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



Executive Summary

SANDOZ DYNACIRC CALCIUM CHANNEL BLOCKER CLEARED FOR U.S. marketing on Dec. 20 for the treatment of mild to moderate hypertension. Approval comes five years after the NDA was originally submitted in December 1985. The twice-daily antihypertensive was given a "1-C" rating (new chemical entity with little or no therapeutic gain); the drug will try to find a position in a market with five major brands and two standard-release products available as generics. Sandoz says a launch is expected "in the near future." DynaCirc is the subject of a co-promotion agreement between Sandoz and Glaxo's Allen & Hanburys division under a cross-licensing deal announced in December 1987. Sandoz traded co-promotion rights to DynaCirc for the rights to develop an OTC version of Glaxo's Zantac (ranitidine) anti-ulcer product for the U.S. ("The Pink Sheet" Jan. 4, 1988, p. 16). If an OTC ranitidine is approved in the U.S., Glaxo is supposed to have the primary marketing and distribution rights to DynaCirc, and Sandoz becomes the co-promoter. Glaxo did not talk about OTC ranitidine at a recent review of its major commercial markets and prospects. "The combined professional sales force committed to DynaCirc is approximately 1,300 sales representatives," Sandoz said. At the time of the deal, Glaxo predicted a 1988 approval. Sandoz began running "coming soon" ads in December of 1988 in preparation for a launch two years ago. The delay has made the market much tougher for Sandoz: generic nifedipine has recently entered the market and Pfizer has been successfully switching the market to its once-a-day Procardia XL. Pfizer says that that product, in combination with its standard release brand of Procardia, is now the leader in the cardiovascular field in terms of new prescriptions, surpassing Merck's Vasotec ("The Pink Sheet," Nov. 5, p. 7). Sandoz has an NDA pending for a once-a-day version of DynaCirc licensed from Alza, which developed the system for Procardia XL. DynaCirc will be the third of the second generation calcium channel blockers, joining Syntex' Cardene (nicardipine) and Miles' Nimotop (nimodipine) as the only approved second-generation calcium channel blockers. Miles' Baypress (nitrendipine), Merck's Plendil (felodipine), and Pfizer's Norvasc (amlodipine) have had NDAs pending at FDA. Isradipine has also been studied for atherosclerosis. A study at six U.S. centers was begun in mid-1989. The product is further being evaluated for treatment of stroke patients in Europe ("The Pink Sheet" June 26, 1989, T&G-3).

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




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