Hospira, Inc.'s Retacrit(TM) Receives Marketing Authorization in The EU
LAKE FOREST, Ill., Dec. 19 /PRNewswire-FirstCall/ -- Hospira, Inc. , the world leader in generic injectable pharmaceuticals, announced today that the European Commission (EC) has authorized it to market Retacrit (epoetin zeta), a "biosimilar" erythropoietin, for the treatment of anemia associated with chronic renal failure (administered intravenously) and chemotherapy. Retacrit has demonstrated comparable efficacy and safety to Eprex(R)/Erypo(R) (epoetin alfa). Hospira will launch the product in various European Union countries, beginning with Germany in early 2008.
"We are proud to offer Retacrit to patients and healthcare professionals in Europe, because it will lead the way in establishing a well-tolerated and effective anemia treatment with significant cost savings," says Michael Kotsanis, president, Europe, Middle East and Africa, Hospira. "As our first marketed biosimilar, Retacrit continues Hospira's long history of providing high-quality products that also help to reduce healthcare costs."
The EC approved Retacrit on the basis of strong, compelling safety and efficacy data, as well as compliance with extensive quality, clinical and non-clinical guidelines. The product is manufactured and packaged in Europe using advanced technology and following Good Manufacturing Practice (GMP) standards.
"Healthcare providers and patients can always be confident of Retacrit's quality," says Kotsanis.
Hospira will offer Retacrit in a wide range of convenient pre-filled syringes, with doses ranging from 1,000 to 40,000 international units (IU).
Biosimilars are high-quality, cost-effective alternatives to proprietary biopharmaceuticals, which are large-protein molecules derived from genetically modified cell lines. In contrast, "traditional" pharmaceuticals are made from small-molecule, chemical substances. With a growing number of patents for biopharmaceuticals expiring, Hospira has significantly expanded its comprehensive competencies to develop, manufacture and market biosimilars.
The European Medicines Agency (EMEA) has developed a regulatory pathway to approve biosimilars in Europe, but a comparable Food and Drug Administration (FDA) approval pathway does not yet exist in the United States, where the products are often referred to as "follow-on proteins" or "biogenerics." The U.S. Congress is expected to continue to move the issue forward when it reconvenes in January 2008.
Retacrit is being developed, manufactured and distributed under agreements between Hospira; STADA Arzneimittel AG; and BIOCEUTICALS Arzneimittel AG, a STADA-initiated company.
About STADA
STADA Arzneimittel AG, headquartered in Bad Vilbel, Germany, is an international pharmaceutical company with a focus on generic and non-patented branded pharmaceutical products. STADA is one of the leading generic companies in Germany and in the European Union. It is listed on the Frankfurt Stock Exchange. STADA's news releases and other information can be found at www.stada.com.
About BIOCEUTICALS
Initiated by STADA and located in Bad Vilbel, Germany, BIOCEUTICALS Arzneimittel AG is focused on the development of biosimilar products. BIOCEUTICALS is predominantly financed via venture capital and is not quoted on a stock exchange.
About Hospira
Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness(TM) by developing, manufacturing and marketing products that help improve the productivity, safety and efficacy of patient care. In February 2007, Hospira acquired Mayne Pharma Limited to become the world leader in specialty generic injectable pharmaceuticals. With 70 years of service to the hospital industry, Hospira's portfolio includes one of the industry's broadest lines of generic acute-care and oncology injectables, which help address the high cost of proprietary pharmaceuticals; and integrated solutions for medication management and infusion therapy. Headquartered north of Chicago in Lake Forest, Ill., Hospira has approximately 15,000 employees worldwide. Hospira's news releases and other information can be found at www.hospira.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Hospira cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Economic, competitive, governmental, technological and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks and uncertainties set forth under the heading "Item 1 Business -- Risk Factors" in Hospira's Annual Report on Form 10-K for the year ended Dec. 31, 2006, filed with the Securities and Exchange Commission, which are incorporated by reference. Hospira undertakes no obligation to release publicly any revisions to forward-looking statements as the result of subsequent events or developments.
Eprex and Erypo are registered trademarks of Janssen-Cilag, a subsidiary of Johnson & Johnson.
CONTACT: U.S. Media, Jason Hodges, +1-224-212-2863, or European Media,
Richard Kenyon, +44 7831 569 940, or Financial Community, Lynn McHugh,
+1-224-212-2363, all of Hospira
Web site: http://www.hospira.com/
http://www.stada.com/