By Brady Huggett

Inspire Pharmaceuticals Inc. and Allergan Inc. are scratching each other¿s backs in a licensing, development and marketing deal ¿ potentially valued at $39 million ¿ for their dry-eye products.

The agreement covers Inspire¿s INS365 Ophthalmic and Allergan¿s Restasis, both of which are in Phase III trials. It is Allergan¿s experience, both scientifically and in the market, that won over Inspire, said Mary Bennett, vice president, operations and communications, at Inspire.

¿[Allergan] is a real leader in dry eye,¿ she said. ¿They basically have a very strong background in ophthalmology and a very strong commercial capability.¿

Irvine, Calif.-based Allergan also saw something it liked.

¿It¿s [Inspire¿s] technology in P2Y2 receptors,¿ said Christine Cassiano, manager of public relations at Allergan. ¿And that is part of the components in tears. They are an excellent partner for Allergan and their expertise should be complementary to our products.¿

Allergan obtains an exclusive license to develop and commercialize INS365 Ophthalmic worldwide, with the exception of Japan and nine other Asian countries covered by Inspire¿s agreement with Santen Pharmaceutical Co. Ltd., of Osaka, Japan. Inspire could receive up to $39 million in up-front and milestone payments, but also it has a co-promotion arrangement for INS365 Ophthalmic in the United States and will get payments based on sales.

In the agreement, Inspire, of Durham, N.C., has an option to co-promote Allergan¿s Restasis in the U.S. and can receive royalties on net sales of Restasis, excluding the Japan, Taiwan, Korea, Hong Kong and China markets. Lastly, the agreement provides for Inspire to potentially co-promote at least one separate Allergan product ¿ one either currently on the market or one in the future.

¿We will create joint project teams and these teams will work together to complete the Phase III development of INS365,¿ Bennett told BioWorld Today. ¿From that point, Allergan will take it forward and do all the remaining work ¿ manufacturing, logistics, etc.¿

Bennett said the co-promotion of INS365, besides helping sales, also will be a valuable teaching tool.

¿It¿s just much better for a product if you have it co-promoted,¿ she said. ¿More importantly to us, we are establishing an ophthalmology franchise. We are partnering where we think we need to. During the next couple of years, we will be building marketing capabilities. This will allow us to build that and then market on our own.¿

Inspire has a product for retinal detachment in Phase I/II trials now. That product, Bennett said, Inspire would like to keep all to itself. With the building of a capable marketing core, it should be able to do so, she said.

The agreement is built on the assumption that both Restasis and INS365 Ophthalmic receive regulatory approval. Bennett said the Phase III trial for INS365 Ophthalmic is making ¿excellent¿ progress ¿ it is more than 50 percent enrolled and is on target to finish next year. If all goes well, the company is anticipating a new drug application filing in the latter half of 2002 and a product launch sometime in 2003. Things are much the same on Allergan¿s end with Restasis, Cassiano said.

¿We expect the Phase III to be done by mid-2003 and we would file then,¿ she said. ¿And we hope to get approval by late 2003.¿

Bennett said the contract has built-in clauses that cover the failure of either product before approval.

Inspire has five products in the clinic, three of which are respiratory products recently returned to Inspire from Genentech Inc., of South San Francisco. It also has a cancer diagnostic product in Phase III trials and a preclinical product being developed for vaginal dryness. That product, Bennett said, is ¿getting close¿ to the clinic. (See BioWorld Today, June 21, 2001.)

The broken deal with Genentech could have been worth $78 million. But with the $39 million coming from Allergan, Inspire is looking to grow.

¿We think this is a tremendous opportunity for Inspire,¿ Bennett said. ¿It allows us to build our ophthalmology franchise. Also, it gives us some financial security.¿

Inspire¿s stock (NASDAQ:ISPH) rose 6 cents Wednesday to close at $12.09. Allergan¿s stock (NYSE:AGN) rose 70 cents to close at $82.20.

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