Baxter International Inc. : Baxter Announces Collaboration with Chatham Therapeutics for Factor IX Hemophilia B Gene Therapy Treatment
06/04/2012| 09:20am US/Eastern
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Baxter International Inc. (NYSE:BAX) today announced that it has entered
into an exclusive global agreement with Chatham Therapeutics, LLC, an
affiliate of Asklepios BioPharmaceutical, Inc. (AskBio), for the
development and commercialization of potential treatments for hemophilia
B utilizing Chatham's gene therapy technology.
The collaboration will allow Baxter to investigate Chatham's Biological
Nano ParticlesTM (BNP), an advanced recombinant
adeno-associated virus-(rAAV) based gene therapy technology that has
shown potential therapeutic benefit in early clinical studies. A small
independent study involving six patients using Chatham technology
components was the topic of a 2011 article in The New England Journal
of Medicine.i This agreement will involve the next
generation of this gene therapy technology, which Baxter and Chatham
will investigate through U.S.-based hemophilia B clinical trials. Baxter
has obtained global rights for the marketing and commercialization of
the new treatment.
''This collaboration demonstrates Baxter's ongoing commitment to
scientific innovation in advancing treatment options for patients living
with hemophilia. This initiative complements Baxter's extensive
hemophilia portfolio and helps to address unmet needs of hemophilia
patients,'' said Ludwig Hantson, Ph.D., president of Baxter's BioScience
business.
Baxter made a $25 million upfront cash payment for the development and
advancement of the program through early clinical trials, and will
record this amount as a special pre-tax in-process research and
development charge in the second quarter of 2012. Baxter may make
additional payments over the next several years based on certain
development and commercial milestones.
''This agreement initiates a clinical development collaboration
dedicated to advancing a potential long-term treatment paradigm for
hemophilia patients. We look forward to working with Baxter and view
this transaction as the optimal path toward providing a sustainable
therapeutic to a worldwide patient population,'' said Jade Samulski,
Vice President at AskBio and Co-Founder of Chatham Therapeutics.
Hemophilia B is the second most common type of hemophilia (also known as
Christmas disease) and is the result of insufficient amounts of clotting
factor IX, a naturally occurring protein in blood that controls bleeding.ii
Hemophilia B occurs in about one in 25,000 males, with approximately
4,000 people in the United States currently diagnosed with the disease.iii
Hemophilia B is often a debilitating, chronic disease with complications
that include bleeding episodes, hemophilic arthropathy (bleeding into a
joint) and hospitalization.iv
Baxter is pursuing a number of research opportunities in hemophilia. The
company is conducting a Phase I/III clinical trial of BAX326, a
recombinant Factor IX being evaluated for the treatment of patients with
hemophilia B, and expects to file for U.S. approval by the end of 2012.
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 worldwide.
About Chatham Therapeutics, LLC.
Chatham Therapeutics, LLC is a private clinical development-stage
biotechnology company engaged in the development of novel, gene
therapy-mediated cures for hemophilia. The company is currently engaged
in gene therapy-based therapeutic programs for both hemophilia A and B.
Chatham Therapeutics, LLC is an affiliate of Asklepios
BioPharmaceutical, Inc. (AskBio). AskBio is currently developing
proprietary gene-delivery technologies for therapeutics, targeting
diseases in the heart, CNS, muscle, ocular and liver tissues. For
additional information, visit AskBio's Web site at http://www.askbio.com.
This release includes forward-looking statements concerning a
collaboration agreement between Baxter and Chatham Therapeutics, LLC as
well as Baxter's existing recombinant Factor IX program. The
statements are based on assumptions about many important factors,
including the following, which could cause actual results to differ
materially from those in the forward-looking statements: satisfaction of
regulatory and other requirements; actions of regulatory bodies and
other governmental authorities; clinical results validating the use of
BAX326 to treat patients with hemophilia B; changes in laws and
regulations; product quality or patient safety issues; and other risks
identified in Baxter's most recent filing on Form 10-K and other SEC
filings, all of which are available on Baxter's website. Baxter does not
undertake to update its forward-looking statements.
i Nathwani, et al. Adenovirus-Associated Viral
Vector-Mediated Gene Transfer in Hemophilia B. N Engl Jrnl Med,
2011;365:2357-2365.
ii Frequently Asked Questions About Hemophilia. World
Federation of Hemophilia. Accessed on April 20, 2012 Available at: http://www.wfh.org/index.asp?lang=EN
iii World Hemophilia Foundation. Annual Global Survey 2009.
iv Lee, C. A. (2011) Hemophilia Care in the Modern World, in
Current and Future Issues in Hemophilia Care (eds E.-C.
Rodríguez-Merchán and L. A. Valentino), Wiley-Blackwell, Oxford, UK.
Accessed on April 20, 2012. Screen shot of page available here
Baxter International Inc.
Media Contacts
Brian
Kyhos, (847) 948-4210
Deborah Spak, (847) 948-2349
or
Investor
Contacts
Mary Kay Ladone, (847) 948-3371
Clare Trachtman,
(847) 948-3085
© Business Wire 2012
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