Sun Pharma partner Philogen withdraws EU application for skin cancer drug

Experts believe that the drug still holds potential for future market entry, and the current development should be viewed as a temporary setback

Sun Pharmaceutical’s European partner Philogen S.p.A has voluntarily withdrawn its marketing authorisation application for its investigational skin cancer therapy Nidlegy in the European Union (EU). The decision comes a year after the application was submitted to the European Medicines Agency (EMA) for the treatment of locally advanced, fully resectable melanoma.

 

Analysts believe while this development may not have any immediate financial repercussions for Sun Pharma, it could influence the company’s long-term strategic positioning, particularly in the European and Australian markets.

 

“The timing of this development is also unfavourable for the company, considering the setback earlier this month when another investigational drug, SCD-44, failed to meet efficacy expectations, resulting in an 18 per cent decline in the company’s stock price,” stated Nilaya Varma, group CEO and cofounder, Primus Partners.

 

The stock remained stable on Wednesday. It ended the day's trade on the BSE flat at ₹1,668 apiece.

 

Philogen, a biotech firm headquartered in Siena, Italy, announced that the withdrawal was due to the unavailability of certain Chemistry Manufacturing and Controls (CMC) and clinical data within the EMA’s stipulated timeframe. The company, however, emphasised its intention to make the therapy available as it continued to interact with the EMA and with the medical community.

 

Nidlegy, also known as Daromun, is a biologic product composed of two pro-inflammatory cytokines that targets tumors using a proprietary antibody. It was evaluated in a Phase-III international trial involving 256 patients across 22 sites in Europe. The trial showed that the drug reduced the risk of relapse or death by 41 per cent compared to standard-of-care surgery alone. The safety profile was primarily characterised by low-grade local adverse events.

 

As Philogen intends to resubmit the application for Nidlegy, experts further believe that the drug still holds potential for future market entry, and the current development should be viewed as a temporary setback. “Other drugs in the pipeline like Fibromun (L19TNF), which has completed two phases of clinical trials, present a promising development for Sun Pharma’s expansion of oncology portfolio,” Varma further added. 

 

“There is no approved therapy in the neoadjuvant setting for locally advanced, fully resectable melanoma. The promising data from our trial strengthens our belief in Nidlegy's potential,” said Dario Neri, CEO of Philogen. “We are working closely with EMA and plan to resubmit an updated application soon,” he said.

 

Philogen’s candidate Nidlegy is licensed to Sun Pharma for the treatment of skin cancers in Europe, New Zealand, and Australia.

 

To date, more than 450 patients with various skin cancers have received Nidlegy. Besides melanoma, the therapy is also being studied in Phase-II trials for high-risk basal cell carcinoma, and other non-melanoma skin cancers.

 

Philogen’s therapeutic strategy centers around using targeted ligands to deliver potent anti-tumor agents to cancerous tissue while sparing healthy cells. The company operates from Siena, with a research subsidiary in Zurich, Switzerland.

 

Sun Pharma, India’s largest drugmaker by market capitalisation, has been actively expanding its oncology pipeline through partnerships and in-licensing deals as it seeks to strengthen its specialty and biologics portfolio globally.