Co-development for Actelion's Selective S1P1 Receptor
Agonist in Multiple Indications With Co-promotion and Profit
Share -- Actelion to Receive Upfront Payment of US$75 Million --
Additional Milestones of Up to US$555 Million for First
Compound -- Further Compounds Would Trigger Further Milestones --
Undisclosed Royalties to Actelion on All Product Sales
ALLSCHWIL, Switzerland and BASEL, Switzerland, July 17, 2006 (PRIMEZONE) -- Actelion Ltd.(Other OTC:ALIOF) (SWX:ATLN) and Roche (SWX:ROG) have announced today that they have entered into an exclusive worldwide collaboration to jointly develop and commercialize Actelion's selective S1P1 receptor agonist, an immunomodulator with the potential for once-a-day oral dosing. The compound is currently being developed in Phase I. The two companies plan to jointly develop and commercialize this novel compound for multiple autoimmune disorders.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "I am very proud about our collaboration with Roche, an excellent partner to develop and promote multiple indications in parallel. Together, we are well prepared to turn Actelion's scientific breakthrough in selective S1P1 receptor agonists into a treatment that has the potential to dramatically improve medical care for patients with autoimmune disorders."
"We are very pleased to partner with Actelion in this area where there are still a number of high unmet medical needs and only few treatment options are available," said Roche Chairman and CEO, Franz B. Humer. "This collaboration is a further step to strengthen our emerging autoimmune disease franchise."
About financial terms of the collaboration
The S1P1 collaboration covers both the current selective S1P1 receptor agonist in Phase I as well as any other selective S1P1 receptor agonists resulting from Actelion's research efforts in the field. Roche will pay Actelion an upfront payment of US$75 million in the second half of 2006. In the case of future development and approval milestones being achieved, Actelion will be eligible to receive payments of up to US$555 million for the first compound for all targeted indications. Further development and approval milestone payments are due for further compounds. On all product sales, Roche will pay Actelion undisclosed royalties.
For the current selective S1P1 receptor agonist, Actelion will fully fund all development activities up to the end of Phase II for the first two indications. All subsequent development and commercialization costs will be shared equally between Roche and Actelion. Both companies will co-promote any product resulting from this collaboration and equally share profit.
The science behind selective S1P1 receptor agonists
Sphingosine-1-phospate (S1P) is a phospholipid released by platelets, mast and other cells. It is currently established that S1P stimulates at least five different G-protein coupled receptors (GPCRs): S1P1, 2, 3, 4 and 5. Activation of these GPCRs mediates a complex variety of biological responses, such as lymphocyte migration, endothelial cell proliferation, blood vessel constriction, heart rate modulation and others.
Actelion's efforts in the field of selective S1P1 receptor agonists started in 1999 by focusing on receptors found on the endothelium, the inner lining of blood vessels. The result of these research efforts is Actelion's orally active selective S1P1 receptor agonist currently undergoing Phase I safety and tolerability testing.
Additional discovery and early pre-clinical development efforts in the field of selective S1P1 receptor agonists are underway at Actelion's research facilities in Allschwil, Switzerland.
About autoimmune disorders
Autoimmune disorders are diseases caused by the body producing an immune response against its own tissues. The cause of autoimmune disorders is unknown. Some of the most common types of autoimmune disorders include psoriasis, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and rejection of transplanted organs. These disorders affect millions of people worldwide.
About Roche as a Partner
Roche is a valued partner to more than 50 companies worldwide. Over the past two years, Roche has led the pharmaceutical industry in the number of clinical compound deals signed. In 2005, Roche entered into nine partnerships to jointly develop products for optimal patient benefit and value. Partnerships continue to strengthen Roche's positions in oncology, virology, transplantation, and primary care. Roche's partnering culture encourages innovation through a unique pairing of collaboration and autonomy.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005, sales by the Pharmaceuticals Division totaled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
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).
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Monday, July 17, 2006, 15:30 CET / 14:30 BST / 9:30 a.m. EDT
Dial: +41 (0) 91 610 56 00 (Europe)
+1 (1) 866 291 41 66 (U.S.)
+44 (0)207 107 06 11 (U.K.)
Webcast -- Live and replay on demand
Actelion webcasts its Investor Conference Call. On the Web, you may either follow the call live or have the call replayed later on demand.
To access the webcast live, simply visit the link on our homepage http://www.actelion.com/ 5-10 minutes before the conference is due to start.
Approximately 60 minutes after the call has ended, the archived investor webcast will be available for replay on the website "Investors/Past Events."