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Bristol Myers Squibb: strengthening the hepatitis C pipeline
  Wed. January 14, 2009; Posted: 08:00 AM
Jan 14, 2009 (Datamonitor via COMTEX) -- BMY | Quote | Chart | News | PowerRating -- Bristol-Myers Squibb has acquired the rights to co-develop PEG-Interferon lambda for the treatment of hepatitis C from ZymoGenetics. Although current interferon alpha therapy is relatively successful in treating hepatitis C infection, it has several drawbacks, leaving significant room for the development of alternative interferon products as well as novel classes.
Bristol-Myers Squibb (BMS) has formed a global partnership with ZymoGenetics to develop PEG-Interferon lambda, which is currently in Phase Ib development for the treatment of hepatitis C virus (HCV). Having successfully penetrated the hepatitis B and HIV markets, this collaboration indicates that BMS is keen to expand its presence into the HCV field. The company also has two small molecule antivirals in early stage development for the treatment of HCV.
Under the agreement, potentially worth up to $1 billion, BMS is to pay ZymoGenetics an upfront cash payment of $85 million for the development and commercialization rights to PEG-Interferon lambda plus a license fee of $20 million in 2009. ZymoGenetics could receive further payments based on pre-defined development and regulatory milestones for PEG-Interferon lambda in HCV and other potential indications . The two companies have agreed to co-develop PEG-Interferon lambda in the US and Europe.
ZymoGenetics has to date completed and presented data from a Phase Ia study; a Phase Ib study is ongoing. The company is expected to continue conducting a significant portion of the Phase I and certain parts of the Phase II development program.
Pegylated interferon and ribavirin therapy form the mainstay of HCV treatment. Despite the proven benefits of interferon alphas, limited efficacy in patients infected with genotype 1, frequent weekly injections, side effects such as flu-like symptoms, anemia and depression are major draw-backs. Recognizing these unmet needs, several companies have focused their developmental efforts on improving the pharmacokinetics of interferons to reduce the frequency of dosing and improve tolerability. Alternative interferon products in development include Human Genome Sciences/Novartis's Albuferon in Phase III and Biolex's Locteron in Phase II.
Despite this interest in new injectable immunomodulators, Datamonitor expects their future role to become increasingly limited as novel small molecule drugs with improved efficacy begin to be used in combination with each other. While interferons are expected to remain the backbone of HCV therapy in the medium term, their long-term commercial prospects are a lot less certain.
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