Ligand Partner GlaxoSmithKline Gains FDA Breakthrough Therapy Designation for Promacta®/Revolade® for Severe Aplastic Anemia
SAN DIEGO--
Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) today announced
that the U.S. Food and Drug Administration (FDA) has granted its partner
GlaxoSmithKline plc (LSE:GSK) Breakthrough Therapy designation for
Promacta®/Revolade® (eltrombopag) for the treatment of cytopenias in
patients with severe aplastic anemia (SAA) who have had insufficient
response to immunosuppressive therapy.
“Promacta continues to be the basis of ground breaking and promising
science in important areas with significant unmet medical needs” said
John Higgins, President and CEO of Ligand. “We congratulate the global
Promacta/Revolade development team at GSK, and commend them for their
continued scientific and regulatory progress.”
SAA is a rare disorder in which the bone marrow fails to make enough new
blood cells. There are no approved therapies available for SAA patients
who are unresponsive to initial immunosuppressive therapy (IST). Of
those patients unresponsive to initial IST, approximately 40% die from
infection or bleeding within five years of their diagnosis.i
The Breakthrough Therapy designation was based on the results from an
open-label, Phase II National Institute of Health (NIH) study
(09-H-0154) of eltrombopag in 43 heavily pre-treated SAA patients with
an insufficient response to IST.
About Breakthrough Therapy Designation
The Breakthrough Therapy designation was enacted as part of the 2012 FDA
Safety and Innovation Act (FDASIA) and is intended to expedite
development and review of drugs to treat serious or life-threatening
medical conditions when preliminary clinical evidence demonstrates that
the drug may have substantial improvement on at least one clinically
significant endpoint over available therapies. Breakthrough Therapy
designation includes all the features of the Fast Track designation, as
well as more intensive guidance from the FDA on a drug’s clinical
development program.ii
About Promacta
For full U.S. Prescribing Information and Medication Guide and EU
Patient Information Leaflet or Summary of Product Characteristics (SPC)
for eltrombopag please visit http://www.gsk.com/products.html.
Promacta is not approved or licensed anywhere in the world for use in
SAA.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company focused on assembling a large
portfolio of revenue generating assets through licensing and acquisition
with the goal to generate sustainable cash-flow and profitability.
Ligand has a diverse asset portfolio addressing the unmet medical needs
of patients for a broad spectrum of diseases including thrombocytopenia,
multiple myeloma, diabetes, hepatitis, muscle wasting, dyslipidemia,
anemia and osteoporosis. Ligand’s Captisol platform technology is a
patent-protected, chemically modified cyclodextrin with a structure
designed to optimize the solubility and stability of drugs. Ligand has
established multiple alliances with the world's leading pharmaceutical
companies including GlaxoSmithKline, Onyx Pharmaceuticals (a subsidiary
of Amgen Inc.), Merck, Pfizer, Baxter International, Lundbeck Inc., Eli
Lilly & Co. and Spectrum Pharmaceuticals. Please visit www.captisol.com
for more information on Captisol or www.ligand.com
for more information on Ligand.
Follow Ligand on Twitter @Ligand_LGND.
References
i Valdez JM, et al. Decreased Infection-Related Mortality and
Improved Survival in Severe Aplastic Anemia in the Past Two Decades.
Clinical Infectious Diseases 2011;52(6):726–735.
ii U.S.
Food and Drug Administration. Fast Track, Breakthrough Therapy,
Accelerated Approval and Priority Review. Available at: http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm.
Accessed January 28, 2014.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that
involve risks and uncertainties and reflect Ligand’s judgment as of the
date of this release. These forward-looking statements include comments
regarding eltrombopag and other drug candidates, data analysis and
evaluation of eltrombopag, utility or potential benefits to patients,
the potential commercial market for eltrombopag and plans for continued
development and further studies of eltrombopag. Actual events or results
may differ from Ligand’s expectations. For example, there can be no
assurance that other trials or evaluations of eltrombopag or other
product candidates will be favorable or that they will confirm results
of previous studies, that data evaluation will be completed or
demonstrate any hypothesis or endpoint, that eltrombopag or other
product candidates will provide utility or benefits to certain patients,
that any presentations will be favorably received, that eltrombopag or
other product candidates will be useful, that marketing applications
will be filed or, if filed, approved, or that clinical or commercial
development of these product candidates will be initiated, completed or
successful or that our rights to eltrombopag and other related product
candidates will not be successfully challenged. The failure to meet
expectations with respect to any of the foregoing matters may reduce
Ligand’s stock price. Additional information concerning these and other
risk factors affecting Ligand can be found in prior press releases
available at www.ligand.com
as well as in public periodic filings with the Securities and Exchange
Commission, available at www.sec.gov.
Ligand disclaims any intent or obligation to update these
forward-looking statements beyond the date of this press release. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
Ligand Pharmaceuticals Incorporated
John L. Higgins, President and
CEO
(858) 550-7500
or
LHA
Don Markley
(310)
691-7100
dmarkley@lhai.com
Source: Ligand Pharmaceuticals Incorporated
Released February 3, 2014