Pfizer Inc. (PFE - Analyst Report) recently announced positive top-line data on its once-daily formulation of Lyrica (pregabalin). Results were presented from a double-blind, placebo-controlled, multi-center, randomized withdrawal phase III study that was conducted to evaluate the safety and efficacy of Lyrica controlled release (CR) in patients suffering from fibromyalgia.
Pfizer said that Lyrica had a statistically significant positive effect compared to placebo. The primary endpoint was time to loss of therapeutic response (LTR). According to the company, fibromyalgia affects more than five million people in the US. Other players in the fibromyalgia market include Eli Lilly’s (LLY - Analyst Report) Cymbalta and Forest Labs’ Savella.
The fibromyalgia study is the second of three studies evaluating once-daily Lyrica. Pfizer had reported top-line results from the first of these studies also. Results from the study, which was conducted in adults with partial onset seizures with epilepsy, showed that Lyrica failed to meet the primary endpoint of change in the frequency of seizures compared to placebo. The third phase III study is evaluating the use of once-daily Lyrica 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.
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.