EU medicines agencies ready themselves for ‘No Deal’ Brexit
As the EU27 and the UK both warn that a ‘No Deal’ Brexit is a real possibility, Europe’s national medicines regulators are preparing themselves for the shock, Reuters news agency reports.
The UK’s MHRA is one of the biggest contributors to the network of expertise which feeds into the European Medicines Agency, but will no longer contribute after 29 March 2019 if no post-Brexit collaboration can be agreed.
Other national agencies, such as the Netherlands’
“It’s a real pity that we are going to lose the UK expertise, which is certainly very strong,” said Hugo Hurts, executive director of the Netherlands’ Medicines Evaluation Board.
“It’s a real challenge, but I’m not going to say there is not enough knowledge to replace that in the rest of the network,” Hurts told Reuters.
Germany, Sweden and the Netherlands are among the other big contributors to the EU medicines review process, in addition to the UK.
The Netherlands agency has already added more than a dozen extra staff, and other member states’ regulators are also hiring more people.
Read more at Reuters
Is a GSK spin-off in the works?
GlaxoSmithKline is weighing up the merits of spinning off its consumer health division in response to investor demand.
The Financial Times spoke to the company’s chairman Philip Hampton (pictured) late last week, who says he has been in discussion with its biggest shareholders about splitting off the division.
This would leave the more highly profitable pharma and vaccines divisions behind, creating what many investors would see as a more attractive investment.
The company’s top brass has rejected such a move in recent years – ex-CEO Andrew Witty resisted the idea, even when high profile investor Neil Woodford sold his stake in the firm.
However the new CEO Emma Walmsley has now paid out $13 billion to buy out Novartis from their consumer health joint venture, giving the division a scale which would make it a sustainable standalone business.
One major shareholder told Hampton that the logic of such a spin-off would be “pretty clear,” as the financial dynamics and business needs of a pharma and consumer health division were quite different.
Walmsley has repeatedly stated that growth in the core pharma division is her priority, and a multi-billion sell-off of the consumer division would create options – including M&A.
Analysts will also want to see organic growth from new launches in the pharma and vaccines divisions, especially as GSK’s respiratory blockbuster Advair is living on borrowed time.
Walmsley will undoubtedly face a grilling from analysts on tomorrow’s Q3 results call, especially if the figures are less than sparkling.
Also expected to set out his vision in detail for the first time on tomorrow’s call is GSK’s new research supremo Hal Barron.
Read more at The Financial Times
Reata Pharma success in kidney disease treatment
Reata Pharmaceuticals has produced phase II results showing its bardoxolone methyl (bardoxolone) can prevent or dealy kidney failure in a rare form of chronic kidney disease (CKD).
The Texas-based specialist pharma company has released positive one-year data from the phase II portion of its Cardinal trial, in patients with CKD due to Alport syndrome, and from the Phoenix trial in the autosomal dominant polycystic kidney disease (ADPKD) cohort.
In the phase II portion of the trial, significantly increased estimated glomerular filtration rate (eGFR) at Week 48 from baseline was observed.
Reata collected historical eGFR data for 22 out of the 25 phase II study subjects. The historical eGFR data demonstrate that the phase II study subjects’ kidney function was declining at an average annual rate of 4.2 mL/min/1.73 m2 prior to study entry. The observed 10.4 mL/min/1.73 m2 improvement after one year of treatment with bardoxolone represents a recovery of approximately two years of average eGFR loss.
The FDA has already indicated that in Alport syndrome patients, a significant improvement in placebo-corrected retained eGFR after one year of bardoxolone treatment may support accelerated approval and, after two years of bardoxolone treatment, may support full approval.
The company’s share price rose 65% on the news, and it has now announced a public offering of 3m shares.