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InSite regains development rights, joins Merck in patent lawsuit

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InSite Vision Inc. announced that the company has signed an agreement to regain North American development rights to azithromycin ophthalmic solution 2%, trademarked as AzaSite Xtra, from Inspire Pharmaceuticals Inc., a subsidiary of Merck & Co. Inc, according to an InSite press release.

Under the terms of the agreement, a joint development committee composed of representatives from both companies will oversee development and submission of applications for regulatory approval in the U.S. and Canada for AzaSite Xtra, according to the release.

Merck retains an option to acquire AzaSite Xtra for a one-time payment and royalties on any product sales, it said.

AzaSite (azithromycin ophthalmic solution) 1% is indicated for the treatment of bacterial conjunctivitis in patients 1 year and older caused by the following organisms: CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group and Streptococcus pneumoniae, the release said.

InSite also announced in a separate press release that it will join Merck and Pfizer Inc. in filing a patent infringement lawsuit against Mylan Pharmaceuticals Inc.

Mylan recently filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking to market a generic version of AzaSite before expiration of the patents covering AzaSite and its use.

This lawsuit triggers an automatic stay, or bar, of the FDA’s approval of the ANDA for up to 30 months or until a final court decision of the infringement lawsuit, whichever comes first, the release said.

On May 26, 2011, InSite and Merck filed a similar patent infringement lawsuit against Sandoz Inc. A trial date for the Sandoz ANDA suit has been set for July 11, 2013. The companies have agreed that Merck will take the lead in prosecuting both lawsuits. Each company will be responsible for their own legal costs, with InSite assuming a monitoring role, according to the release.