Pfizer Inc. (PFE - Free Report) announced that the FDA has granted pediatric exclusivity to its epilepsy drug, Lyrica. With this grant, the exclusivity of the drug has been extended by six months to Jun 30, 2019.
The pediatric exclusivity was granted based on data from Lyrica Pediatric Epilepsy Program. The program was carried out by Pfizer upon FDA’s request to evaluate Lyrica as an adjunctive therapy to treat partial onset seizures in pediatric patients, aged four years and older, with epilepsy.
Lyrica is also approved for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in the United States.
The drug 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.
Several companies are looking to launch generic versions of Lyrica. This six-month patent-term extension from the FDA for pediatric exclusivity will keep generic competition at bay til June 2019.
The drug is one of the leading brands in Pfizer’s marketed drug portfolio. Global sales of the drug declined 4.2% in the first nine months in 2018 to $3.6 billion, mainly due to lower sales in the regions where it lost exclusivity.
In May 2018, Pfizer had announced successful completion of a phase III study evaluating Lyrica as adjunctive therapy for partial onset seizures in pediatric epilepsy patients aged one month to less than four years. The drug is not approved for this indication.
Shares of Pfizer have lost 1.5% year to date compared with industry’s decline of 3.8%.
Zacks Rank & Stocks to Consider
Pfizer currently has a Zacks Rank #3 (Hold)
Some better-ranked stocks in the same space are Bristol-Myers Squibb Company (BMY - Free Report) , Gilead Sciences Inc. (GILD - Free Report) and Merck & Co. (MRK - Free Report) . While Bristol-Myers and Gilead sport a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings per share estimates have increased from $3.62 to $3.87 for 2018 and from $3.82 to $4.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters with the average being 11.99%.
Gilead’s earnings per share estimates have increased from $6.60 to $6.93 for 2018 and from $6.53 to $6.83 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with the average being 6.99%.
Merck’s earnings per share estimates have increased from $4.27 to $4.34 for 2018 and from $4.63 to $4.71 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all the trailing four quarters, the average being 3.96%. Shares of the company have increased 35.6% year to date.
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