Shire plc (NASDAQ:SHPG) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for the label expansion of Revestive (teduglutide) 5 mg powder for injection in pediatric patients (aged 1 to 17 years) suffering from short bowel syndrome (SBS).
We note that the European Commission (EC) generally takes the CHMP’s opinion into account while reviewing drug applications but is not bound to abide by the same. A final decision from the EC is expected in Aug 2016.
We remind investors that Revestive is already approved in Europe for the treatment of adult patients with SBS who have become stable following a period of intestinal adaptation post surgery. The drug is approved in the U.S. as Gattex for injection for the treatment of adult patients with SBS who are dependent on parenteral support.
We note that Shire acquired NPS Pharmaceuticals Inc. in Feb 2015, thereby adding Revestive/Gattex and Natpara (hypoparathyroidism) to its portfolio and providing a major boost to its gastrointestinal franchise. A label expansion of Revestive for use in the pediatric population will further boost its sales.
Shire has a solid presence in the gastrointestinal, neuroscience and rare disease markets. The impending acquisition of Baxalta (NYSE:BXLT) will diversify its presence in the fields of hematology, immunology and oncology.
Shire currently carries a Zacks Rank #2 (Buy). A couple of favorably placed stocks in the healthcare sector are Pfizer Inc. (NYSE:PFE) and Bristol-Myers Squibb Company (NYSE:BMY) , both sporting a Zacks Rank #1 (Strong Buy).
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