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Basel, 30 November 2005
Roche and BioCryst
collaborate on clinical compound BCX-4208 for transplantation and autoimmune diseases
Roche
and BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced an exclusive license to develop and
commercialize BioCryst’s phase I compound, BCX-4208, for the prevention of acute rejection in transplantation
and for the treatment of autoimmune diseases. BCX-4208 is believed to have a potent ability to modulate
T-cell activity. T-cells help the body determine when to initiate immune responses and when to accept
or reject newly transplanted organs. By specifically modulating T-cell activity, BCX-4208 may offer
transplant and autoimmune patients a more efficacious and tolerable treatment option.
“We
are extremely pleased to enter into this agreement with Roche, a leader in the transplant and autoimmune
disease markets,” stated Charles E. Bugg, Ph.D., BioCryst’s Chairman and CEO. “This collaboration not
only produces a substantial strategic and economic benefit to BioCryst, it also provides all of the
essential elements for the rapid, comprehensive and competitive development of BCX-4208.”
“BioCryst’s
BCX-4208 is a promising addition to our pipeline,” said Peter Hug, Roche’s Global Head of Pharma Partnering.
“As a new therapeutic agent with a novel mechanism of action, it has the potential to offer significant
improvement in treatment for transplant recipients and patients suffering from autoimmune related diseases.”
Under
the terms of the agreement, Roche will obtain worldwide rights to BCX-4208 in exchange for a $25 million
up-front payment and a $5 million payment as reimbursement for supply of material during the first 24
months of the collaboration. Future event payments could reach $530 million in addition to royalties
on product sales of BCX-4208. For five years, Roche will have a right of first negotiation on existing
back-up PNP inhibitors in transplant rejection or autoimmune diseases. BioCryst retains the right to
co-promote BCX-4208 in the U.S. for several indications. Any new PNP inhibitor discovered subsequent
to this agreement will be exempt from this agreement and BioCryst will retain all rights to such compounds.
About
BCX-4208
BCX-4208, a second generation transition-state analog inhibitor of the
enzyme purine nucleoside phosphorylase (PNP), may have the potential to offer greater efficacy and activity
in the treatment of autoimmune disease and transplant rejection than currently available therapies.
BioCryst successfully completed a phase I ascending single oral dose clinical trial consisting of 84
healthy volunteers in March 2005. The trial had seven dosing cohorts with twelve patients in each cohort.
In August 2005, BioCryst initiated a phase Ib trial in healthy volunteers to evaluate the safety, tolerability
and pharmacokinetics of multiple oral doses of BCX-4208.
About
Transplant Rejection
The greatest threat to transplant patients is rejection of
the transplanted organ by the body's own immune system. For this reason, transplant recipients must
take drugs to suppress the immune response and prevent rejection usually for the rest of their lives.
A regimen combining several drugs is usually given and this treatment has to be continued indefinitely.
Rejection of the new kidney by the patient's immune system can lead to loss of the transplanted organ
and a return to dialysis for kidney transplant recipients. For heart, lung and liver transplant patients,
loss of the transplanted organ presents an immediate threat to life.
About
Autoimmune Diseases
Autoimmune diseases occur when the immune system attacks the
body’s own cells rather than invading microorganisms. There are more than 80 clinically distinct autoimmune
diseases (i.e. multiple sclerosis, rheumatoid arthritis and some types of diabetes), each affecting
the body in different ways. Presentation of these diseases can also vary from patient to patient with
the same condition, and can lead to organ failure requiring transplantation. Corticosteroids are still
the mainstay of treatment for many autoimmune diseases and physicians have to constantly balance the
requirement for best possible disease control with the drug related morbidities associated with long
term steroid exposure.
Roche as a Partner
Roche
is a valued partner to over 50 companies worldwide. In the past two years, Roche has led the pharmaceutical
industry in the number of product deals signed. In 2004, Roche Pharma Partnering brought nine potential
products into the company and strengthened Roche’s positions in oncology, virology and primary care.
Roche’s alliance strategy is to create a partnering culture where innovation flourishes and the partnership
grows.
About BioCryst
BioCryst Pharmaceuticals,
Inc. designs, optimizes and develops novel drugs that block key enzymes involved in cancer, cardiovascular
diseases, autoimmune diseases, and viral infections. BioCryst integrates the necessary disciplines of
biology, crystallography, medicinal chemistry and computer modeling to effectively use structure-based
drug design to discover and develop small molecule pharmaceuticals. For more information about BioCryst,
please visit the company's website at www.biocryst.com.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of
innovative products and services for the early detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche
is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and
a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss
francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly
65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai. Additional information about the Roche
Group is available on the Internet (www.roche.com).
All
trademarks used or mentioned in this release are legally protected.
Conference
Call
BioCryst will sponsor a conference call at 8:30 a.m. Eastern Time on Wednesday,
November 30, 2005 to discuss today’s news in more detail. This call is open to the public and can be
accessed live either over the Internet from the company’s website www.biocryst.com
or by dialling 1-800-811-7286 (U.S.) or 1-913-981-4902 (international). No passcode is needed for the
call.
Conditions
The
transaction may be subject to review by Federal Trade Commission under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976.
Forward-looking statements
These
statements involve known and unknown risks, uncertainties and other factors which may cause our actual
results, performance or achievements to be materially different from any future results, performances
or achievements expressed or implied by the forward-looking statements. These statements reflect our
current views with respect to future events and are based on assumptions and subject to risks and uncertainties.
Given these uncertainties, you should not place undue reliance on these forward-looking statements. |
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Researcher on a mircroscope
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