Exhibit 99.1
Contact:
Michael Watts
Director, Investor Relations and
Corporate Communications
(858) 550-7850
FDA Approves AVINZA(TM)Once-Daily for Chronic, Moderate-to-Severe Pain
-- Ligand Planning Second Quarter Launch into $2.3 Billion Market --
San Diego, Calif., March 21, 2002 - The U.S. Food and Drug Administration
has granted marketing approval for AVINZA (morphine sulfate extended release
capsules) for the once-daily treatment of moderate-to-severe pain in patients
who require continuous, around-the-clock opioid therapy for an extended period
of time, Ligand announced today.
AVINZA (formerly Morphelan(TM)) was developed by Elan (NYSE: ELN), which
licensed the U.S. and Canadian marketing rights to Ligand (Nasdaq: LGND) in
1998. AVINZA's approval triggers a $5 million milestone payment from Ligand to
Elan, which Ligand will pay in the form of approximately 302,554 shares of
common stock.
"We are pleased with the approval of our new drug application for AVINZA,"
said Donal Geaney, Chairman and CEO of Elan Corporation, plc. "We are looking
forward to working with our partner, Ligand, to help patients suffering from
chronic pain."
"The approval of AVINZA is a major milestone in Ligand's commercial
acceleration toward becoming a profitable, high-growth specialty pharmaceutical
company," said David E. Robinson, Chairman, President and CEO of Ligand. "We're
eager and prepared to launch the product early in the second quarter into the
rapidly expanding sustained-release opioid market, which grew to an estimated
$2.3 billion in the U.S. in 2001, clearly the largest initial market Ligand has
entered to date. We believe that with the combined efforts of Ligand and Elan,
AVINZA may become, over time, an important new therapeutic of choice for
patients requiring chronic daily opioid analgesia."
The U.S. sustained-release opioid market, which has grown by an average of
46% annually since 1996, includes sales of OxyContin(R), Duragesic(R), MS
Contin(R), Oramorph(R) SR and Kadian(R). Despite this recent growth, studies
indicate that as many as 30-85% of select chronic pain patients still are
undertreated.
Ligand's sales force strategy for AVINZA includes coverage of
hematologists, oncologists and HIV specialists through the company's existing
oncology and dermatology sales forces, as well as the creation of a new, third
sales force to target selected general pain centers. Ligand's goal through the
co-promotion option with Elan is to optimize AVINZA's potential by adding
sufficient sales force coverage of a broad universe of pain specialists and
other key physician groups treating chronic, moderate-to-severe pain
(anesthesiologists, neurologists, rheumatologists, etc.). Elan has a
co-promotion option that permits it to participate in promoting AVINZA to these
pain specialists.
Clinical Trial Results
AVINZA has been studied in more than 140 healthy volunteers and 560
patients with chronic, moderate-to-severe pain from diseases of malignant and
non-malignant origin. The patients included people who were receiving or had
received chronic opioid therapy, as well as people who had a sub-optimal
analgesic response to acetaminophen and/or NSAIDs.
In controlled clinical studies, patients were followed from seven days to
up to four weeks. In open-label studies, patients were followed for up to six to
12 months. In the study of 295 patients with osteoarthritis pain, once-daily
treatment with AVINZA 30 mg. in the morning or evening was more effective than
placebo at reducing pain.
As described in its approved labeling, AVINZA consists of two components:
an immediate-release component that rapidly achieves plateau morphine
concentrations in plasma, and an extended-release component that maintains
plasma concentrations throughout the 24-hour dosing interval. AVINZA once-daily
creates and maintains the plateau-like plasma concentration profile after
steady-state plasma morphine concentrations have been achieved.
In pharmacokinetic studies, the amount of morphine absorbed from AVINZA was
similar to that absorbed from other oral morphine formulations. In addition, the
pharmacokinetics of AVINZA were shown to be dose-proportional over a single oral
dose range of 30-120 mg. in healthy volunteers, and over a multiple oral dose
range of at least 30-180 mg. in patients with chronic, moderate-to-severe pain.
AVINZA will be available with a doctor's prescription in 30, 60, 90 and 120
mg. capsules. According to its approved labeling and under a doctor's
supervision, AVINZA can be taken with or without food. Patients who have
difficulty swallowing an AVINZA capsule can open it, sprinkle its contents on
applesauce, and swallow
without chewing. Pharmacokinetic studies showed that the rate and extent of
morphine absorption from this dosing method were bioequivalent to swallowing the
same dose from an intact capsule. AVINZA capsules must not be chewed, crushed or
dissolved due to the risk of rapid release and absorption of a potentially fatal
dose of morphine.
AVINZA's side effects were dose-dependent and similar to those typically
seen with opioid therapy. In clinical studies, the most common side effects
reported by patients at least once were constipation, nausea, somnolence,
vomiting and headache.
Morphine is a Schedule II controlled substance that can be abused in a
manner similar to other legal or illicit opioids. However, AVINZA's approved
labeling notes that concerns about abuse, addiction and diversion should not
prevent proper pain management. Toward this end, Ligand and Elan have developed
a risk-management program for AVINZA and will continue to work closely with the
FDA on that program and our post-approval study commitments.
About Ligand
Ligand discovers, develops and markets new drugs that address critical
unmet medical needs of patients in the areas of cancer, 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).
(i) Web Cast Conference Call
Ligand will host a live web cast, open to all interested parties, of a
conference call during which Ligand management will discuss the approval of
AVINZA. The web cast will be available at www.streetevents.com and
www.ligand.com (investor relations page) at 8:30 a.m. Eastern Time (5:30 a.m.
Pacific Time) Thursday, March 21.
B. Caution Regarding Forward-Looking Statements
This news release may contain certain forward-looking statements by Ligand
that involve risks and uncertainties and reflect the company's judgment as of
the date of this release. These statements include those related to product
launch, co-promotion, product potential, benefits of AVINZA for patients, market
size and growth, and sales strategy. Actual events or results may differ from
Ligand's expectations. For example, AVINZA sales may not meet expectations due
to lack of doctor or patient
acceptance; delays in its launch, co-promotion or supply; decline in the market;
or our sales strategy. In addition, Ligand and Elan may not agree on a
co-promotion plan in a timely manner. AVINZA is a controlled substance and
therefore has a number of special regulatory restrictions. It also may be abused
or misused, causing injury or death. Any of these factors could reduce sales
significantly. Additional information concerning these and other risk factors
affecting Ligand's business can be found in prior press releases as well as in
the company's public periodic filings with the Securities and Exchange
Commission, which are 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.
Full prescribing information for Ligand's products can be obtained in the
United States from Ligand Professional Services by calling 800-964-5836, or on
Ligand's internet site at www.ligand.com. The package insert for AVINZA will be
available in approximately one week.
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