HALIFAX, Nova Scotia, Feb. 27, 2015 (GLOBE NEWSWIRE) -- via PRWEB - Immunovaccine Inc. ("Immunovaccine") (TSX: IMV), a clinical stage vaccine and immunotherapy company, today announced that the U.S. Food and Drug Administration has approved its application for Fast Track designation and Phase I clinical trials of the DPX-Anthrax and DPX-Ebola vaccines, in conjunction with the mutual co-development agreement signed with Gilead Life Sciences. The company had previously obtained Fast Track designation for the DPX-Survivac.
"We have been in talks with several major pharmaceutical companies for some time due to the very strong interest in the DepoVax platform, and this milestone was the key driver in pushing forward the partnership" said Marc Mansour. "We could not hope for a better partner than Gilead due to their already extensive portfolio of immunodefense products, and we look forward to working with their team to ensure the efficacious and rapid development of our DPX-Biodefense pipeline. We are especially excited to be the first company to have a viable Ebola vaccine going into clinical human trials."
Under the agreement, Immunovaccine has granted Gilead an exclusive license for the research, development, manufacture and commercialization of DPX-Anthrax and DPX-Ebola for therapeutic uses in all human disease indications in the US, Canada and select International Markets. A National Institutes of Health (NIH) led study had already demonstrated the potential of DepoVax as a universal enabler of single dose rPA-based anthrax vaccines, and in August 2014 the DPX-Ebola vaccine had proven to be 100% effective in inducing total immunity to Ebola in a primate study.
The development of both programs will be continue at the National Institute of Health, as well as the Edgewood Chemical Biological Center (ECBC) in Maryland where the delivery mechanisms for both programs will be further explored and developed in parallel with the Phase I clinical trials.
Joseph Corriveau, Director of ECBC stated: "Over the last few years, we have evaluated several chem-bio protection agents and those developed by Immunovaccine for Anthrax and Ebola are the most promising due to their ability to provide immunity in one single dose, compared to multiple dosing of existing vaccine. We have worked extensively with the FDA to ensure that such life saving therapies get the just priority their national security implication deserves. We anticipate that this cooperation with Immunovaccine and Gilead and the consequent accelerated development we will have the ability to provide rapid immunization against these potent diseases to our warfighters as well as at-risk civilian populations in the US and abroad within 24 months."
As part of the agreement, Immunovaccine will receive an up-front fee from Gilead of US$40 million and could potentially receive over US$100 million in development milestone through the completion of Phase I trials, with a further $200 million upon final FDA approval, along with tiered double-digit royalties based on sales of licensed products.
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future, is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.
Neither TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
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Contacts:
For Immunovaccine:
Marc Mansour, Chief Executive Officer
T: (902) 707-1190 E: mmansour(at)imvaccine.co
Tim Brons, Vida Strategic Partners (media)
T: (415) 448-6450 E: tbrons(at)vidacommunication.co
For Gilead Sciences, Inc.
Ryan McKeel, (650) 246-9550 (Media)
This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit http://www.prweb.com/releases/2015/02/prweb12533346.htm
Marc Mansour +1 9027071190
