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Shire's Filing Accepted by FDA for Gattex's Label Expansion

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Shire's Filing Accepted by FDA for Gattex's Label Expansion

The FDA accepts Shire's (SHPG) sNDA and is expected to take action in March 2019.

Shire plc SHPG, the global leader in rare diseases, announced that the FDA has accepted for filing the company’s supplemental new drug application (sNDA) to expand the label of Gattex (teduglutide) for injection to pediatric patients (aged 1-17 years old)  with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Gattex is already indicated for the treatment of adult patients with SBS who are dependent on parenteral support. Shire submitted the sNDA to the FDA on Sep 11, 2018. The FDA is expected to reach a decision in March 2019.

The application was supported by data from two completed phase III studies as well as interim data from two ongoing extension studies. Both the phase III studies evaluated the efficacy, safety, and pharmacodynamics of Gattex in children with SBS who were stable on their required parenteral nutrition (PN)/intravenous (IV) support that provided at least 30% of caloric and/or fluid/electrolyte needs for at least three months prior to screening.

Shares of the company have increased 16.6% year to date against the industry’s decline of 7.5%.

 

 

Shire’s efforts to develop its Gastrointestinal (GI) franchise are encouraging. Gattex was added to the company’s portfolio after it acquired NPS Pharma in February 2015. The acquisition also added Natpara/Natpar (an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism) to Shire’s portfolio. Natpar received conditional marketing authorization from European Commission (EC) in April 2017 as hormone therapy for the treatment of adult patients with chronic hypoparathyroidism. The NPS Pharma acquisition boosted Shire’s revenues and also complements the company’s GI portfolio.

In June 2016, Shire also licensed the global rights to all indications of Pfizer’s PFE candidate, SHP647 (formerly PF-00547659). SHP647, an investigational biologic, is being evaluated for the treatment of moderate-to-severe inflammatory bowel disease, Crohn's disease in phase I and phase II studies. 

The company is also expanding its immunology business. In September 2018, Shire acquired sanaplasma AG, a source plasma collection company headquartered in Switzerland. The acquisition of sanaplasma is expected to increase Shire’s access to plasma in the longer term and add to its European plasma collection network, complementing existing core capabilities in plasma supply and manufacturing. This acquisition is expected to support growth of the Immunology business and help meet the needs of patients around the world.

Shire plc Price

Shire plc Price | Shire plc Quote

Zacks Rank & Stocks to Consider

Shire is a Zacks Rank #3 (Hold) stock.

Some better-ranked stocks worth considering are Bristol-Myers Squibb Company BMY and Eli Lilly and Company LLY. While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Lilly carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.59 to $3.84 for 2018 and from $3.83 to $4.07 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 11.99%.

Lilly’s earnings per share estimates have increased from $5.43 to $5.51 for 2018 and from $5.67 to $5.80 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 10.03%. Shares of the company have increased 33.1% year to date.

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