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Allergan's Actions
There were several parties due royalties from Allergan based on the future sales of Restasis®. UGA and in turn, Dr. Kaswan were due royalties. Novartis, the initial licensor of the patent and also Inspire Pharmaceuticals had royalty arrangements with Allergan tied to future Restasis® sales. Niv Caviar, self-styled "deal maker for Allergan", was the architect of the secret "Florida Plan", the strategy developed to buy out royalty obligations at a huge discount by convincing Allergan's partners that Restasis® was a risky proposition at best, with an uncertain sales future. By obtaining a deeply discounted buy-down agreement with UGARF and their other partners, Allergan would avoid hundreds of millions, perhaps a billion dollars in future royalty payments that would have otherwise been due to their Restasis development partners, and Caviar would distinguish his young career.

Allergan has fought to keep the court documents and records under court seal and obscured from public scrutiny. Niv Caviar, self-styled “deal maker for Allergan” was the designer of the “Florida Plan,” the strategy developed to convince Allergan's partners in Restasis® that it was a risky proposition at best, with an uncertain sales future.

Allergan delayed the roll out of the consumer targeted television commercials in order to keep 2003 revenues in the "underperforming range" to support the grossly underestimated sales projections Caviar suggested to UGARF during the buy-down negotiations that Allergan and Inspire had jointly submitted and discussed with FDA. Stockholder class actions suits subsequently waged against Inspire, but not Allergan, alleged public misrepresentation of the anticipated FDA diquafosol approval.

Caviar falsely informed UGARF that Allergan and Inspire's competing product, diquafosol, would be FDA approved imminently and urged UGARF to sign before Allergan executives could recant the offer. This misrepresentation caused analysts for UGARF to include erroneous risk factors in their sales projections, as well as false urgency to seal the deal. Days after execution of the buy-down agreement, the FDA denied approval of diquafosol based on poor efficacy results.

Allergan was well aware of the poor clinical trial results of diquafosol, and its imminent rejection for FDA approval. In fact, in January 2002, Inspire Pharmaceuticals, Allergan's partner in the development of diquafosol saw a nearly 75% plunge in stock price when the company reported poor results in their first set of clinical trials. Subsequent clinical trials fared no better; the treatment was appanrently no more effective than placebo.

Allergan's CEO, David E.I. Pyott stated, “Given the challenges associated with the research, development and regulatory approval of dry eye pharmaceuticals, we have always taken a conservative approach and have not included diquafosol in our strategic plans. Instead, our strategic plans have focused on vigorously building Restasis®, the only pharmaceutical approved by the FDA for the treatment of chronic dry eye disease."

Allergan has staunchly litigated to keep their UGA contract and legal proceedings secreted from public review and under court seal. However, Georgia Sunshine Laws require contracts between state agencies and private corporations be made public.

Also of Interest...

The Patent Litigation Explosion

How Can Research Networks Improve the Innovation Process?

Court Opinion: Bayh-Dole Is Not a Patent Law

 
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