Blog Coverage Redhill Receives QIDP Fast-Track Designation from FDA for its Nontuberculous Mycobacteria Infections Combination Therapy

Upcoming AWS Coverage on Juno Therapeutics

LONDON, UK / ACCESSWIRE / January 12, 2017 / Active Wall St. blog coverage looks at the headline from RedHill Biopharma Ltd. (NASDAQ: RDHL) (“RedHill”) as the Company announced on January 11, 2017, that RHB-104 has been granted Qualified Infectious Disease Product (QIDP) designation by the US FDA for the treatment of Nontuberculous Mycobacteria (NTM) infections. Register with us now for your free membership and blog access at: http://www.activewallst.com/register/.

One of RedHill Biopharma’s competitors within the Biotechnology space, Juno Therapeutics, Inc. (NASDAQ: JUNO), is estimated to report earnings on 06 March, 2017. AWS will be initiating a research report on Juno Therapeutics following the releases of its next earnings results.

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

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What is QIDP Status?

The QIDP designation was granted under the FDA’s Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for the treatment of serious or life-threatening infections. The QIDP designation allows RedHill to benefit from Fast-Track status, with an expedited development pathway for RHB-104 for the treatment of NTM infections, as well as Priority Review, which provides for a shorter review time by the FDA of a future potential marketing application. If approved for the treatment of NTM infections, RHB-104 would also receive an additional five years of US market exclusivity on top of the standard exclusivity period.

RHB-104

RHB-104 is a proprietary antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.

A first Phase III study with RHB-104 for the treatment of Crohn’s disease (the MAP US study) is currently ongoing in the US and additional countries. The development of RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease, and potentially other autoimmune diseases, are related to Mycobacterium Axium subspecies paratuberculosis (MAP) infection in susceptible patients.

Recently, RedHill also completed a Phase IIa, proof-of-concept clinical study, evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for relapsing remitting multiple sclerosis. Top-line final results from the CEASE MS study suggest meaningful positive safety and clinical signals upon 24 weeks of treatment with RHB-104 as an add-on therapy, thereby supporting further clinical development.

Dosing for RHB-105

On January 10, 2017, RedHill announced first dosing in a three-way crossover pharmacokinetic (PK) study with RHB-105 in 18 subjects, intended to evaluate the bioavailability (BA) of RHB-105 actives versus the comparator in the planned confirmatory Phase III study and a food-effect study with RHB-105.

These PK studies are intended to support the planned confirmatory Phase III study with RHB-105, a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection. The two-arm, randomized, double-blind, active comparator confirmatory Phase III study, comparing RHB-105 against a dual therapy amoxicillin and omeprazole regimen at equivalent doses, is planned to be initiated by April of 2017, after completion of the ongoing supportive PK program and submission of clinical study reports to the FDA. The planned confirmatory Phase III study, along with the results from the successfully completed first Phase III study with RHB-105 and data to be obtained from the ongoing supportive PK program, are expected to support a US New Drug Application (NDA) for RHB-105.

Exercise of Stock Options

On January 09, 2017, RedHill announced the exercise, of stock options to purchase an aggregate of 1,700,000 ordinary shares (equivalent to 170,000 American Depositary Shares (ADSs) by members of the Company’s Board of Directors, senior management and Advisory Board. The exercise of stock options resulted in net proceeds to the Company of approximately $0.6 million. Following issuance of the ordinary shares underlying these stock options, the total number of outstanding ordinary shares of RedHill totalled 168,005,274 (equivalent to 16,800,527 ADSs).

Stock Performance

At the close of trading session on January 11, 2017, RedHill Biopharma’s stock price rose slightly by 0.96% to end the day at $10.55. A total volume of 96.92 thousand shares were exchanged during the session, which was above the 3-month average volume of 60.41 thousand shares. The stock currently has a market cap of $1.34 billion.

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