Neurocrine Biosciences generates the lion’s share of its revenue from a movement disorders drug, and the biotech has been an active dealmaker as it tries to broaden its portfolio and build up its drug pipeline. In the latest deal, Neurocrine is paying $100 million up front for a portfolio of preclinical and clinical-stage neuroscience compounds, including a lead program ready for Phase 2 testing in schizophrenia.
The upfront cash payment is going to Tokyo-based Sosei Heptares. Neurocrine will also fund a research collaboration in which both companies will work together to advance preclinical candidates through Phase 1 testing. Neurocrine said it plans to study the Sosei Heptares compounds for treating schizophrenia, dementia and other neuropsychiatric disorders. Depending on the progress of those drug candidates, Sosei Heptares could receive up to $1.5 billion in development and regulatory milestone payments. The Japanese company also stands to earn royalties from Neurocrine’s sales of drugs that emerge from the alliance.
The partnered drugs are based on Sosei Heptares’s work developing compounds that target muscarinic receptors. These receptors are key to brain function and have been validated as drug targets in psychosis and cognitive disorders. The receptors M1 through M5 are found in the brain and some peripheral tissues, but the challenge has been developing drugs that can target M4 and M1 receptors without sparking side effects by also activating M2 and M3 receptors.
Sosei Heptares has developed drugs that target the M4 and M1 receptors individually, as well as drugs that target both receptors simultaneously. Sosei Heptares says its drugs can selectively hit these receptors to deliver therapeutic effects. The company also contends its drugs avoid the side effects caused by non-selective drugs as well as the efficacy problems that some older patients can experience with a different class of neuro drugs called positive allosteric modulators.
Neurocrine is licensing the Sosei Heptares drugs after AbbVie gave up its chance to develop them. They were initially partnered with Allergan under an alliance signed in 2016. AbbVie inherited that partnership with its acquisition of Allergan last year. The North Chicago drugmaker pruned a number of Allergan’s drug candidates as it digested the acquisition and the Sosei Heptares alliance was among the programs that did not make the cut. The Japanese company regained full rights to the muscarinic agonist drugs earlier this year.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
According to deal terms announced Monday, Neurocrine gets global rights to Sosei Heptares’ muscarinic receptor agonist drugs. Sosei Heptares retains the rights to develop M1 agonists in Japan in all indications, but Neurocrine has the option to co-develop and co-commercialize these drugs in Japan. The most advanced Sosei Heptares drug covered under the Neurocrine pact is HTL-0016878, a drug that selectively activates M4. Neurocrine said it plans to submit to the FDA an application to begin clinical testing in 2022; a placebo-controlled Phase 2 study in schizophrenia could follow later in the year.
Schizophrenia is also part of a partnership that Neurocrine inked with Takeda Pharmaceutical last year, a deal that spans seven programs from the Japanese pharma giant’s pipeline. Other partnerships that Neurocrine science has added in recent years include agreements with Xenon Pharmaceuticals and Idorsia, both deals covering forms of epilepsy.
Sosei Heptares isn’t the only company with clinical-stage drugs designed to selectively stimulate muscarinic receptors as a way of treating neurological disorders. Anavex Life Sciences has tested its muscarinic receptor agonists in Alzheimer’s disease and frontotemporal dementia. Karuna Therapeutics is developing its lead drug for schizophrenia. Cerevel Therapeutics formed three years ago with drug candidates acquired from Pfizer including an M4-selective drug in development for schizophrenia.
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