Orphan Drug Product Candidate Development Provides Revolutionary Solutions for Treatment of Severe Injuries and Innovative Therapies for Rare Diseases & Conditions

Jul 15, 2015, 08:15 ET from FN Media Group LLC

CORAL SPRINGS, Florida, July 15, 2015 /PRNewswire/ --

As modern biotechnology continues to provide breakthrough products and technologies to combat debilitating rare diseases, treat severe injuries and offer therapeutic treatments for many areas of various medical conditions, today's leading biotech & biopharmaceutical companies such as Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), EPIRUS Biopharmaceuticals, Inc. (NASDAQ: EPRS), ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA), Celldex Therapeutics, Inc. (NASDAQ: CLDX) and Receptos, Inc. (NASDAQ: RCPT) race to introduce the newest technologies and products that help improve the lives and overall health of patients worldwide.

Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), a biotechnology company focused on developing therapeutic and diagnostic products for diseases in the areas of neurology, psychiatry, ophthalmology and regenerative medicine, announced that it has completed the acquisition of Cutanogen Corporation ("Cutanogen") from Lonza Walkersville, Inc. ("Lonza"), a subsidiary of Lonza Group Ltd. Cutanogen has an exclusive worldwide license to intellectual property rights associated with Engineered Skin Substitute ("ESS"), an autologous full thickness skin replacement product in development for the treatment of severe burns. ESS has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of hospitalized patients with deep partial and full thickness burns requiring grafting.  With this agreement, Amarantus has engaged Lonza via a long-term services agreement to manufacture ESS under Good Manufacturing Practices for human clinical trials, and subsequent commercial distribution.

Read the full AMBS press release at http://www.financialnewsmedia.com/profiles/ambs.html

"The completion of the acquisition of Cutanogen from Lonza represents a cornerstone of Amarantus' therapeutics acquisition strategy as the company prepares for its upcoming listing on a national exchange," said Gerald E. Commissiong, President & CEO of Amarantus. "ESS is a potentially revolutionary solution for the treatment of severe burns that has demonstrated initial human proof-of-concept in an investigator-initiated setting. Going forward, Amarantus plans to take this program through a stringent corporate-sponsored regulatory development program under an already open IND with the FDA, to gain marketing approval, initially for the treatment of severe burns in the United States. The company intends to work closely with US regulatory authorities under the orphan drug designation pathway to achieve this objective."

In other biotech news and current happenings:  EPIRUS Biopharmaceuticals, Inc. (NASDAQ: EPRS) and Polpharma Group announced the signing of a multi-product, multi-region profit-sharing collaboration for select EPIRUS biosimilars, including BOW015 (infliximab, reference biologic Remicade®), BOW050 (adalimumab, reference biologic Humira®) and BOW070 (tocilizumab, reference biologic Actemra®), representing $6 billion in innovator sales in the specified territoriesi. Polpharma Group is a leading generics company based in Poland with annual sales of approximately $1 billion and a strong commercial infrastructure, including a salesforce of over 1,700 employees globally. 

ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) back in June announced long-term follow up from its pivotal Phase 2 trial of Iclusig® (ponatinib), its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study now shows that with a median follow-up of approximately 3.5 years for chronic phase CML (CP-CML) patients and a median follow-up of approximately 2.9 years in all patients in the trial, Iclusig continues to demonstrate anti-leukemic activity in patients with limited treatment options. Responses have been maintained long-term in CP-CML patients. Eighty-three percent (83%) of CP-CML patients who achieved a major cytogenetic response (MCyR) are estimated to remain in MCyR at three years.

Celldex Therapeutics, Inc. (NASDAQ: CLDX) recently announced that an independent Data Safety and Monitoring Board (DSMB) recommended continuation of the Phase 3 ACT IV study of RINTEGA(R) (rindopepimut) in patients with newly diagnosed glioblastoma.  The ACT IV study is a randomized, double-blind, placebo controlled study of rindopepimut plus GM-CSF added to standard of care temozolomide in patients with newly diagnosed, surgically resected, EGFRvIII-positive glioblastoma. 745 patients were enrolled into ACT IV to reach the required 374 patients with minimal residual disease (assessed by central review) needed for analysis of the primary overall survival endpoint. All patients, including those with disease that exceed this threshold, will be included in a secondary analysis of overall survival as well as analyses of progression-free survival, safety and tolerability, and quality of life. The timing of the overall survival primary endpoint data is event-driven. Interim analyses assessing safety, futility and efficacy conducted by an independent DSMB were prespecified at 50 percent and 75 percent of events.

Receptos, Inc. (NASDAQ: RCPT) and Celgene Corporation (NASDAQ: CELG) announced the signing of a definitive agreement in which Celgene has agreed to acquire Receptos. Under the terms of the merger agreement, Celgene will pay $232.00 per share in cash, or a total of approximately $7.2 billion, net of cash acquired.  The acquisition of Receptos significantly enhances Celgene's Inflammation & Immunology (I&I) portfolio, further diversifies the Company's revenue beginning in 2019 and beyond, and builds upon Celgene's growing expertise in inflammatory bowel disease (IBD). The transaction adds Ozanimod, a novel, potential best-in-class, oral, once-daily, selective sphingosine 1-phosphate 1 and 5 receptor modulator (S1P) to Celgene's deep and diverse pipeline of potential disease-altering medicines and investigational compounds.

InVivo Therapeutics Holdings Corp. (NASDAQ: NVIV) recently announced a one-month post-implant update for the third study patient and a six-month post-implant update for the second study patient in the company's ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with complete acute spinal cord injury.  InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries.

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