Shire plc announced that it will license global rights to all indications of Pfizer’s (PFE - Free Report) candidate, PF-00547659.
PF-00547659 is an investigational biologic which is being evaluated for the treatment of moderate-to-severe inflammatory bowel disease (IBD) in phase I and phase II trials, with phase III trials expected to begin after a consultation with global health authorities.
The IBD indication includes ulcerative colitis (UC) and Crohn's disease (CD). The candidate has been evaluated in phase II trials for the treatment of UC (TURANDOT) and CD (OPERA). Data from the TURANDOT study showed that adult patients with moderate-to-severe active UC, who have failed at least one previous treatment and were treated with PF-00547659, showed an increased rate of remission, response, and mucosal healing at week 12, compared to placebo. The trial had met its primary and secondary endpoints.
As per the company, IBD is estimated to affect more than 3.5 million people in the U.S., Europe and Japan.
Other details of the transaction were, however, not disclosed.
We are encouraged by Shire’s efforts to develop its gastrointestinal (GI) franchise. The licensing of rights to Pfizer’s candidate will strengthen the company’s GI pipeline. In Feb 2015, the company had taken over NPS Pharma, adding Gattex (short bowel syndrome) and Natpara (hypoparathyroidism) to its portfolio.
Earlier this week, Shire obtained Breakthrough Therapy Designation from the FDA for two of its GI candidates – SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE) and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2). The company had acquired global rights to SHP625 through its 2014 buyout of Lumena, while the Meritage Pharma acquisition provided it with the worldwide rights to SHP621.
Shire currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector include Abbott Laboratories (ABT - Free Report) and Johnson & Johnson (JNJ - Free Report) . Both stocks have a Zacks Rank #2 (Buy).
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It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
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Shire plc announced that it will license global rights to all indications of Pfizer’s (PFE - Free Report) candidate, PF-00547659.
PF-00547659 is an investigational biologic which is being evaluated for the treatment of moderate-to-severe inflammatory bowel disease (IBD) in phase I and phase II trials, with phase III trials expected to begin after a consultation with global health authorities.
The IBD indication includes ulcerative colitis (UC) and Crohn's disease (CD). The candidate has been evaluated in phase II trials for the treatment of UC (TURANDOT) and CD (OPERA). Data from the TURANDOT study showed that adult patients with moderate-to-severe active UC, who have failed at least one previous treatment and were treated with PF-00547659, showed an increased rate of remission, response, and mucosal healing at week 12, compared to placebo. The trial had met its primary and secondary endpoints.
As per the company, IBD is estimated to affect more than 3.5 million people in the U.S., Europe and Japan.
Other details of the transaction were, however, not disclosed.
We are encouraged by Shire’s efforts to develop its gastrointestinal (GI) franchise. The licensing of rights to Pfizer’s candidate will strengthen the company’s GI pipeline. In Feb 2015, the company had taken over NPS Pharma, adding Gattex (short bowel syndrome) and Natpara (hypoparathyroidism) to its portfolio.
Earlier this week, Shire obtained Breakthrough Therapy Designation from the FDA for two of its GI candidates – SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE) and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2). The company had acquired global rights to SHP625 through its 2014 buyout of Lumena, while the Meritage Pharma acquisition provided it with the worldwide rights to SHP621.
Shire currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector include Abbott Laboratories (ABT - Free Report) and Johnson & Johnson (JNJ - Free Report) . Both stocks have a Zacks Rank #2 (Buy).
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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