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Pfizer's Epilepsy Drug Lyrica Succeeds in Pediatric Study
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Pfizer Inc. (PFE - Free Report) announced that a phase III study evaluating its epilepsy drugLyrica (pregabalin) in pediatric patients met the primary endpoint. The study was evaluating the use of Lyrica Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age, an indication for which Lyrica is not yet approved.
Top-line results from the study showed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo which was the primary efficacy endpoint. However, treatment with Lyrica at lower dose of 7 mg did not result in statistically significant reduction in seizure frequency versus placebo.
These data along with the data from previous studies will be submitted to the FDA for Lyrica pediatric exclusivity determination.
Lyrica has already lost patent exclusivity in Europe, Russia, Turkey, Israel and Central Asia. In the United States, a favorable court decision in July 2012 regarding generic challenges should protect Lyrica from genericization through Dec 30, 2018.
Meanwhile, Pfizer is pursuing a six-month patent-term extension from the FDA for pediatric exclusivity, which, if granted, will keep generic competition at bay till June 2019. We believe that the positive data from the pediatric study may ease Pfizer’s effort to get pediatric exclusivity.
Other than epilepsy, Lyrica is indicated to treat post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury in the United States. Lyrica is also indicated to treat partial onset seizures in patients four years of age and older. Sales of Lyrica declined 1% to $1.13 billion in the first quarter of 2018.
Shares of Pfizer have lost 1.5% year to date compared with industry’s decline of 3.8%.
Illumina’s earnings per share estimates have moved up from $4.60 to $4.84 for 2018 and from $5.34 to $5.57 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 23.17%. The stock has rallied 68.2% so far this year. The stock has rallied 22.9% so far this year.
Ligand’s earnings per share estimates have moved up from $4.07 to $4.37 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 31.79%. The company’s shares have rallied 39.6% year to date.
Enanta’s earnings per share estimates have moved up from 86 cents to $2.97 for 2018 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 372.02%. The stock has rallied 80.8% so far this year.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
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Pfizer's Epilepsy Drug Lyrica Succeeds in Pediatric Study
Pfizer Inc. (PFE - Free Report) announced that a phase III study evaluating its epilepsy drugLyrica (pregabalin) in pediatric patients met the primary endpoint. The study was evaluating the use of Lyrica Oral Solution CV as adjunctive therapy for partial onset seizures in pediatric epilepsy patients one month to less than four years of age, an indication for which Lyrica is not yet approved.
Top-line results from the study showed that adjunctive treatment with Lyrica 14 mg/kg/day resulted in a statistically significant reduction in seizure frequency versus placebo which was the primary efficacy endpoint. However, treatment with Lyrica at lower dose of 7 mg did not result in statistically significant reduction in seizure frequency versus placebo.
These data along with the data from previous studies will be submitted to the FDA for Lyrica pediatric exclusivity determination.
Lyrica has already lost patent exclusivity in Europe, Russia, Turkey, Israel and Central Asia. In the United States, a favorable court decision in July 2012 regarding generic challenges should protect Lyrica from genericization through Dec 30, 2018.
Meanwhile, Pfizer is pursuing a six-month patent-term extension from the FDA for pediatric exclusivity, which, if granted, will keep generic competition at bay till June 2019. We believe that the positive data from the pediatric study may ease Pfizer’s effort to get pediatric exclusivity.
Other than epilepsy, Lyrica is indicated to treat post-herpetic neuralgia and diabetic peripheral neuropathy, fibromyalgia, neuropathic pain due to spinal cord injury in the United States. Lyrica is also indicated to treat partial onset seizures in patients four years of age and older. Sales of Lyrica declined 1% to $1.13 billion in the first quarter of 2018.
Shares of Pfizer have lost 1.5% year to date compared with industry’s decline of 3.8%.
Zacks Rank & Stocks to Consider
Pfizer has a Zacks Rank #3 (Hold)
Some better-ranked stocks from the same space worth considering are Illumina, Inc. (ILMN - Free Report) , Ligand Pharmaceuticals (LGND - Free Report) and Enanta Pharmaceuticals, Inc. (ENTA - Free Report) . While Illumina sports a Zacks Rank #1 (Strong Buy), Ligand and Enanta carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earnings per share estimates have moved up from $4.60 to $4.84 for 2018 and from $5.34 to $5.57 for 2019 over the past 30 days. The company delivered a positive earnings surprise in all the trailing four quarters, with an average beat of 23.17%. The stock has rallied 68.2% so far this year. The stock has rallied 22.9% so far this year.
Ligand’s earnings per share estimates have moved up from $4.07 to $4.37 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 31.79%. The company’s shares have rallied 39.6% year to date.
Enanta’s earnings per share estimates have moved up from 86 cents to $2.97 for 2018 over the past 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 372.02%. The stock has rallied 80.8% so far this year.
Pfizer Inc. Price
Pfizer Inc. Price | Pfizer Inc. Quote
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>