Actelion updates US Healthcare Professionals for patients with type 1
Gaucher disease - Information
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ ALLSCHWIL/BASEL, SWITZERLAND - 8 September 2009 - Actelion Ltd (SIX:ATLN) has distributed updated information to Healthcare Professionalswho treat type 1 Gaucher patients in the United States regarding thepotential use of Zavesca® (miglustat) to minimize the impact of thesupply shortage of imiglucerase (produced and marketed by GenzymeCorporation under the brand name Cerezyme®).Despite strict supply conservation measures currently beingimplemented, some patients are facing the prospect of an interruptionof their imiglucerase treatment. This shortage is now expected tolast longer and to affect more patients than initially predicted inJune 2009 by the product manufacturer.Accordingly, Actelion has taken all the necessary steps to ensureaccess to Zavesca® where this important oral therapy has beenapproved for use by patients with Type 1 Gaucher disease, asdetermined by their physicians. In the United States, Zavesca® hasbeen available since 2003.Following communication with the US Food and Drug Administration(FDA), Actelion has issued the following letter to remind Health CareProfessionals in the United States about the availability of Zavesca®as an immediate treatment option for appropriate type 1 Gaucherpatients in relation to the current imiglucerase shortage. HealthCare Professionals may also receive additional information by email(usmedinfo(at)actelion.com) or by calling toll-free (866) 228-3546. ###Notes to the editor:About Zavesca®Zavesca® (100 mg miglustat capsule) is indicated for the oraltreatment of adult patients with mild to moderate type 1 Gaucherdisease. Zavesca® may only be used in the treatment of type 1 Gaucherpatients for whom enzyme replacement therapy is unsuitable (EuropeanUnion) or is not a therapeutic option (United States). It is approvedin the European Union, the United States, Canada, Switzerland,Brazil, Australia, Turkey, Israel, South Korea and New Zealand.In the European Union, South Korea and Brazil, Zavesca® is alsoindicated for the treatment of progressive neurologicalmanifestations in adult patients and paediatric patients withNiemann-Pick type C disease.About type 1 Gaucher diseaseType 1 Gaucher disease, an inherited autosomal recessive disorder, isthe most common disease among all inherited glycosphingolipid storagedisorders, affecting approximately 7,000 patients world-wide. It is amulti-system disease characterized by hepatomegaly, splenomegaly,anemia and thrombocytopenia. In addition, bone manifestations areoften underdiagnosed and include osteopenia, lytic lesions, chronicpain, acute episodes of 'bone crisis', bone infarcts, andosteonecrosis, resulting in long-term disability. Approved treatmentsfor patients with type 1 Gaucher disease include intravenous enzymereplacement therapy with Cerezyme® (imiglucerase) and oral substratereduction therapy with Zavesca® (miglustat).Zavesca® safety informationGastrointestinal events, mainly diarrhea, have been observed in morethan 80% of patients treated with Zavesca®, either at the onset oftreatment or intermittently during treatment. The majority of casesare mild and are expected to resolve after the first weeks ontherapy. In clinical practice, diarrhea has been observed to respondto diet modification (reduction of lactose and other carbohydrateintake), to taking Zavesca® away from meals, and/or to antidiarrhealmedicinal products such as loperamide. In some patients, temporarydose reduction may be necessary. Patients with chronic diarrhea orother persistent gastrointestinal events that do not respond to theseinterventions should be investigated according to clinical practice.Zavesca® has not been evaluated in patients with a history ofsignificant gastrointestinal disease, including inflammatory boweldisease.Cases of peripheral neuropathy have been reported in patients withtype 1 Gaucher disease treated with Zavesca®. Peripheral neuropathyseems to be more common in patients with type 1 Gaucher diseasecompared to the general population. All patients should undergobaseline and repeat neurological evaluation. Patients who developsymptoms such as numbness and tingling should have a carefulre-assessment of risk benefit.Zavesca® may cause fetal harm if administered to a pregnant woman andis contraindicated in women who are or who may become pregnant;patients should be informed of the potential hazard to the fetus.There is a risk of impaired fertility in men. Men should maintainreliable contraceptive methods and not plan to conceive while takingZavesca® and for three months thereafter.Actelion LtdActelion Ltd is a biopharmaceutical company with its corporateheadquarters in Allschwil/Basel, Switzerland. Actelion's first drugTracleer®, an orally available dual endothelin receptor antagonist,has been approved as a therapy for pulmonary arterial hypertension.Actelion markets Tracleer® through its own subsidiaries in keymarkets worldwide, including the United States (based in South SanFrancisco), the European Union, Japan, Canada, Australia andSwitzerland. Actelion, founded in late 1997, is a leading player ininnovative science related to the endothelium - the single layer ofcells separating every blood vessel from the blood stream. Actelion'sover 2000 employees focus on the discovery, development and marketingof innovative drugs for significant unmet medical needs. Actelionshares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) aspart of the Swiss blue-chip index SMI (Swiss Market Index SMI®).For further information please contact:Roland HaefeliVice President, Head of Investor Relations & Public AffairsActelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil+41 61 565 62 62+1 650 624 69 36http://www.actelion.comhttp://hugin.info/131801/R/1339270/320219.pdfhttp://hugin.info/131801/R/1339270/320241.pdf --- End of Message ---Actelion Pharmaceuticals LtdGewerbestrasse 16 Allschwil SwitzerlandWKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP, SMIM, SPI, SPIEX;Listed: Main Market in SIX Swiss Exchange;
Datum: 08.09.2009 - 17:35 Uhr
Sprache: Deutsch
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