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Abbott Laboratories (ABT) - free report >>
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Shire Gets Breakthrough Status for Rare Disease Candidates
Shire plc announced that the FDA has granted Breakthrough Therapy Designation to two candidates in its rare diseases pipeline – SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).
The FDA generally grants Breakthrough Therapy Designation to a candidate that is intended to treat a serious or life-threatening disease or condition with preliminary clinical evidence indicating that the drug could demonstrate substantial improvement on one or more clinically significant endpoints over the current standard of care. This designation will enable the company to obtain intensive guidance from the FDA and be eligible for a rolling and priority review for the drug application.
Shire acquired global rights to SHP625 through its 2014 buyout of Lumena while the Meritage Pharma acquisition provided it with worldwide rights to SHP621.
SHIRE PLC-ADR Price
SHIRE PLC-ADR Price | SHIRE PLC-ADR Quote
We remind investors that the company suffered a setback when preliminary results of a phase II study, CAMEO, on SHP625 for cholestatic liver disease showed no significant reduction from baseline in serum alkaline phosphatase or other liver parameters.
Currently, SHP621 is in phase III development for EoE, while SHP625 is in phase II trials for PFIC. Successful development and commercialization of these candidates will strengthen Shire’s gastrointestinal (GI) franchise significantly. The Feb 2015 takeover of NPS Pharma acquisition also boosted Shire’s GI portfolio by adding Gattex (short bowel syndrome) and Natpara (hypoparathyroidism) to its portfolio.
Shire currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector are Pfizer, Inc. (PFE - Free Report) , Bristol-Myers Squibb Company (BMY - Free Report) and Abbott Laboratories (ABT - Free Report) . While the first Pfizer and Bristol-Myers sport a Zacks Rank #1 (Strong Buy), Abbott Labs is a Zacks Rank #2 (Buy) stock.
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