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Can-Fite Signs Development and Distribution Agreement for Piclidenoson and Namodenoson in China.

M2 PHARMA-August 8, 2018-Can-Fite Signs Development and Distribution Agreement for Piclidenoson and Namodenoson in China

(C)2018 M2 COMMUNICATIONS

- Israeli biotechnology company Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) has signed a License, Collaboration and Distribution Agreement with CMS Medical Venture Investment Ltd. for the commercialisation of Can-Fite's Piclidenoson for the treatment of rheumatoid arthritis and psoriasis and Namodenoson for the treatment of advanced liver cancer and NAFLD/NASH in China (including Hong Kong, Macao and Taiwan), the company said.

Under the terms of the agreement, CMS Medical is making an upfront payment of USD 2m to Can-Fite and is required to pay to Can-Fite milestone payments of up to USD 14m upon the achievement of certain regulatory milestones and payments of up to USD 58.5m upon the achievement of certain sales milestones.

In addition, the agreement provides for double-digit royalty payments on net sales.

CMS Medical is a wholly-owned subsidiary of China Medical System Holdings Ltd. (SEHK: 867), a specialty pharmaceutical company based in China, focusing on marketing, promotion and sales of prescription drugs and other medicinal products to therapeutic departments in hospitals.

CMS builds up its product portfolio for its target markets by asset acquisition, equity investment, licensing and distribution as well as in-house R and D. CMS is listed on the Hong Kong Stock Exchange with a current market capitalization of approximately HKD 34bn as at August 1, 2018.

According to the agreement, CMS will be responsible for the development of Piclidenoson and Namodenoson to obtain regulatory approval in China and shall be further responsible for obtaining and maintaining regulatory approval in China for the indications described above.

Can-Fite may, at the option of CMS, supply finished product to CMS.

Can-Fite is currently enrolling patients for its Phase III ACRobat trial of Piclidenoson for the treatment of rheumatoid arthritis and plans to shortly initiate patient enrollment for its Phase III Comfort trial of Piclidenoson for the treatment of psoriasis.

The rheumatoid arthritis and psoriasis therapeutic market is dominated by biological drugs that are primarily administered via intravenous injection and have potential side effects.

Rheumatoid arthritis and psoriasis are huge unmet need markets, where rheumatoid arthritis is estimated to reach USD 35B in 2020 and psoriasis is forecast to reach USD 9B in 2018.

Phase II studies with Namodenoson for the treatment of advanced liver cancer (hepatocellular carcinoma, Child Pugh B) and NAFLD/NASH are currently ongoing.

The last patient for the advanced liver cancer trial was enrolled in August 2017, and treatment of remaining patients is still ongoing.

Can-Fite BioPharma is an advanced clinical stage drug development company with a platform technology that is designed to address multibn-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.

The company's lead drug candidate, Piclidenoson, is currently in a Phase III trial for rheumatoid arthritis and is expected to enter a Phase III trial for psoriasis in 2018.

Can-Fite's liver cancer drug, Namodenoson, is in Phase II trials for hepatocellular carcinoma, the most common form of liver cancer, and for the treatment of non-alcoholic steatohepatitis.

Namodenoson has been granted Orphan Drug Designation in the US and Europe and Fast Track Designation as a second line treatment for HCC by the US Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma.

CF602, the company's third drug candidate, has shown efficacy in the treatment of erectile dysfunction in preclinical studies and the company is investigating additional compounds, targeting A3AR, for the treatment of sexual dysfunction.

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Publication:M2 Pharma
Geographic Code:9CHIN
Date:Aug 8, 2018
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