MONTREAL, July 20, 2015 /CNW Telbec/ - Telesta Therapeutics Inc. (TSX: TST; PNK: BNHLF) announced today that it has entered into an exclusive license, supply and distribution agreement with BL&H Co. Ltd., a leading Korean specialty pharmaceutical company, for the commercialisation of MCNA1 in South Korea. Under the terms of this partnership, Telesta will receive a combination of upfront payments, regulatory milestones and sales milestones in excess of US$2 million in addition to a significant transfer price, allowing Telesta to receive a large proportion of the revenue related to MCNA sales in South Korea. Telesta will be responsible for the manufacturing and supply of the drug product, while BL&H will cover all costs for registration, sales and marketing in the territory. In addition, BL&H has concurrently subscribed for a private placement in Telesta common shares for an amount of US$200K at market price.
Dr. Michael Berendt, Chief Executive Officer and Chief Scientist commented: "We are pleased to have established this relationship with BL&H whose established track record of successful registrations, market access and launches of oncology and specialty products in South Korea were the deciding factors in our decision to choose to work with them for the launch of MCNA in this important market. This regional transaction represents our first transaction as we continue our discussions with potential strategic partners for all of the key global markets and as we move MCNA towards a near term regulatory approval in the United States, the world's largest pharmaceutical market."
Mr. D.C. Roh, President and CEO of BL&H noted that "MCNA represents a major breakthrough for the treatment of high-risk non-muscle invasive bladder cancer patients who have failed first line BCG therapy. In Korea, as in the rest of the world, this patient group and their treating urologists are very keen to have access to a therapeutic option, to prevent or delay radical cystectomy, a life-altering surgery. We are extremely pleased to have partnered with Telesta to be part of the global effort to bring forward this important medicine to patients."
The South Korean Food and Drug Administration registration process is adapted to products already approved by the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA), Registration and price reimbursement can be expected approximately within one year from application. South Korea is currently the world's 14th largest market for global pharmaceutical sales.
Telesta submitted a Biologics License Application (BLA) to the U.S. FDA for MCNA on June 29, 2015. MCNA is a biologic therapy derived from the cell wall fractionation of a non-pathogenic bacteria. Its activity is believed to be through a dual mechanism of immune stimulation and direct anti-cancer effects. MCNA was developed to be delivered as a sterile suspension for intravesical administration by urologists and urology nurses, following the same dosing paradigm as first-line BCG therapy, with the advantage that it can be prepared, handled and disposed of easily and safely. The efficacy, duration of responses and safety data from MCNA's pivotal Phase 3 trial were recently published in the Journal of Urology2. Telesta continues to prosecute novel composition of matter, methods of use and manufacturing patents in most regions of the world and recently announced the granting of the key composition of matter patent in the United States providing intellectual property coverage of MCNA to 2031.
About Telesta Therapeutics Inc.
Telesta Therapeutics Inc. is a late stage therapeutics company with near term commercial potential focused on the manufacturing, marketing and licensing/acquisition of proprietary and innovative therapies for the global health market. The Company's primary goal is to develop and commercialize products that advance human health and increase shareholder value. For more information, please visit www.telestatherapeutics.com
About BL&H Co. Ltd.
BL&H Co. Ltd. is a privately owned pharmaceutical company based in South Korea. BL&H was established in 1999 with the aim of becoming a leader in the delivery of pharmaceuticals and services that fulfill unmet medical needs in the Korean market. BL&H specializes in specialty and hospital-based products in key areas including oncology. The BL&H management team has extensive experience in the pharmaceutical and healthcare sectors and in bringing specialty products to market.
Except for historical information, this news release may contain "forward-looking statements" and "forward-looking information" within the meaning of applicable securities laws that reflect the Company's current expectation regarding future events. Forward-looking statements and information are necessarily based upon a number of estimates and assumptions that, while, considered reasonable by management, are inherently subject to significant business, economic and competitive uncertainties and contingencies. Readers are cautioned that any such forward-looking statements and information are not guarantees and there can be no assurance that such statements and information will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements and information. These forward-looking statements and information involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting. The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements and information whether as a result of new information, future events or otherwise. All written and oral forward-looking statements and information attributable to us or persons acting on our behalf
1 Mycobacterium phlei cell wall-nucleic acid complex
2 Morales A, Herr H, Steinberg G, et al. Efficacy and safety of MCNA in patients with nonmuscle invasive bladder cancer at high risk for recurrence and progression after failed treatment with bacillus Calmette-Guérin. J Urol. 2015; 193: 1135-1143.
SOURCE Telesta Therapeutics Inc.
For further information: Donald Olds, Chief Operating Officer, Telesta Therapeutics Inc., Telephone: (514) 394-7921, [email protected]