Shire (SHPG) Receives MAA Validation For Veyvondi By EMA

Shire plc (NASDAQ:SHPG) announced that the European Medicines Agency (EMA) validated the Marketing Authorization Application (MAA) for Veyvondi to prevent and treat bleeding episodes and peri-operative bleeding in adults (age 18 and older) diagnosed with von Willebrand Disease (VWD).

Veyvondi is the first and only recombinant von Willebrand factor (rVWF) treatment for adults living with VWD. It is currently available in the U.S. as Vonvendi [von Willebrand factor (Recombinant)].

Notably, Shire plc underperformed the Zacks classified Medical-Drugs industry year to date. The stock gained 0.2%, while the industry gained 7.9%.

In Dec 2016, Shire announced positive top-line results from a phase III trial of Vonvendi to treat bleeds in elective surgical settings for adults with severe VWD. The study met its primary endpoint and indicated that VonvendiI effectively controlled bleeding and blood loss during an operation in adults undergoing major, minor and oral elective surgical procedures. THE EMA filing is based on results of this trial.

Willebrand Disease is the most common inherited bleeding disorder worldwide, caused by a deficiency or dysfunction of VWF. This in turn results in impaired blood clotting, and affects women and men equally. In this context, Veyvondi is considered to be an innovative VWF replacement therapy.

Additionallly, Shire is also seeking prophylaxis and pediatric indications for Vonvendi, with trials anticipated to end in 2019 and 2020, respectively.

Shire PLC Price and Consensus

Zacks Rank and Stocks to Consider

Shire plc currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in health care sector include VIVUS, Inc. (NASDAQ:VVUS) , MEI Pharma, Inc. (NASDAQ:MEIP) and Sanofi (NYSE:SNY) . While VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy), Sanofi carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’ loss per share estimates narrowed from 50 cents to 39 cents for 2017 over the last 60 days. The company delivered positive earnings surprises in all four trailing quarters, with an average beat of 233.69%.

MEI Pharma’s estimates moved up from loss per share of 1 cent to gain per share of the same for 2017, over the last 60 days. The company came up with positive earnings surprises in three of the four trailing quarters, with an average beat of 66.56%. The share price of the company has increased 47.9% year to date.

Sanofi’s earnings per share estimates increased from $3.08 to $3.18 for 2017 and from $3.26 to $3.30 for 2018, over last 30 days. The company pulled off positive earnings surprises in three of four trailing quarters, with an average beat of 5.10%. The share price of the company has increased 20.2% year to date.

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