Lupin partners US firm AbbVie for novel oncology drug

India's third largest pharmaceutical company Lupin on Monday said it has licensed out its first-in-class blood cancer drug prospect to US-based biopharma company AbbVie Inc.

Through this deal, AbbVie gains exclusive global rights to develop and commercialise Lupin's MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitors.

MALT1 is a protein involved in T-cell and B-cell lymphocyte activation and AbbVie intends to pursue development across a range of hematological cancers, many with limited current treatment options, the company said in a press statement.

AbbVie intends to pursue development across a range of hematological cancers, many with limited current treatment options.

Under the terms of the agreement, AbbVie will pay Lupin an upfront payment of $30 million for an exclusive licence to the programme. Upon successful completion of regulatory, development and commercial milestones, Lupin is eligible to receive total milestone payments of up to $947 million. Additionally, Lupin will be entitled to receive a double-digit royalty on the sales of the product and will retain commercial rights to the programme in India.

Nilesh Gupta, managing director, Lupin, said it is a "landmark" day for the company. "We are pleased to partner with AbbVie who share a commitment to deliver high-quality medicines in areas that lack approved treatment and have a dire medical need. Their proven success in rapidly commercialising new targeted oncology treatments made them our partner of choice for this program," Gupta said.

However, he did not share details on the amount of spends that will go into developing this compound. "This is early days for us. We have to get development plan in place along with AbbVie," he said.

Raj Kamboj, president of Lupin's Novel Drug Discovery and Development (NDDD), said, "We are delighted with the success of our NDDD program to bring the country's first pharmaceutical innovation in this space. This is a first-in-class drug discovery programme delivered exclusively by Lupin right from concept generation through the various stages of drug discovery and development.

According to him, this product has the potential to go into multiple indications within the haematological cancer. "That will add to the development cost," he said.

Lupin is currently working on two more compounds in the area of solid tumours for indication of non-small cell lung cancer, and chronic kidney disease.

The programme for MALT1 inhibitor was started almost five years ago with a focus to address the unmet medical needs in this certain kind of cancer. According to him, the experimental studies showed a complete "regression" or elimination of all cancer cells. From the conceptualisation till its current development stage, the product has been developed at the company's research and development centre in Pune in the last five years.

Kamboj said the product is in the midst of regulatory investigative new drug (IND) enabling studies. Under IND programme, a pharma company obtains permission to start human clinical trials and to ship an experimental drug to clinical investigators before a marketing application for the drug has been approved.

...& ANALYSIS

• Under the terms of the agreement, AbbVie will pay Lupin an upfront payment of $30 million for an exclusive licence to the programme
   
• Upon successful completion of regulatory, development and commercial milestones, Lupin is eligible to receive total milestone payments of up to $947 million