Javelin Pharmaceuticals, Inc has entered into an exclusive European marketing partnership for Dyloject (diclofenac sodium for injection) with Therabel Pharma NV (Therabel), worth up to $71 million in upfront, sales, and regulatory milestone payments plus a double digit royalty on future sales.
"Partnering Dyloject in Europe bolsters our financial resources and extends our cash until 2010 before achieving future milestones and potential additional product partnerships. We are retaining significant upside in Dyloject's future EU growth with a high quality marketing partner while eliminating our European commercialization expenses," stated Martin Driscoll, Javelin's CEO. "We are excited to be partnering with Therabel, with their demonstrated market success in hospital sales and pain management products in the EU. We believe Therabel will accelerate market uptake for Dyloject in the UK and will assure future growth as Therabel introduces the product in key countries throughout the European Union."
Javelin will receive approximately $12 million in upfront cash payments, inclusive of its Dyloject inventory, and up to $59.5 million in sales and regulatory milestones. In addition, Javelin will earn a double digit royalty on future net sales of Dyloject in all countries covered by the agreement.
Upon closing, Therabel will assume all Dyloject commercialization, regulatory, and manufacturing responsibilities and expenses in the UK along with those for future European market approvals. Javelin will remain involved in Dyloject's EU development through a Joint Steering Committee. The agreement will become effective upon receipt of customary third party licensing consents.
John Taylor, vice president of Business Development for Javelin, commented, "Today's announcement is the culmination of a competitive process for the commercial rights to Dyloject in the EU. Therabel's enthusiasm for Dyloject in Europe validates the product's opportunity and instils confidence in completing a major partnership in the US for Dyloject or Ereska."
Dyloject is an injectable formulation of diclofenac in Phase 3 clinical development in the United States and marketed in the United Kingdom.
With corporate headquarters in Cambridge, MA, Javelin applies innovative proprietary technologies to develop new drugs and improved formulations of existing drugs to target unmet and underserved medical needs in the pain management market.