BioSpace BioPharm Exec
Wednesday, November 28, 2012
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Here's to Hepatitis C Success! Cocktails, Anyone?

Cocktail hour is truly upon us. Most of the headlines out of the recent annual meeting of the American Association for the Study of Liver Diseases concerned the race to develop an all-oral cure for hepatitis C--one that hopefully doesn't involve any nasty interferons. The very fact that we're focused on these things--cures rather than treatments, convenience of dosing, minimizing side effects--is a sign of how far we've come in a remarkably short time. It's a credit to some great science and a huge industry effort, but also to an evolution in the way we approach combination therapies. More...

More By Karl Thiel

In additional to all the hepatitis C news from the past month, there were some impressive phase 3 results from Biogen-Idec's long-acting clotting agent for hemophilia. And Amgen's big bet on its cholesterol-lowering drug AMG-145 looks like it may pay off in time to make up for generic competition to Aranesp and Epogen. At the highest dose, LDL ("bad") cholesterol dropped so far in some patients who received the drug that they weren't eligible to receive a second dose. -KT
ViiV Healthcare Says Phase III Data From VIKING-3 Dolutegravir Study Encouraging
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Johnson & Johnson (JNJ) Isn't Giving Up on Alzheimer Drug
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Clavis Pharma ASA, Clovis Oncology (CLVS) Tank as Pancreatic Cancer Drug Fails Late-State Test
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Biogen Idec, Inc. (Massachusetts) (BIIB) Hemophilia Drug Wows in Phase 3 Study
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Amgen (AMGN) Drug Cuts Bad Cholesterol Up to 66 Pct in Patients - Trial
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More Bench To Clinic News
There's been some horrible news in the past month, from a bizarre murder at the 11th International Congress on Drug Therapy in HIV Infection to a tragic explosion at a Canadian facility manufacturing omega-3 from krill oil. But there is at least some good news about new jobs--even R&D jobs!--to go along with the familiar cuts. -KT
Regeneron Pharmaceuticals, Inc. (REGN) to Add 300 Jobs in New York
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Targacept, Inc. (TRGT) Appoints Stephen A. Hill, M.D., President and CEO
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Gilead Sciences, Inc. (GILD) Quietly Plans Expansion, to Hire R&D Staff
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The Axe Falls: Bristol-Myers Squibb Company (BMY) to Cut Nearly 500 Jobs
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Biogen Idec, Inc. (Massachusetts) (BIIB) Names Exelixis, Inc. (EXEL)'s George Scangos CEO
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More Career Track News
It's not exactly a green light for open source collaboration, but pharma companies are increasingly seeing the wisdom in sharing certain resources and information. In September, 10 leading pharma companies formed Transcelerate Biopharma, a joint venture among aimed at sharing information and expertise. Now three companies--including Merck, not part of the original Transcelerate alliance--have announced a further collaboration. The companies are seeking to improve efficiency when it comes to selecting and approving trial sites and training investigators. It will be interesting to see if 3 proves to be a more workable number than 10.

Foundation Medicine announced its sixth and seventh partnerships of 2012 this past month, with AstraZeneca and Ariad Pharmaceuticals, respectively. Foundation does detailed genomic profiling that can be used to guide clinical development programs and clinical trials, develop companion diagnostics, or focus drugs already in development to their area of highest efficacy. The company also raised a Series B financing in September. Its mission is obviously finding a lot of traction with both researchers and investors. -KT
Johnson & Johnson (JNJ), Eli Lilly and Company (LLY), Merck & Co., Inc. (MRK) Team Up to Form Clinical Trial Site Database
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Forest Laboratories, Inc. (FRX) and Adamas Pharmaceuticals Form Alliance for Up to $160 Million
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Amgen (AMGN) Closes Deal With Financial Firm to Open New Biotech Company Atara Biotherapeutics
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Foundation Medicine and AstraZeneca PLC (AZN) Announce Genomic Profiling Collaboration
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Takeda Pharmaceutical Co. Ltd. (TKPYY) Shells Out $140 Million for Envoy Therapeutics
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More Golden Handshakes News

Top Jobs
• DeutscheBio (Germany)

Autonomic Technologies
Vice President, Sales Europe
Responsible for all sales activities in Europe consistent with ATI’s overall business goals. While this is primarily a Sales position, it also provides leadership for marketing activities. This position is situated in Europe, but US candidates with extensive European experience will be considered. Initially it is anticipated that the VP of Sales will spend the majority of his or her time in the field with individual accounts.

• Genetown (Cambridge ,Massachusetts)

ARIAD Pharmaceuticals, Inc.
Senior Director, Tax and Treasury (137-419)
This person will be responsible for strategic planning as it relates to international tax and treasury matters, tax reporting and compliance, risk management relating to financial resources, management of external advisors, the design, implementation and maintenance of internal controls related to tax and treasury functions and related activities.

• Pharm Country (Newark, New Jersey)

Celgene
Executive Director, Global Quality Ops Development Job
This position provides leadership and direction for the regional Quality Operations function responsible for the quality and compliance management of manufacturing, packaging, testing and logistics facilities performing operations in support of Celgene’s development and investigational products globally. This position has accountability for the relevant site decisions affecting product quality and sustainable cGMP compliance.

• BioCapital (Washington, DC)

MedImmune, LLC
Sr. Director, Head of Safety Evaluation, Patient Safety
Will be responsible for: leadership of Safety Evaluation team comprised of safety physicians covering MedImmune therapeutic areas at R&D sites in US and UK. The Head of Safety Evaluation should ensure succession planning as part of a forward thinking hiring strategy at all levels within his/her team to develop talent within the PS department. Maintain clinical safety knowledge regarding biologics and ensure consistent safety input across the therapeutic areas.

Get Noticed! Add your resume to the BioSpace Career Center!
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Just when you thought life sciences venture financing was dead, here comes Intarcia Therapeutics. The company is developing an implantable device that delivers a special formulation of the diabetes drug exenatide (the active ingredient in Byetta and Bydureon) over the course of a year. It raised a whopping $210 million--a huge sum for a private round--from existing investors and some newcomers that don't always play in the life sciences, like Fidelity and Seth Klarman's Baupost hedge fund.

Abbvie, the pharma spin-off of Abbott Labs, set a record in dollar-denominated debt sales with its $14.7 billion bond issue. According to FiercePharma, that beats a previous record held by Pfizer and Roche. -KT
Intarcia Therapeutics, Inc. Secures $210 Million Financing to Fund Its Global Phase 3 Program
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Pearl Therapeutics Grabs $65 Million in VC Funding, Moves COPD Drug Toward Phase III Trials
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Cardioxyl Pharmaceuticals Raises $28 Million in Series B Financing
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Visterra, Inc. Boosts Series A to $26 Million, Adds Bill & Melinda Gates Foundation as Investor
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Abbott Laboratories (ABT) Announces Pricing of AbbVie's $14.7 Billion Private Placement Notes Offering
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More Money Talk News

A nice little lesson in shareholder unfriendliness from Pluristem Therapeutics: Beware of companies that use breathless prose in their press releases. Saying that an early stage experimental treatment "saved" a patient's life, is a "breakthrough" and a "miracle" (all claims from Pluristem press releases) clearly indicates management isn't interested in dispassionate communication of facts. When the patient whose life was "saved" subsequently died, Pluristem failed to mention it, saying death subsequent to hospital release isn't something they track. They may make the dubious argument that this wasn't a material event, but shareholders should take warning.

Alnylam more or less amicably settled its relationship with Tekmira, buying its way out of an obligation that would have had Temira manufacturing its RNAi and lipid nanoparticle compounds....just in time for a phase 3 study of its lead drug. It also paid $35 million to reduce future milestone and royalty obligations on its lead programs. -KT
GlaxoSmithKline (GSK) Pays $90 Million to Settle States' Avandia Claims
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Tiny Tekmira Pharmaceuticals Corporation Lands $65 Million Settlement Plus $10 Million in Near-Term Milestone Payments From Alnylam Pharmaceuticals (ALNY)
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GlaxoSmithKline (GSK) Employee Blows Whistle on Drug Promotions
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Girl Dies as Pluristem Therapeutics (PSTI) Sells on Gains With Miracle Cells
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Johnson & Johnson (JNJ) Settles 845 Levaquin Lawsuits
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More Legal Briefs News
FDA raised concerns about the heart risks associated with Tresiba, Novo Nordisk's long-acting insulin it has been counting on to compete with Sanofi's Lantus. But despite those worries, an FDA panel voted 8-4 to approve the product, although they also unanimously said the company should further study the risks. Another new molecular entity was approved this past month: Pfizer's JAK inhibitor Xeljanz is predicted to be a blockbuster with peak sales in the neighborhood of $2.5 billion. The pill will go up against Abbott's Humira injection.

And it looks like there is another novel drug approval on the way: Novartis' Signifor is a new chemical entity that offers an alternative for patients with Cushing's disease, which is typically treated by surgery.

-KT
Dynavax Technologies Corporation (DVAX) Falls After Vaccine Fails to Win Panel Backing
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FDA Approves Pfizer Inc. (PFE)'s Rheumatoid Arthritis Pill
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FDA Panel Gives Unanimous OK to Novartis AG (NVS)'s Cushing's Drug
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Novo Nordisk A/S (NVO)'s Insulin Tresiba Has Heart Safety Risks, FDA Says
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Novo Nordisk A/S (NVO) Upbeat on Tresiba Insulin's U.S. Prospects
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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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