The future of Biogen's MS drug Tecfidera?
Tecfidera was approved in April 2013, hitting the market behind Novartis' ($NVS) Gilenya and Sanofi's ($SNY) Aubagio but quickly surpassing them in sales. Then in October 2014, Biogen reported the death of a Tecfidera patient suffering from progressive multifocal leukoencephalopathy (PML), a rare brain infection. After the FDA added that information to the drug's official label, sales of the drug lost momentum.
The Motley Fool had some comments on Biogen's MS drugs:
In the treatment of multiple sclerosis, there's long been a dichotomy between safety and efficacy. Tecfidera hit the ground running because it offered an unprecedented combination of both. That notion took a tumble last year, along with its growth rate, when it was associated with multiple cases of PML, a deadly brain infection not uncommon among more potent MS therapies. The FDA has added PML to Tecfidera's list of warnings and precautions, and last year sales of the oral MS therapy grew just 25%, much slower than the market had been expecting.
Luckily, the warning on Tecfidera's label isn't of the black-box variety, the FDA's most severe. Unfortunately for Biogen, a possibly larger threat to its main growth driver is in late-stage development. Although Tecfidera's pill form does improve patient compliance, Roche has a injectable multiple sclerosis candidate, ocrelizumab, that could slow Tecfidera's growth even further, as it might only require administration once every six months.
As to administration, Tecfidera (whose chemical identity is simply methyl esters of fumaric acid) is oral, while ocrelizumab is a monoclonal antibody, to be administered by infusion.
Kyle Bass challenged certain patents related to Tecfidera.
http://ipbiz.blogspot.fr/2015/09/ptab-declines-to-institute-ipr-against.html, including the text:
One notes that if a study showed a product containing a mixture of fumaric acid
esters reduced the number of gadolinium-enhancing (Gd+) lesions in
patients with RRMS , then therapeutic effectiveness
has been established. The Kappos people had already found --a therapeutically effective amount--.
Optimizing amounts when the effect is demonstrated is usually considered "obvious."
MRI measurements are standards used by the FDA to judge effectiveness for many
disease-modifying MS drugs. [note: the "gadolinum" refers to an MRI scan technique,
including paramagnetic gadolinium, which is sensitive to newly-formed lesions;
this is related to the NMR relaxation time T1, and is distinct from MRI measures
related to T2, which are not necessarily solely related to "newly-formed" lesions]
Separately, from Blawgsearch on March 12, 2016: