NEW YORK, July 21, 2020 /PRNewswire/ -- Seelos
Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage
biopharmaceutical company focused on the development of therapies
for central nervous system disorders and rare diseases, today
announced it has received a positive opinion on European Orphan
Drug Designation for SLS-005 in Sanfilippo syndrome from the
European Medicines Agency (EMA) Committee for Orphan Medicinal
Products (COMP).
The positive opinion issued by COMP will be sent to
the European Commission, which is expected to grant the
orphan designation within 30 days. Under orphan designation in the
European Union (EU), Seelos stands to benefit from several
incentives such as protocol assistance, reduced regulatory fees and
market exclusivity. European guidelines for Orphan Drug Designation
are for diseases affecting not more than five in 10,000 people in
the EU.
In April, SLS-005 was granted Orphan Drug Designation from the
U.S. Food and Drug Administration (FDA) for Sanfilippo syndrome.
SLS-005 was previously granted Orphan Drug Designation from the FDA
and EMA for Spinocerebellar Ataxia Type 3 (SCA3) and
Oculopharyngeal Muscular Dystrophy (OPMD). SLS-005 has also been
granted Fast Track designation from the FDA for OPMD.
Forward Looking Statements
Statements made in this press release, which are not
historical in nature, constitute forward-looking statements for
purposes of the safe harbor provided by the Private Securities
Litigation Reform Act of 1995. These statements include, among
others, those regarding the receipt of Orphan Drug Designation for
the EU for SLS-005 in Sanfilippo syndrome from the European
Commission, the expected timing for receiving Orphan Drug
Designation from the European Commission and the expected
incentives associated with receiving Orphan Drug Designation for
SLS-005. These statements are based on Seelos' current expectations
and beliefs and are subject to a number of factors and
uncertainties that could cause actual results to differ materially
from those described in the forward-looking statements. Risks
associated with Seelos' business include, but are not limited to,
the risk that the European Commission does not grant Orphan Drug
Designation for the EU for SLS-005 in Sanfilippo syndrome, the risk
of not successfully executing its preclinical and clinical studies
and not gaining marketing approvals for its product candidates, the
risks associated with the implementation of a new business
strategy, the risks related to raising capital to fund its
development plans and ongoing operations, risks related to Seelos'
current stock price, risks related to the global impact of
COVID-19, as well as other factors expressed in Seelos' periodic
filings with the U.S. Securities and Exchange Commission, including
its Annual Report on Form 10-K and Quarterly Reports on Form
10-Q. Although we believe that the expectations reflected in
our forward-looking statements are reasonable, we do not know
whether our expectations will prove correct. You are cautioned not
to place undue reliance on these forward-looking statements, which
speak only as of the date hereof, even if subsequently made
available by us on our website or otherwise. We do not undertake
any obligation to update, amend or clarify these forward-looking
statements, whether as a result of new information, future events
or otherwise, except as may be required under applicable securities
laws.
Contact Information:
Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
View original
content:http://www.prnewswire.com/news-releases/seelos-therapeutics-receives-positive-ema-opinion-on-orphan-drug-designation-for-sls-005-trehalose-in-sanfilippo-syndrome-301096451.html
SOURCE Seelos Therapeutics, Inc.