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
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