Current Stage of Development
Our pipeline includes two internally discovered humanized monoclonal antibodies, one wholly-owned program and one partnered program, as well as preclinical programs targeting additional indications that are in the discovery phase.
ALD403 is our wholly-owned novel monoclonal antibody targeted to calcitonin gene-related peptide, or CGRP, for migraine prevention. CGRP is a validated target that is believed to play a key role in migraine. Approximately 36 million Americans suffer from migraines; however, only 22.3 million migraine sufferers have been clinically diagnosed. Migraine is a significant cause of disability, generally affecting individuals between the ages of 20 and 50, which are prime working years. The Migraine Research Foundation estimates U.S. employers lose more than $13 billion each year as a result of 113 million lost work days due to migraine. We believe the area of critical unmet need in migraine is preventive therapy with improved efficacy and tolerability to treat patients who have five or more migraine days per month. For the 12.6 million U.S. migraine patients who are candidates for migraine prevention, there are few therapeutic options to manage their disease. We believe this group of migraine patients is highly-motivated to seek new treatments due to the limited success of current therapies.
We recently completed a double blind, randomized, placebo-controlled proof-of-concept trial of ALD403 in patients suffering from five to 14 migraine days per month, or high frequency migraine. Results were presented at the 56th Annual Scientific Meeting of the American Headache Society.
Clazakizumab is a novel monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin-6, or IL-6, and is being developed for both rheumatoid arthritis, or RA, and psoriatic arthritis, or PsA. RA is a chronic inflammatory disorder that principally attacks joints. Approximately 2.4 million patients, predominantly women, suffer from RA in the United States. Uncontrolled RA is also associated with substantial morbidity and mortality. There is increasing recognition that treating patients aggressively early on in the course of their disease delays irreversible structural damage to joints. We estimate that global sales of the RA therapies was more than $12 billion in 2012 and will grow to $15 billion by 2016. The RA market is currently dominated by a class of drugs that target tumor necrosis factor alpha, or anti-TNFs. Nevertheless, anti-TNFs are associated with low rates of disease remission and the response to these agents is not typically durable. In 2012, the American College of Rheumatology recommended that treatment of RA should be directed at achieving remission in patients or low disease activity if remission cannot be achieved.
In November 2009, we entered into a license and collaboration agreement with Bristol-Myers Squibb, or BMS. In a recently completed Phase 2b trial, the rates of disease remission in patients treated with Clazakizumab plus methotrexate were numerically higher than those treated with Humira plus methotrexate. Phase 2b dose-ranging trials are ongoing in preparation for progression to Phase 3 trials if supported by the data.