Justice Department, Allergan also will be required to publish information about its payments to doctors. I am not anticipating that Allergan’s physician payment information will be easy to analyze considering that much more ethical drug companies have failed to be transparent in this regard (see “Transparency Vs. Translucency in Reporting Physician Payments“).

Read more from the original source
"Reasonable" $600 Fine for Misbranding BOTOX: I Guess Allergan’s Suit Against FDA Paid Off!

Fred Hassan of Schering-Plough, by far is a high-paid layoff leader. Last year he pocketed nearly $50 million when his firm merged with Merck and while 16,000 workers were receiving pink slips. Hassan’s 2009 pay could have covered the average cost of these workers’ jobless benefits for more than 10 weeks.

How do you think the rank and file at Merck feel about that ?  How do you think the 16,000 people who were laid off feel about that ?  Just because it’s OK to do it doesn’e mean it’s the right thing to do.

How do you think Allergan employees feel when they read that Allergan agreed on Wednesday to pay $600 million to settle charges that it illegally promoted and sold the drug through 2005 for unapproved uses like treating headaches ?

The company developed and put in place a wide-ranging marketing program, according to the complaint, that included paying kickbacks to doctors to induce them to prescribe Botox for conditions — like pain and severe spasms in the limbs of children with cerebral palsy — not included in the drug’s label.

Federal prosecutors also accused the company of teaching doctors how to get reimbursement from Medicare and Medicaid for off-label uses by putting in the codes for an approved treatment.

Based on this would you be proud to be an Allergan employee ?  What’s going on here and why does this continue to happen.  One word: sales.   The culture within certain pharma companies is that sales rule and do whatever we have to do to support sales.  It starts at the top with the CEO and trickles down.

When is a CEO going to come forward and say “patients always come first.  When we put patients first it leads to good business” ?   What is so troubling about the Allergan story is that the culture existed that allowed multiple employees to illegally sell Botox.  Where are the good people who should have raised their hand and were they silenced by people who are only concerned about the size of their bonuses ?

Of course not all CEO’s of drug companies are bad.  There are a lot of good ones who are leading the charge at companies like Amgen and Genentech Roche.  However, their good work is being overshadowed by the bad leadership of others within and industry that can’t afford too many more scandals.

Read more from the original source
Help Wanted: Pharma CEO who can provide leadership and focus on patients

Fred Hassan of Schering-Plough, by far is a high-paid layoff leader. Last year he pocketed nearly $50 million when his firm merged with Merck and while 16,000 workers were receiving pink slips. Hassan’s 2009 pay could have covered the average cost of these workers’ jobless benefits for more than 10 weeks.

How do you think the rank and file at Merck feel about that ?  How do you think the 16,000 people who were laid off feel about that ?  Just because it’s OK to do it doesn’e mean it’s the right thing to do.

How do you think Allergan employees feel when they read that Allergan agreed on Wednesday to pay $600 million to settle charges that it illegally promoted and sold the drug through 2005 for unapproved uses like treating headaches ?

The company developed and put in place a wide-ranging marketing program, according to the complaint, that included paying kickbacks to doctors to induce them to prescribe Botox for conditions — like pain and severe spasms in the limbs of children with cerebral palsy — not included in the drug’s label.

Federal prosecutors also accused the company of teaching doctors how to get reimbursement from Medicare and Medicaid for off-label uses by putting in the codes for an approved treatment.

Based on this would you be proud to be an Allergan employee ?  What’s going on here and why does this continue to happen.  One word: sales.   The culture within certain pharma companies is that sales rule and do whatever we have to do to support sales.  It starts at the top with the CEO and trickles down.

When is a CEO going to come forward and say “patients always come first.  When we put patients first it leads to good business” ?   What is so troubling about the Allergan story is that the culture existed that allowed multiple employees to illegally sell Botox.  Where are the good people who should have raised their hand and were they silenced by people who are only concerned about the size of their bonuses ?

Of course not all CEO’s of drug companies are bad.  There are a lot of good ones who are leading the charge at companies like Amgen and Genentech Roche.  However, their good work is being overshadowed by the bad leadership of others within and industry that can’t afford too many more scandals.

Read the original here
This is leadership ?

The study examined nearly 10,000 people 55 and older with pre-existing cardiovascular disease, type 2 diabetes or both, who were given Meridia or a placebo. They also participated in a diet and exercise program. On average, Meridia was taken for more than three years and the risk of a heart attack or stroke was 16 percent higher. Those taking the diet pill, which has been on the US market since 1997, were not more likely to die of cardiovascular disease, although it’s worth noting the drug is known to increase blood pressure and heart rates.

Read more from the original source

Orexigen’s deal, which bears a close resemblance to the pact rival Arena Pharmaceuticals inked with Eisai for its experimental weight drug, leaves the biotech with co-promotion rights in the big U.S. market. There hasn’t been a new obesity drug approved in the U.S. in more than a decade. And with the obesity epidemic tipping scales throughout the market, any approved drug could achieve blockbuster status.

So far, though, none of the three contenders, which includes Vivus, has been able to get a blockbuster-sized upfront check–a sign of the serious concerns about potential safety issues at the agency. That leaves much of these deals back-ended, built around milestones and the tiered double-digit royalty rate that Orexigen can earn from Takeda. Noticeably absent from the deal-making are the U.S. pharma companies, several of which have been badly burned by obesity drugs’ troubled safety record. Investors, however, were excited by the size of the pact, driving up Orexigen’s shares by 26 percent in early trading today.

The agency’s safety concerns were on full display during a recent FDA panel review of Arena’s drug lorcaserin, which was rejected by a majority of the agency’s experts ahead of the FDA’s final ruling. Orexigen now faces a panel review on December 7^th, with a final decision deadline of January 31. Contrave is a combination of naltrexone SR and bupropion SR.

“Contrave represents an important addition to Takeda’s cardiovascular and metabolic disease franchise and we look forward to partnering with Orexigen,” said Shinji Honda, the CEO of Takeda Pharmaceuticals North America. “Takeda has deep experience in providing important medicines to treat chronic disease and Contrave will help us provide a full spectrum of treatment to patients for the management of obesity.”

- here’s the Orexigen release
- see TheStreet‘s report

Related Articles:
Three biotechs race for Holy Grail of drug development
Orexigen weight-loss drug shows positive results in study
Orexigen lands panel review as obesity drug race heats up

Read more from the original source
Orexigen and Takeda ink a billion-dollar pact on weight loss drug

As most everyone in the biotech space is focused on the events coming in September/October, it’s a good idea to scan for companies with longer term, yet largely ignored, future catalysts. One such company with an impending future catalyst is Inspire Pharmaceuticals (ISPH).

Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases.⁽¹⁾ Inspire receives revenues through several product offerings targeting bacterial conjunctivitis, allergic conjunctivitis and dry eye. The referenced future catalyst involves their Phase 3 drug candidate Denufosol Tetrasodium, an inhalation solution for cystic fibrosis. According to the Company:

Complete Story »

By Brian Hicks

Last Saturday, the New York Times ran a rather lengthy piece on the Alzheimer’s epidemic. The article came on the heels of the high-profile failure of Lilly’s (LLY) late-stage AD drug, Semagacestat.

Complete Story »

By Roger Nachman

Don’t people buy stocks because they think the stocks will go up in value?

Complete Story »

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

• Herald Sun – Botox maker to pay $674m
• TheStreet.com – Allergan, Xbox Live: Hot Trends
• The Times – Botox maker to pay $600m for off label misuse
• USA Today – Botox maker to pay $600M to resolve federal investigation

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

• Bloomberg – Pfizer Agrees to Acquire FoldRx in Rare-Disease Treatment Expansion Effort
• Bloomberg Businessweek – Pfizer To Buy FoldRx in Rare-Disease Drug Expansion

• Minnapolis Star Tribune – Couche Tard raises buyout offer for Casey’s, which says it will review it
• Montreal Gazette – Couche-Tard further sweetens bid to buy Casey’s
• Montreal Gazette – Couche-tard extending the date of its tender offer

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.

This is especially true when it is straight up with no ulterior motive. We recently got amazing feedback from a client who chose us for a lot of great reasons. When asking for feedback, I always ask how we can do better. Ah. That’s where it gets interesting. Their feedback was essentially, that they liked us and they chose us because we approachable, knowledgeable, different, casual, informal. Moving forward, the feedback was that we should be more formal and a bit less casual. Hmmm.

Our clients and our competition acknowledge that we are market leaders but at what point should we suit up, lawyer up, and basically act like our competitors? How would we be different then?

I donated all of my suits to the Hope Program before we left NY, so I’m kind of screwed there. Although I do like our lawyers a lot, I’m not sure we need them at our meetings. I think we are in the process “buttoning up” in our own way, but we’ll still stick to our core values (and wardrobe) and keep winning new business.

Read more here
Acting Like a Market Leader

Key Insights & Trends (2010 vs. 2009)

We are seeing a significant rise in people using online to take charge of their health and better educate themselves about conditions and treatment options; allowing them to make informed decisions and have knowledgeable discussions with their doctors.

They rely on online information to…..• • • •

• Feel better informed when talking with their doctor, making it a two way dialogue rather then a one way conversation (68%)
• Research medications and therapies (62%)
• Get lifestyle suggestions to improve overall health and wellness (53%)
• Verify what doctors tell them (49%)

The trend of no longer just relying on doctors and filling prescriptions right away is accelerating. Right after diagnosis with a new condition, respondents took the following actions:

• Used search engines to find more information about conditions (65% in 10 vs. 47% in 09)
• Used search engines to learn about different treatment options (47% in 10 vs. 16% in 09)
• Went to health websites to find more information about conditions (43% in 10 vs. 20% in 09)

People are using health ads as information resources significantly more than last year, to help educate themselves. Online ads…

• Makes them aware of different treatment options (47% in 10 vs. 42% in 09)
• Inform them about symptoms and conditions (46% in 10 vs. 42% in 09)
• Makes it easier for them to speak knowledgably with their doctors (26% in 10 vs. 17% in 09)

People are also viewing health ads as helpful in coping with diseases and learning about medication side effects and safety. They are looking for pharmaceutical advertisers to provide them with information on:

• Possible side effects and drug safety (58% in 10 vs. 28% in 09)
• Ways to cope with a condition or disease (47% vs. 20%)
• Drug effectiveness (55%)

People find printable health tips (40%), free trial offers (38% in 10 vs. 18% in 09), and brief user stories (29%), as helpful in health ads

There are some differences for ad receptivity by age

• Younger adults 25-54 find user stories about people who experience the same symptoms more helpful compared to adults 55+ (32% vs. 27%)
• Adults 55+ are more receptive to ads that have information about coping with diseases (58% vs. 51%) and medication side effects/safety (69% vs. 62%), compared to younger adults

Ads that incorporate humor (45%) and visually appealing ads with a lot of color & pictures (44%), would grab the most attention

• Younger adults 25-54 are more receptive to ads with social elements and Interactive ads, while older adults 55+ are more receptive to video ads

Online health ads activate consumers. As a result of seeing a healthcare ad online…

• 44% researched medication in more detail as a result of seeing a healthcare ad online (vs. 36% in 09)
• 35% talked to their doctor after seeing an online healthcare ad

60% took action as a result of seeing a healthcare ad on About.com. The following actions were taken as a result of a health ad on About.com:

• Researched the medication in more detail (70%)
• Talked to my doctor (56%)
• Spoke to friends/family about the medication (33%)
• Visited pharmaceutical website (24%)

While Web MD is still considered the number one health portal 41% feel About.com is ‘Extremely Trustworthy’ for health information, more then most leading health sites:

• WebMD (48%),
• Everyday Health (8%),
• MSN Health (8%),
• Yahoo! Health (6%),
• AOL Health (6%)

DTC marketers should ensure that health information is consistent among sites and this means that they need to think of every touch point on the Internet.   Consumers are going to go to multiple health sites to get information so consistency of information is vital to communicate brand messages.

Read the original here
About.com 2010 Health Study

I do not remember opting in to receive email from Insyst Media — the company that sent me this email. But, who knows, it may be one of those “third-party partners” of a website where I signed up to learn more about cholesterol.

So, naturally, I clicked on the “GET THE FACTS” button and was delivered to this intriguing Web page (click on image for an enlarged, more readable view):

Again,I don’t recall opting in to any list maintained by  SearchNext, which is the company that seems responsible for this page. But being really curious where all this was leading, I obey and click on the button as indicated and end up on this page (click on image for an enlarged, more readable view):

Needless to say, I also never opted in to receive ads from FreshDeals.com –the entity that maintains this page. But I suspected that I was getting close to the sources who paid for all these companies to deliver ads to me. So I click on each ad on this page and discover that the top three links lead to pharmaceutical drug.com sites. One leads to Vytorin (Merck), another to Lipitor (Pfizer), and the third takes me to Zetia (also Merck). The last link goes to a Genentech non-branded site.

Following the Money Trail
I’m not interested in tracking down ALL these entities. I did, however, learn that SearchNext is a “pay-per-click advertiser marketplace that makes it easy to expand your already successful Google campaigns. Simply send us a dump of your AdWords campaigns and we will target your best converting keywords, geos and demos with our proprietary targeting and user qualification platform to turn users searching for your products into sales.”

This “marketplace” conveniently puts 3 degrees of separation between the spam email I received and the pharmaceutical advertiser:

Pharmaco — Fresh Deals — SearchNext — Insyst Media

I wonder if Merck, Pfizer, and Genentech realize that their Adword campaign is paying for spam e-mail? With 40% of pharma’s online advertising budget allocated to search marketing, I can’t imagine them NOT knowing!

Read more from the original source
Pharma Email Spam: Three Degrees of Separation for Merck, Pfizer, and Genentech

F4Q10 Earnings Call

September 1, 2010 10:00 a.m. ET

Complete Story »

“This program, based in ethical professional conduct, will be a culmination of education, training and experience. It is the logical next step for me based back in my academic home,” DeAngelis says in a statement, which notes she was vice dean for Academic Affairs and Faculty at Hopkins School of Medicine before going to JAMA and is a professor of pediatrics there.

Read the original here

The men allegedly met while attending the Executive MBA program at the Wharton School of Business in the mid-1990’s and, in March 2007, Self exec passed along confidential info about MedImmune. At the time, investment bankers were shopping the biotech to 22 drugmakers and Self had been assigned to evaluate a potential acquisition, according to the lawsuit. In fact, Self was “involved in practically all of the meetings” for due diligence and submitting a bid, the SEC alleges.

Read more here

At issue was whether Elizabeth Coleman could have reasonably known that her breast cancer was linked to one of the HRT meds she was prescribed prior to the 2002 disclosure by the Women’s Health Initiative showing the drugs can cause the afflication. A lower court determined Coleman should have known or had reason to investigate such a link even before the WHI study was released. The ruling backed Pfizer, which aruged a two-year statute of limitations in which to file a lawsuit had expired.

Read the original here

Another $225 million is being paid to in fines to cover civil claims asserted by the DOJ under the False Claims Act – there were three separate whistleblower lawsuits filed by Allergan employees that prompted the government probe (read them here, here and here). In addition, the drugmaker, which denies liability for the civil claims, is required to enter into a Corporate Integrity Agreement that will be overseen by an outside party and govern its marketing practices for several years. In a statement, Allergan issued the usual declaration that dispensing with all of the legal problems at once is in the best interest of shareholders.

Read more from the original source

And it’s a hard one to answer, because I had to do some backtracking, as so often happens in total synthesis. This was of the “Dang it all, turns out I can’t install that carbon at that step, so I’m going to have to go back, put it in earlier, and hope the downstream stuff still works” variety. (Not all of it did, of course). So how do you account for tactical moves like that? There are several layers.

How long would it have taken if I’d chosen the right move each time, and each reaction worked on the first shot? Even then, that’s a tricky one, because one typically runs things on a test scale and then on larger amounts as the ground firms up beneath you. So if things had worked every time, just fine, and I’d scaled up as soon as they did each time. . I’d say around a year. Maybe even nine months; it’s hard to say, because the concept of everything working is so alien.

Then one could ask, how long would it take to run through the chemistry in your dissertation, straight through, knowing what there is to know about it? In that case, it would be shorter. Just flogging away at the procedures, nonstop, and having nothing go wrong along the way (hah!), I think you could beat through everything in mine in two or three months. Boy howdy, would I hate doing that.

What does that leave out, then, of a degree that took me four and a half years? (A flippin’ short span, I might add, considering some of the other degrees coming out of my old group). Well, there are all those false starts down synthetic routes that ended up painting me into corners. Being carbohydrate-based synthesis, many of those were protecting group problems, but there were a couple of rip-the-whole-sequence-up episodes, too, when things just wouldn’t go any further. And there were things like finding out that a base camp of material I’d stored in the freezer had gone to hell anyway, in the dark, under argon. And realizing that a TBDMS group had up and migrated on me, such annoyances as that, which also involve proving that it happened and making sure that I knew where everything was still attached.

And there’s an awful lot of time spent just getting each reaction to work – six or eight or ten ways to bring in a methyl group. Four or five different reduction conditions. All those choices, every time: borane THF or borane-dimethylsulfide? Swern or PCC? Hydrogenation catalysts, Lewis acids, finding out that switching from BuLi to KHMDS when making methylene Wittig reagent changed the yield of alkene from 10% to 90%. Chip, chip, chip, at every step along the way. At the time, it seemed as if my legs were mired in not-so-fresh concrete, three feet deep across the lab. Looking back, though, I think I must have been flying. . .

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How Long Would It Take – If Everything Worked?

Developed in collaboration with cardiologist researchers, the app is simple to use: thedoctor presses it to the patient’s chest while using good-quality headphones (heart sounds are too deep to hear using the ubiquitous white ones that come with Apple devices). After listening, the doctor can shake the iPhone to hear the last 8 seconds and see a phonocardiograph display and a spectrogram. The audio and the spectrogram image can then be e-mailed. There have been some 500 apps downloaded ever since the free version was introduced in mid-August, according to its inventor Peter Bentley.

Read more from the original source
iStethoscope turns iPhone into a stethoscope

Things have changed, of course, as they always do. Now I scout for new Fierce 15 companies year-round. Any private developer I come across that has a compelling story to tell about great science, the venture funds they’ve raised, a stellar team of executives and wonderful prospects gets a note in the F-15 file. And some of these executives I know fairly well by now.

Over the next few weeks I’ll be putting the finishing touches to the 2010 Fierce 15, FierceBiotech’s ninth annual extravaganza. And while I have a number of prospective companies on my list, I haven’t finished the selection process. So, if you know of a private biotech company that deserves special recognition, drop me a note. We even have a handy new form for you to fill out.

This year we’re also making a major change to the selection process. Subscribers will have the chance to select one of the Fierce 15 in a reader’s choice selection. Just follow the link to place your recommendation and we’ll count the votes. Just keep in mind that the biotech you vote for has to be a private company.  

Click here to nominate your choice for this year’s Fierce 15.

We’ll have the report out later this month. I’ll keep you posted on the timing.  – John Carroll (twitter | email)

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Last call: Deadline looms for 2010 Fierce 15

> During its first meeting, the board of directors of Pierre Fabre appointed Olivier Bohuon as the company’s CEO. Pierre Fabre release

> Bionor Pharma has announced that Henrik Lund will take over the position of CEO from Trond Syvertsen. Bionor release

> Synexus has tapped Christophe Berthoux to become chief executive. Synexus release

> Oncothyreon has named Julie Eastland as CFO and VP, corporate development, effective Sept. 7. Oncothyreon release

> David Cohen is set to become COO of Millennium Laboratories. Millennium release

> King Pharmaceuticals has tapped Jeffrey Bailey to become chief commercial officer. King release

> Industry association LifeSciences British Columbia has appointed Don Enns as the new president of the organization effective Sept. 7. LifeSciences BC release

> Easton Pharmaceuticals has announced that Lee Hendelson will join the company as CFO. Easton release

> AmStem has named Dwight Brunoehler as president of the company. AmStem release

> Inspire Pharmaceuticals has appointed Robert Savel, II, to the position of senior VP and chief technical officer, effective Sept. 20. Inspire release

> PPD has named Neil McCullough as VP of quality management systems. PPD release

> MethylGene has appointed Martin Godbout as chairman of the board of directors. MethylGene’s board now numbers seven. MethylGene release

> XOMA has elected Jack Wyszomierski to its board of directors. Xoma release

> EUSA Pharma has appointed Stephen Stamp to the company’s board as an independent non-executive director. EUSA release

> Flagship Biosciences has formed a scientific advisory board composed of experienced leaders in the pharmaceutical industry. The members are John Bloom, Joseph Krueger, David Eberhard, Hadi Yaziji, Holger Lange, Robert Dunstan, Lewis Kinter, Jens Nyengaard, Jerry Hardisty, Neal Goodwin and David Fairley. Flagship release

Read the original here
Theratechnologies names Huss president, CEO

As reported earlier this year, the volume of regulatory action letters flowing from FDA's DDMAC continued to increase during the first half of the year at a rate that, if the trend continues, would see between 70-80 letters for the year – a substantial increase over recent years.

 

But what about the substance of those letters?  The numbers certainly tell us one aspect of the story – that enforcement is up, but it doesn't tell us what tripwires have been most commonly crossed.  

Read more here

Today I will listen to the BlogTalkRadio show “E-patients, Cyberchondriacs, and Why We Should Stop Calling Names,” which promises to be an “open, honest and stimulating discussion” about the “potential implications of the use of the term e-Patient and why some argue that it should be reconsidered.” As background to that discussion, see this blog post by Susannah Fox (@SusannahFox) who leads the Pew Internet & American Life Project’s health research. Susannah will be a guest on the BlogTalkRadio show today and will be speaking at the e-Patient Connections 2010 conference next month in Philadelphia, PA.

In her post, Susannah says: “In short, the data — Pew Internet’s and others’ — are quite clear that the online health revolution is over and that use of digital tools in tackling health problems is the natural state of affairs.”

I would argue that the online health revolution is no where near “over” just because the data shows that seeking health information online is now part of mainstream America (ie, 61% of American adults looked online for health information in the past year).

Seeking and FINDING credible, actionable, and personal health information online are TWO DIFFERENT things!

One piece of the online health revolution that has not yet occurred is the ability of the majority of Americans to easily access online their personal health information — things like summaries of doctor visits, medications you are currently taking, or test results. I have been thinking about this recently. With diet and exercising — something pharma marketers are often required to suggest in ads — I recently lost 25 lbs. But my doctor told me my cholesterol is still too high. She wanted to prescribe a stronger cholesterol-lowering drug that I would have to take for the rest of my life, whereas one of my goals for losing weight was to stop taking this medication all together. What I wanted to know — and what my physician didn’t tell me — was how my numbers compared pre and post weight loss. To get that information, I would have to go back to the doctor’s office and ask her for the data. Why can’t I just push a button in my Internet browser and get the data myself???

Yesterday, the Markle Foundation released a policy paper that said the ability for people to download their health records should be a priority in the nationwide push to upgrade health information technology. A public-private collaborative group of 46 providers, consumers, technology companies, insurers, and privacy advocates envisions a “blue button” as a common offering among secure websites for patients and beneficiaries by medical practices, hospitals, insurers, pharmacies, laboratories, and information services (see “Empowering the ePatient: A Simple “Blue Button” to Access Medical Records Online“).

“By clicking the blue button, you could get your own health information electronically—things like summaries of doctor visits, medications you are currently taking, or test results. Being able to have your own electronic copies and share them as you need to with your doctors is a first step in truly enabling people to engage in their health care,” said Carol Diamond, MD, MPH, managing director at Markle.

Soon US Veterans will have such a “blue button” (see Blue Button: Download My Data): President Obama announced the blue button for veterans in an August 3 address. “For the first time ever, veterans will be able to go to the VA website, click a simple blue button and download or print your personal health records so you have them when you need them, and can share them with your doctors outside of the VA,” the President said.

IMHO, when ALL Americans have access to a “blue button” the online health revolution will truly have just BEGUN!

P.S. “Question to Ask Your Doctor”: Where’s My Blue Button?

After posting this, I saw a tweet from @AstraZenecaUS:

“September is National Cholesterol Education Month. See your doctor and visit http://ow.ly/2qo5v for a list of questions to ask.”

This resolves to a page on the Crestor Web site. It just so happens that Crestor is the drug my doctor wants me to take instead of generic pravachol.

There are about 16 questions in AZ’s list! Given that the average time a patient has with a physician during an office visit is maybe 10 minutes, that’s about 38 seconds to ask each question and get an answer! Is AZ kidding? No wonder we don’t remember what the physician told us!

One question that AZ left was “How can I get my personal health record online so that I remember all this and can use it?”

It’s also amusing that AZ suggests you print out the pdf version of its list of questions and bring it with you to the doctor’s office. How quaint! Shouldn’t there be a “Share This With Your Physician” button on the page so that you can send the questions immediately to your physician before you even see her? Now that’s when the online health revolution will truly begin here in the US!

Read more from the original source
Until All of Us Have This "Blue Button," the Online Health Revolution Has Not Even Begun!

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Celator gains $20M round for cancer drug dev

Archimedes has toyed with the notion of going public, but opted instead to stay out of the soured public exchanges and raised $100 million last year for its commercial launch of the new pain therapy. Archimedes Pharma uses its nasal drug delivery system to deliver fentanyl in a “rapid but controlled manner.”

“The grant of European marketing authorization for PecFent provides a new therapy to improve the treatment options for adult patients with breakthrough cancer pain,” said CEO Jeffrey Buchalter. “This is also a transformative milestone for Archimedes Pharma as we have established commercial operations in Europe and look forward to launching PecFent in major European markets in the coming months.”

Just a week ago Archimedes said that it had decided to set up its U.S. beachhead in Bedminster, NJ, with plans to hire 75 workers to push PecFent.

- see the Archimedes release for more info

Related Articles:
Archimedes Pharma: Top 5 Biotech VC deals, H1 2010
Archimedes readies U.S. commercial ops for cancer pain
Archimedes starts recruiting for new U.S. headquarters

Read more here
Archimedes snags EMA approval for new pain therapy

FoldRx’s lead drug is tafamadis, which is designed to treat TTR amyloid polyneuropathy. A second tafamidis program has pushed through Phase II on TTR amyloid cardiomyopathy, which leads to heart failure. Last summer FoldRx touted the results of a II/III trial of tafamidis-calling it the “first disease-modifying agent targeting the underlying cause of a human amyloid disease.” The research has been funded by the National Institutes of Health, the Skaggs Institute for Chemical Biology, and The Lita Annenberg Hazen Foundation. FoldRx has filed for European approval and is close to filing its app with the FDA.

“This transaction will add another important component to the growing portfolio of innovative in-line and investigational medicines for orphan and rare diseases within Pfizer’s Specialty Care Business,” said Geno Germano, the president and general manager of Pfizer’s Specialty Care Business Unit, “and will complement the current and planned future research and clinical development taking place in Pfizer’s Specialty Care Neuroscience disease area.” FoldRx’s portfolio includes clinical and pre-clinical programs for investigational compounds to treat diseases caused by protein misfolding.

“Over the past five years the FoldRx team has successfully developed tafamidis from the bench stage to MAA submission,” said Richard Labaudiniere, president and chief executive officer of FoldRx. “Pfizer’s strong clinical and regulatory resources, global marketing reach, and commitment to the treatment of rare diseases will significantly enhance the ability to pursue the goal of efficiently bringing tafamidis to all patients affected by this devastating neurodegenerative disease.”

- here’s the FoldRx release

Related Articles:
FoldRx banks $29M for neurodegenerative drug application
FoldRx touts tafamidis data
EXCLUSIVE: Pfizer plans to move fast on rare disease pacts
Pfizer creates a new R&D unit for rare diseases

Read more from the original source
Pfizer buys FoldRx for rare disease division

Recently, Alimera Sciences’ (ALIM) pipeline received a boost when the US Food and Drug Administration ("FDA") accepted the New Drug Application ("NDA") for its lead candidate, Iluvien. Furthermore, the agency has decided to review the application on a priority basis. The company is looking to gain approval for Iluvien for the treatment of diabetic macular edema (DME).

The company filed the NDA with the FDA in late June 2010. The US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases having no adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission instead of the usual ten months. Based on that criterion, a response from the FDA should be out in the fourth quarter of 2010.

Complete Story »

CLT- 008 is in a Phase I study in patients undergoing cord blood transplants for the treatment of hematological malignancies. It’s designed to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation. This is Cellerant’s second contract with BARDA, following its move to proffer $11 million for the same development program in 2008.

BARDA’s on something of a roll these days, pushing new biodefense programs on several fronts. Just yesterday Achaogen–which was in the 2009 class of Fierce 15 companies–announced that it had nailed a $64 million BARDA contract to support the company’s lead antibiotic ACHN-490.

 ”We are delighted to have been awarded this new contract from BARDA,” said Ram Mandalam, Ph.D., president and CEO of Cellerant Therapeutics. “We believe Cellerant is at the forefront of the development of a solution for ARS and we share BARDA’s commitment to developing CLT-008 as an effective countermeasure to support our biodefense interests.”

- take a look at the Cellerant release

Related Article:
Cellerant Therapeutics – 2005 Fierce 15 Revisited
Achaogen wins $64M biodefense contract

Read the original here
Cellerant lands $153M BARDA contract for ARS program

Of course, jobs are coming and going all the time. And as we have noted before, it remains possible the picture is even worse, because the report may not capture every lost job. Layoffs often occur in dribs and drabs, which means some job losses do not land on radar screens monitored by the media or state labor departments, which require notice when a certain number of jobs are to be eliminated. Cypress Bioscience, however, recently notified California authorities that 123 jobs will soon go (see this). This approach to layoffs will continue for the foreseeable future, so getting a true picture remains challenging.

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Pharma Job Cuts Fell In August: Survey

Americans spend twice as much as residents of other developed countries on healthcare, but get lower quality, less efficiency and have the least equitable system.   Source: Reuters

Consumers want more help from their doctors in finding relevant health information on the web, but their doctors are often failing to deliver, according to new research by consumer engagement specialist Kyp and Opinion Research Corporation.  According to the study;

• 76% of respondents search the internet for health information

• only 22% use the web as their first port of call after they suspect a health problem – seemingly because of the confusing number of online sources.

• Even in the 18-34 demographic, more than half (55%) report that “there is just too much choice” and that they “simply don’t know where to turn for the best advice.

Source: Medical Marketing & Media

The presence of one’s near and dear ones on an online social network doesn’t stop people from being wary of the network itself, according to the findings of a Vision Critical survey.  Respondents to the polling (fielded online in March) were asked how trustworthy they think online social networks are.

• Few of the U.S. respondents said they regard such networks as “completely trustworthy” (5 percent) or “very trustworthy” (11 percent).

• Thirty-five percent rated them “fairly trustworthy.”

• Nearly half said they’re “not very” (32 percent) or “not at all” (17 percent) trustworthy.  Source: Adweek May 25th, 2010

About 57% of men have visited the doctor within the past year, compared with about 74% of women, according to surveys by the federal Agency for Healthcare Research and Quality (AHRQ). Black and Hispanic men are even less likely than white men to have routine checkups. At the same time, men are hospitalized at significantly higher rates than women for preventable conditions such as congestive heart failure and complications of diabetes and pneumonia that can be prevented with a vaccination. Source: Wall Street Journal

One-third to one-half of all patients do not take medication as prescribed, and up to one-quarter never fill prescriptions at all, experts say. Such lapses fuel more than $100 billion dollars in health costs annually because those patients often get sicker. Source: New York Times

Studies show that nearly 9 out of 10 adults may lack the skills needed to manage their health and prevent disease

Source: 2003 National Assessment of Adult Literacy Study.

The number of physicians who were “rep-accessible,” defined as meeting with at least 70% of salespeople who come calling, dropped by 18% from last year, according to sales and marketing consultants ZS Associates.  In a report out today, the firm says 58% of prescribing doctors now fall into that rep-friendly category, down from 71% in the previous survey. The proportion of physicians who see fewer than 30% of reps who visit now sits at 9%, up from 6% in the last survey. Source: Wall Street Journal

If Americans reduced their salt intake to the recommended maximum amount, hypertension cases could be cut by 11 million with a savings of $18 billion in healthcare costs and 312,000 years of life gained.   Source: LA Times.

Figures from the National Center for Health Statistics showed 34% of American adults age 20 and older were obese in 2007-08 while 68% were considered overweight or obese. In children ages 2 through 19, 17% were considered obese while 32% were considered overweight. Broadly, the figures are similar to rates seen in 1999-2000.

A University of Chicago study estimates that Americans with diabetes will increase from 24 million people to about 44 million people by 2034, with direct health care costs increasing from $116 billion a year to $336 billion a year. This is a tremendous cost to our economy and a painful reality for millions of Americans.  Source: Forbes.

A survey, released in November 2009, found 86% of U.S. physicians use the Internet to gather health, medical or prescription drug information.  That number echoes other surveys showing large numbers of physicians relying on the Internet for health information. A study earlier in 2009 by Manhattan Research put the number at 89%.  Of physicians who use the Internet for health information, 92% said they accessed it from their office, while 21% said they did so with a patient in the examination room. Meanwhile, 88% said they looked for health information online from home, while 59% reported doing so from a mobile device. Physicians who responded to the survey could give more than one answer about their Internet use. Source: American Medical News.

Nearly half of women seeking health answers online do so first, before talking to their doctors or family members, according to a Harris Interactive poll, conducted on behalf of iVillage, an online community for women.  The online survey of 2,608 adults, 1,342 of whom were women, found that anonymity and the ability to share common experiences with other members of an online community are what drives 49% of the women respondents to look online first. About half that, 25%, said they would go to a doctor first. Source: American Medical News

Read more here
Healthcare facts n’ figures

Building on their release in early August, researchers found a 28 percent reduction in LDL levels in the drug group compared to a five percent increase among the placebo arm. “Having these data presented is a great milestone for the mipomersen program,” said Paula Soteropoulos, vice president and general manager of Genzyme’s cardiovascular business. “The data underscore our belief that mipomersen has the potential to help those familial hypercholesterolemia patients who are ‘left behind’ by current therapies, and are in need of new treatment options.”

Genzyme wants to use the drug to treat familial hypercholesterolemia, a genetic disorder that triggers high levels of bad cholesterol. But analysts have been buzzing that a spike in liver enzymes–a classic red flag for researchers–could significantly curtail the drug’s overall market reach.

According to their release from the European Society of Cardiology’s Congress in Stockholm, Sweden, liver enzymes spiked in seven percent of the drug group, forcing three of the 83 patients in the drug arm to drop out of the study. Another seven were forced out citing other side effects such as injection site reactions.

“In all four of the Phase III studies we have completed, we have seen consistent and robust reductions in LDL cholesterol and other atherogenic lipids that support our plan to initially target homozygous and severe heterozygous familial hypercholesterolemia patients,” Isis Pharmaceuticals Chairman and CEO Stanley Crooke, said in a statement.

- check out the Genzyme/Isis release
- read the Reuters story
- here’s the report from the Boston Globe

Related Articles:
Isis, Genzyme brace for new round of late-stage cholesterol data
Isis hits Ph3 endpoint but shares slide on liver worries
Isis cholesterol drug hits bulls-eye in pivotal trial
Genzyme: Phase III mipomersen a success

Read the original here
PhIII: Liver enzymes spike in 7% of mipomersen group

Who were the layoff leaders? Topping the list was Fred Hassan, the former Schering-Plough ceo, according to a report by the Institute for Policy Studies. Hassan received a $33 million golden parachute when the drugmaker was bought by Merck last year. Meanwhile, 16,000 jobs are being eliminated (background). Hassan’s total 2009 pay of nearly $50 million could cover the average cost of these workers’ jobless benefits for more than 10 weeks.

Next up is the king of recalls, Johnson & Johnson ceo, Bill Weldon, who took home $25.6 million, more than three times as much as the S&P 500 CEO average, at a time when his firm was slashing about 9,000 jobs (more background). Among the cuts are 300 jobs at a McNeil Consumer Healthcare plant in Fort Washington, Pa., where a plant is shuttered in the wake of the recall of millions of bottles of pediatric over-the-counter meds (see here). Weldon also bought a nice home recently (see here).

“CEOs are clearly not hurting. But they are…causing others to needlessly hurt — by cutting jobs to feather their own already comfortable executive nests…Most careful analysts of the high-finance meltdown that ushered in the Great Recession have concluded that excessive executive compensation played a prime causal role. Outrageously high rewards gave executives an incentive to behave outrageously, to take the sorts of reckless risks that would eventually endanger our entire economy,” ISP writes, which uses the report to call for Congress to reform executive pay and bring it back to “mid-20th century levels.”

Read more from the original source
Did Layoffs Help Hassan And Weldon Prosper?

To wit, the FDA noted that Sun Pharma was aware last September that bottles of Gemfibrozil tablets, which are used to regulate cholesterol and triglycerides, were imploding in its sample room, but did nothing about the problem until the agency showed up this past March. There was no field alert issued. There was no recall until March of this year. And there was no explanation as to why Sun failed to investigate until the FDA arrived.

Not surprisingly, this led the FDA to write – with a bit of understatement – that Sun’s process for manufacturing Gernfibrozil tablets “is not in a state of control and is not capable of producing batches of consistent quality.” For now, Sun is not manufacturing the tablets, but this set of events hardly inspires confidence. Sun, after all, manufactures many generics; for instance, the drugmaker just received FDA approval to sell a copycat version of Eli Lilly’s Straterra for ADHD (take a look).

Imagine if bottles of some other meds start imploding on store shelves. By comparison, that could make the musty smelling Tylenol bottles sold by Johnson & Johnson’s McNeil Consumer Healthcare unit smelling like, well, roses.

Read more from the original source
Sun Pharma And Its Incredible, Imploding Bottles