BioSpace BioPharm Exec
Wednesday, January 30, 2013
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Good Things Ahead

We're going to miss you, 2012. Last year was great for biotech and has set the stage for good things ahead. Just how did the sector shine in 2012, and what might it mean for the future? Let me count the ways... More...

More By Karl Thiel

The Medicines Company's anti-clotting drug cangrelor had looked dead in the water back in 2009 after it failed to outperform clopidogrel in two large studies, but last year's BRIDGE study revived hope for the drug. Now the large CHAMPION study, which again compared cangrelor and clopidogrel, provides a strong enough signal for the company to seek an approval. This is an enormously important drug for The Medicines Co., which managed to extend its patent on Angiomax but still faces generic competition in 2015.

Genentech's decision to take Exelixis' GDC-0973 into a pivotal study for malignant melanoma is a reminder that, while Exelixis has placed all its chips behind cabozantinib (now Cometriq), its robust discovery engine has produced a lot of partnered assets working their way through the clinic. Genentech is looking at GDC-0973 in combination with Zelboraf, since that recently approved drug, while effective, generally stops working for most patients after a while. Exelixis' option to co-promote the drug could be used to start building an oncology sales force.

-KT
Pfizer Inc. (PFE) Reports Positive Results in Studies of Toviaz, Pristiq, Chantix
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Teva Pharmaceutical Industries Limited (TEVA)'s NUVIGIL® Fails Phase 3 Trial Again
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Celgene (CELG)'s Abraxane Keeps Pancreatic Pts Alive an Extra Two Months in Trial
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Genentech (RHHBY) Takes Exelixis, Inc. (EXEL) Drug Into Phase III Melanoma Trial
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The Medicines Company (MDCO) Jumps on Anti-Clotting Drug Study
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More Bench To Clinic News
A Swiss referendum that forces binding votes on executive compensation, as well as eliminating golden parachutes and some takeover bonuses, goes up for a vote on March 2. The proposal, which began with a petition started by a disgruntled shareholder of the bank UBS, is given a decent chance of passage. It could even become a model for other countries troubled by the growing gulf between rich executives and...well, just about everyone else. Novartis got ahead of the vote by slashing the pay of chief executive Joe Jiminez by 16%, while departing chairman Dan Vasella took a slight 3% cut in salary. Opponents warn that the law could make Swiss companies less competitive. So what's a poor exec to do?! Oh, yeah--they could communicate with their shareholders to convince them that they deserve these lavish compensation packages. -KT
Novartis AG (NVS) Slashes CEO, Chairman Pay; Vasella Steps Down
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MedImmune (AZN) Execs Shuffled After AstraZeneca PLC (AZN) Shakeup, Unit Split in 3
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Forest Pharmaceuticals Breaks Ground in Ohio, Will Create 125 New Jobs
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Job Cut Fears at AstraZeneca PLC (AZN)'s Research Hub
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The Long Goodbye: as Drug Giant Roche (RHHBY) Exits Nutley, What Comes Next for Sprawling Site?
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More Career Track News
Allergan's offer to buy MAP Pharmaceuticals has a lot riding on MAP's Levadex inhalation for migraine. Levadex is essentially MAP's only asset, and it isn't approved--it received a complete response letter last March. Since the issues relate mostly to manufacturing and controls, Allergan is confident they can win an approval. But if spring passes without FDA's blessing, Allergan will be facing shareholders who all look like they just got a face full of Botox. -KT
Allergan Inc. (AGN) to Buy MAP Pharmaceuticals, Inc. (MAPP) for $958 Million
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Life Technologies (LIFE) Gains on Buyout Speculation
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Shire plc (SHPG) Rises on AstraZeneca PLC (AZN) Bid Talk: Traders
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MacroGenics, Inc.'s DART Platform Grabs Potential $1 Billion Gilead Sciences, Inc. (GILD) Deal
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Amgen (AMGN), BIND Biosciences, Inc. Ink $180 Million Tumor Treatment Deal
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More Golden Handshakes News

Top Jobs
• Pharm Country (Edison, New Jersey)

Oriel STAT A MATRIX
Vice President of Business Development - Life Sciences
Responsible for new account acquisition and the development of existing accounts within the practice. To execute sales strategy and initiatives for high-dollar consulting services for prospect/client companies. To manage all phases of the business development cycle to successfully close, including opportunity development, proposal development, implementation estimating, scope, and client presentations.

• Biotech Bay (San Carlos, California)

Natera, Inc
Vice President, Laboratory Operations
Selected candidate will manage the operations of the team, reporting to either the COO or the CEO. Candidate will also interface with the following members of senior management: CTO, General Counsel, VP Sales, VP Research (Bio) and VP Research (Informatics). Key responsibility will be to manage a laboratory operation in meeting aggressive milestones.

• Biotech Beach (San Diego, California)

HUYA Bioscience International
Chief Scientific Officer
Expertise in oncology, metabolic disease, cardiology, or infectious disease strongly preferred but not required. The successful candidate will be capable of critically analyzing and accurately summarizing a wide range of preclinical and clinical data in a broad range of therapeutic areas, evaluating programs for scientific merit and competitive advantage, managing preclinical and early clinical development programs, as well as interacting with Chinese and western pharmaceutical partners.

• Biotech Bay (Redwood City, California)

Genomic Health, Inc.
Vice President, Bioinformatics
Will Set overall strategy for bioinformatics at Genomic Health, that will support the collaborative efforts of Research and Development to discover and develop validated genomic tests, and that enhance the company's reputation for excellent science and technology.Direct managerial responsibilities include, but are not limited to, recruiting bioinformatics personnel, mentoring, and developing staff of 15+ staff and building the necessary infrastructure for the Department.

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Onyx is definitely one of the "haves" (rather than have-nots) in biotech, and it's flexing its muscles with a $359 million capital raise--its largest ever and one of the larger biotech follow-ons in recent memory--intended to advance Kyprolis as a frontline therapy for multiple myeloma. InterMune's $229 million raise will support development and hopefully a 2014 launch of its idiopathic pulmonary fibrosis drug pirfenidone.

Aileron will be using its latest venture round to launch the first-ever clinical trial of a stapled peptide. These are peptides that have been stabilized so that they don't unravel in cells and get broken down by proteases. In theory, they should open up a whole new range of targets that have previously been "undruggable." -KT
IPO Could Value Pfizer Inc. (PFE)'s Zoetis at Up to $12.5 Billion
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InterMune, Inc. (ITMN) Announces Pricing of Concurrent Public Offerings of $105,000,000 Principal Amount of Convertible Senior Notes and 13,500,000 Shares of Common Stock
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Onyx Pharmaceuticals, Inc. (ONXX) Announces Pricing of Public Offering of Common Stock
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Aileron Therapeutics Nabs $12 Million for First-Ever Stapled Peptide Clinical Trial
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Foundation Medicine Expands Series B Financing to $56 Million
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More Money Talk News

Not content to merely try blocking generic threats to its multiple sclerosis drug Copaxone, Teva Pharmaceuticals is going after other novel MS drugs. Specifically, it has petitioned FDA to not approve Biogen Idec's potential blockbuster BG-12 without first holding an advisory committee meeting. The PDUFA date for BG-12 is March 27, and so far no committee meeting has been scheduled. Teva counts on Copaxone for about 20% of sales, of course, so this is an important outcome for them.

Teva is on the other side of the innovator-imitator divide when it comes to the cancer drug Alimta. Teva hopes to launch a generic after Eli Lilly's patent expires in 2016, but there's buzz that Lilly could potentially extend exclusivity on the drug, projected to have $3.5 billion in peak sales, until 2022. That's because a method-of-use patent covers the administration of vitamin B12 and folic acid prior to giving Alimta. At least some patent attorneys think this is more defensible than most method patents, and that Lilly actually has a chance of prevailing. The trial begins this summer. -KT
Teva Pharmaceutical Industries Limited (TEVA) Asks FDA Not to Approve Biogen Idec, Inc. (Massachusetts) (BIIB) MS Drugs
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Amgen (AMGN) Whistleblower Fights to Unseal Documents
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Otsuka Can Block Generic Abilify as Court Rejects Appeal
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Pfizer Inc. (PFE) Can be Sued for Injury Caused by Generic
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Eli Lilly and Company (LLY) May Have a $15 Billion "Wild Card" Up Its Sleeve: Analysis
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More Legal Briefs News
An impressive 39 new chemical entities approved in 2012 was helped along by a very busy December in Rockville, with 8 approvals. Ariad Pharmaceuticals' Iclusig for leukemia got an early nod, and other December approvals included GlaxoSmithKline's raxibacumab for inhalation anthrax, Novartis' Signifor for Cushing's disease, NPS Pharmaceuticals' Gattex for short bowel syndrome, Aegerion Pharmaceuticals' Juxtapid for hypercholesterolemia, and Salix Pharmaceuticals' botantical Fulyzaq for HIV/AIDS-related diarrhea. But arguably, the real highlights were J&J's Sirturo, the first new tuberculosis drug in 40 years, and Eliquis, a potential blockbuster blood thinner from Bristol-Myers Squibb and Pfizer.

But that was last year! We've already got 2013 approvals to talk about...

-KT
Allergan Inc. (AGN)'s Botox Gets FDA Approval for Overactive Bladder
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NuPathe Inc. (PATH) Shares Jump After FDA Approves Migraine Patch
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Santarus Inc. (SNTS) Wins FDA Approval for Ulcerative Colitis Therapy; Will Add 85 New Sales Reps to Support Drug
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FDA Panel Backs Johnson & Johnson (JNJ)'s Risky Diabetes Drug
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Bristol-Myers Squibb Company (BMY)-Pfizer Inc. (PFE)'s Blood Thinner Eliquis Wins FDA Approval
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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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