BioSpace BioPharm Exec
Wednesday, December 15, 2010
Top 10: 2010 In Review

As traditions go, this one is still in short pants. Nevertheless, the arrival of December means it is time for our third annual Top 10 Year in Review--Biopharm Executive's entirely subjective look back at 10 stories or trends that shaped the year we just lived through...and perhaps the one ahead. Let the countdown begin.

#10: Wikileaks. This is, of course, about a lot more than the biotech and pharma industry, but there seems to be no limit to the revelations coming from these leaked documents. We learned about overseas pharma facilities that the U.S. government deems vital to U.S. security--mainly those making vaccines of various kinds, but also other products that could "critically impact the public health, economic security, and/or national and homeland security of the United States." And we saw some documents talking about Pfizer's seamy dealings in Nigeria. What will come out next?! More...

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Amarin produced some very impressive clinical results in its phase 3 study of AMR101--so impressive that the company is looking to file for FDA approval earlier than expected on the basis of this single study. AMR101 is derived from Omega-3 fatty acids (you know, fish oil!) and is intended to lower triglyceride levels in the blood, and it did just that in a pivotal clinical trial. But perhaps more importantly, it apparently did it without raising "bad" LDL cholesterol levels. That may distinguish it from GlaxoSmithKline's Lovaza, the only other approved drug for high triglycerides.
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Amarin Corporation PLC (AMRN) Omega-3 Drug, AMR101, Lowers Blood-Fat Levels in Clinical Trial; Stock Rises; Drug Will Be Submitted for FDA Approval Earlier Than Expected
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Teva Pharmaceutical Industries Limited (TEVA)/Active Biotech AB's MS Pill Shines in Phase III Study
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Onyx Pharmaceuticals, Inc. (ONXX) Drug Carfilzomib Reduces Cancer in a Third of Patients With Deadly Blood Cancer in Phase 2 Study; Raising Stakes in Rivalry with Millennium: The Takeda Oncology Company
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Seattle Genetics, Inc. (SGEN) and Millennium: The Takeda Oncology Company's Experimental Drug, SGN-35 Shrinks Hodgkin's Tumors, Study Shows
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Pfizer Inc. (PFE)'s Investigational Compound Bosutinib Fails to Meet Primary Endpoint in Phase 3 Study For Chronic Myeloid Leukemia
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More Bench To Clinic News
Pfizer CEO Jeff Kindler surprised the industry on December 5 by announcing that he was retiring at age 55. He makes a compelling case about what I'm sure is indeed an "extremely demanding" job, but the size of his retirement package suggests he may have been pressured to leave. The immediate pressure, according to various media reports, didn't come so much from the company's underperformance or a series of marketing and legal issues--including some Wikileaks allegations about the company's conduct in Nigeria--but because he wouldn't name Ian Read as COO. Read will now succeed Kindler as CEO, although the chairman role will now be filled by a different person.
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Pfizer Inc. (PFE) CEO Leaves 'Extremely Demanding' Job; Ian Read to Replace Jeffrey B. Kindler
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Merck & Co., Inc. (MRK) Elevates Frazier to Succeed Clark as CEO
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Pfizer Inc. (PFE) Names Simmons Head of Emerging Markets
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Cephalon, Inc. (CEPH) Announces Chairman and CEO to Remain on Medical Leave of Absence Indefinitely
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Elan Corporation PLC (ELN) Names Ex-GlaxoSmithKline (GSK) CEO Robert Ingram Chairman, Replacing McLaughlin
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More Career Track News
Sanofi-Aventis' hostile bid for Genzyme has expired, leaving the companies at an impasse. Since Genzyme couldn't muster up a white knight bid (it tried and failed with Takeda last month), the French pharma has little reason to immediately up its bid. On the other hand, with Genzyme shares still trading over the $69 bid price, investors have little reason to tender shares right now. So some deal extensions are the likely outcome--perhaps until Sanofi calls Genzyme shareholders' bluff by saying it refuses another extension. Then we'll see what happens to the share price.

J&J is making a bid to expand its presence in the global vaccine market by acquiring the rest of Crucell--and in this case, the acquiree's management is on board. And since last month, I pointed out that Pfizer had raised some doubts about RNAi progress by scrapping its Alnylam programs, it's only fair to point out that Kyowa Hakko is expanding its existing agreement with Dicerna for its Dicer substrate RNAi-cleaving technology.
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As Deadline Nears, Suitor Sanofi-Aventis (France) (SASY.PA) May Have to Revise Bid For Genzyme Corporation (GENZ)
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Johnson & Johnson (JNJ) Launches $2.3 Billion Bid for Crucell N.V. (CRXL)
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Dicerna Pharmaceuticals Expands Pact Kyowa Hakko Kirin; Original Agreement Worth $1.4 Billion Potentially
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GE Healthcare and Johnson & Johnson (JNJ)'s Janssen Pharmaceutica N.V. Deal Pairs Two Alzheimer's Powerhouses
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Merck & Co., Inc. (MRK) to Buy SmartCells, Inc. in Deal Worth Possibly $500 Million
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More Golden Handshakes News

Top Jobs
• BioMidwest (Chicago, Illinois)

Leland Partners
Director of Clinical Affairs and Health Economics
The Director will contribute to improved profitability and continued growth of the company by examining the payment environment in key markets, developing compelling analysis to provide strong economic value propositions for payers of their products and implement a selected course of action to ensure that there is integration with R&D, NPD, Marketing, Clinical Research and local business needs.

• Biotech Bay (Berkeley, California)

Dynavax Technologies
Associate Director, Oligonucleotide Technology
Initiate, manage and lead oligonucleotide technology development activities that contribute to the development of the companys scientific and product programs. Responsible for operational and strategic oversight for the CMC component of Dynavaxs Oligonucleotide programs. The position is expected to partner with other members of the Companys scientific team to apply the companys core technology in the identification and advancement of new product opportunities.

• Genetown (Boston, Massachusetts)

On Assignment Clinical Research
Director of Clinical Operations
The Director, Clinical Operations will function as the Clinical Operations Program Lead and be responsible for the operational oversight for the companys premier drug. Oversight includes operational strategy, timelines, metrics, budget and preparation for submissions. He/she will be a key member on the Clinical Development Team and other cross-functional forums.

• Pharm Country (New York City, New York)

BGB Communications, LLC
Vice President, Group Account Director
The Vice President, Group Account Director (VP, GAD) is responsible for all the accounts assigned to his/her group. Essentially, this group head's function is one of personal leadership in client relations and in internal management of accounts. The VP, GAD is the person to whom the account team looks for support, guidance, and mentorship, and to whom clients look as the agency's representative on medical education strategy and execution.

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Pharm Country Career Fair Pharm Country Career Fair
Bridgewater Marriott Thursday, February 10, 2011, 11am - 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the tri-state area.
Genetown Career Fair Genetown Career Fair
Cambridge Marriott, Tuesday, February 22, 2011, 11am - 4pm Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Northeast region.
Geron replenished its coffers after striking a cash-and-stock deal with Angiochem. The deal gives Geron access to Angiochem's peptide technology for ferrying molecules across the blood-brain barrier. And there were some more IPOs that went out--of course--at huge discounts. Boron chemistry company Anacor was one, following the discounted IPO from Zogenix that came right before Thanksgiving. But Fluidigm, perhaps emboldened by the relative success of fellow genetic instrument maker Pacific Biosciences (which at least didn't have to slash its offering price, though it hasn't fared so well in the aftermarket)...is having another go.
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Momenta Pharmaceuticals, Inc. (MNTA) Nabs $57.4M in Stock Offering
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Geron Corporation (GERN) Plans to Raise $87M in Stock Sale
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Genetics Instrument Maker Fluidigm Corporation Refiles for $86 million IPO
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Anacor Pharmaceuticals, Inc. Completes $70 Million Initial Public Offering and Concurrent Private Placement
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QuantaLife Raises $17.2M in Series B Financing
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More Money Talk News

The European Commission has been raiding the offices of European pharma companies--including AstraZeneca, GlaxoSmithKline, and Nycomed--in hopes of finding evidence that companies have been colluding to keep generics off the market. According to a report in the In Vivo Blog, GSK chief Andrew Witty, at least, was supremely unconcerned--an indication that his company has nothing to hide, or perhaps that it has already been thoroughly hidden.
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Pfizer Inc. (PFE), Novartis AG and AstraZeneca PLC (AZN) Cancer Drugs Aromasin, Arimidex, and Femara Increase Heart Risks
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Drug Companies Abbott Laboratories (ABT), B. Braun Medical Ltd. and Roxane Laboratories, Inc., Paying $421 Million to Settle Government Case
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AstraZeneca PLC (AZN) Raided By European Antitrust Officials
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AMAG Pharmaceuticals, Inc. (AMAG) Dodges “Black Box” FDA Warning on Anemia Drug, Feraheme
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US Cable: Pfizer Inc. (PFE) Sought Dirt on Nigerian official
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More Legal Briefs News
Third time's the charm? After the advisory panel and/or FDA rejections of Arena Pharmaceuticals Inc.'s lorcaserin and Vivus Inc.'s Qnexa, it looked like no weight loss drugs could overcome the agency's concerns about heart risks. But Orexigen's Contrave won a positive panel vote, 13-7 in favor of approval, while 11-8 with one abstention said the heart risks needed to be further studied after approval. That looks like the best of all worlds for Orexigen, which not only got a panel nod but could shed its two main competitors along the way. However, investors are going to be on eggshells until there is an actual approval, and many investors are still holding out hope for Qnexa, which resulted in larger weight loss than Contrave.
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FDA Panel Endorses Orexigen Therapeutics, Inc. (OREX) Weight-Loss Drug Contrave
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Roche (RHHBY) Drug Avastin Rejected by U.K. Agency National Institute for Clinical Excellence (NICE) for Use in Breast Cancer
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FDA Declines to Approve GlaxoSmithKline (GSK) and Valeant Pharmaceuticals International (VRX)'s Epilepsy Drug
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FDA Panel Backs AstraZeneca LP (AZN)'s Drug, Vandetanib, For Rare Thyroid Cancer but Asked to Rethink Drug Dosage
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Merck & Co., Inc. (MRK)’s Proscar Fails to Win U.S. FDA Panel’s Backing for Prostate Cancer
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More Rockville Files News
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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