Wednesday, June 26, 2013

Scilone Pharma Inlicenses China marketing rights to ProFlow® - A treatment for Peripheral Arterial disease

SciClone Pharmaceuticals, Inc. will pay to Taiwan Liposome Company (TLC) upto $39.5 million as and when certain clinical, regulatory and sales related milestones are achieved. 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 commercialization, including pre- and post-launch activities. ProFlow has been submitted to the China Food and Drug Administration (CFDA) for approval, and it is expected that some additional clinical testing may be required prior to approval.  Taiwan Liposome company has given the Japan rights for ProFlow to Nihon Generic company.

ProFlow is a novel lipid emulsion-based formulation of prostaglandin E1 (PGE1), a vasodilator and platelet inhibitor. TLC's proprietary lipid-based delivery systems (LDDS) are designed to modify and broaden the use of existing drugs and enhance their therapeutic index. ProFlow has demonstrated to have twice the shelf life as 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.

Peripheral arterial disease is a serious cardiovascular condition in which blood flow to the limbs (usually the legs) is restricted due to arterial plaque build-up. PAD can cause severe pain and restricted mobility, and potentially life-threatening blood clots. PAD represents a large and growing market opportunity in China. The current market leading drug generates annual revenue of more than $200 million.

About Taiwan Liposome Company
Incorporated in 1997, Taiwan Liposome Company is a biopharmaceutical company engaging in research, development and commercialization of proprietary drug delivery system for improving the treatment of cancer, ophthalmic conditions, and infectious diseases. TLC was founded and led by renowned scientist Dr. Keelung Hong, who has over 30 years of research and development experience in liposomes with over 100 publications. Led by Dr. Hong, TLC has a team of scientists, management, manufacturing experts and advisors working together to build the company into an organization recognized for its excellence in drug delivery and rapid advancement of products. TLC currently operates its headquarter in Taipei (Taiwan), and subsidiary offices in South San Francisco (US) and Leiden (The Netherlands). For more information, visit http://www.tlcbio.com.

About SciClone
SciClone Pharmaceuticals is a US-based, China-focused specialty pharmaceutical company with a product portfolio of therapies for oncology, infectious diseases, cardiovascular, urological, respiratory, and central nervous system disorders. SciClone's ZADAXIN® (thymalfasin) is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV) and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Besides ZADAXIN, SciClone markets about 14 mostly partnered products in China, including Depakine®, the most widely prescribed broad-spectrum anti-convulsant in China; Tritace®, an ACE inhibitor for the treatment of hypertension; Stilnox®, a leading hypnotic for the short-term treatment of insomnia (marketed as Ambien® in the US); and Aggrastat®, a recently-launched interventional cardiology product. SciClone is also pursuing the registration of several other therapeutic products in China. SciClone is headquartered in Foster City, California. For additional information, please visit www.sciclone.com.








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