Date: 2015-10-28
Type of information: Licensing agreement
Compound: MCNA (Mycobacterium phlei Cell wall-Nucleic Acid complex)
Company: Ipsen (France) Telesta Therapeutics (Canada)
Therapeutic area: Cancer - Oncology
Type agreement: licensing development commercialisation
Action mechanism: live product. MCNA is a biologic therapy developed to provide high risk non-muscle invasive bladder cancer patients who are refractory to or relapsing from front line therapy with bacillus Calmette-Guérin (BCG) with a therapeutic alternative to surgery. MCNA is 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 anticancer 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.
Disease: high risk non-muscle invasive bladder cancer (NMIBC)
Details: * On October 28, 2015, Ipsen and Telesta Therapeutics announced that they have entered into an exclusive licensing agreement for Ipsen to develop and commercialize MCNA for the treatment of high risk non-muscle invasive bladder cancer (NMIBC) in all countries of the world, with the exception of the United States, where Telesta is establishing commercial operations, Canada, South Africa, Mexico, South Korea and Japan. Telesta recently filed a Biologics License Application (BLA) with the FDA for MCNA for the treatment of high risk non-muscle invasive bladder cancer patients who are refractory or relapsing from BCG front-line treatment. The FDA has assigned priority review to Telesta’s BLA with a review (PDUFA) date of February 27, 2016. Telesta retains full and sole ownership of MCNA rights in the US and Japan and will be responsible for the commercial launch of MCNA in the United States while Ipsen will initiate discussions with regulatory authorities to identify the regulatory path and potential requirements for the product in Europe and other key licensed territories.
Financial terms: Under the financial terms of the agreement, Telesta is eligible to receive up to $137 million in upfront and milestone payments comprising a $10 million upfront payment and additional payments contingent upon achievement of regulatory and sales milestones. In addition, Telesta is eligible to receive meaningful tiered double-digit royalties on net sales of MCNA in the licensed territories.
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