BRUSSELS, Belgium and ALLSCHWIL, Switzerland, Nov. 17, 2005 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) and UCB (Euronext:UCB) today announced that the two companies have replaced their existing license agreement with immediate effect 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, where Enzyme Replacement Therapy (ERT) is not suitable or not an option.
As part of the agreement, the previous licence between Searle and Oxford Glyco Sciences (OGS) (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 prior UCB obligations on Zavesca(r) manufacturing and supply chain as well as the management of patent-related activities. Actelion will also ensure the supply of drug to Teva, the licence holder for Zavesca(r) in Israel. In addition, Actelion will be responsible for all clinical and pre-clinical activities including those that were not covered by the previous licence 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 glycolipid storage disorders currently in clinical development, such as Late onset Tay-Sachs disease, Niemann-Pick type C and Gaucher disease type 3.
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). We are also committed to fully exploring the medical benefit Zavesca(r) might offer in other glycolipid storage disorders, given Zavesca(r)'s potential to reduce the synthesis and accumulation of pathological lipid storage inside the cells of patients affected with glycosphingolipid (GSL) disorders. 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 type 1 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 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 away from 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 chilbearing potential. Zavesca should not be used 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
Actelion Ltd is a biopharmaceutical company with its corporate headquarter 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 (ticker symbol: 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 (UCB / UCBBt.BR / UCB BB).
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