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Pfizer Inc. (PFE) recently presented positive top-line data on its blockbuster drug, Lyrica (pregabalin) from a phase III study.  Pfizer said that Lyrica achieved each of its three co-primary endpoints in the study that was conducted in patients with restless legs syndrome (RLS). Lyrica succeeded in showing a significant improvement compared to placebo and pramipexole.

The randomized, double-blind, 12-month trial, A0081186, was conducted with more than 700 patients. Patients participating in the study were randomized to receive either a placebo, Lyrica (300 mg/day, pramipexole (0.25 mg/day) or pramipexole (0.5 mg/day).

Initial results showed that patients in the Lyrica arm experienced a statistically significant improvement in RLS symptom severity (as measured by the International Restless Leg Group Rating Scale) after 12 weeks of treatment compared to placebo.

A statistically significant improvement in the proportion of patients responding to treatment was observed in the Lyrica arm compared to the placebo arm (as measured by the Clinical Global Impression Improvement scale) after 12 weeks of treatment.

Besides this, treatment with Lyrica resulted in a statistically significant reduction in the rate of augmentation (worsening of RLS symptoms that occur after an RLS medication is started) compared with pramipexole 0.5 mg/day over 12 months.

Common adverse events in the Lyrica arm included dizziness, somnolence, fatigue, headache and nasopharyngitis (inflammation of the nasal cavity and throat). Pfizer will conduct further analysis of the data.

Lyrica, a key drug in Pfizer’s product portfolio, has experienced a very strong ramp since its introduction. Total Lyrica sales in 2010 were $3.0 billion. The product is approved in 110 countries and regions for indications like diabetic nerve pain, pain after shingles, fibromyalgia and partial onset seizures in adults with epilepsy who take one or more drugs for seizures. Other players in the fibromyalgia market include Eli Lilly’s (LLY) Cymbalta and Forest Labs’ (FRX) Savella.

While Pfizer said that it currently does not intend to seek approval for the RLS indication, we note that Lyrica is being evaluated for additional indications like chronic central neuropathic pain following traumatic spinal cord injury and peripheral neuropathic pain. Approval for additional indications would boost Lyrica sales.

We currently have a Zacks #2 Rank (short term Buy rating) on Pfizer. We are encouraged by the company’s efforts to retain market share for blockbuster drug, Lipitor, despite the loss of exclusivity on the product. Longer-term, we are Neutral on Pfizer.

 
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