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Hospira Works With FDA to Help Avert Methotrexate Shortage; Shipping One Month's Supply of New Product Immediately and on Track to Ensure Sustainable Supply
Date:2/21/2012

LAKE FOREST, Ill., Feb. 21, 2012 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), the world's leading provider of injectable drugs and infusion technologies, announced today that it began shipping 31,000 vials of 1-gram methotrexate to U.S. hospitals and treatment centers on Monday, enough for one month's U.S. demand. In addition, Hospira continues to work closely with the U.S. Food and Drug Administration (FDA) to ensure that by mid-March the company will have produced enough supply of this life-saving drug for the full year.

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Methotrexate is an injectable drug used to treat a variety of cancerous and rheumatologic conditions, including acute lymphoblastic leukemia (ALL), a childhood blood cancer.

Hospira began working to address the U.S. methotrexate shortage late last year by increasing production of the product when it first became aware of potential manufacturing challenges with other suppliers. Since then, Hospira has worked with the FDA to secure new supplies of the drug's active ingredient, and by mid-March will have manufactured enough 1-gram methotrexate to meet expected full market demand and also to begin establishing a safety stock to ensure patients and their families do not have to face fear of a shortage again. 

During an FDA briefing regarding progress on drug shortages today at the FDA's headquarters in White Oak, Md., Hospira CEO F. Michael Ball said:

"Commissioner Hamburg, ladies and gentlemen, it is an honor for me to be here today to represent Hospira and to show our continued support to our patients and U.S. hospitals. Hospira, headquartered in Illinois, is the largest provider of generic injectable products in the world, and I am proud to announce that through our continued partnership with the FDA, we will be able to avert a drug shortage crisis for methotrexate. 

"Accelerating the manufacture and delivery of methotrexate is a top priority for our entire company -- we have been, and will continue to do, everything we can to bring more product to the market. In fact, we have been working to address this issue since late last year when we first became aware of potential manufacturing challenges with other suppliers.

"As a result of those efforts, I'm thrilled to relay that, 24 hours ago, we began directly shipping 31,000 vials of new product -- enough to address more than a month's worth of demand -- and it is being received in hundreds of our nation's hospitals and treatment centers today. This represents the first step in our commitment to provide uninterrupted supply of this critical drug.

"Our ability to increase methotrexate production is contingent upon two things -- additional active ingredient and a streamlined system for product manufacture and release. Working in close cooperation with and approval from the FDA, we are able to achieve both. We worked aggressively and creatively to secure as much additional active ingredient as we could obtain by scouring the globe for FDA-approved active pharmaceutical ingredient (API) that we simply didn't have registered, but was in use by other companies who also manufacture the drug, to facilitate our qualification of the suppliers.

"As we speak, we are transporting well over 100 kilograms of new active ingredient to our manufacturing facility from locations around the world.

"Bolstered by our newly secured active ingredient, our manufacturing facility is literally working day and night to turn it into product.

"As a result, next week, we'll release an additional 34,000 vials. And by mid-March, we'll have enough product not only to meet the full market demand, but also to begin establishing safety stock to ensure patients and families never have to face this type of fear again.

"I specifically want to commend Commissioner Hamburg and the efforts by FDA's Center for Drugs and the Drug Shortage Program, led by Dr. Sandra Kweder and Captain Valerie Jensen, for the Agency's rapid response to the methotrexate shortage and for their tireless efforts to help address the challenges of drug shortages overall. Hospira supports, and has been providing, early warning notification to the Agency, and we believe this is a necessary step in our continued collaboration to prevent drug shortages. I also want to commend the members of Congress who have rallied support and pledged their commitment to combat drug shortages and the serious burden they place on patients and families.

"As everyone gathered here today knows, drug shortages in general have been a widespread and serious issue. Hospira is taking action to address shortages by investing hundreds of millions of dollars to increase capacity at existing facilities, build additional capacity and improve our manufacturing plants. We take our responsibility to this country and our patients seriously, and we look forward to working with key stakeholders to help prevent future shortages and avoid these types of frightening situations from recurring.

"Commissioner, we thank you for this opportunity, and on behalf of our 15,000 employees who are dedicated to the hospitals, healthcare providers, patients and families who need our products, we look forward to continuing our work with you to stop drug shortages."

Earlier today, the FDA issued a press release on progress addressing the methotrexate shortage. The press release can be accessed at the following link: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292658.htm

About Hospira
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 15,000 employees. Learn more at www.hospira.com.


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SOURCE Hospira, Inc.
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