Two months after being awarded government funding for its influenza antiviral peramivir, BioCryst Pharmaceuticals Inc. licensed Japanese rights to the product in a potential $130 million deal.
That figure includes a $14 million up-front payment from Osaka, Japan-based Shionogi & Co. Ltd., which gains rights in Japan to develop injectable formulations of peramivir for seasonal and potentially life-threatening influenza. On top of that, BioCryst could receive clinical milestones of up to $21 million and sales milestones of up to $95 million. Upon commercialization in Japan, BioCryst would be eligible for royalty payments in the range of 10 percent to 20 percent.
The company could not be reached for comment, but said in a press release that the collaboration is expected to accelerate the development of peramivir in Japan, while further strengthening its cash position. BioCryst, which ended 2006 with $46.2 million, received a four-year, $102.6 million contract in January from the Department of Health and Human Services to fund continued development of peramivir. That funding will be put toward worldwide Phase II and Phase III studies, as well as manufacturing and approval requirements. The compound potentially could be included in the national stockpile. (See BioWorld Today, Jan. 5, 2007.)
The agreement with Shionogi is similar to one signed in June with the Korea-based firm Green Cross Corp., under which BioCryst licensed Korean rights to peramivir in exchange for a license fee, event-based milestones and royalties. BioCryst retains all commercialization rights in the rest of the world. (See BioWorld Today, June 15, 2006.)
Peramivir, a neuraminidase inhibitor, is designed to treat both influenza A and B, and has shown promising preclinical activity against the highly pathogenic H5N1 virus, a subtype of influenza A. Earlier this year, BioCryst began a Phase II trial to measure the safety and efficacy of two doses of peramivir, administered via intramuscular injections.
The FDA has designated injectable peramivir a fast-track product.
Elsewhere in its pipeline, BioCryst has partnered programs aimed at cancer and autoimmune diseases. Fodosine (forodesine), which is in a Phase III trial in acute lymphoblastic T-cell leukemia, is being developed with Cambridge, UK-based Mundipharma International Holdings Ltd., which holds rights to the compound in Europe, as well as additional markets in Asia and Australia. Fodosine, a transition-state analogue inhibitor of purine nucleoside phosphorylase (PNP), also is in development against cutaneous T-cell lymphoma, chronic lymphocytic leukemia and B-cell acute lymphoblastic leukemia.
The company also is collaborating with Basel, Switzerland-based F. Hoffmann-La Roche Ltd. to develop BCX-4208, a second-generation PNP inhibitor, for transplantation and autoimmune diseases. That product is in Phase I testing, and the companies expect to initiate Phase II development, with an initial focus on psoriasis.
Shares of BioCryst (NASDAQ:BCRX) closed at $9.77 Tuesday, up 73 cents.