ALLSCHWIL, Switzerland and BRUSSELS, Belgium, Nov. 17, 2005 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) (Other OTC:ALIOF) and UCB (Euronext: UCB, UCBBt.RR, UCB BB) today announced that the two companies have, with immediate effect, replaced their existing license agreement covering Zavesca(r) (miglustat), an orally active therapeutic medicine that is currently approved in the European Union, the United States, Canada, Israel and Switzerland for the treatment of adult patients with mild to moderate Gaucher type 1 disease, for whom Enzyme Replacement Therapy (ERT) is not suitable or not a therapeutic option.
As part of the agreement, the previous license between Searle and Oxford Glyco Sciences (later Pfizer and Celltech/UCB respectively), including relevant iminosugar patents from the OGS/Celltech patent estate, are assigned to Actelion. As a consequence, Actelion will assume full responsibility for the pre-UCB obligations on Zavesca(r) manufacturing and supply chain as well as the management of patent-related activities. Actelion will also ensure the drug supply to Teva, the license holder for Zavesca(r) in Israel. Actelion will be responsible for all clinical and pre-clinical activities in addition to those that were already covered by the previous license extension concluded in June 2004 with Celltech, now an integral part of UCB.
Actelion will make an undisclosed upfront payment to UCB in return for a single-digit royalty rate on future Zavesca(r) sales in type 1 Gaucher disease and -- potentially -- in other glycosphingolipid (GSL) storage disorders such as Late onset Tay-Sachs disease, Niemann-Pick type C and Gaucher disease type 3, currently in clinical development.
Jean-Paul Clozel, M.D., Chief Executive Officer of Actelion, commented: "Following a short transition period, Actelion will be in full control of all aspects of Zavesca(r). Actelion is hereby re-enforcing its commitment to the only orally available treatment option for type 1 Gaucher disease. We are also committed to fully exploring the medical benefit Zavesca(r) might offer to patients affected with other GSL storage disorders, given the potential of Zavesca(r) to reduce the synthesis and subsequently the accumulation of pathological lipids in tissues. In addition, the ability of Zavesca(r) to cross the blood-brain barrier might play an important role in diseases affected with pathological accumulation of GSLs in the neuronal cells in the brain."
Roch Doliveux, Chief Executive Officer of UCB, commented: "UCB believes that Actelion is in the best position to maximize the clinical and commercial potential of Zavesca(r). The restructured collaboration ensures that this important treatment reaches those patients who will benefit the most."
Note to the Editor:
About Zavesca(r) in type1 Gaucher Disease (GD1)
Zavesca(r) (miglustat) is the first oral treatment option for adults with mild to moderate Type 1 Gaucher disease for whom enzyme replacement therapy is not suitable or not a therapeutic option. It is the first in a new class of drugs known as substrate reduction therapy (SRT). Zavesca(r) reduces the rate of formation of glucosylceramide, the first intermediate in the synthesis of a large family of glycosphingolipid (GSL) that accumulates in GD, to a level that can be cleared by the remaining glucocerebrosidase enzyme. This prevents the build up of excess glucosylceramide and other GSLs in the cells of the reticuloendothelial system. Zavesca(r) is approved and available in the European Union, United States, Canada, Israel and Switzerland.
Zavesca(r) safety information
Peripheral neuropathy and tremor has been reported in Type 1 Gaucher patients treated with Zavesca(r). Patients should undergo a neurological exam at the start of treatment and regularly thereafter. Zavesca(r) should be reassessed in patients who develop symptoms of peripheral neuropathy. Zavesca(r) is associated with a high incidence of gastrointestinal (GI) intolerability in the form of diarrhea, especially during the early phases of treatment. GI tolerability improves over time on treatment and is helped by diet modification, taking Zavesca(r) outside meals and/or use of loperamide. Zavesca(r) may cause fetal harm if administered to a pregnant woman and is contraindicated during pregnancy. Contraceptive measures should be used by women of childbearing potential. Zavesca(r) should not be use during breast-feeding. There is a risk of impaired fertility in men. Men should maintain reliable contraceptive methods and not plan to conceive while taking Zavesca(r) and for 3 months thereafter.
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 as well as 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 (Other OTC:ATLN).
UCB
UCB (www.ucb-group.com) is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specializing in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders, as well as oncology. UCB key products are Keppra(r) (antiepileptic), Xyzal(r) and Zyrtec(r) (antiallergics), Nootropil(r) (cerebral function regulator), Tussionex(tm) (antitussive) and Metadate(tm) / Equasym XL(tm) (attention deficit/hyperactivity disorder). UCB employs over 8,500 people operating in over 40 countries. UCB is listed on Euronext Brussels (Euronext: UCB, UCBBt.RR, UCB BB).