Interest in Biogen lately has focused on its new Alzheimer’s disease drug, but multiple sclerosis medicines still fill the company’s portfolio and account for the bulk of its revenue. Generics, however, are eroding sales of Biogen’s top MS medicine, so the company is reaching overseas to acquire a brain-penetrating molecule that could become its next big MS therapy.
Biogen has agreed to pay $125 million for the rights to orelabrutinib, a clinical-stage drug from Beijing-based InnoCare Pharma. The deal gives Biogen the right to develop the oral drug for MS and other autoimmune diseases globally, excluding China, Hong Kong, Macau, and Taiwan, where InnoCare retains rights.
Depending on Biogen’s progress developing the drug in the rest of the world, the Cambridge, Massachusetts-based company could hand its partner up to $812.5 million in milestone payments. InnoCare would also receive royalties from Biogen’s sales of the drug—if it reaches the market.
MS is an autoimmune disorder in which the immune system attacks myelin, the protective layer covering nerve cells. The disease is categorized into different types. InnoCare has been developing its drug for the relapsing-remitting form of the disease, which is characterized by attacks of neurological symptoms followed by a period of remission. That’s the same form of the disease that Biogen’s top-selling drug, Tecfidera, is approved to treat. Tecfidera generated $3.9 billion in global sales last year, a 12.1% decrease compared to sales in the prior year. The company has attributed the revenue decline to the multiple generic competitors entering the market.
InnoCare’s orelabrutinib is a small molecule designed to block Bruton’s tyrosine kinase (BTK), an enzyme that’s part of the signaling cascade of immune cells. BTK plays a role in the signaling that leads to the proliferation and survival B cells, a type of immune cell. The enzyme is also key to the signaling of myeloid cells, which are a different type of immune cell. The drug has the ability to cross the blood brain barrier, giving it the potential to block immune cells in the central nervous system and on the periphery of the CNS. According to Biogen, the drug may be able to treat all forms of MS. InnoCare is currently testing the drug in a global Phase 2 clinical trial.
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.
In acquiring the InnoCare drug, Biogen will try to catch other companies that are developing BTK-blocking therapies for MS. After Principia Biopharma reached Phase 3 testing with its brain-penetrating, BTK-blocking small molecule last year, partner Sanofi agreed to a nearly $3. 7 billion deal to acquire the biotech. Merck KGaA has reached Phase 3 testing of evobrutinib, a small molecule that’s also designed to penetrate the brain to block BTK. But Biogen believes that the InnoCare drug can stand out among BTK-blocking therapies.
“Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTKi programs,” Alfred Sandrock, Biogen’s head of research and development, said in a prepared statement.
Orelabrutinib is already available in China, but as a cancer therapy. Chinese regulatory authorities have approved the drug for chronic lymphocytic leukemia and small lymphocytic lymphoma, as well as for treating mantle cell lymphoma.
Public domain image by Flickr user affen ajlfe
