Generic asthma inhaler drug breathes fresh life into Cipla

Generic drugmaker Cipla Ltd on Monday announced the launch of Serroflo, the aerosol copy of GlaxoSmithKline's anti-asthma inhaler Adviar, in two European markets - Germany and Sweden - in a move that could help the company push sales to bigger markets such as the UK and the US.

Serroflo is the generic version of GlaxoSmithKline's 'Seretide', which is used to treat asthma and breathing disorders. The market size of Seretide in Germany and Sweden is expected to be around $50 million.

With the launch of Serroflo, its Salmeterol/Fluticasone combination metered dose inhaler, in Germany and Sweden, Cipla opens the door for affordable and highly efficient treatments in the European healthcare market, the company said, adding that Serroflo will substantially improve the affordability of fixed combination drugs in Europe and help manage health costs for respiratory treatment.

''With Serroflo, we offer in Germany and Sweden an alternative which is effective and efficient and therefore brings many advantages into a market which suffers from limited resources'', said Frank Pieters, head of Cipla Europe.

In Germany, the new product is distributed under the name 'Serroflo', whereas in Sweden the combination is launched as `Salmeterol / Fluticasone Cipla'.

Both Serroflo and Salmeterol / Fluticasone Cipla will be available with HFA (an inhaler that contains hydrofluoroalkane) propellant in two strengths, ie, 120 doses of 25 / 125 mcg and 25 / 250 mcg salmeterol / fluticasone.

Cipla said, apart from Germany and Sweden the combination is already available in Croatia under the name Duohal, and other markets will follow.

''Over the next 12-18 months we will see a series of launches throughout Europe as we know that there is a common need for high quality, affordable, reliable and thus sustainable therapy-alternatives - and this is what Cipla stands for'' said Subhanu Saxena, managing director and global CEO of Cipla Limited.

In Europe, an estimated 30 million patients under 45 years suffer from asthma causing a huge burden and triggering significant disability and work loss.

The introduction of Salmeterol / Fluticasone in Germany and Sweden, is a key milestone in Cipla's ambition to improve treatment adherence in asthma and to offer better healthcare solutions for patients irrespective of what disease they suffer from. Cipla will also bring patient engagement programmes aimed at enhancing disease knowledge and improve adherence in order to achieve good disease control.

Over 50 per cent of patients of asthma in Europe have suboptimal control and the introduction of Serroflo, Salmetero l/ Fluticasone Cipla will provide a new cost efficient option for many people with asthma.

Though the benefit from the launch may not materialise in the near term, it raises hopes about Cipla's approval and launch in other key markets such as the UK, France and Spain over the next few months.

The launch of Seretide in these larger markets will not only boost the company's revenues but also profitability given the healthy margin for inhalers. The potential for Seretide in EU is around $800 million, while the market size in the UK is over $350 million.

Cipla has filed for over 10 inhaler products so far in the EU market. This includes the generic version of AstraZenca's Symbicort brand, which recorded global sales of $3.5 billion in 2013.

The EU approval of Teva Pharma's DuoResp Spiromax, which is the generic equivalent of AstraZeneca's inhaler brand Symbicort, in April this year, provides confidence about approval of Cipla's generic version of Symbicort. This, when happens, will provide a big leg up to Cipla's revenues and profits.

The company posted revenue growth of over 9 per cent in the June quarter. Due to one-off revenue from sales of Dymista (inhaler) during the same period last year, Cipla's net profit declined over 39 per cent to Rs295 crore in the June quarter.

However, a favourable revenue mix driven by strong growth in the home market helped the company improve its operating profit margin by over 3.7 percentage points sequentially to 19.9 per cent.