Ligand Signs Global License Agreement with Spectrum Pharmaceuticals for Captisol-Enabled® Melphalan

  Ligand Signs Global License Agreement with Spectrum Pharmaceuticals for
  Captisol-Enabled® Melphalan

     Ligand to Receive License Fee, Eligible for Milestones and Royalties

  Raises Full Year Revenue and Earnings Guidance and Provides First Quarter
                                   Forecast

Business Wire

SAN DIEGO -- March 14, 2013

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces the signing of
global license and supply agreements with Spectrum Pharmaceuticals, Inc.
(NASDAQ: SPPI) for the development and commercialization of Ligand’s
Captisol-enabled^®, propylene glycol-free (PG-free) melphalan. Under the terms
of the license agreement, Ligand is entitled to receive a license fee and is
eligible to receive more than $50 million in potential milestone payments.
Ligand is also eligible to receive royalties on future net sales of
Captisol-enabled melphalan. Further details regarding the transaction are
provided in Ligand’s Form 8-K that is being filed today.

The Captisol-enabled melphalan program is currently in a pivotal trial for use
as a conditioning treatment prior to autologous stem cell transplant for
patients with multiple myeloma. Spectrum will immediately assume all
development of the program as a result of this license.

“We are pleased to have forged this agreement,” commented John Higgins,
President and Chief Executive Officer of Ligand Pharmaceuticals. “Spectrum has
an established oncology and hematology business, and this melphalan product is
an ideal complement to their two commercial hematology products, Zevalin and
Folotyn, including an expected high degree of commercial call overlap.
Spectrum’s highly experienced, oncology-focused R&D team is committed to the
efficient development of Captisol-enabled melphalan, and has established
relationships with key investigators.”

Full Year 2013 Revenue and Earnings Guidance and First Quarter Forecast

Ligand now expects 2013 total revenues to be in the range of $43 million to
$46 million, versus previous guidance of $41 million to $44 million. Earnings
per share for 2013 are expected to be in the range of $0.47 to $0.51, versus
previous guidance of $0.35 to $0.39. Ligand estimates revenue for the first
quarter of 2013 to be in the range of $10 million to $11 million, with first
quarter earnings per share in the range of $0.10 to $0.13. Earnings per share
guidance does not include the effects of any increase or decrease in
contingent liabilities.

About Captisol-enabled Melphalan

Ligand's Captisol-enabled, PG-free melphalan program is a new intravenous
formulation of melphalan being investigated for the multiple myeloma
transplant setting, and has been granted Orphan designation by the FDA.
Ligand's formulation avoids the use of propylene glycol, which has been
reported to cause renal and cardiac side-effects that limit the ability to
deliver higher quantities of therapeutic compounds. The use of the Captisol^®
technology to reformulate melphalan is anticipated to allow for longer
administration durations and slower infusion rates, potentially enabling
clinicians to safely achieve a higher dose intensity of pre-transplant
chemotherapy. In December 2012 Ligand announced the initiation of a pivotal
trial of Captisol-enabled melphalan. This multi-center trial will evaluate
safety and efficacy in 60 patients, and is intended to confirm the results
from an earlier Phase 2 study demonstrating that the Captisol-enabled
melphalan formulation was safe and well-tolerated, and met the requirements
for establishment of bioequivalence to the current commercial intravenous
formulation of melphalan (sold by GlaxoSmithKline as Alkeran^® for Injection).

About Multiple Myeloma and Melphalan

Multiple myeloma is a cancer of plasma cells, a type of white blood cell
present in the bone marrow. In multiple myeloma a group of plasma cells
(myeloma cells) becomes cancerous and multiplies, raising the number of plasma
cells to a higher-than-normal level. There are an estimated 20,000 new cases
of multiple myeloma in the United States each year, with an incidence of new
cases increasing by approximately 1.7% per year.

The current intravenous melphalan market is approximately $130 million
annually, with predominant use in stem cell transplants. The rate of
autologous stem cell transplants for patients with multiple myeloma is growing
by approximately 3.3% annually.

About Captisol^®

Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs. Captisol
was invented and initially developed by scientists in the laboratories of Dr.
Valentino Stella at the University of Kansas' Higuchi Biosciences Center for
specific use in drug development and formulation. This unique technology has
enabled six FDA-approved products, including Onyx Pharmaceuticals’ Kyprolis^®,
Baxter International's Nexterone^® and Pfizer's Vfend^® IV. There are
currently more than 30 Captisol-enabled products in development, including
Lundbeck’s carbamazepine IV, The Medicines Company's MDCO-157 and Rib-X's
delafloxacin IV program.

About Ligand Pharmaceuticals

Ligand is a biopharmaceutical company that develops and acquires assets it
believes will generate royalty revenues and, under its lean corporate cost
structure, produce sustainable 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,
Merck, Pfizer, Baxter International, Bristol-Myers Squibb, Celgene, Lundbeck
Inc., Eli Lilly & Co., Spectrum Pharmaceuticals and The Medicines Company.
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.

Forward-Looking Statements

This news release contains certain 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 clinical trials of
Captisol-enabled melphalan's profile, market size and possibility of
commercial success, efficacy, potency, competitiveness and the strength of
Ligand's product portfolio. Actual events or results may differ from our
expectations. For example, there can be no assurance that Captisol-enabled
melphalan or other potential Captisol-enabled drugs will progress through
clinical development or receive required regulatory approvals within the
expected timelines or at all, that further clinical trials will confirm any
safety or other characteristics or profile described in this press release,
that there will be a market of any size for Captisol-enabled melphalan or that
Captisol-enabled melphalan will be beneficial to patients or successfully
marketed. In addition, there can be no assurance that Ligand will achieve its
guidance or forecast. The failure to meet expectations with respect to any of
the foregoing matters may have a negative effect on Ligand's stock price.
Additional information concerning these and other risk factors affecting
Ligand's business can be found in prior press releases available via
www.ligand.com as well as in Ligand's public periodic filings with the
Securities and Exchange Commission at www.sec.gov. 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
Jennifer Capuzelo, Investor Relations
jcapuzelo@ligand.com
(858) 550-7584
or
LHA
Don Markley
dmarkley@lhai.com
(310) 691-7100
 
Press spacebar to pause and continue. Press esc to stop.