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Microcap & Penny Stocks : Tokyo Joe's Cafe / Societe Anonyme/No Pennies -- Ignore unavailable to you. Want to Upgrade?

To: TokyoMex who wrote (8390)	11/5/1998 6:32:00 AM
From: Tom Latham	Read Replies (1) \| Respond to of 119973

Must be one them in a gorilla-suit got lose, re: Alien-tech post. Never did figure that'n out.....

To: TokyoMex who wrote (8390)	11/5/1998 8:36:00 AM
From: bob	Read Replies (1) \| Respond to of 119973

[ Business \| US Market \| By Industry \| IPO \| AP \| S&P \| International \| PRNews \| BizWire ] Thursday November 5, 6:02 am Eastern Time Company Press Release SOURCE: Anesta Corp. U.S. FDA Clears Actiq for Breakthrough Cancer Pain; First Product Approved for Treating Breakthrough Cancer Pain SALT LAKE CITY, Nov. 5 /PRNewswire/ -- Anesta Corp. (Nasdaq: NSTA - news) announced today that the U.S. Food and Drug Administration (FDA) has cleared Actiq(R) (oral transmucosal fentanyl citrate) for marketing. Actiq is the first product specifically designed and studied for breakthrough cancer pain. It is indicated only for the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy. Breakthrough cancer pain is a flare of severe cancer pain, which ''breaks through'' the medication that is being administered at regular intervals for persistent cancer pain. Breakthrough cancer pain is a component of chronic cancer pain that is particularly difficult to treat due to its severity, rapid onset and frequent unpredictability. Approximately 50 percent of all cancer pain patients, more than 800,000 patients in the United States, experience breakthrough cancer pain. Actiq is contraindicated in the management of acute or postoperative pain and must not be used in opioid non-tolerant patients. It is intended to be used only in the care of cancer patients by oncologists and pain specialists who are skilled in the use of Schedule II opioids to treat cancer pain. The most common adverse events observed with product use in breakthrough cancer pain patients are somnolence, nausea, vomiting and dizziness, which are generally associated with opioid therapy. ''We believe that Actiq will provide a valuable new tool for clinicians to help cancer patients control their breakthrough cancer pain,'' said Thomas B. King, Anesta's president and chief executive officer. ''We have worked diligently with the FDA to address their questions related to Actiq's careful use in the home setting, clinical results, data analysis, and manufacturing information. Actiq is expected to be available during March 1999.'' The introduction and marketing of Actiq will be accompanied by a comprehensive risk management program of educational and safe use messages which inform health care professionals, patients and their families of proper use, storage, handling and disposal of the product. This program is designed to address potential risk situations; accidental ingestion by children, improper patient selection and diversion or abuse. The most clinically meaningful adverse event concern is the potential for respiratory depression. As with all strong pain medicines, steps must be taken to prevent access to Actiq by anyone other than the person for whom the product was prescribed. Abbott Laboratories (NYSE: ABT - news) will market Actiq, which will be available only by prescription for cancer patients who are already receiving opioid analgesic therapy. ''We have partnered with Anesta Corp. since 1989, for their OT-fentanyl product line,'' said Richard A. Gonzalez, senior vice president, hospital products at Abbott. ''We are extremely pleased to move forward with this exciting new product for breakthrough cancer pain, expanding Abbott's offering of pain management and oncology products.'' Anesta is a leader in oral transmucosal drug delivery. The company's first oral transmucosal product, Fentanyl Oralet(R), is cleared for marketing by the FDA for use in surgical premedication and for sedation/analgesia prior to diagnostic or therapeutic procedures in hospital settings. Other products in clinical development using Anesta's OT-system for drug delivery include OT- nicotine for smoking cessation and OT-etomidate for short-acting sedation. Further information is available on the Anesta homepage at anesta.com. This news release contains forward looking statements regarding the anticipated date of product availability that involve risk and uncertainties. Future events may differ materially from those discussed herein, due to a number of factors, including uncertainties related to manufacturing, timing of product introduction, and regulatory action, as well as other factors which are more fully discussed in the Company's Annual Report on Form 10-K for the year ended December 31, 1997. SOURCE: Anesta Corp.