Industry Roundup: Nexium 24HR Tablet, Glanbia Deal, FDA Warnings

Nexium 24HR tablet ready

Pfizer Inc. prepares to launch a tablet version of Nexium 24HR (20mg esomeprazole), the OTC switch of the Rx blockbuster Nexium it markets under license from AstraZeneca. FDA’s Center for Drug Evaluation and Research in a Nov. 23 letter informed Pfizer that its new drug application for Nexium 24HR delayed-release tablets for the treatment of frequent heartburn in adults 18 years of age and older was approved. Pfizer launched Nexium 24HR in 2014 following FDA approval of AstraZeneca’s NDA to make a 20mg esomeprazole product available nonprescription (Also see "OTC Nexium 24HR Rides Blockbuster History Into Full Field Of Competitors" - Pink Sheet, 9 May, 2014.).

Glanbia has thinkThin idea

Irish nutritional ingredient firm Glanbia plc enters the ready-to-eat bar category and looks to augment its brand in additional channels with its $217m acquisition of Los Angeles firm thinkThin LLC. Glanbia will acquire thinkThin under an agreement it and San Francisco private equity firm TSG Consumer Partners LLC announced Nov. 16 and expect to close by the end of 2015. TSG said thinkThin recently expanded with the launch of Protein & Fiber Hot Oatmeal and Protein Bites. With thinkThin, Glanbia said it has “exposure to the rapidly expanding nutrition bar segment which is currently valued at $2.8b in US retail.” Glanbia said it will fund the transaction with debt from existing facilities and expects it to “be marginally earnings accretive in 2016.”

FDA warns Nature’s Mojo

Nature's Mojo Inc. is the latest own-brand dietary supplement marketer to hear from FDA about compliance with good manufacturing practices requirements. In a Nov. 12 warning letter, the Office of Regulatory Affairs’ New Jersey District also advised the Ledgewood, N.J., firm about marketing unapproved new and misbranded drugs due to disease claims for its liquid herbal extract products, including its alfalfa leaf "may be very beneficial in easing pain from both osteo and rheumatoid arthritis, helpful for those who suffer kidney or bladder conditions ... aid in blocking the absorption of cholesterol" and its ginkgo biloba leaf “can also be beneficial for conditions due to reduced blood flow to the brain ... headache ... hearing disorders.” ORA officials determined during a June inspection that Nature's Mojo was out of compliance with supplement GMP requirements by failing to establish product specifications to provide sufficient assurance for products it receives from suppliers; to establish and follow written procedures for the responsibilities of quality control operations; and to make and keep records of product distribution. The firm’s response stated its policies and procedures would be written for each of the requirements, but it did not include supporting documentation regarding the specifications, according to the letter.

‘Serious Concern’ On Seeds Of Light

Miami firm Seeds of Light Enterprises Inc. attracts FDA interest as a potential repeat offender in marketing dietary supplements spiked with sibutramine, a banned drug ingredient. In an Oct. 15 warning letter “to express our serious concern about” the safety of products Seeds of Light Enterprise markets, the Office of Regulatory Affairs’ Florida District said FDA tests found sibutramine in the firm’s Meizi Super Power Fruits.” ORA also warned the firm that a review of its website showed claims for its products including “feel how easy it is to lose weight” and “lose weight, eat freely with no diet.” The claims and the presence of sibutramine render the product an unapproved new drug with inadequate directions for its intended use. Other product brands the firm markets also have been linked to spiking with sibutramine and phenolphthalein, a drug ingredient that has no history of approval for use in the US.

Doctors mum on probiotics for IBS

In a survey of 607 consumers 18 and older diagnosed with irritable bowel syndrome, 71% talk to health care providers about probiotics, but only 10% said their doctor is educating them about which probiotic is best for their condition and only 13% of doctors advise that certain probiotics may not help with their condition. Survey sponsor Sigma-Tau Pharmaceuticals Inc., marketer of the VSL#3 high-probiotic medical food brand, said in a Nov. 23 that the research by Harris Interactive also found 49% are taking a probiotic and 69% say probiotics have helped change their life for the better.

Mobius crowd-funds protein drink launch

Mobius Nutrition LLC launches a crowd-funding campaign to raise $30,000 to support full-scale production of Mobius Breakfast. The powdered meal-replacement drink is positioned as supporting natural energy and focus while providing necessary nutrition. The chocolate-flavored formula contains coconut, milk, protein and caffeine derived from 100% Arabica coffee beans “to keep up energy levels and support muscle and joint health,” the Boulder, Colo., firm said Nov. 3, noting additional electrolytes, multivitamins and nootropics in the formula “increase focus, decrease stress and supplement necessary daily nutrients.” The IndieGoGo campaign, which closes Dec. 3, was at more than $25,000 through Nov. 25.

Nutrilite Health Institute appoints three board members

Direct seller Amway's Nutrilite Health Institute announces three scientific board members whose expertise in healthy aging, weight management and traditional Indian medicine “will be invaluable as we develop plans for research to support new product ideas.” The Buena Park, Calif.-based Nutrilite brand on Nov. 24 said the members are Bradley Wilcox, professor and director of research at the Department of Geriatric Medicine at the University of Hawaii School of Medicine; Eric Ravussin, director of the Nutrition Obesity Research Center and associate executive director for clinical sciences; and Padma Venkatasubramanian, a professor and advisor at the School of Life Sciences at the Institute of Transdisciplinary Health Sciences & Technology in Bangalore, India.

Pulse Beverage expands distribution

[Pulse Beverage Corp.] secures distribution of its Natural Cabana lemonades, limeades and coconut waters through Mahaska Bottling Co., a beverage brand bottler/distributor covering 157 counties in Iowa with more than 4 million consumers, according to Pulse. The Northgleen, Colo., firm is expanding distribution in US stores, most recently launching its flagship product, Pulse Heart & Body Health, in 97 Fresh & Easy Neighborhood markets (Also see "Industry News: Twinlab Into Resveratrol, Hi-Tech Buys LG Brands" - Pink Sheet, 18 Aug, 2015.).

Mannatech sales VP

[Mannatech Inc.] names Ben Mayo global sales systems vice president, responsible for developing innovative tools, training and best practices to support Mannatech's independent sales associates globally, the firm announces Nov. 23. As part of Mannatech President and CEO Al Bala's vision to provide world-class support to sales associates, Mayo will work with regional presidents, general managers and field leaders to identify associates' needs and develop sales programs, tools and training to help associates to grow their businesses, the firm notes.

Beldt Labs products debut on Amazon

Beldt Labs Inc., a marketer of nutritional and weight loss products, announces a direct vendor partnership with Amzon.com including the recently launched SKALD: Oxydynamic Fat Scorcher ($69.95) and VASST: Premium Nitric Oxide Load (price not yet available). The Boca Raton, Fla., firm also will introduce three others products in the first half of 2016 on the online retail site. The deal with Amazon came together with help from Beldt's distributor Nutritional Products International, which helped the firm partner with online health retailer RevNutrition.com, also announced Nov. 23.

PureFormulas interactive health site

Health supplement online retailer PureFormulas Inc. launches “The Inside Story” interactive body map guiding through nutrients to support concerns from brain health to foot care, the Miamifirm said Nov. 23.The app offers suggestions in 15 categories and 26 sub-categories, including brain health, eye care, immune support, cardiovascular health, respiratory health, joint health and more, the firm notes.

Dr. Smith’s expansion, promotion

Dr. Smith's Diaper Rash ointment and spray reach retailers Babies “R” Us, buybuy BABY and Target, Mission Pharmacal Co. announces Nov. 17. The expansion represents a “key milestone” for growth, says the San Antonio-based firm, which is partnering with The Bump, “the definitive voice for millennial parents” on a Happy Baby sweepstakes promotion to give away $4,000 in gift cards.

Rockin Refuel signs singer

Shamrock Foods Co. signs country music singer Kellie Pickler to promote the Phoenix firm's Rockin Refuel protein drink. As part of the deal announced Nov. 18, Shamrock sponsored and provided Rockin Fuel for Pickler as she competed in the Warrior Dash muddy obstacle race near Nashville Oct. 10. Picker joins the brand's representatives including NFL wide receiver A.J. Green and WNBA player Skylar Diggins.

Aspire Sports sponsorship

Aspire Sports Drinks are named the official beverage of the Under Armour All-America High School Football Game on Jan. 2, 2016, through a deal between Aspire Beverage Co., Intersport and ESPN, the beverage company announces Nov. 19. The ninth Under Armour-sponsored game will feature more than 90 senior high school football players in front of a national audience on ESPN2. As part of the multi-year partnership, Aspire Beverage will exclusively supply hydration stations and bottled sports drinks during the game, the Minneapolis, Minn.-based firm said. Aspire drinks also will be incorporated into year-round marketing campaigns, social media initiatives, in-store promotions and grass roots activities for the Under Armour All-America Game platform.

Hangover drink gains distribution

NOHO Inc. enters an exclusive distribution agreement with a second Scottsdale, Ariz., firm, TDG Brands Inc., for distribution of NOHO The Hangover Defense, the company says Oct. 30. TDG Brands services more than 48,000 stores in the domestic US with “big name brands” says NOHO. In 2014, the firm launched distribution of NOHO shots in Asia (Also see "In Brief: DXM, NPLEx, AHPA, Merck, Novel Ingredients" - Pink Sheet, 7 Apr, 2014.).

Klean Athlete and USA Water Polo

Klean Athlete partners with USA Water Polo Inc. to help athletes build a solid nutritional foundation and avoid unsafe or banned substances. The Huntington Beach, Calif, company, owned by Hi-Vidomin Laboratories Inc., on Nov. 9 said it also is offering nutritional supplement education safety sessions. Klean Athlete markets a line of 10 nutritional supplements that are NSF Certified for Sport, meaning each product undergoes a “meticulous testing and verification process,” the company says.