Streamlined firm will focus on neurology and aims to launch five new products by 2015.
Biogen Idec will divest or outlicense its oncology assets, terminate its cardiovascular R&D programs, and lose about 13% of its workforce as part of a restructuring effort the firm hopes will save some $300 million a year but still allow it to launch five new products by 2015. The reorganization will also involve consolidation at Biogen Idec’s U.S. sites. The company will relocate its U.S. workforce from six current locations into three existing facilities in Weston and Cambridge, Massachusetts, and Research Triangle Park. Facilities in San Diego, Waltham, MA, and Wellesley, MA, will be closed.
The Biogen Idec that will emerge aims to focus on neurology, but also keep its hand in the hemophilia and immunology fields. The drugs it hopes could potentially reach the market by 2015 include four candidates against MS, one each for hemophilia A and B, and the ALS candidate dexpramipexole, which has recently been taken on by the firm through a partnership with Knopp Pharmaceuticals. Biogen Idec says its overall aim going forward is to exploit strengths in biologics R&D and manufacturing to develop what it calls high-impact biological therapies.
Eleven R&D programs at Biogen Idec are being axed overall, including a number of neurology and immunology development projects, notably neublastin for neuropathic pain and anti-TWEAK. Small molecule discovery and process development efforts will also be significantly reduced.
“Biogen Idec will be “leaner, more nimble, and more decisive,” claims CEO George Scangos, Ph.D. “We have been operating in too many therapeutic areas and haven’t maximized our opportunities. We will now focus on a few areas where we can be among the best, and this starts with neurology. We also have some excellent programs in hemophilia and immunology and will pursue select projects in those therapeutic areas as well.” To this end, the firm’s existing development programs for a long-acting rFactor VIII (Phase II for hemophilia A) and rFActor IX (Phase III for hemophilia B) will be continued.
Biogen Idec’s existing marketed drugs and retained pipeline of development candidates is weighted heavily in favor of therapies for multiple sclerosis (MS). However, the firm says it aims to develop a neurological diseases pipeline that spans other disorders, including amyotrophic lateral sclerosis (ALS) and Parkinson disease. In August the firm expanded into the ALS field through the collaboration with Knopp Biosciences for development and commercialization of dexpramipexole. Biogen Idec says it aims to start a Phase III clinical trial with the candidate during the first half of 2011.
Outside the hemophilia and partnered ALS drug programs, the most obvious prospects for new drug approvals will depend on the continued progress of Biogen Idec’s MS pipeline. The firm’s commercial MS portfolio is headed by the marketed drugs Avonex® (interferon beta-1a) and Tysabri® (natalizumab). Its clinical MS pipeline comprises several mid- to late-stage drugs. Fampridine is an oral, prolonged-release 4-aminopyridine therapy that is already approved in the U.S. as dalfampridine, and is being commercialized outside the U.S. by Biogen Idec under a licensing agreement with Acorda Therapeutics. A PEGylated interferon for relapsing forms of MS is currently in Phase III trials, along with the small molecule immune modulator BG-12, which is also in Phase III for relapsing MS. The humanized IL2 receptor antibody daclizumab is in Phase III development under a collaboration agreement with PDL BioPharma. Biogen Idec’s early-stage MS pipeline includes its Anti-LINGO candidate.
Biogen Idec had been developing the anti-cd20 mAb ocrelizumab in collaboration with Genentech, but just a couple of weeks ago the firms amended their agreement, and ocrelizumab development for the MS indication is now the sole responsibility of Genentech. Biogen Idec will instead receive royalties on future U.S. sales of the drug by its partner. The restructured deal with Genentech also affects the firm’s Rituxan® collaboration in the U.S. As a result Biogen Idec is axing its current Rituxan oncology and rheumatology sales forces. This move, in combination with the consolidation of Biogen Idec’s U.S. facilities, will result in the overall loss of some 650 full-time positions at the firm.
Streamlining of the firm’s internal R&D and therapeutic focus will be accompanied by a drive to establish strategic partnerships in biologics development and manufacturing. “Our objective is to focus our resources on the high-priority area where we see significant value-creation opportunities for patients,” Dr Scangos continues. “In addition, I expect Biogen Idec to become a leading partner in biotechnology. We are the optimal size and scale to understand the needs of our partners while exploiting our significant strengths in biologics. These changes will help us increase our return on R&D investment and better position the company to deliver on its mission.”