Barr Laboratories Inc dedicated its Adenovirus Vaccine Virus Types 4 and 7 Manufacturing and Packaging facility, a 20,000 square foot building designed specifically to produce vaccines for recruits in the U.S. Armed Forces. The newly completed facility is located on the Company's 72-acre site here that includes approximately 340,000 square feet of pharmaceutical manufacturing, packaging, warehouse and laboratory facilities. The new facility is part of a $35.4 million, six-year contract from the United States Department of Defense (DOD), which was announced in September 2001, for the clinical development and production of Adenovirus Vaccine Types 4 and 7 tablets.
"The adenovirus vaccines that we are developing for the DOD, which will be manufactured at this facility, represents a significant unmet need for the U.S. military," said Bruce L. Downey, Barr's Chairman and Chief Executive Officer, at the dedication ceremony. "Adenovirus, a flu-like illness that is spread in the close quarters of military barracks, results in as many as 30% of all military recruits suffering lost time from critical training exercises.
“The Armed Forces have been without a vaccine for this illness since 1999, when previously stockpiled supplies were exhausted. We are proud to be working with the Department of Defense to develop, obtain Food and Drug Administration approval, and begin manufacturing these vaccines."
"Additionally, working with the adenovirus builds on Barr's strengths in the area of specialized manufacturing capabilities," Downey continued. "It will also provide us with substantial experience in the area of oral vaccine technology that may be transferable to the development and ultimate marketing of generic biologics, a $16 billion pharmaceutical market that represents the next frontier for significant consumer savings."
Adenovirus types 4 and 7 are associated with flu-like symptoms that include sore throat, high fever, cough, runny nose, headache and chest pain. Recovery takes an average of three to 10 days, but nearly 40 percent of infected people require two weeks. As a result recruits can lose valuable training time.
The Department of Defense first began vaccinating recruits in 1971 after adenovirus infections spread through the Army, Navy and Marine Corps training units in the 50's and 60's. Affecting 50 to 80 percent of recruits, adenovirus infections cost the U.S. government millions in missed recruit training days and millions of dollars over the years related to treatment of the symptoms. For a number of reasons, in 1996 production of the adenovirus oral vaccine, then manufactured by Wyeth, ceased and government stockpiles ran out in 1999.
Construction on the new Barr facility began in 2002, and includes specialized manufacturing and packaging facilities and quality control laboratories that will allow the Company to isolate the adenovirus from contact with the outside environment and employees involved in the production process. As a result of the recent expansion of the Company's packaging and warehouse facilities, and the expansion of parking to accommodate the growing workforce, Barr located the new facility on a level site in the rear of the main manufacturing complex. The adenovirus manufacturing and packaging facilities are similar to the specialized manufacturing suites currently used by Barr at the Forest site to manufacture and package its cancer treatments, hormone therapies, and its warfarin anti-coagulant product.
Barr indicated that FDA approval of its adenovirus vaccine could come as early as calendar 2007. Following successful approval, Barr would manufacture the vaccines under contract to the government specifically for dispensing to the armed forces.
Under terms of the contract with the DOD, the government is providing Barr with approximately $17.4 million to support Phase I clinical development of the Adenovirus Types 4 and 7 vaccine product, and $18 million to support Phase II and Phase III clinical studies as well as the filing of the biological license applications. Also as part of the agreement, Barr was required to construct a dedicated facility to support the production of supplies necessary to complete the approval process and support projected needs of the Department of Defense.