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Boehringer Ingelheim Bolsters HCV Research Portfolio With Biota Deal

This article was originally published in The Pink Sheet Daily

Executive Summary

German firm will pay $102 mil. for rights to develop and commercialize Biota’s novel nucleoside analogues for hepatitis C.

Boehringer Ingelheim is strengthening its virology research portfolio through a collaboration with Melbourne, Australia-based Biota Holdings to develop and commercialize Biota's nucleoside analogues for the treatment of hepatitis C and potentially other diseases.

Biota announced Nov. 27 that BI will pay the firm up to $102 mil. in up-front and potential milestone payments for the rights to develop the early-stage compounds.

"We've had a lot of interest in our HCV intellectual property and believe the value and opportunity created through this deal represents a very good outcome for our shareholders," Biota CEO Peter Cook stated.

Under the terms of the agreement, Biota is responsible for drug discovery research, while BI is responsible for the development and commercialization of the compounds.

"BI is internationally recognized as one of the leaders in the research and development of antiviral therapeutics," Cook added. "They will contribute development and commercialization expertise, and we shouldn't lose sight of the fact that BI has the financial capacity to support late-stage trials in hepatitis C, which are particularly difficult and expensive."

BI already has several antivirals in development internally, including treatments for HCV and HIV. The German company's current research in the area of HCV is directed toward identifying inhibitors targeting essential viral enzymes, such as the HCV serine protease and RNA polymerase.

BI's marketed antivirals include the protease inhibitor Aptivus (tipranavir) and the non-nucleoside reverse transcriptase inhibitor Viramune (nevirapine), both for HIV. Aptivus was approved in June 2005 for use in highly treatment experienced patients (1 (Also see "Aptivus Labeling Recommends Genotypic And Liver Function Testing" - Pink Sheet, 23 Jun, 2005.)).

Biota has other research collaborations with drug manufacturers, including a deal for zanamivir with GlaxoSmithKline, which has resulted in one marketed product, Relenza for influenza. That product is being stockpiled by national governments (2 (Also see "GSK Seeks Manufacturing Partners For Flu Treatment Relenza" - Pink Sheet, 27 Oct, 2005.)).

The company also signed a development deal with MedImmune last year for a series of drug candidates aimed at respiratory syncytial virus. That deal was valued at about $112 mil., Cook said.

"Our HCV compounds are appreciably earlier in the drug discovery process, yet we've been able to achieve a comparable value," the exec said. "I'd suggest that reflects the current strong global interest in HCV programs by big pharma and the potential market for any likely product."

Indeed, several such research collaborations have closed recently. In October, Roche signed a deal with InterMune to develop a protease inhibitor, ITMN-191, with the potential for twice-daily dosing. That deal included a $60 mil. up-front payment and up to $470 mil. in milestone payments (3 (Also see "Roche Gets Hep C Inhibitor With Potential Twice Daily Dosing From InterMune" - Pink Sheet, 17 Oct, 2006.)).

Earlier in the year, Johnson & Johnson partnered with Vertex on the development of the protease inhibitor VX-950 (telepravir), offering an up-front payment of $165 mil. and an additional $380 mil. in milestones and tiered royalties (4 (Also see "J&J, Vertex Partner To Commercialize VX-950 For Hepatitis C" - Pink Sheet, 30 Jun, 2006.)).

Novartis also partnered with Human Genome Sciences to develop Albuferon (albumin interferon alfa-2b), in a deal including $45 mil. in up-front payments and $507.5 mil. in milestones and other payments (5 (Also see "Novartis Bolsters Hep C Pipeline With Human Genome Sciences Collaboration" - Pink Sheet, 6 Jun, 2006.)).

-Jessica Merrill ([email protected])

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