RECORDATI: MARKET AUTHORIZATION APPLICATION FOR ARS-1 (EPINEPHRINE NASAL SPRAY) ACCEPTED BY EUROPEAN MEDICINES AGENCY
30 11월 2020 - 10:00PM
RECORDATI: MARKET AUTHORIZATION
APPLICATION FOR ARS-1 (EPINEPHRINE NASAL SPRAY) ACCEPTED BY
EUROPEAN MEDICINES AGENCY
Milan, 30 November 2020 – Recordati announces
that the European Medicines Agency (EMA) has accepted a Marketing
Authorization Application (MAA) submission by ARS Pharmaceuticals
for review of ARS-1 (known as NeffyTM in the USA), an epinephrine
nasal spray for the emergency treatment of severe allergic
reactions, including anaphylaxis. On 21 September 2020 Recordati
announced the signing of an exclusive license agreement with ARS
Pharmaceuticals, a private U.S. company, for the commercialization
of ARS-1 in 93 countries including those in the European Union.
The MAA submitted to EMA includes data from
multiple clinical studies showing that 1 mg of ARS-1 achieves
epinephrine exposures that are similar to a 0.3 mg epinephrine IM
injection, with rapid absorption (time to peak plasma levels) and
clinical response based on surrogate endpoints. Because of its
innovative delivery method, ARS-1 has the potential to be as
effective as injections in the treatment of severe allergic
reactions in a more convenient and less intimidating delivery
device. Its needle-free, small and easy-to-use delivery
system may help eliminate anxiety and overcome hesitation that is
common with injectable epinephrine.
In Europe, based on epidemiology data, about 4%
of the general population has experienced an anaphylactic episode.
Overall annual net sales of epinephrine auto-injectors in Europe
are around € 100 million based on IQVIA prescription data,
representing less than 10% of the eligible population. According to
the European Anaphylaxis Registry, less than 15% of anaphylaxis
episodes are self-treated with an auto-injector. The introduction
of ARS-1 in Europe would be a welcome new tool for more patients
with severe allergies to administer lifesaving epinephrine safely,
quickly and painlessly.
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.
Recordati (BIT:REC)
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