RECORDATI LICENSES AN INNOVATIVE EPINEPHRINE NASAL SPRAY IN DEVELOPMENT FOR ANAPHYLAXIS PREVENTION
September 21 2020 - 2:27PM
RECORDATI LICENSES AN INNOVATIVE EPINEPHRINE NASAL SPRAY IN
DEVELOPMENT FOR ANAPHYLAXIS PREVENTION
RECORDATI LICENSES AN INNOVATIVE
EPINEPHRINE NASAL SPRAY IN DEVELOPMENT FOR ANAPHYLAXIS
PREVENTION
Milan, 21 September, 2020 - Recordati announces
the signing of an exclusive license agreement with ARS
Pharmaceuticals, a private U.S. company, for the commercialization
in the European Union, Iceland, Liechtenstein, Norway, Switzerland,
United Kingdom, Russia/CIS, Turkey, Middle East and French-speaking
African countries, of ARS-1, an epinephrine nasal spray in
late-stage development for the emergency treatment of severe
allergic reactions that can lead to anaphylaxis. Under the terms of
the agreement an upfront payment is due by Recordati upon signature
of the contract and further milestone payments are linked to the
regulatory process and commercial performance.
Anaphylaxis is a severe, generalized allergic
reaction, characterized by life-threatening breathing or
cardiovascular problems and usually associated with skin and
mucosal changes. The trigger is exogenous and can be associated
with food, insect bites or other allergenic substances. ARS-1 is a
liquid formulation of epinephrine associated with Intravail®, an
absorption enhancer, contained in a disposable, mono-dose nasal
spray device. This innovative formulation represents a new route of
administration compared to existing products, increasing patient
compliance and fulfilling an unmet medical need. Easy-to-use and
needle-free, this solution may eliminate the anxiety and hesitation
associated with using an injection device. With use at the first
signs of allergic response, it could provide patients and their
families the preventive solution to anaphylactic progression.
The marketing authorization application for the
1 mg dose of the product is expected to be filed in the EU by the
end of 2020. Furthermore, a dosage strength of 0.65 mg is under
development for pediatric patients.
“We are very pleased that ARS Pharmaceuticals
has granted Recordati the exclusive license to market its
innovative product for the prevention of severe allergic reactions
in Europe, Russia, the Middle East and other countries”, stated
Andrea Recordati CEO. “This effective innovative formulation of a
product for the prevention of life-threatening allergic reactions
reinforces our Specialty and Primary care pipeline and provides
further diversification to our portfolio in an area where medical
needs are not fully satisfied.”
Recordati, established in 1926,
is an international pharmaceutical group, listed on the Italian
Stock Exchange (Reuters RECI.MI, Bloomberg REC IM, ISIN IT
0003828271), with a total staff of more than 4,300, dedicated to
the research, development, manufacturing and marketing of
pharmaceuticals. Headquartered in Milan, Italy, Recordati has
operations throughout the whole of Europe, including Russia,
Turkey, North Africa, the United States of America, Canada, Mexico,
some South American countries, Japan and Australia. An
efficient field force of medical representatives promotes a wide
range of innovative pharmaceuticals, both proprietary and under
license, in a number of therapeutic areas including a specialized
business dedicated to treatments for rare diseases. Recordati is a
partner of choice for new product licenses for its territories.
Recordati is committed to the research and development of new
specialties with a focus on treatments for rare diseases.
Consolidated revenue for 2019 was € 1,481.8 million, operating
income was € 465.3 million and net income was € 368.9 million.
For further information:
Recordati website: www.recordati.com
Investor Relations
Media
Relations
Marianne
Tatschke
Studio Noris
Morano
(39)0248787393
(39)0276004736, (39)0276004745e-mail: investorelations@recordati.it
e-mail:
norismorano@studionorismorano.com
Statements contained in this release, other than
historical facts, are "forward-looking statements" (as such term is
defined in the Private Securities Litigation Reform Act of 1995).
These statements are based on currently available information, on
current best estimates, and on assumptions believed to be
reasonable. This information, these estimates and assumptions may
prove to be incomplete or erroneous, and involve numerous risks and
uncertainties, beyond the Company’s control. Hence, actual results
may differ materially from those expressed or implied by such
forward-looking statements. All mentions and descriptions of
Recordati products are intended solely as information on the
general nature of the company’s activities and are not intended to
indicate the advisability of administering any product in any
particular instance.
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