S. Harachand, Contributing Editor10.15.19
Research and development is back in the news in the Indian pharma sector after a protracted lull.
Making a big splurge into the oncology segment, Lupin announced a licensing deal with Germany’s Boehringer Ingelheim in September to develop and commercialize one of the company’s lead MEK inhibitors.
This class of drugs is currently approved for treating certain variants of melanoma in combination with other agents. Several MEK inhibitors are under clinical evaluation for their efficacy in different cancer types.
Lupin’s MEK candidates have shown preclinical activity both as a single agent and in combination. In addition, they have demonstrated early clinical benefit in a small subset of patients, according to a company statement.
The new partnership will see Lupin’s LN3794 clinically validated in combination with Boehringer’s innovative KRAS inhibitors for patients with gastrointestinal and lung cancers harboring a broad range of oncogenic KRAS mutations.
The complementary mechanisms of action of KRAS inhibitors with MEK drugs results in increased anti-tumor activity keeping KRAS-driven cancers in check, based on preclinical data. According to Norbert Kraut, head of global cancer research at Boehringer Ingelheim, the drugs are expected to provide “more effective and durable responses for patients with cancers driven by activated KRAS who currently have limited treatment options available.”
The deal will bring an upfront payment of $20 million to Lupin as well as potential additional payments for successful achievement of defined clinical, regulatory and commercial milestones for a total value of more than $700 million.
Meanwhile, the deal entitles Boehringer with the global rights to commercialize the drug except in India. Lupin will receive double-digit royalties on the sales of the product.
Last December, Lupin started a similar collaboration with U.S.-headquartered AbbVie to develop and commercialize its Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1 (MALT1) inhibitors as novel treatments for hematological cancers. AbbVie licensed exclusive global rights to Lupin’s MALT1 inhibitor program. MALT1 protein is involved in the activation of T-cell and B-cell lymphocytes.
Under the terms of the agreement, Lupin is eligible to receive total milestone payments of up to $947 million. The Mumbai-based firm has received an upfront payment of $30 million.
The high-stakes discovery research gamble has never been a priority area for most of the Indian generic players. Of course, a few among them did venture out into the arena of discovery research with partial success.
Interestingly, some of the leading players have suddenly wanted to accelerate their drug discovery efforts and started building a robust research pipeline, along the lines of Lupin.
Sun Pharma’s recent tie-up with HitGen is a case in point. Sun Pharma Advanced Research Company (SPARC) entered into a pact with the Chinese biotech firm in March to pursue small molecule leads. HitGen uses a platform technology based on DNA-encoded library design, synthesis and screening to identify novel leads. The technique is found to be capable of yielding huge numbers of DNA-encoded molecules, with each compound screened against protein targets for strong binding properties.
Diversity of compounds coupled with quick turnaround time and relatively lower costs makes HitGen’s DNA-encoded chemistry an attractive proposition to pharma companies.
Under this collaboration, HitGen will discover novel leads for SPARC and receive upfront and milestone payments.
Firms that do not have a direct stake in discovery research are now intensifying their pursuit in R&D, reports show.
Aurobindo Pharma, for example, has decided to spend over 5 percent of its sales value on R&D for the current financial year 2019-20. The Hyderabad-based drug manufacturer, which raked in annual sales revenue of $2.6 billion in 2017-18, invested 4.5% of its turnover in R&D last fiscal. Aurobindo is planning to boost its biosimilar development program in addition to formulations and API research.
In a related development, AstraZeneca opened a development operations center in Bangalore to support clinical research in India. The center, which was opened in May, will support the development of AstraZeneca’s innovative medicines and host clinical trial experts focused on core therapeutic areas such as oncology, cardio-vascular, renal and metabolism, and respiratory, said a company release. The facility can handle 20 studies across 150 sites.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
Making a big splurge into the oncology segment, Lupin announced a licensing deal with Germany’s Boehringer Ingelheim in September to develop and commercialize one of the company’s lead MEK inhibitors.
This class of drugs is currently approved for treating certain variants of melanoma in combination with other agents. Several MEK inhibitors are under clinical evaluation for their efficacy in different cancer types.
Lupin’s MEK candidates have shown preclinical activity both as a single agent and in combination. In addition, they have demonstrated early clinical benefit in a small subset of patients, according to a company statement.
The new partnership will see Lupin’s LN3794 clinically validated in combination with Boehringer’s innovative KRAS inhibitors for patients with gastrointestinal and lung cancers harboring a broad range of oncogenic KRAS mutations.
The complementary mechanisms of action of KRAS inhibitors with MEK drugs results in increased anti-tumor activity keeping KRAS-driven cancers in check, based on preclinical data. According to Norbert Kraut, head of global cancer research at Boehringer Ingelheim, the drugs are expected to provide “more effective and durable responses for patients with cancers driven by activated KRAS who currently have limited treatment options available.”
The deal will bring an upfront payment of $20 million to Lupin as well as potential additional payments for successful achievement of defined clinical, regulatory and commercial milestones for a total value of more than $700 million.
Meanwhile, the deal entitles Boehringer with the global rights to commercialize the drug except in India. Lupin will receive double-digit royalties on the sales of the product.
Last December, Lupin started a similar collaboration with U.S.-headquartered AbbVie to develop and commercialize its Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1 (MALT1) inhibitors as novel treatments for hematological cancers. AbbVie licensed exclusive global rights to Lupin’s MALT1 inhibitor program. MALT1 protein is involved in the activation of T-cell and B-cell lymphocytes.
Under the terms of the agreement, Lupin is eligible to receive total milestone payments of up to $947 million. The Mumbai-based firm has received an upfront payment of $30 million.
The high-stakes discovery research gamble has never been a priority area for most of the Indian generic players. Of course, a few among them did venture out into the arena of discovery research with partial success.
Interestingly, some of the leading players have suddenly wanted to accelerate their drug discovery efforts and started building a robust research pipeline, along the lines of Lupin.
Sun Pharma’s recent tie-up with HitGen is a case in point. Sun Pharma Advanced Research Company (SPARC) entered into a pact with the Chinese biotech firm in March to pursue small molecule leads. HitGen uses a platform technology based on DNA-encoded library design, synthesis and screening to identify novel leads. The technique is found to be capable of yielding huge numbers of DNA-encoded molecules, with each compound screened against protein targets for strong binding properties.
Diversity of compounds coupled with quick turnaround time and relatively lower costs makes HitGen’s DNA-encoded chemistry an attractive proposition to pharma companies.
Under this collaboration, HitGen will discover novel leads for SPARC and receive upfront and milestone payments.
Firms that do not have a direct stake in discovery research are now intensifying their pursuit in R&D, reports show.
Aurobindo Pharma, for example, has decided to spend over 5 percent of its sales value on R&D for the current financial year 2019-20. The Hyderabad-based drug manufacturer, which raked in annual sales revenue of $2.6 billion in 2017-18, invested 4.5% of its turnover in R&D last fiscal. Aurobindo is planning to boost its biosimilar development program in addition to formulations and API research.
In a related development, AstraZeneca opened a development operations center in Bangalore to support clinical research in India. The center, which was opened in May, will support the development of AstraZeneca’s innovative medicines and host clinical trial experts focused on core therapeutic areas such as oncology, cardio-vascular, renal and metabolism, and respiratory, said a company release. The facility can handle 20 studies across 150 sites.
S. Harachand
Contributing Editor
S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at harachand@gmail.com.
