BioSpace BioPharm Exec
Tuesday, November 24, 2009
Where'd the Jobs Go?

The Pharmaceutical Research and Manufacturers of America (PhRMA) took great exception to a recent story published in the New York Times. It suggested that drug manufacturers have raised prices this year to cushion themselves against future cuts that would come with health care reform.

Not so, says PhRMA senior vice president Ken Johnson. He notes that the costs cited in the article don't reflect many of the discounts and rebates that ultimately accrue to many consumers. And he raises some fair points. But one of the main thrusts of his argument is that the industry is in bad shape, financially speaking, and is responding to its own internal forces and those of the market, not the threat of new legislation. Raising prices is a matter of survival, not profiteering.

Certainly one could counter that price hikes, whatever the reason for them, are still price hikes. They are hard to shoulder for consumers that rely on brand name drugs, even if many others are now saving money with new generics. In any case, Johnson's attempt to challenge the indelible image of an industry awash in profits will probably fall on deaf ears, because he's a flak for a trade association, after all. But that's kind of his point--the image is too seldom challenged by ostensibly independent journalists.

This is a new wrinkle on an age-old battle, of course. But I was struck by one small detail in his piece: Johnson says that 58,000 industry jobs have been lost so far this year.

That statistic was attributed to Forbes. More...

More By Karl Thiel

The annual meeting of the American Heart Association took place this month in Orlando, Florida, so this month's clinical news came straight from the heart (well, mostly). In addition to some good news for AstraZeneca (and bad news for Plavix--see Rockville Files below), The Medicines Co. resurrected hopes for Cangrelor, its antiplatelet drug that was halted in a large-scale pivotal study back in May after failing to meet its primary endpoint. They now say the data shows evidence of efficacy in patients undergoing percutaneous coronary intervention. Isis had good news on its cholesterol drug, and Merck continued to play down negativity around Zetia and Vytorin. Good stuff all around.

As for other matters of the heart, there was some news there, too. Vivus continues to advance its erectile dysfunction drug, and Boehringer Ingelheim now has positive phase 3 data on flibanserin, its treatment for Hypoactive Sexual Desire Disorder (HSDD) in women. Much as Pfizer did away with the term "impotence" with ED breakthrough Viagra, Boehringer is avoiding the unpleasant term "frigidity." Probably a smart move. But a winning product? It's not a pill you pop when you're in the mood (or wish you were in the mood); it takes three to six weeks to kick in. And then there's the whole issue of whether this is really a medical issue at all. Sure, there's a large potential market and this could prove a surprise success much as Viagra once did, but it looks like an uphill climb.
-KT

AstraZeneca PLC (AZN): Ticagrelor (BRILINTA(TM)) Demonstrated Greater Efficacy Over Clopidogrel in the Most Urgent Clinical Setting
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Merck & Co., Inc. (MRK) Expresses Confidence in the Efficacy and Safety Profiles of ZETIA(R) (ezetimibe) and VYTORIN(R) (ezetimibe/simvastatin) as Effective Medicines for Managing Elevated Cholesterol
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The Medicines Company (MDCO)'s Full Analysis of CHAMPION Phase III Data Shows Cangrelor Significantly Improves Patient Outcomes Following PCI
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Isis Pharmaceuticals, Inc. (ISIS) (JOBS) Cholesterol Drug Meets All Goals of Key Trial
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VIVUS, Inc. (VVUS) Says Erectile Dysfunction Trial Meets Goals
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Boehringer Ingelheim Corporation (JOBS) Drug Shown to Kindle Female Sex Drive
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The Obama Administration just nominated a gonzo consumer watchdog--one with a long history of goosing pharma companies--to one of two new commissioner posts at the Federal Trade Commission. The In Vivo Blog reports that Brill, who spent much of the past decade as attorney general of Vermont, is responsible for a lot of innovative/arduous/insert-your-favorite-term-here regulation on the industry. That includes the state's requirement that companies publicly disclose gifts to physicians, among other things. It will be interesting to see if this in any way influences the looming battle on REMS and promotional strategies that I mentioned in last month's intro.
-KT

Julie Brill Nominated to FTC: A Message to Drug Manufacturers?
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Pfizer Inc. (PFE) (JOBS) to Shutter Six Out of 20 R&D Sites
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Eli Lilly and Company (LLY) (JOBS) Snags AstraZeneca PLC (AZN) (JOBS) Executive as New R&D Head
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Cannasat Therapeutics Inc. (CTH.TO) Announces New Chief Executive Officer: Anthony J. Giovinazzo, M.B.A., C.Dir.
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Big pharma is shelling out big bucks for drugs that inhibit nerve growth factor. Abbott is paying $170 million upfront--upfront!--for global rights to PanGenetics' pain drug even though it is still in phase 1 (!). And Sanofi-Aventis has agreed to pay Regeneron a sweet $160 million a year in R&D financing through 2017 to forward a broad monoclonal antibody program, a generous expansion of an existing collaboration. And the most advanced compound to come out of that partnership is an anti-NGF drug currently in phase 2.

Meanwhile, Obesity Drug Madness heated up with a potentially big deal between Takeda and Amylin, Bristol-Myers Squibb continued to narrow its focus, and Merck completed its merger with Schering-Plough.
-KT

Abbott Laboratories (ABT) (JOBS) to Acquire Novel Investigational Biologic from PanGenetics B.V.'s to Treat Chronic Pain for $190 Million
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Regeneron Pharmaceuticals, Inc. (REGN) (JOBS), Sanofi-Aventis (France) (SASY.PA) (JOBS), Expand Drug Partnership; Sanofi to Increase Funding to Regeneron to $160 Million
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Bristol-Myers Squibb Company (BMY) (JOBS) to Spin Off Mead Johnson Nutrition Company Stock
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Amylin Pharmaceuticals, Inc. (AMLN) (JOBS) Strikes $1 Billion Deal with Takeda Pharmaceutical Co. Ltd. (TKDG.DE) (JOBS) to Co-Develop Weight Loss Drugs
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Symphony Capital has been very forward-thinking in the world of biotech financing, structuring itself as a private equity group dedicated to funding clinical development programs at publicly-held biotech companies. (That is, ones that nonetheless can't get all the funding they need through the public markets.) It has essentially bought drugs or clinical programs from companies, helped the innovators with funding and development, and then sold them back. Dynavax just bought back rights to its hepatitis C program (having already bought back rights to its hepatitis B program earlier). But whether that closes the book on another successful Symphony transaction remains to be seen. The private equity firm isn't shy about risk, having given up its product rights (along with $20 million in cash) for a 24% ownership stake in the company. It's good to see some of the creativity and healthy risk-taking necessary to push innovative products to market, and Dynavax's subsequent success or failure will help determine if this model catches on more widely.
-KT

Dynavax Technologies Corporation (DVAX) to Acquire Symphony Dynamo, Inc., Including $20 Million in Unrestricted Cash
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Cell & Gene Therapy Forum 2010 and Washington Vaccine Forum Phacilitate's Cell & Gene Therapy Forum 2010 and Washington Vaccine Forum will take place together for the 5th time in 2010. These 2 sector leading conferences run in parallel with all networking taking place in a shared exhibition area. 500+ senior level life sciences decision-makers have attended in each of the last 3 years. Event Sponsors Sangamo Biosciences, Lonza, Progenitor Cell Therapy, BioLife Solutions, DynPort Vaccine Company and Emergent BioSolutions CHI's 17th International Molecular Medicine Tri-Conference Shaping The Future CHI's 17th International Molecular Medicine Tri-Conference - Shaping The Future. February 3-5, San Francisco. 3,000 attendees, 1200 participating companies, 150 exhibitors As the need for better information, new technologies, improved strategies and competitive intelligence becomes ever more acute, this event provides compelling research insight into the future of molecular medicine.
As healthcare reform gets closer to the day of reckoning, it has become the lobbying Olympics out there. Sure, lobbying is a fact of life, but Genentech has proven unusually adept at it. The talking points it drafted, and disseminated through its lobbyists Sonnenschein Nath & Rosenthal, have shown up in the mouths of a remarkable number of elected officials, according to the New York Times. They were parroted by 42 members of the House of Representatives--22 Republicans and 20 Democrats. At least a couple--Joe Wilson (R-S.C) and Blaine Luetkemeyer (R-Mo.)--repeated points verbatim. It's always good to remember the origin of much of our political rhetoric.

Nevertheless, the larger point is that members of Congress on both sides of the aisle used Genentech's rhetoric to argue with each other--an indication that support for the biosimilars part of the House bill, at least, is pretty solid.
-KT

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It was a tough month for Plavix, the mega-blockbuster Sanofi-Aventis/Bristol-Myers Squibb antiplatelet drug, thanks in large part to AstraZeneca. First, AstraZeneca released results of a head-to-head study in which its just-submitted Brilinta proved superior to Plavix in reducing risk of death, heart attack and stroke and patients with acute coronary syndrome. Then FDA required Plavix to be relabeled to indicate a risk of interaction with the heartburn drugs Prilosec and Nexium, made by...you guessed it...AstraZeneca. Also, new joint guidelines from the American Heart Association, American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions designate the newest competitor to Plavix, Eli Lilly's Effient (prasugrel), as a Class 1 therapeutic for patients with severe heart attack or undergoing percutaneous coronary intervention. Even The Medicines Co. got in on the action by refusing to let its aspiring entrant to the field, Cangrelor, go gentle into that good night. Facing patent expiration in 2011, it doesn't look like Plavix will be able to relax and enjoy its golden years.

Oh...and traces of rubber and steel found in certain Genzyme drugs, including Cerezyme? Sheesh! Get it together, people!
-KT

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Karl Thiel is an analyst for The Motley Fool, a columnist for BioWorld Today, and a contributor to Nature Biotechnology. He lives in Portland, Oregon.

You may contact Karl Thiel at Karl.thiel@biospace.com.

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