ESPOO, FINLAND and RESEARCH TRIANGLE PARK, N.C. - April 15, 2002 - Orion Corporation (Hex: ORIBS) and Quintiles Transnational Corp. (Nasdaq: QTRN) today announced the signing of a letter of intent to form a drug development venture to develop a portfolio of selected proprietary products currently in Phases I through III from Orion Pharma, the pharmaceutical division of Orion Corporation. Orion and Quintiles will have a non-controlling minority interest in the new company, and plan to offer a majority ownership to outside investors.
Orion and Quintiles have selected a portfolio of drug candidate projects from the R&D project portfolio of Orion Pharma and now will seek additional capital investment in the new venture to structure the company financially.
The new company will operate on an independent basis, but Orion and Quintiles will put development resources into it. The new company will be based in the United States and is targeted to be operational by the third quarter of 2002. Jyrki Mattila, M.D., Senior Vice President, Orion New Ventures, has been assigned to head the team in charge of preparation for the venture.
It is anticipated that Orion Pharma will initially contribute up to five drug candidates from its research and development (R&D) portfolio to be licensed to the new company. After additional funding from investors has been secured, the new company may license additional projects from Orion Pharma or other third parties. Orion intends to retain options for future marketing rights for certain products for specified ex-USA territories.
Drug development projects from the Orion Pharma product portfolio planned to be offered to the new company include oral formulation of levosimendan for chronic heart failure; MPV-2426 (fadolmidine) for spinal analgesia; OR-1384 (orazipone) for asthma/chronic obstructive pulmonary disease and inflammatory bowel disease. Other projects now being offered to the new company will be disclosed later.
"We are pleased to partner with Quintiles in this exciting new company. Quintiles is globally recognized for its expertise and high quality work in drug development. Combining this expertise with Orion Pharma's unique product innovations and skills creates a competitive advantage," said Jukka Viinanen, President and Chief Executive Officer of Orion Corporation. "Orion Pharma is well known among medium size European pharmaceutical companies for its ability to create novel medicines. Many Orion Pharma innovative products are on the market; others are currently in large Phase 3 trials. Significant resource needs of these Phase 3 trials have created a roadblock preventing newer projects in the development pipeline to optimally move on. Utilizing the new venture with Quintiles, we intend to leapfrog this roadblock."
Dennis Gillings, Ph.D, Chairman, Quintiles Transnational said, "Through this agreement, Quintiles and Orion have combined the efficiencies of a virtual organization with the synergies of two great companies. With our expertise and global resources, Quintiles will deliver a wide range of development services to support an impressive product portfolio from Orion. This venture represents an important phase in the evolution of pharmaceutical product development."
Orion Pharma, a research-oriented pharmaceuticals division, is the core of the Orion Corporation, Finland's leading company for pharmaceuticals and related products. With 2001 net sales of EUR 487 million (US$428 million), Orion Pharma accounts for 50 percent of the Orion Corporation net sales and for 71 percent of the Group operating profit. Sixty percent of Orion Pharma's total net sales come from international operations. Orion Pharma is, however, also the leader in the pharmaceutical market in Finland. In Europe it has subsidiaries in nine countries. During the recent years it has launched several new products 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 16 percent of the 2001 pharmaceutical net sales. Original proprietary products account for an increasing share of Orion Pharma's sales. The best selling product in Orion's portfolio is Comtess (entacapone), also available as Comtan, which is Orion Pharma's own invention for Parkinson's disease, now registered and launched in more than 40 countries including the EU and the U.S. In the cardiology field Orion Pharma recently obtained approval in several countries for Simdax (levosimendan) infusion, which is a unique life saving hospital product for the treatment of acute heart failure. Two new products Indivina and Diviseq for hormone replacement therapy have recently been approved in many European countries and are currently being launched. For more information visit www.orion.fi.
Quintiles Transnational Corp.
Quintiles Transnational helps improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries. Headquartered near Research Triangle Park, North Carolina, Quintiles is a member of the S&P 500 and Fortune 1000. For more information visit the company's Web site at www.quintiles.com.
Dr. Kari Varkila, Senior Vice President, Communications, Orion Corporation Orion Pharma, phone +358 10 429 3325, mobile phone +358 50 429 3325
Additional information on products to be licensed to the new company by Orion Pharma
Additional information on products to be licensed
to the new company by Orion Pharma
Levosimendan increases the heart's pumping ability through a novel pharmacological mechanism called calcium sensitisation. The heart's pumping ability is enhanced when levosimendan, in the presence of calcium, binds to a protein called troponin C in the heart muscle. Binding of levosimendan to troponin C uncovers the heart muscle's contractile proteins and induces contraction. The drug also opens potassium channels in the vascular smooth muscle and in cardiac cells, thereby inducing vasodilatation and allowing more efficient blood circulation through the heart. The data from clinical studies and clinical experience indicate that levosimendan is less likely to induce arrhythmias or adverse changes in myocardial energy consumption than the conventional therapies.
Levosimendan infusion (Simdax®) has been approved in 15 countries for the treatment of acute heart failure in hospitalised patients. It is in Phase 3 clinical development in the US.
The oral formulation of levosimendan is being studied in Phase 2 clinical development for the treatment of chronic heart failure.
MPV 2426 (fadolmidine) is a novel spinal analgesic agent under development for the treatment of postoperative, obstetric and chronic pain. Pharmacologically it acts as an alpha-2 adrenergic agonist. Because of its unique pharmacological profile, fadolmidine provides a new treatment concept. It offers significant benefits over the current treatments allowing more optimal pain relief which in turn results in higher patient satisfaction and improved cost-effectiveness of overall treatment. Fadolmidine is analgesic when administered intrathecally or epidurally. It has shown potent anti-nociceptive effects in various animal models. Phase I and II studies indicate that at analgesic doses, fadolmidine is devoid of common adverse effects associated with opioids and local anaesthetics and it does not induce pronounced cardiovascular effects (bradycardia, hypotension) like other alpha-2 adrenergic agents. Further clinical Phase 2 studies with MPV 2426 are currently ongoing.
Orazipone is a locally acting immunomodulating agent that modulates thiol groups and inhibits inflammatory cell activation and decreases proinflammatory cytokine production. Experimental studies in animals have shown good anti-inflammatory efficacy indicating that orazipone would be a potent new drug for the treatment of asthma, chronic obstructive pulmonary disease and inflammatory bowel disease. Phase 1 clinical studies for both respiratory and for gastrointestinal dosage forms of orazipone have been completed.
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