Cypress Bioscience Conference Call - Final.

Original Source: FD (FAIR DISCLOSURE) WIRE

JAY KRANZLER, CHAIRMAN, CEO, CYPRESS BIOSCIENCE: Good morning, and welcome to Cypress' conference call summarizing the topline results from our second pivotal Phase III trial of Milnacipran for the treatment of fiber myalgia. I'm Jay Kranzler, Cypress' Chairman and CEO. Before beginning my remarks I must remind you that this conference call as well as Cypress' SEC filings and website at Cypressbio.com contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the potential of Milnacipran to treat fibromyalgia syndrome and our continued development of Milnacipran, including our proposed NDA filing timeline. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress' annual report on Form 10-K, the most recent quarterly report on Form 10-Q, and any subsequent SEC filings, including but not limited to the Form 8-K that was filed on May 22, 2007.

Let me first start by providing a few details about this morning's logistics. Because of the level of investor interest in Cypress' recent news release, there will be two chances to catch my remarks. First, right now, during this conference call, and then again at 10:30 a.m. Eastern standard time as part of the Citibank healthcare conference, either by your attendance in person at that session or via the simultaneous webcast. My formal remarks in both settings will be identical, so I don't recommend you listen to both. Each is expected to last about 20 minutes. After I've completed my formal remarks, we'll have a 20-minute question-and-answer period, both following this call as well as in a separate breakout session following the presentation at the conference.

Although you may not have heard much from me since then, many of you will recall that I hosted Cypress' last conference call. It goes back more than 18 months ago in conjunction with a similar investment conference in New York City in which I described and bemoaned our less-than-perfect results from our first Phase III experience with Milnacipran, yet also asserted our continued conviction in Milnacipran's ultimate promise. This complex message was further complicated by the fact that Cypress was the first to report any Phase III findings in fibromyalgia and as a result any question specific to Milnacipran's promise as a drug were also being evaluated in the context of healthy skepticism within the investment community as to whether it would be possible to develop drugs to treat FMS, that could meet the standards for regulatory approval.

I like the situation a lot better today. My task is simpler as I have the benefit of working with data while directionally consistent with the last trial is far more robust and therefore more compelling. Moreover, our results combined with data reported by others in the field have shifted the discussion from whether there'll be drugs approved for FMS to which drugs will be approved and when. I hope and expect that yesterday's results combined with today's presentation will convince you of Milnacipran's potential to play an important role and build strong position in this newly developing and clinically needy market.

First, let me introduce you to the players who contributed to this program. Although I'm speaking today as a representative of Cypress, yesterday's news was issued in a joint release by Cypress and our long-standing corporate partner, Forest Laboratories reflecting the substantial contributions of resources, ideas, and efforts from both teams acting together as one. While Forest is not formally represented on this call, their work is represented in the results that I will present. With me on the call from Cypress are Sabrina Johnson, our Chief Business Officer and CFO; Mike Gendreau, our Chief Financial Officer; Srini Rao, our Chief Scientific Officer; and Denise Wheeler, our VP of Legal Affairs. Although I'll take the lead in today's presentation, as I do once every 18 months or so, it's only to give the others a break, as Mike, Srini, and the others on the team have been working hard over the many intervening months with their counterparts at Forest Labs to ensure effective design and efficient execution of the clinical trial program.

Meanwhile, Sabrina and Denise have shouldered the bulk of our Investor Relations activities over the past year, which was quite a challenge as Sabrina patiently repeated the same presentation over and over again at investor conferences and continued to cultivate our investment base despite having very little new to answer to investors' ongoing questions. We're lucky we have retained the entire team that was represented in Cypress' last conference call, who while disappointed by the earlier results, remain confident of the drug's efficacy and believe that by incorporating lessons from the first round to subsequent designs we'd be able to demonstrate Milnacipran's efficacy with greater clarity.

Likewise, we maintained our strong partnership with Forest Laboratories, who shared our positive view of the prior results and committed significant corporate resources to ensure that we move the program along as quickly as possible. As a result, our clinical teams completed the largest fibromyalgia trial reported to date, 1200 patients, which will be the subject of today's discussion while initiating a third trial in the U.S. and supporting a fourth one run by our partner Pierre Fabre in Europe. Pierre Fabre also is absent from today's call and was not directly involved in the U.S. trials for Milnacipran, but their discovery of the drug and historical development and commercialization of the product as an antidepressant enabled and accelerated our own development efforts.

Today, I'm happy to report all of the Company's principals involved as well as our respective investors are being rewarded for our collective patience and perseverance with strong clinical results that confirm Milnacipran's…