Wednesday, February 29, 2012

Bubble, Billions, or Both? -- Feb. 29, 2012

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BioSpace BioPharm Exec
Wednesday, February 29, 2012
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Bubble, Billions, or Both?

Another month, another batch of big hepatitis C news. Is all the furious dealmaking in the space indicative of biotech's own mini-bubble? Or is it a matter of assets finally maturing to a point that they can realistically address a huge, and previously underserved, opportunity?

It all began quietly enough, with Roche announcing last October that it would buy Anadys and its phase 2b hepatitis C drug setrobuvir for $230 million. This was a relatively cheap acquisition of an asset with a potential role in a future combo therapy. Despite some encouraging clinical results, it had been languishing unnoticed by investors. But if Wall Street wasn't paying attention, pharma companies most definitely were. And shortly after the deal, things went hyberbolic. More...

More By Karl Thiel

Gilead Sciences suffered a major reversal of fortune this month. The company's stock soared after it reported that GS-7977--the hepatitis C treatment it paid $11 billion for in acquiring Pharmasset--quickly cured a small group of non-responders. This is a tough subpopulation, and no other hep C drug had managed a similar feat. Then just two weeks later, it reported that most of the seemingly cured patients had relapsed. Of course, this doesn't mean that GS-7977 isn't a valuable product or even that it might not work in non-responders--ironing out these kinks is what mid-stage clinical trials are all about. But it was a pretty stark reminder of how fast fortunes can change in this industry. -KT
Gilead Sciences, Inc. (GILD) Drops as Patients Relapse on Hepatitis C Drug
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Threshold Pharmaceuticals, Inc. (THLD) Soars on Positive Phase 2b Pancreatic Cancer Trial Results
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Actelion Ltd. (ALIOF.PK) CEO Says 120 Patients Died in Lung Drug Study
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Medivation, Inc. (MDVN) Soars as Prostate Cancer Drug is Well-tolerated in Phase 3 Trial
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Takeda Pharmaceutical Co. Ltd. (TKDG.DE)'s Inflammatory Bowel Disease Drug Meets Phase 3 Targets
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More Bench To Clinic News
Sure, they earn millions of dollars a year and get corporate perks worth more than their workers' salaries...but when there's trouble at a company, the buck stops with the CEO, right? Well that certainly didn't seem to be the case at Johnson & Johnson, which has gone from one product recall problem to another since 2009 (review the list yourself!). While a couple executives fell on their swords, chief exec William Weldon has stubbornly stuck to the corner office. No longer: He's being replaced by Alex Gorsky as the culmination of what the company describes as a multiyear succession process. In its 126 year history, J&J has always promoted chief executives from within, and this case is no different. But still, it must have been tempting to break with tradition and bring in someone with no baggage.

Oh--and not at all surprisingly, Weldon is getting a sweetheart deal as he makes his exit. -KT
Johnson & Johnson (JNJ) CEO Weldon Out, Successor Named
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GlaxoSmithKline (GSK) to Cut 3 Discovery Performance Units (DPUs), Will Add 4 New Units as Focus Shifts to R&D Productivity
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AstraZeneca PLC (AZN) to Axe 7,300 Jobs in Global Restructuring
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Dendreon Corporation (DNDN) Taps Savient Pharmaceuticals, Inc. (SVNT)'s Johnson as CEO
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Procter & Gamble (PG) to Slash 5,700 Jobs and Cut Costs by $10 Billion
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More Career Track News
No, the race for hepatitis C assets is not over, as Novartis--something of a latecomer to the space--proves with its deal for Enanta's early stage assets.

There's also a fight shaping up in the furiously disruptive sequencing space. Roche, which has always been tenacious when it comes to getting what it wants, is making a hostile bid for market leader Illumina. But Illumina is already suffering serious competition from Life Technologies and eyeing some commercial third-generation technologies. This month, stealth startup Oxford Nanopore presented some stunning data on its technology, one implementation of which is a USB memory stick-sized sequencer that the company says will cost just $900! -KT
Enanta Pharmaceuticals, Inc. Strikes Hep C Drug Deal With Novartis AG (NVS) Worth Up to $440 Million
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Pfizer Inc. (PFE) Eyes Tie-Ups With More Chinese Drugmakers; Will Ally With Zhejiang Hisun to Invest $545 Million in Generic Drug JV
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Roche (RHHBY) Digs in for Long Fight as Illumina, Inc. (ILMN) Rejects $5.7 Billion Bid
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Merck KGaA (MKGAF.PK) Signs $550 Million Cancer Pact With Threshold Pharmaceuticals, Inc. (THLD)
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AngioChem, GlaxoSmithKline (GSK) Form $331 Million Pact to Discover and Develop Treatments of Lysosomal Storage Diseases
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More Golden Handshakes News

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San Francisco Marriott Marquis, Wednesday, March 7, 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 Bay Area.
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Celgene has taken an interest in Acetylon, which is developing histone deacetylase (HDAC) inhibitors -- a class in which Celgene found success with the cancer drug Istodax, which it acquired with Gloucester Pharmaceuticals. Rather than partner on a program, Celgene is for now simply making an investment in Acetylon and taking an "observer" role on the board -- but not a board seat. And Ironwood is back at the trough for the first time since its early 2010 IPO -- a debut that was distinguished for the large capital raise it accomplished at a very dificult time. And Radius, working on osteoporosis therapies, is lining up for its own IPO. -KT
Celgene Corporation (CELG) Pours $15 Million Into Acetylon Pharmaceuticals, Takes "Observer" Role on Board
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Radius Files IPO, Aims for $86 Million
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Ironwood Pharmaceuticals Announces Exercise of Over-Allotment Option in Public Offering of Common Stock
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ChemoCentryx, Inc. Completes IPO
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Pfizer Inc. (PFE) Mulls $3 Billion Partial IPO for Animal Healthcare Unit: Report
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More Money Talk News

The great rheumatoid arthritis battle is over, now that the Supreme Court has declined to consider an appeal from Johnson & Johnson over Abbott Laboratories' alleged infringement of patents covering Remicade and Simponi. Abbott had been ordered by a District court in 2009 to pay J&J $1.67 billion in damages for infringing certain J&J patents. But a Federal Appeals court overturned that decision a year ago. With the Supreme Court declining to hear the case, that's the end of the matter. -KT
Supreme Court Rejects Johnson & Johnson (JNJ)'s Lawsuit Over Abbott Laboratories (ABT)'s Humira
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Illumina, Inc. (ILMN) Announces Favorable Patent Claim Construction Ruling in Litigation Against Complete Genomics, Inc.
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Roche (RHHBY) Warns of Counterfeit Avastin in the U.S.
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GlaxoSmithKline (GSK) Settles 20,000 Lawsuits Over Avandia, Lawyer Says
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Pfizer Inc. (PFE)'s Wyeth (WYE) Unit Seeks $960 Million in Damages From Sun Pharmaceutical Industries Ltd
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More Legal Briefs News
It's been a big month for drug approvals, with the tally that includes two new molecular entities -- Vertex's cystic fibrosis drug Kalydeco and Genentech's cancer drug Erivedge. That follows the approval of three NMEs in January. The real fireworks, however, were not about an approval but rather a positive advisory panel. Vivus nearly doubled after getting a 20-2 vote in favor of its weight loss drug Qnexa. Although we certainly know that doesn't guarantee approval from an FDA that asked some skeptical questions of the advisory panel, the stock is holding on to those gains. Here's hoping! -KT
FDA Approves Vertex Pharmaceuticals (MA) (VRTX)'s Cystic Fibrosis Drug
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FDA Approves Genentech (RHHBY)'s Erivedge (Vismodegib) Capsule, the First Medicine for Adults with Advanced Basal Cell Carcinoma
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VIVUS, Inc. (VVUS) Doubles After Winning Panel Backing for First Weight-Loss Pill in 13 Years
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FDA Panel Backs Forest Laboratories, Inc. (FRX),Almirall COPD Drug
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Amgen (AMGN) Fails to Win Panel Backing for Expanded Xgeva Use FDA
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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.

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