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

RHONE-POULENC RORER LICENSES NOVEN PROGESTIN PATCHES under an agreement announced June 29. RPR will receive worldwide marketing rights to Noven's progestin transdermal patch and its combination estrogen/progestin patch. Both products are "intended for use in postmenopausal related disorders including the relief of menopausal symptoms, the prevention of bone loss and osteoporosis," the two companies said. Miami-based Noven expects to file INDs for both products during 1992. RPR will also receive Japanese marketing rights to Noven's Phase III estrogen replacement transdermal patch, Menorest. RPR previously had rights worldwide except North America and Japan; Ciba-Geigy has North American rights from Noven. The company forecast a 1992 NDA filing for Menorest at a February securities analysts meeting ("The Pink Sheet" Feb. 24, p. 12). While Noven is currently pursuing an NDA for the estrogen patch, an ANDA (citing Ciba-Geigy's Estraderm as the innovator) has been pending at FDA since 1989. As part of the deal, RPR paid $5 mil. for warrants to purchase 1 mil. Noven shares (about 6.5% of the company) exercisable for an additional $8 mil. The companies did not estimate the total value of the agreement. RPR will also fund construction of a manufacturing facility for transdermals, to be leased by Noven, and pay all development costs for the three products. The new manufacturing facility will supplement Noven's own plant, which the firm estimated in February would be capable of producing 25 mil. units per year. Rhone-Poulenc Rorer said that the deal would help it "to build on our global bone metabolism franchise with innovative, life- enhancing hormone replacement therapy products." RPR currently markets the bone metabolism product Calcimar (calcitonin). Noven completed a secondary public offering in April, raising $17.7 mil. The company sought public equity after a proposed merger with Ivax fell through in October ("The Pink Sheet" Oct. 28, 1991, In Brief). Noven ended 1991 with $2.4 mil. in cash on hand. In addition to the hormone replacement products, Noven has an ANDA pending for a transdermal nitroglycerin patch.

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

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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