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BioSpace BioPharm Exec
Wednesday, July 25, 2012
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6 Ways to Save Biotech

Here we are a bit past mid-year, and figures from the first half of 2012 point to a rapidly worsening environment for early-stage biotech companies.

According to various sources, venture capital has dried up like a contact lens on a carpet. Bloomberg says there were just 59 deals totaling $550 million in the second quarter, down 43% from a year earlier, backing up similar figures from Dow Jones' VentureSource. More...

More By Karl Thiel

Roche has been hush-hush about RG7652, a drug that targets the PCSK9 gene. The gene is involved in cholesterol homeostasis, and there are some indications that inhibiting it leads not only to reductions in cholesterol but to even bigger reductions in coronary heart disease. There's obviously a huge potential market here, but there are also a number of competitors going after the same target--some of whom are well ahead of Roche in the development process.

Baxter surprised the neuroscience community with some early-stage results on Gammagard, a plasma-derived drug that has long been available for treating immunodeficiency. The study of just four patients was too small to draw conclusions from, but all the patients saw progression of Alzheimer's symptoms halt over a three-year period--an unusual result. Results of a phase 3 trial are expected in early 2013--which will be several months after we hear about higher profile Alzheimer's drugs from J&J/Pfizer/Elan and Lilly. -KT
Roche (RHHBY) Moves Secret Heart Drug to Phase III Trial
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Biogen Idec, Inc. (Massachusetts) (BIIB), Bayer AG (BAY.F) Drugs Fail to Slow MS Progression
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Baxter International, Inc. (BAX) Alzheimer's Drug Keeps Four Patients Stable for 3 Years
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Alnylam Pharmaceuticals (ALNY) Gains on Treatment Data for Deadly Nerve Disease
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Merck & Co., Inc. (MRK) Bone Drug Shows Benefits So Trial is Stopped
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More Bench To Clinic News
FDA has been monitoring the communications of a number of its staffers. That's not by itself all that unusual, but there's a question of whether the agency crossed the line in violating attorney-client privilege... or if it was perhaps trying to suppress whistleblower efforts. Meanwhile, Roche's latest cuts are aimed at efficiencies that can support a growing number of development programs, rather than a trimming down the number of programs. Roche's head of pharma research is among those leaving. And David Brennan is certainly leaving AstraZeneca a wealthy man, but the fact that's he's being asked to leave any money on the table is a contrast to what we're used to seeing stateside. -KT
FDA Spied on Its Own Scientists
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AstraZeneca PLC (AZN)'s Ex-CEO Forfeits 2012 Bonus
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Forest Laboratories, Inc. (FRX) Hires Search Firm to Hunt for New CEO
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QLT Inc. (QLTI) Slashes Workforce by Two-thirds, CEO Quits After Shareholder Coup
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Roche (RHHBY) to Cut 1,000 Research Jobs in U.S.
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More Career Track News
The Life Sciences Report 6 Biotech Stocks Riding the Baby Boomer Wave
By Diane Alter, Money Morning

"While no one has discovered a cure for Alzheimer's, cancer, Parkinson's or other ailments that come along with old age, several biotech companies are racing to cure a long list of diseases and disorders. More...
The Life Sciences Report 5 Ways to Spot the Next Hot Biotech Stock
By Keith Fitz-Gerald, Money Morning

"For all their potential, biotech stocks remain among the most challenging for investors to identify, select and earn money on. However, with a little bit of guidance you can narrow your list to the stocks with the highest likely upside."More...
Bristol Myers Squibb is buying Amylin--with a little help from AstraZeneca--for $31 a share, considerably more than the $22 it offered a year ago. The deal will help make it a global player in diabetes, though far from the leader. And GlaxoSmithKline has ended its hostilities with Human Genome Sciences and is buying the company in a friendly deal valued at almost $3 billion. That gives GSK full rights to the lupus drug Benlysta, which the companies have been co-marketing, as well as some interesting pipeline products. Two questions for GSK: Can it boost the so-far lackluster sales of Benlysta? And...is BioMarin next? -KT
GlaxoSmithKline (GSK) Clinches Deal to Buy Human Genome Sciences, Inc. (HGSI) for $2.8 Billion
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Verastem, Inc. (VSTM) Buys Pfizer Inc. (PFE) Cancer Drug Candidate in Deal Worth $126.5 Million
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AstraZeneca PLC (AZN), Bristol-Myers Squibb Company (BMY) Join Forces in $7 Billion Deal for Amylin Pharmaceuticals, Inc. (AMLN)
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Alnylam Pharmaceuticals (ALNY), Ascletis, Inc. Create Strategic Collaboration to Develop ALN-VSP
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Life Technologies (LIFE) Buys Navigenics for Genetic Diagnostics
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More Golden Handshakes News

Top Jobs
• BioCapital (Silver Spring, Maryland)

International Partnership for Microbicides
Chief Financial Officer
Will work as a key member of the Executive Team to lead and manage all aspects of the organizations strategic and operational financial plans. The CFO will work very closely with the CEO, the Board of Directors and their Finance Committee and colleagues on the Executive Team to align the strategic views of the Board and CEO with the activities of the organization and provide overall leadership in the areas of financial management and business development. This position will oversee financial analysis and reporting of expenditures involving all federal and privately funded budgets, etc.

• Biotech Bay (Sunnyvale, California)

Pharmacyclics, Inc.
Vice President, Regulatory Affairs
Responsible for developing and implementing balanced regulatory strategies and establishing and maintaining relationships with US and international regulatory agencies for effective communication and collaboration of clinical, non-clinical and CMC plans, activities, and updates. Will interface with potential and current alliance partners, and external contracted operational sites in achieving the highest standards in regulatory and quality compliance.

• BioMidwest (Northbrook, Illinois)

Astellas Pharma US
Vice President, Global Clinical Science
Responsible for development and maintenance of excellence in the strategic planning and conduct of clinical trials expertise in APGD, and for the successful application of this expertise globally (EU and US) to all phases of drug development in all Astellas' therapeutic areas of focus.Reports to the head of Global Development Operations, is a member of GDO senior leadership team and participates in the creation and execution of GDO mission, objectives and 3-5 year strategic plan.

• Genetown (Cambridge, Massachusetts)

Pfizer Inc.
Sr Director, BioTx Precision Medicine Clinical Head
Duties: Acting as a BioTx PM Clinical Head, responsible for providing and overseeing the implementation of patient segmentation hypotheses and strategies for BioTx. As BioTx PM Clinical Head, ensures a precision medicine approach is applied to all project transitions (e.g., from POM to POC) and acts as the go-to advisor to the CSOs. The PM Clinical Head liaises with cross-functional groups supporting PM throughout Pfizer and with the BUs to assure alignment on PM approaches etc.

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GenKyoTex raised more money from existing investors (including Edmond de Rothschild Partners, which has also recently raised a new fund) to advance its oral NOX inhibitor for diabetic neuropathy. Synageva went public through reverse merger into the remains of Trimeris, but missing the IPO party isn't stopping the company from raising cash. It is looking to advance its enzyme replacement therapy for lysosomal acid lipase--yup, another rare disease play. Juventas is looking to give patients the benefits of stem cell therapy without all that troublesome mucking about with stem cells. The company says its JVS-100 activates natural stem cell repair pathways and is studying its impact on chronic heart failure and critical limb ischemia. It has also spun off a company to study the same drug in skin and bone. Two companies for one early-stage compound? Anything to help the fundraising effort. -KT
Agile Therapeutics, Inc. Raises $40 Million in a Series C Financing
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Juventas Therapeutics, Inc. Raises $22.2 Million Series B Financing
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Durata Therapeutics, Inc. Prices $68 Million IPO
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GenKyoTex S.A. Raises $26 Million for Phase II Development of Diabetic Nephropathy Drug
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Synageva BioPharma (GEVA) Announces $80 Million Proposed Public Offering of Common Stock
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More Money Talk News

Vivus had little time to celebrate after the approval of its weight-loss drug Qsymia. Short-seller firm Citron Research published a report suggesting the company doesn't have sufficient patent protection to protect the product, which is a combination of two generic drugs. Enough investors remember what happened to NitroMed and its heart failure drug BiDil (another combination of generics now sold by Arbor Pharmaceuticals) to get spooked.

And there's more on the K-V Pharmaceutical saga. FDA recently agreed to take "normal" enforcement action against pharmacists who continue to compound hydroxyprogesterone instead of using K-V's rather more expensive Makena. But since the agency found little threat in the homegrown versions of the drug it inspected, normal means little to none. Now K-V is suing the agency in hopes of getting it to beef up its enforcement--and to perhaps save the company from bankruptcy. -KT
VIVUS, Inc. (VVUS) Diet Pill Patents are Questioned and Stock Sinks
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U.S. Charges 48 People in $500 Million Medicaid Drug Scheme
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Merck & Co., Inc. (MRK)'s Schering-Plough Corporation (SGP)'s K-Dur Pay-for-Delay Ruling Reversed
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K-V Pharmaceutical Company (KV-A) Sues FDA Over Makena in Fight for Survival
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GlaxoSmithKline (GSK) Settles Healthcare Fraud Case for $3 Billion
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More Legal Briefs News
It's two down, one to go for the trio of obesity drugs that investors have been following the past few years. Both Vivus's Qsymia (previously Qnexa) and Arena's Belviq (lorcaserin) got the agency's green light. Orexigen's Contrave is considerably behind in the race, although the company said enrollment of its required cardiovascular safety study is ahead of schedule and that interim results will be available by the end of 2013, a little earlier than expected.

Big strides in HIV, too. In addition to approving the first at-home test for HIV infection, the agency approved Gilead's Truvada to prevent infection in high-risk individuals. And Onyx gets its first wholly-owned drug approved, which the company expects to be available August 1. -KT
FDA OKs Onyx Pharmaceuticals, Inc. (ONXX)'s Kyprolis for Multiple Myeloma
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FDA Approves Novartis AG (NVS)'s Afinitor for Breast Cancer
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FDA Approves VIVUS, Inc. (VVUS)'s Weight-Loss Pill
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FDA Approves Gilead Sciences, Inc. (GILD)'s Truvada Pill for HIV Prevention
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FDA Approves Arena Pharmaceuticals, Inc. (ARNA) Obesity Drug; First in 13 Years
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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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