Transgene has signed an exclusive agreement with Novartis for the development and commercialisation of a new targeted immunotherapy product for non-small cell lung cancer (NSCLC) and other potential cancer indications.
The two companies will form a joint working group to oversee the implementation of the global development program.
Transgene has granted Novartis an option to acquire an exclusive worldwide license for the therapy, for which, Novartis will pay a $10 million option fee.
If Novartis takes up this option and the development, regulatory and commercial milestones in various indications are achieved, Transgene will receive up to €700 million.
Transgene will retain control over the next clinical development phase of the drug, a pivotal, global phase IIb/III clinical trial. The study will involve approximately 1,000 patients with MUC1-positive NSCLC who have normal levels of activated Natural Killer (NK) cells at time of trial entry. The final results of the trial are expected by the end of 2013.
If Novartis opts to acquire the drug, the company will assume all development, regulatory and commercialisation costs across all indications. Transgene will receive a non-refundable licence issuance fee, further payments based on certain targets and royalties on global sales.
Transgene will also retain primary manufacturing rights, as well as co-promotion rights in certain countries including France and China.
“We are delighted to have reached this agreement with Novartis and believe they will be an excellent partner for TG4010, given their broad expertise, experience and resources in oncology and their long standing world-class research and development capabilities in cancer immunology,” commented Philippe Archinard, Chief Executive Officer of Transgene.
“We now look forward to closely working with Novartis in order to rapidly advance the Phase IIb/III development of TG4010 so that cancer patients may benefit from a new treatment option.”