Merck, Iowa firm sign Ebola vaccine licensing deal

AP News
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Posted: Nov 24, 2014 3:57 PM

TRENTON, N.J. (AP) — Merck & Co., a top creator and seller of vaccines, has joined the fight against Ebola, the often-fatal hemorrhagic virus that's been ravaging parts of West Africa for months.

Merck, based in Whitehouse Station, New Jersey, said Monday it has entered a global partnership with a small U.S. drug developer to research and manufacture a potential Ebola vaccine now in initial patient testing.

The exclusive deal involves rVSV-EBOV, a vaccine candidate under early development by BioProtection Systems, the vaccine-development subsidiary of NewLink Genetics Corp. of Ames, Iowa.

It was created in labs of the Public Health Agency of Canada, which in 2010 signed a deal giving BioProtection Systems an exclusive license for the vaccine and the technology for producing it.

NewLink's vaccine is in the first phase of human testing, a study run by the U.S. National Institutes Of Health in healthy volunteers. It's meant to determine whether it stimulates their immune system to make antibodies against Ebola, and to spot any safety problems and help determine the best dosage. Other early-phase studies are to begin shortly in other countries.

Dr. Mark Feinberg, chief public health and science officer for Merck's vaccines division, said that the vaccine was shown to be very effective in preventing infections in nonhuman primates exposed to Ebola.

Early next year, he said, the NIH and multiple public health and corporate partners are to begin late-stage testing of rVSV-EBOV, plus a second Ebola vaccine jointly developed by Britain's GlaxoSmithKline PLC and the NIH's National Institute of Allergy and Infectious Diseases.

Detailed plans are being finalized, but that study should include about 30,000 participants — people at high risk of Ebola infection, including health workers, household contacts of patients and people who bury deceased patients, because corpses are particularly infectious. Feinberg said they're aiming for very quick results, compared to the decade or so it normally takes to bring a vaccine or drug to market.

Ebola, which has killed up to 90 percent of people infected in past outbreaks, is spread through contact with bodily fluids and causes sudden fever and muscle pain, followed by vomiting, diarrhea and sometimes internal and external bleeding. As of Friday, nearly 5,500 deaths and more than 15,000 infections had been reported, mainly in six African countries, according to the World Health Organization.

"Effective Ebola vaccines will be a critical component of comprehensive prevention and control measures for people at risk of Ebola virus infection and to stem future outbreaks globally," Dr. Julie Gerberding, the president of Merck Vaccines and former head of the federal Centers for Disease Control and Prevention, said in a statement.

Under its deal, Merck gets exclusive rights to the vaccine and any follow-up products, meaning other vaccines that may be developed for related hemorrhagic fevers such as Marburg virus, Feinberg said. NewLink is to receive a $30 million upfront payment for signing the deal, then $20 million when more-advanced testing begins. It also can receive royalties on sales of the vaccine in certain countries.

Meanwhile, Johnson & Johnson also is developing an Ebola vaccine, and other companies are trying to create treatments. Those include MAPP Pharmaceuticals Inc. of San Diego, the maker of the experimental drug ZMapp that was given to some infected American medical workers before supplies ran out, and Tekmira Pharmaceuticals Corp. of Canada.

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Follow Linda A. Johnson at http://twitter.com/LindaJ_onPharma