September 9, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Biogen, Inc., headquartered in Cambridge, Mass., announced today that it licensed MT-1303 from Mitsubishi Tanabe Pharma Corporation, located in Osaka, Japan. MT-1303 is being investigated in a number of autoimmune disorders, including multiple sclerosis (MS), ulcerative colitis, Crohn’s disease and others.
Biogen will obtain worldwide rights to MT-1303, excluding Asia. It will oversee global commercialization as well as development costs outside of Asia. Biogen will pay MTPC $60 million upfront with a possible $484 million in milestone payments. MTPC may also participate in clinical trials worldwide and can co-promote non-MS indications in the U.S.
“Based on compelling efficacy and safety data, we believe that MT-1303 could be a best-in-class S1P modulator,” said Alfred Sandrock, group senior vice president and chief medical officer of Biogen in a statement. “There is a great need for effective oral therapies for the treatment of inflammatory bowel disease and other autoimmune indications, and we are excited to strengthen our late-stage pipeline with this next-generation oral investigational therapy.”
Ben Fidler, writing for Xconomy, speculates that Biogen may have been an unidentified bidder for San Diego-based Receptos , but walked away from the deal. He also points out that licensing MT-1303 is the first strategic action Biogen has made since its sales of Tecfidera (dimethyl fumarate) for MS had mixed results.
As reported in the company’s second quarter financials, Tecfidera revenues were $883 million in 2015’s second quarter, compared to $700 million in the same quarter in 2014. They were made up of $721 million in the U.S. and $163 million outside the U.S. “Tecfidera revenues in the second quarter of 2015 increased 7 percent from $825 million in the first quarter of 2015. In the U.S., Tecfidera revenues increased 11 percent, which was partially offset by an 8 percent decrease outside the U.S. The decrease outside the U.S. was primarily due to lower pricing in Germany, as unit volume increased 14 percent.”
Apparently this made some investors jittery, despite overall volume sales increases. “Tecfidera, which is now the most prescribed oral MS therapy globally, is experiencing moderated patient growth following rapid initial uptake,” said George Scango, company chief executive officer in a statement.
There has been some potentially bad news regarding Tecfidera in terms of safety issues, although the cases reported are somewhat speculative. One patient may have died from a reaction to a common ingredient in the drug, developing treatment-related progressive multifocal leukoencephalopathy (PML). However, she was not receiving Tecfidera, but some of the active ingredients in Tecfidera put together at a compounding pharmacy in Holland.
Another case in November 2014 was reported by the U.S. Food and Drug Administration (FDA) of a patient being treated with Tecfidera developing PML, a very rare condition, and the FDA did indicate that, “It is unknown whether the low lymphocyte count contributed to the development of PML in this patient, or if low lymphocyte counts are a risk factor for PML development in Tecfidera-treated patients.”
Perhaps more notable, Biogen’s Phase Ib clinical trial for aducanumab for Alzheimer’s disease has shown positive data. The study showed reduced amyloid plaque in the brain. Swiss-based Roche has a similar compound, gantenerumb, which has similar activity to aducanumab, but Roche hasn’t had quite as good of results as Biogen’s product in clinical trials.
Receptos was bought by Celgene Corporation for $7.2 billion in July. Included in the acquisition was the drug ozanimod, which is similar to MT-1303 and is being tested for MS and ulcerative colitis and works on the same receptor, sphingosine 1-phosphate (S1P). It’s possible that Biogen’s acquisition of MT-1303 is an attempt to go head-to-head with Celgene. The potential market for the drug or drugs could range from $4 to $6 billion in annual sales.
Fidler speculates that the two companies, Celgene and Biogen could be in a race to see which product can make it to the market first. Celgene’s Phase III trials for ozanimod in MS are expected in 2017 and for ulcerative colitis in 2018. Biogen’s Phase II study of MT-1303 in ulcerative colitis is in progress and could be completed in 2016.
However, Mark Schoenebaum, an analyst with Evercore ISI, thinks that MT-1303 is two to three years behind ozanimod in MS. “We like this deal in that it’s cheap and an obvious strategic fit for Biogen,” Schoenebaum wrote in a research today. “However, we obviously need much more data before including it in our model.”
