BioSpace BioPharm Exec
Wednesday, October 27, 2010
Lilly's Shopping Plans Go Against the Grain

Eli Lilly is not up for sale. That's the official message that CEO John Lechleiter delivered to investors during the company's third quarter conference call last week. But the very fact that he's stating his opposition to any "large-scale combinations" that would end Lilly's independence means such considerations are very much on the table, at least as far as investors go. And while Lechleiter's resistance to the idea is well supported by the history of large pharma company mergers, he may feel increasing pressure to go down that road anyway.

But if Lechleiter gets his way, he'll deal with his company's woes by doing something surprisingly few large corporations are willing to do these days: Loosen the purse strings and go shopping. More...

More By Karl Thiel

It was a great month for antibody-drug conjugates. ImmunoGen and Roche were surprised to find FDA unwilling to accept their application for accelerated approval of the breast cancer drug T-DM1 this summer, but that takes nothing away from the great efficacy data they produced, and now ImmunoGen has landed a new partnership with Novartis. Seattle Genetics, meanwhile, has shown how strong its ADC technology is with some very impressive data in lymphoma.

It was not quite so great a month for prostate cancer therapies, with failures from Pfizer's Sutent and Astrazeneca's Zibotentan, not to mention an FDA warning about cardiovascular and diabetes risks, associated with some current therapies. But Johnson & Johnson, at least, had some good news to report for Abiraterone.
-KT

MacroGenics, Inc. and Eli Lilly and Company (LLY) Announce Pivotal Clinical Trial of Diabetes Drug Teplizumab Did Not Meet Primary Efficacy Endpoint
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Johnson & Johnson (JNJ) Drug Abiraterone for Prostate Cancer Extends Life in Phase III Study
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Seattle Genetics, Inc. (SGEN)' Second Brentuximab Trial for Lymphoma Succeeds
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Phase II Study with Genentech (RHHBY) and Biogen Idec, Inc. (Massachusetts) (BIIB)'s Ocrelizumab Shows Significant Reduction in Disease Activity for Multiple Sclerosis Patients
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AVI BioPharma, Inc. (AVII) Says MD Drug, AVI-4658 Does Well in Test
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More Bench To Clinic News
Ipsen's CEO Jean-Luc Belingard is leaving the company over unspecified "differences" between him and his board of directors, but we don't know exactly what those are. Ipsen has had a difficult year, particularly with a setback on its development program for taspoglutide, a diabetes drug partnered with Roche. But Belingard has generally been a bold leader, and investors at least don't seem to be cheering his departure.
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Ipsen Announces CEO Departure Due to Differences; Appoints Marc de Garidel as New CEO and Chairman
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Drug Giant Roche (RHHBY) to Add 500 Jobs in Arizona
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Biogen Idec, Inc. (Massachusetts) (BIIB) to Implement Restructuring Program; to Cut Jobs
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Sanofi-Aventis (France) (SASY.PA) to Cut 1700 US Jobs
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Genzyme Corporation (GENZ) Chief Says Could Step Down Next Year
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More Career Track News
Exelixis took a big hit last year when its partner Bristol-Myers Squibb backed out on further development of XL-184. While the companies' new partnership may not say anything about that particular molecule, it does suggest that BMS continues to have a good working relationship with Exelixis and to value the company's discovery capabilities--a much-needed vote of confidence.
-KT

Exelixis, Inc. (EXEL) Licenses Two Drug Programs To Bristol-Myers Squibb Company (BMY); Exelixis Nabs $60M Upfront, Potentially $505M More
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Pfizer Inc. (PFE) To Buy King Pharmaceuticals®, Inc. For $3.6 Billion Cash
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ImmunoGen, Inc. (IMGN) Signs Cancer Treatment Deal With Novartis AG; Immunogen to Receive $45 Million Upfront With Potential for $200 Million
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UCB SA And Synosia Therapeutics Sign Parkinson's Disease Alliance Worth $745 Million Potentially
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BIOCON, Inc., Pfizer Inc. (PFE) In Potential $350 Million Insulin Licensing Deal
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More Golden Handshakes News

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Where will the next generation of biotech companies come from? They're going to have a tough time raising venture capital, according to data from Dow Jones VentureSource, which says 2010 is on track to equal 2009 in terms of VC fundraising--hardly a notable achievement, since 2009 represented a six-year low. The In Vivo Blog cites this report and adds that the companies that do have money (cough, cough, Big Pharma) are less willing to spend it. They say overall licensing activity is down 20% this year versus 2007, and that M&A activity is down from last year. C'mon, Lilly, show us another way!

In any case, there are some companies out there that can still raise money, and we don't just mean Cephalon. Pacific Bioscience's IPO plans, if successful, could get VCs salivating again. And look at Synosia (see Golden Handshakes)--their deal with UCB is part of a series C financing.
-KT

Celgene (CELG) Prices $1.25 Billion of Senior Unsecured Notes
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Pearl Therapeutics Raises $69 Million Series C Financing
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Regeneron Pharmaceuticals, Inc. (REGN) Announces The Sale of 4,500,000 Shares of Common Stock
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Pacific Biosciences to Raise Up to $230 Million in IPO
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Convergence Pharmaceuticals Successfully Launched out of GlaxoSmithKline (GSK) to Focus on Novel High Value Analgesics; Raised $35.4 Million
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More Money Talk News

Amgen has a lot riding on Prolia (denosumab), its recently launched osteoporosis drug. The most exciting news will come later this year, when an ongoing study will reveal whether the drug is effective in halting the spread of cancer to the bone, potentially adding billions in denosumab sales. But its plain vanilla osteoporosis label alone should propel the drug to blockbuster status, especially now that FDA has issued new warnings on the entire class of bisphosphonate osteoporosis drugs. That includes old mainstays like Merck's Fosomax and newer drugs like Roche's Boniva.
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US FDA Warns Of Thigh Fractures With Bone Drugs, Bisphosphonates Made By Merck & Co., Inc. (MRK), Roche Holding AG (RHHBF.PK), Novartis AG, and Warner Chilcott, PLC (WCRX); All Bisphosphonates to Carry New Warning
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Biogen Idec, Inc. (Massachusetts) (BIIB), Roche Holding AG (RHHBF.PK)'s Genentech (RHHBY) End Dispute Over Rituxan Follow-Ons
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Sanofi-Aventis (France) (SASY.PA) and Bristol-Myers Squibb Company (BMY) Wins $442 Million Award Against Apotex Corp. Over Plavix Patent
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SIGA Technologies, Inc. (SIGA) to Get $2.8 Billion U.S. Drug Contract; Shares Jump
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Novartis AG Settles Off-Label Marketing Case Over 6 Drugs for $422.5 Million
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More Legal Briefs News
Arena's obesity drug Lorcaserin was officially turned down by FDA--not a huge surprise after the negative advisory panel vote in September--but the agency's response to an investor/consumer petition protesting how the panel was handled got a lot of observers in a tizzy. The agency said it "regrets" not having had an expert on rat carcinogenicity present at the meeting, which means...well...it probably doesn't mean much except an expression of regret. Still, having the agency offer any sort of acknowledgement of frustration over what seems like an increasingly risk-averse approval process was by itself cathartic for investors.

Next up for the obesity trifecta is Vivus' Qnexa, which also has a negative panel vote under its belt but perhaps a better shot at approval. FDA is due to make a decision later this week (just a little too late to include here). And finally, Orexigen's Contrave will go before an advisory panel in early December before a January 31 PDUFA date.
-KT

Arena Pharmaceuticals, Inc. (ARNA) Obesity Drug Fails to Win FDA Approval, May Need More Clinical Testing
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FDA Seeks More Data On Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly and Company (LLY) and Alkermes (ALKS) Diabetes Drug
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FDA Warns On Possible Heart, Diabetes Risk With Prostate Cancer Drugs Including Abbott Laboratories (ABT)' Lupron, AstraZeneca PLC (AZN)'s Zoladex, Sanofi-Aventis (France) (SASY.PA)'s Eligard, and Pfizer Inc. (PFE)'s Synarel
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FDA Approves Roche Holding AG (RHHBF.PK) Drug Herceptin For Advanced Stomach Cancer
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Talecris Biotherapeutics (TLCR) Receives FDA Approval for Gamunex(R)-C
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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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