RECORDATI ANNOUNCES MARKETING APPROVAL FOR CYSTADROPS®
(Thomson Reuters ONE) -
Milan, 27 January 2017 - Recordati announces that the European Union Commission
has granted the European marketing authorization for its orphan medicinal
product Cystadrops® 3.8mg/mL. Cystadrops® is the first eye-drop solution
containing cysteamine hydrochloride approved in the European Union for "the
treatment of corneal cystine crystal deposits in adults and children from 2
years of age with cystinosis". The European Commission granted Cystadrops®
orphan drug designation in November 2008.
Cystinosis is a rare congenital lysosomal storage disorder recognized as a
severe life threatening condition. Cystinosis is characterized by an
accumulation of cystine crystals which negatively affects all organs in the
body, especially the kidneys and eyes. The cystine crystal deposits start in the
cornea, leading progressively to increased sensitivity to light (photophobia),
corneal surface deterioration (keratopathy) and loss of vision. Cystinosis
benefits from systemic treatment with cysteamine orally administered. However,
oral cysteamine does not adequately address ocular cystinosis because of the
non-vascularization of cornea. Without a proper, continued, local eye treatment,
cystine crystals accumulate in the cornea, leading to severe ophthalmic
consequences and possibly to blindness in the long term.
Cystadrops® eye-drop solution has been developed specifically for cystinosis
patients by Orphan Europe (Recordati Group). Cystadrops® is available as a 3.8
mg/mL eye-drop solution. The active substance of Cystadrops® is cysteamine, a
cystine-depleting agent. The benefit of Cystadrops® is its ability to reduce
corneal cystine crystal accumulation.
Cystadrops® is the first pharmaceutical product to be approved in the European
Union for this indication.
The formulation of Cystadrops® allows four instillations per day which should
considerably favour patient's compliance with the treatment and decrease
ophthalmic complications for all patients suffering from cystinosis.
"We are extremely pleased that the European Commission has granted the marketing
approval for Cystadrops®, an important therapeutic solution for the ophthalmic
complications affecting cystinosis patients" declared Andrea Recordati, Vice
Chairman and Chief Executive Officer. "The product had already been made
available to patients through early access programs in Europe and in some other
countries and therefore many patients affected by the ocular manifestations of
cystinosis have already been able to benefit from treatment with Cystadrops®."
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, in the United States of America and in some Latin American countries.
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.
Approval Cystadrops:
http://hugin.info/143644/R/2073985/779664.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: RECORDATI via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 27.01.2017 - 11:59 Uhr
Sprache: Deutsch
News-ID 520381
Anzahl Zeichen: 6239
contact information:
Town:
MILANO
Kategorie:
Business News
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