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Business Profiles 2014 29
Octapharma USA, headquartered at the Waterfront Corporate Center in Hoboken, entered the U.S. ma...
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Octapharma USA advertorial profile in NJBIZ - page two

Yankee Public Relations wrote this two-page advertorial profile for Octapharma USA in NJBIZ.

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Octapharma USA advertorial profile in NJBIZ - page two

  1. 1. Business Profiles 2014 29 Octapharma USA, headquartered at the Waterfront Corporate Center in Hoboken, entered the U.S. marketplace in 2004 and has consistently grown marketshare every year. The Swiss company hopes to bring the full Octapharma product portfolio to the U.S. has been critical to Octapharma’s international success. It’s an extremely exciting time in the company’s history, particularly in the U.S.” Just this month, Octapharma USA submitted a Biologi- cal License Application (BLA) to the U.S. Food and Drug Administration (FDA) for one of its most novel protein therapies to date—the first purely human recombinant clotting factor VIII (FVIII) from a human cell-line designed for the treatment of hemophilia A patients. The FDA submission followed a recent recommendation from the European Union’s central regulatory body, the Committee for Medicinal Products for Human Use (CHMP), medical advisors to European Medicines Agency (EMA), which adopted a positive opinion toward Octapharma’s human cell-line recombinant human FVIII. CHMP recommended marketing authorization for the treatment and prophylaxis of bleeding (also during and after surgery) in both pediatric and adult patients with hemophilia A (congenital FVIII deficiency). Although Octapharma is optimistic about the success of this product in the U.S., there is no connection between the FDA submission and the endorsement of Octapharma’s human cell-line FVIII in Europe. Recombinant proteins are produced in cultured human cells. Human recombinant proteins produced in human cell-lines show identical properties to the same protein derived directly from human tissues and blood plasma. They are, therefore, assumed to show improved tolerance in patients compared to currently available recombinant products derived from animal cell-lines. “There is an increasing interest in a recombinant FVIII concentrate derived from a human cell-line,” says Nielsen. “The development of inhibitors remains one of the major challenges in hemophilia care. Octapharma looks forward to contributing to the unmet patient needs in this respect, as the results from clinical trials accumu- lated thus far look promising.” Octapharma was among the first to develop human proteins based on recombinant technologies and human cell-lines. The company’s new 110,000-square-foot R&D facility in Heidelberg, Germany, which opened in 2012, is just one example of the company’s continuing commit- ment to this science. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico, and continues to invest in its production facilities with a focus on projects to increase plasma fractionation capacity. In the U.S., which represents approximately 50 percent of the global plasma market, Octapharma is this year investing significantly into building a state-of-the-art facility in Charlotte, N.C., which will house a plasma-testing laboratory, plasma storage facility and the new headquarters of Octapharma Plasma Inc., a subsidiary that operates 45 U.S. plasma collection centers across the country. “Octapharma did not enter the U.S. until 2004, but we have successfully grown market share each year,” explains Nielsen. “The company’s success is mainly due to the col- laborations we have established with the patient and clini- cal communities. We look forward to growing our product portfolio in the U.S. and providing patients with novel therapies that demonstrate Octapharma’s commitment to the absolute highest standard of medical care.” Octapharma USA 121 River St., Suite 1201 Hoboken, NJ 07030 Phone: (201) 604-1130 Fax: (201) 604-1131 Email: uscustomerservice@octapharma.com Web: www.octapharma.com No. of Employees: 70 Top Executive: Flemming Nielsen, President of Octapharma USA/ Board Member of Octapharma AG Products/Services: Hematology (coagulation disorders); Immunotherapy (immune disorders); Critical Care (emergency medicine) Year Founded: 2004 with a Commitment to Patient Safety