Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

SMOKING CESSATION BUSINESS IS PATCHWORK QUILT OF LITIGATION

Executive Summary

SMOKING CESSATION BUSINESS IS PATCHWORK QUILT OF LITIGATION with three patent infringement suits pending on nicotine transdermal patches. Meanwhile, shipments of the first patch approved, Marion Merrell Dow/Alza's Nicoderm, are held up pending resolution of one of the lawsuits. That suit, brought by Elan and Lederle against MMD/Alza, was the subject of a Dec. 6 hearing in San Francisco federal court. The court plans to issue an initial ruling Dec. 9 but has continued a temporary restraining order against Nicoderm shipments in the meantime. That situation could provide an opportunity for Ciba-Geigy's Habitrol patch, approved Nov. 27 (see previous T&G). Ciba-Geigy entered the nicotine patch patent fray Nov. 27 by also suing Marion Merrell Dow/Alza. The suit, filed in Federal Court in Newark, N.J., alleges that "the manufacture, use or sale" of Alza and Marion Merrell Dow's Nicoderm nicotine patch "infringes patent rights exclusively licensed to Ciba-Geigy." The court on Dec. 4 refused to grant Ciba-Geigy's request for a temporary restraining order on the manufacture, use or sale of Nicoderm. A hearing is scheduled for Dec. 23 to rule on Ciba- Geigy's request for a preliminary injunction against the Marion Merrell Dow/Alza patch. Alza maintained Dec. 2 that the suit is "without merit" and that it would "defend against it vigorously." Alza said Ciba's suit involves patent 5,106,652, issued May 21, 1991, which covers a "method and apparatus for aiding in the reduction of incidence in tobacco smoking" and is assigned to The Regents of the University of California, Berkeley. The first patent suit on transdermal nicotine patches, Elan v. Cygnus Therapeutic Systems, continues in litigation. Filed last May, the suit alleges that Nicotrol 16, which is pending approval at FDA, violates a method of use patent held by Elan ("The Pink Sheet" May 20, T&G-4). Cygnus and Kabi Pharmacia codeveloped Nicotrol 16 using Cygnus' proprietary matrix technology. Cygnus will manufacture the patch, while Warner-Lambert has licensed the marketing rights from Kabi. Warner-Lambert has stated that it does not forsee any obstacles to its marketing of the patch once regulatory approval is obtained. Marion Merrell Dow Chairman and CEO Joseph Temple predicted Dec. 3 that while MMD sees Nicoderm, approved Nov. 7, as "becoming the lead product in our smoking cessation line," Nicorette gum will retain a "significant share" of the market. Based "on a simultaneous launch by us and one competitor, we've predicted that the combined 1992 sales potential of Nicorette and Nicoderm will be in excess of $ 150 mil. and growing from there," Temple said at the Mabon Securities Research Conference. MMD sales of Nicorette through the third quarter (ended Sept. 30) were $ 86 mil. Temple also outlined the company's strategy for positioning the patch and gum for different types of patients. The Nicoderm patch will be targeted to patients who prefer their physicians to take more charge of treatment, have compliance problems, are more heavily addicted, or have dentures or jaw conditions that preclude frequent gum chewing. Temple noted that MMD is backing up Nicoderm with a 10-week "quitters program" providing patient educational materials to help them taper from the 21 mg patch to the 14 mg and 7 mg patches ("The Pink Sheet" Nov. 11, T&G-1). In contrast, Nicorette gum will be targeted to patients who view themselves as more independent, who are less addicted, or who need either the oral gratification or the "ritual" of chewing gum to replace smoking, Temple said. The gum also is more likely to be used by patients with allergies or skin problems. In addition, Temple said, the gum might have potential for use when smokers are confined to areas where smoking is prohibited, such as airplanes or offices.

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

Latest Headlines
See All
UsernamePublicRestriction

Register

PS020139

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