Orion comments on ANDA filed by Mylan Pharmaceuticals Inc. for a generic version of Orion's proprietary drug Stalevo® (carbidopa/levodopa/entacapone) in the United States
Company states generic competition is not imminent based on this application.
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 generic tablets (strengths 12,5/50/200 mg; 18,75/75/200 mg; 25/100/200 mg; 31,25/125/200 mg; 37,5/150/200 mg and 50/200/200 mg) in the United States, with carbidopa, levodopa and entacapone as active ingredients in the same proportion as in Orion's Stalevo®. The product is an enhanced levodopa treatment originated by Orion Corporation and marketed in the United States by its exclusive licensee, Novartis, for the treatment of Parkinson's disease.
At this point, the ANDA review process of Mylan is just beginning in the United States and generic competition is not imminent based on this application.
Mylan has filed the so-called Paragraph IV certifications challenging Orion U.S. patents No. 5,446,194 No. 6,500,867 and No. 6,797,732 covering Orion's product Stalevo® 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 currently evaluating together with Novartis 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 President and CEO | Olli Huotari SVP, 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 a globally operating Finnish company developing pharmaceuticals and diagnostic tests - a builder of well-being. Orion develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients and diagnostic tests. The company is continuously developing new drugs and treatment methods. Pharmaceutical R&D focuses on central nervous system drugs, oncology and critical care drugs, and Easyhaler® pulmonary drugs.
Orion's net sales in 2011 amounted to EUR 918 million and the company had about 3,400 employees. Orion's A and B shares are listed on NASDAQ OMX Helsinki.