Drugmaker Lupin has formalised a licensing agreement with Boehringer Ingelheim (BI) to develop and commercialise a novel cancer drug in a deal valued at $700 million.

The partnership looks to develop a targeted therapy involving Lupin’s MEK inhibitor compound in combination with one of BI’s KRAS inhibitors for patients with gastrointestinal and lung cancer that shows KRAS mutations, said a Lupin note.

The KRAS gene provides instructions for making a protein called K-Ras that is part of a signalling pathway that instructs a cell to grow and divide (proliferate) or mature and take on specialised functions (differentiate), explains the US National Library of Medicine.

Preclinical data have shown that the combination of BI’s KRAS inhibitors with MEK inhibitors resulted in increased anti-tumour activity that helped keep KRAS-driven cancers in check, Lupin added.

Upfront payment

The deal is Lupin’s second deal in less than a year, and the Mumbai-based drugmaker will get an upfront payment of $20 million this quarter, said Managing Director Nilesh Gupta. The first one could be labelled luck, but a second in quick succession is a validation of the company’s drug discovery programme, he added.

Last December, Lupin and AbbVie had announced a partnership to develop and commercialise Lupin’s novel oncology drug to treat haematological cancers — a $947-million deal with a $30-million upfront payment.

In the BI partnership, the combined targeted therapy product will enter the process of clinical trials where it is tested for safety and efficacy, among others. It will be a BI-led trial, said Gupta, with milestone payments over the years as the trial achieves its clinical and regulatory benchmarks. The deal valuation does not include “double digit” royalty payments that Lupin will get on the sale of the product, he added.

Raj Kamboj, Lupin President (Novel Drug Discovery and Development), said the targeted treatment looks to address an unmet medical need, and hence, the approval processes will be fast-tracked when it came to it.

The entire process will take place over six-seven years, the management said.

“The licensing of Lupin’s novel MEK inhibitor enables us to pair with our innovative KRAS inhibitors to develop new combination treatment concepts providing more effective and durable responses for patients with cancers driven by activated KRAS who currently have limited treatment options available,” said Norbert Kraut, BI’s Head of Global Cancer Research.

The collaboration’s focus would be on patients with gastrointestinal or lung cancers defined by KRAS mutations, sub-populations that currently need more effective therapeutic options. KRAS mutations occur in 1 in 7 of all human metastatic cancers making it the most frequently mutated cancer-causing gene, with mutation rates of more than 90 percent in pancreatic cancers, more than 40 percent in colorectal cancers and more than 30 per cent in lung adenocarcinomas, a Lupin note said.

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