Gruss E.
FDA Approves Eligard(R) 30mg (Leuprolide Acetate for Injectable Suspension), Four-Month Prostate Cancer Product -- Approval Provides Full Market Participation -- Third NDA Approval in Thirteen Months -- Company Provides Information on Fourth Quarter/
FORT COLLINS, Colo., Feb 18, 2003 /PRNewswire-FirstCall via COMTEX/ -- Atrix
Laboratories, Inc. (Nasdaq: ATRX) announced today that the company has received
approval from the U.S. Food and Drug Administration (FDA) for Eligard(R) 30mg
(leuprolide acetate for injectable suspension), for the palliative treatment of
advanced prostate cancer. Similar to the other Eligard products, this approval
came 10 months from submission.
Eligard approval
This approval, along with the approvals of both Eligard 7.5mg one-month and
Eligard 22.5mg three-month prostate cancer products, means that the Eligard
product line now has the opportunity to compete in the entire $1 billion U.S.
hormone therapy market opportunity for hormone-sensitive prostate cancer.
Eligard 30mg will be marketed in the U.S. by Sanofi- Synthelabo (NYSE: SNY).
Sanofi-Synthelabo currently markets Eligard 7.5mg and Eligard 22.5mg in the U.S.
"A third FDA approval in 13 months clearly demonstrates the world-class skill
and expertise of the Atrix team," said David R. Bethune, Atrix's chairman and
chief executive officer. "Sales of the first two Eligard products are increasing
month-to-month and we expect further reorders in the coming months. The approval
of Eligard 30mg now enables the franchise to compete in the complete U.S.
marketplace. Almost half of the total $1 billion market for prostate cancer
hormone therapy consists of the four-month product. With the near-term launch of
Eligard 30mg, we now have the opportunity to begin to understand the real
adoption cycle for these products."
Sustained levels of leuprolide decreases testosterone levels to suppress tumor
growth in patients with hormone-responsive prostate cancer. The liquid Eligard
products are injected subcutaneously with a small gauge needle, forming a solid
implant in the body that slowly releases leuprolide as the implant is
bioabsorbed.
Eligard 30mg, like other hormonal treatments for prostate cancer, causes a
transient increase in serum concentrations of testosterone during the first week
of treatment. Patients may experience worsening of symptoms or onset of new
signs and symptoms during the first few weeks of treatment. Response to Eligard
30mg should be monitored by measuring serum concentrations of testosterone and
prostate specific antigen periodically.
Fourth Quarter
The company also estimates 2002 fourth quarter losses will be between $0.28 -
$0.32 per share and a full year 2002 loss in the range of $0.96 - $0.99 per
share.
Brian Richmond, Atrix's chief financial officer commented, "Issues impacting the
fourth quarter 2002 were primarily based on timing of the Eligard launch and
adoption. Also, we have increased R&D spending relating to the Atrisone(TM)
Phase III trials and also incurred one-time expenses due to the establishment of
a sales force in Germany for the direct marketing of Atridox(TM). We believe
that these expenses are investments in the future. Comparing year-to-year
financials, we continue to exhibit consistent revenue growth. For the year-ended
2002, we estimate a 70-75% increase in total revenue compared to total revenue
for the year-ended 2001. Based on current trends in revenue growth, particularly
with respect to Eligard, we remain on track in 2003. We project R&D spending to
grow moderating within a range of $35 - $39 million, focusing the majority of
our R&D budget on near-term value drivers including Atrisone(TM) and the
extended-release Eligard 45mg product.
The company believes that results for 2003 will be affected by a number of
factors including the approval of products, the ramp up in sales of the Eligard
product line, sale of Atridox in Europe and the U.S., and specific R&D
expenditures, other international and national economic trends, conditions and
other factors.
About Atrix Laboratories, Inc.
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