09.05.2008 14:09:00
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CORRECTING and REPLACING Progenics Pharmaceuticals Reports First Quarter 2008 Results
The second bullet point under Recent Highlights should read: The
FDA approval of RELISTOR for subcutaneous use triggered a $15 million
milestone payment from Wyeth to Progenics. (sted: from Progenics to
Wyeth.)
PROGENICS PHARMACEUTICALS REPORTS FIRST QUARTER 2008 RESULTS
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its
results of operations for the quarter ended March 31, 2008.
Revenues for the quarter totaled $14.8 million compared to revenues of
$17.6 million for the same period in 2007. Revenues primarily reflect
reimbursement by the Company’s collaborator,
Wyeth, for development work performed by the Company under its
methylnaltrexone collaboration ($8.9 million in 2008 and $10.5 million
in 2007), recognition of a portion of the $60 million upfront payment
received from Wyeth in December 2005 ($3.2 million in 2008 and $5.0
million in 2007) and funding from government grants and contracts ($2.6
million in 2008 and $2.1 million in 2007).
The Company’s expenses for the first quarter
of 2008 were $32.2 million, compared to $29.9 million for the first
quarter of 2007. Research and development expenses increased by $0.8
million, relating to the collaboration with Wyeth, preparation for
clinical trials for other product candidates and an increase in research
and development headcount. General and administrative expenses increased
$0.9 million, primarily due to an increase in headcount. Depreciation
expense also increased $0.6 million due to purchases of capital assets
and additional leasehold improvements made after the first quarter of
2007.
The Company reported a net loss of ($15.5 million) or ($0.52) per share
(basic and diluted) for the first quarter of 2008, compared to a net
loss of ($10.4 million) or ($0.40) per share (basic and diluted) for the
first quarter of 2007. At the end of the first quarter of 2008,
Progenics had $155.0 million in cash, cash equivalents and marketable
securities compared to $170.4 million at December 31, 2007.
"The approval of RELISTOR by the U.S. Food and
Drug Administration in April 2008 was a transformative event for
Progenics Pharmaceuticals,” says Paul J.
Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science
Officer, Progenics Pharmaceuticals, Inc. "RELISTOR
will soon be available as a subcutaneous injection for the treatment of
opioid-induced constipation in patients with advanced illness who are
receiving palliative care, when response to laxative therapy has not
been sufficient. The development of innovative, breakthrough drugs that
are first-in-class is crucial in the current commercial environment.
Progenics will continue to strive to set an example of leadership and
innovation in the biotechnology industry.” First Quarter 2008 Highlights
In January 2008, the Company initiated two, phase 2 clinical trials
for PRO 140, an investigational drug for the treatment of human
immunodeficiency virus (HIV) infection. The objective of the studies
is to identify an optimal dosing regimen of PRO 140 for evaluation in
pivotal clinical trials, as well as to further assess safety and
tolerability.
In March, Progenics announced that preliminary results from the phase
3 intravenous methylnaltrexone clinical trial for post-operative
ileus, conducted by Wyeth, showed that treatment did not achieve the
primary end point of the study: a reduction in time to recovery of
gastrointestinal function (i.e., time to first bowel movement) as
compared to placebo. The study also did not show that secondary
measures of surgical recovery, including time to discharge
eligibility, were superior to placebo. By mid-year, Progenics expects
to have results of a second phase 3 trial that it has conducted and is
similar in design to the Wyeth study.
At the end of March, following a priority review, RELISTOR™
(methylnaltrexone bromide injection) for subcutaneous use was approved
for marketing in Canada. Health Canada’s
decision regarding RELISTOR marked the first regulatory approval of
this novel medication anywhere in the world.
Recent Highlights
On April 24th, Wyeth and Progenics received
United States Food and Drug Administration (FDA) approval of RELISTOR
(methylnaltrexone bromide) subcutaneous injection for the treatment of
opioid-induced constipation in patients with advanced illness who are
receiving palliative care, when response to laxative therapy has not
been sufficient. On the same day, the Companies also announced they
received a Positive Opinion for RELISTOR (methylnaltrexone bromide)
subcutaneous injection from the Committee for Medicinal Products for
Human Use (CHMP), the scientific committee of the European Medicines
Agency (EMEA).
The FDA approval of RELISTOR for subcutaneous use triggered a $15
million milestone payment from Wyeth to Progenics. Progenics has
announced that its Board of Directors has approved a share repurchase
program to acquire up to $15 million of its outstanding common shares,
funding for which will come from the milestone payment.
(PGNX-F)
About the Company Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a
biopharmaceutical company focusing on the development and
commercialization of innovative therapeutic products to treat the unmet
medical needs of patients with debilitating conditions and
life-threatening diseases. Principal programs are directed toward
gastroenterology, virology – including human
immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections –
and oncology. Progenics, in collaboration with Wyeth, is developing
RELISTOR™ (methylnaltrexone bromide) for the
treatment of opioid-induced side effects, including constipation
(subcutaneous and oral formulations) and post-operative ileus
(intravenous formulation). In the U.S., RELISTOR (methylnaltrexone
bromide) subcutaneous injection is indicated for the treatment of
opioid-induced constipation (OIC) in patients with advanced illness who
are receiving palliative care, when response to laxative therapy has not
been sufficient. In Canada, RELISTOR (methylnaltrexone bromide
injection) for subcutaneous use is indicated for the treatment of OIC in
patients with advanced illness receiving palliative care. Applications
are pending related to the potential marketing of RELISTOR in Europe,
where a Positive Opinion has been rendered by the Committee for
Medicinal Products for Human Use, the scientific committee of the
European Medicines Agency, as well as in Australia and other countries.
In the area of virology, Progenics is developing the HIV entry inhibitor
PRO 140, a humanized monoclonal antibody targeting the entry co-receptor
CCR5, which has completed phase 1b clinical studies with positive
results. PRO 140 is currently in phase 2 clinical testing. Pre-clinical
programs for the development of novel HCV entry inhibitors are also
underway. In the area of oncology, the Company is developing a human
monoclonal antibody-drug conjugate (ADC) for the treatment of prostate
cancer – a selectively targeted cytotoxic
antibody directed against prostate-specific membrane antigen (PSMA).
PSMA is a protein found on the surface of prostate cancer cells as well
as in blood vessels supplying other solid tumors. Progenics is also
developing vaccines designed to treat prostate cancer by stimulating an
immune response to PSMA.
PROGENICS PHARMACEUTICALS, INC. CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except net loss per share)
Three Months Ended
March 31,
2008
2007
Revenues:
Research and development from collaborator
$
12,110
$
15,499
Research grants and contracts
2,613
2,119
Product sales
39
19
Total revenues
14,762
17,637
Expenses:
Research and development
22,790
22,421
License fees – research and development
1,149
750
General and administrative
7,152
6,276
Depreciation and amortization
1,114
492
Total expenses
32,205
29,939
Operating loss
(17,443)
(12,302)
Interest income
1,958
1,869
Net loss
$
(15,485)
$
(10,433)
Net loss per share; basic and diluted
$
(0.52)
$
(0.40)
Weighted average shares outstanding
29,834
26,365
CONDENSED BALANCE SHEETS
(unaudited)
(in thousands)
March 31, 2008
December 31, 2007
Cash, cash equivalents and marketable securities
$
154,968
$
170,370
Accounts receivable
1,607
1,995
Fixed assets, net
13,194
13,511
Other assets
3,931
3,663
Total assets
$
173,700
$
189,539
Liabilities
$
35,850
$
42,040
Stockholders’ equity
137,850
147,499
Total liabilities and stockholders’ equity
$
173,700
$
189,539
DISCLOSURE NOTICE: The information contained in this document
is current as of May 9, 2008. This press release contains
forward-looking statements. Any statements contained herein that are not
statements of historical fact may be forward-looking statements. When
the Company uses the words ‘anticipates,’ ‘plans,’ ‘expects’
and similar expressions, it is identifying forward-looking statements.
Such forward-looking statements involve risks and uncertainties which
may cause the Company’s actual results,
performance or achievements to be materially different from those
expressed or implied by forward-looking statements. Such factors
include, among others, the uncertainties associated with product
development, the risk that clinical trials will not commence or proceed
as planned, the risks and uncertainties associated with dependence upon
the actions of our corporate, academic and other collaborators and of
government regulatory agencies, the risk that the Company’s
licenses to intellectual property may be terminated because of its
failure to have satisfied performance milestones, the risk that products
that appear promising in early clinical trials do not demonstrate
efficacy in larger-scale clinical trials, the risk that the Company may
not be able to manufacture commercial quantities of its products, the
uncertainty of future profitability and other factors set forth more
fully in the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2007 and other reports filed
with the Securities and Exchange Commission, to which investors are
referred for further information. In particular, the Company cannot
assure you that any of its programs will result in a commercial product. Progenics does not have a policy of updating or revising
forward-looking statements and assumes no obligation to update any
forward-looking statements contained in this document as a result of new
information or future events or developments. Thus, it should not be
assumed that the Company’s silence over time
means that actual events are bearing out as expressed or implied in such
forward-looking statements. Editor’s
Note:
Additional information on Progenics available at http://www.progenics.com.
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