Tesaro licenses worldwide rights to Amgen ALK inhibitors for cancer
This article was originally published in Scrip
Privately held Tesaro has licensed exclusive worldwide rights from Amgen to develop, manufacture, commercialize and distribute anaplastic lymphoma kinase (ALK) inhibitors for oncology indications, including ALK-positive non-small-cell lung cancer (NSCLC).
The firms did not disclose the financial terms, only stating that Waltham, Massachusetts-based Tesaro will pay Amgen an undisclosed up-front payment, along with potential future milestone payments, plus royalties.
Amgen spokeswoman Mary Klem told Scrip that the license agreement involves certain, oral small molecules targeting ALK, including three lead compounds in preclinical development.
Under the partnership, Tesaro will be responsible for worldwide development and commercialization of the ALK inhibitors.
ALK, a receptor tyrosine kinase expressed during embryonic development, is thought to be a key driver of certain types of cancers, including a sub-population of about 5% of NSCLC patients. Abnormal ALK proteins also are associated with sub-populations of other cancers, including lymphoma and neuroblastoma. ALK is generally not expressed in normal adult tissue and therefore represents a promising molecular target for the development of a cancer therapeutic.
Rick Rodgers, executive vice president and chief financial officer at Tesaro, said the potency, selectivity and pharmaceutical properties of the compounds was what attracted his firm to the deal.
The ability to identify a patient population with a very high likelihood of responding to inhibition of the validated target, along with the fact that the clinical proof-of-concept exists from another compound – Pfizer's crizotinib (PF-02341066) – also were incentives that drew Tesaro to the collaboration with Thousand Oaks, California-based Amgen, Mr Rogers told Scrip.
New York-based Pfizer in January initiated a rolling new drug application (NDA) submission to the US FDA for crizotinib, a first-in-class oral ALK inhibitor, as a treatment for advanced ALK-positive NSCLC. The company expects to complete the submission in the first half of this year (scripintelligence, 13 January 2011).
Data reported in October 2010 in the New England Journal of Medicine demonstrated that 57% of ALK-positive NSCLS patients receiving crizotinib either had a complete or partial response to the treatment, although only one of those patients had the complete response.
Dr Mary Lynne Hedley, Tesaro's president and chief scientific officer, said her firm intends to "rapidly complete" the necessary studies and activities required for submission of an investigational new drug application and "advance this promising therapeutic for cancer patients to clinical phase testing".
"Obtaining rights to this potentially best-in-class program advances our mission to make a difference in the lives of cancer patients and enhances our company’s pipeline of cancer therapeutics and supportive care agents," Dr Hedley said.