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West Coast Biotech Roundup: Gilead, Conatus, Exelixis, and More

Xconomy San Diego — 

Those of you who thought that DreamWorks’ Shrek franchise ended in 2010 with Shrek Ever After may have been surprised when a new installment played out over the past week with the big green ogre re-imagined as a former hedge-fund-manager-turned biotech executive.

Martin Shkreli, CEO of Turing Pharmaceuticals, called down the wrath of the Twitter-verse this week by increasing the price of pyrimethamine (Daraprim), a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection, by over 5,000 percent—from $13.50 to $750 a tablet.

As a predictable controversy ensued, major biotech stock indices plunged, Democratic presidential candidate Hillary Clinton seized a golden opportunity to discuss price-gouging by the pharmaceutical industry, Newsweek reported that Shkreli is under investigation, and BIO’s board expelled Turing from the life sciences industry organization.

In his column this week, Alex Lash, Xconomy’s National Biotech Editor describes the Shkreli affair as “a springboard into deeper waters” while delving into an overview of a dozen or so ways that Clinton would alter the U.S. healthcare business if she is elected president. He focuses in particular on her ideas for allowing Medicare to negotiate drug prices.

The Shkreli story was so intense, however, that folks might well ask if there was any other biotech news this week. So here is our roundup of West Coast life sciences news.

—One political dustup eclipsed by Shkreli was the California biotech industry’s reaction to comments made by California Republican Rep. Darrell Issa about pending legislation (H.R. 9) intended to reform patent litigation. As reported by Politico, Issa argued that if the bill is amended to protect biopharmaceutical patents, “there will be expensive, on-patent medicines that are, in fact, not new and innovative.” In a letter to Issa, the California Life Sciences Association and Biocom said his comments seem to dismiss the very real and serious concerns that life sciences companies and affiliated groups have about the proposed legislation.

—While Turing Pharmaceuticals reignited the drug price debate in the U.S., the U.K.’s powerful drug-price regulator, known as NICE, praised Foster City, CA-based Gilead Sciences (NASDAQ: GILD) for playing nice with the price of its cancer drug ideasilib (Zydelig). NICE approved ideasilib for certain chronic lymphocytic leukemia patients in combination with rituximab, and an official cited Gilead’s willingness to provide the drug at a discount.

—Aduro Biotech (NASDAQ: ADRO) of Berkeley, CA, added antibody technology expertise by acquiring Dutch firm BioNovion for 29 million Euro ($32.4 million), half in cash, half in stock, with possible future payments as well. Announced late Thursday, the deal adds to Aduro’s preclinical pipeline; its lead program is in Phase 2b trials for pancreatic cancer.

—The FDA has asked San Diego’s Pathway Genomics for more information about a new liquid biopsy test for cancer the company recently introduced. The agency raised concerns about CancerIntercept Detect, a diagnostic test Pathway launched earlier this month to detect tumor DNA in healthy patients at high risk of cancer. The letter reads, in part, “Based on our review of your promotional materials and the research publication [a white paper on the company’s website], we believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health.” In a response posted on the company’s blog, Pathway Genomics says it is offering the test as a certified clinical laboratory test that meets regulatory standards, and, “We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept testing.” The company said it is considering the FDA’s concerns and will be responding to their letter.

—Human Longevity, the San Diego diagnostics company founded by the genomics pioneer J. Craig Venter, plans to offer comprehensive genetic sequencing and analysis to members of the Discovery healthcare company, an insurer based in South Africa that has about 4.4 million members. Including affiliated organizations, as many … Next Page »

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