Date: 2014-05-29
Type of information: Distribution agreement
Compound: Glybera® (alipogene tiparvovec)
Company: Uniqure (The Netherlands) Medison Pharma (Israel)
Therapeutic area: Rare diseases - Genetic diseases
Type agreement: distribution
Action mechanism: gene therapy. Glybera® is an adeno-associated viral vector (AAV1) based gene therapy, administered intramuscularly (IM) at multiple-sites in a single session. AAV1 carrying the human variant LPLS447X gene is delivered to skeletal muscle, where it becomes active. The LPL protein is expressed and transported to the capillary endothelium where it binds to chylomicrons and VLDL. Alipogene tiparvovec is intended as a curative measure for patients with LPLD and, as well as enhancing chylomicron metabolism, may prevent episodes of pancreatitis.
Disease: lipoprotein lipase deficiency (LPLD)
Details: * On May 29, 2014, uniQure and Medison Pharma, Israel’s leading international healthcare marketing group, announced an exclusive distribution agreement under which Medison will market Glybera®, uniQure’s gene therapy product for the treatment of lipoprotein lipase deficiency (LPLD), in Israel and the Palestinian Authority. Medison will also be responsible for obtaining regulatory approval for Glybera® in both territories. Glybera® is approved in the EU as a treatment for LPLD. Through this partnership Glybera will be available to LPLD patients in Israel and the Palestinian Authority sooner than otherwise possible. uniQure remains focused on the advance of Glybera® toward the initiation of the regulatory process in the USA this year, as well as the further development of our candidate gene therapies currently in the clinic.
Financial terms: Financial terms of the agreement have not been disclosed.
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