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Biotech / Medical : Indications -- diabetes -- Ignore unavailable to you. Want to Upgrade?

To: keokalani'nui who wrote (10)	9/7/2001 8:40:46 PM
From: hmpa	Respond to of 278

I was at EMIS investor day. Amazingly well attended - probably 150-200 people, including a bunch from big pharma. [I don't know how many came for a free breakfast]. Looks like the dissapointment was caused by Goldberg's words that Phase II will take at least a year, and lengthy safety studies will be required (I do not understand why it is perceived as a surprise...). Clearly stated that ALL subjects in Phase I had insulin delivered in bloodstream (this sounds clearly better than the stated 30% non-responders in Nobex trials). Reuters' take: biz.yahoo.com Related Quotes EMIS 20.15 -5.07 delayed 20 mins - disclaimer Friday September 7, 3:23 pm Eastern Time Emisphere down despite upbeat oral insulin results LOS ANGELES, Sept 7 (Reuters) - Shares of Emisphere Technologies Inc. (NasdaqNM:EMIS - news) fell nearly 20 percent on Friday on profit taking after an August run-up in anticipation of positive results from early-stage trials of the company's oral insulin, analysts said. -------------------------------------------------------------------------------- The Tarrytown, New York-based company's shares were down $4.94 at $20.30 on Nasdaq. The stock gained about 30 percent in August, although it had already given back some of those gains early this month. ``This is a case of buy on rumor, sell on news, along with an unhelpful stock market,'' said David Steinberg, an analyst at Deutsche Banc Alex. Brown. ``While it was encouraging data, it is still very early.'' An analyst at J.P. Morgan said he thought Friday's sell-off was overdone. ``I think investor expectations were high going into the meeting, which you can see from the stock's run-up. They presented very good Phase 1 data, but it is only Phase 1, and perhaps people are not willing to hold on to the stock,'' said Corey Davis, an analyst at J.P. Morgan. Earlier Friday, Emisphere held an investor conference at which it unveiled results from three Phase 1 clinical trials showing its oral form of insulin is safe and effective. The company also said its capsule form of the hormone produced a therapeutic response that was comparable to what was observed in a typical, injected dose of insulin. ``They clearly demonstrated they have been able to do something that no one else has been able to do,'' said Michael Hearle, an analyst at Leerink Swann & Co. Emisphere uses a ``carrier'' molecule to keep insulin, which is a protein, in a fat-soluble state inside its delivery capsule, but allows it to fold into a water-soluble shape once it crosses intestinal membranes. Insulin is a hormone produced by the pancreas that helps convert food into energy. In diabetes, affecting about 16 million Americans, the body is unable to produce or properly use insulin, resulting in too much sugar in the blood. Currently, insulin is usually administered as an injection, but it is also delivered through infusion pumps and inhaled forms have been tested in advanced clinical trials. ``This is the Holy Grail for diabetics on insulin,'' Davis said, noting that Emisphere had 10 big pharmaceutical companies with either insulin or diabetes franchises in attendance at Friday's conference. ``It sets up a nice little auction process,'' the analyst said. He cited companies that make and sell insulin, such as Eli Lilly and Co. (NYSE:LLY - news), Pfizer Inc. (NYSE:PFE - news), Aventis SA and Novo Nordisk A/S , as well as firms with strong diabetes product franchise, like Johnson & Johnson (NYSE:JNJ - news) or Bristol-Myers Squibb Co. (NYSE:BMY - news), as likely partners for Emisphere. Hearle said he expected the stock to move higher when a partnership is announced, which would likely be in the first quarter of next year. ``This is by far the most promising oral insulin product out there, but they still have to conduct a very rigorous Phase 2 and then Phase 3. With diabetes there are many permutations so the clinical trial process is complicated,'' Davis said. Emisphere said so far there have been no negative side effects associated with its oral insulin. Email this story - Most-emailed articles - Most-viewed articles

To: keokalani'nui who wrote (10)	9/8/2001 12:28:54 AM
From: Miljenko Zuanic	Read Replies (1) \| Respond to of 278

WE, CC is a must. Just finished listening. Fist, today stock price reaction was one of the most ridiculous, for the period that I follow market. Remain me on REGN (when they reported HSV re-activation, however I did almost have hard attack that day). Second, wish that there is several more days like today. Yes, I agree that those were very small PI trials in healthy volunteers and one should not make much of it. It is proof of principle for oral delivery, with data so far equal if not better than SC route. Systemic Insulin conc, should be in 20-100 uU/ml range. Bioaveability for oral route is in 7-10% range, maybe higher??? They did achieve desired therapeutic insulin level (as indicated by glucose level reduction, ~30%.. Hypoglecimia). Regards the Symlin, problems are in glucose level control when insulin by itself can not do it. I do believe that Symlin is good drug, but it is hard to prove it and to define dosing/regime in insulin combination, from safety and efficacy standpoint. Miljenko PS: BTW, hope that EMIS can produce some results with Axokine.