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Pfizer's Varma says switching is a necessity
Τετάρτη 10 Ιούν 2015
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"Switching is not just a megatrend, it is a necessity for our industry," according to Suneet Varma, Pfizer Consumer Healthcare's new worldwide president.
Speaking at a recent gathering of the European OTC industry, Varma said switching had been important for the industry in the past and presented an opportunity in the present and the future. "The time is right to push on with switching," he told delegates attending the 51st Annual Meeting of the Association of the European Self-Medication Industry (AESGP) in Barcelona, Spain.

According to Varma, switching was a "group effort". He stressed the importance of bringing together all the interested parties – industry, regulators, governments/payors, advocacy groups, healthcare professionals and consumers – to create a favourable environment for switch.

Varma explained that Pfizer Consumer Healthcare was focusing its switch efforts on two types of medicine. Firstly, the company was seeking to launch additional treatment options in existing OTC categories, he said, citing the proton-pump inhibitor Nexium (esomeprazole) in the heartburn category as an example. Secondly, Pfizer wanted to create entirely new categories, he added, pointing to Lipitor (atorvastatin) and cholesterol lowering.

Seeking to switch Lipitor

Pfizer is currently seeking to switch Lipitor from prescription-to-OTC status in the US.

Albert Bourla – Pfizer's president of Vaccines, Oncology and Consumer Healthcare – said in April 2014 that the company would soon have the results of its actual-use trial for Lipitor in a simulated OTC setting. The results of the study would "inform the next steps and timelines for a potential New Drug Application (NDA) filing", added Bourla (click here to read the News story).

Switching the cholesterol-lowering drug to OTC status in the US is a challenge. Although another statin, simvastatin, was switched in the UK in 2004, previous applications to switch statins in the US have all been rejected by the Food and Drug Administration (FDA).

According to Varma, "cholesterol treatment gaps" existed in the US despite the availability of prescription medicines.

Varma pointed out that around two-thirds of adults had been screened for cholesterol, but less than half of the 71 million adults with high levels of low-density lipoprotein (LDL) cholesterol were currently treated with a prescription medicine.

Noting that this left a large, untreated population, Varma said switching could provide an "incremental societal benefit".

Varma said a study carried out by the US National Consumers League had found that 82% of consumers said an OTC statin would be preferable to a prescription statin.

Furthermore, another study suggested that increased utilisation of statins following a switch in the US could prevent more than 250,000 coronary events and save more than US$8 billion over a 10-year period.

Technology could be an important factor

Technology could be an important factor in creating entirely new categories.

Varma pointed out that consumers wanted to have a greater role in managing their healthcare, and had become increasingly adept at using various tools to self-manage common medical conditions. This combination of consumer empowerment and technology was "creating a new level of power in the consumer landscape," he maintained.

Commenting on the recent switch of Nexium, Varma said more than two-thirds of frequent heartburn sufferers were dissatisfied with their current treatments, despite the fact that proton-pump inhibitors had been available without a prescription for many years. "There are still opportunities," he stressed, "even in mature markets and even in existing categories."

Noting that Pfizer Consumer Healthcare was "quite satisfied" with the progress of Nexium so far, Varma said "only time will tell how this will play out".

Pfizer acquired exclusive global rights to non-prescription versions of AstraZeneca's Nexium in 2012. The deal comprised an upfront payment of US$250 million to AstraZeneca, as well as milestone and royalty payments based on product launches and sales.

The first launch came on 27 May 2014, when Nexium 24HR was introduced in the US as an OTC medicine for frequent heartburn. Since then, Pfizer has launched Nexium Control in a number of European countries including France, Germany, Ireland, Italy, Malta, the Netherlands and the UK.

Reporting its financial results for the first quarter of 2015, Pfizer said worldwide Consumer Healthcare sales had risen by 6% compared to the same period a year earlier. Sales were up by 12% on an operational basis to US$808 million.

Pfizer said the rise was "primarily due to the launch of Nexium 24HR in the US in late-May 2014 as well as growth of the base business in certain emerging markets".

Πηγή:  OTCToolBox

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