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Year 2014: Billion-dollar eye in the industry
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Dr Anuj Gupta
December 12 , 2014
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With 2014 coming to an end, couple of pharmaceutical companies-Novartis and Valeant-are on verge to launch billion-dollar drugs. These drugs will not only help them write-off there revenue losses due to patent cliff 2014-15, but will also establish their dominance in related therapeutic fields. While Novartis'psoriatic arthritis drug is expected to enjoy extended patent protection (being a biologic) and market dominance (due to limited available options); Valeant's glaucoma drug (Vesneo) will reap benefits from the blockbuster draught in glaucoma market. Its major competitors are facing generic heat and therefore, it is expected to grab substantial market share at proposed launch.
Novartis’ Breakthrough Relief for PsA
After years of waiting, Novartis is on verge of housing a billion dollar drug. Its new generation anti-inflammatory drug for psoriatic arthritis (PsA)-Secukinumab-is likely to ensure a significant market share for the company. The company declared that the results of related phase III clinical trial met all primary and secondary end-points and the drug will soon be up for regulatory approval.
The company (Novartis) has already filed approvals of Secukinumab in psoriasis. Both these approvals (psoriasis and PsA) are expected to come through by early 2015. Further, the company is in process of developing the drug for ankylosing spondylitis and rheumatoid arthritis. If the company manages to pull off these four approvals, they can expect to reap a more than $1 billion annual sales by 2020.
Many pharma companies have been struggling hard to establish dominance in psoriatic arthritis market. While the incidence of PsA, in the US, among the general population is 6-7/100,000; however, nearly 20-30% psoriasis patient inculcate arthritis as secondary infestation. The disease is common among the age group of 30-50-year-olds and affects men more than women.
The first drug to enter the PsA market was a biologic from Amgen/Pfizer-Enbrel (entanercept) in 2002-and was later followed by more drugs, such as Abbott's Humira (adalimumab) in 2005 and Centocor's Simponi (golimumab) in 2009. Since most of the approved drugs are biologics, the PsA market is relatively less threatened by me-too (biosimilar) drugs. The companies can expect to reap financial gains for substantial longer duration.
Valeant Hits the Bulls-eye with an Eye Drug
The serial acquirer of pharma-Valeant-has been well known to avoid R&D investments. This strategy has often left enough for the company to acquire and grow.
The company hit gold from its one such $8.7 billion acquisition-Baush + Lomb. It picked up B + L's in-development glaucoma drug-Vesneo (formerly known as latanoprostene bunod)-as a part of this deal, which was originally in-licensed from the French drugmaker, Nicox. With the phase III clinical trial meeting its primary and secondary end-points, the Canadian company is likely to apply for FDA approvals in second quarter of 2015, hoping for a launch in first half of 2016.
During 2010-2018, the global glaucoma market is expected to grow at an average annual rate of 0.6% from $3 billion in 2010. By 2020, nearly 20 million people are expected to suffer from the disease. The disease accounts for more than 11% cases of blindness in the US and affects more than 2.2 million people in the country.
Further, the Vesneo announcement comes at a time when the glaucoma market is suffering from huge revenue losses due to LOE/patent expiries. Among the major sufferers are Pfizer's Xalatan (latanoprost), Allergan's Lumigan (0.01% and 0.03% bimatoprost) and Alphagan P (0.1% and 0.15% brimonidine tartrate ophthalmic solution). Xalatan from Pfizer is among the most prescribed glaucoma drugs; however, it lost patent protection in 2010. According to SeekingAlpha (an equity research platform), the glaucoma market share (by revenue) in overall ophthalmology market is expected to decline from 36% in 2011 to 23% in 2018, primarily due to erosion by generics. Further, the glaucoma market has seen a blockbuster draught since 1996.
Given the above, Valeant can expect to rapidly invade the ophthalmology market and ensure substantial market share for its new-age drug. With no new drug launches in more than a decade, this new generation drug can be looked upon as a promising billion-dollar candidate for the company.
US - Hot-Property for New Drug Launches
Interestingly, despite all major pharma focussing on emerging markets (such as BRIC nations and LATAM), the US remains a key market for any new drug launches.
Valeant expects to reap nearly 50% of the proposed revenues for Vesneo from the US, while Novartis is expected to stay focussed on both the US and EU.
(The author is group manager, ops, WNS – Healthcare)
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