EBS, REGN Get FDA Nod, OVAS To Deliver, Recro Recuperates, Watch Out For ZSAN

(RTTNews) - Dermira Inc. (DERM), which recently announced positive results from a phase 2a clinical trial for DRM01 in patients with acne, expects to start a phase 2b trial in April 2015.

The company also intends to commence its phase 3 program in hyperhidrosis (abnormally increased sweating) for DRM04 in the second half of the year, subject to an end-of-phase 2 meeting with the FDA.

A phase 3 clinical program of CIMZIA in adult patients with moderate-to-severe chronic plaque psoriasis is underway, and Dermira expects topline results from this program in 2017.

DERM closed Wednesday's trading at $14.65, down 3.17%.

Emergent BioSolutions Inc.'s (EBS) Anthrasil has received FDA approval for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. The approval triggers a $7 million payment to the company under a development contract with the Biomedical Advanced Research and Development Authority.

Anthrasil qualifies for seven years of market exclusivity as it has received Orphan Drug designation from the FDA.

EBS closed Wednesday's trading at $27.61, down 5.77%.

OvaScience (OVAS) is scheduled to present detailed clinical reports of its AUGMENT treatment on March 27, 2015 during the Society for Reproductive Investigation 62nd Annual Scientific Meeting in San Francisco, California. The first clinical experience presentations will include initial pregnancy data of the AUGMENT treatment.

The AUGMENT treatment is a fertility treatment specifically designed to use the mitochondria, or energy, from a woman's own egg precursor cells - immature egg cells found inside the protective ovarian lining - to improve egg health. Improved egg health is important for fertilization and embryo development during in vitro fertilization, or IVF.

The treatment is available to patients in select international IVF clinics but is not available in the United States.

OVAS touched a new high of $55.69 on Wednesday before closing the day's trading at $49.80.

Recro Pharma Inc. (REPH) is scheduled to report top-line data from a phase II clinical trial of Dex-IN in management of post-op pain starting Post Op Day 1 after bunionectomy surgery in mid 2015.

The primary efficacy endpoint of the trial is the summed pain intensity difference over 48 hours, starting on Postoperative day one.

Recro went public last March, priced at $8 per share. The shares took a hit last September when the company decided to close a phase IIb trial of Dex-IN in the treatment of acute post-operative pain following bunionectomy surgery on Post Op Day 0, as interim analysis revealed that the study may not reach statistical significance in that design.

The following month - in September of 2014 - the company initiated a phase II trial of Dex-IN in management of post-op pain starting Post Op Day 1 after bunionectomy surgery. The trial, designed to enroll approximately 200-250 patients, is currently recruiting participants, and as mentioned earlier, data are expected in mid-2015.

REPH touched a new high of $9.93 on Wednesday before closing the day's trading at $9.40.

Regeneron Pharmaceuticals Inc.'s (REGN) eye drug EYLEA has received FDA approval for yet another indication - this time, for the treatment of diabetic retinopathy in patients with diabetic macular edema.

Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the United State.

EYLEA is already approved in the U.S. for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME).

Regeneron collaborates with Bayer HealthCare on the global development of EYLEA. Bayer has rights to market EYLEA outside the U.S., where the companies share equally in development costs and in profits from EYLEA sales. Within the U.S., Regeneron retains exclusive commercialization rights to EYLEA and is entitled to all profits from any future sales.

The global sales of EYLEA in 2014 increased 48% to $2.78 billion - with $1.74 billion coming from sales in the United States and $1.04 billion in rest of the world.

REGN closed Wednesday's trading at $453.99, down 4.17%.

The FDA has approved Sanofi's (SNY) Quadracel DTaP-IPV vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.

SNY closed Wednesday's trading at $50.30, down 1.60%.

Vical Inc. (VICL) has expanded its infectious disease portfolio with the addition of a novel antifungal candidate, ASP2397, in-licensed from Astellas Pharma Inc.

ASP2397 represents a potential new class of antifungal compounds to address invasive Aspergillus infections, which are major causes of morbidity and mortality in immunocompromised patients, including transplant recipients.

Vical expects to initiate a phase 1 trial of ASP2397 in the first half of 2016. But that's not all. Astellas, which is also Vical's partner for the ASP0113 CMV vaccine program in transplant recipients, will become a shareholder in Vical.

Vical and Astellas initiated a multinational phase 3 registration trial of ASP0113 in hematopoietic cell transplant (HCT) recipients in June 2013 and a phase 2 trial in solid organ transplant (SOT) recipients in December 2013.

VICL closed Wednesday's trading at $0.86, down 4%. In after-hours, the stock was up 11.11% at $0.96.

Zosano Pharma Corp. (ZSAN) looks forward to confirm phase 3 clinical trial design of ZP-PTH for osteoporosis with regulatory authorities by the end of this year. The company has an exclusive license agreement with Eli Lilly (LLY) for ZP-PTH.

Zosano expects to complete a phase 2 clinical trial of ZP-Glucagon in diabetic patients with induced hypoglycemia in Q3 2015, and a phase 1 clinical trial of ZP-Triptan for migraine by the end of this year.

The company went public in January 2015, offering its shares at a price of $11 each.

ZSAN closed Wednesday's trading at $9.77, down 4.78%.