Mylan settles patent litigation related to Celebrex capsules
PITTSBURGH — Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan’s abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules, 50-mg, 100-mg, 200-mg and 400-mg strengths.
This product is the generic version of Celebrex, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.
Under the terms of the agreement, Mylan will begin selling product at the earliest market formation, however, in any case not later than December. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission, Mylan stated.
In addition, Mylan has appealed the decision by the United States District Court for the Northern District of West Virginia denying Mylan’s request for an injunction in its suit against the FDA. Mylan continues to believe that the FDA “seriously erred” in its decision awarding one-party eligibility for 180 days of exclusivity on celecoxib, and will continue with this suit independent of the aforementioned settlement, the company stated.
As reported by Drug Store News, the U.S. District Court for the Northern District of West Virginia denied a motion filed by Mylan and issued an opinion and order affirming a decision by the FDA under which Teva should receive sole 180-day “first-to-file” exclusivity for generic Celebrex (celecoxib) 100-, 200- and 400-mg capsules
For the 12 months ended March 31, 2014, Celebrex had U.S. sales of approximately $2.34 billion, according to IMS Health.
Dollar General celebrates opening of 12th distribution center in Bethal, Pa.
GOODLETTSVILLE, Tenn.— Nearly 1,000 Dollar General employees and their families, company executives and government officials celebrated on Saturday the grand opening of the discount retailer’s 12th distribution center in Bethel, Pa.
Steve Kujovsky, Dollar General’s Bethel Distribution Center director, celebrates the grand opening of the company’s 12th distribution center alongside Dollar General executives today in Bethel, Pa. (Photo: Business Wire)
Located in Berks County, the distribution center represents a local investment of approximately $100 million and the creation of 500 local jobs, the company stated.
“Dollar General is excited to celebrate the grand opening of our Bethel distribution center,” stated Rick Dreiling, chairman and CEO of Dollar General. “Our presence in Pennsylvania represents another opportunity to help our stores better serve our customers. We also look forward to a longstanding partnership with the Bethel community as we continue to be focused on our mission of serving others.”
Dollar General announced plans to build the 930,000 square foot facility in 2012 and broke ground on the facility in fall 2012 with Kinsley Construction. It began shipping products in January and is currently scheduled to serve more than 1,000 stores in seven states throughout the Midwest and Northeast at full capacity.
“Our keystone location to markets, improving infrastructure and workforce of more than 6.4 million of the hardest working people in America drive companies like Dollar General to locate and invest in Pennsylvania,” stated Tom Corbett, Governor of the Commonwealth of Pennsylvania. “My administration is proud to partner with Dollar General in bringing 500 new jobs to Berks County.”
Dollar General’s other distribution centers are located in Scottsville, Ky.; Ardmore, Okla.; South Boston, Va.; Indianola, Miss.; Fulton, Mo.; Jonesville, S.C.; Alachua, Fla.; Zanesville, Ohio; Marion, Ind.; Bessemer, Ala., and Lebec, Calif.
myGMDC expands services
The challenge GMDC chose to accept: How do you extend the productivity derived from GMDC meetings into a year-round, access-from-anywhere service that doesn’t require a 100-page user manual to start up? The solution: the recently reconstructed myGMDC, a members-only portal that gives access to a myriad of fresh services and education exclusive to GMDC members. That includes services like GMDC*Connect, which opens the door to high-definition video conferencing to member companies, or the new GM Hierarchy, a data repository created in partnership with Nielsen that measures the general merchandise business across the industry.
The fact is there are a lot of relatively new services that can be accessed through myGMDC. To bring attendees of the 2014 GMDC Health, Beauty and Wellness Marketing Conference up to speed on all of them, Keith Wypyszynski, GMDC VP business development and chief member officer, joined Michael Winterbottom, GMDC VP information technology and chief technology officer, on the stage Sunday afternoon to showcase the many services available.
Keith Wypyszynski, GMDC VP business development and chief member officer (left), and Michael Winterbottom, GMDC VP information technology and chief technology officer (right), spoke about GMDC’s services during Sunday’s business session.
GMDC*Connect is a free video conferencing tool that can make follow-ups after a GMDC conference both more efficient and less expensive. But it goes beyond being a tool member companies can use in conferencing with other member companies — they can use it for any purpose, including the facilitation of internal meetings or meetings with companies outside of GMDC. Only the host of the conference — which can field as many as 25 connections — needs to be a GMDC member. GMDC*Connect is compatible with any device, including legacy video conferencing systems, Winterbottom said. “You can also have an unlimited number of people watching that exchange in real time,” Winterbottom added.
With regard to the GM Hierarchy, GMDC plans to refresh it this fall, Wypyszynski said. Wypyszynski added that there also is an enhanced HBW section that tracks more than 60 health and beauty categories and is updated on a monthly basis. “We think these two services will now provide you a greater ability to look across all the non-food areas, not only health and beauty, but general merchandise for all of our members,” he said.
Another new service is GMDC’s Virtual Store Tour in partnership with RetailNetGroup. GMDC has been offering local store tours as part of its GM conference for several years, Winterbottom noted. Now those store tours are being hosted and archived online, which allows retailers and suppliers to review new store formats from anywhere in the world. “It’s a great way at looking at the top retail trends as seen around the world,” Wypyszynski said.
Members exploring the myGMDC site also will find that they have an industrywide online directory service at their fingertips, which enables them to identify any buyer or supplier by the categories they sell or buy. “If you truly want to maximize the value derived from your GMDC membership, one of the keys is to keep your profile fresh,” Winterbottom said.
GMDC also is leveraging the content delivered at its conferences to its website. For example, GMDC has already taken Saturday’s lunch presentation presented by Nielsen’s Todd Hale and NMI’s Maryellen Molyneaux and archived it on the site. “One thing that’s nice is through GMDC*Connect, we have the ability now to use the same video technology service and broadcast that live 365 days per year,” Wypyszynski noted. “We already have 16 presentations that have been made [available] through the service online. In addition to that, we have a number of whitepapers and research studies that are available.”
The bottom line: There are a number of new, technology-driven services available through myGMDC that are worth checking out.