March 14, 2006

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March 14, 2006

March 14 – March 20

March 15th: U.S. Food and Drug Administration clears NOGA(R) XP -- 3D Electromechanical Mapping and Navigation System, an innovative cardiac navigation technology.

The U.S. Food and Drug Administration (FDA) has cleared for marketing an innovative 3D imaging system and the only such guided electromechanical cardiac navigation technology available to physicians for use in a wide variety of advanced medical procedures.

Biologics Delivery Systems Group, Cordis Corporation, will launch the NOGA® XP Cardiac Navigation System, the most advanced technology currently available on the market to create highly precise, 3-dimensional images of the heart. Based on these images, physicians are able to accurately identify tissue that could potentially benefit from a variety of targeted investigational therapies. The NOGA® XP Cardiac Navigation System is currently being used to map the heart in more than 17 ongoing clinical studies worldwide, investigating the use of adult stem cell and gene therapies to treat conditions such as congestive heart failure and chronic ischemia.
Biosense Webster, Inc. developed and manufactured the NOGA® XP Cardiac Navigation System. Biologics Delivery Systems Group, Cordis Corporation, will distribute the technology.

March 16th: FDA Approves New Imaging System to Help Detect Cervical Pre-Cancer

The Food and Drug Administration today approved a new imaging system that can help detect a cervical cancer precursor, an indication of possible cancer development, by identifying sites on the cervix that may contain pre-cancerous cells. The LUMA Cervical Imaging System, manufactured by MediSpectra, Inc. of Lexington, Mass., is intended to be used along with colposcopy, a high magnification evaluation of the cervix for women who have recently had an abnormal Pap test. The firm's study showed that the new device can detect additional cancer precursors missed by colposcopy. Of the 50 cases of pre-cancer detected in the study, colposcopy caught 41 cases of cervical pre-cancer and LUMA caught an additional 9 cases of cervical pre-cancer that colposcopy had missed. The approval of this imaging system gives health care providers an additional tool to help detect cervical cancer precursors and identify pre-disease that may have been missed by a colposcopy.

The LUMA Cervical Imaging System shines a light on the cervix and analyzes how different areas of the cervix respond to this light. The LUMA Systems assigns a score to tiny areas of the cervix and produces a color map that helps the doctor decide where to biopsy. The colors and patterns on the map help the doctor distinguish between healthy tissue, and potentially diseased tissue. Clinical study of 193 women who underwent colposcopy, followed by LUMA, showed that the device is safe and effective and that when used along with colposcopy the LUMA system will help detect additional cervical cancer precursors.

March 20th: Ranbaxy Purchases Rights and Assets to Senetek's Autoinjector Device

Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), today announced it has purchased patents, trademarks and automated manufacturing equipment for Senetek PLC's proprietary disposable autoinjector for self- administration of parenteral drugs, including epinephrine for emergency treatment of anaphylactic shock from peanut and other allergies.

The agreement provides for a non-refundable payment by Ranbaxy to Senetek on signing and milestone payments based on regulatory approvals and cumulative sales milestones. Terms also include a percentage of Ranbaxy's and/or its licensees' quarterly net sales of the product(s) to be paid to Senetek. Initially, Ranbaxy will focus on pre-filling the autoinjector device with epinephrine. Ranbaxy will also evaluate the development of other parenteral drugs (including Senetek's patented erectile dysfunction drug Invicorp®).

Ranbaxy will make infrastructure investments, including building the required clean room suites at its facility in New Brunswick, New Jersey to house the highly automated autoinjector production line. Under the terms of the agreement, Ranbaxy will obtain regulatory approvals and market the product. Ranbaxy has also agreed to discuss the possibility of manufacturing and supplying Invicorp® in the autoinjector device to Senetek's licensees.

Anaphylactic shock due to allergic reaction to peanut-based food additives is a growing health risk that currently results in over 30,000 emergency room trips, and 150 to 200 preventable deaths in the U.S. each year, not including an additional 50 deaths from bee stings and other allergic reactions. Senetek's patented, modular autoinjector is ideally suited for this acute self-medication market, which is growing at over 25% annually as health and educational organizations build popular awareness of these risks.

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