[Ip-health] FT: Dutch doctors fight pharma company’s 500-fold drug price rise

Thiru Balasubramaniam thiru at keionline.org
Mon Sep 3 05:25:53 PDT 2018


Dutch doctors fight pharma company’s 500-fold drug price rise
Regulator urged to probe Leadiant Biosciences’ alleged abuse of market power


A group of Dutch doctors and health advocates are taking action against an
Italian pharmaceutical company, which has pushed through a 500-fold price
increase of a life-saving drug.

The Dutch Pharmaceutical Accountability Foundation, a non-profit group set
up to tackle high drug prices, is set to file a claim this week with The
Netherlands’ Authority for Consumers and Markets to probe alleged abuse of
market power by Leadiant Biosciences over its drug chenodeoxycholic acid

Wilbert Bannenberg, head of the foundation, said: “Some companies are
misusing the system to get higher profits, and patients are being affected
when cheap, affordable old products are no longer available. This may be
legal but it’s not socially acceptable.”

In a saga with echoes of the tactics adopted by the US investor Martin
Shkreli’s company Retrophin, Leadiant sharply raised the price of CDCA from
€300 a year to more than €150,000 since gaining full control of supplies
and winning approval by European regulators for a decade-long monopoly as a
treatment for cerebrotendinous xanthomatosis (CTX), a rare disease, in 2017.

Separately, doctors treating patients for CTX at the Amsterdam Medical
Center are preparing to manufacture a rival version at cost price to
sharply undercut Leadiant’s product.

The actions have won support from Dutch health insurers, which have
temporarily agreed to fund Leadiant’s drug in the absence of cheaper
alternative supplies, without which patients risk seizures and dementia.

The case will spark fresh debate over the current terms of European orphan
drug legislation, which allows a manufacturer to win exclusivity even after
patents have expired on a drug when it is approved for the first time to
treat very rare diseases.

CDCA, a simple chemical compound, was developed by a German researcher in
the 1970s, and had been widely used as a cheap drug against gallstones
until sales dropped sharply after the adoption of better treatments.

No official regulatory approval had ever been granted for its use to treat
CTX, but doctors started prescribing it “off label” in the late 20th
century after discovering CDCA was highly effective in tackling the
extremely rare disease. It is currently given to about 55 patients in the

Leadiant bought up rival CDCA suppliers and withdrew the drug from the
market, before relaunching it last year after gaining approval by the
European Medicines Agency on the basis of two small clinical trials.

The company then called in the Dutch regulators to stop the Amsterdam
Medical Center manufacturing its own version, after an audit identified
some impurities in the production.

Carla Hollak from the centre pledged it would improve manufacturing and
relaunch production if Leadiant maintained its price. “This is essential
medication,” she said. “I’m fully against these kind of actions by the
pharmaceutical industry to gain a monopoly and sell a drug for a price that
suggests it has cost an enormous amount.”

Leadiant said it was “very open and willing to dialogue” and sought “a
sustainable and constructive long-term solution”.

It said: “The commercial fundamentals and operational costs . . . to
manufacture and bring to the European market a newly approved drug in 28
countries, compliant with the most recent quality and safety standards and
regulations, destined to treat this ultra-orphan disease cannot be
benchmarked against other products used as unlicensed or off label, in most
EU countries.”

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

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