Tekmira starts limited manufacturing of therapeutic for Ebola

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[October 22, 2014]  (Reuters) - Canadian drugmaker Tekmira Pharmaceuticals Corp has begun limited manufacturing of a therapeutic targeting the Ebola-Guinea virus.

The pharmaceutical company said on Tuesday that the new drug, part of its TKM-Ebola program, would be available by early December but did not specify how many doses it was making.

Tekmira was not available for comment on the therapeutic, including whether it was manufacturing a drug or vaccine.

Tekmira's investigational new drug application to U.S. regulators for TKM-Ebola remains on partial clinical hold, with the issue expected to be resolved in the quarter.

U.S.-listed shares of the company rose as much as 6 percent in trading after the company gave an update on its Ebola program.

Tekmira has completed the design of a modified RNAi (ribonucleic acid interference) drug that targets the Ebola-Guinea variant, the virus responsible for the worst outbreak on record that has hit hardest Liberia, Sierra Leone and Guinea.

TKM-Ebola, an RNAi therapeutic, works by preventing the virus from replicating.

The European Medicines Agency said on Monday it was ready to offer Ebola treatments and vaccines the benefits of "orphan" drug status - including extended market exclusivity - in a bid to encourage their development.

Initial clinical trials of Ebola vaccines from GlaxoSmithKline and NewLink Genetics are already under way, the World Health Organization said on Tuesday.

Mapp Biopharmaceutical Inc gave its experimental Ebola treatment ZMapp to American medical workers Dr. Kent Brantly and Nancy Writebol, who recovered after contracting Ebola in Liberia, and to at least one Spanish priest, who died.

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Mapp said it had begun manufacturing the drug using traditional methods, which would allow the company to produce more of the drug so that human testing can be carried out.

Three Ebola cases have been diagnosed in the United States: Liberian Thomas Eric Duncan, who died on Oct. 8 at Texas Health Presbyterian Hospital in Dallas, and two nurses who treated him.

In September, U.S. and Canadian regulators authorized the use of Tekmira's TKM-Ebola in patients who have confirmed or suspected infections from the deadly virus.

(Reporting by Tanvi Mehta in Bangalore; Editing by Lisa Shumaker)

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