Biotechs Ramp up Clinical Trial Programs as FDA Looks at More Efficient Drug Development Programs

PALM BEACH, Florida, September 13, 2017 /PRNewswire/ --

The hope of new measures for the FDA to advance the regulatory path for drug development is forging ahead incorporating relatively swift pivotal data in seeking accelerated approvals. FDA commissioner Scott Gottlieb recently backed some of the speedy clinical trials the industry has been seeing in the cancer field as an ideal platform for what can work, paving the way to the accelerated approval pathway at the FDA. Active companies today in the biotechnology sector and drug development activities include: Moleculin Biotech, Inc., (NASDAQ: MBRX), Aldeyra Therapeutics Inc. (NASDAQ: ALDX), Teva Pharmaceuticals Limited (NASDAQ: TEVA), Forward Pharma A/S (NASDAQ: FWP) and Marinus Pharmaceuticals Inc. (NASDAQ: MRNS)

Moleculin Biotech, Inc., (NASDAQ: MBRX), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, today announced it has engaged contract research organization ('CRO') Bioscience SA ('Bioscience') to prepare for a proof-of-concept clinical trial in Poland to study its drug candidate WP1220 for the treatment of cutaneous T-cell lymphoma ('CTCL'). Read this and more news for Moleculin Biotech at: http://www.marketnewsupdates.com/news/mbrx.html

"We believe we are in a position to move quickly to develop WP1220," commented Walter Klemp, Chairman and CEO of Moleculin. "We have a complete IND-enabling data package already, so we should be able to make application soon to the Polish regulatory authorities for a clinical trial authorization. In this case, we believe a proof-of-concept trial in Poland can be completed sooner and for less investment than in the US, giving us a very efficient means to develop yet another asset in our portfolio. As well, success with this trial could help us position WP1220 for accelerated approval in the US."

CTCL is a rare life-threatening skin cancer with limited treatment options. Pre-clinical studies have suggested that some CTCL cell lines may be particularly sensitive to inhibition of the activated form of STAT3, something for which the Company believes WP1220 is especially well suited. The Company's initial approach will be to administer WP1220 as a topical drug to Stage 1 through 2a patients in an effort to inhibit the progression of the disease.

In other biotech/big pharma developments in the markets: 

Aldeyra Therapeutics Inc. (NASDAQ: ALDX) closed up over 34% on Tuesday at $5.65 on over 11.1 million traded by the market close. The company recently announced positive results from a Phase 2a clinical trial of topical ocular ADX-102 in patients with dry eye disease. "ADX-102 is a promising agent for the treatment of dry eye disease, a persistently challenging condition for many people worldwide," commented John Sheppard, M.D., Professor of Ophthalmology, Eastern Virginia Medical School. "The evidence of rapid-onset activity and the tolerability profile demonstrated in the Phase 2a clinical trial suggests that ADX-102 could provide important patient benefits relative to existing therapies." The randomized, dose-ranging, parallel-group, double-masked Phase 2a clinical trial investigated three formulations of ADX-102 (0.1% ophthalmic solution, 0.5% ophthalmic solution, and 0.5% lipid formulation) in 51 dry eye disease patients (17 per arm) treated for 28 days.

Teva Pharmaceuticals Limited (NASDAQ: TEVA) came to a close up 4.49% on Tuesday at $19.33 with over 59.7 million shares traded on the day. The company recently announced it has entered into a definitive agreement under which CooperSurgical will acquire PARAGARD^® (intrauterine copper contraceptive), a product within its global Women's Health business, in a $1.1 billion cash transaction. PARAGARD^® had revenues of approximately $168 million for the trailing twelve month period ending June 30, 2017. This transaction includes Teva's manufacturing facility in Buffalo, NY, which produces PARAGARD^® exclusively. Teva continues to actively pursue additional divestiture opportunities, including the sale of the remaining assets of its global Women's Health business, as well as its Oncology and Pain businesses in Europe. Teva continues to expect to generate at least $2 billion in total proceeds from the sale of these businesses, as well as additional asset sales to be executed by year end 2017.

Forward Pharma A/S (NASDAQ: FWP) closed up over 35% on Tuesday at $6.99 with over 1.7 million shares traded by the market close and was up slightly in after hours trading. The company recently announced the filing in the U.S. Court of Appeals for the Federal Circuit (the 'Federal Circuit') of the opening brief for the appeal of the PTAB decision that ended the interference proceeding between the Forward 11/576,871 patent application (the '871 application') and an issued Biogen patent. "We continue to believe that our intellectual property is strong and that we have presented compelling arguments to have the PTAB interference decision reversed," said Dr. Claus Bo Svendsen, CEO of Forward. He added, "Our appeal is progressing on schedule, and, along with the European '355 Opposition Proceeding, is the key focus of Forward Pharma."

Marinus Pharmaceuticals Inc. (NASDAQ: MRNS) recently announced that top-line data from the Phase 2 open-label study in patients with CDKL5 disorder support advancing ganaxolone into a definitive late-stage clinical trial. Oral ganaxolone, in addition to baseline treatment, showed a sizable and durable seizure-frequency reduction in the majority of patients, with some achieving an increase in the number of seizure-free days and reporting behavioral benefits. CDKL5 disorder is a severe, rare genetic epilepsy that results in early-onset, treatment-refractory seizures, pervasive neuro-developmental delay and disabling behavioral issues. There are no approved or effective available treatment options. Marinus plans to meet with regulatory agencies to obtain agreement on the clinical development plan that would be needed for approval of ganaxolone for CDKL5 disorder.

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