SAN
DIEGO, Mar 21, 2002 (BW HealthWire) -- The U.S. Food and Drug
Administration has granted marketing approval for AVINZA(TM)
(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).
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.
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.
Ligand Pharmaceuticals' releases are available on the World
Wide Web at www.businesswire.com/cnn/lgnd.htm.
CONTACT:
Ligand, San Diego
Michael Watts, 858/550-7850
Director, Investor Relations and Corporate Communications
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