Lead Product ARC19499 Is Potential Subcutaneous Hemophilia Therapy
Currently In Phase I Clinical Development
DEERFIELD, Ill., November 19, 2010 - Baxter International Inc. (NYSE: BAX)
announced today that it has entered into a definitive agreement to acquire all of
the hemophilia-related assets of a privately-held biopharmaceutical company,
Archemix, and entered into an exclusive license agreement for certain related
intellectual property assets.
The lead product associated with the arrangement is ARC19499, a
synthetic, subcutaneously-administered hemophilia therapy currently in a Phase I
clinical trial in the UK. ARC19499 blocks Tissue Factor Pathway Inhibitor (TFPI)
activity, thereby augmenting and improving blood clotting, potentially reducing
replacement factor therapy for patients with hemophilia A and B.
"Baxter is committed to optimizing hemophilia care and improving the lives
of people living with hemophilia around the world," said Hartmut Ehrlich, M.D.,
vice president, global research and development and medical affairs, for Baxter's
BioScience business. "This anti-TFPI program is an important addition to other
Baxter hemophilia development programs focusing on longer-acting rFVIII and
rFIX and non-intravenous therapies."
Baxter expects to record a special pre-tax in-process research and
development charge of approximately $30 million in the fourth quarter of 2010
relating to an upfront payment associated with the transaction. In the future, Baxter may also make milestone-related payments to Archemix of up to $285
million. Subject to regulatory approvals and other conditions, the companies
expect to complete the transaction by year-end.
ARC19499 is part of a new therapeutic class referred to as "aptamers." As
an aptamer is smaller than a protein or biologic, these molecules have the
potential to be developed for subcutaneous administration. The Phase I clinical
trial for ARC19499 was initiated by Archemix in the UK in August 2010 and
continues to enroll patients. Currently there is one aptamer approved by the U.S.
FDA and available to patients today: Macugen®, for the treatment of age-related
Hemophilia is a rare genetic blood clotting disorder that primarily affects
males.1 People living with hemophilia do not have enough of, or are missing, one
of the blood clotting proteins naturally found in blood.1 Two of the most common
forms of hemophilia are A and B.1 In people with hemophilia A, clotting factor VIII
is not present in sufficient amounts or is absent.1 Without enough FVIII, people
with hemophilia can experience spontaneous, uncontrolled internal bleeding that
is painful, debilitating, damaging to joints and potentially fatal.1 People with
hemophilia B (also called Christmas disease) do not have sufficient amounts of
clotting factor IX.1 In about 30 percent of cases, there is no family history of
hemophilia and the condition is the result of a spontaneous gene mutation.1
According to the World Federation of Hemophilia, more than 400,000 people in
the world have hemophilia.2 All races and economic groups are affected equally.2
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures
and markets products that save and sustain the lives of people with hemophilia,
immune disorders, cancer, infectious diseases, kidney disease, trauma and other
chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices,
pharmaceuticals and biotechnology to create products that advance patient care
Mary Kay Ladone,