BioSpace BioPharm Exec
Wednesday, March 27, 2013
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Speaking the Unspeakable

This past December, the U.S. Court of Appeals for the Second Circuit handed down a decision in U.S. vs. Alfred Caronia, overturning a 2009 ruling finding Alfred Caronia--a drug rep for Orphan Medical, now part of Jazz Pharmaceuticals--guilty of a criminal misdemeanor for the off-label promotion of the narcolepsy drug Xyrem. The lower court had taken the standard line in the case, which is that any promotional activity that strays from a drug's approved label is by definition false or misleading. Or put another way, that FDA is the final arbiter of truth. More...

More By Karl Thiel

Biogen Idec is building a formidable franchise in multiple sclerosis. In addition to having recently regained full rights to Tysabri, the company is awaiting approval of BG-12 (Tecfidera) and recently secured a patent granting market exclusivity through 2028. And another MS drug in its pipeline, Plegridy, is looking pretty promising in phase 3. Teva Pharmaceuticals is watching closely...and nervously. -KT
Amgen (AMGN)'s Melanoma Drug Shows Promise in Key Trial
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Biogen Idec, Inc. (Massachusetts) (BIIB)'s Injectable MS Drug Cut Relapse Rate by 36 Pct
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Merck & Co., Inc. (MRK) Says a Crucial Vytorin Study Will Continue
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Celgene Corporation (CELG)'s Apremilast Succeeds in Phase 3 Psoriasis Trial
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FDA Halts Amgen (AMGN) Trial After Teen Death
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More Bench To Clinic News
There's no question that AstraZeneca and its new CEO Pascal Soriot are stealing all the headlines when it comes to this month's career news. First the company announced 1,600 job cuts (about 650 in the U.S.), focused on R&D operations. Then another 2,300 layoffs were layered on top--sales and administrative positions. Add that to the 1,150 R&D-related jobs still to be axed from the cuts announced in 2012, and you get 5,050. Unions are upset about relocations and the closing of the Alderley Park facility in Cheshire, U.K., and have hinted at a possible strike. MedImmune, meanwhile, stands to gain about 300 positions. Given that the MedImmune acquisition has been fairly disappointing for AstraZeneca, this might be tinged with irony. But the company is looking to make Gaithersburg one of its major R&D centers. -KT
AstraZeneca PLC (AZN): 2300 More Layoffs; Global Total Now 5050
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Affymax, Inc. (AFFY) May File for Bankruptcy; Cuts 75 Pct of Workforce
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Compensation Jumps 43 Pct for AbbVie (ABBV) CEO
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Johnson & Johnson (JNJ) Cuts Executive Bonuses, Citing "Disappointments"
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Performance Pay Package Halved for GlaxoSmithKline (GSK) CEO
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More Career Track News
We know the tenure of AstraZeneca's new CEO, Pascal Soriot, will be marked by a leaner sales and R&D operation. But what will it mean in terms of strategic priorities? We got one early hint this month: He is taking a bit of a Hail Mary pass in a deal with Moderna Therapeutics, aimed at using messenger RNA to stimulate protein production in the body. The deal calls for a massive $240 million upfront payment, plus milestones and royalties. It's a bold deal in that Moderna has not yet advanced a product to the clinic.

Ambit Biosciences is in an awkward spot--less than a month after it filed for an IPO, Astellas ended the companies' collaboration on FLT3 kinase inhibitors. And Celgene is stepping into gene therapy, in a deal with bluebird bio aimed at modifying patients' T-cells into efficient cancer killers. -KT

AstraZeneca PLC (AZN) Shells Out $240 Million Upfront for Moderna Therapeutics mRNA Drugs
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bluebird bio Forms Cancer Drug Partnership With Celgene Corporation (CELG)
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Astellas Pharma Inc. (YPH.BE) and Ambit Biosciences to End Collaboration for Joint Development and Commercialization of FLT3 Kinase Inhibitors
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Receptos Licenses AbbVie (ABBV) Antibody for Co-Development
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Presage Biosciences Snags $13 Million From Celgene Corporation (CELG) to Pick Winning Cancer Drug Combos
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More Golden Handshakes News

Top Jobs
• Biotech Bay (South San Francisco, California)

Achaogen
Chief Medical Officer
The Chief Medical Officer is responsible for leading and directing the clinical development of the Company's therapeutic agents. Plans and supervises clinical trials, clinical data analysis and safety monitoring. The CMO will be a key member of the senior management team, making strategic decisions for the Company with respect to allocation of resources, advancing existing programs to the next stage of development, and taking on new therapeutic initiatives.

• Biotech Beach (San Diego, California)

Clinical Research Management, Inc.
Chief of Research Oversight and Compliance
Responsibilities include: Expertise and experience with Air Force (or military service) specific human clinical research protocols and guidelines. Knowledge of and experience with IRB policies regarding human experimentation, emergency protocols, and adverse events. Knowledge of and experience with IACUC policies regarding animal experimentation and adverse events.

• Pharm Country (New Brunswick, New Jersey)

Omega Management Group
Senior Director Regulatory Affairs
Some Specific Responsibilities Include: Provides Strategic Regulatory input into Clinical development programs, Phase IIIb and LCM activities. Provides Strategic and Operational oversight to Regulatory CMC activities. Provides Strategic Regulatory input for all interactions with state and federal Regulatory agencies, as needed.

• Genetown (Cambridge, Massachusetts)

ARIAD Pharmaceuticals, Inc.
Vice President - Quality
This role collaborates with the GxP (GCP, GMP and GLP) functional areas in order to facilitate quality and compliance in all GxP-related activities. The incumbent will serve as a mentor and coach to the department, modeling behaviors aligned with the company values.

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The Nasdaq Biotech Index tipped over 1,600 on March 6, and reached a new all-time high on March 8, thirteen years and one day after its previous peak. Yes, that means we're sailing past the heights of the 2000 bubble. As I write, the S&P 500 also stands on the brink of a new all-time high, but it can't quite seem to make it. (That has some chart-oriented pundits warning of a dreaded triple-top and disaster ahead, although I wouldn't head for the bunker quite yet).

What does this really mean? On the one hand, not a lot. All the index says is that the aggregate value of this particular bunch of companies is higher than the aggregate value of a different bunch of companies from 2000...not exactly the stuff of revelation. Still, it does reflect how much value has been created in the biotech industry over the past decade-plus.

Not surprisingly, these gains are attracting new IPOs. We've seen recent filings from Omthera Pharmaceuticals, Chimerix, and GW Pharmaceuticals, as well as recent debuts from Enanta and TetraPhase Pharmaceuticals. Expect more ahead.

-KT
Enanta Pharmaceuticals, Inc. Raises $56 Million in IPO
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Omthera Pharmaceuticals, Inc. Files for a $75 Million IPO
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Tesaro, Inc. Nets $91 Million
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NABsys, Inc. Raises $20 Million From Investors
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Emergence-Backed Veeva Systems, Inc. Seen Seeking $2 Billion Valuation With IPO
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More Money Talk News

If Syntrix's $96 million patent infringement verdict against Illumina sounds familiar, it may be because the company also lost a major patent infringement suit to Affymetrix back in 2007. Illumina eventually paid Affymetix a similar $90 million to settle that dispute. I don't have an opinion on the merits of this current case (Illumina continues to believe they are not infringing and plan to appeal), but it is certainly notable that some significant IP violation, at least as determined by the courts, hasn't really gotten in the way of Illumina's success. -KT
Syntrix Wins $96 Million Verdict Against Illumina, Inc. (ILMN) in DNA Patent Suit
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Merck & Co., Inc. (MRK) Hid Fosamax's Bone-Weakening Risks, Lawyer Contends
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Federal Trade Commission Slams Actelion Pharmaceuticals US, Inc. (ATLN.VX) for Withholding Samples
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AbbVie (ABBV) Seeks to Block Release of Clinical Trial Data
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Interpol, Dozens of Drug Makers Ramp Up Fight Against Counterfeit Drugs
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More Legal Briefs News
The U.K.'s NICE has turned down the breast cancer drug Afinitor because it believes the survival benefits don't warrant the high price tag. It's a stark illustration of how the high cost of some very innovative drugs can impact healthcare budgets. Or as critics would have it, a cautionary tale of what could come to the U.S. if we go down the road of rationing on the basis of cost-effectiveness.

And it was one step forward, two steps back for menopause related drugs this month. FDA panels, by wide margins, rejected both Depomed's Sefelsa (a formulation of gabapentin) and Noven Pharmaceuticals' LDMP (a low-dose paroxetine salt) for vasomotor symptoms (hot flashes, etc.). But Shinogi's Osphena, for painful intercourse due to post-menopause vulvar/vaginal atrophy, was given the FDA green light. Osphena is a SERM (selective estrogen receptor modulator), but unlike SERMs used in cancer treatment (like Evista), which tend to act as agonists in the bone and antagonists at the breast and/or uterus, Osphena is an agonist at the endometrium. It is a new chemical entity.

-KT
FDA Rejects Pharmaxis Ltd (PXS.AX) Drug Push Bid
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Heart Warning Added to Pfizer Inc. (PFE)s "Z-Pak" Antibiotic by FDA
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FDA Panel Rejects Depomed, Inc. (DEPO) Menopause Treatment
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FDA Approves Shionogi, Inc.'s Drug for Painful Intercourse in Women
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Cell Therapeutics, Inc. (CTIC) Receives Complete Response Letter from the FDA for Pixantrone NDA; FDA Recommends Additional Trial
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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
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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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