Tuesday, December 16, 2008

Heat sensitive liposomal doxorubicin

Biopharmaceutical company Celsion Corp. of Columbia has taken another step on the road toward commercializing its first product, by closing a deal with Yakult Honsha of Tokyo, which develops and markets pharmaceuticals, foods, beverages and cosmetics.

Celsion and Yakult announced Monday an agreement in which Yakult will pay Celsion licensing fees to acquire the rights to ThermoDox, a treatment for primary liver cancer, for the Japanese market. Yakult will pay Celsion $2.5 million "immediately," followed by an $18 million payment conditioned upon the approval of ThermoDox by the Japanese Ministry of Health, Labor and Welfare, according to Celsion information. After that, additional milestone payments are tied to achievement of certain levels of sales and the approval of other indications.

Celsion CFO Sean Moran said ThermoDox must go succeed in a clinical trial in Japan to win regulatory approval. He said Yakult is responsible for conducting the clinical trial and the trial would begin "as soon as possible."

Moran called the Yakult agreement "exciting" for Celsion. "I think it's indicative of the value of the product," he said, "to get this interest from a company like Yakult."

Yakult Honsha reported sales of about $3.5 billion in its last fiscal year, which ended March 31.

The agreement, Moran said, "indicates the product is very promising for the treatment of liver cancer. Most people die from liver cancer because there is no cure and there are no great treatments for it out there now."

Celsion is involved in developing and commercializing oncology drugs including tumor-targeting treatments using focused heat energy in combination with heat-activated drug delivery systems. ThermoDox is Celsion's proprietary heat-sensitive liposomal encapsulation of doxorubicin, an approved and frequently used drug used to treat various cancers, according to company information. Localized heat releases the entrapped doxorubicin from the liposome and this delivery technology enables high concentrations of doxorubicin to be deposited locally in a targeted tumor.

Michael H. Tardugno, Celsion president and CEO, said in a statement, "We have worked diligently over the past few months to arrive at this significant agreement with Yakult and we are very pleased to announce its execution. This achievement is an example of the commitment of our two companies to a long-term, mutually rewarding relationship. It is also example of Celsion delivering on its stated goal of licensing ThermoDox to pharmaceutical partners with the expertise and capabilities essential to market success. We view this partnership with Yakult as further validation of the ThermoDox platform and its potential to treat the expanding hepatocellular carcinoma population in Japan."

"The remarkable evidence of clinical activity suggested by ThermoDox in early phase clinical trials provides Yakult with the confidence necessary for the investment required to support marketing approval in Japan," said Kiyoshi Terada, head, pharmaceutical division, and senior managing director of Yakult Honsha. "ThermoDox has the potential to hold great promise for those suffering with this difficult cancer."

According to the National Cancer Center of Japan, primary liver cancer is the third leading cause of cancer deaths in Japan among adults and more than 40,000 people are diagnosed with the disease annually.

Celsion, with 21 employees, has a phase 3 trial of ThermoDox under way in the U.S., Korea and Taiwan, Moran said.

"Data from that trial would facilitate filings [for regulatory approval] in many markets," Moran said. Thermodox is also in a phase 2 trial for recurrent chest wall breast cancer.

Last month, Celsion reported a net loss of $4.3 million for quarter ended Sept. 30, compared with a net loss of $3.6 million a year ago. For the nine months ended Sept. 30, Celsion reported a net loss of $10.9 million, compared with net income of $38.2 million in the comparable period in 2007.

Tardugno said then, "Our cash position is strong, and we remain well-positioned to fund our phase 3 primary liver cancer study to a point where we have sufficient results to determine if there is support for [a new drug application] filing [to the Food and Drug Administration]. That said, we will continue to be prudent in our spend management while fully supporting our development pipeline."

Moran, a veteran bioscience company CFO who joined Celsion last month after serving as CFO for Transport Pharmaceuticals of Framingham, Mass., said Monday, "We have enough cash, between what we have and a payment due in June from Boston Scientific of $15 million, those funds are sufficient for us to complete trials for ThermoDox and get us to filing for FDA approval."

From Gazzette.net