OverTheCounterToday

Novartis To Launch Nycomed's PPI Pantoloc Control In 14 European Countries

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Novartis will launch the OTC proton pump inhibitor Pantoloc Control (pantoprazole 20 mg) in 14 European countries in the second quarter of 2010 under a co-marketing agreement with the product's originator Nycomed.

The deal, signed in the fourth quarter of 2009 and announced Jan. 26, is "a significant launch for us," a Novartis spokeswoman said in an email.

Novartis considers the European heartburn remedy market largely untapped. While AstraZeneca sells omeprazole OTC as Losec in some countries, the nonprescription stomach remedy market in Europe is less saturated than in the U.S.

"The market in Europe is large," she said. "Reflux symptoms, including heartburn are suffered by up to 45 percent of adults across Europe and frequent heartburn is a major burden for millions of Europeans."

Brian McNamara, European region head for Novartis OTC, said in a release, "Until now the effective treatment choices available over-the-counter were fairly limited."

This Week In Cosmetics & Personal Care: Table Of Contents

 

P&G's eStore To Serve As "Learning Lab" For Studying Consumer Habits Online
Procter & Gamble will launch an e-shopping Web site for its products this spring, with the primary goal of gaining a better understanding of its consumers' online purchasing behavior.

Maker Of Silk'n Hair-Removal Device To Launch Acne, Anti-Aging Systems
Israeli firm Home Skinovations will introduce home-use Silk'n devices for acne treatment and skin rejuvenation in 2010 while it and TRIA Beauty continue to battle for the upper hand in home hair removal.

Beiersdorf Study On Body Odor Spurs Work On Ethnically Sensitive Deodorants
Findings from a recent study on the metabolic causes of body odor could pave the way for the development of deodorants that address the needs of specific ethnic populations, German consumer products firm Beiersdorf reports.

Long Arms Of Laws Touch OTCs, Supplements

Emerging laws of different types and different origins could affect the supply of OTC drugs and nutritional products, "The Tan Sheet" finds this week. While in the U.S. more states are considering Rx-only laws for all pseudoephedrine-containing drugs and in Europe the EU drug regulator recommends pulling an Rx weight-loss ingredient off the market, the law of nature could affect the supply of omega-3 fatty acids.

River of Rx-only PSE bills reaches Mississippi: Local media report…

Alli could benefit from EU pulling Rx weight-loss ingredient: European media state…

Fatty acid sales may trim the fish population: Time magazine says…

This Week In OTCs And Supplements: Table Of Contents

 

Changes are afoot in the dietary supplement arena as FDA's supplement program director Bill Frankos prepares to leave the agency, a firm pleads guilty in a steroid supplement case and ingredient supplier Martek Biosciences moves to expand its supplement portfolio with the proposed acquisition of Amerifit. The Jan. 25 issue of "The Tan Sheet" discusses the ramifications of these changes on the supplement industry. We also explore how the latest twist in the health reform bill debate will impact the pharma industry.

FDA To Fill Frankos' Shoes As Major Dietary Supplement Initiatives Pend – FDA's supplement program director Vasilios "Bill" Frankos exits the agency in March. With NDI guidance pending and GMP inspections continuing, potential successors will face a full plate

Martek Pursues Direct Consumer Access With Pending Acquisition Of Amerifit – Martek bids $200 mil. for the health and wellness company, which offers the ingredient developer a substantially expended portfolio with brands including Culturelle, Estroven and AZO. The deal also marks the omega-3 DHA ingredient supplier's first major foray into consumer marketing. Planned launches include a DHA product aimed at seniors

GSK's Quick Warning On Fake Alli Exemplifies Effective Crisis Management – GlaxoSmithKline and FDA warn consumers Jan. 18 of a "small quantity" of counterfeit alli – just over a month after the firm began receiving consumer complaints. The quick turnaround is "the way crisis management should be done," compared to McNeil's handling of complaints of musty-smelling Tylenol, crisis management expert Bernstein says

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NY Beverage Tax May Use Fluid Definition Of "Dietary Aids"

New York State's proposed tax on soda, energy drinks and sports beverages is riling industry and retailers opposed to what they call a regressive and economically damaging levy. But industry also may have questions about exactly what the dedicated tax means by excluding "dietary aids" and where liquid dietary supplements, medical foods and other nutritional products would fall. 

Gov. David Paterson's 2010-2011 executive budget proposal notes on page 130 that "New York can make great strides in combating the obesity epidemic by applying lessons learned in our battle against tobacco," which the state has heavily taxed. Hence, the proposed tax of about $.01 per ounce of bottled soft drinks and other sugary beverages lacking a certain amount of fruit or vegetable juice.

A coalition of New York retailers oppose the tax and the American Beverage Association rejects the idea of the tax reducing obesity rates. We noted the public health arguments in favor of such a policy here.

FDA Dietary Supplement Leadership Vacancy

 FDA's food center will soon be filling a Bill Frankos-sized hole in its leadership.

The director of FDA's Division of Dietary Supplement Programs at the Center for Food Safety and Applied Nutrition, Vasilios "Bill" Frankos, will retire from the agency in March and move to Herbalife, taking the position of senior VP of product compliance and safety, the firm announces Jan. 19.

Frankos joins the global marketer of weight-loss, nutritional and personal care products effective in April, the firm says.

"Bill Frankos exemplifies Herbalife's commitment to providing science-based nutritional supplements of the highest quality available in the marketplace," says Michael O. Johnson, Herbalife chairman and CEO, in the Los Angeles-based firm's release.

Frankos, whose responsibilities at FDA include directing policy, budget, and administrative activities related to supplement activities, has been overseeing the "full implementation" of the Dietary Supplement Health and Education Act during the good manufacturing practices era, Herbalife notes in its announcement.

It is not yet known who will fill Frankos' shoes at the agency when he departs.

Daniel Fabricant, VP of scientific and regulatory affairs at the Natural Products Association, said Brad Williams, currently Frankos' assistant, is a "possibility" for a replacement.

Fabricant said it was a smart move on Herbalife's part, to have someone on staff with Frankos' expertise. "Under his watch, we had GMPs. We had AERs," he pointed out.

During his time at FDA, Frankos published the final rule for supplement good manufacturing practices and implemented the serious adverse event reporting requirements.

- Katie Stevenson

This Week In Cosmetics & Personal Care: Table Of Contents

OCA, Organic Purists File Complaint Against "Cheaters" With Obama's USDA
The Organic Consumers Association and a triumvirate of like-minded personal-care brands are leveraging recent court proceedings and the recommendation of the National Organic Standards Board in a complaint filed with the U.S. Department of Agriculture, claiming rampant organic "fraud.

Shiseido Looks To U.S. For Growth With $1.7 Bil. Offer For Bare Escentuals
Tokyo-based Shiseido Co. is set to acquire mineral makeup leader Bare Escentuals Inc. for $1.7 billion in a move to strengthen its U.S. and North American business.

Dove Line May Capture Men Who've Dropped The Axe On The Mating Game
Unilever is extending its Dove personal-care brand with the line's first offerings designed specifically for men - presumably those who have outgrown its prurient Axe grooming brand.

This Week In OTCs And Supplements: Table Of Contents

In the Jan. 18 issue of "The Tan Sheet," we look at what Arcadia Bioscience did right in eliciting FDA acknowledgement for its new dietary ingredient, as well as what J&J/McNeil did not-so-right in the lead-up to its recall of Tylenol, Motrin and other OTCs. We've also got news on Reckitt's attempt to slow the advance of generic Mucinex and how industry sees the current incarnations of health care reform legislation.

(To get full access to "The Tan Sheet" this week and every week, start your subscription today. Click here to sign up for your free 30-day trial.)
  

FDA Denial Of Mucinex Petition Stops Reckitt's Bid To Delay Generics
FDA stymies Reckitt Benckiser's attempt to delay private label competition for Mucinex OTC cough products by rejecting the firm's request to redefine bioequivalence standards for guaifenesin generics.

Firms Share NDI Notification Tips And Experts Reveal Common Pitfalls
Early and frequent communication with FDA is key to earning an elusive FDA acceptance of a new dietary ingredient notification on the first try, an agriculture-tech firm executive says.

McNeil Expands Tylenol Recall As FDA Criticizes Firm's Response To AERs
McNeil Consumer Healthcare's reaction to signs of potentially contaminated packaging for OTC products including Tylenol raised FDA's ire and is now costing the firm an extensive product recall.

Surviving An FDA Advisory Panel

 
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It's January 20th, and you can read about our panelists and the program at our Windhover Conferences page here.

- Christopher Walker

Venezuela Devalues Its Bolivar; International CPG Firms Adjust Financial Outlook

Venezuelan President Hugo Chavez’s devaluation of the country’s currency late last week is expected to impact the finances of U.S. personal-care firms, the Wall Street Journal reports here.

U.S. companies with business in Latin America, where growth has continued even through the global recession, are likely to see reduced earnings in Venezuela as the value of the bolivar drops from approximately 2.15 to 2.6 per dollar for essential goods and 4.3 for non-essentials.

Colgate-Palmolive expects its products to fall into the non-essential category, according to a company release.