Teva and Xenon Announce FDA Orphan Drug Designation for Pain Drug XEN402
JERUSALEM & BURNABY, British Columbia--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Xenon
Pharmaceuticals Inc. (Xenon) announced today that the US Food and Drug
Administration (FDA) has granted orphan-drug designation to the
investigational drug XEN402 being developed for the treatment of pain
associated with erythromelalgia (EM).
EM is a rare autosomal dominant condition characterized by debilitating
spontaneous or easily evoked attacks of symmetrical burning pain in the
feet and hands, typically associated with elevated skin temperature and
erythema (redness of the skin). Symptoms are generally induced by
exercise, prolonged standing, exposure to heat, and/or changes in
humidity. The pain can be so severe that it can lead to suicide, and
adequate treatment remains very challenging.
Orphan Drug Designation is granted by the FDA Office of Orphan Drug
Products to novel drugs intended to treat rare disease or condition
affecting fewer than 200,000 people in the U.S. This designation confers
special incentives to the drug developer, including tax credits towards
the cost of clinical trials, prescription drug user fee waivers and may
entitle a period of seven years U.S. market exclusivity upon FDA
"We are very pleased to receive orphan drug designation for XEN402.
Through development of this drug, we hope to address the significant
unmet medical need for patients who suffer from chronic pain related to
erythromelalgia, said Dr. Michael Hayden, President of Global R&D and
Chief Scientific Officer for Teva Pharmaceutical Industries, Ltd.
XEN402, which inhibits the SCN9A sodium channel, is being developed as
a non-opioid approach to pain management."
The granting of this orphan-drug designation is another important
milestone for our XEN402 development said Simon Pimstone, President and
CEO of Xenon. Xenon was founded with a commitment to identifying novel
targets and from these, novel drugs for difficult to treat rare
diseases. We are excited by the promise XEN402 has shown in early
proof-of-concept trials and are committed to its development as a novel
therapy for the treatment of pain associated with erythromelalgia.
XEN402 is a novel chemical entity that has been exclusively licensed
worldwide to Teva Pharmaceutical Industries Ltd (NYSE: TEVA). XEN402
inhibits the SCN9A sodium channel. Data from a published phase II study,
suggest that XEN402 may relieve the pain associated with erythromelalgia
(Pain 2012 Jan; 153(1):80-5).
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global
pharmaceutical company, committed to increasing access to high-quality
healthcare by developing, producing and marketing affordable generic
drugs as well as innovative and specialty pharmaceuticals and active
pharmaceutical ingredients. Headquartered in Israel, Teva is the world's
leading generic drug maker, with a global product portfolio of more than
1,000 molecules and a direct presence in about 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 46,000 people around the world and reached $20.3 billion
in net revenues in 2012.
Xenon is a privately owned, rare disease company developing innovative
medicines based on our genetically validated drug targets. For more
information, visit the Company's website at http://www.xenon-pharma.com.
This release contains forward-looking statements, which express the
current beliefs and expectations of management. Such statements
Teva IR:United States 215-591-8912orIsrael972 (3) 926-7656orTeva PR:Israel972 (3) 926-7246orUnited States, 215-591-8974orXenon:Canada, 604-484-3363SVP, Business & Corporate
Source: Teva Pharmaceutical Industries Ltd.