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BioSpace BioPharm Exec
Wednesday, August 29, 2012
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Patent Threats, and the Cheap Cost of R&D

Myriad Genetics won the latest battle in its long-fought struggle to maintain its patents on BRCA genes and related diagnostic tests. The case has been closely watched ever since a surprising court decision threw the patentability of genes--long assumed but never confirmed--into question.

Here's a quick recap of events: Back in March 2010, Federal District Court Judge Robert Sweet ruled More...

More By Karl Thiel

Elan Pharmaceuticals once had an enormous amount riding on bapineuzumab, an antibody that attacks the beta amyloid plaques thought to be responsible for Alzheimer's disease. But when the drug finally flunked out of two phase 3 studies this month, Elan's stock barely budged--in part because the company had turned over most of its interest to Pfizer and Johnson and Johnson, and in part because failure was already pretty widely anticipated.

Not surprisingly, Eli Lilly's similar compound, solanezumab, also didn't fare well. But it did offer a glimmer of hope--a pre-defined pooled analysis that showed a statistically significant slowing in cognitive decline. For both these drugs, the clinical trial post-mortem will be critical. We don't know how successful bapi was in clearing plaques, for instance. Many researchers still believe going after beta amyloid is the right strategy, and there are many reasons apart from the breakdown of this hypothesis as to why bapi and solanezumab, as studied, didn't work. Bapi looks done for, but Lilly plans to speak with FDA on how to proceed with its drug.

Overall it has been a disappointing month for clinical trials, with high profile failures from Amgen, Pfizer, Merck, Lilly, and AstraZeneca/BTG. The fiercely competitive field of hepatitis C nucleoside poymerase inhibitors also got narrower after Bristol-Myers Squibb halted development of BMS-986094--an Inhibitex compound for which it paid $2.5 billion at the height of the hepatitis C bubble. -KT
Pfizer Inc. (PFE), Johnson & Johnson (JNJ) Scrap Alzheimer's Drug After Phase III Study Fails
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Idenix Pharmaceuticals, Inc. (IDIX) Hepatitis C Drug Put on Partial Hold
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Roche (RHHBY) Says Avastin Slows Brain Cancer Tumor Growth
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Amgen (AMGN) Halts Pancreatic Cancer Trial After Drug Failure
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Human Genome Sciences, Inc. (HGSI) Lung Cancer Drug, Mapatumumab in Combination with Chemotherapy Agents Fails to Improve Survival
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More Bench To Clinic News
Forest Labs handed some more fuel to activist investor Carl Icahn. The company recently received an FDA warning letter concerning promotion of the COPD drug Daliresp--which, Icahn points out., is the second warning letter the company has received in the past 18 months relating to promotional practices. It also follows a $300 million settlement with the Department of Justice in 2010, again relating to the company's drug promotion activity. This latest misstep helped Icahn land a seat on Forest's board.

Abbott Labs took exception to a report from the Institute for Policy Studies that names it as one of 26 companies that paid its CEO more than it paid in federal taxes last year. Abbott's defense is that it paid more in taxes than IPS gives it credit for. What the company didn't attempt to do was justify CEO Miles White's compensation--heck, he's only 82nd on Forbes' 2012 list of highest paid CEOs, after all. That's behind the chief executives of Baxter International, Allergan, Gilead Sciences and...number one by a long shot...McKesson. -KT
Abbott Laboratories (ABT) Rebukes CEO Salary Study
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Cipla Medpro Suspends CEO for "Serious" Charges
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Icahn May Win One Board Seat at Forest Laboratories, Inc. (FRX)
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Ex-Pfizer Inc. (PFE) Chief, Joins VC Firm Lux Capital
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Baxter International, Inc. (BAX) Facility to Create 1,500 New Jobs
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More Career Track News
The Life Sciences Report Chen Lin's Key to Huge Biotech Profits: Make It Personal
By George S. Mack of The Life Sciences Report

Chen Lin is a well-known expert junior metals and energy investor, but he has found compelling reasons to diversify into biotechnology. In this exclusive interview with The Life Sciences Report, Lin meshes common sense and personal experience with his More...
The Life Sciences Report Special Report Reveals Biotech Stock Drivers: Michael Hay
By George S. Mack of The Life Sciences Report

Certain predictable dates and events bring profound effects to bear on biotech stocks. Michael Hay, vice president of Sagient Research Systems, successfully applies the art and science of important catalysts to predict when biotech stocks will move up or down. More...
Regulus, the brainchild of Alnylam and Isis Pharmaceuticals, notched two deals in August. AstraZeneca has become an investor in the company and has partnered with Regulus on microRNA therapeutics. Focusing on three target in oncology, cardiovascular, and metabolic disease, Regulus will take microRNA compounds as far as the start of human trials, after which AstraZeneca takes over. One program will be in atherosclerosis, where Regulus has already produced some impressive preclinical results. Biogen Idec, meanwhile, hopes to use microRNA to discover new biomarkers for multiple sclerosis, both for optimizing clinical trials and designing companion diagnostics. Biogen Idec has also become an equity investor in the company.

Elan is spinning out its Neotope Biosciences drug discovery business, a contingency plan following the failure of Alzheimer's drug bapineuzumab (see Bench to Clinic) that will make the company immediately profitable. It will also leave the company without much R to its R&D, and may be an invitation for an acquisition--say, by its Tysabri partner Biogen Idec. -KT
AstraZeneca PLC (AZN) Buys Into Regulus Therapeutics, Inc.' MicroRNA Therapeutics for $28 Million
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Allergan Inc. (AGN), Molecular Partners AG Ink $1.5 Billion Exclusive Pact
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Elan Corporation PLC (ELN) Fuels Buyout Plans With $130 Million R&D Spinout, Unit Will Have Around 80 Staffers
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GlaxoSmithKline (GSK) Completes $3.6 Billion Takeover of Human Genome Sciences, Inc. (HGSI)
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S*Bio of Singapore Sells Cancer Drug Rights to MEI Pharma (MEIP) (Formerly known as Marshall Edwards, Inc.) (MSHL) for $75 Million
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More Golden Handshakes News

Top Jobs
• Biotech Beach (La Jolla, California)

Shire
VP- Head of Manufacturing
Responsible for the manufacturing strategy, organizational design and operations at all three internal manufacturing plants at Shire RM. Reporting to the Senior Vice-President of Technical Operations, the Head of Manufacturing has: two Plant Managers, Facilities & Eng and EHS. As a member of the Technical Operations leadership team, partners closely with all functions within Technical Operations, to include MSc, Quality, Facilities & Engineering, and Supply Chain, as well as the Regulatory function to ensure consistent, complaint, efficient production of biologic products.

• Biotech Bay (Berkeley, California)

Dynavax Technologies
Vice President of Sales
He/She is responsible for oversight and leadership of the Company's US sales organization. This individual will be a member of the senior management team and will develop sales strategies and forecasts, and will be directly responsible for achieving the revenue goals for the Company's lead commercial product, Heplisav™. He/she will participates in setting strategies for the new product launch and brand management to optimize revenue generation and product placement for market share advantage.

• Pharm Country (New York City, New York)

Eli Lilly and Company
VP - Cancer Signaling
This position will oversee the Tumor immunology, Cancer Signaling and Operations groups at the ImClone Research facility. Candidates should have a strong background in cancer signaling, Tumor Immunology and Antibody-based therapeutics, and be a recognized leader in the field of oncology drug discovery as reflected through publications and conference presentations.

• Genetown (Lexington, Massachusetts)

Cubist Pharmaceuticals, Inc.
Sr. Director, Biostatistics
Duties: Leads or supports the resource planning and management for the therapy area, and setting of therapy area group strategy and vision. Serve as the premier technical leader within biostatistics, liaise with product strategy teams, and communicate therapy area plans and strategy to colleagues in Biostatistics, Clinical Research, Regulatory, and other functions etc.

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

Pharm Country Career Fair Pharm Country Career Fair
Bridgewater Marriott, September 13, 2012, 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 tri-state area..
Biotech Beach Career Fair Biotech Beach Career Fair
Hyatt Regency La Jolla, Thursday, September 20, 2012, 1pm to 6pm. Job seekers can spend a day with HR representatives and Hiring Managers from top biotech, pharma, and medical device companies in the Southern California region.
Regulus, riding high in the wake of two partnerships with AstraZeneca and Biogen Idec (see Golden Handshakes) has decided it's time to take its microRNA technology public. Meanwhile, Idenix managed a well-timed cash round--raising $191 million just days before its hepatitis C nucleoside polymerase inhibitor IDX-184 was placed on partial clinical hold by FDA. That knocked the stock down about 30% in one session, well below that $8 a share at which it priced its recent offering. But management really can't be praised or blamed here--the problem that prompted FDA's action apparently had nothing to do with IDX-184 but rather a serious cardiac event--and subsequent death--related to Bristol-Myers' now-discontinued nuke. -KT
Regulus Therapeutics, Inc. Files for Up to $58 Million IPO
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Idenix Pharmaceuticals, Inc. (IDIX) Prices Public Offering of Common Stock
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KV Pharmaceutical Files for Chapter 11; Cites Makena Drug Woes
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Burrill & Company Touts New Life Sciences Fund Worth $505 Million
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Biotech Start-Up Atterocor Raises $16 Million Series A
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More Money Talk News

The threat of doctors prescribing the two generic drugs that make up Qsymia (formerly Qnexa), rather than Qsymia itself, continues to weigh on Vivus. Meanwhile, Gilead Sciences is getting some pressure about the pricing of its "Quad" HIV treatment from Rep. Alcee Hastings (D-Fla.). In urging Gilead to show "restraint" over the drug's rumored $34,000 price tag, Hastings couldn't help but point out that CEO John Martin is the tenth most highly paid CEO in the U.S. Zing! But hey, at least Gilead pays more than Martin's compensation in federal taxes. -KT
Myriad Genetics, Inc. (MYGN) Wins Gene Patent Ruling From US Appeals Court
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VIVUS, Inc. (VVUS) Tumbles on Concerns About Generic Qsymia
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Gilead Sciences, Inc. (GILD) Warned by Democrats Over "Quad" Pricing
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Pfizer Inc. (PFE) to Pay $60 Million for Making Foreign Bribes
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U.S. Appeals Court Tosses Momenta Pharmaceuticals, Inc. (MNTA) Injunction Against Generic Lovenox
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More Legal Briefs News
FDA has already approved over 20 new molecular entities in 2012 (depending on how you count), and another--Sanofi and Regeneron's Zaltrap--joins the list this month. It will compete against Bristol's Erbitux and Roche's Avanstin, and while it's not expected to unseat these older drugs, it should bring in a peak $300 million to $400 million in sales. That's a significant product for Regeneron, which has co-promotion rights outside Japan but has to repay half of Sanofi's development costs. It will be more significant still if the companies can expand a second-line label to include first-line treatment of metastatic colorectal cancer. That's the hope, but the drug has a spotty clinical history that may make this a tough hurdle. Perhaps more likely is the inclusion of the drug in a combination therapy. Meanwhile, Merck expects Singulair sales--over $5 billion last year--to drop around 90% now that FDA approved generic versions of the drug from 10 different manufacturers. -KT
FDA Approves Talon Therapeutics, Inc. (TLON.OB)'s Marqibo to Treat Rare Type of Leukemia
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FDA Approves Roche (RHHBY)'s Lucentis to Treat Diabetic Macular Edema
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FDA Approves First Generic Copies of Merck & Co., Inc. (MRK)'s Singulair
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FDA Approves Sanofi (France) (SAN.PA)-Regeneron Pharmaceuticals, Inc. (REGN)'s Zaltrap for Metastatic Colorectal Cancer
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GlaxoSmithKline (GSK) Files Two Melanoma Drugs for U.S., Europe Approvals
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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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