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Pfizer & Lilly Get Fast Track Designation for Pain Candidate

Zacks

Pfizer Inc. PFE and Eli Lilly and Company LLY announced that the FDA has granted fast track designation to their pipeline candidate, tanezumab for the treatment of chronic pain in patients with osteoarthritis (OA) and chronic low back pain (CLBP).

We note that the FDA's fast track process facilitates development and expedites the review of drugs to treat serious conditions and fill an unmet medical need. The candidate is the first nerve growth factor (NGF) inhibitor to receive this designation.

So far this year, shares of Lilly and Pfizer have risen 10.5% and 0.3%, respectively, underperforming the Zacks classified Large Cap Pharmaceuticals industry, which has increased 10.7% in that period.


An ongoing phase III program comprising six studies is evaluating the subcutaneous administration of tanezumab for treating OA, CLBP or cancer pain in patients who were treated with approved therapies but did not experience adequate pain relief. The results from the studies are expected in 2018.

In Oct 2013, the two companies signed an agreement for the joint development and commercialization of tanezumab across the world.

According to the company’s press release, chronic pain is a significant health problem in the U.S. with more than 27 million Americans currently suffering from osteoarthritis and 23 million living with chronic low back pain. However, the majority of them experience inadequate pain relief after treatment with currently available pain medications.

We are encouraged by the FDA’s decision to grant fast track designation to tanezumab, especially considering its potential patient population.

We remind investors that Regeneron Pharmaceuticals, Inc. REGN and Teva Pharmaceutical Industries Limited TEVA are also developing a NGF antibody, fasinumab for treating OA and CLBP. However, in Oct 2016, the phase IIb study evaluating fasinumab in CLBP was placed under clinical hold by the FDA while another phase III study is ongoing for the treatment of OA.

Zacks Rank

Pfizer and Lilly carry a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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