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C h a i n D r u g s t o r e D a i l y M o n d a y, A p r i l 1 8 , 2 0 1 6 1 4 SMARTMOUTH CHIEF EXECUTIVE OFFICER EXPLAINS BAD BREATH An interview with Andrew Burch, Chief Executive Officer, Triumph Pharmaceutical. CDD: What causes bad breath? AB: The creation of bad breath is a natu- ral and ongoing process in our mouths each day. There are millions of germs in our mouths, which break down protein particles that are always present in our saliva. This results in the production of foul smelling sulfur gas. This gas is what we perceive as embarrassing bad breath. CDD: Is bad breath mostly a cosmetic issue? AB: Not just a cosmetic issue, bad breath is a social taboo that can interfere with every relationship, and the problem is virtually universal. Everyone has experi- enced it in the form of morning breath and at least one in four people suffer from a more serious bad breath problem. CDD: What is the solution for bad breath? AB: Most of the so-called bad breath remedies only mask bad breath or pro- vide you with a temporary fix, lasting only five minutes, or up to 60 minutes max. To get all day fresh clean breath, you first have to understand the cause of bad breath. The answer to eliminating and preventing bad breath long term is SmartMouth Mouthwash, for clinically proven 12-hour fresh breath with each rinse. One rinse in the morning, once before bedtime, and SmartMouth's patented zinc-ion technology will elimi- nate and prevent bad breath 24 hours around the clock. Never ever have bad breath. It's really that simple. CDD: Do the two solutions still need to be in separate bottles? AB: SmartMouth Mouthwash's patented, dual-solution technolo- gy requires two key solutions to be kept separate until just prior to rinsing. This ensures that SmartMouth is freshly activated with each use. For two decades, each SmartMouth Mouthwash purchase came with two bottles of liquid that were mixed at the time of use. However, we recently launched our new dual-pour dual chamber bottle technology, where the two solutions are poured and activat- ed from one bottle with a new patented dual pour spout. No more boxes, one beautiful bottle and no more pumps. CDD: Why Does SmartMouth offer three different formulas? AB: Three formulas are available: the original formula, Gum & Plaque formu- la, and we recently launched a new inno- vative Dry Mouth formula, already per- forming very well at Walmart. Many young people, mostly under 40, are using the original formula because their focus is on 24 hours of clean fresh breath for personal hygiene and social reasons. Middle aged and older adults tend to choose the Gum & Plaque formula so that they never have bad breath, but also enjoy anti-plaque and anti-gingivitis benefits. Consumer sales of the two are actually pretty even. Everyone that purchases SmartMouth gets 24 hours of clean fresh breath (two daily rinses), but thousands of consumers want that 'plus' factor where they also get the full clinical benefits to protect gums along with fighting plaque, or now also protection and prevention of dry mouth, a condition that prevails with the use of many common prescription drugs, and so many other reasons. But with SmartMouth, the dry mouth formulation helps to prevent bad breath rather than to actually cause bad breath. For more information, contact David Biernbaum at 314.434.6008 or dbiernbaum@smartmouth.com, or visit www.smartmouth.com. MAYNE PHARMA'S TRANSFORMATIONAL YEAR Mayne Pharma experienced a transforma- tional year in 2015. Chief Executive Officer Scott Richards said, "The acquisi- tion of the Doryx brand and distribution rights diversified the U.S. business plat- form into an integrated pharmaceutical business with growth platforms in generics, contract services and specialty brands." "The company continues to invest in its facilities and product pipeline. The dual-site expansion to materially enhance both manufacturing capacity and capability announced in August 2015, remains on track for completion in 2018. The company also significant- ly increased its investment in research and development, focusing on products with intrinsic barriers to entry that uti- lize our capabilities in potent com- pounds, controlled substances and advanced drug delivery technologies such as SUBA™ and multi-particulate controlled-release." The generics division added 14 NDCs to seven molecules in 2015, with four of those being new molecules for Mayne Pharma. The products introduced include Methamphetamine tablets, Oxycodone HCl tablets, Oxycodone- Acetaminophen tablets, Oxycodone- Aspirin tablets, and Butalbital- Acetaminophen-Caffeine tablets. In May 2015, the company brought the distribution of Methamphetamine and Oxycodone products in-house and also acquired full ownership of the Methamphetamine and BAC 3 ANDAs during FY15 enabling the company to control the manufacture, distribu- tion and sales of these products and increase the economic benefit that flows to Mayne Pharma. The U.S. pipeline includes a range of products, including 10 modified release products, 11 controlled sub- stances and six potent compounds. Mayne Pharma has 18 products pending approval at the FDA. Seven of these pending products have now received 2016 target action dates. Mayne Pharma's most significant generic pipeline product is the filing for Dofetilide capsules, which is a paragraph IV product and first-to-file market opportu- nity. This product is now in the final stages of the FDA's review and the company expects to be awarded 180 days of generic market exclusivity following approval, which is expected to occur in 2016. Favorable market conditions in the contract services industry has seen growth strengthen to high single digits in calendar 2015 driven by expanding R&D portfolios across the pharmaceutical and biotech sectors and the increased trend towards outsourcing early stage development work, particularly for advanced drug delivery technolo- gies requiring specialized expertise. The new Specialty Brand division was successfully introduced in May 2015 with the 200mg delayed-release Doryx brand. The product was out-licensed in the U.S. more than 20 years ago. Mayne Pharma was the original manufacturer and remains the manufacturer. Mayne Pharma introduced a 50mg Doryx™ tablet in August 2015, which is continu- ing to show growth. Mayne Pharma is an ASX-listed spe- cialty pharmaceutical company focused on applying its drug delivery expertise to commercialize branded and generic phar- maceuticals. Mayne Pharma also pro- vides contract development and manu- facturing services to more than 120 clients worldwide. For more information, visit www.mayne pharma.com or call 800.344.8661. NOVAVAX APPOINTS BOB DARIUS SENIOR VICE PRESIDENT, QUALITY OPERATIONS Novavax, Inc., a clinical-stage vaccine company focused on the discovery, devel- opment and commercialization of recom- binant nanoparticle vaccines and adju- vants, has announced the appointment of Bob Darius, Senior Vice President, Quality Operations. He will be responsi- ble for leading the global Quality Operations of the company, including both Quality Assurance and Quality Control, as well as serving as a member of the company's senior management team. Darius joins Novavax with more than 25 years of experience in Quality Assurance, Quality Control and strategic manufacturing. As Vice President Quality Operations at GlaxoSmithKline (GSK) Biologicals, he provided oversight of the North American and German Vaccine Manufacturing Operations for more than 10 years and most recently transitioned to Head Quality Advocacy Liaison. Darius also held positions of increasing responsi- bility at the Food and Drug Administration, Center for Biologics Evaluation and Research, where he was a Senior Reviewer and Inspector, Advisor to the Deputy Center Director, Medicine, on counter-bioterrorism products. He earned a Bachelor of Science degree in Biology from George Mason University and completed graduate work in biotech- nology at Johns Hopkins University. For more information, go to www.novavax.com.