Promacta
eltrombopag
Treatment for Idiopathic (Immune) Thrombocytopenic PurpuraLigand Earns $1 Million Milestone Payment as GlaxoSmithKline Submits New Drug Application for Promacta (eltrombopag)
SAN DIEGO--(BUSINESS WIRE)--Dec 20, 2007 - Ligand Pharmaceuticals Incorporated (the Company or Ligand) today announced that it has earned from GlaxoSmithKline (GSK) a milestone payment of $1 million as a result of GSK's submission of a New Drug Application (NDA) for Promacta (eltrombopag). If approved, Promacta would be the first oral platelet growth factor therapy for the short-term treatment of previously treated patients with chronic idiopathic thrombocytopenic purpura (ITP) to increase platelet counts and reduce or prevent bleeding. Chronic ITP is a disorder marked by increased platelet destruction and/or inadequate platelet production in the blood, which causes an increased risk of bruising and bleeding. Promacta is an investigational, once-daily oral treatment that induces the proliferation and differentiation of cells in the bone marrow to produce platelets.
The milestone payment arises from a drug discovery alliance with GSK to focus on the discovery of small-molecule TPO mimetics. Under the terms of the collaboration, Ligand is eligible to receive an additional milestone payment of $2 million upon approval of Promacta by the U.S. Food and Drug Administration (FDA), as well as royalty payments on any future sales of the drug.
"We are very pleased with GSK's progress with Promacta. Their team has done an excellent job executing its clinical activities, and they have obtained encouraging results. This milestone reinforces our belief in Ligand's science and technology that has yielded the first oral TPO receptor agonist," said John L. Higgins, President and Chief Executive Officer of Ligand Pharmaceuticals. "Our collaborations with pharmaceutical industry leaders such as GSK are representative of Ligand's commitment to leverage its technology and research capabilities to create value for shareholders."
Ligand and GlaxoSmithKline Collaboration
The GSK-Ligand collaboration began in 1997 to utilize Ligand's expertise and technology to discover small-molecule drugs to control hematopoieses and treat patients with cancer, anemia or platelet deficiencies. The research phase of the collaboration ended in 2001. GSK is responsible for the registration and worldwide marketing of Promacta.
About Ligand Pharmaceuticals
Ligand discovers and develops new drugs that address critical unmet medical needs of patients in the areas of thrombocytopenia, hepatitis C, cancer, hormone-related diseases, osteoporosis and inflammatory diseases. Ligand's proprietary drug discovery and development programs are based on its leadership position in gene transcription technology, primarily related to intracellular receptors.
Caution Regarding 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 statements include those
related to future action by the FDA for the recently submitted NDA;
the promise of Promacta (eltrombopag) future regulatory
approvals; increases in shareholder value; and future milestone and
royalty payments. Actual events or results may differ from our
expectations. There can be no assurance GlaxoSmithKline, or any of
our other partners will continue clinical development of any
compound(s); that clinical development will be successful; that
future clinical trial data will be favorable or that such trials
will confirm any improvements over other products or lack of
negative impacts; that drugs will receive required regulatory
approvals or that they will be commercially successful therapies,
provide new options or be successfully marketed; that our partner
portfolio will continue to mature, that our business will continue
to grow or that shareholder value will increase, that the FDA will
accept any filing, or that any future milestone or royalty payments
will be received. Our stock price could be harmed if any of these
events or trends fails to occur, is delayed or otherwise differs
from expectations. Additional information concerning these and
other risk factors affecting Ligand's business can be found on the
company's prior press releases as well as in public periodic
filings with the Securities and Exchange Commission, available via
www.ligand.com. Ligand disclaims any intent or obligation to update
these forward-looking statements beyond the date of this release.
This caution is made under the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995.
Contact
Ligand Pharmaceuticals Incorporated
John L. Higgins, President and CEO or
Erika Luib, Investor Relations
858-550-7896
or
Lippert/Heilshorn & Associates
Don Markley, 310-691-7100
dmarkley@lhai.com
Related Articles:
Ligand Partner GlaxoSmithKline Receives FDA Extended Priority Review for Promacta NDA - June 23, 2008
Promacta (eltrombopag) Receives Unanimous Recommendation by FDA Advisory Panel - May 30, 2008
FDA Grants Priority Review for Promacta (eltrombopag) - March 3, 2008
GlaxoSmithKline Files for FDA Approval of Promacta (eltrombopag) to be the First Oral Platelet Growth Factor for Rare Blood Disorder - December 20, 2007
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