- NDA (New Drug Application) for AZEDRA® (iobenguane I 131) Submitted to the
U.S. Food and Drug Administration( FDA) on October 31st
- Positive Results from the Pivotal Phase 2b Study of AZEDRA Highlighted at Multiple Medical Conferences
- Clinical Trials for Prostate Cancer Product Candidates Continue to Advance
- Third Quarter 2017 RELISTOR® Net Sales of
“The recent completion of our NDA submission for AZEDRA represents a major achievement for our growing company,” said
Third Quarter and Recent Key Business Highlights
AZEDRA, Ultra-Orphan Radiotherapeutic Candidate
- New Drug Application (NDA) for AZEDRA (iobenguane I 131) Submitted to the
U.S. Food and Drug Administration( FDA) on October 31st
As announced earlier today, Progenics has submitted 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 United States. The NDA remains subject to FDAregulatory review and approval. AZEDRA holds Breakthrough Therapy and Orphan Drug statuses, as well as Fast Track designation.
- Multiple Presentations of Additional Data from Phase 2b Trial of AZEDRA
Progenics has recently presented the positive results from its pivotal Phase 2b study evaluating AZEDRA at the 5th International Symposium on Pheochromocytoma and Paraganglioma (ISP), the
North American Neuroendocrine Tumor Society(NANETS) 2017 Annual Symposium, and the 30th Annual Congressof the European Association of Nuclear Medicine(EANM). The Phase 2b trial met the primary endpoint evaluating the proportion of metastatic pheochromocytoma and paraganglioma patients who achieved a 50% or greater reduction of all antihypertensive medications for at least six months. The results further demonstrated that sustained reduction of antihypertensive medications was positively correlated with favorable tumor responses, including radiographic tumor responses, tumor biomarker response and overall survival. AZEDRA was shown to be safe and generally well tolerated.
PSMA-Targeted Prostate Cancer Pipeline
- Progress Continues for Clinical Studies of 1404, PyL™ and 1095
Progenics continues to enroll patients in: the Phase 3 trial of 1404, a SPECT/CT imaging agent; the Phase 2/3 study of PyL, a PET/CT imaging agent; and the Phase 1 open-label dose escalation study of 1095, a radiotherapeutic that selectively binds to PSMA.
RELISTOR, Treatment for Opioid-Induced Constipation (partnered with
- Third Quarter 2017 RELISTOR® Net Sales of
The third quarter 2017 sales, as reported to Progenics by its partner Valeant, translated to
$2.6 millionin royalty revenue for Progenics for the quarter. Oral RELISTOR prescriptions increased 40% over the preceding quarter.
Third Quarter 2017 Financial Results
Third quarter revenue totaled
Third quarter research and development expenses increased by
Net loss attributable to Progenics for the third quarter was
Conference Call and Webcast
Progenics will review third quarter financial results in a conference call today at
- Financial Tables follow -
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|For the Three Months Ended
|For the Nine Months Ended
|Research and development||10,344||9,827||31,641||26,964|
|General and administrative||5,958||7,220||17,986||18,637|
|Change in contingent consideration liability||700||600||3,300||1,400|
|Total operating expenses||17,002||17,647||52,927||47,001|
|Operating (loss) income||(14,305||)||36,203||(45,118||)||17,776|
|Other (expense) income:|
|Interest (expense) income, net||(1,047||)||79||(3,230||)||176|
|Total other (expense) income||(1,047||)||79||(3,230||)||176|
|Net (loss) income||(15,352||)||36,282||(48,348||)||17,952|
|Net loss attributable to noncontrolling interests||-||(21||)||-||(58||)|
|Net (loss) income attributable to Progenics||$||(15,352||)||$||36,303||$||(48,348||)||$||18,010|
|Net (loss) income per share attributable to Progenics - basic||$||(0.22||)||$||0.52||$||(0.69||)||$||0.26|
|Weighted average shares outstanding – basic||70,270||70,013||70,233||69,970|
|Net (loss) income per share attributable to Progenics - diluted||$||(0.22||)||$||0.52||$||(0.69||)||$||0.26|
|Weighted average shares outstanding –diluted||70,270||70,297||70,233||70,006|
|CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||98,279||$||138,909|
|Accounts receivable, net||2,619||4,864|
|Property and equipment, net||4,352||4,760|
|Intangible assets, net and goodwill||43,496||43,655|
|Acquisition-related contingent consideration liability||17,500||14,200|
|Long-term debt, deferred tax and other liabilities||62,243||63,667|
|Total stockholders’ equity||60,080||104,762|
|Total liabilities and stockholders’ equity||$||152,882||$||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® and 1095), 2) PSMA-targeted imaging agents for prostate cancer (1404 and PyL™), and 3) imaging analysis tools. 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. Please follow us on LinkedIn®. Information on or accessed through our website or social media sites is not included in the company's
Source: Progenics Pharmaceuticals Inc.