Late-stage research and development pipeline
At the end of 3Q15, Biogen (BIIB) had a strong late-stage research and development (or R&D) pipeline. Biogen has five investigational medicines in phase three clinical trial phase, targeting diseases such as Alzheimer’s, spinal muscular atrophy, secondary progressive multiple sclerosis, and diffuse large B-cell lymphoma.
The above diagram shows Biogen’s investigational drugs, which are currently in phase three clinical trials. As discussed in the previous article, Zinbryta is currently under US Food and Drug Administration (or FDA) review.
On September 8, 2015, Biogen announced the enrollment of its first patient in the phase three program for its early stage Alzheimer’s drug, Aducanumab. The phase three program consists of two studies, ENGAGE and EMERGE. On July 22, 2015, Biogen (BIIB) presented mixed interim results from its phase 1b PRIME study for its experimental Alzheimer’s drug BIIB037.
Though results were less positive than investors had expected, the drug continues to be a major part of Biogen’s research and development strategy. This novel therapy aims to cure Alzheimer’s disease. Other medications currently available in the market such as Allergan’s (AGN) Namenda, Aricept, which is co-promoted by Pfizer (PFE) under a license from Eisai, and Novartis’s (NVS) Exelon help only to reduce the severity of Alzheimer’s symptoms. Thus, if approved, Aducanumab is expected to become a blockbuster therapy. To find out more about the results of the PRIME study, please refer to Biogen Presents Data from PRIME Study of Its Alzheimer’s Therapy.
In addition to Aducanumab, Biogen is also involved in other early stage research programs such as BAN2401 and E2609 in collaboration with Eisai to develop a cure for Alzheimer’s disease.
Multiple sclerosis therapy
Currently marketed as Tysabri for relapsing-remitting multiple sclerosis, Natalizumab is also being explored for treating patients suffering from secondary-progressive multiple sclerosis (or SPMS). The results of this ASCEND study are pending.
Biogen is developing ISIS-SMNrx, a spinal muscular atrophy therapy, in collaboration with Isis Pharmaceuticals. Additionally, the company is also exploring Obinutuzumab in collaboration with Genentech, a subsidiary of Roche Holdings, for indolent non-Hodgkin’s lymphoma and diffuse large B-cell lymphoma. Both the diseases are types of cancer of the immune system.
Instead of directly investing in Biogen and being exposed to excessive company-specific risks, you can invest in the company through the Health Care Select Sector SPDR ETF (XLV). Biogen accounts for 2.5% of XLV’s total holdings.