RECORDATI AND RICHTER SIGNED A LICENSE AGREEMENT FOR MARKETING CARIPRAZINE IN WESTERN EUROPE
(Thomson Reuters ONE) -
Milan, Italy - Budapest, Hungary, 2 August 2016 - Recordati and Gedeon Richter
today announced the signing of an exclusive license agreement to commercialize
cariprazine, a novel atypical antipsychotic in Western Europe and in Algeria, in
Tunisia and in Turkey.
Cariprazine was discovered by Richter scientists and is licensed to Allergan
(earlier Forest / Actavis), in the U.S. and Canada. Following its FDA approval
in September 2015, the product was launched in the USA in March 2016 under the
trademark of VRAYLAR(TM) for the treatment of both bipolar mania and
schizophrenia. The European Medicines Agency (EMA) started the evaluation of
Richter's marketing authorisation application for cariprazine for the treatment
of schizophrenia in March 2016.
Under the terms of the agreement Recordati shall make an upfront payment upon
signature of the contract, and further milestone payments shall be made
depending on the progress of both the regulatory procedure and the
commercialization of the product. In addition, further sales related royalties
will become payable to Richter following the launch of the product.
In line with the agreement Richter shall be responsible for conducting Pediatric
Clinical Studies according to the Pediatric Investigation Plan, as required by
the European Medicines Agency's PDCO (Paediatric Committee) and it shall be co-
financed with Recordati.
"We are pleased having Recordati as our marketing partner in Western-Europe,
given our long standing relationship and their approach of successfully managing
the company for many decades. Their experience and well established
international sales network are reflected in a proven track record of
introducing successfully new products on the markets. This partnership is
aligned with Richter's strategy to bring cariprazine to the market for the
millions of people living with schizophrenia and who are seeking an effective
new treatment option", stated Erik Bogsch, Managing Director of Gedeon Richter
Plc.
"We are very pleased with the addition of this innovative treatment for
schizophrenia to our corporate pipeline", stated Giovanni Recordati, Chairman
and CEO. "The central nervous system therapeutic sector represents a further
area of growth for the group. We believe that the overall high quality of our
sales organization together with specific experience matured in some countries
in the area of mental health will enable us to create the necessary awareness in
our territories for the adoption of this important new treatment for
schizophrenia, a serious invalidating mental condition."
About Schizophrenia
Schizophrenia is a chronic and disabling disorder that has a worldwide
prevalence approaching 1%. It imposes significant burden on patients, their
families, and society. Symptoms fall into three broad categories: positive
symptoms (hallucinations, delusions, thought disorders, and movement disorders),
negative symptoms (such as loss of motivation and social withdrawal), and
cognitive symptoms (problems with executive functioning, focusing, and working
memory).
About cariprazine
Cariprazine is an orally active and potent dopamine D(3)/D(2) receptor partial
agonist with preferential binding to D(3) receptors and partial agonist at
serotonin 5-HT(1A) receptors. Cariprazine was discovered by Richter, having been
developed for the treatment of bipolar mania and schizophrenia jointly by
Allergan (earlier Forest / Actavis) and Richter and was approved by FDA in both
indications in 2015. Currently it is under development by Richter in the EU for
the treatment of schizophrenia and for the treatment of schizophrenia with
predominant negative symptoms while ongoing clinical developments of cariprazine
are being managed by Allergan (earlier Forest / Actavis) and Richter for bipolar
depression (BD) and as adjunctive therapy for major depressive disorder (MDD) in
the US. Additionally, Mitsubishi-Tanabe Pharma Corporation (MTPC) is developing
cariprazine for the treatment of schizophrenia in Japan and in other Asian
countries.
Gedeon Richter Plc. (www.richter.hu), headquartered in Budapest/Hungary, is a
major pharmaceutical company in Central Eastern Europe, with an expanding direct
presence in Western Europe. Having reached a market capitalisation of EUR 3.3
billion (US$ 3.6 billion) by the end of 2015, Richter's consolidated sales were
approximately EUR 1.2 billion (US$ 1.3 billion) during the same year. The
product portfolio of Richter covers many important therapeutic areas, including
gynaecology, central nervous system, and cardiovascular areas. Having the
largest R&D unit in Central Eastern Europe, Richter's original research activity
focuses on CNS disorders. With its widely acknowledged steroid chemistry
expertise, Richter is a significant player in the female healthcare field
worldwide. Richter is also active in biosimilar product development.
For further information:
RICHTER:
Investors: Katalin Ördög: +36 1 431 5680
Media: Zsuzsa Beke: +36 1 431 4888
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 around 4,000, dedicated to the research,
development, manufacturing and marketing of pharmaceuticals. Headquartered in
Milan, Italy, Recordati has operations in the main European countries, in
Russia, in other Central and Eastern European countries, in Turkey, in North
Africa and in the United States of America. 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 within the
urogenital therapeutic area and of treatments for rare diseases. Consolidated
revenue for 2015 was ? 1,047.7 million, operating income was ? 278.5 million and
net income was ? 198.8 million.
For further information:
Recordati website: www.recordati.com
Investor Relations Media
Relations
Marianne Tatschke
Studio Noris Morano
(39)0248787393
(39)0276004736, (39)0276004745
e-mail: inver(at)recordati.it e-mail:
norismorano(at)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.
Cariprazine license joint release:
http://hugin.info/143644/R/2032462/756602.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: RECORDATI via GlobeNewswire
[HUG#2032462]
Unternehmensinformation / Kurzprofil:
Datum: 02.08.2016 - 08:09 Uhr
Sprache: Deutsch
News-ID 486672
Anzahl Zeichen: 9184
contact information:
Town:
MILANO
Kategorie:
Business News
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