Navigation Links
Hospira Begins Phase I U.S. Clinical Trial of Biosimilar Erythropoietin in Renal Patients
Date:7/26/2010

LAKE FOREST, Ill., July 26 /PRNewswire-FirstCall/ -- Hospira, Inc. (NYSE: HSP), the world leader in generic injectable pharmaceuticals, today announced the start of a U.S. Phase I clinical trial of its biosimilar erythropoietin (EPO) in patients with renal (kidney) dysfunction who have anemia, an important step on the road toward introducing a biosimilar product in the United States. Erythropoietin is a treatment for anemia associated with chronic renal failure and chemotherapy.

The controlled, randomized trial of patients on hemodialysis who have already been treated with Amgen's Epogen® (epoetin alfa), is taking place at 20 different hemodialysis centers across the United States. Patients in the trial will be treated with both Epogen and Hospira's EPO, with each patient receiving one drug first and then being switched to the second drug. The goal of the Phase I trial is to test safety and pharmacokinetics, or measurements of the drug's blood level and distribution in the body, compared with the reference product. Pending successful completion of the Phase I trial, Hospira would launch an expanded Phase III trial in 2011, also comparing safety and efficacy of Hospira's EPO with Epogen.

"This trial marks a key milestone for Hospira's biosimilars program," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "Congressional approval of a regulatory pathway for biosimilar drugs in the U.S. set the stage for our development of a U.S. biosimilar EPO. We hope to leverage our leadership in generics and our biosimilars experience in Europe to make affordable, safe and effective biosimilars available to U.S. patients and their healthcare providers once patents expire over the next several years."

Hospira already sells a biosimilar EPO in Europe, Retacrit™, and is the first U.S.-headquartered company with biosimilars on the European market. Retacrit, introduced in early 2008, now has a more than 50 percent share of the total short-acting EPO biosimilar market in Europe. In addition, Hospira recently launched Nivestim™, a biosimilar version of filgrastim, in the United Kingdom, Germany and Ireland. Filgrastim is a granulocyte colony-stimulating factor (G-CSF) used to treat neutropenia, a condition in which the body makes too few infection-fighting white blood cells. The condition is often caused by drugs prescribed for cancer treatment.

Hospira's Phase I study is being conducted with the participation of DaVita Inc. (NYSE: DVA), and Fresenius Medical Care AG & Co. KGaA (NYSE: FMS, FMS/P). Although Phase I trials are most often conducted with healthy volunteers, Hospira received U.S. Food and Drug Administration (FDA) approval to conduct its Phase I trial with patients.

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, and has one of the largest biosimilar pipelines in the industry.

About Hospira

Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has approximately 13,500 employees. Learn more 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, including statements related to Hospira's biosimilars program and other statements regarding Hospira's goals and strategy. 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, legal, technological and other factors that may affect Hospira's operations and may cause actual results to be materially different from expectations include the risks, uncertainties and factors discussed under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Hospira's latest Annual Report on Form 10-K filed with the Securities and Exchange Commission and subsequently filed Quarterly Reports on Form 10-Q, 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.


'/>"/>
SOURCE Hospira, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Hospira TheraDoc(TM) Infection Control Assistant(TM) Documents Interventions to Help Hospital Reduce Catheter-Related Infections
2. Hospira Announces Intention to Complete Tender Offer for Shares of Javelin Pharmaceuticals
3. Hospira Receives FDA Approval for Meropenem for Injection, USP (I.V.)
4. Hospira Announces Further Extension of Tender Offer for Shares of Javelin Pharmaceuticals
5. Hospira to Standardize Intravenous (I.V.) Administration Sets Portfolio to Non-DEHP
6. Hospira Highlights a Year of Significant Progress at Its 2010 Annual Meeting of Shareholders
7. Hospira to Present at Citi 2010 Global Health Care Conference May 27, 2010
8. Hospira Supports Disaster Relief Efforts in Haiti With Products and Cash Grants
9. Hospira to Present at J.P. Morgan 28th Annual Healthcare Conference Jan. 13, 2010
10. Hospira to Host Conference Call for Fourth-Quarter 2009 Results and 2010 Projections
11. Hospira Expands VisIV(TM) Portfolio to Offer Complete Range of Environmentally Friendly I.V. Containers
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... 11, 2016 SI-BONE, Inc., a medical ... iFuse Implant System, a minimally invasive surgical (MIS) ... the sacroiliac (SI) joint, announced the publication of ... MIS SI joint fusion for patients suffering from ... or SI joint disruption.  In the first article, ...
(Date:2/11/2016)... CITY, Calif. , Feb. 11, 2016  AcelRx ... a podium presentation will be made at the 38th ... and Wound Care Symposium, which is being held ... This international conference covers the latest advancements in wound ... by the American Burn Association, Australian-New Zealand Burns Association, ...
(Date:2/11/2016)... , Feb. 11, 2016  NanoViricides, Inc. ... it has entered into an agreement with the ... nanoviricides® drug candidates in standard animal models of ... , Research Director. Dr. Romanowski has extensive experience ... --> Eric Romanowski , Research ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... 2016 , ... LaserShip, a regional parcel carrier that services the eastern U.S., ... last Friday in order to aid in the Flint water crisis. In 2014, LaserShip ... located in Clio, only 15 miles away from Flint. , “We have deep roots ...
(Date:2/10/2016)... ... February 10, 2016 , ... InDemand Interpreting ... Healthcare, recently partnered with Heart City Health Center to improve access ... years, Heart City Health Center has provided the Elkhart community with access to ...
(Date:2/10/2016)... ... , ... 10 Best Water is excited to announce a new ... that topped the list as a result of their commitment to offering clients creative, ... Tibet 5100, a top notch water company that specializes in providing the public with ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... organization, welcomes S.S. Nesbitt as the latest addition to its growing list of ... other locations throughout the Southeast, from Orlando to Huntsville and in between. , ...
(Date:2/10/2016)... ... February 10, 2016 , ... ... measure change in their patients. Research shows that the Goal Attainment Scale (GAS) ... therapists overcome this challenge and learn more about the Goal Attainment Scale, Education ...
Breaking Medicine News(10 mins):