BioSpace BioPharm Exec
Wednesday, October 31, 2012
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Our Next President

Here we sit less than a week from the election. You probably made up your mind long ago about which way you'll vote, and if you're anything like me, your decision is about more than one issue or even one area of policy. But whether or not things go your way--right now it's a toss-up who will win--it makes sense to think about what the future will bring. Both candidates paint this as a vitally important election between leaders with starkly different views of policy and governing. So if the fate of the life sciences potentially hangs in the balance, what are we likely to see in the months ahead? More...

More By Karl Thiel

There was a lot of clinical news this month, and it was hard to narrow it down to just five headlines. Lilly got some much-needed good news on dulaglutide, its GLP-1 analog that outperformed Byetta in a phase 3 study. (It wasn't tested against Bydureon). Pfizer didn't have the same luck in expanding its label for Inlyta--it narrowly failed to show a significant extension of progression-free survival in renal cancer versus sorafenib in treatment naive patients. Sanofi looks like it may have a winner in its oral Gaucher's treatment, but we don't know how the pill will fare against IV infusions like Cerezyme or Shire's Vpriv. The ENCORE study comparing eliglustat and Cerezyme should have top-line results early next year. -KT
Eli Lilly and Company (LLY) Diabetes Medicine Meets Goal in 3 Studies
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Bayer HealthCare (BAY)'s Lung Drug Shows Promise in Phase 3 Study
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Pfizer Inc. (PFE) Kidney Cancer Drug Fails as Initial Treatment
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Genentech (RHHBY)'s T-DM1 Stuns as Approval Creeps Up
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Sanofi (France) (SAN.PA)'s Gaucher Pill Meets Goal in Phase 3 Trial
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More Bench To Clinic News
Merck, after 20 years at Whitehouse Station, is moving its global headquarters to Summit, N.J., in order to cut costs. It's a facility the company inherited when it acquired Schering-Plough in 2009. The company is in the process of shedding about 12% to 13% of the total headcount it had at the completion of the merger.

Job cuts are what happen when you undergo a huge merger. On the other hand, if you're company splits into two parts, the result is...job cuts. Abbott Laboratories, in the process of splitting into a pharma company called AbbVie and a diagnostics and devices company, announced 550 job cuts with more to come. So far, all the cuts are on the diagnostic/device side. However, the recent failure of Abbott and Reata Pharmaceuticals' kidney disease drug bardoxolone, on which blockbuster hopes were resting, didn't help things for the pharma side of the business. -KT
Johnson & Johnson (JNJ) Cuts 130 Jobs After Alzheimer Drug Fails
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CORTEX Plans $186 Million in New Biotech Development; 1,400 New Jobs
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Abbott Laboratories (ABT) Lays Off 550, More Cuts to Come
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Merck & Co., Inc. (MRK) Moves Global HQs to Cut Expenses, Consolidate Properties
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Cipla Ltd. CEO Resigns to Avoid Hearing
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More Career Track News
The Life Sciences Report Disruptive Biotechnologies Stir Up Profits: Ray Blanco
By George S. Mack of The Life Sciences Report

As coeditor of Technology Profits Confidential and contributor to Breakthrough Technology Alert and Penny Sleuth at Agora Financial, Ray Blanco searches far and wide for breakthrough ideas and disruptive technologies that will change the lives of very sick patients. More...
The Life Sciences Report What Moves Biotech Stocks? Ed Arce Has Answers
By George S. Mack of The Life Sciences Report

Biotech stocks move on material news, which means clinical data, regulatory progress, new partnerships and big contracts with new customers. Analyst Ed Arce of MLV & Co. holds to these principles as he shares compelling biotech names in this exclusive interview with The Life Sciences Report. More...
The first deal announced under the tenure of AstraZeneca's new CEO Pascal Soriot gives us a glimpse of where he is leading the company. They licensed Ardelyx's sodium-hydrogen antiporter 3 (NHE3) program, including a drug for irritable bowel syndrome about to go into phase 2. This is part of a broader focus on renal health and diabetes.

AiCuris landed its first deal, and it's a doozy--Merck is paying $177 million upfront, another $535 million in various potential milestones, and royalties. The subject of the excitement is Letermovir, a novel quinazoline designed to inhibit the terminus of human cytomegalovirus (CMV) that is poised to enter phase 3. CMV is a major cause of disease and death in transplant and other immunocompromised patients. AiCuris was spun out of Bayer Healthcare in 2006. -KT
Theravance, Inc. (THRX), Merck & Co., Inc. (MRK) Ink $153 Million Cardiovascular Pact
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Pfizer Inc. (PFE) Will Buy NextWave Pharmaceuticals for Up to $680 Million
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Evotec AG (EVTG.F) and Bayer AG (BAY.F) Enter Into $765 Million Multi-Target Alliance to Fight Endometriosis
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Merck & Co., Inc. (MRK), AiCuris Ink $571 Million CMV Pact
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AstraZeneca PLC (AZN) Boosts Pipeline With $272 Million Ardelyx Inc. Drug Deal
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More Golden Handshakes News

Top Jobs
• Biotech Bay (Redwood City, California)

3-V Biosciences, Inc.
Sr. Director/Vice President, Chemistry
This scientific leader has the opportunity to work on projects that span discovery stage assets through development stage scale-up. The successful candidate will manage and mentor a team focused on discovering and developing 3-Vís current and future compounds. This leader will work closely with other entrepreneurs at 3-V to shape the current and future portfolio of effective drugs that treat infectious diseases and a variety of other potential indications.

• BioChina (Beijing, China)

HOB Biotech Group
VP, R&D, IVD Industry, Immunoassay Field
As a key member of the top executive management team and reporting to the CEO, the Vice President (VP) is responsible for establishing the company's technical vision and leading all aspects of the company's technology and product development. The VP is the company's top technology executive, playing a critical role in the company's strategic direction, development, and future growth.

• Pharm Country (Newark, New Jersey)

Chronos Consulting
VP, Outsourced Laboratory Services
Reporting to President, you will be responsible for: Driving and developing strategic business initiatives, operations, marketing, client management, pricing and identifying & assessing potential acquisitions. Managing an organization of 300 + and responsible for full P&L in a few locations. Achieving aggressive revenue targets and identifying new areas for growth etc.

• BioCapital (Washington, DC)

Veterans Health Administration
Chief R&D Officer
Will be responsible for conceiving, developing and executing the medical and prosthetics research program for the Veterans Health Administration. In this role you will be responsible for policy development, information dissemination, and oversight of the administration of research and the overall direction of the VA research program.

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Hot biotech IPOs? Sounds like a relic of years long past. But both Intercept and Kythera managed to get out without slashing their offering price, to debut at the top of their range, and even to go up in subsequent trading. No surprise that some other companies are lining up for the exit.

MIT's Andrew Lo has modest proposal to push cancer research forward: A massive $30 billion fund that would invest in 150 early-stage compounds at any given time. The scale would be enough to find a few winners among the inevitable failures, he says, and give investors a decent return. Certainly it's another welcome answer to the pressing problem of funding high-risk, early-stage research, although it's unclear if Lo, also a hedge fund manager, will really be able to get it off the ground. -KT
Puma Biotechnology Raises $138 Million in Public Offering of Common Stock
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Aclaris Therapeutics Raises $21 Million in Series A Financing
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KaloBios Pharmaceuticals, Inc. Files for IPO
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Massachusetts Institute of Technology (MIT) Economist Pitches $30 Billion Cancer Megafund
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Intercept Pharmaceuticals, Kythera Biopharmaceuticals Take Off in IPOs
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More Money Talk News

Ever find yourself barely scraping by at home, only to open up your bank statement and realize that you're raking it in Europe? No? Well, you're not Pfizer, then. The SEC has for the past several months been corresponding with the pharma giant about how its accounting puts all its profits in low tax jurisdictions. This isn't a new story, or indeed a new tactic, but Pharmalot recently drew attention to it. I don't know exactly what Pfizer is saying, but I'll bet they've got some really smart bean counters with some very good answers. Heck, both presidential candidates have admitted U.S. corporate tax rates are too high!

The deadly outbreak of meningitis traced back to New England Compounding Center in Framingham, Massachusetts, is likely going to bring specialty pharmacies under some intense scrutiny. No clear explanation yet as to why aspergillus fungus was present in high concentrations in supposedly sterile rooms, but early reports suggest procedures and oversight at the facility were weak at best. -KT
FDA Warns Celltex Therapeutics Corporation Over Violations
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Johnson & Johnson (JNJ) Loses a Preemption Case Over Infant Tylenol
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Pfizer Inc. (PFE) to Shell Out $164 Million in Investor Lawsuit Over Celebrex
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SEC Investigates Pfizer Inc. (PFE) Over Odd Results
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FDA: New England Compound Center Drugs Tied to Meningitis
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More Legal Briefs News
It was a good month for approvals and positive recommendations. Since our last issue, FDA has approved four new molecular entities--including Teva's Synribo (the first protein synthesis inhibitor for chronic myeloid leukemia); Esai's Fycompa (for epileptic seizure); Thrombogenics' Jetrea (for an eye condition called symptomatic vitreomacular adhesion); and, at the end of September, Bayer's Stivarga for colorectal cancer. And if the agency follows the advice of its advisory panels, it looks like we'll be seeing some more NMEs approved in the coming weeks--like Isis' Kynarmo and Aegerion's exciting Lomitapide, part of a new molecular class called microsomal triglyceride transfer protein (MTP) inhibitors. -KT
FDA Approves Teva Pharmaceutical Industries Limited (TEVA) Leukemia Drug
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FDA Approves Eisai Inc. (ESALF.PK) Drug for Epileptic Seizures
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FDA Panel Backs Sanofi (France) (SAN.PA) and Isis Pharmaceuticals, Inc. (ISIS) Drug for Rare Genetic Disorder
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Aegerion Pharmaceuticals, Inc. (AEGR) Soars as FDA Panel Backs Cholesterol Drug
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FDA: ThromboGenics NV (TBGNF) Main Drug Cleared for U.S. Launch
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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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