Pfizer Inc. (PFE - Analyst Report) recently presented disappointing top-line data from a phase III study that was conducted to evaluate a once-daily dose of Lyrica (pregabalin) in epilepsy patients.
The double-blind, placebo-controlled, randomized study was conducted with two doses of Lyrica controlled release – 165 mg and 330 mg. Results showed that Lyrica failed to meet the primary endpoint of change in the frequency of seizures compared to placebo.
Pfizer is conducting two more phase III studies that are evaluating the use of once-daily Lyrica. While one study is evaluating once-daily Lyrica in fibromyalgia, the other is being conducted in patients with post-herpetic neuralgia.
Lyrica, a key drug in Pfizer’s product portfolio, has experienced a very strong ramp since its introduction. Total Lyrica sales in 2011 were $3.7 billion. The product is approved in 120 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 - Analyst Report) Cymbalta and Forest Labs’ Savella.
Lyrica continues to perform well and we believe Lyrica has the most potential within Pfizer’s current product suite. Pfizer is looking to expand Lyrica’s label for additional indications.
We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). Pfizer is currently facing generic competition for several of its products including Lipitor, Geodon and Xalatan. These products are all facing declining sales due to generic competition.
Pfizer has been looking to offset the impact of generic competition by bringing new products to market. The company has been focusing on the development of treatments in the fields of oncology, cardiology, metabolic disorders, neuroscience, immunology, inflammation and vaccines. These are areas in which the company believes it can take leading positions.