Pfizer Inc. PFE and Eli Lilly and Company LLY announced that they are preparing to resume the phase III study on their chronic pain candidate, tanezumab.
We note that this announcement came after the FDA’s decision to lift the partial hold on the tanezumab development program after reviewing the nonclinical data submitted to the agency in Feb 2015.
The FDA had imposed a partial hold on tanezumab and all other anti-nerve growth factor antibodies on account of adverse events (initially described as osteonecrosis) all of which led to total joint replacement.
However, the partial hold was not imposed on studies of tanezumab for terminal cancer pain, which were allowed to proceed.
Meanwhile, in Oct 2013, Pfizer signed an agreement with Eli Lilly for the joint development and commercialization of tanezumab across the world. Under the terms of the agreement, the companies will share development costs, gross margins and certain commercialization expenses equally. As per the agreement, Eli Lilly was to make an upfront payment of $200 million to Pfizer, provided that the FDA lifts its partial hold on the program. Now, with the FDA finally agreeing to lift the hold, Pfizer expects to receive this payment from Eli Lilly. Eli Lilly could also pay success-based regulatory milestones of up to $350 million and sales-based milestones of up to $1.23 billion.
Chronic pain is a significant health problem in the U.S. For many patients, the treatment of chronic pain becomes inadequate due to the limited availability of effective treatments and inadequate patient and clinical knowledge of the best ways to manage chronic pain. According to the company press release, it is estimated that nearly one in five adults suffer from chronic pain.
We are encouraged by the FDA’s decision to lift the partial hold on tanezumab studies, especially considering its potential patient population.
Pfizer and Eli Lilly both carry a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Lannett Company, Inc. LCI and Cambrex Corporation CBM. Both companies sport a Zacks Rank #1 (Strong Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Be the first to comment