ALLSCHWIL/BASEL, SWITZERLAND and SLOUGH, U.K., June 16, 2004 (PRIMEZONE) -- Actelion Ltd. (SWX:ATLN):
-- Actelion and Celltech extend Zavesca(r) license agreement
-- Celltech grants unrestricted license to Actelion until patent
expiry
-- Actelion to take full responsibility for the management of all
clinical trials
-- Advances in clinical programs exploring Zavesca(r) in three
lipid-storage disorders other than type 1 Gaucher disease
-- First results in Late Onset Tay-Sachs disease by the end of 2004
Actelion Ltd (SWX:ATLN) and Celltech Group plc (LSE:CCH) (NYSE:CLL) today announced that the companies have modified their existing license agreement covering Zavesca(r) (miglustat), an orally active therapeutic medicine approved for type 1 Gaucher disease in the European Union, the United States, Canada and Israel.
Actelion will take full responsibility for the management of ongoing or planned clinical trials in the approved indication as well as those exploring the use of Zavesca(r) in other glycolipid storage disorders. In return, Celltech Group plc has agreed to grant Actelion unrestricted license rights for the use of miglustat in the field of glycolipid storage disorders. Previously, Celltech had retained rights to reacquire Zavesca(r) rights after five years of market availability.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, said: "Actelion is reinforcing its commitment to further explore the potential of Zavesca(r) in rare metabolic diseases with high unmet medical needs and to improve patient care with new therapeutic options. By reorganizing clinical trial activities, Actelion will be able to optimize its relationships with both regulatory authorities and clinicians."
There is strong preclinical evidence to support the use of Zavesca(r) in other related lipid storage diseases for which currently no therapy exists. Consequently, Phase III trials in other lipid storage disorders, such as Late Onset Tay-Sachs, Type 3 Gaucher disease and Niemann-Pick Type C disease, are being conducted.
First results of a 1-year, 30-patient, open-label, controlled study in Late Onset Tay-Sachs disease should be available by the end of 2004. Tay-Sachs disease is a rare autosomal recessive genetic disorder causing a deficiency in B-hexosaminidase, the enzyme responsible for the breakdown of the lipid GM2. This leads to extensive and toxic accumulation of GM2 and related glycosphingolipids in the lysosomes of neuronal cells, resulting in a neurodegenerative disease including muscle weakness and cramps, tremors, unsteady gait, psychoses and depression. There is currently no drug therapy available to treat patients with Tay-Sachs disease.
Terms of the new license agreement
Under the terms of the new agreement Actelion remains the license holder for Zavesca(r) worldwide, with the exception of Israel where the drug is also approved. Actelion will be responsible for all clinical, regulatory and marketing activities and will book all sales of Zavesca(r). Celltech is responsible for manufacturing and receives undisclosed royalties on sales. Financial terms of the new license agreement were not disclosed. Actelion originally in-licensed Zavesca(r) from Oxford GlycoSciences, now part of Celltech Group plc.
About Zavesca(r) in type 1 Gaucher disease:
In the European Union (EU) and the United States of America (US), Zavesca(r) is approved for the oral treatment of mild to moderate type 1 Gaucher disease. Zavesca(r) may only be used in the treatment of patients for whom Enzyme Replacement Therapy is unsuitable (e.g. due to constraints such as allergy, hypersensitivity, or poor venous access).
Gaucher disease is a rare genetic disorder, which results from reduced activity of glucocerebrosidase, an enzyme responsible for the degradation of glucosylceramide, a lipid subclass. Symptoms include enlargement of liver and spleen, bone disease, thrombocytopenia and anemia.
In the European Union, Zavesca(r) was approved in November 2002. Zavesca(r) is currently commercially available in the UK, Germany, the Netherlands, France, Spain, Sweden and Austria. It will be marketed in other European countries in the coming months.
In the United States, Zavesca(r) became commercially available in January 2004 following FDA approval.
In Canada, Zavesca(r) has been approved in March 2004. Actelion will pursue further registration and launches in other territories.
Zavesca(r) has been granted orphan medicinal product status in the EU and the US, allowing for a ten- and seven-year marketing exclusivity period following approval.
About Celltech
Celltech Group plc (LSE:CCH) (NYSE:CLL) is one of Europe's largest biotechnology companies, with an innovative development pipeline funded by its profitable, cash-generative pharmaceutical business. Celltech also possesses drug discovery capabilities of exceptional strength, including a leading position in antibody engineering.
About 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 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).