The transaction will give Meda exclusive rights to distribute Onsolis in all countries except Taiwan and South Korea for a one-time cash payment to BDSI of $3 million. The royalty rate will be the same as that agreed to for distribution rights in Europe.
BDSI has previously granted Meda the rights to distribute Onsolis in the US, Canada, Mexico and Europe and will retain the rights for Taiwan and South Korea.
BDSI and Meda have also agreed on a $3 million advance by Meda against the anticipated aggregate $30 million approval milestone owed by Meda for Onsolis.
Based on a review period as indicated to BDSI by the FDA of up to six months, approval of Onsolis is anticipated during the second quarter of 2009.
Additionally, as a result of a continuing dialog between BDSI and Meda and their monitoring of the opioid market in preparation for the commercial launch of Onsolis, the companies have agreed to make certain adjustments to Meda’s commercial plan in North America.
Mark Sirgo, president and CEO of BDSI, said: This $6 million in total proceeds will allow us to continue to support the regulatory and manufacturing requirements for Onsolis in preparation for approval and launch that we continue to anticipate in the second quarter of 2009, and will also allow us to progress our other pipeline products.