Quinones

UroGen Pharma Announces License and Supply Agreement with Neopharm to Pursue Regulatory Approval and Commercialization for Jelmyto® in Israel

Retrieved on: 
Wednesday, July 28, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Chemical compounds, Organic compounds, Heterocyclic compounds, Aziridines, Breakthrough therapy, Mitomycin C, Oncology, Quinones, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UroGen Pharma Ltd., Neopharm, JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UROGEN PHARMA LTD., NEOPHARM

We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.

Key Points: 
  • We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.
  • I am confident that our well-established expertise and heritage of collaboration with innovative biopharmaceutical companies will make Jelmyto a success in Israel.
  • UroGen is committed to bringing the promise of Jelmyto to as many patients as possible, as quickly as feasible.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210728005968/en/

UroGen Pharma Announces Podium Presentation of Final Jelmyto® Data From Pivotal OLYMPUS Trial at the Annual Meeting of the Society of Urologic Oncology

Retrieved on: 
Thursday, December 3, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Health sciences, Health, Orphan drugs, Cancer treatments, Antineoplastic drugs, Mitomycin C, Quinones, Fast track, Breakthrough therapy, Pharmacovigilance, Food and Drug Administration, the Phase 3 OLYMPUS Trial, Jelmyto®, UroGen Pharma Ltd.

The safety profile in the final OLYMPUS data was consistent with previously reported results.

Key Points: 
  • The safety profile in the final OLYMPUS data was consistent with previously reported results.
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.

Complete and Durable Responses Observed in OPTIMA II Phase 2b Final Results for UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Tuesday, November 17, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Organic compounds, Chemical compounds, Infectious causes of cancer, Aziridines, Carbamates, Enones, Quinones, Chemistry, Bladder cancer, Mitomycins, Cancer, UGN, the Phase 2b OPTIMA II Trial, UGN-102

As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy.

Key Points: 
  • As previously reported, 65% (41/63) of patients receiving UGN-102 achieved a complete response (CR) three months after the start of therapy.
  • The Company expects to initiate a Phase 3 study evaluating UGN-102 versus current standard of care by the end of the year.
  • The current approach to treating patients diagnosed with low-grade intermediate risk non-muscle invasive bladder cancer is surgery.
  • UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer.

UroGen Pharma Reports Third Quarter 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, November 9, 2020
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, Health sciences, Health, Breakthrough therapy, Clinical medicine, Orphan drugs, Antineoplastic drugs, Aziridines, Mitomycin C, Quinones, Fast track, Transitional cell carcinoma, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 2b OPTIMA II Trial

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
  • Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S.
  • Our primary focus is on the health and well-being of patients, caregivers, and UroGen employees at this critical juncture.

UroGen Announces Positive Data from Pivotal OLYMPUS Trial Evaluating Jelmyto™ in Patients with Low-Grade Upper Tract Urothelial Cancer

Retrieved on: 
Friday, May 15, 2020
Research, FDA, Public relations, Investor relations, Clinical trials, Communications, General Health, Pharmaceutical, Health, Science, Oncology, Organic compounds, Chemical compounds, Neoplasms, Carcinoma, Transitional cell carcinoma, Aziridines, Carbamates, Enones, Quinones, Transitional epithelium, Mitomycins, Urinary bladder, the Phase 3 OLYMPUS Trial, Jelmyto™ (mitomycin) for pyelocalyceal solution, UroGen Pharma Ltd.

UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq:URGN) today announced the presentation of positive data from the UGN-101 (Jelmyto (mitomycin) for pyelocalyceal solution) Phase 3 OLYMPUS trial in patients with low-grade upper tract urothelial cancer (LG-UTUC).
  • OLYMPUS (Optimized DeLivery of Mitomycin for Primary UTUC Study) is an open-label, single-arm Phase 3 clinical trial of Jelmyto (mitomycin) for pyelocalyceal solution to evaluate the safety, tolerability and tumor ablative effect of Jelmyto in patients with low-grade upper tract urothelial cancer.
  • Jelmyto (mitomycin) for pyelocalyceal solution is a drug formulation of mitomycin for the treatment of low-grade upper tract urothelial cancer (LG-UTUC) in adult patients.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Friday, April 3, 2020
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical trials, Organic compounds, Chemical compounds, Cancer, Aziridines, RTT, Carbamates, Enones, Quinones, Mitomycins, Bladder cancer, UGN-102, UroGen Pharma Ltd.

UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq:URGN) announced positive interim data analysis of UGN-102 (mitomycin) for intravesical solution in patients with low-grade intermediate risk non-muscle invasive bladder cancer (LG IR-NMIBC).
  • The Phase 2b OPTIMA II trial demonstrated a complete response (CR) rate at three months following onset of treatment of 65% (41/63 patients).
  • In this subset of patients, 31/32 patients (97%) and 17/20 patients (85%) remained free of disease at six and nine months follow-up, respectively.
  • UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade non-muscle invasive bladder cancer (LG NMIBC).

Soligenix Receives US Patent for Improved Production of Synthetic Hypericin Composition

Retrieved on: 
Thursday, October 24, 2019
Organic compounds, Hydroxyarenes, Hypericin, Polyketides, Quinones, Virucides, Fluorescent lamp, Oxygen compounds, Chemistry

The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin.

Key Points: 
  • The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin.
  • 10,053,413) protecting the composition of the purified synthetic hypericin and is expected to expire in 2036.
  • The Phase 3 study is referred to as the FLASH (Fluorescent Light Activated Synthetic Hypericin) trial.
  • "This recently issued patent continues to expand, strengthen and protect our synthetic hypericin patent estate," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix.

UroGen Reports Positive Data from Two Important Studies: UGN-101 OLYMPUS Pivotal Trial in LG UTUC and UGN-102 Phase 2b OPTIMA II Trial in LG Bladder Cancer

Retrieved on: 
Tuesday, September 24, 2019
Research, Clinical trials, Biotechnology, Pharmaceutical, Health, Oncology, Science, Organic compounds, Medicine, Clinical medicine, Aziridines, Carbamates, Enones, Quinones, RTT, Hematuria, Bladder cancer, Mitomycins, Urinary tract infection, The Phase 3 OLYMPUS Trial, UGN-101, The Phase 2b OPTIMA II Trial, UGN-102, UroGen Pharma Ltd.

In the interim data from OPTIMA II, the most common adverse events observed were dysuria, pollakiuria, fatigue, hematuria and urinary tract infection.

Key Points: 
  • In the interim data from OPTIMA II, the most common adverse events observed were dysuria, pollakiuria, fatigue, hematuria and urinary tract infection.
  • The Company intends to initiate a pivotal Phase 3 trial in 2020 following discussion with the FDA.
  • PDE involved a ureteroscopy and wash cytology, a standard microscopic test of cells obtained from the urine to detect cancer.
  • UGN-102 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 2b development for the treatment of low-grade non-muscle invasive bladder cancer (LG NMIBC).

Servier announces European Commission decision to convert conditional approval into standard marketing authorization in patients with aggressive non-Hodgkin B-cell lymphoma for PIXUVRI® (pixantrone)

Retrieved on: 
Thursday, June 13, 2019
Health, Biotechnology, Oncology, Pharmaceutical, Amines, Pixantrone, Quinones, Cancer treatments, Antibody-drug conjugates, Drugs, Chemistry, Breakthrough therapy, Brentuximab vedotin

Servier today announced that the European Commission (EC) has approved the conversion of the conditional approval of PIXUVRI (pixantrone) into a standard marketing authorization as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.

Key Points: 
  • Servier today announced that the European Commission (EC) has approved the conversion of the conditional approval of PIXUVRI (pixantrone) into a standard marketing authorization as a single agent for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.
  • PIXUVRIhas demonstrated efficacy in late stage disease and the EC approval confirms PIXUVRIas a treatment option for these patients.
  • The EC approval is based on data from the global clinical development of PIXUVRI.
  • PIXUVRI has been benefitting patients since its conditional approval in 2012 but todays decision brings reassurance to patients and clinicians that this medicine remains a relevant treatment option in this indication.

PIXUVRI® (pixantrone) Receives Positive CHMP Opinion to Convert Conditional Approval into Standard Marketing Authorization in Patients with Aggressive non-Hodgkin B-cell Lymphoma

Retrieved on: 
Tuesday, April 9, 2019
Health, Biotechnology, Clinical trials, Oncology, Pharmaceutical, RTT, Medicine, Clinical medicine, Drugs, Genentech, Amines, Pixantrone, Quinones, Rituximab, Lymphoma, Oncology, Gilles Salles

The CHMPs opinion will now be sent to the European Commission (EC) for the adoption of the decision.

Key Points: 
  • The CHMPs opinion will now be sent to the European Commission (EC) for the adoption of the decision.
  • "Patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma have limited treatment options, said Prof Pier Luigi Zinzani from the University of Bologna Institute of Hematology and Medical Oncology in Bologna, Italy.
  • In this patient population, PIXUVRI offers a treatment option in later lines.
  • In the study PIX306, all patients were previously treated with rituximab, and the treatment was possible as a second line.