Making hepatitis C an A-list concern

Jeffrey Bouley
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BRISBANE, Calif.—January 9, 2007—InterMune announced it had successfully completed large-scale synthesis and delivery of the API for Hepatitis C virus drug candidate ITMN-191 to Roche. The milestone triggered a $10-million payment from the large pharma.
BRISBANE, Calif.—InterMune Inc. recently announced an exclusive worldwide agreement to col­laborate with Nutley, N.J.-based Roche on its hepatitis C virus (HCV) protease inhibitor pro­gram.
The agreement focuses on InterMune's lead candidate compound, ITMN-191, which is expected to enter clinical tri­als before the end of the year. However, "the value creation potential of this collaboration goes beyond ITMN-191," notes InterMune president and CEO Dan Welch, because the com­panies will also collaborate on a research program to iden­tify, develop and commercialize novel second-generation HCV protease inhibitors.
"We had previously commu­nicated that we had planned to continue to develop ITMN-191 without a partner through Phase Ib proof of concept and partner thereafter," Welch notes. "This plan would have put us in a deal around the third or fourth quar­ter of 2007.
But InterMune had also noted in corporate communications that it would partner earlier than Phase Ib if it were able to secure "substantially the same terms" that it would have expected at Phase Ib.
Under this deal, Roche will exclusively license ITMN-191 and will have the right to exclusively license further HCV protease inhibitor development candidates resulting from the research collab­oration. For ITMN-191, InterMune will conduct Phase I studies, and thereafter Roche will lead clinical development and commercializa­tion. Upon closing, InterMune will receive from Roche an upfront payment of $60 million.
In addition, assuming the suc­cessful development and com­mercialization of ITMN-191 in the United States and other coun­tries, InterMune could potentially receive up to $470 million in mile­stone payments, including $35 mil­lion within the next year.
"The terms we secured for this collaboration are extremely strong and compare very favorably to programs partnered at Phase I," Welch says. "ITMN-191 is one of several HCV protease inhibitor programs in development, and we recognize that speed to market is one of the most powerful value drivers in our industry."
Roche's HCV marketing expertise also loomed large for InterMune. The future HCV mar­ket will be "larger, far more com­plex and far more competitive," Welch notes, and therefore his company needs marketing muscle and know-how on a global scale.

Jeffrey Bouley

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