BioSpace BioPharm Exec
Wednesday, November 30, 2011
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The Bad Old Days in Europe?

As the euro crisis seems to worsen (or simply goes on without resolution), more voices are willing to speak a fear that, even a couple months ago, was limited to a small fringe: The collapse of the euro.

At this point, there simply is no realistic option except to have the European Central Bank act more like the Federal Reserve and issue massive numbers of bonds to support member countries (that is, print money, equivalent to our own "quantitative easing"). This path will weaken the stronger EU nations, which is why Germany has remained steadfastly opposed. It doesn't want the inflation, it doesn't want to see its own perceived creditworthiness weakened in the form of higher interest rates (something that's already starting to happen), and it doesn't want to be on the hook to rescue weaker countries. And who can blame them? Indeed, the German constitution may even ties the hands of legislators and prevent them from participating in some forms of European bond issuance. More...

More By Karl Thiel

The American Heart Association's annual meeting brought some good news for patients with low levels of "good" cholesterol, and a much-needed boost for Eli Lilly & Co. When it comes to deep vein thrombosis and pulmonary embolism, however, the news wasn't as good. The Bristol-Myers Squibb and Pfizer drug Eliquis (apixaban) is the latest anti-clotting agent to fail to establish superiority over tried-and-true Lovenox when it comes to preventing blood clots in bedridden patients. Merck's vorapaxar also fell short (the company had previously halted trials, so this wasn't a big surprise). This follows on the previous failure of J&J and Bayer's Xarelto to prove superiority. Astellas dropped its own phase 2 entry, darexaban, in September.

Roche's multiple sclerosis therapy looks promising in phase 2 trials and offers a starkly different dosing schedule to current therapeutic mainstays--just once every six months. Biogen Idec also continues to produce excellent data for BG-12, and the twice daily oral dosing schedule offers an advantage over current therapies. But the company still needs to keep an eye on the rearview window. -KT
Genzyme Corporation (GENZ) MS Drug Significantly Reduces Relapse, Disability in Phase III Trial
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Eli Lilly and Company (LLY) Experimental Drug Doubles Good Cholesterol in Race With Merck & Co., Inc. (MRK), Roche (RHHBY)
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Bristol-Myers Squibb Company (BMY), Pfizer Inc. (PFE) Clot Drug Fails to Help Ill Patients
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Roche (RHHBY)'s New MS Drug "Cuts Relapses by 80 Percent" in Phase 2 Trial
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Medivation, Inc. (MDVN) Soars on Positive Phase 3 Prostate Cancer Data
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More Bench To Clinic News
Job cuts coming at Cephalon? That's the rumor circulating, but it's one Teva Pharmaceuticals denies...sort of. Actually, they just say they haven't decided yet. Former Genentech exec Art Levinson is now the chairman of the world's largest company--proof enough that if you can succeed in biotech, you can succeed at anything. And any slippery CEOs out there would do well to look at China, where the head of a pharma company who was found guilty of embezzling and accepting bribes just received his verdict--a death sentence. -KT
Novartis AG (NVS) Staff on Strike Over Job Cuts
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Bayer HealthCare (BAY) Sells Indiana Facility, 270 Workers in Danger of Losing Jobs
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Apple (AAPL) Taps Former Genentech (RHHBY) Chief as New Chairman
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Teva Pharmaceutical Industries Limited (TEVA) to Sack 1,500 Cephalon, Inc. (CEPH) Workers
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Allergan Inc. (AGN) to Open New R&D Facility in New Jersey, Will Create 400 New Jobs
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More Career Track News
Lilly and Amylin are calling it quits, ending an oft-acrimonious partnership around the diabetes drug Bydureon. Amylin will get full rights to the drug, but will pay Lilly $250 million upfront and $1.2 billion from future sales. Gilead is making an awfully big bet on Pharmasset and the hepatitis C space, although that company did just report some great clinical results. But still...$11 billion for, in essence, a single drug in phase 2 trials, in an indication that will be marked more by cures than ongoing treatment? That's a serious spin of the wheel. -KT
Gilead Sciences, Inc. (GILD) to Acquire Pharmasset, Inc. (VRUS) for $11 Billion
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AMAG Pharmaceuticals, Inc. (AMAG) Hires Jefferies and Co. to Explore Sale
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Gilead Sciences, Inc. (GILD) and Johnson & Johnson (JNJ)'s Tibotec Pharmaceuticals Ltd to Create Combination HIV Therapy
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Lundbeck Inc. Pays Otsuka Pharmaceutical Co., Ltd. $200 Million Upfront in CNS Drug Deal, Complete Deal is Worth $1.8 Billion if Milestones are Met
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Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) End Bydureon Pact; Amylin to Make $1.45 Billion in Payments
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More Golden Handshakes News

Top Jobs
• Biotech Bay (South San Francisco, California)

Crescendo Bioscience
Vice President of Regulatory Affairs & Quality Assurance
Will report directly to the Chief Executive Officer, act as the Compliance Officer for the Company, and advise and support the Companys Commercial Operations, Clinical Laboratory, Research and Development functions to ensure compliance with all applicable Federal and state laws, rules and regulations.

• BioMidwest (Deerfield, Illinois)

Astellas Pharma US
Executive Medical Director, Global Medical Affairs
Responsible for ensuring that strategies and tactics are in place for global compounds in the portfolio to support launch plans, post-marketing needs and medical input into life cycle management.

• Biotech Bay (Bay Area, California)

MedImmune, LLC
Senior Director, BST
Provides financial leadership for critical functions at the core of MedImmune's business including Manufacturing, Supply Chain, Engineering and Quality. Responsible for supporting those leaders with financial, analytical and business decision support services.

• BioChina (Taicang, Suzhou, China)

Crown Biosciences
Director, Cell Biologist/Biochemist
The individuals will use their extensive knowledge of biochemistry and cell biology techniques to facilitate target validation as well as to develop a wide range of assays for drug R&D.

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Clovis Oncology and NewLink Genetics both managed to get out the IPO window--and perhaps more remarkably, both have managed to hold their IPO value in the aftermarket, which is saying something when you consider the headwinds in worldwide stock markets. Agios' huge $78 million C round gives it three or four years to advance its research into rare genetic disorders. And Portola managed a very large Series D round for its anticoagulant candidate, despite (or perhaps because of) some of the difficulties encountered by other entrants in this crowded drug class (see Bench to Clinic). -KT
Clovis Oncology (CLVS) Raises $130 Million in IPO
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Portola Pharmaceuticals, Inc. Announces Completion of $89 Million Financing
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Agios Pharmaceuticals Secures $78 Million Series C Financing
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NewLink Genetics Raises $43.4 Million in IPO
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Human Genome Sciences, Inc. (HGSI) Prices $430 Million Convertible Notes Offering
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More Money Talk News

In paying nearly $1 billion to settle charges of illegal promotion of Vioxx between 1999 and 2002, Merck is closing the book on litigation that began seven years ago and getting closer to the end of its troubles with the painkiller it withdrew from the market in 2004. But despite the fact that it has pled guilty to a misdemeanor criminal charge involving the off-label promotion of Vioxx for rheumatoid arthritis, Merck is still going through the standard motion of not admitting any wrong doing. Or at least, mostly not admitting it, since two-third of the fine relates to civil charges and only one-third to the criminal charges. It looks like another victory for Merck CEO Kenneth Frazier's aggressive legal tactics. And hey, did you know Frazier is heading up Penn State's special investigation into the Sandusky scandal? Penn State obviously chose its man...carefully.

It's also worth noting that GlaxoSmithKline did offer a tacit admission of wrongdoing in discussing its decision to settle another 2004 investigation into sales and marketing practices. GSK CEO Andrew Witty said the agreement-in-principle is "a significant step toward resolving difficult, long-standing matters which do not reflect the company that we are today." Witty wasn't the CEO back in 2004, so he can say that...but he has been at the company since 1985 and came up through the sales and marketing side. -KT
Merck & Co., Inc. (MRK) to Pay $950 Million in Vioxx Settlement
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GlaxoSmithKline (GSK) to Pay $3 Billion to Settle U.S. Government Probes
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'Significant' Offenses Cited at Mylan Inc. (MYL) Plant
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Bayer AG (BAY.F) May Have Pitched Birth-Control Pill for Unapproved Use
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Pfizer Inc. (PFE) Agrees to Pay $60 Million to Settle Probe into Bribes
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More Legal Briefs News
The approvals just keep coming! Incyte won approval for the first JAK inhibitor, ruxolitinib. It's indicated for myelofibrosis, a rare cancer, but JAK inhibitors are being pursued by a number of companies for a wide range of big-ticket indications, from rheumatoid arthritis to psoriasis. EUSA also scored a win for patients with rare cancers, while Transcept finally pushed through sleep-drug Intermezzo after years of struggle and two resubmissions. Judging by the stock reaction, investors weren't expecting much luck this time, either, and got a pleasant surprise. Oh, and FDA rejected Genentech's Avastin as a breast cancer treatment, but that really comes as no shock. -KT
FDA Approves Transcept Pharmaceuticals, Inc. (TSPT)'s Intermezzo, the First Insomnia Drug for Middle-of-The-Night Waking
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Regeneron Pharmaceuticals, Inc. (REGN) Wins FDA Approval for Blindness Drug Eylea
More...

FDA Panel Backs Pfizer Inc. (PFE) Vaccine for Adults
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FDA Approves Incyte Corporation (INCY)’s Jakafi(TM) (ruxolitinib) for Rare Bone-Marrow Disease
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EUSA Pharma Announces FDA Approval of Orphan Drug ERWINAZE(TM) for Treatment of Acute Lymphoblastic Leukemia
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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.

BioSpace, Inc.
6465 South Greenwood Plaza, Suite 400
Centennial, Colorado 80111 U.S.A.
Phone: 877-277-7585
Fax: 800-595-2929
BioSpace, Inc.
90 New Montgomery Street, Suite 414
San Francisco, California 94105 U.S.A.
Phone: 877-277-7585
Fax: 415-576-9217



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