Full Press Release Details
Signs Distribution Deal for Liver Cancer Drug CF102 in South Korea
| Deal provides for up to $3,000,000 in upfront and milestone payments & a percentage rate of royalty payments in the low twenties | ||
| Includes right of first refusal to distribute CF102 for other indications including NASH |
TIKVA, Israel, October 25, 2016 -- Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a
pipeline of proprietary small molecule drugs being developed to treat inflammatory and liver diseases, cancer, and sexual dysfunction,
today announced it has signed a distribution agreement with Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS)
for the exclusive right to distribute CF102 for the treatment of liver cancer in South Korea, upon receipt of regulatory approvals,
for up to $3,000,000 in upfront and milestone payments, plus a percentage rate of royalties on net sales in the low twenties.
The distribution agreement further provides that Can-Fite will deliver finished product to CKD and grants CKD a right of first
refusal to distribute CF102 for other indications for which Can-Fite develops CF102.
agreement marks our first distribution deal for CF102 as we near completion of patient enrollment in our Phase II trial of CF102
as a second line treatment for hepatocellular carcinoma. The pressing need for an effective drug in this difficult to treat cancer
makes CF102, in our opinion, a strong potential candidate as we look towards Phase II results and ahead to Phase III in the U.S.
where CF102 has Fast Track Designation in this indication," stated Can-Fite CEO Dr. Pnina Fishman. "We look forward
to working with CKD to advance CF102 in South Korea."
51,000 people had liver cancer in Korea, with approximately 11,000 deaths in 2012 according to a study published in Cancer
Research and Treatment: Official Journal of Korean Cancer Association in 2015.
is currently conducting a global Phase II double-blind, placebo controlled study evaluating the efficacy of CF102 as a second-line
treatment for advanced HCC. The primary endpoint is overall survival. In the coming quarters, Can-Fite intends to initiate a Phase
II study of CF102 in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis
agreement with CKD marks Can-Fite's second distribution and licensing deal in South Korea, where the Company's Piclidenoson
(CF101) has already been out-licensed to Kwang Dong Pharmaceutical Co. for the treatment of rheumatoid arthritis.
is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is
highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the
excellent safety profile of the drug. In Can-Fite's pre-clinical and clinical studies, CF102 has demonstrated a robust anti-tumor
effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data
showing CF102 has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received
Orphan Drug Designation for CF102 in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment
for hepatocellular carcinoma.
Can-Fite BioPharma Ltd.
BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology
that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction.
The Company's lead drug candidate, Piclidenoson, is scheduled to enter Phase III trials in 2016 for two indications, rheumatoid
arthritis and psoriasis. The rheumatoid arthritis Phase III protocol has recently been agreed with the European Medicines Agency.
Can-Fite's liver cancer drug CF102 is in Phase II trials for patients with liver cancer and is slated to enter Phase II for the
treatment of non-alcoholic steatohepatitis (NASH). CF102 has been granted Orphan Drug Designation in the U.S. and Europe and Fast
Track Designation as a second line treatment for hepatocellular carcinoma by the U.S. Food and Drug Administration. CF102 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 is being prepared for an
IND submission to the FDA and a Phase I trial. These drugs have an excellent safety profile with experience in over 1,000 patients
in clinical studies to date. For more information please visit: www.can-fite.com.
Chong Kun Dang Pharmaceutical Corp.
in 1941, CKD is a fully integrated pharmaceutical company employing over 1,800 people. It is one of the leading local pharmas
in Korea and through in-licensing and in-house R&D, it has significantly contributed to improving health and quality of life
of people mainly in Korea for more than 70 years. Domestically, it has a strong presence in cardiovascular and immunosuppressant
areas and has local offices established in Vietnam and Indonesia. Since launching its drug Camtobel for lung and ovarian
cancer, CKD has continued to strengthen its R&D capability and in-license innovative drugs from business partners worldwide.
press release may contain forward-looking statements, about Can-Fite's expectations, beliefs or intentions regarding, among other
things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition,
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