Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

CADEMA's DY-165 FOR RHEUMATOID ARTHRITIS: NDA FILING

Executive Summary

CADEMA's DY-165 FOR RHEUMATOID ARTHRITIS: NDA FILING for RA of the knee is planned for the fourth quarter of 1988, according to the company's 1986 annual report. Under development for use in radiation synovectomy (direct injection), dysprosium-165 ferric hydroxide microaggregate has been in clinicals since April. "If these clinical trials are successful, the company expects to file its NDA for Dy-165 in the fall of 1988," the annual report states. The radiopharmaceutical product has been in development for 10 years by Clement Sledge, MD, Chairman of Orthopedic Surgery at Harvard Medical School and Brigham and Women's Hospital. Approximately 200 rheumatoid arthritis patients have received radiation synovectomy using Dy-165. One study published in the Journal of the American Rheumatism Association reported that of 74 treated knees 59-72% "showed good results depending on the stage of the disease," Cadema said. The company estimates the cost of treatment at $2,000-$2,500. According to the annual report, Dy-165 is not a patentable drug. Under an agreement with Brigham and Women's Hospital, Cadema is providing approximately $150,000 for clinical development as well as 29,895 shares o common stock. Brigham also has rights to 5% of all profits derived from product sales for a seven-year period. A second agreement, covering research on radiation synovectomy, gives MIT 18,935 shares and about $100,000. "Because of its short half-life, Dy-165 is effectively potent for a maximum of 12 hours after its manufacture," the annual report states. "Because the company believes this limits the commercial potential of Dy-165, the company is developing an alternative compound for treatment of rheumatoid arthritis of the knee that has a half-life several times longer than that of Dy-165 and which, if successfully developed, may be feasible for wider use." Originally engaged in gold exploration as Nevada Resources, the company took its present name and moved into the medical technology area with the 1986 acquisition of Cadema. The firm still retains rights to one undeveloped gold property located near Mt. Shasta, California. Other Cadema compounds that have not reached the clinic include: a radioactive agent for treatment of rheumatoid arthritis in the hand; a diphosphonate product in combination with a low-energy radioisotope for treatment of metastatic bone cancer; and radiopharmaceuticals for treatment of malignant ascites. In the diagnostic area, the company currently markets a disposable aerosol inhalation apparatus, which accounted for about $800,000 of the company's total $1 mil. in 1986 revenues. Two other diagnostic products are also in development -- a red blood cell kit for diagnosing heart disorders and gastrointestinal bleeding, and a Tc-99m antimony trisulfide colloid kit for imaging a patient's regional lymph system. The rights to the latter were acquired in 1982 from Roche subsidiary Cintichem.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

LL1130421

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel