BioSpace BioPharm Exec
Wednesday, August 25, 2010
Lilly, By Any Other Name...

This has not been Lilly's month.

I got on CEO John Lechleiter's case last month, over the miserably bad PR strategy behind having a pharma exec try to stir up support for more H-1B visas. But I certainly understand his desperation to do something quickly about the fortunes of Indianapolis's favorite son.

The company already faces the steepest patent cliff in the industry, losing key patents on its antidepressant/pain drug Cymbalta in 2013 and its top-selling antipsychotic Zyprexa in 2011. These two drugs together are by themselves responsible for over a third of Lilly's revenue. More...

More By Karl Thiel

The failure of Lilly's semagacestat for Alzheimer's Disease is a deeply disappointing development in the field--potentially the failure not just of a single compound but of an entire therapeutic approach pursued for more than 20 years. Derek Lowe has an excellent post about it on his blog, In the Pipeline. I remain (perhaps naively) hopeful that the problems really are specific to the compound, not to gamma secretase as a target, but those results sure looked bad.
-KT

Eli Lilly and Company (LLY) Halts Development Of Alzheimer's Drug
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Amgen (AMGN) Announces Top-Line Results of Phase 3 Head and Neck Cancer Trial; Vectibix Fails to Meet Primary Endpoint
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Vertex Pharmaceuticals (MA) (VRTX) Hep C Drug Works In Half The Time of Current Therapy
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In Pivotal Phase III Studies, Merck & Co., Inc. (MRK)'s Investigational Medicine Boceprevir Helped Majority of Patients with Chronic Hepatitis C Genotype 1 Infection Achieve Sustained Virologic Response, the Primary Endpoint of the Studies
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Isis Pharmaceuticals, Inc. (ISIS), Genzyme Corporation (GENZ) Cholesterol Drug Meets Study Goals; Meet Primary Endpoints with 36 and 37 Percent LDL-C Reductions in Severe Hypercholesterolemia and High-Risk Patients
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More Bench To Clinic News
Okay, here's a funny one. When is the last time you heard about a company selling one of its experimental drugs on the side as a low-cost dietary supplement? Yeah, never. But it turns out that's exactly what two GlaxoSmithKline execs were doing (on a non-profit basis) without Glaxo's knowledge. The drug in question was SRT501, a formulation of resveratrol (which is itself commonly sold as a dietary supplement). The non-profit was set up by two former execs from Sirtris Pharmaceuticals, which developed SRT501 and which Glaxo acquired in 2008 for $720 million. Interestingly, a paper published by a Pfizer research team in January called into question whether SRT501 actually works at all, so maybe the supplement approach is the best way to recoup some of that investment.
-KT

An Embarassed GlaxoSmithKline (GSK) Spanks Two Key Executives
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Help Wanted: Johnson & Johnson (Caguas, Puerto Rico) (JNJ) Seeks Quality-Control Workers After Recalls
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Eli Lilly and Company (LLY) Plans More Reductions, to Lay Off 500 More Employees
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Ranbaxy Laboratories (RANBAXY.BO)' CEO To Step Down, Quarterly Profit Falls 52%
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Former Solvay Pharmaceuticals, Inc. Chief Werner Cautreels, Ph.D. Takes Lead Role at Startup Selecta Biosciences, Inc.
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More Career Track News
The battle for Genzyme has been engaged, with key Sanofi shareholders objecting to a bid over $70 per share and many analysts suggesting Genzyme won't take less than $80. Pfizer's agreement to sell its Idun Pharmaceuticals subsidiary to Conatus is interesting in that Conatus essentially is Idun...or at least it is the company same management team formed after the 2005 sale. As In Vivo Blog points out.), Pfizer has recently sold back the assets of two other acquired companies at discount prices--Vicuron and Esperion.
-KT

Any Sanofi-Aventis (France) (SASY.PA) Deal For Genzyme Corporation (GENZ) May Take Time, At Limited Price
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Quark Pharmaceuticals Inc., Novartis Corporation (NVS) Sign $670-Mln Drug Deal
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Conatus Pharmaceuticals Inc. Buys Back Idun Pharmaceuticals, Inc. From Pfizer Inc. (PFE)
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Life Technologies (LIFE) To Buy DNA Sequencing Company, Ion Torrent Systems, Inc. For $375 Mln
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Alectos Therapeutics Announces Collaboration With Merck & Co., Inc. (MRK) to Develop Drugs for Alzheimer's Disease; Alectos Therapeutics Could Receive $289 Million
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More Golden Handshakes News

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Bio NC Career Fair Bio NC Career Fair
Sheraton Imperial Hotel & Convention Center, Thursday, Monday, September 13, 2010, 11am to 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, medical device and diagnostics companies in the South East region.
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If you're at all given to numerology, you'll glance at the headlines below and wonder about the significance of the number 86.3. Is there some luck in it that can ward off the slashed prices and cool reception of this year's IPOs? In any case, that's the amount Aegerion Phamraceuticals, Horizon Biopharm, Endocyte, and Complete Genomics--three bona fide biopharmaceutical companies and a gene sequencing company--are looking to raise. They follow the recent IPOs of Trius Therapeutics and NuPathe, both of which have, despite slashing their offering prices, languished in the aftermarket. And Pacific Biosciences, which was pointed out as a likely upcoming IPO just in our last issue, has wasted no time in taking advantage of the current buzz around the sub-$1,000 genome.
-KT

Pacific Biosciences Files For $200 Mln IPO
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Biotech Horizon Biopharm Files To Sell Up To $86.3 Mln In IPO
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Biopharma Company Endocyte, Inc. Files Plan For $86.3 Mln IPO
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Cholesterol-Drug Developer Aegerion Pharmaceuticals, Inc. Revives Plan for $86.3M IPO
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Arena Pharmaceuticals, Inc. (ARNA) to Receive $60 Million from Deerfield Management, to Use $30 Million of Proceeds to Prepay Outstanding Debt
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More Money Talk News

Sanofi is making a long-shot but inevitable bid to keep generic Lovenox off the market after last month's approval of a copycat blood thinner made by Momenta and Sandoz. The judge is at least taking Sanofi's arguments about an inappropriate approval, which FDA calls "meritless," seriously. Lilly, meanwhile, was handed a serious setback when a judge invalidated a key patent on its ADHD drug Strattera, clearing the way for the immediate launch of generics instead of giving the company until 2017. The follows a similar blow on its cancer drug Gemzar at the end of July.
-KT

Lovenox Decision Held Off
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Can Eli Lilly and Company (LLY) Win Any Important Patent Lawsuit?
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US FDA Objects to Dendreon Corporation (DNDN) Promotions for Provenge
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Drugmakers Fire Back At FTC Over Pay To Delay
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PDL BioPharma, Inc. (PDLI) Says Genentech (RHHBY) Claims Drugs Don't Breach EU Patents; PDL Stocks Fall at Market Close
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More Legal Briefs News
One bright spot for Lilly this month is that a potential competitor to Cymbalta in the fibromyalgia space, Jazz Pharmaceuticals' sodium oxybate, appears less likely to reach the market after a 20-2 advisory panel vote against approval. The reasoning, however, calls into question FDA's mission to the public. The agency appeared satisfied that the drug was safe and effective in its briefing documents; the panel's primary concern is that it is related to the notorious "date rape" chemical and that it could be abused. Isn't that what drug scheduling is for? FDA was willing to work around more serious concerns about, for instance, thalidomide analogs, known to cause severe birth defects, when it came to treating multiple myeloma. But it's questionable if fibromyalgia, already a controversial disease for which other treatments are available, will rise to the same level.
-KT

US FDA Panel Rejects Jazz Pharmaceuticals, Inc. (JAZZ) Drug For Fibromyalgia; Stock Falls at Market Close
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FDA Panel Backs Wider Use Of Eli Lilly and Company (LLY)'s Cymbalta
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FDA Approves HRA Pharma, Watson Pharmaceuticals, Inc. (WPI)'s "Morning-After" Pill Ella
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U.S. FDA Panel Backs GlaxoSmithKline (GSK), Valeant Pharmaceuticals International (VRX) Epilepsy Drug; Glaxo Stock Rises
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Cardiome Pharma Corp. (COM.TO) Says Heart Drug Program Delayed, Shares Fall
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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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