Progenics Pharmaceuticals Announces Second Quarter 2011 Financial Results
— Second quarter U.S. sales of RELISTOR® increased 99% over first quarter and 50% over prior year quarter —
— Enrollment in phase 3 trial of oral methylnaltrexone completed —
— Conference call and webcast at
"We and our partner Salix have made significant advances toward our goals for the RELISTOR franchise in these early months of our collaboration," said
Net income for the second quarter was
Second quarter revenue totaled
Second quarter 2011 global net sales of RELISTOR were
Royalty income for the second quarter of 2011 was
Expenses for the second quarter of 2011 were
Second Quarter Highlights
Submitted a supplemental New Drug Application in June to the
U.S. Foodand Drug Administrationseeking approval for RELISTOR to treat opioid-induced constipation (OIC) in patients with chronic, non-cancer pain.
Presented data from the one-year phase 3 safety study of subcutaneous methylnaltrexone in non-cancer pain patients with OIC. At a fixed dose of 12 mg, the drug was shown to be generally safe and well tolerated, with a safety profile similar to that from a previously reported, shorter-duration efficacy study, and with no observed unexpected safety signals. Data were presented at the annual meeting of the
American Pain Society.
Oral Trial Enrollment Completed
Patient enrollment was completed in the phase 3 trial of oral methylnaltrexone in chronic, non-cancer pain patients who are experiencing OIC as a result of their pain management regimens. This study is being conducted in collaboration with Salix, Progenics' global partner for RELISTOR (methylnaltrexone bromide), a first-in-class treatment for OIC currently approved for advanced illness patients. Subcutaneous RELISTOR is also in clinical trials in
Conference Call and Webcast
Progenics will review second quarter financial results in a conference call today at
- Financial Tables follow -
|PROGENICS PHARMACEUTICALS, INC.|
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(in thousands, except net loss per share)|
|For the Three Months Ended||For the Six Months Ended|
|June 30,||June 30,|
|Collaboration revenue||$ 72,460||$ 880||$ 73,543||$ 1,093|
|Research and development||13,302||10,659||32,481||22,551|
|License fees — research and development||88||291||452||1,107|
|General and administrative||4,952||5,680||10,149||12,154|
|Depreciation and amortization||525||874||1,061||1,751|
|Operating income (loss)||55,470||(15,257)||32,525||(33,855)|
|Total other income||16||16||34||31|
|Net income (loss)||$ 55,486||$ (15,241)||$ 32,559||$ (33,824)|
|Net income (loss) per share; basic||$ 1.66||$ (0.47)||$ 0.97||$ (1.05)|
|Weighted average shares outstanding; basic||33,510||32,396||33,397||32,251|
|Net income (loss) per share; diluted||$ 1.64||$ (0.47)||$ 0.97||$ (1.05)|
|Weighted average shares outstanding; diluted||33,787||32,396||33,567||32,251|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|June 30,||December 31,|
|Cash and cash equivalents||$ 82,405||$ 47,918|
|Auction rate securities||3,516||3,608|
|Fixed assets, net||4,909||5,878|
|Total assets||$ 97,634||$ 62,738|
|Liabilities||$ 7,699||$ 11,430|
|Total liabilities and stockholders' equity||$ 97,634||$ 62,738|
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.
The information in 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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