Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology Licensing

 News Release - March 22, 2011

TESARO Enters into Exclusive License Agreement with Amgen to Acquire Rights to Anaplastic Lymphoma Kinase (ALK) Program

TESARO will be responsible for worldwide development and commercialization

Amgen’s oral, small molecule ALK inhibitors are highly potent and selective, and possess desirable pharmaceutical properties

Recent clinical proof-of-concept has been demonstrated for ALK inhibition in patients with ALK positive non-small cell lung cancer


BOSTON--(Healthcare Sales & Marketing Network)-- TESARO, Inc., an oncology-focused biopharmaceutical company, today announced the signing of an agreement with Amgen Inc. granting TESARO exclusive worldwide rights for the development, manufacture, commercialization and distribution of small molecule inhibitors of Anaplastic Lymphoma Kinase (ALK). TESARO plans to develop one or more compounds for oncology indications, including the treatment of patients with non-small cell lung cancer (NSCLC) whose tumors are ALK-positive. The agreement includes an upfront payment and potential future payments and royalties associated with the achievement of certain development and commercial milestones.

Abnormal ALK fusion proteins are thought to be a key driver of certain types of cancers, including a sub-population of NSCLC as demonstrated in recent clinical trials of an ALK inhibitor. Sub-populations of other cancers including lymphoma and neuroblastoma are also associated with abnormal expression of ALK proteins. ALK is generally not expressed in normal adult tissue and therefore represents a promising molecular target for the development of a cancer therapeutic. Amgen’s oral, small molecule ALK inhibitors are highly potent and selective, and possess desirable pharmaceutical properties.

“TESARO is very pleased to announce this license agreement and intends to rapidly complete the necessary studies and activities required for submission of an IND application and advance this promising therapeutic for cancer patients to clinical phase testing,” said Mary Lynne Hedley, Ph.D., President and Chief Scientific Officer of TESARO. “Molecularly targeted therapies associated with companion diagnostic tests could allow for more rapid and efficient drug development and increase the likelihood of success in defined patient populations. ALK inhibition shows great promise for a specific and identifiable population of patients. 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.”

About Anaplastic Lymphoma Kinase and Non-Small Cell Lung Cancer

ALK gene fusions that result in constitutive activation of ALK are associated with sub-sets of certain cancers including non-small cell lung cancer. ALK is thought to be a key driver of certain types of cancers, including a sub-population of NSCLC as demonstrated in recent clinical trials of an ALK inhibitor. Abnormal ALK proteins are also 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.

Worldwide, over 1.3 million new lung cancer cases are identified annually. Lung cancer is the leading cause of cancer death in men and the second leading cause of cancer death in women. NSCLC is responsible for approximately 85% of all lung cancer cases with 75% of these patients being diagnosed with metastatic or advanced disease, for which the five-year survival rate is approximately 5%. ALK is believed to be a key driver of tumor development in approximately 5% of all NSCLC patients.

About TESARO, Inc.

Founded in 2010, TESARO is a privately held oncology-focused biopharmaceutical company dedicated to improving the lives of cancer patients by acquiring, developing and commercializing safer and more effective therapeutics. The Company is developing rolapitant, a potent, selective neurokinin-1 receptor antagonist that has completed Phase 2 clinical testing for the prevention of chemotherapy induced nausea and vomiting. Phase 3 clinical testing of rolapitant is planned to commence during 2011. TESARO was co-founded by former executives of MGI PHARMA, an oncology and acute-care focused biopharmaceutical company that Eisai Co., Ltd. acquired in 2008 for $3.9 billion. TESARO is headquartered in Waltham, Massachusetts. For more information, visit www.tesarobio.com.


Source: TESARO

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