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UPDATE 6-Drugmakers to join forces to make millions of Ebola vaccine doses

Wed, 22nd Oct 2014 18:57

* GlaxoSmithKline sees first vaccine doses ready this year

* J&J and GSK executives discuss Ebola vaccine collaboration

* J&J investing up to $200 mln to accelerate programme

* Bavarian Nordic to receive cash injection from J&J

* Europe expected to announce funding for new vaccines (Adds European announcement)

By Ben Hirschler

LONDON, Oct 22 (Reuters) - Leading drugmakers plan to worktogether to speed up the development of an Ebola vaccine andhope to produce millions of doses for use next year.

Europe is also expected to announce 200 million euros ($250million) of funding to develop new Ebola vaccines, drugs anddiagnostic tests, sources said on Wednesday.

U.S. firm Johnson & Johnson said it aims to produceat least 1 million doses of its two-step vaccine next year andhas already discussed collaboration with Britain'sGlaxoSmithKline, which is working on a rival vaccine.

The economics of an Ebola vaccine are still unclear but drugcompanies with an eye on their reputations are under pressure torespond to the major international health crisis now ravagingone of the poorest corners of Africa.

J&J's head of research Paul Stoffels said it was importantto have several experimental vaccine candidates in development,since it is not clear which ones will work, but resources couldin future be focused on one clear winner.

GSK's chief executive Andrew Witty told reporters onWednesday that a meeting of experts in Geneva this week woulddiscuss ways to ensure that all companies, including those withno direct involvement in the Ebola work, pulled together to helpremove supply bottlenecks.

The European funding is expected to be announced this weekunder a scheme jointly paid for by the pharmaceuticals industryand the European Commission, according to two people with directknowledge of the situation.

Much of the money is likely to be used to help financeclinical trials of three experimental vaccines.

There is currently no proven vaccine against the deadlydisease and drug companies have been wary in the past of pouringresources into Ebola since previous outbreaks have been small.As a result much of the research effort to date has been drivennot by concerns about sporadic outbreaks in Africa but by fearsin the West that Ebola might become a bioterror weapon.

FRONTLINE HEALTH WORKERS

Clinical tests on GSK's vaccine and another from NewLinkGenetics are under way, while human tests on J&J'svaccine will start in January.

The World Health Organization (WHO) hopes that tens ofthousands of people in West Africa, including frontlinehealthcare workers, can start receiving Ebola vaccines fromJanuary as part of large-scale clinical trials.

Liberia, worst-hit by the virus, welcomed the announcementbut said any vaccine must be affordable and available insufficient quantities.

Minister of Information Lewis Brown said: "It is importantto remember clinical trials are in their early stages. We shouldnot be complacent. The good news today should spur on furtherresearch into a disease that has been ignored for far too long."

The first doses of GSK's Ebola vaccine are expected to beready late this year. "It will give WHO and other agencies auseful tool," Witty said, adding that the GSK product was likelyto be the first vaccine to be deployed on a limited basis.

Witty and Stoffels said they had talked several times inrecent days about collaboration, including swapping ideas onproduction and vaccine development. "It might even be that wehave to combine their vaccine with ours," Stoffels said.

J&J expects the accelerated work on its Ebola vaccine, whichhas been helped by recent advances in technology, would yield250,000 doses by May.

The U.S. company plans to test its vaccine for safety andimmune response in healthy volunteers in Europe, the UnitedStates and Africa from early January, having committed up to$200 million to accelerate the programme.

BOOST FOR BAVARIAN NORDIC

West Africa's Ebola outbreak began in March and has killedmore than 4,500 people, most of them in Liberia, Sierra Leoneand Guinea, according to the WHO. Outbreaks in Senegal andNigeria have been declared over by the WHO and there have been ahandful of cases in Spain and the United States.

The J&J vaccine was discovered in collaboration with theU.S. National Institutes of Health (NIH) and includes technologyfrom Denmark-based Bavarian Nordic, which will nowreceive a cash injection from the American healthcare company.

The total potential deal value for Bavarian Nordic could bemore than $187 million, including up-front payments, milestonepayments based on product progress, a supply contract and thepurchase by J&J of shares in the Danish biotech business.

Bavarian Nordic's share price jumped 23 percent to 185Danish crowns after the announcement of J&J's plans.

J&J has simplified and fast-tracked its vaccine programme inthe light of the world's worst Ebola outbreak.

It had been working to develop a vaccine against both theZaire and Sudan strains of Ebola, as well as a related conditioncalled Marburg disease. However, it is now also developing avaccine targeting only the Zaire strain behind the currentepidemic, which should yield results faster.

PROMISING SIGN

Although the safety and effectiveness of J&J's and otherexperimental vaccines has yet to be proven, they have providedgood protection against the Zaire strain of Ebola when tested onmacaque monkeys, which is seen as a promising sign that they arelikely to work in humans.

Like a number of experimental vaccines against variousdiseases, J&J's vaccine uses a common cold virus, called anadenovirus, to carry its payload.

Immunisation with the J&J vaccine, which was developed byits Crucell unit in the Netherlands, consists of two injections:one to prime the immune system and a second to boost theresponse. In contrast, researchers are testing a single shot ofGSK's vaccine.(1 US dollar = 5.8566 Danish crowns) (Additional reporting by Supriya Kurane in Bangalore; Editingby David Goodman, Greg Mahlich and Giles Elgood)

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