Navigation Links
FDA Grants Orphan Drug Designation for Nektar's Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer
Date:4/21/2011

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 duration of the regulatory review and approval process.

About Ovarian CancerOvarian 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)  Approximately 22,000 new cases of ovarian cancer will be diagnosed and 14,000 deaths are expected to be caused by ovarian cancer in the United States 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. (2)  

About NKTR-102Nektar 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 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.  

About NektarNektar Therapeutics is a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technology platforms. Nektar has a robust R&D pipeline of potentially high-value therapeutics in oncology, pain and other areas. In the area of pain, Nektar has an exclusive worldwide license agreement with AstraZeneca for NKTR-118, an investigational drug candidate, being evaluated in Phase 3 clinical studies as a once-daily, oral tablet for the treatment of opioid-induced constipation.  The agreement also includes NKTR-119, an earlier stage development program that is a co-formulation of NKTR-118 and an opioid.  NKTR-181, a novel mu-opioid analgesic molecule, is being evaluated in Phase 1 clinical studies.  In oncology, NKTR-102, a novel topoisomerase I-inhibitor, is being evaluated in Phase 2 clinical studies for the treatment of breast, ovarian and colorectal cancers.  NKTR-105, a novel anti-mitotic agent, is in a Phase 1 clinical study in cancer patients with refractory solid tumors.

Nektar's technology has enabled seven approved products in the U.S. or Europe through partnerships with leading biopharmaceutical companies, including UCB's Cimzia® for Crohn's disease and rheumatoid arthritis, Roche's PEGASYS® for hepatitis C and Amgen's Neulasta® for neutropenia.

Nektar is headquartered in San Francisco, California, with additional R&D operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

Forward-Looking StatementsThis press release contains forward-looking statements that reflect management's current views regarding NKTR-102 and certain other drug candidates in Nektar’s pipeline.  These forward-looking statements involve numerous risks and uncertainties, including but not limited to: (i) Nektar's product candidates and those of its collaboration partners are in various stages of clinical development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval for numerous reasons including safety and efficacy findings even after positive findings in preclinical and clinical studies; (ii) the timing of the commencement or end of clinical trials and the successful commercial launch of our drug candidates may be delayed or unsuccessful due to slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, regulatory delay, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iii) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of the application of Nektar's technology platform to potential new drug candidates is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (iv) Nektar's patent applications for its proprietary or partner product candidates may not issue, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required in the future; (v) the outcome of any future intellectual property or other litigation related to Nektar's proprietary product candidates or complex commercial agreements; and (vi) certain other important risks and uncertainties set forth in Nektar's Annual Report on Form 10-K and Current Report on Form 8-K filed with the Securities and Exchange Commission on March 1, 2011.  Actual results could differ materially from the forward-looking statements contained in this press release.  Nektar undertakes no obligation to update forward-looking statements, whether as a result of new information, future events or otherwise.Nektar Investor Inquiries:Jennifer Ruddock/Nektar Therapeutics

(650) 631-4954Susan Noonan/SA Noonan Communications, LLC

(212) 966-3650Nektar Media Inquiries: Karen Bergman/BCC Partners

(650) 575-1509 Michelle Corral/BCC Partners

(415) 794-8662(1) American Cancer Society, 2011.

(2) Ovarian Cancer National Alliance


'/>"/>

SOURCE Nektar Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Grants Priority Review for VEGF Trap-Eye for the Treatment of Wet Age-Related Macular Degeneration
2. FDA Grants 510(k) Clearance to Life Technologies Stem Cell Growth Medium
3. Court Grants Preliminary Approval to Class Action Settlement that Provides Benefits Of Approximately $20 Million to Healthcare Providers that Purchased a SS1 Before January 1, 2009
4. Sequenom Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
5. FDA Grants Full Approval for PROMACTA® (eltrombopag) for Treatment of Rare Blood Disorder
6. Life Technologies Announces Visionary Winners of the Ion Torrent PGM Grants Program in Europe
7. FTC Grants Early Termination of Waiting Period Under Hart-Scott-Rodino Act
8. FDA Grants Orphan Drug Designation to Bayers Investigational Compound Regorafenib for the Treatment of Gastrointestinal Stromal Tumors
9. Alpha-1 Foundation Awards Two Research Grants with Support from Talecris Biotherapeutics, Inc.
10. NASDAQ Grants Insmed Incorporated 180-Day Extension to Regain Compliance with Minimum Bid Price Rule
11. HA&W Obtains Approximately $2 M in Credits and Cash Grants for Clients Through the Therapeutic Discovery Project Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/19/2017)... HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, robotically assisted, platform ... leadership team developments today:   ... ... Tom Tefft ... Veteran medical device executive Josh Stopek , PhD, who has led ...
(Date:9/18/2017)... Pa. and KALAMAZOO, Mich. , Sept. 18, ... , and OptiMed Specialty Pharmacy of ... to offer a strategic hub service that expedites and ... sought-after personal spirometer, Spiro PD 2.0, and wellness management ... spirometer is a medical device used to measure lung ...
(Date:9/13/2017)... Sept. 13, 2017   OrthoAtlanta has been named ... Football Host Committee (AFHC) for the 2018 College Football Playoff ... 2018, at Mercedes-Benz Stadium in Atlanta, Georgia ... AFHC "I,m In" campaign, participating in many activities leading up ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate professor Janice ... of cardiovascular diseases during the 15th Annual Women’s Health Conference. The SIU ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Ellevate Network, the ... business to advocate for action towards gender equality at their inaugural Summit in New ... the globe, and reached a social audience of over 3 million. To watch the ...
(Date:10/13/2017)... ... ... Journey: From the Mountains to the Mission Field”: the story of a missionary couple ... From the Mountains to the Mission Field” is the creation of published author, Carole ... and currently teaches a class of ladies at her church, which she has taught ...
(Date:10/12/2017)... ... 12, 2017 , ... The company has developed a suite ... regulatory authorities worldwide. From Children’s to Adults 50+, every formula has been developed ... , These products are also: Gluten Free, Non-GMO, Vegan, Soy Free, Non-Dairy*, ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... has recently contributed a medical article to the newly revamped Cosmetic Town ... article spotlights the hair transplant procedure known as Follicular Unit Extraction ...
Breaking Medicine News(10 mins):