) 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
) Cymbalta and
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
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.
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