Nektar Therapeutics (NKTR)

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NKTR-102 Receives Positive Opinion From EMA COMP for Orphan Medicinal Product Designation in Ovarian Cancer

Press Release Source: Nektar Therapeutics On Monday July 18, 2011, 8:00 am

SAN FRANCISCO, July 18, 2011 /PRNewswire/ -- Nektar Therapeutics (Nasdaq:NKTR - News) today announced that the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on its application for orphan medicinal product status for the company's lead oncology candidate, NKTR-102, for the treatment of women with ovarian cancer.

"There is a significant unmet need for additional treatments to address ovarian cancer," said Carlo DiFonzo, PhD, Vice President of Drug Development and Regulatory Affairs for Nektar. "We are pleased to have received a positive opinion from COMP for orphan medicinal product status in Europe to augment the U.S. Orphan Drug Designation recently received in April, as we continue the treatment of patients in our Phase 2 study of NKTR-102 in women with platinum-resistant ovarian cancer."

Nektar has a multi-national 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 yet approved by the FDA, the European Medicines Agency (EMA) or other Health Authorities. Following the issuance of a positive opinion from the EMA COMP, the opinion is forwarded to the European Commission for adoption of the decision and subsequent listing in the Community Register of Orphan Medicinal Products.

About Orphan Medicinal Product Designation in Europe

In the European Union, orphan medicinal product designation is designed to encourage the development of medicinal products for the diagnosis, treatment or prevention of life-threatening or very serious conditions that are rare and affect not more than 5 in 10,000 persons in the European Union (EU). The designation provides incentives for sponsors to develop orphan medicinal products, including market exclusivity to a drug for a particular indication for a ten-year period after the drug is granted marketing approval. Additional incentives for the sponsor may include protocol assistance, filing fee reductions, and research grants.

About European Medicines Agency (EMA):

The EMA is a decentralized body of the European Union with headquarters in London. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. Further information about EMA may be found at http://www.ema.europa.eu.

About Ovarian Cancer

Ovarian cancer is the fifth leading cause of cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.(1) In the European Union, there are approximately 44,000 newly diagnosed cases of ovarian cancer each year and approximately 29,000 deaths result from ovarian cancer each year. (2) In the U.S., approximately 22,000 new cases of ovarian cancer will be diagnosed and 14,000 deaths are expected to be caused by ovarian cancer this year.(1) Treatment options following relapse are limited and overall long-term survival among ovarian cancer patients has not changed significantly in nearly 40 years.(3)

About NKTR-102

Nektar is developing NKTR-102, a next-generation topoisomerase I inhibitor, with reduced peak concentrations and a continuous concentration profile. NKTR-102 was invented by Nektar using its advanced polymer conjugate technology platform, and is the first oncology product candidate to leverage Nektar's releasable polymer technology platform. NKTR-102 has been evaluated in two separate Phase 2 studies for the treatment of platinum-refractory/resistant ovarian cancer and for the treatment of second- and third-line metastatic breast cancer patients. In addition, NKTR-102 is also being tested as a single agent in a Phase 2 clinical trial in patients with second-line colorectal cancer and a Phase 1 clinical trial evaluating NKTR-102 in combination with 5-FU therapy.