- Company Preparing for Potential Commercial Launch of AZEDRA® (iobenguane I 131) Ahead of
U.S. Food and Drug Administration( FDA) April 30thAction Date
- Enrollment Complete in Phase 3 Trial for PSMA-Targeted SPECT/CT Imaging Agent 1404; Top-Line Results Anticipated in Q3’18
- Enrollment Ongoing in Phase 2/3 Trial for PSMA-Targeted PET/CT Imaging Agent PyL™ and Phase 1 Trial for PSMA-Targeted Small Molecule 1095
- RELISTOR® Quarterly Net Sales Reached Record Level of
$24.6 Millionin Q4’17
“2017 was a year of strong progress for our targeted oncology pipeline programs, capped by the FDA’s acceptance for review of the New Drug Application (NDA) for AZEDRA,” said
Mr. Baker continued, “We also continue to build momentum in advancing our development-stage PSMA-targeted radiopharmaceutical programs, which are designed to find, fight and follow prostate cancer. We have completed enrollment in our Phase 3 study for 1404, with results anticipated in the third quarter, and we expect to complete our current Phase 2/3 study for PyL in the second half of this year.”
Fourth Quarter and Recent Key Business Highlights
AZEDRA, Ultra-orphan radiotherapeutic candidate
- Action Date for AZEDRA New Drug Application (NDA) Set for
December 2017, Progenics announced that the FDAaccepted for review the NDA for AZEDRA in patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors for which there are currently no approved treatment options in the U.S. The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA). AZEDRA holds Breakthrough Therapy designation and Orphan Drug status, as well as Fast Track designation.
- Clinical Data from Pivotal Phase 2b AZEDRA Study Presented at Major Medical Meetings
October 2017, Progenics presented the positive results from its pivotal Phase 2b study evaluating AZEDRA at the North American Neuroendocrine Tumor Society(NANETS) 2017 Annual Symposium and the 30th Annual Congress of the European Association of Nuclear Medicine(EANM). Progenics also plans to present biochemical tumor marker data from this study at the upcoming Endocrine Society( ENDO) Annual Meeting in March 2018.
PSMA-Targeted Prostate Cancer Pipeline
- Enrollment Complete in Phase 3 Study of 1404
January 2018, Progenics announced the completion of enrollment in its Phase 3 study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent designed to visualize prostate cancer. The study enrolled approximately 450 patients in the U.S. and Canadawith newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. Top-line data is expected in the third quarter of 2018.
- Phase 2/3 Study of PyL™ Ongoing
Progenics continues to enroll patients in the Phase 2/3 study of PyL, a PSMA-targeted PET/CT imaging agent, evaluating diagnostic accuracy in patients with recurrent and/or metastatic prostate cancer. The Company expects to complete enrollment of this study in the second half of 2018 and initiate a second Phase 3 study in patients with biochemical recurrence of prostate cancer.
- Enrollment Ongoing in Phase 1 Study for 1095
Progenics continues to enroll patients in the Phase 1 open-label dose escalation study of 1095, a small molecule radiotherapeutic that selectively binds to PSMA, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have demonstrated tumor avidity to 1095.
- Initiation of Phase 1 Study for PSMA-TTC Expected in 2018
Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with mCRPC by year end 2018. Bayer was previously granted exclusive worldwide rights to develop and commercialize products using Progenics’s PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides.
RELISTOR, treatment for OIC (partnered with
- RELISTOR® Quarterly Net Sales Reached Record Level of
$24.6 Millionin Q4’17
Full-year 2017 net worldwide sales totaled
$73.1 millionas reported by our partner, Valeant. The fourth quarter 2017 net sales translated to $3.7 millionin royalty revenue for Progenics, while the full year net sales resulted in $11.0 millionin royalty revenue. Net sales of RELISTOR grew 44% over the prior quarter.
Fourth Quarter and Full-Year 2017 Financial Results
Fourth quarter 2017 revenue totaled
Research and development expenses increased by
Net loss attributable to Progenics for the fourth quarter was
Progenics ended the year with cash and cash equivalents of
Conference Call and Webcast
Progenics will review fourth quarter and year-end financial results in a conference call today at
|PROGENICS PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|For the Three Months Ended
|For the Year Ended
|Research and development||10,948||10,605||42,589||37,569|
|General and administrative||6,923||4,719||24,909||23,356|
|Change in contingent consideration liability||(700||)||(6,000||)||2,600||(4,600||)|
|Total operating expenses||17,171||9,324||70,098||56,325|
|Operating (loss) income||(13,282||)||(4,672||)||(58,400||)||13,104|
|Other (expense) income:|
|Interest (expense) income, net||(993||)||(669||)||(4,038||)||(493||)|
|Other expense, net||(62||)||(34||)||(247||)||(34||)|
|Total other (expense) income||(1,055||)||(703||)||(4,285||)||(527||)|
|(Loss) income before income tax (expense) benefit||(14,337||)||(5,375||)||(62,685||)||12,577|
|Income tax benefit (expense)||11,672||(1,844||)||11,672||(1,844||)|
|Net (loss) income||(2,665||)||(7,219||)||(51,013||)||10,733|
|Net loss attributable to noncontrolling interests||-||(15||)||-||(73||)|
|Net (loss) income attributable to Progenics||$||(2,665||)||$||(7,204||)||$||(51,013||)||$||10,806|
|Net (loss) income per share attributable to Progenics - basic||$||(0.04||)||$||(0.10||)||$||(0.73||)||$||0.15|
|Weighted average shares outstanding - basic||70,437||70,102||70,284||70,003|
|Net (loss) income per share attributable to Progenics - diluted||$||(0.04||)||$||(0.10||)||$||(0.73||)||$||0.15|
|Weighted average shares outstanding - diluted||70,437||70,102||70,284||70,155|
|CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||90,642||$||138,909|
|Accounts receivable, net||3,972||4,864|
|Property and equipment, net||4,122||4,760|
|Intangible assets, net and goodwill||43,443||43,655|
|Acquisition-related contingent consideration liability||16,800||14,200|
|Long-term debt, deferred tax and other liabilities||50,345||63,667|
|Total stockholders’ equity||63,453||104,762|
|Total liabilities and stockholders’ equity||$||145,957||$||198,986|
Progenics has exclusively licensed development and commercialization rights for its first commercial product, RELISTOR, to Valeant. RELISTOR Tablets (450 mg once daily) are approved in
IMPORTANT SAFETY INFORMATION - RELISTOR (methylnaltrexone bromide) tablets, for oral use and RELISTOR (methylnaltrexone bromide) injection, for subcutaneous use
RELISTOR tablets and injection are contraindicated in patients with known or suspected gastrointestinal obstruction and patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation.
Cases of gastrointestinal perforation have been reported in adult patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structural integrity in the wall of the gastrointestinal tract (e.g., peptic ulcer disease, Ogilvie's syndrome, diverticular disease, infiltrative gastrointestinal tract malignancies or peritoneal metastases). Take into account the overall risk-benefit profile when using RELISTOR in patients with these conditions or other conditions which might result in impaired integrity of the gastrointestinal tract wall (e.g., Crohn's disease). Monitor for the development of severe, persistent, or worsening abdominal pain; discontinue RELISTOR in patients who develop this symptom.
If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their healthcare provider.
Symptoms consistent with opioid withdrawal, including hyperhidrosis, chills, diarrhea, abdominal pain, anxiety, and yawning have occurred in patients treated with RELISTOR. Patients having disruptions to the blood-brain barrier may be at increased risk for opioid withdrawal and/or reduced analgesia and should be monitored for adequacy of analgesia and symptoms of opioid withdrawal.
Avoid concomitant use of RELISTOR with other opioid antagonists because of the potential for additive effects of opioid receptor antagonism and increased risk of opioid withdrawal.
The use of RELISTOR during pregnancy may precipitate opioid withdrawal in a fetus due to the immature fetal blood brain barrier and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions, including opioid withdrawal, in breastfed infants, advise women that breastfeeding is not recommended during treatment with RELISTOR. In nursing mothers, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
A dosage reduction of RELISTOR tablets and RELISTOR injection is recommended in patients with moderate and severe renal impairment (creatinine clearance less than 60 mL/minute as estimated by Cockcroft-Gault). No dosage adjustment of RELISTOR tablets or RELISTOR injection is needed in patients with mild renal impairment.
A dosage reduction of RELISTOR tablets is recommended in patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of RELISTOR tablets is needed in patients with mild hepatic impairment (Child-Pugh Class A). No dosage adjustment of RELISTOR injection is needed for patients with mild or moderate hepatic impairment. In patients with severe hepatic impairment, monitor for methylnaltrexone-related adverse reactions.
In the clinical studies, the most common adverse reactions were:
OIC in adult patients with chronic non-cancer pain
- RELISTOR tablets (≥ 2% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (14%), diarrhea (5%), headache (4%), abdominal distention (4%), vomiting (3%), hyperhidrosis (3%), anxiety (2%), muscle spasms (2%), rhinorrhea (2%), and chills (2%).
- RELISTOR injection (≥ 1% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (21%), nausea (9%), diarrhea (6%), hyperhidrosis (6%), hot flush (3%), tremor (1%), and chills (1%).
OIC in adult patients with advanced illness
- RELISTOR injection (≥ 5% of RELISTOR patients and at a greater incidence than placebo): abdominal pain (29%) flatulence (13%), nausea (12%), dizziness (7%), and diarrhea (6%).
Progenics develops innovative medicines and other technologies to target and treat cancer. Progenics' pipeline includes: 1) therapeutic agents designed to precisely target cancer (AZEDRA®, 1095 and PSMA TTC), 2) prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (1404 and PyL™), and 3) imaging analysis technology. Progenics' first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with
This press release may contain projections and other "forward-looking statements" regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. 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 unpredictability of results of clinical trials and other development activities and collaborations, such as the Phase 3 clinical program for 1404; our ability to successfully develop and commercialize the products of
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. Information on or accessed through our website or social media sites is not included in the company's
Source: Progenics Pharmaceuticals Inc.