Lead Pharma Teams with Roche on Oral Small Molecules for Immune-Mediated Diseases

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Lead Pharma has entered into a collaboration and license agreement with Roche, hoping to lead the way in the development of oral small molecules for immune-mediated diseases like rheumatoid arthritis, psoriasis and inflammatory bowel diseases. 

Located in Oss, the Netherlands, Lead Pharma is a clinical-stage biopharmaceutical company focused on the development of novel small-molecule therapies for patients suffering from autoimmune diseases (a subset of immune-mediated diseases) and cancer. 

The agreement encompasses Lead Pharma’s entire pipeline. This includes therapies against the nuclear receptor RORγt, which drives the production of key pro-inflammatory proteins, and the estrogen-related receptor α (ERRα), the upregulation of which is responsible for the poor prognosis, recurrence and metastasis of cancers including melanoma, breast and colon cancer.

Under the $308 million (€260 million) license deal, the two companies will work together up to the selection of a pre-clinical candidate, at which point Roche will take over the further development and global commercialization efforts. 

“Our ambition is to develop life-changing treatments for patients. We are delighted to team up with Roche to pursue this goal,” said Lead Pharma CEO Frans van den Berg. “Partnering is a key element of our strategy, this collaboration is yet another validation of the value of Lead Pharma’s innovation power.”

In 2015, Lead Pharma partnered with Sanofi to develop and commercialize small-molecule therapies against RORγt for the treatment of autoimmune diseases, which occur when the body’s immune system attacks its own cells and tissues as foreign invaders. 

While the antibody responsible for immune-mediated diseases is yet to be identified, they are thought to be regulated by an aberrant immune response. The four primary forms of immune-mediated disease are hypersensitivity, autoimmunity, immunodeficiency, and immune system neoplasia. Humans as well as cats and dogs can be affected. 

Under the terms of the agreement, Lead Pharma will receive a €10m upfront payment and be eligible for research funding along with pre-clinical milestone payments.

“We are committed to advancing innovative science and transformative medicines for people affected by different immune-mediated diseases,” said Roche Pharma Global Head of Partnering, Dr. James Sabry. “We are looking forward to further building on our expertise in this field and collaborating with Lead Pharma, aiming to make a difference for those patients.”

Depending upon the attainment of various research, development, regulatory, and sales milestones, Lead Pharma stands to collect €260m, in addition to royalties from global sales.

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