Cardiome submits NDA for Oxyprim(TM)
December 23 2003 - 1:30PM
PR Newswire (US)
Cardiome submits NDA for Oxyprim(TM) TSX: COM VANCOUVER, Dec. 23
/PRNewswire-FirstCall/ -- Cardiome Pharma Corp (TSX: COM) (the
"Company" or "Cardiome") today announced that it has submitted a
New Drug Application ("NDA") to the United States Food and Drug
Administration ("FDA") seeking marketing approval for oxypurinol
(proposed tradename: Oxyprim(TM)), for the treatment of
allopurinol-intolerant hyperuricemia (gout). The NDA application
was submitted under the provisions of the Orphan Drug Act and under
Subpart H of the Food and Drug Act in the U.S. "This application
represents a significant milestone for Cardiome in several ways"
stated Cardiome CEO Bob Rieder. "Most importantly, it may begin the
transition of Cardiome from development-stage to commercial-stage.
It also affirms Cardiome's rapidly-growing expertise in the
regulatory arena." The treatment of allopurinol-intolerant
hyperuremic gout patients with oxypurinol has been designated an
orphan drug program by the FDA. Orphan drug status is typically
granted to drug development programs for "rare diseases" (high-need
patient population in the U.S. of up to 200,000 patients). Orphan
drug designation provides at least seven years of mandated market
exclusivity in the US market. In addition, such orphan drug
programs often qualify for expedited review by the FDA and are
exempt from the FDA user fees ordinarily charged to submit an NDA.
Dr. Alan Moore, Cardiome's Executive Vice-President of Clinical and
Regulatory Affairs commented "This patient population urgently
requires a therapeutic alternative. Approval by the FDA is never a
certainty, especially in orphan indications. However, we look
forward to working with the FDA to make this a viable therapeutic
opportunity for these patients." Submission of the NDA application
starts an initial review period of the application by the FDA to
ensure the sufficiency of the NDA package. About 30% of NDA
applications fail such review, and are returned to the sponsor for
further work. The remaining NDA applications are then given full
review. Cardiome is currently in discussions with various companies
regarding arrangements to distribute Oxyprim(TM), if approved. No
final decision has yet been made as to whether Cardiome will sell
Oxyprim(TM) directly or enter into other marketing arrangements.
Gout is a chronic and potentially debilitating disease
characterized by painful arthritis attacks that afflicts more than
two million patients in the U.S. Allopurinol is an effective
treatment for hyperuricemia, accounting for approximately 70% of
all gout prescriptions. While allopurinol is well tolerated by most
patients, 2-4% of patients develop allergic reactions that require
immediate discontinuation of the drug. Some of those patients
(estimated at between 2,000 and 10,000 patients) have severe
gout-related hyperuricemia and no disease-modifying treatment
alternatives. These patients currently suffer painful arthritis
attacks, uric acid crystal deposits in joints and skin, and in some
cases kidney stones or even kidney failure. Oxyprim(TM) has the
potential to successfully treat approximately 70% of this
allopurinol-intolerant patient population. Oxypurinol, the
therapeutic agent in Oxyprim(TM), is a xanthine oxidase inhibitor
(XOI) that is the active metabolite of allopurinol. Allopurinol and
oxypurinol are both inhibitors of xanthine oxidase, the enzyme that
is responsible for the conversion of hypoxanthine and xanthine to
uric acid. By inhibiting the formation of uric acid, oxypurinol
lowers uric acid levels in the blood and urine. Allopurinol has
been used as an agent in the suppression of uric acid for patients
with gout since the early 1960's. About Cardiome Pharma Corp.
Cardiome Pharma Corp. is a product-focused cardiovascular drug
development company. Cardiome has three late stage clinical drug
programs focused on atrial arrhythmias, congestive heart failure,
and hyperuricemia (gout). Cardiome's lead antiarrhythmic product,
RSD1235, is an acute-use, intravenous administration treatment for
atrial fibrillation. RSD1235 selectively blocks ion channels in the
heart that are known to be active during episodes of atrial
fibrillation (AF). In a phase II study completed in September of
2002 with new onset AF patients (n equals 56), RSD1235 terminated
AF in 61% of patients versus 5% placebo within 30 minutes of the
end of infusion (p equals 0.0003). In a proof-of-concept oral
dosing study in humans completed in December 2002, RSD1235 was also
shown to have high oral bioavailability, suggesting it could be
used for chronic oral therapy. Currently available drugs for AF
lack sufficient efficacy and have serious safety risks. These
safety issues include risk of drug-induced proarrhythmia,
(ventricular fibrillation, heart attack), and other cardiac
liabilities. On October 16, 2003 Cardiome and Fujisawa Healthcare,
Inc. entered into a partnership agreement granting Fujisawa North
American rights to intravenous RSD1235. Cardiome's lead drug in the
congestive heart failure ("CHF") area is oxypurinol, a xanthine
oxidase inhibitor. CHF is the failure of the heart to pump blood at
a rate sufficient to support the body's needs. Oxypurinol
sensitises cardiac muscle cells to intracellular calcium, leading
to increased cardiac oxygen-use efficiency. Cardiome believes that
increasing the cardiac oxygen-use efficiency will improve the
clinical outcomes for CHF patients. This application of oxypurinol
is currently in a Phase 2/3 study in 400 patients with stage 3 and
stage 4 CHF. Cardiome also has a program applying its congestive
heart failure product, oxypurinol, for the treatment of
allopurinol-intolerant gout. Cardiome is traded on the Toronto
Stock Exchange (COM). Further information about Cardiome can be
found at http://www.cardiome.com/. FOR FURTHER INFORMATION: Don
Graham Director of Corporate Communication (604) 677-6905 ext. 109
Toll Free: 1-800-330-9928 Email: Forward-Looking Statement
Disclaimer Statements contained in this news release relating to
future results, events and expectation are forward-looking
statements within the meaning of the United States Private
Securities Litigation Reform Act of 1995. These forward-looking
statements involve known and unknown risks, uncertainties and other
factors which may cause the actual results, performance or
achievement of the company, or industry results, to be materially
different from any future results, performance or achievements
expressed or implied by such statements. Such factors include,
among others, those described in the Company's annual report on
Form 20-F. The Toronto Stock Exchange has not reviewed and does not
accept responsibility for the adequacy or accuracy of this release.
ON BEHALF OF THE BOARD "Robert Rieder" President & Chief
Executive Officer DATASOURCE: Cardiome Pharma Corp. CONTACT: Don
Graham, Director of Corporate Communication, 604-677-6905 ext. 109,
Toll Free: 1-800-330-9928, Email:
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