Various Development Advancements for Targeted Treatment Therapies for Rare Diseases & Disorders Lead to Newest Orphan Drug Designations by the U.S. FDA
CORAL SPRINGS, Florida, February 10, 2016 /PRNewswire/ --
Today's latest Orphan Drug Designations become vitally important in the development of targeted treatment therapies when granted by the FDA to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders. Biotech companies with recent developments of market importance are Amarantus BioScience Holdings, Inc. (OTCQX: AMBS), Cerus Corporation (NASDAQ: CERS), Medivation, Inc. (NASDAQ: MDVN), Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS) and Celldex Therapeutics, Inc. (NASDAQ: CLDX).
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, today announced that it has received orphan drug designation from the US FDA for Eltoprazine in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID). Amarantus published positive results from a Phase 2 initial proof-of-concept clinical study in February of 2015 in the journal Brain, and highlighted the publication of two independent peer-reviewed scientific publications describing the mechanism of action of eltoprazine for the treatment of PD LID in August of 2015 and December 2016.
Read the full Amarantus (AMBS) Press Release at http://financialnewsmedia.com/profiles/ambs.html
"The grant of this orphan drug designation for eltoprazine in PD-LID squarely positions Amarantus as an orphan drug company, as each of our pipeline candidates in our therapeutics division has received such designations from the FDA for one or more indications," said Gerald E. Commissiong, President & CEO of Amarantus. "PD-LID is a tremendously debilitating disorder, and we will now begin evaluating expedited pathways to market for eltoprazine that may now be afforded by the orphan drug designation." The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent so-called orphan diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.
In other Biotech developments to watch this week: Cerus Corporation (NASDAQ: CERS) announced that the American Red Cross has signed a multi-year purchase agreement for the INTERCEPT Blood System for platelets and plasma, which inactivates a broad spectrum of viruses, gram-positive and gram-negative bacteria, spirochetes, parasites and leukocytes and is intended to reduce the risk of transfusion-transmitted infection (TTI) in platelet and plasma components. The American Red Cross is the largest supplier of blood products in the United States. The Red Cross collects and processes approximately 40 percent of the blood supply, distributing about 780,000 platelet and 1.1 million plasma units last year to nearly 2,600 hospitals and transfusion centers nationwide.
Astellas US LLC, a United States (U.S.) subsidiary of Tokyo-based Astellas Pharma Inc. (TSE:4503), and Medivation, Inc. (NASDAQ: MDVN) recently announced that results from the STRIVE trial of enzalutamide compared to bicalutamide in men with castration-resistant prostate cancer (CRPC) were published in the Journal of Clinical Oncology. The article, titled, "Enzalutamide Versus Bicalutamide in Castration-Resistant Prostate Cancer: The STRIVE Trial," appears in the January 25, 2016 online issue and will be published in a future print issue of the journal
Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS) back in January provided a summary of 2015 corporate highlights and planned future milestones. Adamas, which is developing new medicines for chronic neurological disorders, utilizes its technology platform to improve the pharmacokinetics profiles of approved drugs, alone and in fixed-dose combinations. The company is developing ADS-5102 for two indications: levodopa-induced dyskinesia (LID), a complication associated with the treatment of Parkinson's disease, and major symptoms associated with multiple sclerosis (MS) in patients with walking impairment. Adamas also has ADS-4101 in preclinical development for epilepsy (partial onset seizures). In addition, the company has a partnership with Allergan for two approved products, Namzaric and Namenda XR®, which are marketed in the U.S. by Allergan.
Celldex Therapeutics, Inc. (NASDAQ: CLDX) develops targeted therapeutics to address devastating diseases for which available treatments are inadequate. The Company's pipeline is built from a proprietary portfolio of antibodies and immunomodulators used alone and in strategic combinations to create novel, disease-specific therapies that induce, enhance or suppress the body's immune response. CLDX was one of the leaders yesterday for the Biotech sector closing up at $6.98 on over 3.2Mil shares traded by the market close.
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