Today, eighteen months earlier than planned, GlaxoSmithKline (LSE: GSK) announced the filing of a regulatory submission with the US Food and Drug Administration for the firm’s new three-in-one lung drug.
The company plans a regulatory filing in the EU during the coming weeks and expects to follow that with submissions in other countries. Assuming GSK get the approvals it needs for the new treatment, first-mover advantage could mean the treatment hits the market as early as 2017, beating the firm’s rival treatments, which appear to remain in development.
The potential market is huge
GSK and its research partner Innoviva are up against competitors such as AstraZeneca and Novartis to develop what they refer to as “closed triple” therapies, which aim to treat chronic obstructive pulmonary disease (COPD) with a once-daily single inhaler.
The announcement from GSK today follows a commitment earlier this year to bring forward the timing of the US filing from the first half of 2018. Now, the firm seems on course to beat its rivals to the market with the therapy, which could go on to achieve blockbuster sales for GSK.
The potential market is huge, with COPD affecting around 329 m people worldwide. It is a disease of the lungs that includes chronic bronchitis and emphysema, brought on by long-term exposure to lung irritants such as cigarette smoke, breathing in second-hand smoke, air pollution, chemical fumes or dust from the environment or workplace.
GSK is up against falling sales of older respiratory treatments such as dual therapy inhaler Advair and sees the new triple as a big opportunity. According to Reuters, outgoing chief executive Andrew Witty said the new treatment could be an “absolute clincher” for GSK’s respiratory business.
Ballooning earnings
I reckon the emergence of GSK’s potential new triple COPD treatment is more evidence of the firm’s potential to rebuild its business from its development pipeline after the well-reported patent-cliff headaches of recent years. Treatments timing out on patents sell for less as the market becomes swamped with generic competition. When that happens, profits dive.
However, City analysts following GSK are optimistic. They see earnings ballooning by 31% this year and an uplift of 10% during 2017. After four years of declining earnings, this looks like a significant turnaround for GSK’s fortunes that underlines the value and power of the company’s vibrant research and development operation.
The combination of weighty research and development feeding a robust consumer goods market such as medicines makes GSK an attractive defensive, growing business and an ideal vehicle for investors seeking compounding returns. That’s why master investors such as Neil Woodford are so keen on the shares.
If this new COPD treatment goes on to deliver on profits as hoped, you might end up being glad you looked closely at the opportunity with GSK today.