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BioSpace BioPharm Exec
Wednesday, October 26, 2011
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FDA Gets the Message

We're all familiar with Wall Street banks, major pharmaceutical companies, and other corporations that settle various charges and investigations "without admitting any wrongdoing." Now it seems FDA may be doing something similar. After listening to years of accusations that it has become slow, unpredictable, and overly risk averse--charges it has traditionally redirected back at the shortcomings of industry--FDA is offering up a new plan to speed drug approvals.

FDA Commissioner Margaret Hamburg recently introduced a 40-page blueprint for reform, telling the audience at the 3rd Annual Washington Ideas Forum that "the number of new products in the development pipeline is not where we'd like it to be." That's a regret she certainly shares with most folks in industry, but does this proposal move the needle? More...

More By Karl Thiel

Good news for people with multiple sclerosis this month. Biogen Idec's BG-12 reduced relapse rates by as much as 50% compared to placebo in a study of relapsing-remitting multiple sclerosis. Perhaps just as importantly, new data presented at a medical conference showed no significant safety concerns, clearing the way for BG-12 to become a potential new blockbuster.

Teva and Active Biotech's oral MS drug laquinimod has had a mixed record in clinical trials--including a major phase 3 disappointment earlier this year. Now they've combed through the data and come up with statistically significant, positive results after correcting "meaningful imbalances" in the study groups. At this stage, however, it's unlikely to be much of a factor. Most analysts don't expect laquinimod to make any significant contribution to Teva's revenues. -KT

Biogen Idec, Inc. (Massachusetts) (BIIB)'s Oral MS Drug Shines in Phase 3 Study
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GlaxoSmithKline (GSK)'s Malaria Vaccine Works in Major Trial
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Teva Pharmaceutical Industries Limited (TEVA) and Active Biotech AB (BTPC) Laquinimod Trial for MS Treatment Yields Positive Results
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Halozyme Therapeutics, Inc. (HALO) Announces Positive Results from Roche (RHHBY)'s Subcutaneous Herceptin Phase 3 Trial
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Merck & Co., Inc. (MRK)'s ISENTRESS(R) (raltegravir) in Combination Therapy Shows Benefits Over Efavirenz
More...


More Bench To Clinic News
Abbott's head of Global Pharmaceuticals, Richard Gonzalez, will become CEO of the newly spun-off pharma company, which will have about $18 billion in annual sales. Gonzalez, a throat cancer survivor, actually retired in 2007 but came back to work at Abbott in 2009 at the behest of Abbott CEO Miles White. It's possible that Gonzalez isn't looking for a long-term position and expects the R&D business to be acquired sometime after the deal closes, currently expected around the end of next year.
-KT

Abbott Laboratories (ABT) CEO Miles White Chooses Longtime No. 2 Friend Richard Gonzalez to Head Spinoff Company
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Amgen (AMGN) to Lay Off 380 R&D Workers
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Sequenom Inc. (SQNM) to Bring 242 Jobs in Research Triangle Park
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AstraZeneca PLC (AZN) Plans 400 Job Cuts for U.S. Operations
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IDEXX Laboratories, Inc. (IDXX) Creating 100 Jobs With Expansion
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More Career Track News
Last month we mentioned pharma companies that were too big to succeed, and lo and behold, Abbott labs is getting smaller after well over a century in the biz. It is splitting its pharma R&D operations from its diversified medical products business, with the latter selling the company's world-leading heart stents as well as diabetes products, diagnostic equipment, and generics. But it is being widely speculated that the R&D-driven drug company will become a takeover candidate (because mega-mergers are working so well, right?) Roche, for one, has already indicated that it's not interested.

Roche is shoring up its hepatitis portfolio by acquiring Anadys, shortly after that company reported positive phase 2b clinical results for its hepatitis C candidate.
-KT

Abbott Laboratories (ABT) to Split Into 2 Companies
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GlaxoSmithKline (GSK) May Make $4.8 Billion Bid for Human Genome Sciences, Inc. (HGSI): Source
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Roche (RHHBY) Buys Anadys Pharmaceuticals, Inc. (ANDS) for $230 Million to Boost Hepatitis Ops
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GlycoMimetics, Inc. Inks Licensing Deal Worth Up to $340 Million with Pfizer Inc. (PFE)
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PPD, Inc. (PPDI) to be Acquired by The Carlyle Group and Hellman & Friedman for $3.9 Billion
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More Golden Handshakes News

Top Jobs
• Pharm Country (Radnor, Pennsylvania)

PolyMedix, Inc.
Vice President Regulatory Affairs
Will report to the CEO and will supervise the planning and coordination of clear and effective regulatory submissions and ensure that the regulatory strategy meets the development requirements for our products. The candidate will be expected to interact with consultants.

• BioMidwest (Urbana, Illinois)

Carle Foundation Hospital
Vice President of Research & Graduate Medical Education
Will be responsible for administrative and financial oversight for Carle's Research Institute and its Graduate Medical Education program. This position will function in alliance with the physician leaders over research and graduate medical education. Carle's Research Institute brings together a joint partnership with Carle physician researchers and University of Illinois researchers who conduct translational research and clinical trials in a 25,000 sq. ft. state-of-the-art Biomedical Research Center.

• Biotech Bay (Bay Area, California)

Setren, Smallberg & Associates, Inc.
Chief Medical Officer
Dynamic biotechnology organization seeks to hire an outstanding Chief Medical Officer. Reporting to the Chief Executive Officer, the Chief Medical Officer will be responsible for the full scope of clinical functions, including pre-clinical activities through Phase I-3 trial design and execution, clinical research and data analysis and management. He or she will work closely with the development teams, ensuring effective pre-clinical and clinical trial strategy, design and execution and regulatory submission. Publish study data and present study data at professional conferences.

• Biotech Beach (San Diego, California)

Intrexon Corporation
Vice President, Cellular Engineering Unit
Responsible for the operational leadership of an integrated scientific team with expertise spanning the following disciplines: Prokaryotic/Eukaryotic Cell System Engineering, Bioinformatics, Systems Biology Platform Development, Metabolic Engineering, Genome Engineering, Process Engineering, Fermentation Sciences and Cell Assay Development. This will include directing the operational aspects of CEU team projects and managing the daily activities of CEU personnel.

Get Noticed! Add your resume to the BioSpace Career Center!
See more than 5,000 job postings in the BioSpace Career Center!

BioCapital Career Fair BioCapital Career Fair
Bethesda North Marriott & Conference Center, Tuesday, November 1, 2011, 11am to 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Mid-Atlantic region.
Genetown Career Fair Genetown Career Fair
Cambridge Marriott, Monday, November 7, 2011, 11am to 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Northeast region.
Venture Capitalists may be cutting back on life science investment (see introduction), but there are still some interesting companies being launched. Third Rock has been particularly active in the past month, launching Sage Thereapeutics--focused on allosteric receptor modulators for central nervous system disorders--and Foundation Medicine, which is working on molecular diagnostics. (Third Rock is the founding investor of Foundation and has been joined by Google and Kleiner Perkins Caufield & Byers.)

Topica Pharmaceuticals, another Third Rock company, just raised a Series B round that should take it through Phase 2b/3 trials of its potent antifungal agent luliconazole.
-KT

Third Rock Ventures Launches SAGE Therapeutics with $35 Million Backing
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Topica Pharmaceuticals Announces Completion of $27 Million Series B Financing
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Foundation Medicine Closes Expanded Series A Financing Totaling $33.5 Million; Third Rock Ventures and Google Inc. Ventures Join as Investors
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Sofinnova Ventures Raises $440 Million for Biotech-Only VC Fund
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Cleave Biosciences Raises $42 Million in Series A Financing for Novel Cancer Therapies
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More Money Talk News

The always-entertaining KV Pharmaceutical is in the news again, this time trying to avoid paying its former CEO $37 million in various benefits. Marc Hermelin pled guilty to charges stemming from the company's production and distribution of oversized tablets, including morphine tablets that contained significantly more than the labeled dose. With Hermelin having served 30 days in jail and been barred from participation in federal health care programs, the company understandably doesn't want to dole out a generous golden parachute or pay legal expenses. It's worth noting that Hermelin was no longer CEO when the controversy of Makena pricing arose.
-KT
KV Pharmaceutical Sues Former CEO Over $37 Million in Benefits
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Onyx Pharmaceuticals, Inc. (ONXX), Bayer HealthCare (BAY) Restructure Oncology Agreement; Announce Settlement Reached in Litigation; Onyx Gets $160M in Settlement
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Bristol-Myers Squibb Company (BMY)'s Sprycel May Increase Hypertension Risk, FDA Says
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Pfizer Inc. (PFE) Settles with Teva Pharmaceutical Industries Limited (TEVA) Over Lipitor in UK; Deal Keeps Generic Lipitor at Bay to May 2012
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Teva Pharmaceutical Industries Limited (TEVA), Baxter International, Inc. (BAX), McKesson Corporation Must Pay $20 Million, Nevada Jury Says
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More Legal Briefs News
A blast from the past this month as Vivus resubmits for approval of the obesity drug Qnexa. The company was able to accelerate its study of potential birth defects in women who used one of the Qnexa ingredients as a migraine treatment by tapping into existing medical records.

Amylin is still working toward an FDA approval of diabetes drug Bydureon (it was approved in Europe this past June--just the kind of thing making some argue that FDA is the most difficult and unpredictable of drug regulators). But it has at least secured an expanded label for Byetta. And talk about low expectations--Transcept Pharmaceuticals has seen its stock nearly triple in value for merely getting its resubmitted NDA on the sleep aid Intermezzo accepted as a complete response.
-KT
Eli Lilly and Company (LLY), Amylin Pharmaceuticals, Inc. (AMLN) Diabetes Drug Wins Approval for Expanded Use
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VIVUS, Inc. (VVUS) Resubmits FDA App for Obesity Drug Qnexa
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FDA Approves Boehringer Ingelheim Corporation's Combivent(R) Respimat(R) (ipratropium bromide and albuterol) Inhalation Spray for the Treatment of Patients with Chronic Obstructive Pulmonary Disease
More...

FDA Approves Merck & Co., Inc. (MRK)'s Combination Therapy Juvisync; First Combination Drug to Treat type 2 Diabetes and High Cholesterol in one Tablet
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Transcept Pharmaceuticals, Inc. (TSPT) Shares Soar on Potential Sleeping Pill Approval; Intermezzo(R) PDUFA Action Date of November 27, 2011
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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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