COLLEGEVILLE, Pa., Sept. 8 /PRNewswire/ -- Wyeth Pharmaceuticals, a
division of Wyeth (NYSE: WYE), announced today that product shipments have
begun for XYNTHA(TM) Antihemophilic Factor (Recombinant),
Plasma/Albumin-Free, a new recombinant factor VIII product for both the
control and prevention of bleeding episodes and surgical prophylaxis in
patients with hemophilia A, a rare, inherited blood-clotting disorder.
XYNTHA is produced using state-of-the-art manufacturing and
purification processes designed to reduce the risk of viral contamination.
The manufacturing process for XYNTHA is completely albumin-free from start
to finish, while the purification process utilizes a unique synthetic
ligand totally free of animal materials and a nanofiltration step using a
35 nanometer pore-size filter.
"We believe the state-of-the-art manufacturing and purification
processes used for XYNTHA make it an exciting new therapeutic option for
many patients with hemophilia A," says Robert Repella, Executive
Vice-President and General Manager, Wyeth BioPharma. "The introduction of
XYNTHA is the culmination of many years of research and development, and
demonstrates Wyeth's continued commitment to the hemophilia community." As
an added convenience for patients, Wyeth's one-of-a-kind Rapid
Reconstitution (R2) Kit is provided with XYNTHA. The R2 Kit is designed to
help patients save time by allowing for ease of transportation and fewer
steps during rapid reconstitution.
Shipments of the Company's current recombinant factor VIII product,
ReFacto(R) Antihemophilic Factor (Recombinant) in the United States will be
discontinued as of May 31, 2009. Wyeth anticipates that many patients using
ReFacto may want to talk to their health care provider about XYNTHA.
Wyeth Hemophilia Patient Access Programs
Wyeth works to help patients with hemophilia have ongoing access to
their hemophilia therapies. Through its Factor Resource Program, Wyeth
provides several services to assist patients experiencing financial
hardship or treatment access issues, including the Insurance-Coverage
Program, the Patient Assistance Program, and the Wyeth Hemophilia Hotline
(1-888-999-2349).
About Hemophilia A
Hemophilia A is a rare, inherited blood-clotting disorder characterized
by spontaneous hemorrhages or prolonged bleeding, typically into joints and
soft tissue. People with hemophilia A are deficient in a key protein --
factor VIII -- that is vital in the clotting mechanism to prevent bleeding.
Most patients with hemophilia A are dependent on factor VIII replacement
therapy.
Indication for XYNTHA
XYNTHA Antihemophilic Factor (Recombinant), Plasma/Albumin-Free is
indicated for the control and prevention of bleeding episodes in patients
with hemophilia A (congenital factor VIII deficiency or classic hemophilia)
and for surgical prophylaxis in patients with hemophilia A. XYNTHA does not
contain von Willebrand factor and, therefore, is not indicated in Von
Willebrand's disease.
Important Safety Information for XYNTHA
-- Anaphylaxis and severe hypersensitivity reactions are possible.
Patients should be informed of the early signs of hypersensitivity
reactions [including hives (rash with itching), generalized urticaria,
tightness of the chest, wheezing, hypotension] and anaphylaxis. Patients
should be advised to discontinue use of the product and contact their
physician if these symptoms occur.
-- Patients should be advised to contact their physician or treatment
facility for further treatment and/or assessment if they experience a lack
of a clinical response to factor VIII replacement therapy, as this may be a
manifestation of an inhibitor.
-- The most common adverse reaction in study 1 is headache (24% of
subjects) and in study 2 is fever (41% of subjects). The most common
adverse reactions (greater than or equal to 5% of subjects) in clinical
studies were headache, fever, nausea, diarrhea, vomiting, and weakness.
-- Patients may develop hypersensitivity to hamster protein, which is
present in trace amounts in XYNTHA.
-- Female patients should be advised to notify their physician if they
become pregnant, intend to become pregnant, or are breastfeeding during
therapy.
-- Before traveling, patients using XYNTHA should be advised to consult
with their health care professional and to bring an adequate supply of
XYNTHA for anticipated treatment.
Indication for ReFacto
ReFacto is indicated for the control and prevention of hemorrhagic
episodes and for surgical prophylaxis and for short-term routine
prophylaxis to reduce the frequency of spontaneous bleeding episodes in
patients with hemophilia A. The effect of regular routine prophylaxis on
long-term morbidity and mortality is unknown.
Important Safety Information for ReFacto
-- As with the intravenous administration of any protein product,
adverse reactions may include headache, fever, chills, flushing, nausea,
vomiting, tiredness, or symptoms of allergic reactions.
-- The remote possibility exists for hypersensitivity to non-human
mammalian proteins. Known hypersensitivity to mouse or hamster proteins may
be a contraindication to the use of ReFacto.
-- Allergic reactions such as hives, itching, difficulty breathing,
rapid heart rate, light-headedness and anaphylaxis have been reported for
all factor VIII products. Patients should discontinue use of the product
and contact their health care provider immediately and/or seek emergency
care if any of these symptoms occur.
Please see full Prescribing Information for XYNTHA and ReFacto
available at http://www.wyeth.com.
About Wyeth Pharmaceuticals
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the
areas of women's health care, infectious disease, gastrointestinal health,
central nervous system, inflammation, transplantation, hemophilia,
oncology, vaccines and nutritional products.
Wyeth is one of the world's largest research-driven pharmaceutical and
health care products companies. It is a leader in the discovery,
development, manufacturing and marketing of pharmaceuticals, vaccines,
biotechnology products nutritionals and non-prescription medicines that
improve the quality of life for people worldwide. The Company's major
divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort
Dodge Animal Health. For additional information about the company, please
visit http://www.wyeth.com.
The statements in this press release that are not historical facts are
forward-looking statements that are subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied by such statements. These risks and uncertainties include, without
limitation, the inherent uncertainty of the timing and success of, and
expense associated with, research, development, regulatory approval and
commercialization of our products and pipeline products; government cost-
containment initiatives; restrictions on third-party payments for our
products; substantial competition in our industry, including from branded
and generic products; emerging data on our products and pipeline products;
the importance of strong performance from our principal products and our
anticipated new product introductions; the highly regulated nature of our
business; product liability, intellectual property and other litigation
risks and environmental liabilities; uncertainty regarding our intellectual
property rights and those of others; difficulties associated with, and
regulatory compliance with respect to, manufacturing of our products; risks
associated with our strategic relationships; economic conditions including
interest and currency exchange rate fluctuations; changes in generally
accepted accounting principles; trade buying patterns; the impact of
legislation and regulatory compliance; risks and uncertainties associated
with global operations and sales; and other risks and uncertainties,
including those detailed from time to time in our periodic reports filed
with the Securities and Exchange Commission, including our current reports
on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K,
particularly the discussion under the caption "Item 1A, Risk Factors" in
our Annual Report on Form 10-K for the year ended December 31, 2007, which
was filed with the Securities and Exchange Commission on February 29, 2008.
The forward-looking statements in this press release are qualified by these
risk factors. We assume no obligation to publicly update any
forward-looking statements, whether as a result of new information, future
developments or otherwise.
SOURCE Wyeth Pharmaceuticals
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Related links:
http://www.wyeth.com
CONTACT:
Media, Danielle Halstrom of Wyeth
Pharmaceuticals, +1-484-865-2020, or Douglas Petkus of Wyeth,
+1-973-660-5218; or Investors, Justin Victoria of Wyeth,
+1-973-660-5340
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