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Lilly-Incyte Rheumatoid Arthritis Drug PDUFA Date Extended
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Eli Lilly and Company (LLY - Free Report) and partner Incyte Corporation (INCY - Free Report) announced that the FDA has extended the time to review the company’s New Drug Application (NDA) seeking approval of its pipeline candidate baricitinib for the treatment of rheumatoid arthritis (RA).
Previously, the FDA was expected to give a decision early this year. However, Lilly submitted additional information on the regulatory agency’s request, which the latter deemed a Major Amendment to the NDA. In order to review the additional data, the FDA has extended the PDUFA date by three months. However, Lilly assured that the delay will have no impact on Lilly’s 2017 guidance announced in Dec 2016.
Lilly’s share price has risen 5.2% so far this year, better than the 0.9% increase witnessed by the Zacks-classified Large-Cap Pharma industry. The company’s outperformance was backed by a robust guidance for 2017 and a number of positive regulatory updates announced recently, including a label update of diabetes drug Jardiance and approval of Lartruvo for the treatment of soft tissue sarcoma (STS).
Coming back to baricitinib, we note that in Jan 2016, Lilly had submitted a regulatory application for the candidate in both the U.S. and the EU. In Dec 2016, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the approval of baricitinib. If approved, the candidate would be marketed as Olumiant.
Baricitinib is being co-developed by Lilly and Incyte under an exclusive global license and collaboration agreement inked in Dec 2009.
Meanwhile, baricitinib is being evaluated in phase II studies for the treatment of atopic dermatitis and systemic lupus erythematosus. A phase III study evaluating the candidate for the treatment of psoriatic arthritis is expected to be initiated this year.
Last week, Lilly scored a major win in an important patent infringement case against generic drugmaker, Teva Pharmaceutical Industries Limited (TEVA - Free Report) , with the U.S. Court of Appeals for the Federal Circuit upholding the validity and infringement of the former’s vitamin regimen patent for its cancer treatment, Alimta. A favorable outcome in all remaining challenges will ensure that Alimta does not face generic competition before May 2022.
Pfizer has consistently beaten earnings expectations. In fact, its earnings surpassed expectations in three of the last four quarters, with an average positive surprise of 6.34%.
The New York-based pharma giant is expected to record earnings and sales growth of 7.68% and 3.99%, respectively, in 2017.
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Lilly-Incyte Rheumatoid Arthritis Drug PDUFA Date Extended
Eli Lilly and Company (LLY - Free Report) and partner Incyte Corporation (INCY - Free Report) announced that the FDA has extended the time to review the company’s New Drug Application (NDA) seeking approval of its pipeline candidate baricitinib for the treatment of rheumatoid arthritis (RA).
Previously, the FDA was expected to give a decision early this year. However, Lilly submitted additional information on the regulatory agency’s request, which the latter deemed a Major Amendment to the NDA. In order to review the additional data, the FDA has extended the PDUFA date by three months. However, Lilly assured that the delay will have no impact on Lilly’s 2017 guidance announced in Dec 2016.
Lilly’s share price has risen 5.2% so far this year, better than the 0.9% increase witnessed by the Zacks-classified Large-Cap Pharma industry. The company’s outperformance was backed by a robust guidance for 2017 and a number of positive regulatory updates announced recently, including a label update of diabetes drug Jardiance and approval of Lartruvo for the treatment of soft tissue sarcoma (STS).
Coming back to baricitinib, we note that in Jan 2016, Lilly had submitted a regulatory application for the candidate in both the U.S. and the EU. In Dec 2016, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for the approval of baricitinib. If approved, the candidate would be marketed as Olumiant.
Baricitinib is being co-developed by Lilly and Incyte under an exclusive global license and collaboration agreement inked in Dec 2009.
Meanwhile, baricitinib is being evaluated in phase II studies for the treatment of atopic dermatitis and systemic lupus erythematosus. A phase III study evaluating the candidate for the treatment of psoriatic arthritis is expected to be initiated this year.
Last week, Lilly scored a major win in an important patent infringement case against generic drugmaker, Teva Pharmaceutical Industries Limited (TEVA - Free Report) , with the U.S. Court of Appeals for the Federal Circuit upholding the validity and infringement of the former’s vitamin regimen patent for its cancer treatment, Alimta. A favorable outcome in all remaining challenges will ensure that Alimta does not face generic competition before May 2022.
Lilly has a Zacks Rank #3 (Hold). A better-ranked stock in the large-cap pharma sector is Pfizer, Inc. (PFE - Free Report) with a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Pfizer has consistently beaten earnings expectations. In fact, its earnings surpassed expectations in three of the last four quarters, with an average positive surprise of 6.34%.
The New York-based pharma giant is expected to record earnings and sales growth of 7.68% and 3.99%, respectively, in 2017.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>