FDA Grants Orphan Drug Designation for Nektar's Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer
SAN FRANCISCO, April 21, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced that the company's oncology drug candidate, NKTR-102, has been granted orphan drug status for the treatment of women with ovarian cancer by the U.S. Food and Drug Administration (FDA).
"This designation is an important step in the overall development program for NKTR-102 and underscores our commitment to treating women with ovarian cancer," said Dr. Lorianne Masuoka, Senior Vice President and Chief Medical Officer of Nektar Therapeutics.
Nektar has a Phase 2 study ongoing for NKTR-102 that is enrolling approximately 125 patients with platinum-resistant ovarian cancer whose disease has progressed following treatment with pegylated liposomal doxorubicin (PLD) therapy. In addition, Phase 3 planning is also underway for NKTR-102 in ovarian cancer. For more information about clinical trials for NKTR-102, please visit the Nektar Therapeutics website at www.nektar.com or www.clinicaltrials.gov.
NKTR-102 is an investigational agent and is not approved by the FDA, the European Medicines Agency (EMA) or other Health Authorities.
About Orphan Drug Designation in the U.S.In the United States, the Orphan Drugs Act (ODA) provides for the orphan drug designation which aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses and a possible exemption from the FDA-user fee. The designation does not shorten the duratio