Upcoming AWS Coverage on Patheon Post-Earnings Results

LONDON, UK / ACCESSWIRE / March 28, 2017 / Active Wall St. blog coverage looks at the headline from Allergan PLC (NYSE: AGN) and Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) as both Companies announced on March 27, 2018, positive results for the two Phase-3 trials of sarecycline for the treatment of moderate to severe acne. Sarecycline is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting. Based on these data, Allergan plans to file a New Drug Application (NDA) to the US Food & Drug Administration (FDA) in H2 2017. Register with us now for your free membership and blog access at:

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One of Allergan's competitors within the Drugs - Generic space, Patheon N.V. (NYSE: PTHN), reported on March 16, 2017, its financial results for the quarter ended January 31, 2017. AWS will be initiating a research report on Patheon in the coming days.

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

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Trial Results

The Company's two phase-II study SC1401 & SC1402 were designed to be replicative phase-3 randomized, multicenter, double-blind, placebo-controlled studies to evaluate the efficacy and safety of 1.5 mg/kg per day of sarecycline compared to placebo in the treatment of moderate to severe acne.

The primary objective was to evaluate the efficacy and safety of oral sarecycline 1.5 mg/kg per day compared to placebo in treating inflammatory acne lesions in subjects with moderate to severe acne based on Investigators Global Assessment (IGA) scale score and inflammatory lesion counts. Patients were randomized (1:1) into two treatment groups to receive either sarecycline tablets (60 mg, 100 mg, and 150 mg, providing a dose of 1.5 mg/kg/day) or placebo once a day for 12 weeks.

The companies stated that Sarecycline was statistically significantly superior to placebo with respect to primary efficacy endpoints. The most common adverse events reported in the sarecycline group were nausea, nasopharyngitis, and headache. The rate of discontinuation due to adverse events among sarecycline-treated patients in the two studies combined was 1.4%.

"The positive efficacy results observed in the pivotal phase-3 clinical trials indicate that sarecycline can be an effective treatment option for patients with moderate to severe acne," said David Nicholson, Chief Global Research & Development Officer at Allergan, "We look forward to submitting a new drug application for sarecycline and bringing to market a potential new option for physicians treating patients with acne."

"We are pleased with the results of the sarecycline Phase-3 program and Allergan's intention to move ahead with an NDA submission for approval in the US by the end of 2017," said Evan Loh, M.D., President, Chief Operating Officer, and Chief Medical Officer of Paratek Pharma, "Sarecycline is a narrow spectrum antibiotic, which we believe can offer meaningful clinical benefits for patients afflicted with acne."

Allergan owns the rights for the development and commercialization of sarecycline in US, while Paratek Pharma retains all non-US global rights.

Paratek's lead product candidate, Omadacycline, is the first in a new class of tetracyclines known as aminomethylcyclines, with broad-spectrum activity against Gram-positive, Gram-negative, and atypical bacteria. Omadacycline has been granted Qualified Infectious Disease Product designation and Fast Track status by the US FDA for several indications.

Stock Performance

At the close of trading session on Monday, March 27, 2017, Allergan's stock price rose slightly by 0.86% to end the day at $239.38. A total volume of 2.51 million shares were exchanged during the session. The Company's share price has gained 23.75% in the past three months and 14.31% on YTD basis. The stock currently has a market cap of $85.32 billion and has a dividend yield of 1.17%.

Paratek's stock price surged 9.15% from its previous closing price of $15.85, finishing yesterday's trading session at $17.30. A total of 2.21 million of Company's share were exchanged during the day. Paratek's stock price has gained 14.57% in the past one month and has advanced 17.69% in the last one year. The Company's shares have a market cap of $458.28 million based on Monday's closing price.

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SOURCE: Active Wall Street