Upcoming AWS Coverage on Impax Laboratories Post-Earnings Results
LONDON, UK / ACCESSWIRE / December 5, 2016 / Active Wall St. blog coverage looks at the headline from Shire PLC (NASDAQ: SHPG) as the company announced on December 02, 2016, the results of its Phase-III clinical trial evaluating VONVENDI™ [von Willebrand factor (Recombinant)], in treating bleeds in elective surgical settings for adults with severe von Willebrand disease. During the trial the drug was effective in controlling the bleeding during surgical procedures in these patients. Based on these results the company plans to submit a sBLA (supplemental new drug application) to the US Food and Drug Administration (FDA) for the continued use of the product. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.
One of Shire's competitors within the Drug Manufacturers - Major space, Impax Laboratories, Inc. (NASDAQ: IPXL), reported on November 09, 2016, its third quarter 2016 financial results for the quarter ended September 30, 2016. AWS will be initiating a research report on Impax Laboratories in the coming days.
Today, AWS is promoting its blog coverage on SHPG; touching on IPXL. Get all of our free blog coverage and more by clicking on the links below:
http://www.activewallst.com/registration-3/?symbol=SHPG
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Shire is the leading global biotechnology company focused on treatment for people with rare diseases and other specialized conditions. Its core therapeutic areas include haematology, immunology, neuroscience, ophthalmics, lysosomal storage disorders, gastrointestinal /internal medicine/endocrine, and hereditary angioedema; and oncology.
The Phase III results and implications
The Phase III clinical trials were conducted using VONVENDI™ for treatment of bleeds in elective surgical settings for adults with severe Von Willebrand disease (VWD). The study was successful in reaching its goal and indicated that VONVENDI™ effectively controlled bleeding and blood loss during an operation in adults undergoing major, minor and oral elective surgical procedures. The complete results of the study would be presented at the 58th American Society of Hematology (ASH) Annual Meeting, to be held on December 3rd-6th in San Diego, California. The results of the study will enable Shire to file for regulatory approvals in Europe in 2017 and in other markets globally.
The Phase III clinical trials were conducted on 15 patients above the age of 18 years and with severe VWD. These patients were observed when undergoing major and minor elective surgical procedures. The study assessed the safety and hemostatic efficacy of VONVENDI™ used before, during or after a surgical procedure, with or without, a recombinant Factor VIII (rFVIII) treatment. At the end of the study, all the 15 patients' overall haemostatic efficacy was rated as "excellent" or "good". VONVENDI™ is also being studied for prophylaxis (preventive treatment) and paediatric indications.
About Von Willebrand
VWD is a genetic disorder caused by missing or defective Von Willebrand Factor (VWF), a clotting protein. VWD is often difficult to diagnose. The missing Von Willebrand Factor (rVWF) leads patients to experience spontaneous bleeding. VWF binds factor VIII, a key clotting protein, and platelets in blood vessel walls, which help form a platelet plug during the clotting process. VWD affects an estimated 1 in 100 people, or roughly 3 million people in the US.
About VONVENDI™ [von Willebrand factor (Recombinant)]
VONVENDI™ is "recombinant," which is designed specifically for the treatment of VWD. It is administered intravenously into the blood stream, where it acts like the body's own naturally occurring VWF would.
Background
VONVENDI™ was developed by Baxalta Inc. and was approved by the US FDA in December 2015 for the use for and on-demand treatment and control of bleeding episodes in adults aged 18 and older with VWD. Shire had been pursuing Baxalta for acquisition and had announced the takeover in January 2016. The $32 billion deal was finalized in June 2016.
In August 2016, Shire re-launched VONVENDI™, pushing it as the first and only Von Willebrand Factor (rVWF) treatment for patients with VWD. Until Shire's positioning of VONVENDI™, patients with VWD were treated with a Factor VIII, a drug which was actually meant for the treatment of patients with hemophilia A.
On the same day, i.e. December 02, 2016, Shire also presented the safety data for a 40-year period when using the bypassing agent FEIBA [Anti-Inhibitor Coagulant Complex].
In November 2016, Shire had disclosed its plans to expand its operations in Cambridge, Massachusetts by establishing a rare disease innovation hub spread across a 343,000-square-foot building.
Stock Performance
At the close of trading session on December 02, 2016, Shire's stock price rose 2.23% to end the day at $174.80. A total volume of 972.85 thousand shares were exchanged during the session. The company's share price has gained 4.90% in the past one month. The stock currently has a market cap of $51.45 billion. The company's shares are trading at a PE ratio of 65.79 and have a dividend yield of 0.46%. The stock has a market capital of $51.86 billion.
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