SciClone Pharmaceuticals has entered into an agreement with Taiwan Liposome Company (TLC) granting SciClone a licence and exclusive rights in China, Hong Kong and Macau to promote, market, distribute and sell ProFlow (prostaglandin E1 [PGE1]) for the treatment of peripheral arterial disease and other indications.
ProFlow is a novel lipid emulsion-based formulation of PGE1. TLC's proprietary lipid-based delivery systems are designed to modify and broaden the use of existing drugs and enhance their therapeutic index. ProFlow has been demonstrated to have twice the shelf life of currently-marketed lipid emulsion formulations of PGE1. A patent providing broad protection for ProFlow has been granted in China, Japan and Taiwan. TLC has also applied for worldwide composition of matter patents.
Under the terms of the agreement, TLC will be responsible for the continued development, including potential clinical trials and regulatory activities, as well as the manufacturing and supply of ProFlow, and SciClone will be responsible for all aspects of commercialisation, including pre- and post-launch activities. ProFlow has been submitted to the China State FDA for approval, and it is expected that some additional clinical testing may be required prior to approval.
Financial terms of the agreement include clinical, regulatory and sales milestone payments up to an aggregate of US$39.5 million. The agreement provides for the principal terms of the arrangement between SciClone and TLC, and the companies have agreed to negotiate a supplemental licence and supply agreement.
|Agreement Status:||New||Date Announced:||25 Jun 2013|
|Date Last Reported:||Duration:|
|Est Total Value:||US$39.5 million||Investment To Date:|
|Agreement Type:||Commercialisation Distribution|
|Generic / Brand Name:||ProFlow prostaglandin E1|
|Therapeutic Area:||Cardiovascular System|
|Indication:||Peripheral arterial disease|