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BioSpace BioPharm Exec
Wednesday, January 25, 2012
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Embracing Generics and Emerging Markets

Did you know that the average daily cost of drugs dropped by one third between 2005 and 2010? And that Medicare drug spending has come in below predicted levels? Seems like a strange thing in this age of stealth inflation and $200,000-a-year medicines, but the reason is quite simple: We are in freefall off the patent cliff, and the average drug spend for consumers should continue to decline as popular drugs go generic. Prices should decrease by another third through 2015, according to IMS Health estimates.

That's great news for consumers; maybe not so much for drug companies. But needless to say, they've seen this coming for a long time, and they've been planning. Plan A--to replace all those off-patent drugs with new innovative blockbusters (or value-added versions of the same products) has met with mixed success at best. Plan B--to make highly targeted, very expensive specialty drugs, often linked to companion diagnostics--is shaping up to be one of the most interesting trends of the next decade. But in the meantime, there's Plan C, and it's likely to gain momentum in 2012: The move to emerging markets. More...

More By Karl Thiel

Pfizer's partnership with Medivation has blown up in the wake of another disappointing phase 3 trial result for Dimebon, a potential Alzheimer's treatment. (Dimebon also disappointed in an earlier pivotal study). Pfizer paid a huge $225 million upfront in this partnership, as well as committing up to $500 million in milestones, which may help explain why the company has more recently favored option-type partnerships that let it wait out more of the risk.

Bristol-Myers Squibb has another good shot on goal in hepatitis C to accompany its acquisition of Inhibitex (see Golden Handshakes). Its two-drug regimen produced impressive results in HCV "non-responders" when given with ribavirin and PEG-interferon alfa; not quite so much when given without them. While an all-oral regimen without interferon would be great for patients--and this one looks promising--there's still room for improvement. That's making this space really interesting right now. -KT
Bristol-Myers Squibb Company (BMY) Hepatitis C Pills Clear Virus Without Injections
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Pfizer Inc. (PFE) Ditches $725 Million Medivation, Inc. (MDVN) Pact as Phase 3 Alzheimer Trial Disappoints
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Bayer HealthCare (BAY)'s Colorectal Cancer Drug Regorafenib Shows Promise, Improves Overall Survival Rate by 29 Percent
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Roche (RHHBY)'s Avastin Disappoints Against Ovarian Cancer
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Study Challenges Bristol-Myers Squibb Company (BMY) on Bristol-Myers Squibb Company (BMY) and Sanofi (France) (SAN.PA)'s Plavix
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More Bench To Clinic News
The global pharma industry may not have a king, but it has a new knight: GlaxoSmithKline CEO Andrew Witty--make that Sir Andrew Witty--has been knighted for services to the U.K. economy. Of course, anyone who went through GSK layoffs over the past few years might have a different opinion of that service, but the U.K. government is signaling some faith in the pharma industry as an engine to drive economic growth. Smith & Nephew chairman John Buchanan was also knighted , along with a couple researchers.

Whether or not growth is coming, jobs continue to be cut. Takeda, as part of its integration of its Nycomed acquisition, is slashing its European and U.S. workforces. And Novartis--which had previously announced some large cuts focused on the U.K.--has announced major new cuts in the face of its blood pressure drug Diovan going generic. -KT
Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Plans to Reduce Europe, U.S. Workforce by 2,800 Jobs
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Novartis AG (NVS) Cuts 2,000 U.S. Jobs After Drug Setback
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Quintiles, Inc. (QTRN) to Hire 500 in China
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Human Genome Sciences, Inc. (HGSI) to Cut 150 Jobs Amid Modest Benlysta Growth
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Teva Pharmaceutical Industries Limited (TEVA) Taps Bristol-Myers Squibb Company (BMY) Exec as New CEO; Appointment Hints at More Acquisitions to Come
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More Career Track News
A new front in the battle for hepatitis C dominance has opened with Bristol-Myers Squibb's acquisition of Inhibitex. At a 163% premium to Inhibitex's stock price prior to the offer, BMS's offer is pretty rich, especially considering that this is essentially a single phase 2 asset. But Gilead's $11 billion acquisition of Pharmasset announced in November already set the tone for what has become a fiercely competitive land grab.

Genentech has gotten more serious about adding neuroscience to its pipeline by linking with Xenon for an undisclosed upfront fee. And its partnership with Constellation, starting with a $95 million upfront payment, points to growing interest in the field of epigenetics. Finally, Forma Therapeutics has announced not one but two major screening and optimaztion deals. -KT
Bristol-Myers Squibb Company (BMY) to Acquire Inhibitex, Inc. (INHX) for $2.5 Billion
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Genentech (RHHBY) Pours $95 Million into Constellation Pharmaceuticals Epigenetic Drug Platform, Deal Includes M&A Terms
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Roche (RHHBY) Signs $646 Million Pain Pact With Xenon Pharmaceuticals Inc.
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FORMA Therapeutics, Inc. Cuts $815 Million Deal With Boehringer Ingelheim Corporation to Discover Cancer Drugs
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Alexion Pharmaceuticals Inc. (ALXN) to Pay $1 Billion for Enobia Pharma
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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 CEO, 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. Primary responsibilities will include: providing advice on a daily basis with respect to all laws, rules and regulations governing clinical research and development, manufacturing and commercial sale of CLIA-laboratory products and services, designing, implementing, monitoring and enforcing company-wide compliance programs.

• Biotech Bay (San Francisco, California)

Kelly Scientific Resources
Chief Operation Officer
The position is to assure the successful execution of the company's business mission through business operation and management. This requires not only establishing the company vision but leading all aspects of their business development. The client is looking for a candidate who has experience in the eye product industry and holds a PhD degree.

• Biotechxus (Houston, Texas)

Bellicum Pharmaceuticals
Director of Research
Responsible for conduct and supervision of research personnel involved in development of cell and genetic therapy product candidates for oncology involving harnessing the power of the immune system using cutting edge technologies. This key individual will be responsible for the operations of a research facility for the production of cell and gene therapy products and for oversight of sub-contractors. Specialized knowledge and expertise are used in performing technical aspects of the job, exercising judgment within generally defined practices and policies.

• Genetown (Cambridge, Massachusetts)

Vertex
Sr. Director, Regulatory Affairs Strategy
Will lead the global Regulatory Team as the key strategist to Vertex's Global Clinical Development Teams, providing guidance in the design and construct of development plans. Specifically, s/he will be responsible for overseeing the development and implementation of innovative clinical strategies for successful product development and commercialization, providing clinical / regulatory leadership to ensure that sound regulatory practices are fully integrated in all pre-clinical studies, clinical development, commercialization and post-marketing activities.

Get Noticed! Add your resume to the BioSpace Career Center!
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Warp Drive landed a huge series A round aimed at helping the company discover and develop drugs based around naturally occurring microbes. Warp Drive has been around a couple of years in incubation mode and it's still pretty stealthy now, but it has certainly created some enthusiam among its backers, which includes Sanofi.

RaNA is a platform technology company that aims to upregulate expression of select genes by targeting non-coding RNA. It's backers include Monsanto and GlaxoSmithKline venture arm SR One. -KT
RaNA Therapeutics Emerges With $20.7 Million Startup Financing
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Warp Drive Bio Launches With $125 Million from Third Rock Ventures, Greylock, Sanofi (France) (SAN.PA)
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Elevation Pharmaceuticals Completes $30 Million Series B Financing to Advance Aerosol COPD Therapy
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Acceleron Pharma Secures $30 Million Private Financing
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Icahn Buys More Biogen Idec, Inc. (Massachusetts) (BIIB) on Tysabri Dip
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More Money Talk News

Companies may not find it so easy to settle charges with the SEC while "neither admitting nor denying" wrongdoing. Up until now, a company could admit criminal charges to one arm of the government (the Department of Justice) and then turn around and settle identical SEC charges with a bland non-denial denial. Under a new policy, these kinds of parallel cases can no longer use two different kinds of language. It's largely a symbolic change, but symbols can be important.

J&J is reportedly still negotiating a potential criminal plea in its alleged off-label promotion of the anti-psychotic Risperdal, but it will presumably involve an admission of wrongdoing. Even so, the settlement--which would represent about 5.6% of cumulative Risperdal sales since 2003--doesn't resolve some state matters. Texas alone was looking for around $1 billion, so the company probably feels it got off lightly with a $158 million settlement. -KT
Johnson & Johnson (JNJ) to Pay $158 Million to Settle Texas Risperdal Case
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Roche (RHHBY) Refuses to Disclose Tamiflu Data: Scientists
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Johnson & Johnson (JNJ) to Pay $1 Billion to Settle Risperdal Marketing Probe
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Illumina, Inc. (ILMN) Accuses Life Technologies (LIFE) of Infringing Patent
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House Democrats Probe ADHD Drug Shortage
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More Legal Briefs News
Seattle Genetics has met with investor skepticism over the prospects for Adcetris, its recently approved and fairly expensive non-Hodgkins lymphoma treatment, despite some strong sales out of the gate. The addition of a black box warning to the product's label, noting the risk of progressive multifocal leukoencephalopathy (PML) associated with the drug, could give more fuel to the naysayers, but it actually isn't all that big a deal. The same risk has been noted in other drugs, including the NHL drug Rituxan, and the risk-reward profile still looks pretty compelling. An additional warning that Adcetris is contraindicated for use with bleomycin really shouldn't an issue.

BTG's Voraxaze is only expected to produce peak sales of around $15 million--not every orphan drug is a gold mine after all--but it help patients taking the common chemotherapeutic methotrexate clear the drug from their system in as little as 15 minutes. And Pfizer has submitted for FDA approval of tofacitinib, it's oral JAK inhibitor with blockbuster potential in treating rheumatoid arthritis. -KT
Seattle Genetics, Inc. (SGEN) Lymphoma Drug Gets Boxed Warning on Brain Infection Risk
More...

FDA Approves BTG plc (BGC.L)'s Drug for Cancer Toxicity
More...

FDA Rejects AstraZeneca PLC (AZN)'s and Bristol-Myers Squibb Company (BMY)'s Dapagliflozin for Type 2 Diabetes
More...

FDA Approves Gilead Sciences, Inc. (GILD) NDA for Viread in HIV-Infected Children
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FDA to Review Pfizer Inc. (PFE) Rheumatoid Arthritis Drug
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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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