Upcoming AWS Coverage on TherapeuticsMD Post-Earnings Results

LONDON, UK / ACCESSWIRE / May 19, 2017 / Active Wall St. blog coverage looks at the headline from Shire PLC (NASDAQ: SHPG) as the Company announced on May 18, 2017, positive top-line Phase 3 results for the HELP? study, that evaluated the efficacy and safety of subcutaneously administered lanadelumab versus placebo with Hereditary Angioedema (HAE), a rare, genetic disorder that causes severe swelling in various parts of the body including extremities, gastrointestinal tract, and upper airways. The condition is estimated to affect about 1 in 10,000 to 1 in 50,000 people worldwide. Lanadelumab is an investigational fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein and is being developed as a treatment for the prevention of angioedema attacks in patients with HAE. Register with us now for your free membership and blog access at:

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One of Shire's competitors within the Drug Manufacturers - Major space, TherapeuticsMD, Inc. (NYSE: TXMD), reported on May 02, 2017, its financial results for the quarter ended March 31, 2017. AWS will be initiating a research report on TherapeuticsMD in the coming days.

Today, AWS is promoting its blog coverage on SHPG; touching on TXMD. Get all of our free blog coverage and more by clicking on the link below:

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The HELP Study

Shire stated that the HELP study is a global, multicenter, randomized, parallel group, double-blind, placebo-controlled, Phase 3 trial, treating 125 patients 12 years of age or older with type I/II HAE. Patients were randomized into four arms to receive repeated subcutaneous administrations of lanadelumab 300 mg every two weeks, 300 mg every four weeks, 150 mg every four weeks or placebo in a 2:1 ratio. The primary efficacy endpoint of the study was the number of investigator-confirmed angioedema attacks observed in each lanadelumab treatment arm versus placebo arm during the 26 week treatment period.

The Company stated that the HELP study met its primary endpoint and all secondary endpoints for all three lanadelumab treatment arms compared to placebo. The 300 mg dose administered once every two weeks resulted in a statistically significant reduction in mean HAE attack frequency of 87% compared to placebo. Results were consistent regardless of baseline attack rate. Notably for each of the three lanadelumab regimens studied, whether administered biweekly or monthly, a significantly higher proportion of patients-compared to placebo-were attack free throughout the entire 26 week study period.

Lanadelumab was generally well tolerated over the 26-week treatment period. No treatment-related serious adverse events or deaths were reported. The most common adverse event was injection site pain.

"We are extremely encouraged by these top-line Phase 3 results," said Flemming Ornskov, M.D., M.P.H., Shire's Chief Executive Officer, "We have nearly a decade of experience and a strong portfolio and pipeline in HAE and believe these data demonstrate high potential for transforming the way patients living with this condition are treated."

Moving Forward

Armed with positive results, Shire plans to submit a biologics license application (BLA) for evaluation by the US Food and Drug Administration (FDA) by late 2017 or early 2018. Lanadelumab has received both Orphan Drug Designation and Breakthrough Therapy Designation from the FDA and Orphan Drug Designation from the European Medicines Agency (EMA).

Stock Performance

At the closing bell, on Thursday, May 18, 2017, following the announcement, Shire's stock climbed 4.30%, ending the trading session at $190.00. A total volume of 4.04 million shares were traded at the end of the day, which was higher than the 3-month average volume of 919.94 thousand shares. In the last month and previous three months, shares of the Company have advanced 12.25% and 6.78%, respectively. Moreover, the stock gained 12.00% since the start of the year. The stock is trading at a PE ratio of 102.26 and has a dividend yield of 0.48%.

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SOURCE: Active Wall Street