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

To: Ian@SI who wrote (4578)	8/4/2010 9:57:17 AM
From: bob zagorin	Read Replies (2) \| Respond to of 4676

UPDATE 2-Isis-Genzyme cholesterol drug meets study goals Wednesday 4 August 2010, 12:05 GMT (8:05am EST) * Dramatically cuts bad cholesterol vs placebo * Liver enzyme elevations similar with other studies * To seek approval in first half of 2011 * Isis shares flat in premarket, Genzyme edges lower (Adds details from study, background, shares) By Lewis Krauskopf NEW YORK, Aug 4 (Reuters) - Isis Pharmaceuticals Inc <ISIS.O> and Genzyme Corp <GENZ.O> said their experimental drug mipomersen dramatically cut levels of bad cholesterol in patients already being treated with other therapies, meeting the main goals of two late-stage studies. The companies also reported on Wednesday that elevations in liver enzymes in patients treated with mipomersen, a possible sign of liver damage, were generally similar to those seen in other studies. Analysts have been concerned about the liver toxicity of mipomersen. [ID:nN01148301] Mipomersen is a closely watched experimental drug for Isis and larger partner Genzyme, which is the target of a takeover bid by France's Sanofi-Aventis <SASY.PA>. Isis shares were unchanged at $9.99 in premarket trading. Genzyme shares were off 17 cents at $70.03. The two Phase III studies of mipomersen involved patients who had high cholesterol levels despite being on maximally tolerated lipid-lowering therapy. In one study of 58 patients with very high levels of bad "LDL" cholesterol, or severe hypercholesterolemia, mipomersen was found to reduce LDL by 36 percent compared with a 13 percent increase for placebo. In the second study of 158 patients with hypercholesterolemia and at high risk of developing coronary heart disease, mipomersen reduced LDL levels by 37 percent compared with a 5 percent reduction for placebo. Both studies also met secondary effectiveness goals. In the first study, 15 percent of patients had persistent liver enzyme elevations above three times the upper limit of normal during the treatment period. In the second study, 10 percent of patients had persistent elevations above that level. Genzyme, which is responsible for regulatory applications for the drug, expects to seek approval in the first half of next year for mipomersen. The companies said the initial filing will seek approval for patients with homozygous familial hypercholesterolemia, in which patients are unable to properly metabolize LDL due to dysfunctional LDL receptors, and may also include patients with severe hypercholesterolemia. Mipomersen, which is given weekly by injection, is based on a technology known as antisense, which aims to interfere at the genetic level to prevent rogue proteins from being formed. Isis is a pioneer in the field and has a wide-ranging pipeline of experimental antisense drugs. Analysts, on average, have forecast mipomersen sales of $354 million in 2014, according to Thomson Pharma. Should Genzyme be taken over, Isis has said the buyer would take on the partnership, but, if that company did not want mipomersen, Isis would retain any money received and could relicense the drug.