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

SmithKline's consumer advertising to support its relaunch of Contac will be directed at reawakening brand loyalty for the product by stressing Contac's history of safety and efficacy, the company indicated in comments to the press as it kicked off its campaign to bring the cold and allergy line back to the market. Rather than risk reminding consumers of Contac's recent tampering event by dwelling on the product's new packaging, SmithKline's ad campaign will focus on the longevity of the brand and its effectiveness in treating colds and allergies, the company indicated. "Contact is one of the most successful medications ever sold in this country," SmithKline President Henry Wendt maintained at a May 21 press conference in Philadelphia. "It is a safe product, it is an effective product. The continued popularity of Contac over 25 years is just one proof of that." SmithKline is relying on tampering warnings on the outside of the packaging and a package insert to reassure consumers that the new packaging will make the product tamper-evident. "The packaging is new, but it is clear to us -- not just from our own recent experience but with many other products on the market -- that the best defense against tampering is an alert, well-informed consumer," Wendt declared. "We believe it is essential to help educate the public about tamper resistant packaging. Each carton of Contac will contain educational information to help consumers tell tampering has taken place and we urge consumers to read this carefully." The package insert reads: "This package has been safety sealed at the factory for your protection under strict quality control standards. As with any medicine, you should closely examine the package and the product before using it." The insert then describes each of the tamper resistant features of the packaging and what consumers should look for to detect tampering. The insert concludes: "Your health and safety are our concern. Your attention to these tamper resistant packaging fefatures will help us in assuring your safety." The insert also includes a toll-free number for consumers to call if they have any questions. SmithKline said it will relaunch Contac in both a caplet form and a new capsule with shipments to the trade beginning June 16. The company is planning to stagger its national launch through August and September with advertising and consumer promotions hitting regional makets as the allergy season begins in each area of the country. "Let me explain to you exactly what we're doing," Wendt told the press conference. "First, we are introducing Contac in a new form -- a 12-hour continuous action caplet. . . Not only is it easier to swallow, but clearly the caplet is difficult to tamper with." In addition, Wendt reported that Contac capsules will be transparent and sealed "in a double band of gelatin" -- a technology acquired from Lilly ("The Pink Sheet" May 12, p. 6). Wendt said the "new red Perma-Seal [Lilly's Qualiseal] makes tampering more difficult and, of course, more easy to spot." Both the caplets and new capsules, Wendt continued, will come in a carton "sealed in a clear plastic overwrap . . . printed with the words 'safety sealed.'" The SmithKline exec noted: "Not only will this overwrap make the package more resistant to tampering, it will also help consumers tell the packages that have been tampered with." As another line of defense, both Contac caplets and capsules will also be packaged in blister packs with foil backing, Wendt said. Asked why SmithKline was reintroducing capsules, Wendt explained: "As you might imagine, we've spent a lot of time and a lot of money in the last few months doing extensive market research with our customers and with consumers in general. What that has showed us is that 50% of the Contac consumers would welcome the return of a capsule form and, in fact, other surveys in the industry tend to confirm that." The new tamper resistant packaging "will be applied as the months go on to our other over-the-counter products as well, whether they are in tablet or capsule form," Wendt told the press conference. Wendt said that SmithKline will put in each package its explanatory brochure explaining "the various levels of protection that are available in this packaging form." He noted: "We think that's as important for solid or tablet forms as it is for capsule forms." SmithKline indicated that both the new capsule and caplet will be priced the same as the old Contac capsules prior to the withdrawal in March. SmithKline's factory price for 10s will be $2.45; and for 20s, $4.02. SmithKline's allergy OTC product, Teldrin, will also be relaunched at the same time with Contac in a 12-hour see-through Perma-Seal capsule containing 12 mg chlorpheniramine and a green 4 mg 6-hour tablet. However, SmithKline said it would not relaunch Dietac, which had been withdrawn from the market with Contac and Teldrin following the March tampering incident. Wendt explained that Dietac sales were "quite small and were declining." With the reintroductions of Contac and Teldrin targeted for this fall, SmithKline may be the first company to market OTCs using Lilly's double-banded capsule technology. In announcing the availability of the double-banded capsule technology in April, Lilly said it was in the process of switching its Rx products to the new capsules. SmithKline has acquired two of the Lilly Qualiseal machines. SmithKline's relaunch of Contac before the onset of the next allergy and cold season, in part, is a result of SmithKline's ability to work quickly with several other companies in the drug industry. In addition to purchasing sealing technology from Lilly, SmithKline worked with Sandoz to overcome a regulatory barrier to the launch of the caplet. SmithKline had an existing approved NDA for a 75 mg phenylpropanolamine/8 mg chlorpheniramine capsule, but not for a tablet or caplet form. However, the Sandoz subsidiary Dorsey, markets a 75 mg phenypropanolamine/12 mg chlorpheniramine OTC tablet, Triaminic-12; and SmithKline will be able to ride that dosage. Dorsey will become the contract manufacturer for the new Contac caplet with SmithKline doing the finishing work and packaging. As a result, the Contac caplet will come in a 12 mg strength of chlorpheniramine while the capsule will carry 8 mg chlorpheniramine.

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