BioSpace BioPharm Exec
Wednesday, June 30, 2010
Clean Up Your Act

It's a little late for Spring cleaning, but that's exactly what pharma needs right now, at least according to FDA. A remarkable number of companies have been under fire over the past year for manufacturing and quality control issues, and it's becoming clear that FDA has no intention of stopping its steady flow of warning letters anytime soon.

If you don't think cleanliness is next to godliness, you're in the wrong industry. Genzyme's well-publicized issues with its facility in Allston Landing, Massachusetts, caught activist investor Carl Icahn's attention and threatened the very independence of the company (although, for the moment, Icahn has agreed to a compromise in his proxy battle with the company). More...

More By Karl Thiel

The American Society of Clinical Oncology (ASCO) conference took place early this month, and there has been an absolute slew of clinical data surrounding it, much of it very encouraging. So much, in fact, that we've had a hard time limiting ourselves to a few highlights. But in a month when the Cleveland Clinic claimed to have all but cured breast cancer on the basis of animal studies, you gotta make tough choices.

In any case, based on buzz at least, the hands-down winners of ASCO this year were Bristol-Myers Squibb, with its melanoma drug ipilimumab; and Celgene, which reported for strong data in Revlimid in first-line and maintenance settings. The BMS study was particularly interesting in that it used a controversial control arm--not a placebo or a standard treatment, but an experimental vaccine. Given that patients in the vaccine arm had surprisingly low survival, there may be a question as to whether this vaccine actually caused toxicity and made ipilimumab look better by comparison. BMS is convinced that's not the case, and the data certainly were strong. Right now, the company is feeling happy about the $2.4 billion it paid for Medarex, which discovered the drug.
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Skin Cancer Drug, Ipilimumab News Boosts Bristol-Myers Squibb Company (BMY) Shares
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Celgene Corporation (CELG) Release: At American Society of Clinical Oncology, Oral Presentation from Intergroupe Francophone Du Myelome (IFM) of Phase III Study (IFM 2005 02) Evaluating Continuous REVLIMID® in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
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Celgene International Sárl (CELG) Release: Oral Presentation at American Society of Clinical Oncology from Intergroup Phase III Study (CALGB 100104) Evaluates Continuous REVLIMID® in Patients with Multiple Myeloma Following Autologous Stem Cell Transplant
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Amgen (AMGN) Denosumab Demonstrated Superiority Over Zometa(R) in Delay of Complications Due to Bone Metastases in Advanced Prostate Cancer
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Sunesis Pharmaceuticals, Inc. (SNSS) Announces Data From Phase 2 Clinical Program of Voreloxin in Acute Myeloid Leukemia Support Phase 3 Trial in Relapsed or Refractory Patients
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More Bench To Clinic News
Embattled Elan CEO Kelly Martin has finally decided to bow to shareholder pressure and step down--but on his own terms. Saying he'll wait until 2012 seems like something of a face-saving move, although Martin says he wants to make it a round decade at the company (he has an option to remain as an adviser to the board for another year) to fulfill his commitment, and to plan an orderly succession.

And it didn't take long after former Biogen Idec CEO Jim Mullin's departure for Carl Icahn to increase his foothold at the company, getting a third member on the board. That comes after an agreement earlier this year that kept two Icahn representatives on the board and avoided a repeat of last year's proxy battle. Catching more flies using honey may explain why Icahn is now making nice with Genzyme.
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Irish Drugmaker Elan Corporation PLC (ELN) Says CEO to Quit in 2012
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Biogen Idec, Inc. (Massachusetts) (BIIB) to Name CEO in Coming Weeks; COO to Exit
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Merck & Co., Inc. (MRK) Will Cut 800 Jobs in France
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When Is a Sales Rep Not a Sales Rep? When You're at Abbott Laboratories (ABT), Facing More Layoffs Possibly on June 30th
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Genmab A/S (GEN.CO) CEO Quits Danish Biotech Under Fire
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More Career Track News
It's good to see some early-stage deals: Sanofi-Aventis inked a deal with Regulus (a joint venture of Isis and Alnylam) on microRNA therapeutics, and Gilead Sciences is branching out of antivirals into other areas by acquiring CGI Pharmaceuticals. Notably, neither company has anything in the clinic. Neurocrine Biosciences is on the comeback trail with two deals--Abbott is committing $75 million up front for a deal on an endometriosis/uterine fibroid drug--and Oncomed seals its position as the leader in cancer stem cells in a significant deal with Bayer. And while the combined Biovail and Valeant will retain the latter's name, it is to be headquartered at Biovail's home in Canada. The merged companies will create a diverse specialty and branded generic company.
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Gilead Sciences, Inc. (GILD) to Acquire CGI Pharmaceuticals, Inc. for Up to $120 Million
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Sanofi-Aventis (France) (SASY.PA) and Regulus Therapeutics, Inc. Form Major Strategic Alliance, Largest microRNA Therapeutics Alliance to Date, Valued at Potentially Over $750 Million
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Biovail Corporation (BVF), Valeant Pharmaceuticals International (VRX) in $3.2B Reverse Merger; Valeant Shareholders to Get $16.77/Share Special Dividend
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Bayer Schering Pharma and OncoMed Pharmaceuticals, Inc. Enter Strategic Alliance to Develop Anti-Cancer Stem Cell Therapeutics; OncoMed to Get $40 Million Upfront; up to $387.5 Million
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Abbott Laboratories (ABT), Neurocrine Biosciences, Inc. (NBIX) in Pact for Endometriosis Drug, Elagolix; Neurocrine to Get up to $575 Million
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More Golden Handshakes News

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A few interesting venture deals this month, perhaps an indication that a dreadful first quarter for biotech venture funding marked some sort of nadir. Okay, Castlight isn't exactly in biotech, but it aims to be "the Travelocity of Healthcare," as Xconomy puts it. It is seeking to actually put price tags on the murky and mysterious costs of care. That way, we healthcare consumers who are encouraged to comparison shop can actually, you know, make comparisons. Genzyme raised $1 billion in debt to complete the first part of its $2 billion share repurchase plan, and CRO ReSearch Pharmaceutical Services is wading into the IPO market.

Investors got worried about BMS's decision to return full rights to XL-184 to Exelixis, but there's no clear clinical development linked to that decision, and Exelixis claims it all has to do with control. Specifically, Exelixis has control over many spending and timing issues in the program, and with BMS seeing success elsewhere in its oncology portfolio (see Bench to Clinic), it doesn't want to be limited by Exelixis' terms.
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Castlight Health Raises $60 Million to Support Commercial Rollout
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Genzyme Corporation (GENZ) Prices Private Senior Notes Offerings
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ReSearch Pharmaceutical Services (RPS), Inc. Files for up to $100 Million IPO
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Exelixis, Inc. (EXEL) Regains Full Rights to Develop and Commercialize XL184; Bristol-Myers Squibb Company (BMY) will Make $17 Million Payment in Connection with Return of Drug
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Agile Therapeutics, Inc. Secures $45M in Series B Funding to Progress Lead Contraceptive Patch, AG200-15, Through NDA Filing
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More Money Talk News

Even as Europe struggles to hold its union together, GlaxoSmithKline chief Andrew Witty has come out in favor of a proposal that would further centralize the regulation of drugs in Europe, adding to EMEA some of the relative efficacy decision-making currently made on a country-by-country basis (e.g., the U.K.'s NICE). One can easily understand his preference for having to win the battle once instead of 27 times. On these shores, FDA is considering a less sweeping but still controversial reform: making complete response letters public.
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GlaxoSmithKline (GSK) Chief Andrew Witty Calls For Drugs Overhaul
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House Committee Says Johnson & Johnson (JNJ) Is Dragging Its Heels On Recall Probe
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Pfizer Inc. (PFE) Pulls Leukemia Drug Mylotarg From U.S. Market After Deaths, No Proven Benefit
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AstraZeneca PLC (AZN) Settles U.S. Pricing Lawsuit for $103 Million
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Bayer HealthCare (BAY)'s Lawsuits Forces Teva Pharmaceutical Industries Limited (TEVA) To Admit Gianvi Label Information Was False
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More Legal Briefs News
These are busy times at FDA, and they are going to get busier...or at least higher in profile. Next month (July 13-14), and advisory panel will convene to reconsider the heart attack risk associated with the GlaxoSmithKline diabetes drug Avandia. FDA's Drug Safety Oversight Board narrowly voted to keep the drug on the market back in 2007, and it's been a political circus ever since. Now two new studies may make GSK's case harder to win.

But that's next month. There's plenty going on right now, including the approval of Amgen's osteoporosis drug Prolia. That decision came almost two months before deadline, and sets Amgen running on one of its most important growth catalysts. The drug will compete against some cheap generics (that work by an entirely different mechanism of action), but Amgen has set a relatively low price and offers a compelling data package. The twice-a-year injection should do well against daily bisphosphonates that have notorious compliance issues.
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FDA Approves Amgen (AMGN)'s Prolia(TM) (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture
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FDA Approves Genentech (RHHBY)'s Lucentis(R) (Ranibizumab Injection) for the Treatment of Macular Edema Following Retinal Vein Occlusion
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FDA Approves Sanofi-Aventis (France) (SASY.PA) Prostate Cancer Drug
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FDA Approves Novartis Corporation (NVS)'s Tasigna(R) For Newly Diagnosed Chronic Myeloid Leukemia Patients, Data Demonstrate Major Advance Over Gleevec(R)
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FDA Panel Votes Against NDA For Boehringer Ingelheim Corporation's 'Female Viagra' Flibanserin
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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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