Menarini

Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023
Neoplasm, Patient, Abdominal pain, Constipation, SOC, Headache, Food, Progression-free survival, Fatigue, European Commission, Vomiting, Diarrhea, PFS, Safety, DSM-IV codes, HIV disease progression rates, Holding, Nausea, Republic, Civil service commission, ESR1, Risk, Triglyceride, MBC, ER, Breast cancer, Anemia, Woman, Oncology, Indigestion, Cancer, Therapy, Arthralgia, Creatinine, Potassium, Death, Back pain, Cholesterol, Mutation, Menarini, Medical imaging, Pharmaceutical industry

Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.

Key Points: 
  • Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.
  • Under the Sub-Licensing agreement, SciClone will pursue the development and registration of ORSERDU in China and commercialise ORSERDU upon its regulatory approval in China.
  • "Patients living with metastatic breast cancer need effective and tolerable options," said Elcin Barker Ergun, CEO of the Menarini Group.
  • "We are proud to partner with SciClone in an effort to register a new breast cancer treatment for patients in China that can offer efficacy in a once-daily pill."

Menarini Group and SciClone Pharmaceuticals Announce Exclusive Sub-Licensing Collaboration to Develop and Commercialize ORSERDU® (Elacestrant) in China to Address Advanced or Metastatic Breast Cancer

Retrieved on: 
Tuesday, November 7, 2023
Neoplasm, Patient, Abdominal pain, Constipation, SOC, Headache, Food, Progression-free survival, Fatigue, European Commission, Vomiting, Diarrhea, PFS, Safety, DSM-IV codes, HIV disease progression rates, Holding, Nausea, Republic, Civil service commission, ESR1, Risk, Triglyceride, MBC, ER, Breast cancer, Anemia, Woman, Oncology, Indigestion, Cancer, Therapy, Arthralgia, Creatinine, Potassium, Death, Back pain, Cholesterol, Mutation, Menarini, Medical imaging, Pharmaceutical industry

Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.

Key Points: 
  • Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, focused on bringing transformational oncology treatments to cancer patients, commercializes ORSERDU in the U.S. and E.U.
  • Under the Sub-Licensing agreement, SciClone will pursue the development and registration of ORSERDU in China and commercialise ORSERDU upon its regulatory approval in China.
  • "Patients living with metastatic breast cancer need effective and tolerable options," said Elcin Barker Ergun, CEO of the Menarini Group.
  • "We are proud to partner with SciClone in an effort to register a new breast cancer treatment for patients in China that can offer efficacy in a once-daily pill."

Carrick Therapeutics Announces First Patient Dosed in Phase 2 Clinical Trial of Samuraciclib in Combination with Elacestrant in Patients with Advanced Breast Cancer

Retrieved on: 
Wednesday, October 18, 2023
SERD, Clinical trial, Menarini, Pharmacokinetics, CDK7, ID, Biology, Woman, Therapy, Liquid biopsy, Patient, HR, Pharmaceutical industry

"Dosing the first patient in our Phase 2 clinical trial evaluating the combination of samuraciclib and elacestrant is an important milestone in our goal of improving outcomes for women fighting metastatic breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.

Key Points: 
  • "Dosing the first patient in our Phase 2 clinical trial evaluating the combination of samuraciclib and elacestrant is an important milestone in our goal of improving outcomes for women fighting metastatic breast cancer,” said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.
  • The Phase 2 clinical trial evaluating the novel combination of samuraciclib and elacestrant is being conducted in collaboration with Menarini, pursuant to a clinical trial collaboration and supply agreement for elacestrant.
  • Clinical trial details can also be found on www.clinicaltrials.gov under study ID: NCT05963997 .
  • For additional information on the clinical trial, please contact [email protected] .

European Organisation for Research and Treatment of Cancer & the Menarini Group Launch New Clinical Trial in Early-Stage Breast Cancer

Retrieved on: 
Thursday, October 19, 2023
European Organisation for Research and Treatment of Cancer, Patient, Research, Arm, Metastasis, Plasma, Clinical trial, European Commission, III, SERD, Treatment, SUCCESS, EORTC, Menarini, HIV disease progression rates, German, DNA, Civil service commission, MBC, MRD, Breast cancer, Breast International Group, Woman, Neoplasm, Death, Treat, BIG, Pharmaceutical industry, Medical imaging, Cancer

A molecular residual disease (MRD) test for the detection of circulating tumour DNA (ctDNA) will also be used.

Key Points: 
  • A molecular residual disease (MRD) test for the detection of circulating tumour DNA (ctDNA) will also be used.
  • The study was submitted under the new Clinical Trial Regulation, and it is expected to start the activation process in the fourth quarter of 2023.
  • "We are excited to offer to our high-risk, ctDNA positive, ER+/HER2- early-stage breast cancer patients the possibility to participate in the Treat ctDNA trial.
  • This intergroup trial, managed by the EORTC Breast Cancer Group, will be jointly conducted with several national and international cancer clinical research groups, including the German SUCCESS group under the umbrella of BIG (Breast International Group).

Menarini Asia-Pacific Enters into an Exclusive Licensing Agreement with Astellas to Commercialize Smyraf® in Taiwan and select South-East Asian markets

Retrieved on: 
Wednesday, September 13, 2023
Janus, Partnership, RA, Astellas Pharma, Prevalence, JAK, Disease, GBD, Menarini, Inflammation, Institute for Health Metrics and Evaluation, Person, Pain, Patient, Rheumatoid arthritis, Joint, Diagnosis, Castleman Disease Collaborative Network, IHME, Pharmaceutical industry, Tablet

Smyraf® has been approved in Taiwan and has patent protection for composition of matter until 2032.

Key Points: 
  • Smyraf® has been approved in Taiwan and has patent protection for composition of matter until 2032.
  • Subject to the terms of the agreement, Astellas will receive total payments of up to €5.5 million including upfront and milestone payments.
  • In addition, Menarini will pay Astellas a high-single digit percentage royalties on net sales of Smyraf®.
  • Menarini will have an option to extend the rights to select South-East Asian markets.

Menarini Asia-Pacific Enters into an Exclusive Licensing Agreement with Astellas to Commercialize Smyraf® in Taiwan and select South-East Asian markets

Retrieved on: 
Wednesday, September 13, 2023
Janus, Partnership, RA, Astellas Pharma, Prevalence, JAK, Disease, GBD, Menarini, Inflammation, Institute for Health Metrics and Evaluation, Person, Pain, Patient, Rheumatoid arthritis, Joint, Diagnosis, Castleman Disease Collaborative Network, IHME, Pharmaceutical industry, Tablet

Smyraf® has been approved in Taiwan and has patent protection for composition of matter until 2032.

Key Points: 
  • Smyraf® has been approved in Taiwan and has patent protection for composition of matter until 2032.
  • Subject to the terms of the agreement, Astellas will receive total payments of up to €5.5 million including upfront and milestone payments.
  • In addition, Menarini will pay Astellas a high-single digit percentage royalties on net sales of Smyraf®.
  • Menarini will have an option to extend the rights to select South-East Asian markets.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023
MHLW, Patient, Blastic plasmacytoid dendritic cell neoplasm, Orphan, Menarini, Therapy, BPDCN, Pharmaceutical industry, Health

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

The Menarini Group Announces ELZONRIS® (Tagraxofusp) Designated as an Orphan Drug for BPDCN by Japanese Ministry of Health, Labor and Welfare

Retrieved on: 
Wednesday, August 30, 2023
MHLW, Patient, Blastic plasmacytoid dendritic cell neoplasm, Orphan, Menarini, Therapy, BPDCN, Pharmaceutical industry, Health

BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.

Key Points: 
  • BPDCN is an aggressive orphan hematologic malignancy with historically poor clinical outcomes.
  • Stemline's ELZONRIS® (tagraxofusp) is the only approved treatment for patients with BPDCN, and the first and only approved CD123-targeted therapy, in both the United States and Europe.
  • Orphan drug designation can potentially shorten the period required to obtain regulatory approval in Japan by several months, thereby enabling faster patient access.
  • In Japan, tagraxofusp is being developed by Nippon Shinyaku, which is currently conducting a Phase 1/2 clinical trial.

Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

Retrieved on: 
Friday, July 21, 2023
Medicine, Neoplasm, European Medicines Agency, Diarrhea, Arthralgia, Doctor of Philosophy, Committee, IRCCS, MD, Patient, Division, Risk, European, Committee for Medicinal Products for Human Use, AST, University of Milano-Bicocca, Fatigue, University, Cholesterol, Constipation, Bone pain, EMA, Vomiting, Back pain, HIV disease progression rates, ALT, Headache, Death, Elacestrant, Civil service commission, Creatinine, Triglyceride, CDK, MBC, Indigestion, SOC, Abdominal pain, PFS, European Institute of Oncology, Menarini, European Commission, CHMP, Thrombosis, Progression-free survival, Anemia, ESR1, Advanced Therapy Medicinal Product, Woman, Periodic breathing, European Institute, Drug development, Nausea, Potassium, ER, Breast cancer, Medical imaging, Pharmaceutical industry, EU

ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.

Key Points: 
  • ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
  • "Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options.
  • ORSERDU, if approved, will also provide a convenient daily oral treatment," said Elcin Barker Ergun, CEO of the Menarini Group.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.

Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation

Retrieved on: 
Friday, July 21, 2023
Medicine, Neoplasm, European Medicines Agency, Diarrhea, Arthralgia, Doctor of Philosophy, Committee, IRCCS, MD, Patient, Division, Risk, European, Committee for Medicinal Products for Human Use, AST, University of Milano-Bicocca, Fatigue, University, Cholesterol, Constipation, Bone pain, EMA, Vomiting, Back pain, HIV disease progression rates, ALT, Headache, Death, Elacestrant, Civil service commission, Creatinine, Triglyceride, CDK, MBC, Indigestion, SOC, Abdominal pain, PFS, European Institute of Oncology, Menarini, European Commission, CHMP, Thrombosis, Progression-free survival, Anemia, ESR1, Advanced Therapy Medicinal Product, Woman, Periodic breathing, European Institute, Drug development, Nausea, Potassium, ER, Breast cancer, Medical imaging, Pharmaceutical industry, EU

ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.

Key Points: 
  • ORSERDU would be the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
  • "Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options.
  • ORSERDU, if approved, will also provide a convenient daily oral treatment," said Elcin Barker Ergun, CEO of the Menarini Group.
  • The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.