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news.IntelGenx has acquired full rights to, and ownership of, CPI-300, a high strength formulation of Bupropion hydrochloride (HCl), the active ingredient in Wellbutrin XL. At present, patients requiring a high dosage are prescribed multiples of the lower strengths of HCl tablets.
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On May 7, 2010, IntelGenx executed a project transfer agreement with Cary Pharmaceuticals, its former development partner, whereby Cary assigned its 50% ownership stake in CPI-300 to IntelGenx.
Pursuant to the agreement, IntelGenx and Cary have agreed to terminate the collaborative agreement entered into in November 2007 and the they further agreed that the CPI-300 project will be transferred and assigned to IntelGenx.
In addition, Cary has assigned to IntelGenx all rights and interest in the regulatory approvals that Cary has or may have had, including the new drug application (NDA), and IntelGenx will be responsible for the costs associated therewith. IntelGenx will have full and complete authority with respect to the prosecution and/or amendment of the NDA and the commercialisation of the product and/or the technology encompassed in the CPI-300 project.
IntelGenx will also assume all obligations to, and responsibility for, the Biovail litigation, including the costs thereof. In addition to certain potential pre-commercialization payments, IntelGenx will pay Cary, upon commercialization of CPI-300, 10% of sales royalties received by IntelGenx and 3% of upfront payments received by IntelGenx should a distribution agreement be signed in the future.
Horst Zerbe, president and CEO of IntelGenx, said: “We are very excited to have acquired full control and ownership of CPI-300 at this critical juncture in the product’s development. The manufacturing site change for the product has progressed as planned and engineering scale-up batches at Pillar5 have already been manufactured.
“In addition, we have a meeting scheduled with FDA in early June to address their complete response letter and clarify the required steps to obtain product approval. Finally, the Markman hearing in respect of the Biovail litigation is also scheduled for early June, and we remain optimistic for a positive outcome.
“The timing of this acquisition should yield substantial value to the company and its shareholders because we believe it is an excellent product that will become commercialized in the near future.”