Zegerid could make switch to OTC by year’s end
A Zegerid-branded proton-pump inhibitor might reach drug store shelves by the end of the year after all, following Schering-Plough’s June response to a Food and Drug Administration complete response letter originally issued in January. Santarus, which owns the prescription rights to the PPI, last month announced the FDA’s new action date on the switch application would be this December.
Following the FDA’s initial complete response letter, there was speculation that the Zegerid switch may be in serious jeapordy. That speculation was based on two factors: The FDA 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.
Should the FDA approve Zegerid for sale OTC, it would mark the second PPI to hit the market this year after Novartis’ Prevacid 24HR in the summer. It also would be the first PPI formulation that combines omeprazole with something else—sodium bicarbonate, an antacid that has afforded 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 2010 for marketers of all heartburn remedies. The antacid tablet category was slightly down 1.3%, according to Information Resources Inc. for the 52 weeks ended April 19 across food, drug and mass (excluding Walmart), for the most part on account of the launch of a store-brand equivalent to Procter & Gamble’s Prilosec OTC.
But now with Novartis and Schering-Plough in the PPI offering mix, the category likely will be significantly up from its present $1.1 billion sales base.
Report: Card-check provision removed from Employee Free Choice Act
NEW YORK The New York Times on Friday reported that the “card-check provision” — which would have required employers to recognize a union as soon as a majority of workers signed cards saying they wanted a union as opposed to a secret-ballot election — has been removed from the Employee Free Choice Act in an effort to secure enough Democratic votes to avoid a filibuster.
It was a polarizing issue — the card-check provision was advocated by union organizations because it would have made it easier to unionize a workforce. In its place, several Senate and labor officials told the New York Times, the revised bill would require shorter unionization campaigns and faster elections — with elections to be held within two work-weeks after 30% of a workforce signed cards favoring unionization.
Gilead enters partnership with Tibotec to develop HIV drug
FOSTER CITY, Calif. Gilead Sciences said it entered a partnership with Tibotec Pharmaceuticals to develop a single daily antiretroviral HIV pill.
The proposed drug would combine Gilead’s Truvada with a drug Tibotec is developing called TMC278, or rilpivirine. Terms were not disclosed, but Gilead said it would take the lead in manufacturing and testing the combined drug, working to get it approved by regulators, and selling it.
Gilead said the product would be the second complete antiretroviral treatment for HIV available in one pill. The first is Gilead’s Atripla, which combines three HIV drugs. The company said the combined pills make treatment simpler for patients.
Tibotec, a unit of Johnson & Johnson, would be responsible for developing rilpivirine as a standalone drug.