Pfizer: Phase-3 study of Xalkori met primary endpoint
NEW YORK — Pfizer announced the results of its late-stage clinical trial of Xalkori (crizotinib).
The drug maker confirmed that its Profile 1007 study met its primary endpoint, demonstrating that the drug significantly improved progression-free survival in previously treated patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, compared with those treated with pemetrexed or docetaxel. The study also marked the first randomized phase-3 study in ALK-positive advanced NSCLC patients, Pfizer said.
"These results are important because they demonstrate, for the first time, that Xalkori is superior to standard chemotherapy in prolonging survival without progression in patients with previously-treated ALK-positive advanced NSCLC," said Mace Rothenberg, SVP clinical development and medical affairs for Pfizer’s oncology business unit. "This study provides further support for the precision medicine approach to drug development being taken at Pfizer by demonstrating how knowledge about the underlying genetic abnormalities within a cancer can be used to improve the standard of care for that disease."
FDA declines to approve Pfizer’s tafamidis meglumine
NEW YORK — The Food and Drug Administration has declined to approve a drug designed to treat a rare, progressive and fatal neurodegenerative disease.
The FDA issued a complete response letter to Pfizer pertaining to the company’s new drug application for tafamidis meglumine, requesting the completion of a second efficacy study to establish substantial evidence of effectiveness prior to an approval. The agency also has asked for additional information on the data within the current tafamidis NDA.
Tafamidis meglumine is a novel, investigational medication designed to treat transthyretin familial amyloid polyneuropathy, or TTR-FAP, in adult patients with symptomatic polyneuropathy to delay neurologic impairment. Currently, there is no FDA-approved treatment for this disease.
Pfizer said it will work with the FDA to address the content of the CRL.
AstraZeneca, Rigel partner on worldwide license agreement for chronic asthma treatment
SOUTH SAN FRANCISCO, Calif. — AstraZeneca and Rigel Pharmaceuticals have entered an exclusive worldwide license agreement for the global development and commercialization of an investigational treatment for moderate to severe chronic asthma.
Under the terms of the agreement, Rigel will receive an upfront payment of $1 million, with an additional $8.25 million in early milestone payments anticipated by the end of 2013, for R256, the company’s inhaled JAK inhibitor that has been shown to reduce airway inflammation and improve lung function. Meanwhile, AstraZeneca will have exclusive rights to commercialize R256 around the world. Together with other specified developmental, regulatory and launch milestone payments, the R256 collaboration could be worth up to $100 million. Additionally, upon marketing approval of R256, Rigel will be eligible to receive tiered royalty payments on product sales.
Additionally, AstraZeneca will be responsible for beginning first-in-human clinical studies for R256 and for designing and conducting the clinical development of the compound.
"We are pleased to be expanding our relationship with Rigel and to develop and commercialize this novel asset, R256," AstraZeneca EVP innovative medicines Mene Pangalos saod. "Despite the number of medicines available to asthma patients today, there remains a need for more targeted therapies for moderate to severe chronic asthma. Through this agreement, R256 will benefit from the wealth of experience AstraZeneca has in bringing innovative treatments for respiratory diseases to millions of patients around the world."