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BioSpace BioPharm Exec
Wednesday, March 30, 2011
Pure, Small Pharma

Hoping to see a merged Lilly, an acquired Roche, a tax-optimized GlaxoSmithKline, or an increasingly diversified Pfizer? Not if their chief executives get their way. These are among the companies talking in the past month about the hottest new trend in pharma: Getting...or staying...small.

In the cases of Roche and Lilly, it's a defense of the status quo. Lilly CEO John Lechleiter continues to make his case for staying independent every chance he gets--which is some measure of how much pressure he is feeling to do exactly the opposite. More...

More By Karl Thiel

Head-to-head studies are exactly the kind of thing we need if we as a society are to make better treatment decisions and do a better job of allocating scarce healthcare dollars. They can also be great marketing tools for the winner. The head-to-head study of Novo Nordisk's Victoza and Lilly/Amylin/Alkermes' Bydureon, however, illustrates why such studies aren't always easy to interpret. The surprising (at least to the sponsors) failure of Bydureon to match the efficacy of Victoza took a big chunk out of Amylin's and Alkermes' stock prices. But as a patient, I'm not sure I'd be so eager to trade Victoza's very slightly better efficacy for the much higher rate of nausea, vomiting, and diarrhea reported with the drug. Undoubtedly that's the spin sales reps will put on Bydureon if they win approval.
-KT

Eli Lilly and Company (LLY), Amylin Pharmaceuticals, Inc. (AMLN) and Alkermes (ALKS)' Bydureon Fails Against Novo Nordisk A/S (NVO)'s Victoza in Head to Head Study
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Phase III Clinical Trial of Gilead Sciences, Inc. (GILD)'s Investigational Elvitegravir Meets 48-Week Primary Objective
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Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi-Aventis (France) (SASY.PA) Cancer Drug Misses Phase III Primary Endpoint but Meets Secondary Targets
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Amylin Pharmaceuticals, Inc. (AMLN) Exenatide Once Monthly Showed Positive Results in Phase 2 Study
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Regeneron Pharmaceuticals, Inc. (REGN)'s ARCALYST(R) (rilonacept) Meets Primary and All Secondary Endpoints in Second Phase 3 Trial for Prevention of Gout Flares in Patients Initiating Uric Acid-Lowering Therapy
More...


More Bench To Clinic News
PEGS CHI's 7th Annual PEGS Event consists of 12 conference programs within 4 streams. More... Genzyme Join Genzyme in Manufacturing & Quality Operations for a Promising Future. More...
So...Johnson & Johnson, fresh from one of the worst years in its history--one marked by massive product scandal, dodgy recall strategies, Congressional inquiries, inept efforts to contain the problem or deal with the press, and remarkable success in tarnishing one of the world's most respected brands--gave its chief executive a pay raise. Sure, William Weldon took a 45% cut in his year-end bonus, but increases in salary and other perks means he took home just 7% less in 2010 than he did the prior year. Go figure. GlaxoSmithKline's Witty, for what it's worth, took a 24% cut in overall remuneration--and didn't get his salary raised--because of missed profit targets at the U.K. pharma.
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Johnson & Johnson (JNJ) Gives CEO High Marks and Pay Despite Low Year
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GlaxoSmithKline (GSK) CEO's 2010 Remuneration Cut Due to Missed Profit Targets
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Pfizer Inc. (PFE) Past CEO Steere, a Key Company Builder, Retires from its Board
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Swiss Drugs Giant Novartis AG Reveals UK Jobs Cuts Plan
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Sanofi-Aventis (France) (SASY.PA) Plans 700 Europe Job Cuts
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More Career Track News
We'll take a break from the ongoing Actelion and Genzyme dramas (well...a little on the latter further down...) to look at some other deals: The ink isn't even dry on Human Genome Sciences' approval of Benlysta, and it's looking to its pipeline through a rich deal with FivePrime Therapeutics for an inhibitor of the fibroblast growth factor, which is thought to play a role in tumor survival and growth. $50 million upfront for a drug that is only now entering phase 2 may be the kind of deal a biotech is more likely to offer than big pharma these days. And Seattle Genetics has kept busy--not just with Abbott Labs but also Millennium/Takeda--all since submitting for FDA approval of Brentuximab Vedotin at the end of February.
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FivePrime Therapeutics, Inc. Nabs $495M Deal With Human Genome Sciences, Inc. (HGSI) to Develop Cancer Drug
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Seattle Genetics, Inc. (SGEN) Announces Antibody-Drug Conjugate Collaboration with Abbott Laboratories (ABT); Seattle Genetics Gets $8 Million Upfront; Eligible for as much as $200 Million
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Cephalon, Inc. (CEPH) to Acquire Gemin X Pharmaceuticals, Inc. for $225 Million; up to $300 Million in Milestones
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Daiichi Sankyo, Inc. (D4S.F) to Acquire Plexxikon Inc. for $805 Million Upfront, Approval of PLX4032 Could Bring in an Additional $130 Million
More...

Research Unit Going to China, Pfizer Inc. (PFE) Says; Company Plans Gradual Move of Antibacterials Operations to Shanghai
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More Golden Handshakes News

Top Jobs
• BioMidwest (Deerfield, Illinois)

Astellas Pharma US
Senior Director, Strategic New Product Planning
The Senior Director, Strategic New Product Planning (SNPP) is a critical leader in the continuing development and growth of the Astellas Pharma US, Inc. product portfolio. In addition to providing commercial input for select Astellas developed compounds, the Senior Director, SNPP is also responsible for the recommendation and commercial assessment of potential in-licensing candidates from domestic or global sources.

• Southern Pharm (Boca Raton, Florida)

Biotest Pharmaceuticals
Vice President Clinical and Regulatory Affairs
The successful candidate will provide technical leadership, strategic direction and oversight for successful planning and execution of all technical and manufacturing activities associated with Anacor's active drug substance (process, analytical development, validation, technology transfer, manufacturing, and supply chain logistics) at contract development and manufacturing organizations (CMOs).

• Biotech Beach (San Diego, California)

HUYA Bioscience International
Chief Financial Officer
The Vice President, Finance & Chief Financial Officer will have complete responsibility for the Companys global finance, treasury and controllership functions, and the Companys consolidated worldwide tax position, insurance, banking and investor relationships. The Vice President, Finance & Chief Financial Officer will also play a central role in the strategic partnering and licensing, which is an important part of the Companys growth strategy.

• Genetown(Cambridge, Massachusetts)

Ironwood Pharmaceuticals, Inc.
Vice President, Sales and Sales Operations
The successful candidate will build and deploy specialty and primary care sales forces to drive the growth of a near-term, innovative, first-in-category product with blockbuster potential. This individual will need to work collaboratively with a U.S. commercial partner and internal departments to coordinate all sales activities and functions to establish a synergistic, high-performing, team-oriented, ethical sales culture.

Get Noticed! Add your resume to the BioSpace Career Center!
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Bio NC Career Fair Bio NC Career Fair
Sheraton Imperial Hotel & Convention Center, Monday, April 4, 2011, 11am to 4pm . Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the south east region.
BioMidwest Career Fair BioMidwest Beach Career Fair
Hyatt Regency Woodfield Schaumburg, Monday, April 4, 2011, 11am to 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Midwest region.
Stealth start-up Nimbus scored some prominent backers in its seed round, including Bill Gates. Fifteen years ago, this might have been a "tool" company, partnering its unique technology for calculating water energies at drug binding sites as a royalty-driven means to improve lead optimization for partners' drugs. But today, it is a drug discovery company--albeit one pursuing an interesting business model that sets up each candidate in a separate company, ready for acquisition.
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Nimbus Discovery Unveils First Of Its Kind Drug Discovery Paradigm; Announces Seed Round Co-Led By Bill Gates
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Exelixis, Inc. (EXEL) Tacks on $23M
More...

Solazyme, Inc. Proposes $100 Million IPO and Nasdaq Global Market Listing
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Omthera Pharmaceuticals, Inc. Raises $33.9 Million in Series B Funding Led by New Enterprise Associates
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Aerie Pharmaceuticals, Inc. Completes $30 Million Series B Financing to Fund Further Development of Innovative Glaucoma Product Portfolio
More...


More Money Talk News

A National Public Radio piece this month highlighted Forest Labs in talking about offshore tax havens and corporate tax avoidance strategies with yummy-sounding food-and-drink names like "the Dutch sandwich" and "the Double Irish." Coincidentally (I assume), GlaxoSmithKline chief exec Andrew Witty spoke out this month to the Guardian about such practices. One company that has actually gotten in a tussle with U.S. and U.K. tax authorities over international transfers is AstraZeneca, but it found them more forgiving than it first feared. It will pay only $1.1 billion to resolve its disagreements, far less than the $2.3 billion it set aside. (The tax issue at AstraZeneca involved accounting for inter-company sales of goods and services rather than a tax haven strategy.)
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AstraZeneca PLC (AZN) Lifts Profit Forecast After Agreeing Deal on U.S. Tax Payments
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Genzyme Corporation (GENZ) Fabrazyme Shortage to Worsen
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Celgene (CELG) Discloses Justice Dept Probe Into Drug Marketing
More...

Japan Suspends Use of Pfizer Inc. (PFE), Sanofi-Aventis (France) (SASY.PA) Pediatric Vaccines After Four Deaths
More...

FDA Warns of Birth Defects with Use of Johnson & Johnson (JNJ)'s Topamax
More...


More Legal Briefs News
So far this year regulatory news, at least on this side of the Atlantic, has been dominated more by rejection and delay than new approvals. But there were some high profile green lights month--perhaps most notably Human Genome Sciences' Benlysta for lupus, the first new treatment in over 50 years. Another disease for which there have been few options, melanoma, also has some new hope. Bristol-Myers' Yervoy was approved, and may be followed by a Roche/Plexxikon drug for the same illness in 2012. The success of the latter product in clinical studies helped drive the acquisition of Plexxikon this month by Daiichi for up to $935 million. The Bristol drug is an immunotherapy and could have other potential applications.
-KT
Human Genome Sciences, Inc. (HGSI) and GlaxoSmithKline (GSK) Announce FDA Approval of BENLYSTA(R) (Belimumab) for Treatment of Systemic Lupus Erythematosus
More...

FDA Approves New Bristol-Myers Squibb Company (BMY) Treatment for a Type of Late-Stage Skin Cancer
More...

Neurosearch A/S (NEUR.CO) Shares Plunge as FDA Wants More Data
More...

Novartis AG Receives EU Approval for Gilenya
More...

Forest Laboratories, Inc. (FRX), Nycomed Get Approval for Lung Drug, Roflumilast
More...


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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