Amgen steps back from collaboration with GSK on fast-selling Prolia

According to an 8-K regulatory filing, Amgen and GlaxoSmithKline (GSK) have terminated in part the Collaboration Agreement relating to the commercialization of denosumab for osteoporosis indications

Lloyd Dunlap
THOUSAND OAKS, Calif.—According to an 8-K regulatory filing, Amgen and GlaxoSmithKline (GSK) have entered into a Termination and Transition Agreement terminating in part and amending in part the Collaboration Agreement dated July 27, 2009 relating to the commercialization of denosumab for osteoporosis indications in certain geographic areas. The Collaboration Agreement described in the Form 8-K was filed on November 6, 2009, as an exhibit to Amgen’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009.
 
The Transition Agreement terminates the Collaboration Agreement for all countries and regions of the collaboration territory, including the European Union, Switzerland, Norway, Russia and Mexico. GSK retains rights in Australia to market the drug for osteoporosis and in countries such as China, Brazil, India and South Korea to sell it for other uses. The British pharma will say farewell to a reported £51 million ($84.6 million) in yearly Prolia sales, but in return Amgen will make an initial payment and subsequent milestones tallying $275 million, with an extra $15 million in transition costs.
 
All commercial activities assigned to GSK for the osteoporosis indication under the Collaboration Agreement other than those in Australia will be transitioned back to Amgen no later than December 31, 2014.
 
The Transition Agreement does not change the terms of the separate Expansion Agreement, also dated July 27, 2009, relating to the commercialization of denosumab for all indications in certain geographic territories which continues in full force and effect.
 
In an unrelated development, Amgen today announced top-line results from the primary overall survival (OS) analysis of a Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF). Results showed that, while the primary end point of durable response rate was met (as previously reported), the secondary endpoint of OS was not met, although there was a strong trend in favor of talimogene laherparepvec (p=0.051). The estimated OS hazard ratio and improvement in median OS were similar to what was previously reported at the interim OS analysis.
 
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
 
"We remain encouraged that the study met its primary endpoint of achieving durable responses in patients with metastatic melanoma," said Sean E. Harper, M.D., executive vice president of research and development at Amgen. "We missed statistical significance on the secondary endpoint of overall survival but the strong trend in survival benefit supports further research of talimogene laherparepvec to better understand its role in melanoma, both as a single-agent and in combination with other therapies."
 
The global, randomized, open-label Phase 3 trial enrolled patients with unresected stage IIIB, IIIC or IV melanoma. Patients were randomized 2:1 to receive either talimogene laherparepvec every two weeks through direct tumor injection or GM-CSF subcutaneously for the first 14 days of each 28-day cycle, for up to 18 months.
The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.
 
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin. Melanoma is the most aggressive and serious form of skin cancer. Currently, 132,000 melanoma cases occur globally each year. In the U.S., while melanoma accounts for less than five percent of skin cancer cases, it causes the most skin cancer deaths. The number of new cases of melanoma in the U.S. has been increasing for the past 30 years. Melanoma is considered to be advanced when it has spread, or metastasized, from the origin site to deeper parts of the skin or other organs such as the lymph nodes, lungs or other parts of the body distant from the primary tumor site.
 
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be the world's largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Lloyd Dunlap

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