Pharma Industry Poised For Fast Start in 2016 As U.S. Food &
Drug Administration Receives Requests for Newest Orphan Drug
Designations & Rare Disease Treatments
Coral Springs, FL (December 29, 2015) -- Biotechnology companies
continue to forge ahead with advancing clinical trials and
development of next-generation treatments for rare diseases through
new orphan drug designations and cutting edge drug delivery
products. Today's companies in the spotlight with achievements and
recent developments are Amarantus BioScience Holdings, Inc.
(OTCQX:
AMBS), pSivida Corp. (NASDAQ:
PSDV), Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS), Auris
Medical Holding AG (NASDAQ:
EARS) and Cerus Corporation (NASDAQ:
CERS)
Amarantus BioScience Holdings, Inc. (OTC:
AMBS), a biotechnology company focused on developing products
for Regenerative Medicine, Neurology and Orphan Diseases, announced
that it has requested Rare Pediatric Disease Designation (RPDD) and
Orphan Drug Designation (ODD) from the US Food and Drug
Administration (FDA) to treat GCMN with Engineered Skin Substitute
(ESS). It is estimated that the incidence of GCMN, a rare
dermatological condition present at birth, is between 8 and 80
births annually in the United States.
Read the full Amarantus (AMBS)
Press Release at http://financialnewsmedia.com/profiles/ambs.html
The FDA defines a "rare pediatric disease" as a disease that
affects fewer than 200,000 individuals in the U.S. primarily aged
from birth to 18 years. Under the FDA's Rare Pediatric Disease
Priority Review Voucher program, a sponsor who receives an approval
of a new drug application (NDA) or biologics license application
(BLA) for a rare pediatric disease may be eligible for a voucher,
which can be redeemed to obtain expedited FDA review for any
subsequent marketing application. Vouchers may be sold or
transferred by the recipient; in the last 6 months, 2 priority
review vouchers have been sold for a combined $595M in cash.
The FDA Orphan Drug Designation program provides a special status
to drugs and biologics intended to treat, diagnose or prevent
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: pSivida
Corp. (NASDAQ:
PSDV), a leader in the development of sustained release drug
delivery products for treating eye diseases, today announced that
it plans to file for EU marketing approval of Medidur for chronic
non-infectious uveitis of the posterior segment of the eye
(posterior uveitis) based on data from a single pivotal trial as a
result of the high statistical significance achieved in its first
Phase 3 clinical trial. The U.K. Medicines and Healthcare Products
Regulatory Agency (MHRA) advised pSivida that, consistent with the
published Points to Consider (PtC) of the European Agency for
Evaluation of Medicinal Products, an application for a product
treating a condition like posterior uveitis could be based on
statistically compelling and clinically relevant results from just
one pivotal trial. The MHRA recently provided this specific advice
in formal minutes of a meeting with pSivida held on October 29,
2015 (prior to the Companys receipt of topline results for its
first Phase 3 clinical trial). With those results now available,
pSivida plans to confirm with the MHRA the plan to file for EU
marketing approval of Medidur based on one trial.
Adamas Pharmaceuticals, Inc. (NASDAQ: ADMS) last week announced
that its Phase 3 EASE LID clinical trial evaluating the companys
investigational compound ADS-5102 (amantadine HCl) extended-release
capsules for the treatment of levodopa-induced dyskinesia (LID)
associated with Parkinsons disease met its primary endpoint.
Results from this randomized, placebo-controlled study showed a
statistically significant reduction (p = 0.0009) in LID at 12 weeks
for patients who received ADS-5102 versus placebo as assessed by
the Unified Dyskinesia Rating Scale (UDysRS). This represents
a 23 percent reduction in LID for ADS-5102-treated patients
compared to placebo. The reduction in LID was maintained at
24 weeks (p = 0.0008), a key secondary analysis.
Auris Medical Holding AG (NASDAQ:
EARS), a clinical-stage company dedicated to developing
therapeutics that address important unmet medical needs in
otolaryngology, in November announced enrolment of the first
patient into the pivotal HEALOS clinical trial with AM-111. HEALOS
will evaluate the efficacy, safety and tolerability of single dose
intratympanic injections of AM-111 in the treatment of idiopathic
sudden sensorineural hearing loss (ISSNHL; a.k.a. "sudden
deafness"). The trial will enroll 255 patients suffering from acute
severe to profound hearing loss within 72 hours from
ISSNHL
Cerus Corporation (NASDAQ:
CERS) announced last week that Rhode Island Blood Center (RIBC)
has signed a purchase agreement for the INTERCEPT Blood System for
platelets and plasma. Rhode Island Blood Center is the primary
supplier of blood products to hospitals in Rhode Island, and also
services hospitals in nearby Massachusetts and Connecticut. RIBC
distributes approximately 12,500 platelet and 42,000 plasma units
annually. Continuing to layer on screening tests to detect emerging
pathogens that pose a risk to patients puts an economic strain on
blood centers. We have experienced this first hand with babesiosis,
a serious tickborne disease common in Rhode Island, said Lawrence
Smith, President and CEO of the Rhode Island Blood Center. The
opportunity to proactively decrease the risk of
transfusion-transmitted diseases made implementing INTERCEPT a
priority to continue to fulfill our mission of providing a safe,
plentiful and cost-effective blood supply.
In other recent NASDAQ market news of importance: Fontem
Ventures, owner of market leading e-cigarette brand blu, and Vapor
Corp. (NASDAQ: VPCO), a U.S. based distributor and retailer of
vaporizers and e-liquids, in December announced they have reached a
settlement agreement that resolves ongoing litigation in the USA.
The settlement ends another of eight patent infringement cases
originally brought by Fontem Ventures and Fontem Holdings 1 in
March 2014 in the United States District Court for the Central
District of California in relation to e-vapour technology.
Under the terms of the settlement, Fontem Ventures has granted
Vapor Corp. a non-exclusive royalty-bearing global licence under
the patents asserted in the litigation and certain other e-vapour
technology related patents. The remaining settlement terms are
confidential.
FinancialNewsMedia.com is leading provider of third party
publishing & news dissemination services. If you would
like more information regarding our news coverage solutions, please
visit www.financialnewsmedia.com for more details.
Get an edge on the market with our Premium News Alerts that are
FREE for a limited time at financialnewsmedia.com.
Follow us on
Facebook: facebook.com/financialnewsmedia and
Twitter: twitter.com/FNMgroup.
DISCLAIMER: FN Media Group LLC (FNMG) is a third party
publisher and news dissemination service provider, which
disseminates electronic information through multiple online media
channels. FNMG is NOT affiliated in any manner with any
company mentioned herein. FNMG and its affiliated companies
are a news dissemination solutions provider and are NOT a
registered broker/dealer/analyst/adviser, holds no investment
licenses and may NOT sell, offer to sell or offer to buy any
security. FNMG's market updates, news alerts and corporate
profiles are NOT a solicitation or recommendation to buy, sell or
hold securities. The material in this release is intended to
be strictly informational and is NEVER to be construed or
interpreted as research material. All readers are strongly
urged to perform research and due diligence on their own and
consult a licensed financial professional before considering any
level of investing in stocks. All material included herein is
republished content and details which were previously disseminated
by the companies mentioned in this release. FNMG is not
liable for any investment decisions by its readers or
subscribers. Investors are cautioned that they may lose all
or a portion of their investment when investing in stocks.
For current services performed FNMG has been compensated one
thousand nine hundred dollars for news coverage of the current
press release issued by Amarantus BioScience Holdings, Inc. by the
company FNMG HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS
RELEASE.
This release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E the Securities Exchange Act of 1934, as amended and
such forward-looking statements are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. "Forward-looking statements" describe future expectations,
plans, results, or strategies and are generally preceded by words
such as "may", "future", "plan" or "planned", "will" or "should",
"expected," "anticipates", "draft", "eventually" or "projected".
You are cautioned that such statements are subject to a multitude
of risks and uncertainties that could cause future circumstances,
events, or results to differ materially from those projected in the
forward-looking statements, including the risks that actual results
may differ materially from those projected in the forward-looking
statements as a result of various factors, and other risks
identified in a company's annual report on Form 10-K or 10-KSB and
other filings made by such company with the Securities and Exchange
Commission. You should consider these factors in evaluating the
forward-looking statements included herein, and not place undue
reliance on such statements. The forward-looking statements in this
release are made as of the date hereof and FNMG undertakes no
obligation to update such statements.
Contact Information:
Company: FN Media Group, LLC
Contact email: editor@financialnewsmedia.com
U.S. Phone: (954)345-0611
URL: www.financialnewsmedia.com
Source: FN Media Group