Orion Corporation and Pharmacia Corporation today announced the signing of an agreement under which the two companies will collaborate in the development and commercialization of Orion Pharma's investigational new drug deramciclane in the United States. Deramciclane belongs to a class of anti-anxiety medicines known as 5-HT2 receptor antagonists. It is currently being investigated for generalized anxiety disorder (GAD) in Phase 3 clinical studies in Europe.
Under the terms of the agreement, Orion Pharma and Pharmacia will conduct the Phase 3 clinical studies of deramciclane in the U.S. The clinical development program will be funded by Orion Pharma and planned and supervised jointly by the two companies. Pharmacia's clinical development organization will manage the Phase 3 trials.
Pharmacia will distribute and market deramciclane in the U.S. upon regulatory approval of the product. Orion Pharma will have an option to co-promote the product in the U.S. The agreement further provides Pharmacia with the rights to develop and market deramciclane in countries outside the U.S. and Europe including Japan.
The European studies and registrations are the sole responsibility of Orion Pharma and are not in the scope of the agreement between Orion Pharma and Pharmacia. Orion Pharma's marketing area encompasses the EU and Norway, Iceland and Switzerland. Eastern Europe including Russia and the Commonwealth of Independent States (CIS) are territories of Egis Pharmaceuticals.
Orion will receive an up-front payment of $30 million from Pharmacia upon signing of the agreement and additional milestone payments throughout the clinical development program.
"This agreement with Pharmacia is an important step in our strategy to develop and commercialize deramciclane on a global basis," said Jyrki Mattila, President of Orion Pharma. "Through this partnership, we look forward to working with Pharmacia's experienced clinical development team to execute the Phase 3 clinical trials in the U.S. We also look forward to Pharmacia's involvement in generating awareness of deramciclane and launching the product in the U.S. where the company has a strong market presence."
Mattila added: "The fact that the agreement allows Orion Pharma to co-promote the product in the U.S. is a significant milestone in our company's development and our strategy to establish a presence in the U.S. market."
"We are very pleased to be entering this partnership with Orion Pharma to develop deramciclane for the U.S. market," said Fred Hassan, Pharmacia Chairman and Chief Executive Officer. "Anxiety disorders represent an area of significant unmet medical need and this agreement gives us an opportunity to leverage our company's extensive background in developing new treatments for anxiety and other central nervous system (CNS) disorders."
Orion Pharma licensed deramciclane from Egis Pharmaceuticals, a Hungarian company that discovered the molecule and was involved in the preclinical development of the product. Orion Pharma conducted Phase 1 and Phase 2 studies and has initiated Phase 3 studies in Europe to evaluate deramciclane in the treatment of generalized anxiety disorder (GAD). The Phase 3 program was initiated during 2000 and is currently underway in nine European countries and in South Africa. The program will continue through 2003.
Deramciclane exhibits a novel mechanism of action making it the first molecule in its class to enter Phase 3 clinical trials. It antagonizes human 5-HT type 2A and 2C receptors and has been shown to exert anxiolytic properties in various preclinical models.
GAD - increased awareness of an unmet medical need
Anxiety disorders are the most frequent psychiatric illnesses seen in clinical practice in the western world. A person suffering from anxiety may express disturbing alterations in mood, behavior, thinking and physiological activities. There are no specific triggers or recognizable reasons for anxiety. In clinical medicine anxiety disorders are classified under several forms. Generalized anxiety disorder (GAD), panic disorder, agoraphobia, post-traumatic stress disorder, social phobia, obsessive-compulsive disorder and certain specific fears are among the most common and best known anxiety disorders. The prevalence of all anxiety disorders among adults has been estimated to exceed 16%, whereas the lifetime prevalence of GAD is estimated to be 5%.
Reasons behind anxiety disorders are not fully understood. It is known that both genetic and environmental as well as life experiences may render people susceptible to anxiety disorders, however, a single factor seldom explains why a person is affected by the disease. There is significant comorbidity associated with anxiety disorders, i.e. people with anxiety often suffer from another psychiatric illness such as depression or attention deficit hyperactivity disorder. It is very common that patients who suffer from anxiety disorders also manifest various somatic symptoms such as headache, insomnia, irritable bowel syndrome, chest pain or heart palpitations.
Treatment of anxiety
Researchers have estimated that less than 20% of the patients suffering from GAD receive proper treatment. Usually the treatment of anxiety consists of medication, psychotherapy or a combination of both. Very few breakthrough drugs have been introduced in this indication during the recent years. The most commonly used medicines to treat anxiety include selective serotonin reuptake inhibitors (SSRI), benzodiazepines, serotonin and norepinephrine reuptake inhibitors (SNRI) and tricyclic antidepressants.
Making the necessary antitrust filings to the United States Federal Trade Commission and expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, have been set forth in the agreement as conditions to closing of this transaction.
Dr. Kari Varkila
Senior Vice President, Communications and Medical Information
Phone +358-10-429 3325
Group Director, External Communications
+1 908 901 8770
Vice President, Investor Relations
Orion Pharma, a research-oriented pharmaceuticals division, is the core of the Orion Corporation, Finland's leading company for pharmaceuticals and related products. With 2000 net sales of MEUR 453 Orion Pharma accounts for almost one half of the Orion Corporation net sales and for two thirds of the Group operating profit. Over one half of Orion Pharma's total net sales comes from international operations. Orion Pharma is the leader in the pharmaceutical market in Finland. Orion Pharma has subsidiaries in nine European countries. During the recent years it has launched several new drugs based on its own research on its core therapy areas: central nervous system (CNS), hormone therapy, cardiology and critical care and respiratory diseases. R&D expenditure was 14.6% of the 2000 pharmaceutical net sales. Original proprietary drugs account for an increasing share of Orion Pharma's sales. The CNS portfolio was recently supplemented by Comtess (entacapone), also available as Comtan, which is Orion Pharma's own NCE for Parkinson's Disease, now registered and launched in more than 38 countries including the EU and the U.S. In cardiology field Orion Pharma recently obtained approval in several countries for Simdax (levosimendan), which is a unique life saving hospital drug for the treatment of acute heart failure.
Pharmacia Corporation (NYSE:PHA) is a top-tier global pharmaceutical company with a leading agricultural subsidiary. Pharmacia's innovative medicines and other products save lives and enhance health and wellness. Pharmacia's 59,000 people work together with many diverse stakeholders to bring these benefits to people around the world, and to create new health solutions for the future.
Distribution of this news release:
Helsinki Stock Exchange
Orionintie 1, 02200 Espoo
Corporate communications and investor relations:
Anne Allo, Corporate VP, Communications ad IR
Phone +358 10 429 3735
Fax +358 10 429 2801