Santarus announces Schering-Plough response submission to FDA for OTC Zegerid
NEW YORK There was speculation in January that Schering-Plough’s switch application around the proton-pump inhibitor Zegerid was scuttled after receiving a complete response letter from the Food and Drug Administration.
That speculation was based on two factors — the FDA obviously had additional questions around the switch application, but the general public really had no inclination as to which direction the FDA was leaning on the matter. (That’s because “complete response letters” replaced FDA’s “approvable” and “not approvable” letters.) So some analysts assumed the worst.
Now there is new speculation (at least here in the hallways of Drug Store News), that the Zegerid PPI will be approved by the PDUFA date of December, based entirely on the fact that Schering Plough addressed those FDA concerns within six months.
If that speculation should prove out, it will mark the second PPI to hit the market this year after Novartis’ Prevacid 24HR in the summer, and the first PPI formulation that combines omeprazole with something else — that something else being sodium bicarbonate, an antacid that affords Santarus the prescription marketing claim that Zegerid is the “first and only” immediate-release PPI on the market.
It also will mark a very interesting and volatile year for marketers of all heartburn remedies. The antacid tablet category was slightly down 1.3%, according to Information Resources Inc. data for the 52 weeks ended April 19 for food drug and mass (excluding Walmart), thanks in large part to the introduction of store-brand omeprazole. But now with the introduction of Novartis and Schering Plough to the PPI offering mix, the category likely will be significantly up from its present $1.1 billion sales base — up by as much as 15%.
And that’s an even safer speculation than the Zegerid approval in December. Last year, McNeil Consumer’s launch of Zyrtec generated close to $300 million across its top two SKUs, according to IRI data for the same period, while Schering-Plough’s top three Claritin SKUs lost little more than $20 million in dollar volume, suggesting that Zyrtec scored plenty of consumers outside of converting one-time, loyal Claritin users (the other two big dollar-volume “losers” last year — McNeil’s own Benadryl and Airborne.) Zyrtec was the second second-generation antihistamine to reach the market, so it is similar to Prevacid 24HR in that respect.
But more compelling is the number of massive marketers who all will be looking to protect/grow their shares of stomach, starting with Procter & Gamble (Prilosec OTC), Boehringer Ingelheim (Zantac), McNeil Consumer (Pepcid and Rolaids), Novartis Consumer (Prevacid 24 HR launch and Gas X), GlaxoSmithKline (Tums and Tagamet) and now Schering-Plough with a Zegerid launch.
Perrigo promotes McCormick to consumer healthcare pricing and planning manager
ALLEGAN, Mich. Perrigo earlier this week promoted Shawn McCormick to consumer healthcare pricing and planning manager, where he will be responsible for managing pricing and business planning functions within CHC marketing.
McCormick, a four-year Perrigo veteran, most recently served as the CHC sales and marketing controller. Before joining Perrigo, he worked for Steelcase in finance and with BDO Seidman in auditing.
A Certified Public Accountant, McCormick earned his Bachelor’s of Business Administration in Accounting from Grand Valley State University in 2001.
Bausch & Lomb Vision Care adjusts focus on lens care
ROCHESTER, N.Y. Bausch & Lomb Vision Care on Friday announced a renewed focus on its ReNu brand of lens care solutions through a U.S. consumer rebranding effort that targets both eye care practitioners and consumers with messaging around ReNu Fresh Lens Comfort (formerly ReNu MultiPlus) and ReNu Sensitive Eyes (formerly ReNu Multipurpose Solution). New packaging around Sensitive Eyes begins shipping this month.
Additionally, the company recently established a dedicated U.S. lens care solution and eye care product sales force that primarily is responsible for engaging with eye care practitioners and keeping them updated on the benefits of B&L products for their patients and their practice. The sales team presently is focusing on eye care professionals across the East Coast, and will be moving its emphasis to the West Coast by next year.
“We felt that it was time to rejuvenate our original ReNu brand of lens care solutions … that clearly articulates the specific benefits of each formula,” stated Steven Robins, president, North America, Vision Care. “With ReNu Fresh Lens Comfort and ReNu Sensitive Eyes, we can more directly help meet existing consumer needs, such as the desire for a fresh lens feeling daily or for a solution that is gentle enough for sensitive eyes.”
B&L also has launched a fully integrated consumer marketing campaign, which includes www.renufresh.com, a free-standing advertising insert distributed in newspapers nationally, in-store shelf talkers and banners and an online advertising and search keyword campaign.
The Web site, which features lens care information and tips for consumers, includes a B&L Wear & Care video and a coupon for the Fresh Lens Comfort solution. Consumers also are able to vote for their favorite fresh image of the day.