INDIA – Mumbai-based drug maker Lupin has scooped up an additional US$25 million from AbbVie to fast-track the success of its novel MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program.

This capital injection comes shortly after Lupin and AbbVie entered into an exclusive licensing, development, and commercialization agreement involving Lupin’s novel MALT1 inhibitor program.

Lupin’s proprietary MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program is a protein involved in T-cell and B-cell lymphocyte activation.

Lupin is eligible to get up to US$947 million in milestone payments as part of this exclusive licensing, development, and commercialization agreement.

The company is also entitled to receive a double-digit royalty on the sales of the product and retain commercial rights to the program in India.

As part of the agreement, Lupin has received an additional US$25 million from AbbVie for the initiation of Phase 1 clinical studies successfully.

Lupin has now raised a total of US$55 million from AbbVie to advance research in its proprietary MALT1 program aimed at developing new treatments for various hematological cancers.

In a press release, Nilesh Gupta, Managing Director of Lupin said: “This achievement is another validation of our ability to successfully develop novel treatments for unmet needs.”

AbbVie already made an upfront payment of US$30 million to Lupin for this proprietary MALT1 inhibitor program targeting a range of hematological cancers.

The additional US$25M million-dollar raise is critical operating capital to accelerating the success of Lupin’s novel MALT1 inhibitor program in clinical studies.

Lupin’s Novel Drug Discovery and Development (NDDD) team is focused on building a pipeline of highly differentiated and innovative new chemical entities in the oncology space.

“We look forward to the continued successful development of this important treatment for patients with difficult-to-treat cancers,” underscored Nilesh Gupta.

Through this partnership, AbbVie had exclusive global rights to develop and commercialize Lupin’s MALT1 inhibitors.

It aligns with AbbVie’s strategic objectives to pursue drug development across a range of hematological cancers with limited treatment options.

The partnership also comes as part of Lupin’s strategies to develop and deliver a wide range of branded and generic formulations, biotechnology products, and APIs globally.

US FDA clears Lupin’s Somerset manufacturing facility

In another significant milestone, the U.S. FDA has cleared Lupin’s manufacturing facility in Somerset County, New Jersey for commercial production of its Abbreviated New Drug Application for Cyanocobalamin Nasal Spray.

Lupin’s Cyanocobalamin Nasal Spray is currently available in the strength of 500 micrograms in one spray per bottle.

Cyanocobalamin Nasal Spray under the brand name RLD Nascobal is used to treat patients with vitamin B12 deficiency.

It is the therapeutic equivalent generic version of Nascobal Nasal Spray, which is a 500 mcg/spray manufactured by Par Pharmaceutical, a wholly owned Endo business.

Following the FDA approval, Lupin will begin commercial production of its Cyanocobalamin Nasal Spray at its manufacturing facility located in Somerset County.

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