Various Development Advancements for Targeted Treatment
Therapies for Rare Diseases & Disorders Lead to Newest Orphan
Drug Designations by the U.S. FDA
Coral Springs, FL - (February 10, 2016) - 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 Parkinsons 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 Parkinsons 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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