Exhibit 99.1
Contacts: LIGAND ROYALTY PHARMA
Xxxx X. Xxxxx Xxxxx Xxxxxxxxx
Senior VP and CFO Chief Executive Officer
(000) 000-0000 (000) 000-0000
LIGAND, ROYALTY PHARMA AMEND SERM ROYALTY AGREEMENT
-- ROYALTY PHARMA EXERCISES A $12.5 MILLION OPTION ON OCTOBER 1 --
SAN DIEGO, CA, AND NEW YORK, NY, OCTOBER 2, 2003 - Ligand Pharmaceuticals
(Nasdaq: LGND) and Royalty Pharma have amended their royalty agreement for three
selective estrogen receptor modulator (SERM) products nearing completion of
Phase III development, the companies announced today.
Under the new agreement, Royalty Pharma exercised an option on October 1,
agreeing to pay Ligand $12.5 million, plus cumulative milestones of up to $2.5
million upon the launches of the three SERMs (provided they are approved by
September 30, 2005), in exchange for 0.7% of potential future sales of the
products for 10 years.
In addition, future options were restructured in value and timing to more
appropriately reflect the evolving SERM development timelines, especially of
lasofoxifene, which is in Phase III studies for osteoporosis at Pfizer. The
other SERM products included in the agreement are bazedoxifene and
bazedoxifene/PREMARIN(R), which are in Phase III trials at Wyeth for
osteoporosis and hormone replacement indications.
Under the revised agreement, Royalty Pharma has three additional options to
purchase:
o For $12.5 million, 0.5% of the SERM products' net sales. This option
must be exercised by December 31, 2003, or within 30 days of Phase III
clinical data being released by Pfizer or Wyeth, whichever comes
first.
o For $26.5 million in two equal payments, a total of 0.8% of the SERM
products' net sales. These options are exercisable as NDA acceptance
and approval milestones or specified dates are achieved during 2004
and 2005. For these options, the royalty rates owed to Royalty Pharma
will be reduced if certain events occur, and if SERM product sales
exceed certain thresholds. In addition, if Phase III data for at least
one of the SERM products have not been published by March 31, 2004,
these options will have no fixed expiration date. Instead, they must
be exercised within 30 days of the applicable development milestone.
"We are delighted to continue our successful partnership with Ligand," said
Xxxxx Xxxxxxxxx, chief executive officer of Royalty Pharma. "Next generation
SERMs, such as lasofoxifene, bazedoxifene and the combination product of
bazedoxifene/PREMARIN(R), could become important therapeutics addressing a large
market opportunity. Their effectiveness in the prevention and treatment of
post-menopausal osteoporosis as well as their potential role in the prevention
of breast cancer and hypercholesterolemia should make them valuable alternatives
given the recent data which questions the benefits of long-term use of
traditional HRT therapy."
"We are pleased to have successfully restructured the SERM options based on
the evolving product development timelines so that the current option is
exercised, consistent with our annual guidance, and so that future options
remain balanced and attractive to our shareholders and the optionee," said Xxxx
X. Xxxxx, Xxxxxx's senior vice president and chief financial officer. "Revenue
from SERM option exercises and royalties - which we are targeting for the 2004
to 2006 timeframe - represent the first royalty streams from our pipeline of
corporate partner products. However, our diabetes franchise products such as
LY818 et al, which have faster development tracks and double-digit royalties for
Ligand shareholders, are poised to catch up and augment the SERM franchise
quickly."
Under the terms of the agreement, payments upon exercise of the options are
non-refundable, regardless of whether the products are ever successfully
registered or marketed. Milestone payments owed by Xxxxxx's partners as the
products complete development and registration are not included in the Royalty
Pharma agreement and will be paid to Ligand as earned.
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Ligand has formed a diverse portfolio of partnerships with 11 major
pharmaceutical companies, including Pfizer and Wyeth. These companies currently
have in clinical studies or on human development track more than a dozen
products for major markets such as men's and women's hormone-related diseases,
osteoporosis, diabetes, metabolic disorders, and cardiovascular and inflammatory
diseases. These include three Phase III products, two Phase II products, six
Phase I products, and three compounds on IND tracks.
ABOUT LIGAND
Xxxxxx discovers, develops and markets new drugs that address critical
unmet medical needs of patients in the areas of cancer, pain, skin diseases,
men's and women's hormone-related diseases, osteoporosis, metabolic disorders,
and cardiovascular 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 (IRs) and
Signal Transducers and Activators of Transcription (STATs). For more
information, go to xxx.xxxxxx.xxx.
ABOUT ROYALTY PHARMA
Royalty Pharma invests in pharmaceutical and biotechnology product
royalties and other revenue-producing intellectual property. Royalty Pharma has
been working with research institutions, inventors, and life science companies
for over six years. In addition to its interests in lasofoxifene, bazedoxifene
and Targretin(R) capsules, the company owns royalty interests in nine marketed
products: Rituxan(R), Neupogen(R), ReoPro(R), Thalomid(R), Retavase, TOBI(R),
Simulect(R), Zenapax(R) and Zerit(R); one product candidate for which an NDA has
been submitted, Variza(R); and one product which is in Phase III clinical
trials, alvimopan. More information on Royalty Pharma is available at
xxx.xxxxxxxxxxxxx.xxx.
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CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This news release contains certain forward-looking statements by Ligand and
Royalty Pharma that involve risks and uncertainties and reflect the companies'
judgment as of the date of this release. These statements include those related
to option exercise(s), royalty revenue, milestones, product development,
pipelines and potential, and Ligand's diabetes franchise products. Actual events
or results may differ from expectations. There can be no assurance that studies
of lasofoxifene or bazedoxifene will be successful, that any of the mentioned
products will receive further regulatory approvals, that Ligand will receive
royalties from the eventual sale of lasofoxifene or bazedoxifene, that Royalty
Pharma will exercise any of its other options to purchase royalty rights, or
that any of the drug programs mentioned will be successful. Additional
information concerning these and other risk factors affecting Ligand's business
can be found in prior press releases as well as in Ligand's public periodic
filings with the Securities and Exchange Commission, available at
XXX.XXXXXX.XXX. Ligand and Royalty Pharma disclaim 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.
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