Akari Therapeutics Expands Clinical and Regulatory Teams with Industry Veterans
January 04 2017 - 7:00AM
Akari Therapeutics (NASDAQ:AKTX), an emerging growth,
clinical-stage biopharmaceutical company, has expanded its clinical
and regulatory teams. In December 2016, Dr. Brihad Abhyankar joined
as Head of Clinical Development and Justine Lees joined as European
Head of Regulatory Affairs. In January 2017, Nigel A.S. Hernandez,
PhD, joined as Vice President of Worldwide Regulatory Affairs.
“We are very excited to expand our clinical and
regulatory teams with these industry veterans,” said Dr. Gur
Roshwalb, Chief Executive Officer of Akari Therapeutics. “The
clinical and regulatory experience of these new team members will
help prepare us for our Phase III clinical program, which we
currently expect to begin in the summer of 2017, as well as
accelerate our expansion into new clinical indications,”
Brihad Abhyankar
Dr. Brihad Abhyankar MS FRCS MBA FFPM joined Akari
as Head of Clinical Development. Dr. Abhyankar has 14 years of
experience in the pharmaceutical industry working in clinical
development and medical affairs for many mid- to large-size
pharmaceutical companies. Prior to joining the pharmaceutical
industry, he originally trained and worked as a surgeon. Most
recently, he was Executive Director of global R&D at Takeda
Pharmaceuticals and global clinical lead for an innovative
monoclonal antibody developed for treatment of Crohn’s disease and
ulcerative colitis that has now been registered in more than 50
countries.
Justine Lees
Justine Lees joined Akari as European Head of
Regulatory Affairs and has more than 25 years of biopharmaceutical
experience, including 20 years in Regulatory Affairs. Ms. Lees has
worked for both large and small pharmaceutical companies and for
clinical research organizations at a variety of levels covering a
number of different territories and her responsibilities have
included global oversight of various projects both in development
and in already-marketed drugs. Her experience encompasses novel
chemical entities and biotechnology compounds in a variety of
different therapeutic areas, including oncology, anti-infectives,
CV, CNS, rare diseases, generics and biosimilars. She has extensive
experience of early phase development, agency scientific advice,
orphan drug designations, pediatric development plans and clinical
trials. She is a member of TOPRA and an active participant of TOPRA
clinical development and global development CRED courses. She is
also a member of the DIA pediatric scientific interest group.
Nigel A.S. Hernandez
Nigel Hernandez, PhD, MSc, RAC joined Akari as Vice
President of Worldwide Regulatory Affairs. Nigel has more than 20
years of global regulatory experience (nonclinical through
commercial) in the pharmaceutical industry. He began his regulatory
career at Biopure, then worked at LeukoSite (acquired by
Millennium), Millennium Pharmaceuticals, GMP Regulatory, Archemix
Corp, ARIAD Pharmaceuticals and Tarsa Therapeutics, where he held
roles of increasing responsibility. At Actelion Pharmaceuticals, he
was responsible for global regulatory leadership and strategy for
Veletri (epoprostenol) and Zavesca (miglustat), including several
early and late-stage developmental products in the cardiovascular,
oncology and neurology therapeutic areas. He was most recently at
Esperion Therapeutics where he led the global regulatory
development of bempedoic acid to lower elevated levels of
low-density lipoprotein cholesterol (LDL-C).
About Akari Therapeutics PlcAkari
is a clinical-stage biopharmaceutical company focused on the
development and commercialization of life-transforming treatments
for a range of rare and orphan autoimmune and inflammatory diseases
caused by dysregulation of complement C5 and Leukotriene B4 (LTB4),
including paroxysmal nocturnal hemoglobinuria (“PNH”), atypical
Hemolytic Uremic Syndrome (“aHUS”), and Guillain Barré syndrome
(“GBS”). Akari’s lead product candidate, Coversin™ complement
inhibitor, a second-generation complement inhibitor, acts on
complement component-C5, preventing the release of C5a and the
formation of C5b–9 (also known as the membrane attack complex or
MAC), and independently also inhibits LTB4 activity. C5
inhibition is growing in importance in a range of rare autoimmune
diseases related to dysregulation of the complement component of
the immune system, including PNH, aHUS, and GBS. Exploiting the
power of nature, Akari is also developing other tick derived
proteins and expects to bring additional compounds to clinical
trials over the next several years. The pipeline is focused on
developing bioengineered versions of native tick salivary proteins
that act as anti-inflammatory compounds allowing the tick to remain
on its host. These compounds include PGP sparing LTB4 inhibitors,
classical and alternative complement inhibitors, anti-histamines,
and serotonin inhibitors as examples. Akari is also developing
engineered forms that allow for potential oral absorption, as, for
example, a potential orally absorbed C5 inhibitor, and tissue
specific proteins, as, for example, Coversin™ that acts
specifically at the neuromuscular junction for diseases like
myasthenia gravis.
Cautionary Note Regarding Forward-Looking
StatementsCertain statements in this press release
constitute “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements reflect our current views about our
plans, intentions, expectations, strategies and prospects, which
are based on the information currently available to us and on
assumptions we have made. Although we believe that our plans,
intentions, expectations, strategies and prospects as reflected in
or suggested by those forward-looking statements are reasonable, we
can give no assurance that the plans, intentions, expectations or
strategies will be attained or achieved. Furthermore, actual
results may differ materially from those described in the
forward-looking statements and will be affected by a variety of
risks and factors that are beyond our control. Such risks and
uncertainties for our company include, but are not limited to: an
inability or delay in obtaining required regulatory approvals for
Coversin and any other product candidates, which may result in
unexpected cost expenditures; risks inherent in drug development in
general; uncertainties in obtaining successful clinical results for
Coversin and any other product candidates and unexpected costs that
may result therefrom; failure to realize any value of Coversin and
any other product candidates developed and being developed in light
of inherent risks and difficulties involved in successfully
bringing product candidates to market; inability to develop new
product candidates and support existing product candidates; the
approval by the FDA and EMA and any other similar foreign
regulatory authorities of other competing or superior products
brought to market; risks resulting from unforeseen side effects;
risk that the market for Coversin may not be as large as expected;
inability to obtain, maintain and enforce patents and other
intellectual property rights or the unexpected costs associated
with such enforcement or litigation; inability to obtain and
maintain commercial manufacturing arrangements with third party
manufacturers or establish commercial scale manufacturing
capabilities; the inability to timely source adequate supply of our
active pharmaceutical ingredients from third party manufacturers on
whom the company depends; our inability to obtain additional
capital on acceptable terms, or at all; unexpected cost increases
and pricing pressures; uncertainties of cash flows and inability to
meet working capital needs; and risks and other risk factors
detailed in our public filings with the U.S. Securities and
Exchange Commission, including our Annual Report on Form 10-K filed
on March 23, 2016. Except as otherwise noted, these forward-looking
statements speak only as of the date of this press release and we
undertake no obligation to update or revise any of these statements
to reflect events or circumstances occurring after this press
release. We caution investors not to place considerable reliance on
the forward-looking statements contained in this press release.
Investor Contact:
The Trout Group
Lee Stern
lstern@troutgroup.com
646–378–2922
Media Contact:
Susan Forman / Laura Radocaj
Dian Griesel Int'l.
(212) 825-3210
Akari Therapeutics (NASDAQ:AKTX)
Historical Stock Chart
From Mar 2024 to Apr 2024
Akari Therapeutics (NASDAQ:AKTX)
Historical Stock Chart
From Apr 2023 to Apr 2024