XOMA Receives Orphan Drug Designation From U.S. FDA for Pyoderma Gangrenosum
February 24 2014 - 6:20PM
XOMA Corporation (Nasdaq:XOMA), a leader in the discovery and
development of therapeutic antibodies, announced today gevokizumab,
the Company's IL-1 beta modulating antibody, has been granted
Orphan Drug Designation by the U.S. Food & Drug Administration
(FDA) for the treatment of pyoderma gangrenosum (PG).
Orphan drug designation is granted by the FDA Office of Orphan
Products Development (OOPD) to novel drugs or biologics that treat
a rare disease or condition affecting fewer than 200,000 patients
in the U.S. The designation provides the drug developer with a
seven-year period of U.S. marketing exclusivity, as well as tax
credits for clinical research costs, the ability to apply for
annual grant funding, clinical research trial design assistance and
waiver of Prescription Drug User Fee Act (PDUFA) filing fees. The
OOPD also works on rare disease issues with the medical and
research communities, professional organizations, academia,
governmental agencies, industry, and rare disease patient
groups.
"Selecting pyoderma gangrenosum as our next Phase 3 indication
reflects our commitment to creating and capturing value from
gevokizumab, particularly in indications where patients have few
effective treatment options," stated John Varian, Chief Executive
Officer of XOMA. "We intend to present what we believe are
compelling data from our pilot study in PG and to solicit feedback
from the FDA about the requirements for a Phase 3 program in this
rare disease."
About Gevokizumab
Gevokizumab is a potent monoclonal antibody with unique
allosteric modulating properties and the potential to treat
patients with a wide variety of inflammatory and other diseases.
Gevokizumab binds strongly to interleukin-1 beta (IL-1 beta), a
pro-inflammatory cytokine, and modulates the cellular signaling
events that produce inflammation. IL-1 beta has been shown to be
involved in diverse array of disease states, including
non-infectious uveitis (including Behçet's uveitis), cardiovascular
disease, and other auto-inflammatory diseases.
Gevokizumab currently is being studied in a global Phase 3
clinical program, termed EYEGUARD™, which is being conducted by
SERVIER and XOMA. This program is designed to determine
gevokizumab's ability to treat acute non-anterior non-infectious
uveitis (NIU) in EYEGUARD-A, to prevent disease flares in patients
with Behçet's uveitis in EYEGUARD-B, and to prevent disease flares
in NIU patients who are controlled with steroids and
immunosuppressants in EYEGUARD-C.
XOMA has a Proof-of-Concept (POC) program underway in which the
Company is exploring the efficacy and safety of gevokizumab in
multiple indications. The Company reported promising data in
January 2013 from the interim analysis of a Phase 2 study in
moderate to severe inflammatory acne. Data from the National Eye
Institute's study of gevokizumab in patients with active
non-infectious anterior scleritis is expected in 2014. XOMA
anticipates full results from its two POC studies in patients with
erosive osteoarthritis of the hand in the first quarter of 2014.
Separately, SERVIER initiated a Phase 2 study to determine
gevokizumab's ability to reduce arterial wall inflammation in
patients with marked atherosclerotic plaque inflammation and who
have experienced an acute coronary syndrome in the previous twelve
months, as well as POC studies in polymyositis/dermatomyositis,
giant cell arteritis, and Schnitzler syndrome. Information about
gevokizumab clinical studies can be found at www.clinicaltrials.gov
and www.clinicaltrialsregister.eu.
About Pyoderma Gangrenosum
Pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis of
painful expanding necrotic skin ulcers, which has four
classifications based upon the type of skin ulcers manifested. The
U.S. Department of Health and Human Services' National Institutes
of Health's Office of Rare Disease Research lists PG occurring in
about 1 per 100,000 people. Approximately 50 to 70 percent of the
PG patient population has an underlying systemic condition, while
the remainder is idiopathic (unknown cause). The most prevalent
underlying condition is inflammatory bowel disease (IBD), most
commonly ulcerative colitis and Crohn's disease. The prognosis for
PG is directly linked to the patient's response to therapy for the
underlying disease. Patients receive a combination of topical and
systemic therapy to treat the ulcers, which may take up to two
years to heal. Despite the ongoing use of systemic therapy, up to
46 percent of patients experience a relapse.
About XOMA Corporation
XOMA has built a portfolio of innovative therapeutic antibodies,
both in late-stage clinical development and in preclinical
research. XOMA focuses its antibody research and development on
allosteric modulation, which offers opportunities for new classes
of therapeutic antibodies to treat a wide range of human diseases.
XOMA's lead product candidate, gevokizumab (IL-1 beta modulating
antibody), is in a global Phase 3 program in non-infectious uveitis
with its partner SERVIER and multiple proof-of-concept studies in
other IL-1-mediated diseases. XOMA's scientific research also
produced the XMet program, which consists of three classes of
preclinical antibodies, including Selective Insulin Receptor
Modulators (SIRMs) that could have a major effect on the treatment
of diabetes.
More detailed information can be found at: www.xoma.com.
ABOUT SERVIER
"Since the company's creation, all of our profits are ploughed
back into research" Jacques Servier, Founding President of the
Group.
Founded in 1954, Servier is an independent French pharmaceutical
research company. Its development is based on the continuous
pursuit of innovation in the therapeutic areas of cardiovascular,
metabolic, neurologic, psychiatric, bone and joint diseases, as
well as cancer. With a strong international presence in 140
countries, Servier employs more than 22,000 people worldwide. In
2012, the company recorded revenue of 3.9 billion euros, and 92% of
Servier drugs are consumed internationally. The Servier Group
contributed 57% to the 2012 French trade surplus in the
pharmaceuticals sector. The Company reinvested 25% of its revenues
into R&D in 2012.
More information is available at: www.servier.com.
Forward-Looking Statements
Certain statements contained in this press release including,
but not limited to, statements related to anticipated timing of
initiation and completion of clinical trials and proof-of-concept
trials, sales of approved products, and the positive outcome of our
clinical trials or receipt of marketing approval by the U.S. FDA or
that otherwise relate to future periods are forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933 and Section 21E of the Securities Exchange Act of 1934.
These statements are based on assumptions that may not prove
accurate, and actual results could differ materially from those
anticipated due to certain risks inherent in the biotechnology
industry and for companies engaged in the development of new
products in a regulated market. Potential risks to XOMA meeting
these expectations are described in more detail in XOMA's most
recent filing on Form 10-Q and in other SEC filings. Consider such
risks carefully when
considering XOMA's prospects. Any forward-looking
statement in this press release represents XOMA's views only
as of the date of this press release and should not be relied upon
as representing its views as of any subsequent
date. XOMA disclaims any obligation to update any
forward-looking statement, except as required by applicable
law.
CONTACT: XOMA Corporation
Company and Investor Contact:
Ashleigh Barreto
510-204-7482
barreto@xoma.com
Juliane Snowden
The Oratorium Group, LLC
jsnowden@oratoriumgroup.com
Media Contact:
Canale Communications
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
Servier
Servier Communication Department
+33 1 5572 6037
presse@servier.fr
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