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TLC Adds New Asian Partner in Sciclone PAD Collaboration

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By Dave Silver
Staff Writer

TAIPEI, Taiwan – Drug reformulation specialist Taiwan Liposome Co. (TLC), of Taipei, Taiwan, said it granted Sciclone Pharmaceuticals Inc., of Foster City, Calif., exclusive rights to distribute Proflow, its treatment for peripheral arterial disease (PAD), in China, Macau and Hong Kong.

The agreement adds to a growing list of Proflow distribution partners for TLC across East Asia, including Taiwan, Japan and Korea.

Proflow is a lipid emulsion-based reformulation of prostaglandin E1 (PGE1), and it's one of TLC's stable of reformulated products that use lipid emulsions and liposome encapsulation to modify existing drugs. In the case of Proflow, the reformulation has enabled it to demonstrate a shelf life of two years, double the shelf life of other available forms of PGE1, an important consideration for supply and distribution logistics.

In fact, that limited shelf life had prevented PGE1 from being approved for use as a PAD therapy in most Western countries.

"The original drug had a stability problem. Its one-year shelf life made it difficult for a lot of regulatory agencies to approve," explained George Yeh, general manager of TLC. "And in most markets, you have to return the drug once the shelf life drops below six months. This means after manufacturing and testing, by the time it gets out to hospitals you only have a few months to use up your supply."

PAD is a serious condition in which blood flow to the limbs is constrained due to arterial plaque build-up. Sufferers experience severe pain, restricted mobility and are in danger of life-threatening blood clots. In China, PAD offers an untapped opportunity for the right product, and TLC had been waiting for the right time and partner to enter that market with such a product, and on its own terms.

"There's not really any good product on this market. And if you look at the market, it's really quite big. In China alone about $300 million to $400 million with 30 to 35 percent growth annually," Yeh said.

TLC earlier vetted but turned down a lot of suitors before deciding to partner with Sciclone, which bills itself as a "U.S.-based, China-focused specialty pharmaceutical company."

"With a lot of Chinese companies, it's like 7-11; they pretty much sell everything. It doesn't matter what the product; they just try to sell it. I don't think that's how our product should be taken care of. Although [it is] not the biggest player in China, Sciclone is definitely a niche player for specialty pharmaceuticals. They have demonstrated to us they can generate $100 million-plus in sales for just one product in China," Yeh said.

That product, Zadaxin (thymalfasin), is used for the treatment of hepatitis B (HBV), hepatitis C (HCV) and certain cancers, and as a vaccine adjuvant. "That's impressive. And so I think they will perform quite well with our specialty type of drug."

Under the terms of the agreement with Sciclone, TLC will take care of clinical trials, manufacturing and supply of the drug, with Sciclone responsible for marketing and distribution through its sales force of more than 850 people on the ground in China.

Proflow has been submitted to the China Food and Drug Administration (CFDA) for approval, although some limited clinical testing still will be required before the drug can begin to be sold.

"It's basically an abbreviated type of trial, which will take about a year or a year and a half," Yeh said.

Manufacturing will be taken care of by one of TLC's Taiwan-based contract manufacturing organizations, Shinlin Sinseng Pharmaceutical Co. Ltd. Shinlin originally was part of a Taiwanese joint venture with Kyorin Pharmaceutical, of Japan, and is now an independent company but still fully compliant with PMDA standards (Japan's Pharmaceuticals and Medical Devices Agency). That is important for TLC when supplying Proflow to demanding partners across East Asia; Japan's Nihon Generic Co., part of the Nihon Chouzai Group and one of the country's largest hospital pharmaceutical suppliers; Korea's Ildong Pharmaceutical Co. Ltd.; and in Taiwan, Fundachieve Co. Ltd., a small specialty cardiovascular drug supplier.

TLC was formed in 1997 by Keelung Hong, a prolific liposome researcher with more than 100 publications and more than 30 years of R&D experience in the field. In addition to its headquarters and research facilities in Taipei, TLC has offices in San Francisco and Leiden, the Netherlands. Besides Proflow, other drugs in its line-up include Lipodox, a liposome version of the cancer drug doxorubicin; Ambil, a liposomal formulation of amphotericin B for the treatment of fungal infections; Doxisome, a reformulation of Doxil/Caelyx; and Lipotecan for hepatocellular carcinoma (HCC).

Lipotecan has been granted orphan drug status by the FDA and European Medicines Agency, and in March the company said Lipotecan was being fast-tracked for approval in China under the CFDA's Green Path program, an accelerated approval process for innovative new drugs.