pharmaphorumFebruary 15, 2019
Tag: new drugs , Brexit , MHRA , acromegaly drug
David Meek spoke to pharmaphorum ahead of the company’s full year results announcement, and while he said the company will continue with its presence in the UK after Brexit, he had a somewhat downbeat message about access to the company’s medicines after March 29.
The UK’s Medicines and Healthcare Regulatory Agency (MHRA) looks set to take on the responsibilities of the European Medicines Agency (EMA) after that date, and is working through a set of proposals on how to manage functions such as assessing safety and efficacy of drugs.
Latest proposals from the MHRA include targeting certain products to review after a positive opinion from Europe’s CHMP, and three new assessment procedures for products containing new active substances and biosimilars.
But with uncertainty remaining about the shape of medicines regulation in the UK Meek told pharmaphorum that the country is likely to slip down the company’s list of priorities when it comes to filing new drugs for approval with regulators.
He said: "(Today) We prioritise the FDA and the EMA and then we do the next markets, for example the PMDA in Japan. China’s FDA has made some announcements about global trials and global drug development, and being the second largest market today China’s FDA would certainly move up in the queue.
"Then you have the other markets such as Swissmedic, Health Canada, Australia – the UK would fall into that basket."
The company employs 900 people in the UK, at sites including Wrexham and Slough and Meek said Brexit has been a "disruption and a distraction" from the company’s job to bring new drugs to patients, and for policy makers trying to work with pharma.
Like many pharma companies Ipsen has been stockpiling its medicines on both sides of the EU-UK border to ensure a steady supply of medicines to patients, adding that the company had planned for a "hard Brexit" from the outset.
Ipsen’s full year results showed overall group sales of more than 2.2 million euros, an increase of 20% compared with last year.
The French company has a portfolio of rare disease, neuroscience, and oncologydrugs, and notably has a tie-up with US-based Exelixis to market cancer drug Cabometyx outside the US.
For the first time the company had a blockbuster drug – its acromegaly drug Somatuline (lanreotide) – pushed through the billion-dollar annual sales figure in 2018.
Register as Visitor to CPhI China 2019!
-----------------------------------------------------------------------
Editor's Note:
To apply for becoming a contributor of En-CPhI.cn,
welcome to send your CV and sample works to us,
Email: Julia.Zhang@ubmsinoexpo.com.
Contact Us
Tel: (+86) 400 610 1188
WhatsApp/Telegram/Wechat: +86 13621645194
Follow Us: