Just two weeks after signing a U.S. development and marketing rights agreement for milnacipran, Cypress Bioscience Inc. exercised its option to license the drug's patent portfolio from Collegium Pharmaceutical Inc.

The option came out of the companies' reformulation and new product agreement in August 2002. The patent portfolio contains reformulations and new analogues of milnacipran developed by Collegium under that agreement.

"The basic goal and the reason we entered into this a few years ago was to really try to develop milnacipran-related products that would extend our franchise through patent-protected analogues or formulations of the product," said Sabrina Martucci Johnson, chief financial officer of San Diego-based Cypress, "and also to attempt to come up with follow-on products that might have better performance than the current formulation."

Earlier this month, Cypress partnered with New York-based Forest Laboratories Inc. in a deal worth up to $250 million for the U.S. development and marketing rights for milnacipran. (See BioWorld Today, Jan. 12, 2004.)

Cypress is studying the product in a Phase III program to treat fibromyalgia, a syndrome that affects between 6 million and 12 million people in the U.S., causing them chronic pain. Currently, there are no products on the market for fibromyalgia. The company expects to file a new drug application in 2006.

Cypress's collaboration with Collegium has resulted in a number of patent applications, all of which now are exclusively licensed to Cypress. Collegium will receive an undisclosed license payment, development-based milestone payments and royalties from any products that go to market.

"It's very important to us for a couple of reasons," said Jessica Wolfe, vice president of communications at Collegium, of Cumberland, R.I. "We have a large skill set in product life extensions and also development of analogues as new drugs. Milnacipran, based on Cypress's work, has a very promising future. For us, it's a very good marriage of the companies' two skill sets, where we can bring them our skills in extending their franchise."

Forest will have an option to acquire an exclusive license from Cypress in the U.S. and Canada to any compounds developed under the agreement with Collegium.

Milnacipran is the first of a new class of drugs called norepinephrine serotonin reuptake inhibitors. It is marketed in 22 countries outside of the U.S. for non-pain indications, including depression, and it has demonstrated safety in more than 2 million patients.

With the newest agreement, Cypress and Collegium plan to find the best-acting formulation of milnacipran. Company researchers will look at the drug as a sustained-release or extended-release compound, and they will work to identify particular needs for different patient populations, such as pediatric or geriatric patients. The companies also will look at whether particular versions of the drug cause certain side effects, and they will attempt to reduce those side effects.

"The other thing we're excited about is this is a relatively new class of antidepressants," Wolfe said.

Cypress licensed milnacipran from Pierre Fabre Medicament SA, a division of Paris-based bioMerieux Pierre Fabre, in August 2001. Cypress holds an exclusive license to develop and sell any products with the compound as an active ingredient for any indication in the U.S. and Canada. It started the Phase III trials in fibromyalgia in October.

While the drug is marketed in other countries, it never came to market in the U.S. The compound sat on the shelf for a while, while other antidepressants were developed.

"It just did not have enough patent life left to make it worthwhile for someone to develop it in the U.S." for depression, Martucci Johnson told BioWorld Today.

The composition-of-matter patent for milnacipran expired in 2002. Once Cypress chooses an optimum formulation for milnacipran, gaining patent protection, it can extend its franchise into other indications for milnacipran.

"Right now it would be a little challenging to do because we don't have patent protection," Martucci Johnson said.

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