On August 26, 2019 PharmaMar (MSE:PHM) has reported that it entered into a new Licensing Agreement with Janssen Products, LP (Janssen) for Yondelis (trabectedin), which replaces the 2001 Licensing Agreement entered into by both parties (Press release, PharmaMar, AUG 26, 2019, View Source [SID1234538972]).
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Under this new Licensing Agreement, Janssen will retain the right to sell and distribute, on an exclusive basis, Yondelis and any other product containing its active substance in the United States (U.S.). Both companies may agree to share new product research. The milestones and royalties on Janssen’s U.S. net sales of the product remain the same as in the 2001 Licensing Agreement.
PharmaMar will maintain the exclusive production rights of active ingredient trabectedin, which will be supplied to Janssen for clinical and commercial use.
Simultaneously, PharmaMar and Janssen have entered into a Master Product Transfer Agreement (MPTA), under which Janssen will transfer to PharmaMar all of Janssen’s rights to the compound in the rest of the countries previously licensed to Janssen. This includes all countries of the world with the exception of U.S., Europe and Japan, the last being licensed and marketed by Taiho Pharmaceuticals Co. Ltd.
The implementation of this transfer agreement will take place gradually depending on the specific regulatory requirements of each country. PharmaMar, together with Janssen, is committed to ensuring the supply of Yondelis during the transfer. Janssen will continue to sell the product until the transfer of the marketing authorizations to PharmaMar are complete.
This MPTA will enable PharmaMar to distribute Yondelis in more than 40 additional countries where the product has already been approved. PharmaMar plans to market Yondelis through local partners and does not rule out the possibility of new applications, and health regulatory submissions and approvals in more countries where the product is not currently approved.
Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.