SAN FRANCISCO, May 19, 2014 /PRNewswire/ -- Nektar
Therapeutics (Nasdaq: NKTR), a biopharmaceutical company developing
novel pain and cancer therapeutics, announced that Ivan Gergel, M.D., will serve as the Company's
new Senior Vice President, Drug Development & Chief Medical
Officer effective today. Dr. Gergel will have oversight for
the company's clinical strategy and activities, including direct
supervision of clinical research, clinical operations, medical
affairs, regulatory affairs, and drug safety and surveillance.
"I am exceptionally pleased that Ivan is joining the Nektar
executive team," said Howard W.
Robin, President and CEO of Nektar Therapeutics. "Throughout
his career, Ivan has consistently demonstrated both leadership and
expertise in drug development, including the advancement of
multiple CNS and pain compounds from research stages through
approval. He has an impressive track record with extensive
experience in all aspects of the clinical and regulatory
process. Ivan's leadership skills and experience will be
invaluable to Nektar as we advance the development of our
proprietary pipeline."
Dr. Gergel brings over 25 years of pharmaceutical leadership and
drug development experience to Nektar. From 2008 to 2014, Dr.
Gergel served as Executive Vice President, Research &
Development of Endo Pharmaceuticals and Chief Scientific Officer,
where he led clinical, research, regulatory, project management and
medical affairs. During his tenure with Endo, Dr. Gergel was
responsible for a number of late stage development programs and
product approvals, including BEMA® Buprenorphine, which is in Phase
3, Abuse-Deterrent Opana® ER for chronic pain, and Fortesta® and
Aveed™ for hypogonadism. Prior to joining Endo, Dr. Gergel
served as Senior Vice President of Research and Development for
Forest Laboratories Inc. As the head of the clinical organization
and then as the senior R&D executive for Forest, he oversaw the
successful development programs leading to the approval of numerous
NCEs to treat a range of CNS disorders and other medical
conditions, including Celexa® for depression, Aerospan™ for asthma,
Lexapro® for depression and generalized anxiety disorder, Namenda®
for Alzheimer's Disease, Combunox™ for acute pain and Savella® for
fibromyalgia. Dr. Gergel also led the organization through the
approval and launch of Bystolic® for hypertension and Campral® for
alcohol dependency. In addition, while at Forest, he oversaw
the R&D team responsible for the successful in-licensing or
acquisition of several new agents including Turdoza™ for COPD,
Linzess® for IBS, and the anti-infective Teflaro®. Prior to
Forest, Dr. Gergel was a senior leader at SmithKline Beecham where
he was in charge of the U.S. clinical team responsible for the
development and commercial support of Paxil®, which is approved to
treat depression, OCD, panic disorder, social phobia and
generalized anxiety disorder.
Dr. Gergel received his MD from The Royal Free Medical School of
The University of London and an
MBA from the Wharton School of The University
of Pennsylvania.
Dr. Robert Medve, the company's
former Senior Vice President and Chief Medical Officer, left the
company effective May 16,
2014. The company wishes him well in his future endeavors.
About Nektar
Nektar Therapeutics (NASDAQ: NKTR) has a robust R&D pipeline
of potentially high-value therapeutics in pain, oncology and other
therapeutic areas. In the area of pain, Nektar has an exclusive
worldwide license agreement with AstraZeneca for naloxegol
(NKTR-118), an investigational drug candidate, which has been filed
for regulatory approvals in the U.S., Europe and Canada as a once-daily, oral tablet for the
treatment of opioid-induced constipation. This agreement also
includes NKTR-119, an earlier stage development program that is a
co-formulation of naloxegol and an opioid. NKTR-181, a novel
mu-opioid analgesic molecule for chronic pain conditions, has
completed Phase 2 development in osteoarthritis patients with
chronic knee pain. NKTR-171, a new sodium channel blocker being
developed as an oral therapy for the treatment of peripheral
neuropathic pain, is in Phase 1 clinical development. In oncology,
etirinotecan pegol (NKTR-102) is being evaluated in a Phase 3
clinical study (the BEACON study) for the treatment of metastatic
breast cancer and is also in Phase 2 studies for the treatment of
ovarian, colorectal, lung and brain cancers. In anti-infectives,
Amikacin Inhale is in Phase 3 studies conducted by Bayer Healthcare
as an adjunctive treatment for intubated and mechanically
ventilated patients with Gram-negative pneumonia. Additional
late-stage development candidates that leverage Nektar's
proprietary technology platform include Baxter's BAX 855, a longer-acting PEGylated
rFVIII therapeutic, which is in Phase 3 clinical development for
patients with hemophilia A.
Nektar's technology has enabled eight 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 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.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Forward-looking statements can be identified by words such
as: "anticipate," "intend," "plan," "expect," "believe," "should,"
"may," "will" and similar references to future periods. Examples of
forward-looking statements include, among others, statements we
make regarding the value and potential of our technology and
research and development pipeline. Forward-looking statements are
neither historical facts nor assurances of future performance.
Instead, they are based only on our current beliefs, expectations
and assumptions regarding the future of our business, future plans
and strategies, anticipated events and trends, the economy and
other future conditions. Because forward-looking statements relate
to the future, they are subject to inherent uncertainties, risks
and changes in circumstances that are difficult to predict and many
of which are outside of our control. Our actual results may differ
materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any of these forward-looking
statements. Important factors that could cause our actual results
to differ materially from those indicated in the forward-looking
statements include, among others, (i) our drug candidates and those
of our 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 previous preclinical and clinical studies; (ii) the
timing of the commencement or end of clinical trials and the
commercial launch of our drug candidates may be delayed or
unsuccessful due to regulatory delays, slower than anticipated
patient enrollment, manufacturing challenges, changing standards of
care, 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) the United States Food and Drug Administration (FDA)
is currently planning to hold an advisory committee meeting on
June 11-12, 2014 to discuss the
cardiovascular safety and potential additional safety study
requirements for the peripheral mu-opioid receptor antagonist class
of drugs, including naloxegol, and the outcome of this advisory
committee and the subsequent FDA review determinations for
naloxegol will have a significant impact on the Company's financial
position based on significant potential regulatory and launch
milestone opportunities and potential repayment obligations; (iv)
acceptance, review and approval decisions for new drug applications
by health authorities is an uncertain and evolving process and
health authorities retain significant discretion at all stages of
the regulatory review and approval decision process; (v) scientific
discovery of new medical breakthroughs is an inherently uncertain
process and the future success of the application of our technology
platform to potential new drug candidates is therefore highly
uncertain and unpredictable and one or more research and
development programs could fail; and (vi) certain other important
risks and uncertainties set forth in our Quarterly Report on Form
10-Q filed with the Securities and Exchange Commission on
May 8, 2014. Any forward-looking
statement made by us in this press release is based only on
information currently available to us and speaks only as of the
date on which it is made. We undertake no obligation to update any
forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information,
future developments or otherwise.
Nektar Investor
Inquiries:
|
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Jennifer
Ruddock/Nektar Therapeutics
|
(415)
482-5585
|
Susan Noonan/SA
Noonan Communications, LLC
|
(212)
966-3650
|
|
|
Nektar Media
Inquiries:
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Karin
Bauer/MSL
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(415)
527-8912
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SOURCE Nektar Therapeutics