Zegerid new formulation filed; OTC switch of original still in play
SAN DIEGO Santarus, a specialty pharmaceutical company, on Monday announced that the Food and Drug Administration has accepted for filing the company’s drug application for a new tablet formulation to add to its Zegerid (omeprazole/sodium bicarbonate) family of branded prescription pharmaceutical products.
“In late January, we submitted to the FDA an NDA for an immediate release tablet formulation of Zegerid, which combines omeprazole with a mix of buffers,” Gerald Proehl, Santarus president and CEO, told analysts last month. “We believe this new tablet has the potential to provide features and benefits that … will be important to physicians and their patients with GERD. Our objectives [are] to have the new Zegerid tablet product commercially available in the United States in the fourth quarter of 2009.”
Pursuant to Prescription Drug User Fee Act guidelines, Santarus expects the FDA will complete its review or otherwise respond to the NDA by Dec. 4.
In connection with the FDA’s acceptance for filing of the NDA for a new tablet formulation, Santarus is providing notice to the NDA holder for Prilosec (omeprazole) delayed-release capsules and related patent holders that the new tablet formulation does not infringe the patents listed in the Orange Book for Prilosec or that those patents are invalid.
On a separate front, Schering-Plough, in partnership with Santarus, is currently seeking to switch the current Zegerid formulation (20-mg) from prescription-only to over-the-counter. Schering-Plough HealthCare Products received a Complete Response Letter regarding that switch application in January.
“Santarus believes that the response will be based on further analysis of existing data,” Proehl said. “While we can’t predict with certainty what the FDA will require if the analysis of the existing data is acceptable to the FDA, Santarus does not believe there will be a need for any additional clinical study.”
New research investigates the aging of populations and its influence on markets
LONDON New research released by Datamonitor on Friday identified the aging of populations around the globe and how this trend will have crucial implications for the U.K. markets.
“The aging of populations globally is an issue that will increasingly shape both society and its consumer markets,’ stated Matthew Adams, consumer analyst at Datamonitor and co-author of the reports.
A large proportion of the population in each European country accounted for by consumers aged 50 and above. The U.K. was one of the youngest nations, relatively, in Europe in 2007, but the senior population still exceeded one third of the overall population. The greatest proportional growth in senior is expected to occur in the United States, with a 1.5% compound annual growth rate among seniors.
However, the relative proportion lags behind the norm in Europe by a short margin. In absolute numbers, the senior group of consumers comprises more than 90 million Europeans and should rise to over 100 million by 2012.
Overall, seniors are an ideal target demographic, the report concluded.
“With substantial assets and significant liquid capital, seniors are likely to ‘upgrade’ and choose premium products, particularly those ‘empty nesters’ who have less obligation to support the family and children,” stated Matthew Taylor, consumer market analyst at Datamonitor and also co-author. “The recent ‘less is more’ philosophy might reinforce the pursuit of high quality products. The aging of the baby boomers is also a factor in turning toward a less materialistic approach to the luxury lifestyle. With increased consumer awareness of ‘sustainability’, many products made with natural ingredients cultivated organically, or sourced from specific origins, are becoming popular among these sophisticated consumers.”
Alison Sweeney teams up with the APhA to help fellow allergy sufferers find relief
WASHINGTON The American Pharmacists Association and McNeil Consumer Healthcare Division on Thursday teamed with actress Alison Sweeney on the launch Behind the Counter Counts, a campaign designed to inform nasal congestion sufferers about pseudoephedrine treatment options located behind the pharmacy counter.
The new campaign features an online resource, www.BTCcenter.com, that features Sweeney’s personal tips, a tool to help people figure out if allergies or colds are causing their nasal congestion, and general information about PSE products.
“Congestion and other allergy symptoms can really get in the way when you’re juggling work, family and everyday life,” Sweeney stated. “I initially didn’t realize the medicines that I’ve relied on, Sudafed and Zyrtec-D … were located behind the pharmacy counter until I spoke with my pharmacist. That’s why I hope other allergy sufferers will do the same, because knowing what’s available and where to find it is the first step to finding the medicine that’s right for you.”