SAN CARLOS, Calif., Nov. 8 /PRNewswire-FirstCall/ -- Nuvelo Inc. today announced that it has obtained orphan drug designation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMEA) for its lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion (PAO), or “leg attack.”
The designation provides sponsors with several benefits, including protocol development assistance and a 10-year period of market exclusivity following market authorization. Nuvelo has already obtained orphan drug designation from the Office of Orphan Products Development at the U.S. Food and Drug Administration (FDA) for alfimeprase for the treatment of acute PAO.
“The EMEA’s decision to grant alfimeprase orphan drug designation reinforces our belief that alfimeprase has the potential to become an important treatment option worldwide for patients with acute PAO,” said Michael D. Levy, M.D., senior vice president of research and development for Nuvelo. “In addition, the market exclusivity that this designation provides strengthens our already solid position with potential partners for commercialization of alfimeprase outside of the U.S.”
About Leg Attack
Acute peripheral arterial occlusion (PAO), or “leg attack,” is the blocking of arterial blood flow to a lower limb by a blood clot. Affecting more than 100,000 people in the United States each year, with similar incidence in Europe, acute PAO is the result of underlying peripheral arterial disease, in which chronic fatty plaque buildup restricts blood flow and is then complicated by the formation of an acute clot. If blood flow is not restored quickly, leg attack can lead to permanent nerve and muscle damage, gangrene, and in the most severe cases, amputation and death.
Because no thrombolytic therapies have been approved by the FDA or EMEA to specifically treat acute PAO, off-label use of plasminogen activators often occurs. As noted in published studies, plasminogen activators may require a prolonged infusion averaging 24 to 36 hours in patients with leg attack, carry the risk of significant bleeding complications, and will often require admission to the intensive care unit (ICU) for the duration of the infusion.
About Alfimeprase
Alfimeprase, an enzyme produced by recombinant DNA technology, possesses a unique mechanism of action. It directly degrades fibrin, producing a rapid dissolution of blood clots. In clinical studies, alfimeprase has been shown to have the ability to degrade large arterial clots within four hours of initiation of dosing as well as the ability to clear a majority of occluded catheters in 15 minutes or less. In addition, its lytic activity is localized to the site of delivery due to its rapid inhibition by alpha-2 macroglobulin, a naturally occurring protein in the blood, within seconds of its movement away from the clot and into the general circulation. This clearance mechanism helps focus the thrombolytic activity to the site of delivery and, in clinical testing, appears to minimize bleeding side effects.
Alfimeprase Clinical Trials
Alfimeprase is currently being evaluated for the treatment of acute PAO in a Phase 3 trial. Known as NAPA-2 (Novel Arterial Perfusion with Alfimeprase-2), the trial is a randomized, double-blind study comparing 0.3 mg/kg of alfimeprase with placebo in approximately 300 patients at more than 100 centers worldwide. The NAPA-2 study is the first of two overlapping Phase 3 trials evaluating alfimeprase for the treatment of acute PAO. The second Phase 3 trial, NAPA-3, is expected to begin in the second half of 2005. The Phase 3 acute PAO program is expected to include up to 700 patients between the two trials.
In addition to the treatment of acute PAO, alfimeprase is also under evaluation in a separate Phase 3 clinical program for a second target indication, central venous catheter occlusion. Catheter occlusion, which affects up to 1.25 million patients each year in the U.S. alone, occurs when a clot forms within an in-dwelling catheter, hindering the inward or outward flow of solutions or blood. As these catheters are primarily inserted in patients receiving life-saving medications such as chemotherapy, it is important to restore flow through the catheter as soon as possible. A Phase 2 study demonstrated the ability of alfimeprase to clear a majority of occluded catheters in 15 minutes or less. A Phase 3 study in catheter occlusion is currently enrolling.
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. Nuvelo’s clinical pipeline includes alfimeprase, a direct acting thrombolytic in Phase 3 trials for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion and rNAPc2, an anticoagulant currently in Phase 2 trials that inhibits the factor VIIa and tissue factor complex. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.
Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 650-517-8000.
This press release contains forward-looking statements regarding the timing and progress of Nuvelo’s alfimeprase Phase 3 programs, the size of the potential market for alfimeprase, and the potential improvement or benefit that current clinical trial programs may demonstrate which statements are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo’s recent annual report on Form 10-K for the year ended December 31, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
Nuvelo, Inc.
CONTACT: Nicole Estrin, Associate Director of Corporate Communications &IR of Nuvelo, Inc., +1-650-517-8472, or nestrin@nuvelo.com; or CarolynBumgardner Wang of WeissComm Partners, Inc., +1-415-946-1065, orcarolyn@weisscommpartners.com, for Nuvelo, Inc.
Web site: http://www.nuvelo.com/
