Progenics Pharmaceuticals Announces Third Quarter 2011 Financial Results
"We have been pleased by the efforts of our partner Salix during this second quarter commercializing RELISTOR," said
Net loss for the quarter was
Progenics ended the quarter with cash, cash equivalents and securities of
Third quarter revenue totaled
Royalty income for the quarter was
RELISTOR Net Sales by Collaborators (in millions)
|Three Months Ended||Nine Months Ended|
|U.S.||$ 8.2||$ 2.4||$ 3.5||$ 13.5||$ 7.2|
|Global||$ 9.7||$ 4.1||$ 5.2||$ 18.2||$ 12.2|
Third quarter expenses were
Third Quarter Highlights
- Progenics reoriented its research and development focus on oncology. The Company is allocating additional financial and personnel resources to its clinical-stage PSMA ADC program and pre-clinical development work on multiplex phosphoinositide 3-kinase (PI3K) inhibitors and is seeking to in-license or acquire complementary opportunities in the oncology field. The Company is looking to out-license existing programs not within its oncology focus.
The U.S. Food and Drug Administrationaccepted for filing a supplemental New Drug Application (sNDA) seeking approval for subcutaneous RELISTOR to treat opioid-induced constipation in patients with chronic, non-cancer pain. The FDAissued a PDUFA action date of April 27, 2012.
- The Company announced positive preliminary data from a phase 1 study of PSMA ADC in 26 patients who have received doses ranging from 0.4 mg/kg to 2.0 mg/kg. PSMA ADC has generally been well tolerated at doses up to and including 2.0 mg/kg and a study cohort at a dose of 2.2 mg/kg has commenced.
Angelo W. Lovallo, Jr. was named Treasurer of the Company and David E. Martin, Esq.was appointed General Counsel.
Conference Call and Webcast
Progenics will review third quarter financial results in a conference call today at
- Financial Tables follow -
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except net income (loss) per share)|
For the Three Months Ended
For the Nine Months Ended
|Collaboration revenue||$ 2,855||
|Research and development||12,406||12,967||44,887||35,518|
|License fees — research and development||114||110||566||1,217|
|General and administrative||4,064||5,414||14,213||17,568|
|Depreciation and amortization||520||532||1,581||2,283|
|Operating income (loss)||(11,447)||(17,118)||21,078||(50,973)|
|Total other income||15||17||49||48|
|Net income (loss)||
|Net income (loss) per share; basic||
|Weighted average shares outstanding; basic||33,710||32,814||33,501||32,444|
|Net income (loss) per share; diluted||
|Weighted average shares outstanding; diluted||33,710||32,814||33,664||32,444|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||
|Auction rate securities||3,424||3,608|
|Fixed assets, net||4,439||5,878|
|Total liabilities and stockholders' equity||
Phase 3 Study Design for Oral Methylnaltrexone
The phase 3 study is a randomized, double-blind, placebo-controlled trial, which has completed enrollment of non-cancer pain patients experiencing OIC. Patients receive either placebo or one of three doses of oral methylnaltrexone. Following a two-week screening period, study participants are dosed once daily for four weeks, continuing treatment on an as needed basis for eight additional weeks. The primary efficacy endpoint of the study is the proportion of subjects with a rescue-free bowel movement within four hours of receiving oral methylnaltrexone during the four-week blinded period.
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.
This press release may contain projections and other forward-looking statements regarding future events. Such statements are predictions only, 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, and 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 firstname.lastname@example.org Media: Aline Schimmel Scienta Communications(312) 238-8957 email@example.com
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