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A new drug for the treatment of asthma is badly needed.

There are a large variety of asthma drugs on the market, but the most they can do is alleviate symptoms. They do little about the substance of the disease.

Dupilumab, an injectable medication being developed by Regeneron Pharmaceuticals (NASDAQ:REGN) and partner Sanofi (NYSE:SNY), is part of a new class of drugs to change that.

Dupilumab

Dupilumab, also called SAR231893 or REGN668, is a fully human monoclonal antibody to the alpha subunit of the IL-4 (interleukin-4) receptor intended for patients with persistent, severe asthma and elevated eosinophil levels.

Eosinophils are a type of white blood cells whose natural role is to defend the body against parasites. Eosinophils gather wherever there is a parasite infection or an allergic reaction and release chemicals. The chemicals are very efficient at fighting parasites, but they can also harm the body if released in the wrong place. So the lining of the lungs becomes damaged in asthma. It appears that eosinophilic airway inflammation is closely related to the risk of severe asthma attacks.

There is no specific treatment for eosinophilic asthma other than the inhaled corticosteroids and other controller medications.

Dupilumab blocks the action of interleukin-4 and interleukin-13, two inflammatory chemicals made by the body that are believed to contribute to asthma.

In a small Phase 2, 12-week study, the number of asthma attacks or other symptom outbreaks decreased compared with those getting a placebo, and other measures of lung function and disease control also improved.

A total of 52 patients was assigned to the dupilumab group, and 52 patients were assigned to the placebo group. Baseline characteristics were similar in the two groups. Three patients had an asthma attack with dupilumab (6 percent) versus 23 with placebo (44 percent), corresponding to an 87 percent reduction with dupilumab.

Significant improvements were observed by most measures of lung function and asthma control. Dupilumab reduced biomarkers associated with Th2-driven inflammation. The Th2 (Type 2 helper T cells) inflammation pathway plays a role in about half of the patients with moderate to severe asthma, according to Regeneron.

Huge market

An estimated 25 million Americans have asthma.

According to Transparency Market Research, the global asthma and COPD market was worth $25 billion in 2010 and it expected to reach $26.9 billion in 2017. The asthma drug segment dominated the overall asthma and COPD market at $14.1 billion in 2010. The COPD segment was estimated to be worth $10.59 billion in 2010, and it is expected to reach $12.61 billion in 2017.

The markets are mainly driven by increasing patient population. The other factors include long term use of asthma and COPD drugs, an increase in disposable income and improved access to medical care in emerging economies. In China, for example, the air pollution and smoking are two important factors in the rapid increase of the number of asthma and COPD patients.

Competition

There is intense competition in inhaled corticosteroids, combinational therapies, and beta-agonists. Glaxo's (NYSE:GSK) Advair, AstraZeneca's (NYSE:AZN) Symbicort and Merck's (NYSE:MRK) Singulair used to be the leading drugs in the global asthma and COPD market, but generics gradually are moving in and taking over.

While most patients respond to these treatments, it is estimated 20 percent remain in dire need of help.

For these difficult-to-control asthma patients doctors usually recommend increased adherence to treatment, avoidance of allergens and other exacerbating factors, and control of coexisting conditions such as gastrointestinal reflux, postnasal drip, and sinusitis. Other adjuvant therapies currently available include leukotriene modifiers, theophylline, anti-IgE antibody, bronchial thermoplasty, systemic glucocorticoids, and tiotropium (which is not approved by the FDA for the treatment of asthma).

However, response to these therapies is variable and unpredictable. In the past several years, there have been some successes reported in studies of new asthma treatments that target the cytokines thought to underlie the primary pathogenesis of asthma, including anti-interleukin-5 and anti-interleukin-13.

Teva's (NYSE:TEVA) Cinquil, acquired with the Cephalon purchase, is an antibody being tested in three Phase 3 trials. Results could be reported during the next 12 months, and positive data would be great news for Teva which is in dire need of good news these days.

The Glaxo drug, mepolizumab, is also in Phase 3 trials. In Phase 2 it showed success in deactivating IL-5 (interleukin 5), a cytokine that regulates the activation of eosinophils.

AstraZeneca's Benralizumab, acquired through the purchase of Medimmune, is also an IL-5 drug in Phase 2.

Investor's summary

After two decades of frustration, New York based Regeneron has become a major biotechnology company owing to booming sales of Eylea, developed with Bayer AG, a drug that treats age-related macular degeneration, an eye disease.

Sanofi and Regeneron have also joined forces on Phase 3 efforts to advance alirocumab (REGN727), an LDL-cholesterol-lowering drug that targets PCSK9, and sarilumab (REGN88) for rheumatoid arthritis.

Success in biotech research is expensive. Regeneron pumped $625 million into research in 2012, a whopping 72 percent of its product revenue and an increase of 18 percent over the prior year. Chief scientist Dr. Yancopoulos, who joined Regeneron as founding scientist in 1989, says that his group's success and the big investments in research work hand in hand.

Dupilumab is one of several promising therapies in the collaboration between Regeneron and the French giant Sanofi. The companies plan to advance the therapy into a 500-patient Phase 2 study in allergic asthma patients shortly.

The therapy has also yielded promising evidence in patients with atopic dermatitis, which appears to share similar molecular triggers with allergic asthma.

Source: Regeneron's New Asthma Drug And Its Fierce Competitors