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 Baxter’s buying
January 2011
SHARING OPTIONS:
The lead product associated with the arrangement is
ARC19499, a synthetic hemophilia therapy that is injected under the skin and is
currently in a Phase I clinical trial in the United Kingdom.
The move is a strong indication of Baxter's interest in
bolstering its presence in the fight against hemophilia, a rare genetic blood
clotting disorder that primarily affects males. Current estimates are that more
than 400,000 people in the world have hemophilia. All races and economic groups
are affected equally by the disorder.
“Baxter is committed to optimizing hemophilia care and
improving the lives of people living with hemophilia around the world,” says
Dr. Hartmut Ehrlich, vice president of global research and development and
medical affairs for Baxter’s BioScience business, in a prepared statement. “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.”
ARC19499 is part of a new therapeutic class referred to as
“aptamers.” Aptamers are smaller than a protein or biologic, so the theory is
that these molecules have the potential to be further developed for
subcutaneous administration. They are short, synthetically derived
oligonucleotides that form three-dimensional structures that bind with high
specificity and affinity to protein and non-protein targets.
Currently there is
one aptamer approved by the U.S. Food and Drug Administration and available to
patients today: Macugen, for the treatment of age-related macular degeneration.
The Phase I clinical trial for ARC19499 was initiated by
Archemix in the United Kingdom in August 2010 and continues to enroll
patients.
People living with hemophilia do not have enough of, or are
missing, one of the blood clotting proteins naturally found in blood.
Two of
the most common forms of hemophilia are known as type A and type B. In about 30
percent of cases, there is no family history of hemophilia, and the condition
is the result of a spontaneous gene mutation.
In people with hemophilia A, clotting factor VIII is not
present in sufficient amounts or is absent. Without enough FVIII, people with
hemophilia can experience spontaneous, uncontrolled internal bleeding that is
painful, debilitating, damaging to joints and potentially fatal.
People with
hemophilia B (which is sometimes also referred to as “Christmas disease”) do not have sufficient amounts of
clotting factor IX.
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 expected to complete the transaction by the end of 2010.
In late October, Hikma Pharmaceuticals, a multinational
pharmaceutical group based in London, purchased Baxter’s U.S. generic
injectables business for $112 million in cash.
The deal involved products
currently on the market and in the pipeline, as well as employees and real
estate in New Jersey and Tennessee.
“Baxter’s growth strategy is to focus more on differentiated
offerings derived from the company’s expertise in enhanced packaging and
formulation technologies, resulting in higher-margin products,” explained
company officials at the time.
Baxter officials refused to comment for this story.
Archemix
representatives did not respond to requests for comment.
Archemix is a privately held biopharmaceutical company based
in Cambridge, Mass. The company is leading the development of aptamers as a new
class of directed therapeutics for the prevention and treatment of chronic and
acute diseases. With their unique properties, aptamers offer an alternative to
biologics and small molecules in numerous applications and hold extraordinary
potential to address unmet medical needs. The company’s website states that
Archemix’s business strategy is to build and advance a pipeline of proprietary
aptamer products in the core areas of cardiovascular disease, hematology and
oncology.
TAMPA, Fla.—Baxter also recently signed an agreement with
Accentia Biopharmaceuticals Inc. to provide Accentia with the exclusive,
worldwide right to purchase Baxter’s cyclophosphamide, which is marketed under
the brand name Cytoxan, for the treatment of designated autoimmune diseases
including multiple sclerosis.
According to the companies, further investigation of
cyclophosphamide may identify a potentially valuable treatment option for
patients with devastating autoimmune diseases, including multiple sclerosis,
with high unmet medical need.
The agreement also grants Accentia with the exclusive right
for designated indications to reference Baxter’s proprietary, historical data
related to cyclophosphamide as part of Accentia’s planned clinical and
regulatory development of Revimmune.
The agreement designates Baxter as
Accentia’s sole source of cyclophosphamide for Revimmune.
“We are pleased that, through this agreement, we will be
able to support Accentia Biopharmaceuticals in the ongoing development of Revimmune,”
says Dr. Debasis Chakrabarti, Baxter’s therapeutic area leader for oncology.
“Further investigation of cyclophosphamide may identify a potentially valuable
treatment option for patients with devastating autoimmune diseases, including
multiple sclerosis, with high unmet medical need.”
“With this agreement in place, we are planning a robust
clinical and regulatory development strategy to advance our mission to
establish Revimmune as a new standard-of-care treatment for patients suffering
from autoimmune diseases, including orphan indications with potential
accelerated regulatory pathways, as well as major indications such as multiple
sclerosis,” says Accentia President Samuel S. Duffey. Financial terms of the deal were not released. Code: E011122 Back  |
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