CORRECTING and REPLACING Progenics Announces Third Quarter 2009 Financial Results

http://www.businesswire.com/news/home/20091109005250/en

TARRYTOWN, N.Y.--(Business Wire)--
In the October Highlights section, the third sentence in the second bullet
should read xxx Significantly more patients on study drug experienced laxation
within two and four hours compared to those on placebo (33% versus 0%, [p<0.05]
and 39% versus 7%, [p<0.05], respectively). (sted xxx Significantly more
patients on study drug experienced laxation within two and four hours compared
to those on placebo (39% versus 7%, [p<0.05] and 33% versus 0%, [p<0.05],
respectively)).

The corrected release reads:

PROGENICS ANNOUNCES THIRD QUARTER 2009 FINANCIAL RESULTS

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced its results of
operations for the third quarter and nine months ended September 30, 2009.

Financial Results

Net loss for the third quarter of 2009 was $13.0 million or $0.41, basic and
diluted, per share, compared to $12.2 million or $0.40, basic and diluted, per
share in the third quarter of 2008. Net loss for the nine months ended September
30, 2009 was $30.0 million or $0.97, basic and diluted, per share, compared to a
net loss of $30.1 million or $1.00, basic and diluted, per share for the first
nine months of 2008.

Revenues for the third quarter of 2009 totaled $5.4 million, compared to $17.5
million for the same period of 2008, reflecting a decrease in reimbursement
revenue from Wyeth (NYSE: WYE) for RELISTOR® research and development under the
recently terminated 2005 collaboration between Wyeth and Progenics. For the
first nine months of 2009, Progenics reported revenues of $31.8 million compared
to $60.8 million for the comparable period of 2008. Revenues for nine months
also reflect a decrease in reimbursement and milestone revenue from Wyeth,
offset by recognition in the first quarter of a $15.0 million upfront payment
received in 2008 from Ono Pharmaceutical Co., Ltd. (OSE-TYO: 4528), Progenics`
collaborator for subcutaneous RELISTOR in Japan.

Expenses for the third quarter of 2009 were $18.6 million, compared to $31.2
million for the same period in the previous year. For the nine months ended
September 30, 2009, expenses totaled $63.5 million, compared to $95.9 million
for the same period of 2008.

Progenics ended the quarter with cash, cash equivalents and marketable
securities of $106.8 million, a reduction of $10.7 million from $117.5 million
at June 30, 2009.

The decreases in expenses for the third quarter and nine months ended September
30, 2009 compared to 2008 were attributable primarily to decreases of $10.3
million and $29.9 million, respectively, in research and development expenses.
The overall decreases, which reflect increases in PSMA-related clinical
activities, resulted primarily from:

* Reduced RELISTOR development expenses following completion of
Progenics-conducted clinical trials and other development work; and
* Reduced manufacturing activities for PRO 140 clinical trials.

Global net sales of RELISTOR for the third quarter of 2009 were $3.3 million, as
compared to $3.2 million in sales for the previous quarter and $0.8 million for
the third quarter of 2008 when RELISTOR had only been partially launched by
Wyeth. Of the current period`s global net sales, U.S. net sales comprised $1.8
million, as compared with $2.0 million in the previous quarter.

"During the third quarter, we worked diligently to regain worldwide rights to
RELISTOR, the only approved drug for opioid-induced constipation, and our
announcement just after the closing of this quarter was a significant event,"
said Paul J. Maddon, Founder, Chief Executive Officer and Chief Science Officer
of Progenics Pharmaceuticals. "We are excited about the future of the RELISTOR
franchise, including our plans to submit an sNDA by early 2011 for approval of
subcutaneous RELISTOR for the treatment of opioid-induced constipation in the
broader chronic-pain market and to take immediate responsibility for development
of oral RELISTOR. We believe that RELISTOR is just beginning to realize its
potential in the opioid-induced constipation marketplace."

Third Quarter Highlights

* Applications for a new RELISTOR pre-filled syringe delivery system were
submitted to the U.S. Food and Drug Administration and the European Union
European Medicines Agency. Pre-filled syringes are designed to ease preparation
and administration for patients and caregivers and, if approved, could be
available to advanced-illness patients in the U.S. and Europe as early as the
first half of 2010.
* Mark R. Baker, formerly Executive Vice President - Corporate, was appointed
President and a member of the Board of Directors. He continues to report to Dr.
Maddon. In his new role, Mr. Baker oversees business and commercial development,
strategic planning, investor relations, corporate communications, finance and
accounting, operations and legal affairs.

October Highlights

* Progenics and Wyeth terminated their 2005 collaboration, and Progenics is
regaining all worldwide rights to the RELISTOR franchise. Progenics will assume
full control of future development and commercialization of subcutaneous
RELISTOR after a transition period, and is taking over clinical and non-clinical
development of the oral form of the drug. Wyeth has agreed to pay Progenics a
total of $10.0 million in installments through January 2011, and to provide
support by continuing manufacturing, marketing, sales, distribution, ongoing
clinical studies and regulatory activities for subcutaneous RELISTOR over the
transitional period. Wyeth is also committing up to $14.5 million of funding for
development of RELISTOR in a multi-dose pen delivery system for the chronic-pain
patient population and for pediatric clinical trials. Progenics` out-license of
subcutaneous RELISTOR to Ono Pharmaceutical in Japan is not affected by the
Wyeth collaboration termination.
* Positive data from a phase 2 study of methylnaltrexone treatment during
rehabilitation following orthopedic procedures was presented at the annual
meeting of the American Academy of Physical Medicine and Rehabilitation. The
hypothesis-generating study was conducted by Progenics in 33 patients and served
to evaluate methylnaltrexone in a new patient setting. Significantly more
patients on study drug experienced laxation within two and four hours compared
to those on placebo (33% versus 0%, [p<0.05] and 39% versus 7%, [p<0.05],
respectively). In addition, the median time to laxation in the methylnaltrexone
group was nearly one day earlier than the placebo group. Incidences of adverse
events were comparable between the two treatment groups, and no serious adverse
events were reported. Data from this study will support the safety portion of
the chronic-pain sNDA planned for FDA submission by early 2011.

PROGENICS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except net loss per share)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2009 2008 2009 2008
Revenues:
Research and development $ 4,431 $ 16,015 $ 29,206 $ 54,896
Royalty income 509 44 976 86
Research grants and contract 404 1,377 1,421 5,689
Other revenues 75 61 189 172
Total revenues 5,419 17,497 31,792 60,843

Expenses:
Research and development 11,345 21,478 39,055 68,191
License fees - research and development 136 305 961 1,788
General and administrative 5,844 8,265 19,758 22,530
Royalty expense 51 5 98 9
Depreciation and amortization 1,207 1,166 3,633 3,427
Total expenses 18,583 31,219 63,505 95,945

Operating loss (13,164) (13,722) (31,713) (35,102)

Other income:
Interest income 123 1,502 1,457 5,028
Gain on sale of marketable securities - - 237 -
Gain on disposal of fixed assets 27 - 46 -
Total other income 150 1,502 1,740 5,028

Net loss $ (13,014) $ (12,220) $ (29,973) $ (30,074)

Net loss per share; basic and diluted $ (0.41) $ (0.40) $ (0.97) $ (1.00)
Weighted average shares outstanding; basic and diluted 31,428 30,323 31,060 30,048

CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)

(in thousands)
September 30, 2009 December 31, 2008

Cash, cash equivalents and marketable securities $ 106,756 $ 141,374
Accounts receivable 697 1,337
Fixed assets, net 8,080 11,071
Other assets 1,513 4,051
Total assets $ 117,046 $ 157,833

Liabilities $ 12,547 $ 38,464
Stockholders` equity 104,499 119,369
Total liabilities and stockholders` equity $ 117,046 $ 157,833

About Subcutaneous RELISTOR

RELISTOR subcutaneous injection is approved in the United States 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. The use of RELISTOR beyond four months has not been studied.
The drug is also approved for use in over 30 countries worldwide, including the
European Union, Canada, Australia and Brazil. Applications in additional
countries are pending.

Important Safety Information for RELISTOR

* RELISTOR is contraindicated in patients with known or suspected mechanical
gastrointestinal obstruction.
* If severe or persistent diarrhea occurs during treatment, advise patients to
discontinue therapy with RELISTOR and consult their physician.
* Use of RELISTOR has not been studied in patients with peritoneal catheters.
* The most common adverse reactions reported with RELISTOR compared with placebo
in clinical trials were abdominal pain (28.5% vs. 9.8%), flatulence (13.3% vs.
5.7%), nausea (11.5% vs. 4.9%), dizziness (7.3% vs. 2.4%), diarrhea (5.5% vs.
2.4%), and hyperhidrosis (6.7% vs. 6.5%).
* RELISTOR full Prescribing Information for the U.S. is available at
www.relistor.com.

About Subcutaneous RELISTOR for OIC in the Chronic-pain Setting

In May 2009, Progenics and Wyeth reported a positive outcome from a 470-patient,
phase 3 efficacy clinical trial in patients with chronic, non-cancer pain. This
study showed statistically significant improvements in the occurrence of bowel
movements with the use of RELISTOR. Adverse events observed in this study were
similar to those seen in prior studies. Enrollment was also recently completed
for phase 3 safety study of over 1,000 patients, with results expected by the
end of 2010. Results from these two studies are expected to be included in an
sNDA submission by early 2011. If FDA approval of the application is granted,
Progenics plans to launch subcutaneous RELISTOR in a multi-dose pen for the
chronic-pain OIC market thereafter.

(PGNX-F)

About Progenics

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 supportive care, virology and oncology. Progenics is developing
RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced side
effects. RELISTOR is currently approved in over 30 countries, including the
U.S., E.U. member countries, Canada, Australia and Brazil; marketing
applications are pending elsewhere throughout the world. Progenics is pursuing
strategic alternatives for RELISTOR, including licensing, collaboration,
strategic alliances and U.S. commercialization or co-promotion, following
termination of its 2005 collaboration with Wyeth Pharmaceuticals, which is
continuing manufacturing, sales, marketing, and certain development and
regulatory activities for RELISTOR during the transition. Ono Pharmaceutical
Co., Ltd. has an exclusive license from Progenics for development and
commercialization of subcutaneous RELISTOR in Japan. In the area of virology,
Progenics is developing the viral-entry inhibitor PRO 140, a humanized
monoclonal antibody which binds to co-receptor CCR5 to inhibit human
immunodeficiency virus (HIV) infection. PRO 140 is currently in phase 2 clinical
testing. The Company`s hepatitis C virus discovery program seeks to identify
novel inhibitors of HCV entry. In oncology, the Company is conducting a phase 1
clinical trial of a human monoclonal antibody-drug conjugate (ADC) for the
treatment of prostate cancer-a selectively targeted chemotherapeutic antibody
directed against prostate-specific membrane antigen. 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 conducting phase 1 clinical trials with vaccines
designed to treat prostate cancer by stimulating an immune response to PSMA.

PROGENICS DISCLOSURE NOTICE: This document contains statements that do not
relate strictly to historical fact, any of which may be forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995. When we use the words "anticipates," "plans," "expects" and similar
expressions, we are identifying forward-looking statements. Forward-looking
statements involve known and unknown risks and uncertainties which may cause our
actual results, performance or achievements to be materially different from
those expressed or implied by forward-looking statements. While it is impossible
to identify or predict all such matters, these differences may result from,
among other things, the inherent uncertainty of the timing and success of, and
expense associated with, research, development, regulatory approval and
commercialization of our products and product candidates, including the risks
that clinical trials will not commence or proceed as planned; products appearing
promising in early trials will not demonstrate efficacy or safety in
larger-scale trials; clinical trial data on our products and product candidates
will be unfavorable; our products will not receive marketing approval from
regulators or, if approved, do not gain sufficient market acceptance to justify
development and commercialization costs; competing products currently on the
market or in development might reduce the commercial potential of our products;
we, our collaborators or others might identify side effects after the product is
on the market; or efficacy or safety concerns regarding marketed products,
whether or not originating from subsequent testing or other activities by us,
governmental regulators, other entities or organizations or otherwise, and
whether or not scientifically justified, may lead to product recalls,
withdrawals of marketing approval, reformulation of the product, additional
pre-clinical testing or clinical trials, changes in labeling of the product, the
need for additional marketing applications, declining sales or other adverse
events.

We are also subject to risks and uncertainties associated with the actions of
our corporate, academic and other collaborators and government regulatory
agencies, including risks from market forces and trends; potential product
liability; intellectual property, litigation, environmental and other risks; the
risk that we may not be able to enter into favorable collaboration or other
relationships or that existing or future relationships may not proceed as
planned; the risk that current and pending patent protection for our products
may be invalid, unenforceable or challenged, or fail to provide adequate market
exclusivity, or that our rights to in-licensed intellectual property may be
terminated for our failure to satisfy performance milestones; the risk of
difficulties in, and regulatory compliance relating to, manufacturing products;
and the uncertainty of our future profitability.

Risks and uncertainties also include general economic conditions, including
interest and currency exchange-rate fluctuations and the availability of
capital; changes in generally accepted accounting principles; the impact of
legislation and regulatory compliance; the highly regulated nature of our
business, including government cost-containment initiatives and restrictions on
third-party payments for our products; trade buying patterns; the competitive
climate of our industry; and other factors set forth in our Annual Report on
Form 10-K and other reports filed with the U.S. Securities and Exchange
Commission. In particular, we cannot assure you that RELISTOR will be
commercially successful or be approved in the future in other formulations,
indications or jurisdictions, or that any of our other programs will result in a
commercial product.

We do not have a policy of updating or revising forward-looking statements and
we assume no obligation to update any statements as a result of new information
or future events or developments. It should not be assumed that our silence over
time means that actual events are bearing out as expressed or implied in
forward-looking statements.

Editors Note:

For more information about Progenics Pharmaceuticals, Inc., please visit
www.progenics.com.

For more information about RELISTOR, please visit www.RELISTOR.com.

Investors:
Progenics Pharmaceuticals, Inc.
Richard W. Krawiec, Ph.D., 914-789-2814
Vice President, Corporate Affairs
krawiecr@progenics.com
or
Dory A. Kurowski, 914-789-2818
Associate Director, Corporate Affairs
dkurowski@progenics.com
or
Media:
WeissComm Partners
Aline Schimmel, 312-646-6295

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