Healthcare Industry News: biosimilar
News Release - October 19, 2007
Hospira's Biosimilar Epoetin Retacrit(TM) Receives Positive Opinion Recommending EU ApprovalApproval and Launch of Hospira's First Similar Biologic Expected by Early 2008
LAKE FOREST, Ill., Oct. 19 (HSMN NewsFeed) -- Hospira (NYSE: HSP ), a leading global hospital products company, announced today that it has received a "positive opinion" recommending European Union (EU) approval for Retacrit (epoetin zeta), a treatment for anemia associated with chronic renal failure and chemotherapy-induced anemia. Retacrit is a similar biologic -- often referred to as a "biosimilar" in Europe or "biogeneric" in the United States -- to epoetin alfa.
The Committee for Medicinal Products for Human Use (CHMP) issued the positive opinion; and the European Commission, which approves pharmaceuticals, usually follows CHMP recommendations. Hospira expects EU approval for Retacrit in late 2007. The company plans to launch the product -- which will be Hospira's first marketed similar biologic -- in various EU countries beginning in early 2008.
"As the world leader in generic injectables, Hospira is ready to bring high-quality, lower-cost similar biologics to patients. We are pleased to have crossed this milestone for this important medication," says Michael Kotsanis, president, Europe, Middle East and Africa, Hospira. "Similar biologics like Retacrit can help provide safe, effective patient care while helping to reduce global healthcare costs."
In late 2006 Hospira; STADA Arzneimittel AG; and BIOCEUTICALS Arzneimittel AG, a STADA-initiated company, announced development, manufacturing and distribution agreements for epoetin zeta. Under these agreements, Hospira obtained exclusive distribution rights for the product in countries including the United States and much of Europe, with the exception of Germany, where Hospira and STADA will both market the product. The epoetin zeta project is being pursued through BIOCEUTICALS. STADA controlled the development process and conducted the approval process on behalf of BIOCEUTICALS and Hospira.
Biopharmaceuticals, or biologics, are large-protein molecules derived from genetically modified cell lines. (In contrast, "traditional" pharmaceuticals are made from small-molecule, chemical substances.) A growing number of proprietary biopharmaceuticals' patents are expiring; and similar biologics are opening a large, emerging market. Hospira has significantly invested in expanding its comprehensive competencies to develop, manufacture and market similar biologics.
The European Commission approves similar biologics that demonstrate quality, efficacy and safety that are similar to currently available biopharmaceuticals in the approved indications. It has already approved other similar biologics. A comparable legal and regulatory approval pathway does not yet exist in the United States.
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.
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.
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.
Private Securities Litigation Reform Act of 1995 -- A Caution Concerning Forward-Looking Statements
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.
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