PHILADELPHIA, Sept. 3 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today the launch of the RELENZA(R) (zanamivir) Inhalation Powder Pandemic Readiness for Employers Program (P.R.E.P.) that enables businesses two options when stockpiling RELENZA in preparation for an influenza pandemic. Under the new plan, businesses will have the option to purchase Relenza now at a discounted rate with free storage or to reserve quantities of Relenza for future purchase at a capped rate with a nominal annual fee.
"We are committed to helping employers and other business leaders prepare for an influenza pandemic and its impact on the health of their employees and the operational integrity of their organizations," said Chris Viehbacher, President, North American Pharmaceuticals, GlaxoSmithKline. "By offering employers these options, we aim to reduce the storage and cost barriers associated with implementing an antiviral stockpiling program."
The U.S. Department of Health and Human Services (HHS) encourages employers to take the lead in protecting their workforce and to stockpile the antivirals they will need to protect their employees. HHS acknowledges the importance of diversifying stockpiles and recommends the stockpiling of existing antiviral drugs as part of a comprehensive pandemic plan.
"A diversified stockpile of antivirals is important as we are coming to understand that our concerns for the past few years about resistance of pandemic influenza viruses to antivirals were justified," said Anne Moscona, M.D., Professor of Pediatrics and of Microbiology and Immunology and Vice Chair for Research of Pediatrics, New York-Presbyterian Hospital/Weill Cornell Medical Center. "The recent article in Nature, further explaining the mechanism for this emerging resistance, reinforced the importance of diversifying your antiviral stockpiles in order to help protect the broadest number of employees."
P.R.E.P. includes two purchasing options to help employers enact their antiviral stockpiling programs.
The RELENZA Preferred Pricing option offers a discounted price to reduce the burden of upfront expenses and guarantees the opportunity to repurchase RELENZA at a set discounted price. In addition, the RELENZA Preferred Pricing option includes free storage. As companies prepare for potential emergencies, such as an influenza pandemic, this plan ensures employers will have access to treatment.
The second choice is the RELENZA Reservation option, which reduces the need for large upfront expenditures and locks in a future purchase price for RELENZA. There is an annual fee of $6 per unit to reserve and maintain the reservation during the life of the contract. Customers can secure contract terms for up to 10 years and may cancel at any time with no additional cost. Upon request from customers or in the event of a phase four pandemic alert (human-to-human transmission as declared by the World Health Organization), each business enrolled in the Reservation option would be able to purchase their reserved RELENZA units.
HHS has developed pandemicflu.gov to be a resource for all of these entities when preparing for pandemic influenza.
GSK's Pandemic Planning Web site (http://www.PandemicPlan.gsk.com) offers a variety of tools, materials and information to help organizations with pandemic planning. The site includes links to resources that can assist with storage of medicines, antiviral prescribing, and other pandemic-related activities.
About Avian and Pandemic Flu
Pandemic flu is a type of influenza. Influenza pandemics have occurred three times in the past century -- in 1918-19, 1957-58, and 1968-69. H5N1 is a subtype of avian flu that some experts believe could lead to a global pandemic.
GSK has been working on a pandemic flu vaccine since 1998, long before bird flu became headline news. Recently, GSK has invested over $2 billion in facilities and new technology to more effectively combat influenza through vaccine and to develop governmental stockpiles of its antiviral Relenza. GSK has active clinical trial programs underway for several H5N1 vaccines.
RELENZA is an inhaled antiviral delivered through a device called a Diskhaler(R) to the surface of the upper respiratory tract. RELENZA is indicated for treatment in patients 7 years of age and older and for prophylaxis in patients 5 years of age and older with influenza A and B. H5N1 -- a subtype of the avian flu -- is an influenza type A virus. In-vitro and animal modeling data show activity for RELENZA against H5N1 avian flu. Additionally, RELENZA has retained in-vitro activity to influenza viral mutations that have become resistant to another neuraminidase antiviral agent. The efficacy and safety of RELENZA for treatment and prophylaxis of influenza due to H5N1 or other potential pandemic strains have not been established. Clinical efficacy cannot be concluded from in-vitro data. There have been no clinical trials completed to date studying efficacy of RELENZA in avian flu. RELENZA is not recommended for people who have underlying airways diseases such as asthma or chronic obstructive pulmonary disease. Some patients have had bronchospasm (wheezing) or serious breathing problems when they used RELENZA. Safety and efficacy have not been demonstrated in patients with high-risk underlying medical conditions. Patients should be instructed in the use of the delivery system. Common adverse events include headaches, diarrhea, sinusitis, dizziness, and fever and/or chills. For more information on RELENZA, visit: http://www.relenza.com.
GlaxoSmithKline: A Leader in Flu
GlaxoSmithKline has an active research and development program targeted
at both seasonal and pandemic flu and has recently invested more than $2
billion to expand capacity for manufacturing its flu vaccines FLUARIX(R)
[Influenza Virus Vaccine] and FLULAVAL (TM) [Influenza Virus Vaccine] and
its antiviral flu medication RELENZA. GlaxoSmithKline -- one of the world's
leading research-based pharmaceutical and healthcare companies -- is
committed to improving the quality of human life by enabling people to do
more, feel better and live longer. For company information, visit
GlaxoSmithKline at http://www.gsk.com.
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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK's operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2007.
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