MENARINI GROUP


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Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting

Retrieved on: 
Thursday, May 23, 2024

Both the ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms observed in estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC) and improve patient outcomes through novel oral-oral combination treatment options.

Key Points: 
  • Both the ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms observed in estrogen receptor-positive (ER+), HER2-negative (HER2-) metastatic breast cancer (mBC) and improve patient outcomes through novel oral-oral combination treatment options.
  • Data will be presented at the 2024 American Society of Clinical Oncology (ASCO), on June 2 from 9 a.m. to 12 p.m. CT.
  • Phase 2 for the combination of elacestrant and abemaciclib in ER+, HER2- metastatic breast cancer, irrespective of the metastatic site, is already ongoing.
  • “The data we are presenting at ASCO highlight elacestrant’s potential to further enhance patient outcomes when combined with other compounds.”

New England Journal of Medicine Publishes Positive Results of Cefepime-Taniborbactam from Phase 3 CERTAIN-1 Study of Patients with Complicated Urinary Tract Infection

Retrieved on: 
Tuesday, February 20, 2024

Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.

Key Points: 
  • Venatorx Pharmaceuticals, Melinta Therapeutics LLC (“Melinta”), and Menarini Group today announced that The New England Journal of Medicine (NEJM) published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections (cUTI) and acute pyelonephritis (AP), including those with bacteremia.
  • The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem.
  • This press release features multimedia.
  • View the full release here: https://www.businesswire.com/news/home/20240220917017/en/
    “Gram-negative infections such as cUTI have become increasingly difficult to treat due to acquired bacterial resistance to multiple classes of antibiotics.

Venatorx Pharmaceuticals and Menarini Group Enter Commercial Agreement for Cefepime-Taniborbactam in 96 Countries

Retrieved on: 
Tuesday, January 9, 2024

Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, and Menarini Group, an Italian biopharmaceutical group, today announced that they have entered into an agreement under which Menarini will acquire the exclusive rights to commercialize, upon approval of relevant health authorities, cefepime-taniborbactam in 96 countries in Europe, Latin America, Middle East, Turkey and North Africa and the Commonwealth of Independent States (CIS).

Key Points: 
  • Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, and Menarini Group, an Italian biopharmaceutical group, today announced that they have entered into an agreement under which Menarini will acquire the exclusive rights to commercialize, upon approval of relevant health authorities, cefepime-taniborbactam in 96 countries in Europe, Latin America, Middle East, Turkey and North Africa and the Commonwealth of Independent States (CIS).
  • Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
  • “With its global commercial infrastructure and significant experience in commercializing infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets,” said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
  • “By leveraging our expertise and Menarini’s expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization, upon approval of relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine across our global footprint.”

Venatorx Pharmaceuticals and Menarini Group Enter Commercial Agreement for Cefepime-Taniborbactam in 96 Countries

Retrieved on: 
Tuesday, January 9, 2024

Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.

Key Points: 
  • Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
  • "With its global commercial infrastructure and significant experience in commercializing infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets," said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
  • "At Menarini, we believe that the addition of cefepime-taniborbactam expands our existing AMR anti infectives portfolio and provides the opportunity to further strengthen our building of an important antibiotics portfolio focused on the critical pathogens responsible for the vast majority of antibiotic resistance" said Elcin Barker Ergun, CEO of the Menarini Group.
  • "By leveraging our expertise and Menarini's expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization, upon approval of relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine across our global footprint."

Venatorx Pharmaceuticals and Menarini Group Enter Commercial Agreement for Cefepime-Taniborbactam in 96 Countries

Retrieved on: 
Tuesday, January 9, 2024

Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.

Key Points: 
  • Under the terms of the agreement, Venatorx will receive an upfront licensing fee, additional R&D, regulatory, and sales-based milestone payments, and potential royalty payments based on a percentage of net sales.
  • "With its global commercial infrastructure and significant experience in commercializing infectious disease products, including antibiotics, Menarini is ideally positioned to bring cefepime-taniborbactam to key geographic markets," said Christopher J. Burns, Ph.D., Chief Executive Officer of Venatorx.
  • "At Menarini, we believe that the addition of cefepime-taniborbactam expands our existing AMR anti infectives portfolio and provides the opportunity to further strengthen our building of an important antibiotics portfolio focused on the critical pathogens responsible for the vast majority of antibiotic resistance" said Elcin Barker Ergun, CEO of the Menarini Group.
  • "By leveraging our expertise and Menarini's expansive commercial infrastructure, we will provide the resources needed to optimize the commercialization, upon approval of relevant health authorities, of cefepime-taniborbactam and ensure patient access to this medicine across our global footprint."

Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications

Retrieved on: 
Thursday, January 4, 2024

Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.

Key Points: 
  • Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
  • This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
  • Breast cancer is the most commonly diagnosed tumor type and the leading cause of cancer death among women, globally.
  • Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.

Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications

Retrieved on: 
Thursday, January 4, 2024

Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.

Key Points: 
  • Insilico presented data on the novel molecule at the San Antonio Breast Cancer Symposium in early December.
  • This agreement includes upfront and milestone payments with a combined potential value of over $500m and sales royalties.
  • Breast cancer is the most commonly diagnosed tumor type and the leading cause of cancer death among women, globally.
  • Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.

Menarini Group and Insilico Medicine Enter Global Exclusive License Agreement for Novel KAT6 Inhibitor for Potential Breast Cancer Treatment and Other Oncology Indications

Retrieved on: 
Thursday, January 4, 2024

This is a significant clinical challenge and highlights the urgent need for novel therapies to help overcome treatment resistance.

Key Points: 
  • This is a significant clinical challenge and highlights the urgent need for novel therapies to help overcome treatment resistance.
  • Overexpression of KAT6A correlates with poor clinical outcomes in patients with ER+/HER2- breast cancer, the most common subtype of breast cancer.
  • Insilico presented data on the molecule at the San Antonio Breast Cancer Symposium in early December.
  • Currently, endocrine therapy in combination with CDK4/6 inhibitors is the standard treatment for ER+/HER2- breast cancer patients with advanced or metastatic disease.

Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Monday, December 11, 2023

Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.

Key Points: 
  • Both the ELEVATE and ELECTRA studies were designed with the objective to overcome different resistance mechanisms and enhance patient outcomes with combination treatment options.
  • Data was presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • The ELEVATE study is evaluating elacestrant in combination with inhibitors of the PI3K/AKT/mTOR pathway (everolimus and alpelisib) and cell-cycle pathway inhibitors (palbociclib, ribociclib, and abemaciclib).
  • Additional cohorts are currently under evaluation to assess pharmacokinetics (PK) and determine the recommended phase 2 dose (RP2D) for each combination.

Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023

Retrieved on: 
Friday, December 8, 2023

This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.

Key Points: 
  • This data is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), December 5-9, 2023.
  • ESR1 mutations are present in up to 40% of ER+, HER2- advanced or mBC.
  • “At Menarini Stemline our goal is to provide transformational treatments to help extend and improve the lives of people living with cancer.
  • See here for details of the Menarini Group/Stemline Therapeutics' full range of presentations at SABCS 2023.