Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Comtan® (entacapone) in the United States
(Thomson Reuters ONE) -
ORION CORPORATION STOCK EXCHANGE RELEASE 15 December 2010 AT 4.25 PM
EET
Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version
of Orion's proprietary drug Comtan(®) (entacapone) in the United States
Company states generic competition is not imminent
Orion Corporation has been informed that an Abbreviated New Drug Application
(ANDA) has been filed by Mylan Pharmaceuticals Inc. (Mylan) with the U.S. Food
and Drug Administration (FDA) seeking authorisation to produce and market a
generic version of entacapone (200 mg tablets) in the United States. Entacapone
is the active ingredient in Comtan(®), a product originated by Orion Corporation
and marketed in the United States by its exclusive licensee, Novartis, for the
treatment of Parkinson's disease as an adjunct to levodopa/carbidopa therapy. At
this point, the ANDA review process is just beginning and generic competition is
not imminent.
Mylan has filed so-called Paragraph IV certifications challenging Orion U.S.
patent No. 5,446,194 and U.S. Patent No. 6,599,530 covering Comtan and listed in
the Orange Book, the FDA's official listing of approved drug products.
Paragraph IV certifications are not uncommon in the U.S. Orion is, together
with Novartis, currently evaluating its legal options to protect its rights.
Under the U.S. system, if a patent owner brings a lawsuit against an ANDA
applicant within a certain time limit, there will be a 30-month stay of final
FDA approval. During that time, the FDA can give only a tentative approval to
the ANDA applicant unless the applicant obtains a favorable decision on all
challenged patents in the lawsuit.
Orion Corporation
Timo Lappalainen Olli Huotari
President and CEO Senior VP, Corporate Functions
Contact person:
Olli Huotari, Senior VP, Corporate Functions, phone +358 10 426 3054, gsm
+358 50 966 3054
Publisher:
Orion Corporation
Communications
Orionintie 1A, FI-02200 Espoo
www.orion.fi
Orion is an innovative European R&D-based pharmaceutical and diagnostic company
with a special emphasis on developing medicinal treatments and diagnostic tests
for global markets. Orion develops, manufactures and markets human and
veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic
tests. Orion's pharmaceutical R&D focuses on the following core therapy areas:
central nervous system drugs, cancer and critical care drugs, and Easyhaler(®)
pulmonary drugs.
The Group's net sales in 2009 amounted to EUR 772 million. The Company invested
EUR 95 million in research and development. At the end of 2009, the Group had a
total of 3,100 employees, of whom 2,500 worked in Finland and 600 in other
European countries. Orion's A and B shares are listed on NASDAQ OMX Helsinki.
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters 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: Orion Oyj via Thomson Reuters ONE
[HUG#1472896]
Unternehmensinformation / Kurzprofil:
Datum: 15.12.2010 - 15:25 Uhr
Sprache: Deutsch
News-ID 49751
Anzahl Zeichen: 3736
contact information:
Town:
Espoo
Kategorie:
Business News
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