Philogen, Sun Pharma Announce EMA Validates Nidlegy Marketing Authorization Application

Philogen, Sun Pharma Announce EMA Validates Nidlegy Marketing Authorization Application

By, Admin 5 July 2024

Overview

Philogen S.p.A. (BITHIL) and Sun Pharmaceutical Industries Limited announce that on June 20th the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy, which was finalized on June 3rd.

Words from CEO: Philogen

  • The validation of the dossier by EMA represents the first important milestone for the MAA review process,"" commented Dario Neri, chief executive officer and chief scientific officer at Philogen. 
  • Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy available to patients in need."" 
  • Nidlegy is partnered with Sun Pharma for the treatment of Skin Cancers in Europe, New Zealand and Australia.

 About Nidlegy

  • • Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. 
  • It consists of two active ingredients, L19IL2 and L19TNF. 
  • The two ingredients are manufactured independently and mixed prior to intralesional administration. 
  • The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumours (and other diseases) but absent in most healthy tissues. 
  • Interleukin 2 (IL2) and Tumour Necrosis Factor (TNF) are pro-inflammatory cytokines with a potent anti-tumour activity. 
  • Nidlegy is currently being investigated in two phase III clinical trials for the treatment of locally advanced melanoma, and in phase II clinical trials for the treatment of High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

 Phase III Study

  • Phase III study PIVOTAL is a phase III, international, multi-centre, randomized, comparator-controlled, parallel-group study evaluating the efficacy and safety of intratumoral injections of Nidlegy as a neoadjuvant treatment, followed by standard-of-care treatment (surgery), as opposed to standard-of-care treatment (i.e., surgery alone), in melanoma patients with locally advanced, fully resectable cutaneous, sub-cutaneous (including satellite/in transit metastases), or nodal metastases accessible to intratumoral injection. 
  • For both arms, adjuvant treatment with approved drugs was allowed. Nidlegy was injected intralesionally up to four times, once a week, before surgery. 
  • The trial enrolled 256 patients in Europe across 22 clinical centers in Germany, Italy, France and Poland.

 About Melanoma

  • Melanoma is a skin tumour which begins when melanocytes start growing without control. 
  • Melanocytes are found in the basal layer of the epidermis at the boundary with the next layer (the dermis). 
  • Locally advanced melanoma is a metastatic cancer in which neoplastic lesions have spread to drainage areas of regional lymph nodes and can appear as micrometastases, satellite/in transit metastases, and/or lymph node metastases. 
  • To date, patients with resectable disease receive surgery, possibly followed by approved adjuvant systemic therapies. 
  • There is no approved drug for the treatment of locally advanced fully resectable melanoma in the neoadjuvant setting.

 About Philogen

  • Philogen is an Italian-Swiss biotechnology company specialized in the research and development of innovative pharmaceuticals for the treatment of cancer. 
  • The Group's main therapeutic strategy is based on the use of ligands capable to selectively deliver potent payloads (such as pro-inflammatory cytokines, drugs or radionuclides) to the tumour mass, sparing healthy tissues.

 About Sun Pharma

  • Sun Pharma is the world’s leading specialty generics company with presence in specialty, generics and consumer healthcare products. 
  • It is the largest pharmaceutical company in India and is a leading generic company in the US as well as global emerging markets.

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