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Biotech / Medical : Biotech Lock-Up Expiration Hell Portfolio -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (900)	1/28/2004 3:33:05 AM
From: nigel bates	Respond to of 1005

Cytokinetics, Inc. Files for Initial Public Offering SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Jan. 27, 2004--Cytokinetics, Inc., the leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton, announced today that it has filed with the Securities and Exchange Commission a registration statement relating to the proposed initial public offering of shares of its common stock. All of the shares of common stock sold in the offering will be sold by Cytokinetics, Inc. Goldman, Sachs & Co. is acting as book-runner and lead manager, and Credit Suisse First Boston, Pacific Growth Equities, LLC and Lazard are acting as co-managers in the offering. When available, a preliminary prospectus relating to these securities may be obtained from Goldman, Sachs & Co.'s prospectus department at 85 Broad Street, New York, New York 10004, by telephone at 212-902-1171 or by faxing a request to 212-902-9316. A registration statement relating to these securities has been filed with the Securities and Exchange Commission, but has not yet become effective. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state. Cytokinetics, Incorporated is the leading biopharmaceutical company focused on the discovery, development and commercialization of novel small molecule drugs that specifically target the cytoskeleton. The cytoskeleton is a complex biological infrastructure that plays a fundamental role within every human cell. Our focus on the cytoskeleton enables us to develop novel and potentially safer and more effective classes of drugs directed at treatments for cancer, cardiovascular disease, fungal diseases and other diseases.

To: tuck who wrote (900)	1/28/2004 11:00:05 AM
From: tuck	Respond to of 1005

POZN up big time on substantially clear data for MT100. The data bolster the NDA, and approval looks likely; it's a big market for Pozen: >>CHAPEL HILL, N.C.--(BUSINESS WIRE)--Jan. 28, 2004--POZEN Inc. (Nasdaq:POZN - News) announced today that the results of a two-year rat carcinogenicity study provided no evidence that the concomitant administration of maximum tolerated doses of metoclopramide and naproxen, the two active components in MT 100, produced any statistically significant differences in findings from those seen with metoclopramide alone. None of the tumors observed in the study were considered to be directly related to the administration of metoclopramide or naproxen; all were considered to be secondary to metoclopramide-induced increases in the levels of the hormone prolactin in the affected rats. The study report was submitted yesterday to the U.S. Food and Drug Administration (FDA) and completes the MT 100 New Drug Application submission made by POZEN in July 2003, which was accepted for filing by the FDA in October 2003 and is currently in review. MT 100 is being developed as an oral first-line therapy for the acute treatment of migraine. Study Design The study evaluated the occurrence of tumors among six groups of male and female Wistar han rats that received daily oral doses of metoclopramide and/or naproxen. One group received metoclopramide alone at its maximum tolerated dose (MTD). Another group received naproxen alone at its MTD. Three groups received naproxen at its MTD combined with metoclopramide at either a low or medium dose or at its MTD. A control group received placebo. Study Results The data showed that there were no statistically significant differences in findings between the rats that received the MTD of metoclopramide in combination with naproxen and the rats that received metoclopramide alone at its MTD. The study results are consistent with previous findings reported in rodents with chronically increased prolactin levels. As expected, metoclopramide, alone and in combination with naproxen, produced significant increases in serum prolactin levels compared to the control group, an effect thought to be due to the pharmacologic action of metoclopramide as a dopamine antagonist. Also as expected, increases in rates of prolactin-mediated tumors occurred in prolactin sensitive endocrine glands in rats that received metoclopramide, alone and in combination with naproxen, compared to the control group. Examples of drugs marketed in the U.S. that elevate prolactin hormone levels in rodents include aripiprazole, risperidone, ziprasidone, olanzapine, pimozide, and quetiapine. The data also showed no evidence that naproxen augmented the demonstrated endocrine effects of metoclopramide in the combination. There were also no statistically significant differences in findings between the rats that received naproxen alone and the rats in the control group, confirming results of previous studies with this drug in which there was no evidence of carcinogenicity. Metoclopramide and naproxen are commercially available drugs and have been on the market for more than 20 years. "We are very pleased with the outcome of the study and we are grateful to the FDA for allowing us to submit these data during the NDA review process without affecting the date by which the FDA should complete its review of the NDA, May 31, 2004," said John R. Plachetka, Pharm.D., chairman, president and chief executive officer of POZEN. POZEN previously completed a six-month oral carcinogenicity study in p53 transgenic mice and submitted the report to the FDA in early 2002. The results of that study indicated that MT 100 was not carcinogenic in the p53 transgenic mouse model. MT 100 Clinical Trials The clinical trials conducted by POZEN have consistently provided evidence of the safety and effectiveness of MT 100. Over 8,000 patients with migraine participated in Phase III trials in which MT 100 has been shown to provide significant benefits compared to placebo for the relief of pain and the associated symptoms of migraine including nausea, sensitivity to light and sensitivity to sound. Importantly, in two Phase III trials in which MT 100 was compared to Imitrex® 50mg, the market-leading drug for the treatment of migraine, MT 100 demonstrated comparable efficacy and a lower percentage of patients reporting adverse events. Because of its overall efficacy and safety profile, POZEN believes MT 100, if approved by the FDA, should become the drug of choice as first-line prescription therapy for most migraine attacks. POZEN to Host Webcast Today at 8:30 a.m. Eastern Time POZEN management will host a webcast at 8:30 a.m. Eastern time on Wednesday, January 28, 2004, to discuss the information in this release. The webcast will be live and archived on POZEN's home page at www.pozen.com. << snip Cheers, Tuck