Date: 2014-11-05
Type of information: Milestone
Compound:
Company: Genvec (USA - MD) Novartis (Switzerland)
Therapeutic area: Otorhinolaryngology
Type agreement: R&D
licensing
Action mechanism:
Disease: hearing loss and balance disorders
Details: * On January 27, 2012, GenVec has announced the extension of its Research Collaboration and License Agreement with Novartis. In January 2010, the companies entered into a worldwide licensing and collaboration agreement to discover and develop novel treatments for hearing loss and balance disorders. Under the terms of the agreement, if certain clinical, regulatory, and sales milestones are met, GenVec is eligible to receive up to $213.6 million, including upfront and milestone payments in addition to royalties on future sales. In August 2010, GenVec entered into an additional agreement with Novartis, to manufacture clinical trial material for up to two lead product candidates for this program.
Financial terms: In January 2010, GenVec entered into a worldwide licensing and collaboration agreement with Novartis to discover and develop novel treatments for hearing loss and balance disorders. Under the terms of the agreement, if certain clinical, regulatory, and sales milestones are met,GenVec is eligible to receive up to $213.6 million, including upfront and milestone payments, in addition to royalties on future sales. Under the extension, Novartis will fund research at GenVec through January 2013 to support its hearing loss and balance disorders program.
Latest news: * On May 2, 2016, GenVec announced that it was notified by Novartis that the Data Safety Monitoring Board (DSMB) for the Phase 1/2 clinical trial) of CGF166 in patients with severe to profound hearing loss has recommended that the trial continue, subject to approval by the FDA. * On November 5, 2014, GenVec announced that the company has achieved a milestone in its collaboration with Novartis for the development of treatments for hearing and balance disorders. Novartis has dosed the first patient in a clinical study to assess the safety, tolerability, and efficacy of intra-labyrinthine (IL) CGF166 in patients with severe hearing loss. Under the terms of the collaboration agreement this triggers a $3 million milestone payment to GenVec. The next anticipated milestone will be the dosing of the first patient in a Phase 2B study of the experimental drug. * On February 13, 2014, GenVec has announced that the company has achieved the third milestone in its collaboration with Novartis for the development of treatments for hearing and balance disorders. In January 2014, Novartis filed an Investigational New Drug (IND) application with the FDA for the clinical development of CGF166, the lead product candidate under the collaboration. The IND was deemed effective on February 7, 2014 and this triggered a $2 million milestone payment to GenVec under the terms of the collaboration.
