Respiratory diseases are on the rise globally. While targeted therapies have made steady inroads in treating cancer, the situation for Asthma and Chronic Obstructive Pulmonary Disease (COPD), the two big respiratory ailments, has been less exciting.
Scientists have been deciphering the cellular and molecular signalling pathways that lead to respiratory issues but available animal models and biomarkers are not ideal making the clinical development path more unpredictable.
No doubt progress will be made in years to come but for now the focus remains on better control for symptoms and preventing the disease from getting worse, and it is here that things are about to get very interesting.
For the past decade a handful of drugs and companies have dominated this area but those incumbents are about to face competition. COPD is now a clear focus. This is different to 1999 when COPD was labelled the most underfunded disease in relation to the global burden of disease.
There are over 200 million COPD sufferers globally. The disease develops over time and is characterised by chronic inflammation of the airways that leads to irreversible destruction (emphysema). Lung function declines rapidly and ultimately leads to premature death. Smoking, pollution, poor diet all play a role in COPD, often called ‘smoker’s disease’.
The mainstay of treatment for COPD are bronchodilators that open up the airway. There are two classes; long-acting muscarinic antagonists (called LAMA) and long-acting beta agonists (LABA). The gold standard and only approved LAMA is Boehringer Ingelheim’s Spiriva (sold in alliance with Pfizer with global sales of over $4 billion). The other COPD drugs are LABAs combined with corticosteroids (GSK’s Advair and AstraZeneca’s Symbicort). Both drugs are well-known Asthma therapeutics, Asthma drugs Advair (GSK) and Symbicort (AstraZeneca).
These three drugs combined generate almost $10 billion in COPD sales; a nice portion of sales that other companies now want to participate in. Indeed the race is now on to develop LABA/LAMA combinations and ultimately one molecule that combine LABA/LAMA (so called MABAs). This will be a significant step in managing COPD.
Novartis and Forest (with partner Almirall) are the COPD newcomers. Novartis has assembled a solid line up of new drugs. Its once a day LABA is now available (albeit at lower doses in the US) and can compete with Spiriva, as well as being given in combination with Spiriva. This is a nice start for Novartis to build its presence and pave the way for its LAMA and LABA/LAMA combination, as well as the LABA/corticosteroid combination in Asthma over the coming years.
Forest (in alliance with Spanish Almirall) is the underdog. A US biotech with no prior COPD exposure and obviously less financial resources than pharma. Its LAMA was approved in 2012 but has to be taken twice a day, not ideal commercially. The LABA/LAMA combination could be available by 2015. This is the crucial asset and AstraZeneca may take notice as the LABA component is from AstraZeneca’s Symbicort.
Similarly, AstraZeneca may also watch closely what Pearl Therapeutics, a small private US biotech is doing. Pearl is also combining Astra’s LABA with its own LAMA. This private company is quite conspicuous for its activity in launching earlier respiratory drugs.
GSK and Boehringer Ingelheim do have their own combinations but their commercial positions are unclear. GSK (together with biotech Theravance) has accelerated the filing of its new LABA/LAMA combination to beat Novartis to the US market. Neither drug components are approved making this a risky strategy. Boehringer should have its own LABA approved in 2013 but it is nearly two years behind with a Sprivia/LABA combination.
These are interesting times for COPD and a big opportunity for pharma to use their clinical development and marketing strength to expand this market.
We see Novartis having put together a solid clinical program and line-up of drugs. We see the company gradually becoming a force to be reckoned with in COPD, while Forest may have to consider seeking help from the likes of AstraZeneca to compete effectively.
COPD reminds us of diabetes several years back when we successfully invested in US Merck. The company was new to diabetes but had the right new asset (DPPIV inhibitor) and clinical development program, while the incumbents (GSK was one of them) were behind. Today, Merck has a solid position and its diabetes franchise generates $5.5 billion in sales. There is no reason to believe that a similar scenario will not play out in COPD, a market that will expand given its current dynamics.
 LAMA: blocks nerve endings and causes airway smooth muscle cells to relax, making breathing easier.
 LABA: activates a receptor on smooth muscle cells resulting in airway smooth muscle cell relaxation.
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