Sanofi Pasteur to start shipping new flu vaccines
SWIFTWATER, Pa. – Sanofi Pasteur on Tuesday announced today that its first doses of Fluzone for the 2016-2017 influenza season have been released by the U.S. Food and Drug Administration for shipment.
In the 2015-2016 influenza season, 50% of seniors who were vaccinated received Fluzone High-Dose vaccine, and this number is expected to rise to 60% in the coming season.
“There is general awareness of influenza among the public given its widespread prevalence,” stated David Greenberg, associate VP and regional medical head North America, Sanofi Pasteur. “What is not well known is that influenza can be life-threatening and have a lasting health impact, especially for the most vulnerable populations.”
This shipment represents the first of more than 65 million total doses of seasonal influenza vaccine manufactured by Sanofi Pasteur that will be delivered to U.S. health care providers and pharmacies beginning in July and continuing throughout the remainder of the year.
To address recommendations by the Advisory Committee on Immunization Practices, Sanofi Pasteur has increased production of Fluzone Quadrivalent vaccine where possible. Sanofi Pasteur is the sole provider of injectable influenza vaccine for pediatric patients six months through 35 months of age.
Influenza activity peaked noticeably late last season occurring in early March 2016. Influenza seasons are always unpredictable as new influenza strains emerge and strain activity fluctuates throughout the year, making timely vaccination even more important to help protect against the virus, especially for seniors, young children and infants six months of age and older.
NBTY’s Ester C clinically proven to stay in the body longer
RONKONKOMA, N.Y. – A new clinical study conducted by NBTY demonstrated that Ester-C, a patented form of Vitamin C, stays in immune cells longer than regular Vitamin C (ascorbic acid) currently on the market, NBTY announced Monday.
The study, published in SpringerPlus, reports that Ester-C significantly increases vitamin C concentrations in white blood cells (leukocytes; cell of the immune system) up to 24 hours following a single oral administration of 1,000 mg vitamin C.
"This study is a great example of the commitment NBTY has to scientific diligence around our product innovations," stated Susan Hazels Mitmesser, senior director Nutrition and scientific affairs NBTY and lead author of the study. "As new ingredients and areas of research emerge, our scientific leadership will continue to be a priority and a differentiator in the scientific community and the supplement market with NBTY products leading the way."
"Ester-C is the only product of its kind on the market, and customers can easily find it by the '24-Hour Immune Support' call out on the label," added John Frame, VP marketing for Ester-C. "This product has been clinically studied to stay in the white blood cells longer than regular Vitamin-C – a distinct advantage to anyone looking to nutritionally support their immune system all day long."
This is the first clinical trial comparing vitamin C retention in leukocytes between Ester-C and ascorbic acid in both male and female nonsmokers.
In this double-blind, placebo-controlled, crossover trial, thirty healthy subjects aged 18–60 years were randomized to receive placebo (0 mg vitamin C), ascorbic acid (1,000 mg vitamin C), and Ester-C (1,000 mg vitamin C), each preceded by a 7-day washout period. The Ester-C group had a significantly higher mean concentration change in leukocyte vitamin C, while there was no change in the ascorbic acid or placebo groups. The Ester-C group also had a significantly higher percent change in leukocyte vitamin C compared to ascorbic acid at 8- and 24-hrs after the oral consumption.
Kline: Latest OTC supplier rankings change following multitude of M&As
PARSIPPANY, N.J. – While the U.S. OTC market is not highly dynamic in terms of growth, its competitive landscape has changed significantly over the past five years, with the top 10 rankings shifting in 2015, the Kline Group noted on Monday from its recently published Nonprescription Drugs USA.
Market leaders Johnson & Johnson and Bayer have remained the No. 1 and No. 2 OTC marketers, respectively, for many years. Bayer’s bolt-on acquisition of Merck’s Consumer Health business in 2014 helped solidify its spot as the second-largest OTC marketer. However, the OTC companies ranked 3-10 have been affected by consolidation, mergers and acquisitions.
In 2015, GSK Consumer Healthcare rises to the third-largest position after forming a joint venture with Novartis Consumer Health. Back in 2010, when these businesses were separate, Novartis ranked fourth and GlaxoSmithKline was the fifth-largest competitor. Despite the acquisition of Emergen-C immune boosting supplement and the successful launch of Rx-to-OTC switch Nexium 24HR, Pfizer was pushed down to the fourth ranked position from third as a result of the GSK Consumer Healthcare/Novartis joint venture.
Reckitt Benckiser ranked ninth in OTC sales in 2010, but has risen to be the sixth largest competitor in 2015 after acquiring the large nutritional and digestive Schiff business and the Airborne immune boosting brand. Solid gains for Mucinex cold medication and Delsym cough syrup brands also helped improve Reckitt Benckiser’s ranking over the five-year period.
Prestige Brands and Church & Dwight, neither of which appeared in the top 10 five years ago, are now ranked ninth and tenth, respectively, in the OTC industry. Prestige Brands has grown via acquisitions, adding 17 various OTC brands from GlaxoSmithKline in 2012 and the 2014 acquisition of Insight Pharmaceuticals, which added several brands, namely the Monistat feminine product franchise. Church & Dwight acquired the Vitafusion line of vitamins, which has helped expand its size on the OTC market.
Some of the crucial factors that often propel sales and market share gains can actually have a negative impact on short-term profitability for OTC companies. For instance, the large scale market launch of Nexium 24HR (Pfizer) in 2014 involved a multi-faceted advertising, promotional, and retail marketing campaign to educate consumers, build awareness, and carve out retail shelf space. Despite adding sales over $200 million for Nexium 24HR in its first year on the market, Pfizer’s OTC unit’s margin after marketing expenses and operating margin actually declined from 2013 to 2015, according to Kline’s soon-to-be-published OTC Drugs: U.S. Competitor Cost Structures study. “Often the rewards of large sales gains do not drop to the bottom line until year 2 or 3 post-launch once advertising and other marketing expenses normalize somewhat,” stated Laura Mahecha, Kline’s Healthcare Industry Manager.
Mergers and consolidation also have similar short-term negative impacts on profitability as evidenced by the larger than usual administrative expenses incurred by GSK Consumer Healthcare as a result of the joint venture with Novartis. The July 2014 launch of Flonase Allergy Relief also had a negative impact on the company’s short-term marketing expenses, driving margins downward.