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Actelion Ltd and Nippon Shinyaku announced today that the two companies have signed a license agreement on a novel orally available PGI2 receptor agonist NS-304 originally discovered and synthesized by Nippon Shinyaku for the treatment of pulmonary arterial hypertension (PAH)
ALLSCHWIL/BASEL, SWITZERLAND and KYOTO | April 21, 2008 | Actelion Ltd (SWX: ATLN) and Nippon Shinyaku (TYO: 4516) announced today that the two companies have signed a license agreement on a novel orally available PGI2 receptor agonist NS-304 originally discovered and synthesized by Nippon Shinyaku for the treatment of pulmonary arterial hypertension (PAH), based on the previous binding letter of intent.
The agreement was signed in a formal ceremony at Nippon Shinyaku Headquarters in Kyoto by Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion and Shigenobu Maekawa, President of Nippon Shinyaku. Also present at the ceremony was Satoshi Tanaka, Dr. med. Sci., President and Representative Director of Actelion Pharmaceuticals Japan Ltd.
Under the terms of this license agreement, Nippon Shinyaku will receive from Actelion an upfront payment and additional milestone payments based on development stage and sales achievement. Nippon Shinyaku will also receive royalties on sales. In addition, this agreement enables Nippon Shinyaku to explore the possibility of co-development in Japan of a compound which is being developed by Actelion globally.
In order to promptly bring NS-304 to the market of PAH and other possible indications, Actelion will take over the phase IIa clinical study being conducted by Nippon Shinyaku in Europe and be responsible for global development and commercialization of NS-304 outside Japan. The two companies will co-develop and co-commercialize NS-304 in Japan.
NS-304, originally discovered and synthesized by Nippon Shinyaku, is an orally available long acting prostaglandin I2 receptor agonist), which stimulates PGI2 receptor in blood vessels and exerts vasodilating effects. NS-304 has major potential as a novel treatment of PAH. Nippon Shinyaku has recently completed phase I evaluation in the United Kingdom. A phase II program in PAH patients was initiated in Europe at the end of 2007.
Notes to the editor:
About Pulmonary Arterial Hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected individual. The function of the heart and lungs is severely compromised, manifested by a limited exercise capacity, and, ultimately, a reduced life expectancy. Approximately 100,000 people in Europe and the United States are afflicted with either primary or secondary forms of the disease related to conditions or tissue disorders that affect the lungs, such as scleroderma, lupus, HIV/AIDS or congenital heart disease.
PAH is associated with structural changes in both the pulmonary vasculature and the right ventricle. Recent advances [1] in the understanding of the pathogenic factors leading to the pulmonary vascular disease have led to the development of new therapies targeting specific pathways (the prostacyclin pathway; the endothelin pathway; and the nitric oxide pathway) [2]. The available therapies have positive effects in PAH, but they do not provide a cure, and in many patients the disease will progress. PAH remains a serious life-threatening condition [2,3]. Early recognition and an understanding of the selection and timing of therapeutic options remain critical elements in the optimal management of patients with this disorder.
About Tracleer(R) in Pulmonary Arterial Hypertension (PAH)
Tracleer(R) (bosentan), the first oral dual endothelin receptor antagonist, is approved for the treatment of pulmonary arterial hypertension (PAH) and made available by Actelion subsidiaries in the United States, the European Union, Japan, Australia, Canada, Switzerland and other markets worldwide.
Requires attention to two significant safety concerns: Potential for serious liver injury (including rare cases of liver failure and unexplained hepatic cirrhosis in a setting of close monitoring) - Liver monitoring of all patients is essential prior to initiation of treatment and monthly thereafter. Tracleer(R) treatment must not be initiated in women of childbearing potential unless they practice reliable contraception and participate in monthly pregnancy testing. Due to these risks, Tracleer(R) is only supplied through a controlled distribution.
References
1. Farber HW; Loscalzo J. Mechanisms of disease: pulmonary arterial hypertension. N. Eng. J. Med. 2004; 351: 1655-65.
2. Humbert M; Sitbon O; Simonneau G. Treatment of pulmonary arterial hypertension. N. Eng. J. Med. 2004; 351: 1425-36.
3. Humbert M; Morrell NW; Archer SL; et al. Cellular and molecular pathobiology of pulmonary arterial hypertension. J. Am. Coll. Cardiol. 2004; 43: Suppl. 12: 13S-24S.
4. Tracleer(R) SPC.
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(R), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(R) through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).
SOURCE: Actelion Ltd. and Nippon Shinyaku |
