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Biotech / Medical : Ionis Pharmaceuticals (IONS) -- Ignore unavailable to you. Want to Upgrade?

To: Mailbu who wrote (2271)	9/4/1998 8:00:00 PM
From: G-MAN	Read Replies (3) \| Respond to of 4676

Letter from Stanley Crooke on ISIS website: September 3, 1998 Dear Isis Friends: We have just achieved a seminal accomplishment: FDA approval of VitraveneTM , the first antisense drug. Patients with CMV retinitis will derive extraordinary benefit from VitraveneTM and all of us at Isis are thrilled to play a role in preserving sight in these late stage AIDS patients and easing their medical burden. My purpose in writing this letter is to place the recent approval of our first antisense drug, VitraveneTM , in the context of our overall progress to date, and to give you my perspective on where we stand with antisense technology today. I also would like to describe the emotions we feel at Isis about the behavior of our stock price relative to our performance against the goals we established for 1998. The approval of VitraveneTM is another important piece in the mosaic of proof that antisense technology works and that it will be the revolution in drug discovery and development we all hoped. It demonstrates that the technology can be used to create a remarkably safe and effective drug to treat a terrible disease. Further, the rapid approval of the NDA demonstrates unequivocally that we can manufacture, analyze, formulate and test antisense drugs rigorously enough to meet FDA standards. This accomplishment represents a dramatic reduction in the overall risk of the technology. It also says something important about Isis: Professional management and drug discovery and development experience have allowed us to succeed against extremely difficult odds, while others failed. We are extraordinarily proud of the fact that the first NDA for an antisense drug was approved in just five months. Our investors should be equally proud and very reassured. The importance of the approval of VitraveneTM , needs to be considered in the context of all the other data we have generated about antisense technology. We have demonstrated clinical efficacy in patients with Crohn's disease with ISIS 2302. We have reported preliminary evidence of antitumor activity in patients with cancer for ISIS 3521 and ISIS 5132. We have also shown evidence in these patients that these drugs produce antisense effects, that is, a specific reduction in the target RNA. In studies involving more than 2,000 human beings, we have shown that the first generation antisense drugs have attractive safety. We have scores of examples of antisense activity in animals. We are moving toward the clinic with members of new chemical classes of antisense drugs that are potentially more potent, can be dosed far less frequently, have fewer nuisance side effects, and may be active orally. In short, the evidence is overwhelming that antisense technology works, that we can use it to treat a broad range of diseases, and that the best is yet to come. I have personally never been more confident of the technology or the leadership position in the technology enjoyed by Isis. We are gratified by the response of the scientific community to the evidence in support of the technology we have published and their recognition of the contributions made by Isis. I have never been more proud of the Company's operating performance. My colleagues at Isis share these feelings. Does all this mean that every antisense drug will succeed for every indication? No. Does it mean that every technological hurdle has been overcome? No. There is still much to do. It does mean that the promise of antisense is enormous, and the approval of VitraveneTM represents one more giant step in bringing the dream to reality. We are continuing to create value at all levels in the Company, and I firmly believe that the financial community will recognize this value, in due course. So, why hasn't our stock performed better? I don't know. Given our achievements, I am frustrated by the failure of the stock to outperform the biotech sector. No one I have spoken with has a rational explanation for the decline in our stock price, or what to do about it. Recently, of course, our stock price has been negatively affected by the global market decline, as have so many other stocks. I can tell you that we are examining everything we are doing relative to communication strategies to see if there is more we can do to educate the public about the value we are creating. We will redirect our efforts as appropriate. No CEO can or should promise that an investment in his/her company will result in great stockholder return. What I can do is reiterate the commitments I made when I founded Isis and that are shared by everyone in our Company: We will invest deeply, broadly and wisely in antisense technology. We will apply broad drug discovery and development expertise to create a pipeline of drug products that have the potential to prove the value of the technology and create value for patients and stockholders. We will prudently, but aggressively, move those products to the marketplace. We will work conscientiously to create a return on investment for our stockholders. We will communicate appropriately about our successes and failures. Sincerely, Stanley T. Crooke Chairman and Chief Executive Officer