RESEARCH TRIANGLE PARK, N.C.,
March 3, 2011 /PRNewswire/ --
Talecris Biotherapeutics, Inc. (TLCR) announced today that it has
been granted orphan drug designation by the European Commission for
the development of Plasmin (human) to treat acute peripheral
arterial occlusion (aPAO). Talecris is currently investigating
Plasmin in a phase II clinical trial designed to assess its ability
to treat aPAO, a condition in which arterial blood flow to the
extremities, usually the legs, is blocked by a clot.
Through this designation, the European Medicines Agency (EMA)
will provide Talecris with ten years of market exclusivity if the
product is the first to be approved in the European Union. In
addition, under this designation, EMA will provide Talecris with
clinical development assistance and reduced regulatory fees.
Talecris received orphan drug designation for Plasmin from the U.S.
Food and Drug Administration (FDA) in 2009.
"The European Commission's orphan drug designation represents
another promising development milestone for Talecris in the
expansion of our product pipeline, a pursuit that reflects our
ongoing commitment to offer clinical advancements for patients with
chronic and acute life-threatening conditions," said Steve Petteway, Executive Vice President,
Research and Development at Talecris.
By providing incentives to the pharmaceutical industry, the EU
legislative framework for orphan medicines encourages the
development of products intended to diagnose, prevent and treat
life-threatening or chronically-debilitating conditions that impact
up to 5 in 10,000 people in the European Union. The initiative
helps improve access to quality medical care for patients who have
rare diseases for which there are few, if any, approved
treatments.
About Plasmin
Plasmin is a stabilized formulation of the naturally-occurring
blood enzyme Plasmin, which dissolves blood clots by breaking down
their fibrin matrices and is being investigated for its ability to
restore blood flow. Plasmin, derived from human plasma, is a
direct-acting thrombolytic that exerts its effects directly at the
site of the clot. In contrast, indirect-acting thrombolytics, such
as Plasminogen activators, target clots indirectly by first
stimulating the production of Plasmin.
Talecris recently completed a phase I/II multicenter clinical
trial to investigate dose escalation and safety in the treatment of
acute PAO. Study participants received Plasmin via catheter
directly infused to the site of the clot. A phase II multicenter
clinical trial has been initiated.
About Acute Peripheral Artery Occlusion (PAO)
Acute peripheral arterial occlusion (aPAO) occurs when blood
flow to the extremities becomes blocked by a blood clot. This
condition is most common in people with underlying peripheral
artery disease, in which fatty plaque builds up in artery walls and
cause narrowing of the arteries and restricted blood flow to legs
and arms. Without prompt intervention, acute PAO can result in
significant complications such as permanent nerve and muscle
damage, tissue necrosis and, in severe cases, amputation or
death.
There is an unmet medical need for a proven thrombolytic agent
to treat acute PAO, which affects up to 1.7 per 10,000 people in
the European Union each year. Current methods focus on
pharmacologic, mechanical, or surgical removal of the blood clot,
or bypass grafting to direct flow around the area of the clot.
However, there are no direct-acting thrombolytic drugs currently
approved for this indication, and the treatments currently used
(Plasminogen activators) typically require a prolonged infusion
averaging 24 to 36 hours, which can increase the risk of bleeding
complications.
About Talecris Biotherapeutics: Inspiration.
Dedication. Innovation.
Talecris Biotherapeutics (Nasdaq: TLCR) is a global
biotherapeutic and biotechnology company that discovers, develops
and produces critical care treatments for people with
life-threatening disorders in a variety of therapeutic areas
including immunology, pulmonology, neurology and hemostasis.
(http://www.talecris.com/)
Cautionary statement regarding forward-looking
statements
This press release contains forward-looking statements within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements include,
but are not limited to, quotations from management in this press
release, statements regarding strategic and operation plans, and
statements regarding the development or commercialization of
therapies. Forward-looking statements are based on current beliefs
and expectations and are subject to inherent risks and
uncertainties. You are cautioned not to place undue reliance on
forward-looking statements. Although Talecris believes that the
forward-looking statements contained in this press release are
reasonable, there is no assurance that expectations will be
fulfilled.
The following factors, among others, could cause actual results
to differ materially from those expressed or implied in
forward-looking statements: possible U.S. legislation or regulatory
action affecting, among other things, the U.S. healthcare system,
pharmaceutical pricing and reimbursement, including Medicaid and
Medicare; our ability to procure adequate quantities of plasma and
other materials which are acceptable for use in our manufacturing
processes from our own plasma collection centers or from
third-party vendors; our ability to maintain compliance with
government regulations and licenses, including those related to
plasma collection, production and marketing; our ability to
identify growth opportunities for existing products and our ability
to identify and develop new product candidates through our research
and development activities; and the timing of, and our ability to,
obtain and/or maintain regulatory approvals for new product
candidates, the rate and degree of market acceptance, and the
clinical utility of our products. Additional information about
factors that could affect the business and financial results of
Talecris is contained in its final Prospectus filed pursuant to
Rule 424(b)(1) with the Securities and Exchange Commission on
October 1, 2009. Talecris undertakes
no duty to update any forward-looking statement.
SOURCE Talecris Biotherapeutics, Inc.