HEALTH

Reckitt Benckiser pursuit of Schiff Nutrition a success; companies sign definitive merger agreement

BY Michael Johnsen

SLOUGH, England — Reckitt Benckiser successfully wrapped up its pursuit of Schiff Nutrition on Friday with the signing of a definitive merger agreement in a deal valued at $1.4 billion. Bayer officially relinquished its proposed acquisition on the same day. 

“We are very pleased to have reached a mutually beneficial agreement with Schiff and are excited to enter the $30 billion global vitamins, minerals and supplements market with such a strong portfolio of high-quality branded business in the USA," stated Rakesh Kapoor, Reckitt Benckiser CEO. "Schiff’s portfolio is an excellent fit with our strategic focus on health and hygiene, where in health care in the [United States] we already have Mucinex, Delsym, Cepacol and Durex as major brands.”

Reckitt Benckiser expects the tender offer to close before the end of calendar year 2012.

"Bayer continues to believe that the transaction would have represented a logical and strategic addition for its Consumer Care business," the company stated in a press release issued Friday. "However, [Bayer] came to the conclusion that entering into a competitive bidding process would have resulted in a transaction price outside Bayer’s set financial criteria."

Bayer received a breakup fee of $22 million from Schiff, per the initial merger agreement between those two companies. 

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Black Friday shoppers in Manhattan who overindulged the day before offered relief with Di-Gel

BY Michael Johnsen

NEW YORK — Ilex Consumer Products Group successfully addressed the post-Thanksgiving gastrointestinal distress for New Yorkers who ventured out to Fifth Avenue on Black Friday with more than 2,000 samples of the company’s recently launched Di-Gel for stomach discomfort. 

Di-Gel hosted a “Comfort Zone” along Fifth Avenue in Manhattan with free, clean restrooms for shoppers. “Given the recent events in New York City, we thought this was the right time to host this event, support local businesses and make Black Friday shoppers a little more comfortable,” stated Bernie Kropfelder, EVP and general manager of OTC at Ilex Products Group.

The Di-Gel campaign, which launched with the brand tagline, “When you overdo, undo”, highlights the various triggers that lead soon-to-be users to overdo it at times, such as overeating and stress, among other things. “We all overdo it at times, and we often pay for it with an upset stomach. Di-Gel is the solution for when that catches up with you,” Kropfelder said. 

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Minnesota company barred from going to market for violations of drug and dietary supplement regs

BY Michael Johnsen

SILVER SPRING, Md. — Pharmacist’s Ultimate Health of St. Paul, Minn., and its president, Stephen J. Poindexter, have been barred from distributing any "unapproved new drugs" that the company had distributed under the guise that they were dietary supplements. 

The consent decree of permanent injunction that had been sought by the Food and Drug Administration was signed by U.S. District Judge David Doty of the U.S. District Court for the District of Minnesota on Nov. 6. 

A consent decree for permanent injunction restrains a company from distributing any products into interstate commerce, until they comply with FDA regulations and allows the FDA to assess damages against the company for any future violations of the law or the consent decree.

PUH is to stop distributing its products until all disease claims are removed from its web sites, product labels, and all other products and web sites under PUH’s or Poindexter’s custody or control. 

PUH and Poindexter also must comply with cGMP requirements for dietary supplements.

“The FDA works with companies to ensure that their processes comply with the public health requirements in our laws and regulations,” stated Melinda Plaisier, the FDA’s acting associate commissioner for regulatory affairs. “But when a firm refuses to comply, we will take aggressive enforcement action.”

The company marketed products online at www.puhcorp.com and www.doc-nt.com claiming that the "dietary supplement products" treated serious medical conditions such as prostate cancer, high cholesterol, hypertension and congestive heart failure. Under federal law, products offered for such use are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease. The company’s products are drugs that have not been approved by the FDA for their claimed uses, the agency stated. 

During a 2012 inspection of PUH, the FDA also found that the company distributed dietary supplements that were not manufactured in accordance with the current good manufacturing practice requirements for dietary supplements.    

The products, marketed under the brand names Pharmacists Ultimate Health and Doctor’s Natural Therapy, included capsules, topical creams and botanical extracts under the brand names Allergy Relief Complex, Lycopene Standardized Extract, Co Q-10, Cold and Flu Defense, Cholesterol Homocysteine, Prostate Companion, Ginger Root Standardized Extract and Progesterone Cream, among others.

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