Progenics Pharmaceuticals Announces First Quarter 2011 Financial Results
"The most significant event of our first quarter was completing a license agreement for RELISTOR® with
Progenics' net loss for the first quarter was
First quarter revenue totaled
First quarter 2011 global net sales of RELISTOR were
Expenses for the first quarter of 2011 were
First Quarter Highlights
RELISTOR licensed to
Salix Pharmaceuticalsfor further development and commercialization in all markets worldwide other than Japan. At the start of the second quarter, Salix commenced marketing of subcutaneous RELISTOR in the U.S. directly through its specialty sales force. Outside the U.S., Salix will market RELISTOR through regional sublicensees. Salix also is responsible for completing clinical development necessary to support regulatory applications for potential new indications and formulations.
Data from an ongoing phase 1 study of PSMA ADC presented at
ASCO's2011 Genitourinary Cancers Symposium. This presentation highlighted anti-tumor activity, as reflected by clinical and/or laboratory measures, observed in four of nine patients treated at the highest tested dose of 1.8 mg/kg. The Company plans to continue patient enrollment in this phase 1 study until a maximum tolerated dose is identified.
Progenics announced a change in executive leadership in March, at which time
Mark Bakerassumed the role of chief executive officer. Paul J. Maddon, M.D., Ph.D. was appointed vice chairman of the board of directors and continues as chief science officer.
Conference Call and Webcast
Progenics will review first quarter financial results in a conference call today at
PROGENICS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except net loss per share)
For the Three Months Ended
|Research and development||$ 1,083||$ 213|
|Research and development||19,179||11,892|
|License fees — research and development||364||816|
|General and administrative||5,197||6,474|
|Depreciation and amortization||536||877|
|Total other income||18||15|
|Net loss||$ (22,927)||$ (18,583)|
|Net loss per share; basic and diluted||$ (0.69)||$ (0.58)|
|Weighted average shares outstanding; basic and diluted||33,273||32,103|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$ 88,654||$ 47,918|
|Auction rate securities||3,608||3,608|
|Fixed assets, net||5,371||5,878|
|Total assets||$ 100,825||$ 62,738|
|Liabilities||$ 9,677||$ 11,430|
|Total liabilities and stockholders' equity||$ 100,825||$ 62,738|
About Subcutaneous RELISTOR
RELISTOR subcutaneous injection is approved in
Important Safety Information for RELISTOR
RELISTOR 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. Use of RELISTOR beyond four months has not been studied.
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.
Safety and efficacy of RELISTOR have not been established in pediatric patients.
Rare cases of gastrointestinal (GI) perforation have been reported in advanced illness patients with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the GI tract (i.e., cancer, peptic ulcer, Ogilvie's syndrome). Perforations have involved varying regions of the GI tract: (e.g., stomach, duodenum, colon).
Use RELISTOR with caution in patients with known or suspected lesions of the GI tract. Advise patients to discontinue therapy with RELISTOR and promptly notify their physician if they develop severe, persistent, and/or worsening abdominal symptoms.
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.
Please Note: The information in this press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible safety or efficacy concerns, general business, financial and accounting risks and litigation. More information concerning Progenics and such risks and
uncertainties is available on its website, as well as in its press releases and reports it files with the
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release.
For more information, please visit www.progenics.com.
For more information about RELISTOR, please visit www.RELISTOR.com.
Amy MartiniCorporate Affairs (914) 789-2816 email@example.com Media: Aline Schimmel Scienta Communications(312) 238-8957 firstname.lastname@example.org
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