BioSpace BioPharm Exec
Wednesday, December 19, 2012
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2012 in Review

What important stories shaped this past year...and promise to influence the year ahead? In our tradition of touching on some unscientifically selected highlights from the past year, here are some developments and trends that stood out in 2012 and that may reverberate into next year.

Clinical and Product Highlights...

Hepatitis C: If last year was about furious M&A leading to a swelling hepatitis C bubble, this year is about the apparent winners and losers starting to emerge. More...

More By Karl Thiel

Antibodies intended to treat Alzheimer's disease by binding to beta amyloid peptides in various forms have been a clinical bust so far. Pfizer/J&J/Elan's bapineuzumab and Eli Lilly's solanezumab both failed to produce a meaningful response in phase 3 trials. But researchers are not giving up on the central idea that binding beta amyloid plaques could help mitigate disease. One largely unstudied variable is whether earlier treatment could make a difference.

That's where Genentech's crenezumab comes in. It is in the same family as the other two drugs--although its developers say it doesn't bind to monomeric beta amyloid, which may be neuroprotective. But the company has found a practical way to test it as a preventative measure--by using it in an isolated Colombian town that, because of a high prevalence of a shared mutation, has a huge incidence of Alzheimer's disease. The trial will involve five years of treatment and more follow-up, but the results should help settle, one way or another, the role that beta-amyloid antibodies can play in treatment.

Genentech parent Roche, it's worth noting, is also studying another related compound, gantenerumab, in patients who have not yet shown signs of dementia. -KT
Genentech (RHHBY) Preps for $100 Million Alzheimer's Trial

Oncolytics Biotech Inc. (ONC.TO) Soars on Positive Phase 3 Head and Neck Cancer Data

Celgene (CELG)'s Pomalidomide Helps in Myeloma After Others Fail

Pfizer Inc. (PFE) New Breast Cancer Drug Heralded as Breakthrough

Stunning Data for Ambit Biosciences/Astellas Pharma Inc. (YPH.BE) AML Drug

More Bench To Clinic News
Pfizer has been rewarded for cutting back expenses, at least in terms of share price. The company announced this past June that it would shave off another $1 billion in annual operating expenses. Part of that math, we now learn, involves trimming the primary care sales force. No word yet on the exact number of cuts.

AstraZeneca, meanwhile, is cutting 400 jobs (not 625) in Germany, mostly in sales and commercial operations. It's more fallout from expiring patents, and is an addition to the 7,300 jobs the company said it would cut back in February. -KT
Billionaires Push to Turn Ex-Merck Serono HQs Into R&D Center, New Jobs

Roche (RHHBY) CEO's Proposed Election to Board Criticised

Controversial FDA Official Tom Laughren Retires

Pfizer Inc. (PFE) and the Incredible Shrinking Sales Force

AstraZeneca PLC (AZN) to Cut 625 Jobs

More Career Track News
Out of bankruptcy since early 2010, deCODE genetics has continued its focus on genomic discovery, lately with the idea that its insights could be used to create molecular diagnostics. But the company perhaps makes more sense as a discovery arm of a larger organization with full drug development capabilities. Enter Amgen, with plenty of cash and an exit plan for deCODE's investors.

Isis has signed a couple of big antisense deals this month. Its third tie-up with Biogen Idec brings $30 million up front and covers three neuromuscular targets. Another deal with AstraZeneca brings $25 million up front and covers five targets, including one drug--ISIS-STAT3Rx--already in development to prevent tumor growth in multiple cancers. -KT
Gilead Sciences, Inc. (GILD) Bags Blood Disorder Drug With $510 Million YM BioSciences (YM.TO) Buy

Teva Pharmaceutical Industries Limited (TEVA) Enters $376 Million Deal for Xenon Pharmaceuticals Inc. Pain Drug

Amgen (AMGN) Bags Gene-Hunting Firm deCODE genetics, Inc. (DCGN) for $415 Million Cash

Biogen Idec, Inc. (Massachusetts) (BIIB), Isis Pharmaceuticals, Inc. (ISIS) in Drug Development Pact for Up to $630 Million

Sanofi (France) (SAN.PA) Deal Could Net Selecta Biosciences, Inc. $900 Million

More Golden Handshakes News

Top Jobs
• Biotech Bay (Emeryville, California)

NovaBay Pharmaceuticals, Inc.
Vice President of Product Development
Direct all product development activities for NovaBay's lead compound currently in Phase II/III clinical trials for three indications. Additionally the incumbent will supervise the head of Pharmaceutical Development and Manufacturing responsible for the manufacture, testing and quality assurance and technical support for NovaBay's commercial prescription skin and wound cleanser medical device.

• Biotech Beach (Los Angeles, California)

Puma Biotechnology
Assoc/Director/Sr Director, Program Management
The primary objective of the program management function is to oversee, manage and coordinate cross-functional areas of product development via program team structures. Program management, in concert with the senior management leadership, will manage all aspects of the development project through to registration as well as life-cycle management.

• Pharm Country (Berkeley Heights, New Jersey)

Sr. Director, IT Enterprise Information Services
Position plays a key leadership role in Information Technology at Celgene bearing responsibility for defining, leading, and executing the strategic direction and oversight of the enterprise application portfolio and related information delivery services. This includes systems management and the evaluation, implementation, integration and operation of the portfolio of enterprise applications at Celgene.

• Pharm Country (Princeton, New Jersey)

Novo Nordisk, Inc.
Director-Sr. Director, Clinical Research - Diabetes
Develop, implement and monitor clinical studies (predominantly registration trials from Phase 1 to III) in a team setting. Provide medical and scientific support in other aspects of company activities in the therapeutic area of diabetes.

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Genetown Career Fair Genetown Career Fair
Cambridge Marriott, Wednesday, Thursday, February 21, 2013, 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.
Bio NC Career Fair Bio NC Career Fair
Sheraton Imperial Hotel & Convention Center, Thursday, March 7, 2013, 11am - 4pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the south east region.
Sofinnova's seventh life sciences venture fund will be focused about two-thirds in Europe, most of the rest in the U.S. The firm has a pretty good track record, although it's interesting that the vast majority of previous portfolio companies were sold to pharma companies rather than taken public.

One of Sofinnova's U.S. investments, Flexion, is working on some late-stage sustained release drugs (a steroid and a p38 MAP kinase inhibitor are most advanced) for osteoarthritis. ArmaGen is developing a Trojan horse technology to carry therapeutic proteins across the blood brain barrier. Transcriptic is at a very early stage but is interesting in that it raised $150,000 of its seed funding online through AngelList and SecondMarket, supplementing investments from Mark Cuban, Google Ventures, and others. They are developing automated lab equipment--robots that can do a lot of tedious lab work with the idea that much bench research could ultimately be done from a laptop. Goodbye lab coat, hello bathrobe! -KT
Pfizer Inc. (PFE) to Launch Animal-Health Unit IPO in Early 2013

Biotech Startup Transcriptic Receives $1.2 Million in Seed Funding Led by Google Ventures

Sofinnova Ventures Raises $312 Million for Life Sciences

Fluxion Biosciences Secures $20 Million in Series B Financing

ArmaGen Technologies, Inc. Announces $17 Million Series A Financing

More Money Talk News

An investigation into the sales and promotion of Mediator, a diabetes drug often prescribed as an appetite suppressant until it was pulled from the French market in 2009, has led to manslaughter charges again Servier's 90-year-old founder. Lawsuits over deaths linked to the blood-thinner Pradaxa are nothing new, but they are mounting and Bloomberg has an interesting story on the controversy. J&J drew the ire of Doctors Without Borders (and many others) for refusing to enter the Medicines Patent Pool, which was formed in 2010 with the aim of making HIV drugs more accessible in poor countries. They recently announced they wouldn't enforce patents on the HIV drug Prezista, but at least one pundit thinks it's just inadequate whitewashing. -KT
Servier Founder Faces Manslaughter Charges

Pfizer Inc. (PFE) to Pay $55 Million to Settle Protonix Case

Boehringer Ingelheim Corporation Sued by Hundreds Over Bleeding Tied to Pradaxa

The Op-Ed: Johnson & Johnson (JNJ) Patent Move is "Inadequate"

KV Pharmaceutical to Pay Hologic, Inc. (HOLX) $60 Million to Settle Makena Drug Dispute

More Legal Briefs News
Approval of Ariad's Iclusig is a nice reversal for the company, which saw its sarcoma treatment ridaforolimus rejected this past summer. The icing on the cake is that the approval came about three months earlier than expected. While Iclusig will probably be used mostly in a relatively small subset of patients with chronic myeloid leukemia, it should make a nice niche product for the company. The drug is (I believe) another new molecular entity, and its early approval--along with the approval of Exelixis' Cometriq for medullary thyroid cancer--will boost 2012's final tally. I'm not sure where the final number of NMEs will land--below last year's impressive 30, certainly, but this was still a respectable year for new drug approvals. The problem is, FDA can only approve applications that have been submitted, and this number has declined recently. -KT
Ariad Pharmaceuticals, Inc. (ARIA) Wins FDA Approval for Drug to Treat Rare Leukemias

Johnson & Johnson (JNJ)'s Zytiga Wins Approval for Early Prostate Cancer Use

Exelixis, Inc. (EXEL)'s FDA Approves Cometriq to Treat Rare Type of Thyroid Cancer

Sanofi Pasteur (SASY.PA)'s Meningococcus Vaccine Menactra Approved for Infants Down to 9 Months

Theravance, Inc. (THRX) Halted; FDA Panel to Review VIBATIV NDA

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

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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