Lupin Ltd on Wednesday said it has signed a $700 million licensing, development and commercialization agreement with German drugmaker Boehringer Ingelheim to develop a new drug for patients suffering from difficult-to-treat cancers.
While Lupin will receive an upfront payment of $20 million, additional payments of more than $700 million would be based on successful achievement of agreed clinical, regulatory and commercial milestones. Lupin would also be entitled to receive double-digit royalties on the sales of the product, the company said in a statement.
“With the success of our second new drug discovery program in oncology, we have made a significant mark in bringing novel treatments to patients. Lupin’s MEK Inhibitor program successfully cleared early clinical stages, demonstrating our capabilities in delivering world class innovation," said Nilesh Gupta, managing director of Lupin.
The firm is looking to develop its MEK inhibitor compound in combination with one of Boehringer Ingelheim’s Kirsten rat sarcoma viral oncogene homolog (KRAS) inhibitors for gastrointestinal and lung cancer patients that have a broad range of oncogenic KRAS mutations.
KRAS mutations occur in one in seven of all human metastatic cancers making it the most frequently mutated cancer-causing gene, with mutation rates of more than 90% in pancreatic cancers, more than 40% in colorectal cancers and more than 30% in lung adenocarcinomas, the statement said.
The move is part of Lupin’s novel drug discovery and development team’s efforts to build a pipeline of drugs in multiple therapeutic areas such as oncology, immunology and metabolic disorders. Lupin’s Novel Drug Discovery and Development (NDDD) activities were started in 2010 with the vision to use cutting-edge research in bringing new molecules that address unmet medical needs in multiple therapeutic areas to market globally.
“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 presently have limited treatment options available," said Norbert Kraut, head of global cancer research at Boehringer Ingelheim.
The deal follows Lupin’s licensing pact worth $947 million with biopharmaceutical firm AbbVie Inc. last December, to develop and commercialize Lupin’s MALT1 inhibitors for treatment of hematological cancers. It was then agreed that Lupin would receive an upfront payment of $30 million for an exclusive license to the programme.
Lupin was also entitled to receive a double-digit royalty on sales of the product and will retain commercial rights to the programme in India. MALT1 is a protein involved in T-cell and B-cell lymphocyte activation and AbbVie partnered with Lupin to develop it for a range of hematological cancers, many with limited current treatment options.
Boehringer Ingelheim focuses on three business areas: human pharmaceuticals, animal health and biopharmaceuticals.
In 2018, it reported net sales of nearly €17.5 billion.
“The success of our second NDDD program in oncology has added to our confidence in bringing highly differentiated and best-in-class innovation from India for patients globally. Carrying forward our founder, Dr Desh Bandhu Gupta’s dream in shaping true innovation, we have delivered a novel treatment from conceptualization to clinical stage development with promising results that can be a potential combination treatment for precision oncology," said Raj Kamboj, president of Lupin’s NDDD.