AGN, IPXL In Legal Bout, ANIP Opens Wallet, PFE's Octave Hits Right Notes

(RTTNews) - ADMA Biologics Inc.'s (ADMA) Biologics License Application for RI-002 for treatment of primary immunodeficiency has been accepted for review by the FDA.

Primary immunodeficiency is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly, affecting approximately 250,000 people in the United States.

The regulatory agency's decision on RI-002 is scheduled for the second half of 2016.

ADMA closed Monday's trading at $9.24, up 2.10%.

Alcobra Ltd.'s (ADHD) lead investigational product candidate Metadoxine Extended Release has been granted Fast Track designation by the FDA for the treatment of Fragile X Syndrome.

Fragile X Syndrome, or FXS, is a genetic condition that causes intellectual disability, behavioral and learning challenges. FXS is the leading known genetic cause of autism, accounting for about 2-6% of cases.

A phase II exploratory study of Metadoxine Extended Release (MDX) in adolescent and adult patients with Fragile X Syndrome, the results of which were announced in June of this year, did not achieve statistical significance on the primary endpoint, yet demonstrated significant improvements in certain clinically meaningful behavioral and cognitive endpoints, according to the company. Alcobra plans to discuss the trial results with the FDA later this year.

ADHD closed Monday's trading at $8.15, down 1.33%.

Allergan plc (AGN) has filed an Abbreviated New Drug Application with the FDA seeking approval to market generic version of Impax Laboratories' (IPXL) Parkinson's disease drug, Rytary.

Impax Labs, which received FDA approval for Rytary in January of this year, has filed a suit against Allergan seeking to prevent Allergan from commercializing its ANDA product prior to the expiration of certain U.S. Patents.

AGN closed Monday's trading at $285.62, down 3.27%.

ANI Pharmaceuticals Inc. (ANIP) has agreed to acquire the NDAs for purified corticotropin gel and corticotropin-zinc hydroxide from Merck & Co. Inc. (MRK) for $75 million in cash and a percentage of future net sales.

Corticotropin gel is a purified corticotropin in a sterile solution of gelatin for prolonged activity and Corticotropin-zinc hydroxide is a sterile aqueous suspension of purified corticotropin with zinc hydroxide for repository action. The products are approved for various disease states including Multiple Sclerosis, Rheumatic disorders, Dermatologic diseases, and a variety of Collagen, Ophthalmic, Respiratory diseases as well as Allergic and Edematous states.

ANI Pharma estimates that the current annual U.S. market for the products it is acquiring is approximately one billion dollars as evidenced by sales of H.P. Acthar gel marketed by Mallinckrodt Pharmaceuticals, which is also a corticotropin product.

ANIP closed Monday's trading at $55.40, up 4.39%.

Atossa Genetics Inc. (ATOS) has received green signal from the FDA to begin a phase II study of Fulvestrant in patients with Ductal Carcinoma in Situ or breast cancer. The trial is scheduled to commence in December 2015.

ATOS closed Monday's trading 6.08% higher at $0.87.

Pfizer Inc.'s (PFE) two phase III trials of oral Tofacitinib in adults with moderate-to-severe ulcerative colitis have met their primary endpoints as measured by the proportion of patients receiving Tofacitinib in remission at Week 8 compared to patients receiving placebo.

The trials, dubbed OCTAVE Induction 1 and OCTAVE Induction 2, are two identical studies that randomized a total of 598 patients and 541 patients, respectively, to Tofacitinib 10 mg twice daily or placebo treatment groups.

The OCTAVE program includes two more trials namely OCTAVE Sustain and a long-term extension trial, OCTAVE Open. Results for OCTAVE Sustain are anticipated by the end of 2016.

PFE closed Monday's trading at $32.42, down 1.31%.

Xenon Pharmaceuticals Inc. (XENE) is all set to receive a milestone payment from Genentech, a member of the Roche Group, for the successful joint discovery and identification of a novel pain target under a discovery collaboration signed last March.

Under the terms of the collaboration agreement, Genentech paid Xenon an upfront payment of $1.5 million, and Xenon is eligible for approximately $2.0 million in additional milestone payments, which figure includes the recently earned milestone payment.

XENE closed Monday's trading at $9.53, up 3.81%.