Successfully reported this slideshow.
You’ve unlocked unlimited downloads on SlideShare!
Octapharma USA advertorial profile in NJBIZ - page two
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.”
121 River St., Suite 1201
Hoboken, NJ 07030
Phone: (201) 604-1130
Fax: (201) 604-1131
No. of Employees: 70
Flemming Nielsen, President of Octapharma USA/
Board Member of Octapharma AG
Hematology (coagulation disorders);
Immunotherapy (immune disorders);
Critical Care (emergency medicine)
Year Founded: 2004
with a Commitment to Patient Safety
Yankee Public Relations wrote this two-page advertorial profile for Octapharma USA in NJBIZ.