Thursday, November 27, 2014

Merck’s Entry Marks Third Big Pharma In Ebola Vaccine Race.



Vauhini Vara writes for the New Yorker (11/26) that Merck’s freshly-inked deal with NewLink Genetics over the latter company’s promising Ebola vaccine means that it joins GSK, J&J, and several startups in a test of R&D as the companies try to win the first broad approval. With only a handful of cases in developed countries, Ebola does not have much promise of profit in the traditional drug discovery and development model, but public payers are poised to stockpile large volumes of approved vaccines and therapeutics. Compared to blockbuster vaccines like Merck’s Gardasil, Ebola is likely to generate small profits at best. The New Yorker offers two reasons for Merck’s deal: “it was seen as a promising drug and had features in common with other Merck vaccines, and Merck had experience in developing and producing vaccines that NewLink, as a much smaller company, lacked.”
        Trefis (11/26) agrees that an Ebola vaccine is unlikely to create a blockbuster for Merck, writing “the incremental value addition from a successful launch and commercialization will be low considering Merck’s size and our expectation that the price of vaccine is likely to be low.” Zacks Investment Research (11/26), meanwhile, calls the acquisition” a smart move.”
        Chemical & Engineering News (11/26, Halford) reports that, in contrast to the two doses believed to be required for Glaxo’s ChAd3 vaccine to be effective, Merck/NewLink’s VSV-EBOV should work with only one jab. The difference could be a boon for Merck, as the vaccine is supposed to be deployed in areas with limited healthcare infrastructure or in wealthier countries experiencing a public health crisis. In addition to vaccine R&D, intensive efforts are also underway by numerous companies to develop treatments for those already infected and to produce a fast, cheap, and reliable test for the condition.
        GSK Vaccine Trial Underway. TIME (11/26, Sifferlin) gives an update on the status of one of two experimental Ebola vaccine trials being tested in humans. GlaxoSmithKline and NIH partnered to develop a vaccine being tested at the University of Maryland School of Medicine, University of Oxford, Emory University, and in the field in Mali. Healthy volunteers have already been given the vaccine and researchers are waiting for the 28th day after injection for data, as this is the date at which the immune response would be the strongest due to the vaccine. Researchers hope to bring this vaccine to the WHO by the end of December.
        The Baltimore Sun (11/26, Dance) profiles volunteers who signed up to test the Ebola vaccine at University of Maryland. Volunteers report high fevers immediately following injection and feeling “exhausted.” The Sun reports that volunteers cannot catch Ebola from receiving the vaccine because the vaccine does not contain the virus. Instead, the vaccine uses chimpanzee cold virus to trick the immune system into creating antibodies for Ebola. NIH will compare the results from these volunteers to results in monkeys who were given the vaccine and subsequently exposed to Ebola. Nancy Sullivan, chief of the biodefense research section of NIAID said about the testing, “Unless you have a crystal ball that is well maintained, you can’t really predict how any of these things will perform in humans. ... It’s cautious optimism.”
        Analysis: GeoVax Needs Partner For Ebola Vaccine. A November 18 analysis (off embargo today) by Edison’s Philippa Gardner and Mick Cooper explored GeoVax, a tiny biotech working on a one-shot Ebola vaccine. The company is trying to find a partner, possibly the CDC, to help it test the vaccine (experimental name GOVX-E301). Edison noted that, with a current valuation of $5.6 million, “current cash will be insufficient for further development.” Analysis based on embargoed market research from Thomson Reuters.

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