When GlaxoSmithKline plc (GSK, Financial) CEO Emma Walmsley took the helm at the company back in April this year, she was immediately thrust into the spotlight. She was tasked with helping GlaxoSmithKline overcome what many saw as a potentially major hurdle – bringing new drugs to market to limit the impact of a variety of legacy blockbusters reaching patent maturity and, in turn, suffering from generic competition.
We are now closing in on the end of 2017 and, as far as her remit against the above hurdle is concerned, it's safe to say that she has hit the ball out of the park.
Back in September, the U.S. Food and Drug Administration (FDA) approved an asset called Trelegy Ellipta, which is the first once-daily triple medicine for chronic obstructive pulmonary disease (COPD). Analysts expect that Trelegy could pick up sales of more than $1.5 billion annually at peak and, against a backdrop of falling sales in the company's other respiratory asset, called Advair, was a major win for both Walmsley and the GlaxoSmithKline shareholders.
Fast-forward around 30 days and the agency followed up on its approval in Trelegy with another green light, this time for a shingles vaccination called Shingrix, which it approved in the U.S. for the prevention of shingles in adults aged 50 and over. Analysts put this one as a $1 billion sales asset.
With $2.5 billion in the bag from a peak sales perspective, markets then turned to an HIV combination asset called Juluca, which is produced by ViiV Healthcare, an HIV specialist business majority-owned by GlaxoSmithKline but in which Pfizer and Japanese drugmaker Shionogi also have a stake.
Again, news just hit press that the regulatory pathway for fixed asset has drawn to a favorable clothes for Glaxo and its shareholders.
As per the agency in the U.S.'s latest communication, Juluca is approved as an antiviral therapy for patients with HIV, and the company intends to launch it essentially immediately, with a full commercialization strategy expected to be in place by the middle of the first quarter next year.
The importance of this goes beyond Glaxo's revenue-generating potential on the asset, although that's fairly substantial at $5.5 million annually – what we might call a mega-blockbuster.
The drug is the first two drug regimen HIV treatments to be approved anywhere in the world, with the current standard of care therapies in this space requiring a patient to take three or four different types of antivirals as chronic administration drugs.
The potential to reduce this to two (a potential that just became a reality with the above discussed FDA approval) means that the patients that have to take this drug can now dramatically reduce the toxicity and tolerability issues associated with the current multi-dose regimens.
It looks as though Walmsley, Glaxo and the company's shareholders are in for a great end to 2017. Attention now turns to one of Glaxo's major competitors in HIV, Gilead Sciences Inc. (GILD, Financial), and a three-dose regimen it's trying to get approved in the same indication. The regimen in question, bictegravir in combination with emtricitabine and tenofovir alafenamide, is up for review at the start of 2018.
Disclosure: The author has no positions in any of the stocks mentioned in this piece.
