Lpath (LPTN) Enters Option w/ Pfizer (PFE) Over iSONEP; Has Value Up to $497.5M + Royalties
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On December 16, 2010, Lpath, Inc. (Nasdaq: LPTN) entered into an Option, License and Development Agreement (the “Agreement”) with Pfizer Inc. (NYSE: PFE), which provides Pfizer with an exclusive option for a worldwide license to develop and commercialize iSONEP, the Company’s lead monoclonal antibody product candidate, which is being evaluated for the treatment of wet age-related macular degeneration (wet AMD) and other ocular disorders.
Under the original terms of the Agreement, Pfizer and the Company planned to conduct two studies, including a Phase 1b study in wet AMD patients with Pigment Epithelial Detachment (PED), a complication of wet AMD (the “PEDigree trial”), and a larger Phase 2a study in wet AMD patients generally (the “Nexus trial”). The Company began enrolling patients in the PEDigree and Nexus trials in September 2011 and October 2011, respectively.
As a previously announced, the PEDigree and Nexus trials were placed on clinical hold in January 2012 following a determination by the FDA that the fill-and-finish contractor that had filled the iSONEP clinical trial vials was not in compliance with the FDA’s current Good Manufacturing Practice (“cGMP”) standards during the time period it provided those services to the Company. Thereafter, the Company manufactured new iSONEP drug substance and resumed dosing patients in the Nexus trial in September 2012.
As a result of the clinical hold and the requirement to manufacture new drug substance, the projected costs to complete the iSONEP trials increased significantly. As previously announced, Pfizer requested the Company to consider potential alternatives to reduce the overall cost of the iSONEP trials.
On December 5, 2012, the Company and Pfizer amended the Agreement (the “Amendment”) to, among other things, reflect the parties’ agreement to discontinue the PEDigree trial and to focus on the Nexus trial. The parties modified the protocol for the Nexus trial to include certain wet AMD patients with PED in the Nexus trial. In addition, the Company can elect to conduct the PEDigree trial at any time at its cost. Under the terms of the Amendment, the parties will continue to pursue and share the cost of the iSONEP trials, including any costs associated with discontinuing the PEDigree trial.
As of September 30, 2012, Pfizer had paid the Company $20.0 million pursuant to the terms of the Agreement, including an upfront payment of $14 million. The Amendment does not modify the Company’s obligation to fund the next $6.0 million of Nexus trial costs.
As previously announced, the Company resumed dosing patients in the Nexus trial in September 2012. The Company expects to complete the Nexus trial during the first quarter of 2014. Following completion of this study, Pfizer has the right to exercise its option for worldwide rights to iSONEP for an undisclosed option fee and, if Pfizer exercises its option, the Company will be eligible to receive development, regulatory and commercial milestone payments that could total up to $497.5 million. In addition, the Company will be entitled to receive tiered double-digit royalties based on sales of iSONEP.
Under the original terms of the Agreement, Pfizer and the Company planned to conduct two studies, including a Phase 1b study in wet AMD patients with Pigment Epithelial Detachment (PED), a complication of wet AMD (the “PEDigree trial”), and a larger Phase 2a study in wet AMD patients generally (the “Nexus trial”). The Company began enrolling patients in the PEDigree and Nexus trials in September 2011 and October 2011, respectively.
As a previously announced, the PEDigree and Nexus trials were placed on clinical hold in January 2012 following a determination by the FDA that the fill-and-finish contractor that had filled the iSONEP clinical trial vials was not in compliance with the FDA’s current Good Manufacturing Practice (“cGMP”) standards during the time period it provided those services to the Company. Thereafter, the Company manufactured new iSONEP drug substance and resumed dosing patients in the Nexus trial in September 2012.
As a result of the clinical hold and the requirement to manufacture new drug substance, the projected costs to complete the iSONEP trials increased significantly. As previously announced, Pfizer requested the Company to consider potential alternatives to reduce the overall cost of the iSONEP trials.
On December 5, 2012, the Company and Pfizer amended the Agreement (the “Amendment”) to, among other things, reflect the parties’ agreement to discontinue the PEDigree trial and to focus on the Nexus trial. The parties modified the protocol for the Nexus trial to include certain wet AMD patients with PED in the Nexus trial. In addition, the Company can elect to conduct the PEDigree trial at any time at its cost. Under the terms of the Amendment, the parties will continue to pursue and share the cost of the iSONEP trials, including any costs associated with discontinuing the PEDigree trial.
As of September 30, 2012, Pfizer had paid the Company $20.0 million pursuant to the terms of the Agreement, including an upfront payment of $14 million. The Amendment does not modify the Company’s obligation to fund the next $6.0 million of Nexus trial costs.
As previously announced, the Company resumed dosing patients in the Nexus trial in September 2012. The Company expects to complete the Nexus trial during the first quarter of 2014. Following completion of this study, Pfizer has the right to exercise its option for worldwide rights to iSONEP for an undisclosed option fee and, if Pfizer exercises its option, the Company will be eligible to receive development, regulatory and commercial milestone payments that could total up to $497.5 million. In addition, the Company will be entitled to receive tiered double-digit royalties based on sales of iSONEP.
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