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Pfizer Offers Positive Phase III Data on Pediatric Epilesy Drug
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Pfizer Inc. (PFE - Free Report) announced positive top-line results from a phase III study evaluating its marketed drug, Lyrica (pregabalin), as adjunctive therapy for the treatment of pediatric patients suffering from epilepsy with partial-onset seizures.
Pfizer shares rose 0.9% in the past one month comparing favorably with a decline of the same magnitude for the Zacks classified Large-Cap Pharma industry.
Note that Lyrica is already approved for various indications in more than 130 countries, including partial-onset seizures in adults with epilepsy, who take one or more drugs for the disease.
The 12-week, double-blind, placebo-controlled, study evaluated two fixed doses of Lyrica, both in the capsule form and oral solution, In the study, it was seen that adjunctive treatment with Lyrica 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency comparison to placebo, which was the primary efficacy endpoint. However, treatment with Lyrica 2.5 mg/kg/day resulted in a numerical reduction in seizure frequency, which was not statistically significant. Moreover, the safety profile observed in the study was consistent with the same in adults.
The study was conducted in 295 patients aged 4–16 years at 76 sites across 18 countries.
Per the company’s press release, around 65 million people in the world suffer from epilepsy. In the U.S. alone, about three million people have epilepsy, of which approximately 10% or 300,000 are pediatric patients. It is also expected that one in 26 people will be diagnosed with epilepsy in the near future. Hence, a label expansion of Lyrica in the pediatric indication will give the company access to a huge patient population in the U.S. and globally.
The Lyrica Pediatric Epilepsy Program comprises a total of six studies in epilepsy patients receiving adjunctive therapy, of which three are completed and three are actively enrolling.
Lyrica generated revenues of $3.73 billion in the first nine months of 2016 up 4% on an operational basis from the year-ago period.
Pfizer has an impressive pipeline, with resources focused on the development of treatments in the fields of oncology, cardiology, metabolic disorders, neuroscience, pain, rare diseases, immunology, inflammation and vaccines, and immuno-oncology, each representing significant potential.
Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Heska Corporation , Cambrex Corporation and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates have increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 70.9% year to date.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 6.4% year to date.
Vanda’s loss estimates have narrowed from 68 cents to 56 cents for 2016 while its earnings estimates have increased from 16 cents to 17 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price surged 76.7% year to date.
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Pfizer Offers Positive Phase III Data on Pediatric Epilesy Drug
Pfizer Inc. (PFE - Free Report) announced positive top-line results from a phase III study evaluating its marketed drug, Lyrica (pregabalin), as adjunctive therapy for the treatment of pediatric patients suffering from epilepsy with partial-onset seizures.
Pfizer shares rose 0.9% in the past one month comparing favorably with a decline of the same magnitude for the Zacks classified Large-Cap Pharma industry.
Note that Lyrica is already approved for various indications in more than 130 countries, including partial-onset seizures in adults with epilepsy, who take one or more drugs for the disease.
The 12-week, double-blind, placebo-controlled, study evaluated two fixed doses of Lyrica, both in the capsule form and oral solution, In the study, it was seen that adjunctive treatment with Lyrica 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency comparison to placebo, which was the primary efficacy endpoint. However, treatment with Lyrica 2.5 mg/kg/day resulted in a numerical reduction in seizure frequency, which was not statistically significant. Moreover, the safety profile observed in the study was consistent with the same in adults.
The study was conducted in 295 patients aged 4–16 years at 76 sites across 18 countries.
Per the company’s press release, around 65 million people in the world suffer from epilepsy. In the U.S. alone, about three million people have epilepsy, of which approximately 10% or 300,000 are pediatric patients. It is also expected that one in 26 people will be diagnosed with epilepsy in the near future. Hence, a label expansion of Lyrica in the pediatric indication will give the company access to a huge patient population in the U.S. and globally.
The Lyrica Pediatric Epilepsy Program comprises a total of six studies in epilepsy patients receiving adjunctive therapy, of which three are completed and three are actively enrolling.
Lyrica generated revenues of $3.73 billion in the first nine months of 2016 up 4% on an operational basis from the year-ago period.
Pfizer has an impressive pipeline, with resources focused on the development of treatments in the fields of oncology, cardiology, metabolic disorders, neuroscience, pain, rare diseases, immunology, inflammation and vaccines, and immuno-oncology, each representing significant potential.
PFIZER INC Price
PFIZER INC Price | PFIZER INC Quote
Zacks Rank & Key Picks
Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Heska Corporation , Cambrex Corporation and Vanda Pharmaceuticals, Inc. (VNDA - Free Report) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Heska’s earnings estimates have increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company has posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 70.9% year to date.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 6.4% year to date.
Vanda’s loss estimates have narrowed from 68 cents to 56 cents for 2016 while its earnings estimates have increased from 16 cents to 17 cents for 2017 over the last 60 days. The company has posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price surged 76.7% year to date.
Zacks’ Best Private Investment Ideas
In addition to the recommendations that are available to the public on our website, how would you like to follow all Zacks' private buys and sells in real time?
Our experts cover all kinds of trades… from value to momentum . . . from stocks under $10 to ETF and option moves . . . from stocks that corporate insiders are buying up to companies that are about to report positive earnings surprises. You can even look inside exclusive portfolios that are normally closed to new investors. Starting today, for the next month, you can have unrestricted access. Click here for Zacks' private trades >>