US Treasury Department clears YM BioSciences' nimotuzumab clinical program extension

Sep 25 2009

YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM, AIM:YMBA), a life sciences product development company that identifies and advances a diverse portfolio of promising cancer-related products at various stages of development, today reported operational and financial results for its fiscal year end, ended June 30, 2009.

"Just weeks ago we received clearance from the US Treasury Department to extend our US clinical program for nimotuzumab, permitting us to conduct trials in any cancer indication. Obtaining this clearance will be a transformative event for nimotuzumab and highlights the significant efforts made by YM staff in fiscal 2009 to advance our lead drug in an aligned effort with our licensees," said David Allan, Chairman and CEO of YM BioSciences. "Although encouraging data was presented at ASCO 2009 describing the efficacy of nimotuzumab but without advanced toxicities, we anticipate that, once a broader group of key US oncologists gain experience investigating nimotuzumab in their patients, the benefits of our drug and its potential for best-in-class status will be more fully appreciated by this community, as well as by potential partners and investors."

Nimotuzumab is being advanced globally on multiple fronts supported by a network of cooperative relationships. In total, 32 Phase II and III clinical trials are currently ongoing, 11 of which are being conducted by YM's majority owned subsidiary, CIMYM BioSciences Inc., or its licensees.

- Daiichi Sankyo Co., Ltd., CIMYM's licensee for nimotuzumab in Japan, and YM's licensee in Korea, Kuhnil Pharmaceutical Co., are currently collaborating on a Phase II randomized, open-label trial they are conducting that is evaluating nimotuzumab plus irinotecan compared to irinotecan alone in patients with advanced or recurrent gastric cancer refractory to 5-FU-containing regimens which is designed to complete recruitment in calendar 2009. Daiichi has also launched a Phase II trial in first-line NSCLC bringing to three the number of NSCLC indications being investigated by our direct consortium. - Randomized, Phase II, double-blind trials in brain metastases from non-small cell lung cancer (NSCLC) and in NSCLC patients ineligible for radical chemotherapy were initiated in Canada; recruitment commenced in March 2009 for NSCLC and in September for the brain metastases trial. A Phase II, second-line, single-arm trial in children with progressive diffuse intrinsic pontine glioma (DIPG) is ongoing at multiple sites in the US, Canada, and Israel. - Oncoscience AG (OSAG), CIMYM's licensee for Europe, reports that it continues to recruit for a Phase III trial in adult glioma and a Phase II/III trial in pancreatic cancer. - Innogene Kalbiotech PTE Ltd. (IGK), a subsidiary of Kalbe Farma, the largest public Southeast Asian pharmaceutical company and a CIMYM licensee, reported marketing approval in the Philippines and Indonesia, bringing to 21 the number of countries that are now reported as having approved the drug for sale in specific indications. In January 2009, the National Cancer Centre of Singapore announced that it was launching a worldwide Phase III, 710-patient trial of nimotuzumab in the adjuvant setting in head and neck cancer in cooperation with IGK. This trial is in addition to the on-going investigator-initiated Phase II trial in locally advanced head and neck cancer and the initiation of a Phase II trial in cervical cancer. - Subsequent to the end of the fiscal year, YM received a license from the US Department of the Treasury's Office of Foreign Assets Control (OFAC) to further develop its lead product, nimotuzumab, for patients in the United States. YM's first priority is discussion with the FDA on its two IND submissions to include US citizens in the randomized, double-blind Phase II trial of nimotuzumab in NSCLC patients ineligible for radical chemotherapy and the parallel Phase II trial in patients with brain metastases from NSCLC, both of which YM initiated in Canada during the 2009 fiscal year. Development plans may also include extending one of the Phase III trials being conducted worldwide into the US, such as the multinational 710-patient Phase III trial of nimotuzumab in the adjuvant setting in head and neck cancer.

YM continues to prepare its second late-stage product, AeroLEF(R), for further development internationally. After consulting with regulatory bodies in Europe and Canada, the Company is now determining the optimal clinical path forward and conducting discussions with prospective partners around the Phase III strategy.

The Company continues to evaluate opportunities to amplify and diversify its development portfolio through potential licensing, acquisition or M&A activity. YM filed and received clearance for a "shelf" prospectus in Canada and the USA subsequent to the end of the fiscal year. A "shelf" facilitates financing by a company, reduces the time period during which a company must otherwise wait for a prospectus to be cleared, permits the sale to investors of shares without a "hold period" (thus significantly reducing the cost of capital) and permits the use of freely traded shares in the case of another acquisition by YM, again significantly reducing the prospective cost of capital. The "shelf" registration covers any financing during the forthcoming 25 months.