Cubist Pharmaceuticals, Inc. and Illumigen Biosciences, Inc. announced that they have signed an agreement under which Cubist has an exclusive option to acquire Illumigen on terms that have been agreed to by the parties.
For the option, Cubist will pay $4.7 million and also will pay approximately $1 million for an IND-enabling study of Illumigen's lead compound, IB657, and for Illumigen's operating costs during the option period. IB657 is a protein therapeutic in late-stage pre-clinical development as an interferon replacement product for the treatment of Hepatitis C virus (HCV) infections.
"This option provides us with an opportunity to immediately leverage our antiinfective development and regulatory expertise. The unmet medical need, which IB657 would address, represents a substantial market opportunity. If we exercise our option, adding an HCV compound will be an important step as we develop a pipeline behind our successful IV antibiotic Cubicin, " said, Mike Bonney, president and CEO, Cubist.
"IB657 holds great promise as a therapy that may offer improved safety and efficacy when compared with current standard of care. We believe Cubist is ideally positioned to move the IB657 programme forward," said, Donald Elmer, chairman, Illumigen.
If Cubist exercises its option to acquire Illumigen, Cubist will pay Illumigen shareholders $9 million upfront and up to $75.5 million in HCV development and regulatory milestones. If Cubist develops an Illumigen product for the treatment of viral infections other than HCV, additional development and regulatory milestone payments of up to $117 million would apply. If Illumigen product(s) are commercialised, sales milestones of up to $140 million as well as tiered royalties would apply.
HCV is a virus that primarily targets the liver, currently causing infection in more than 4 million people in the US and 180 million people worldwide. The virus is difficult to eradicate, with infected patients eventually developing chronic liver infection, and, in some cases, liver cancer. HCV infection is the most common reason for liver transplantation in the US and Western Europe and the leading cause of death from liver disease.
No vaccine is currently available to prevent HCV infection. Current HCV therapy combines a pegylated-interferon with ribavirin for up to 48 weeks of treatment. Current therapy has significant problems with both safety (e.g., significant treatment limiting adverse effects and contraindications) and efficacy (e.g., 80 per cent of HCV infections in the US are due to genotype 1 virus for which the efficacy rate of current therapy is approximately 40 to 50 per cent). The pegylated-interferon market is estimated to be more than $1.9 billion.
IB657 is a late-stage pre-clinical protein therapeutic being developed as an interferon replacement. IB657 activates a key antiviral pathway downstream from the point of interferon activation. This pathway is responsible for much of the antiviral activity of interferon. IB657 does not activate the broad range of cellular functions induced by interferon. IB657 is therefore predicted to produce the antiviral activity of interferon but to have fewer side effects. The primary clinical indication targeted for IB657 is treatment of HCV infection. However, based on the proposed mechanism of action, IB657 may have therapeutic utility in the treatment of certain other viral diseases. Pre-clinical studies to assess activity against these viruses may occur in parallel with its development for HCV infection.
Illumigen Biosciences, Inc. was co-founded by Drs. Charles Magness and Shawn Iadonato in 2000 to discover beneficial human genetic mutations that might provide a roadmap for novel therapeutic drug mechanisms. The discovery of IB-657 resulted from an investigation into the cause of apparent immunity to HCV infection enjoyed by people with a specific naturally occurring genetic mutation. Prior to founding Illumigen, Drs. Magness and Iadonato both were involved in the Human Genome Project. Illumigen is a privately held biopharmaceutical company based in Seattle, WA.
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialisation of pharmaceutical products that address unmet medical needs in the acute care environment. In the US, Cubist markets Cubicin (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, and CDAD (Clostridium difficile-associated diarrhoea). Cubist is headquartered in Lexington, MA.