The Rise of Antibodies
Antibody therapeutics—using antibodies as therapy to fight causes of human suffering—is a rapidly emerging field that has seen great clinical success over the years. As a result, antibody therapies are quickly becoming a centerpiece of the biotherapeutics arena, creating markets for manufacturers that can reliably and cost-effectively produce antibodies in volume production.
Antibody products have proved to be highly successful and profitable therapeutics. They are well accepted by patients and physicians. As a result, products such as Rituxan®, Remicade®, Humira®, and others combined for sales of over US$10 Billion in 2004.
By 2010 the market for antibody therapeutics is projected to be well over $30 billion ("Monoclonal Antibody Therapies: Evolving into a $30 billion market," Datamonitor, April 15, 2005). This rapid growth has not escaped the notice of major pharmaceutical companies, which are now actively investing in antibody-focused R&D to bring new antibody therapeutics to market.
The rapid acceptance and clinical success of monoclonal antibodies have created a gap in manufacturing capacity industry-wide. One reason: it costs an estimated $400 million and takes five to seven years to build new manufacturing plants to make monoclonal antibodies. As a result, over 75% of current manufacturing capacity is held by a limited number of companies, creating challenges that affect the entire industry:
- Current capacity cannot supply sufficient quantities of therapeutic monoclonal antibodies to meet clinical needs for the treatment of common chronic diseases.
- The FDA requests that all production be free of animal serum products, further lengthening timelines, increasing costs, and adding risks.
- Viral clearance testing has become more extensive and time consuming, typically taking about six months.
- Royalties for monoclonal antibodies are significant due to the monopoly position of a few key players and the stacking royalties of several technology patents.
Alder's technologies alleviate these problems.
Alder's proprietary technologies allow companies to take control of manufacturing and timelines. The end result is dramatically shorter development cycles—from years to months—with significantly lower costs and far less development risk.
Since antibodies can be produced faster and less expensively, Alder and other manufacturers have the flexibility to test more therapeutic candidates, increasing the probability of success in the clinic. And by eliminating viral clearance testing and simplifying cell bank generation, time to the clinic is drastically reduced by almost a year. New antibody-based therapies get into production, and ultimately into patients, faster and with better drug properties.
Alder’s Therapeutic Platforms
Alder is building a diversified product pipeline by leveraging its key technologies and clinical expertise in the areas of autoimmune and inflammatory disorders, cancer, and anemia of chronic disease. The lead product in the pipeline, ALD518, is a neutralizing monoclonal antibody to a key pro-inflammatory cytokine. ALD518 completed Phase I clinical testing in healthy volunteers and advanced cancer in 2008. Alder’s antibody selection and antibody production technologies played a key role in allowing Alder to advance to the clinic quickly, producing a "best-in-class" agent that went from disease antigen to first dose in man in about 20 months.