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Incyte/Lilly Olumiant Wins CHMP Nod for Rheumatoid Arthritis
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Incyte Corporation (INCY - Free Report) and partner Eli Lilly and Company (LLY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the approval of Olumiant (baricitinib) for the treatment of adults with moderate-to-severely active rheumatoid arthritis (RA).
Note that Incyte’s year-to-date share price movement shows that the company has outperformed the Zacks classified Medical-Biomedical/Genetics industry. Though the stock’s price declined 5.1%, its performance compares favorably to the industry’s 25.2% decline.
Shares of Lilly, on the other hand, underperformed the Zacks classified Large Cap Pharmaceutical industry so far this year. The stock has lost 13% during the period, compared to a drop of 5.2% for the industry.
Coming back to the latest news, the companies are looking to get Olumiant approved, as monotherapy or in combination with methotrexate, for the treatment of adult patients who have responded inadequately to, or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
The CHMP opinion was based on data from five phase III studies – RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON and RA-BEYOND – on the candidate.
With the CHMP recommending a favorable opinion, the application will now be reviewed by the European Commission (EC). A positive CHMP opinion significantly boosts the odds of an EU approval for Olumiant. A final decision from the EC should be out within two to three months.
Note that Incyte was eligible for a milestone payment worth $65 million upon a positive CHMP opinion, which will be triggered by the granting of marketing authorization by the EC as per amendments to the collaboration agreement.
We remind investors that in 2009, Incyte and Lilly had entered into an exclusive worldwide license and collaboration agreement to develop and commercialize Olumiant and certain follow-on compounds for the treatment of patients with inflammatory and autoimmune diseases. As per the terms of the agreement, Lilly holds worldwide rights to develop and commercialize the candidate for inflammatory and autoimmune diseases.
Meanwhile, a New Drug Application (NDA) in the U.S for baricitinib was submitted in Jan 2016 for the treatment of patients with mild-to-moderately severe RA.
According to the World Health Organization’s Global Burden of Disease report, it is estimated that more than 23 million individuals in the world suffer from RA. The disease affects approximately three times as many women as men.
The companies are also evaluating the candidate for other indications including atopic dermatitis (phase IIa) and systemic lupus erythematosus (phase II).
Both Incyte and Lilly currently carry a Zacks Rank #3 (Hold).
Vanda’s loss estimates for 2016 narrowed from 62 cents to 52 cents, while its earnings estimates for 2017 increased from 13 cents to 22 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72% year to date.
Heska’s earnings estimates 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 posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has jumped almost 81% year to date.
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Incyte/Lilly Olumiant Wins CHMP Nod for Rheumatoid Arthritis
Incyte Corporation (INCY - Free Report) and partner Eli Lilly and Company (LLY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the approval of Olumiant (baricitinib) for the treatment of adults with moderate-to-severely active rheumatoid arthritis (RA).
Note that Incyte’s year-to-date share price movement shows that the company has outperformed the Zacks classified Medical-Biomedical/Genetics industry. Though the stock’s price declined 5.1%, its performance compares favorably to the industry’s 25.2% decline.
Shares of Lilly, on the other hand, underperformed the Zacks classified Large Cap Pharmaceutical industry so far this year. The stock has lost 13% during the period, compared to a drop of 5.2% for the industry.
Coming back to the latest news, the companies are looking to get Olumiant approved, as monotherapy or in combination with methotrexate, for the treatment of adult patients who have responded inadequately to, or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).
The CHMP opinion was based on data from five phase III studies – RA-BEGIN, RA-BEAM, RA-BUILD, RA-BEACON and RA-BEYOND – on the candidate.
With the CHMP recommending a favorable opinion, the application will now be reviewed by the European Commission (EC). A positive CHMP opinion significantly boosts the odds of an EU approval for Olumiant. A final decision from the EC should be out within two to three months.
Note that Incyte was eligible for a milestone payment worth $65 million upon a positive CHMP opinion, which will be triggered by the granting of marketing authorization by the EC as per amendments to the collaboration agreement.
We remind investors that in 2009, Incyte and Lilly had entered into an exclusive worldwide license and collaboration agreement to develop and commercialize Olumiant and certain follow-on compounds for the treatment of patients with inflammatory and autoimmune diseases. As per the terms of the agreement, Lilly holds worldwide rights to develop and commercialize the candidate for inflammatory and autoimmune diseases.
Meanwhile, a New Drug Application (NDA) in the U.S for baricitinib was submitted in Jan 2016 for the treatment of patients with mild-to-moderately severe RA.
According to the World Health Organization’s Global Burden of Disease report, it is estimated that more than 23 million individuals in the world suffer from RA. The disease affects approximately three times as many women as men.
The companies are also evaluating the candidate for other indications including atopic dermatitis (phase IIa) and systemic lupus erythematosus (phase II).
Both Incyte and Lilly currently carry a Zacks Rank #3 (Hold).
Key Picks in the Sector
A couple of better-ranked stocks in the health care sector are Vanda Pharmaceuticals Inc. (VNDA - Free Report) and Heska Corp. . Both stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 52 cents, while its earnings estimates for 2017 increased from 13 cents to 22 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72% year to date.
Heska’s earnings estimates 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 posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has jumped almost 81% year to date.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>