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RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS
9 Months Ended
Sep. 30, 2013
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS  
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS

Note 2 — RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS

 

In 2010, Lpath entered into an agreement providing Pfizer Inc. (“Pfizer”) with an exclusive option for a worldwide license to develop and commercialize iSONEP™ (the “Pfizer Agreement”), Lpath’s lead monoclonal antibody product candidate that is being evaluated for the treatment of wet age-related macular degeneration (“wet AMD”) and other ocular disorders.  iSONEP is currently being studied by Lpath in a Phase 2 clinical trial as both monotherapy and adjunctive therapy in wet-AMD patients.

 

The company expects to complete dosing the last Nexus trial patient during the first half of 2014. The actual time required to complete our clinical trials will depend upon a number of factors outside of our direct control, including those discussed in our 2012 Annual Report “Risk Factors — We may have delays in completing our clinical trials, and we may not complete them at all.”

 

Following completion of the clinical trial, Pfizer has the right to exercise its option for worldwide rights to iSONEP for an undisclosed option fee and, if Pfizer exercises its option, Lpath will be eligible to receive development, regulatory, and commercial milestone payments that could total up to $497.5 million.  In addition, Lpath will be entitled to receive tiered double-digit royalties based on sales of iSONEP. As part of the agreement, Lpath has granted to Pfizer a time-limited right of first refusal for ASONEP™, Lpath’s product candidate that is being evaluated for the treatment of cancer.

 

In October 2013, Lpath announced that it had received notice from Pfizer that Pfizer is currently seeking to divest certain ophthalmology research and development assets, including Pfizer’s exclusive option under the Pfizer Agreement.  Lpath has presented an offer to Pfizer to reacquire these rights, and Lpath believes that a number of third parties may have an interest in acquiring these rights as well. Acquisition of the iSONEP option by a third party would not affect the terms of the Pfizer Agreement, as the existing rights and obligations currently held by Pfizer would either transfer to the third party or remain with Pfizer.

 

The company recognized revenue under the Pfizer Agreement as follows:

 

 

 

Nine Months Ended

 

Three Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2013

 

2012

 

2013 

 

2012

 

Cost reimbursements

 

$

—

 

$

1,916,250

 

$

—

 

$

—

 

Amortization of license and development fees

 

4,336,036

 

2,826,920

 

1,845,021

 

1,060,057

 

 

 

$

4,336,036

 

$

4,743,170

 

$

1,845,021

 

$

1,060,057