News

EC fines pharma companies
Enlarge image

RegulatoryDenmarkEUGermanyUK

EC fines pharma companies

20.06.2013 - The European Commission has fined five pharma companies for delaying market entry of generic versions of the anti-depressant citalopram.

Danish drugmaker H.Lundbeck has to pay €93.8m, while the fine for German Merck KGaA/Generics is €21.4, its former subsidiary Generics UK pays €7.7m, while Arrow (now part of Zoetis), Alpharma (now part of Actavis), and Ranbaxy total € 52.2m in fines. According to investigations of the EC, in 2002, Lundbeck agreed with each of the generics makers to delay the market entry of cheaper versions of Lundbeck's branded citalopram, a blockbuster antidepressant.  

"It is unacceptable that a company pays off its competitors to stay out of its market and delay the entry of cheaper medicines“, stressed Commission Vice-President Joaquín Almunia. „Agreements of this type directly harm patients and national health systems, which are already under tight budgetary constraints. The Commission will not tolerate such anti-competitive practices".  “We are surprised and disappointed that the EC has reached this erroneous conclusion, which we totally disagree with, and it is therefore our intention to appeal,” stressed Lundbeck’s CEO Ulf Wiinberg. “It is wrong and extremely misleading to claim that these agreements have delayed the marketing of citalopram copies and thereby violated competition laws,” said Wiinberg. The agreements were meant to protect against patent infringements by the generic companies, he said.  Ranbaxy stated that the Commission misunderstood the facts. 

Citalopram was Lundbeck's best-selling product at the time. After Lundbeck's basic patent for the citalopram molecule had expired, it only held a number of related process patents which provided a more limited protection. Producers of cheaper, generic versions of citalopram therefore had the possibility to enter the market, which would have brought down the price for the medicine by approximately 90%.  According to the Commission, the generic producers agreed with Lundbeck in 2002 not to enter the market in return for substantial payments and other inducements from Lundbeck amounting to tens of millions of euros. 

Internal documents refer to a "club" being formed and "a pile of $$$" to be shared among the participants. Lundbeck paid significant lump sums, purchased generics' stock for the sole purpose of destroying it, and offered guaranteed profits in a distribution agreement. The agreements gave Lundbeck the certainty that the generics producers would stay out of the market for the duration of the agreements without giving the generic producers any guarantee of market entry thereafter. These agreements are very different from other settlements of patent disputes where generic companies are not simply paid off to stay out of the market.

© eurobiotechnews.eu/tg

http://www.european-biotechnology-news.com/news/news/2013-02/ec-fines-pharma-companies.html

R&DEUBelgium

18.12.2014 IMI has launched a €115m call for proposals involving a project in collaboration with the Bill and Melinda Gates Foundation to improve vaccines against whopping cough in children.

PoliticsEUPolandItalySpainUK

16.12.2014 Two consortia combined of 144 European companies, research institutes and universities have been selected for funding by the EIT in the areas of health and raw materials. Both clusters are set to acquire €1.1bn over the next seven years.

M&ALuxembourg

11.12.2014 Luxembourg bio-analytical testing company Eurofins Scientific has signed an agreement to acquire Boston Heart Diagnostics Corp. for an initial €112m.

StudySwitzerlandEU

10.12.2014 When it comes to the biggest investors in Research and Development (R&D) Swiss pharma top dogs Novartis and Roche have defended their positioning among the top ten companies worldwide – according to a recently published EU study.

FinancingUKSpain

09.12.2014 British drug delivery specialist Midatech Pharma plc floated on the London stock market. It is the third biotech IPO on the AIM market this year.

CooperationAustria

05.12.2014 Austrian contract research company VTU has entered into a development and commercialisation agreement with US company RCT. The partners want to combine both companies' Pichia pastoris protein production technologies under VTU's roof.

FinancingDenmark

03.12.2014 Danish biotech pharma Ascendis has successfully completed a €48m Series D financing round. The funding is expected to support its late-stage clinical trials to push its lead drug into Phase III trials.

RegulationUKFranceGermanySpain

01.12.2014 In spite of innovative new medicines on the market, the UK and Germany lag behind other countries and continue to use older medicines - especially in the treatment of cancer. French and Spanish patients, on the other hand, benefit much earlier from medical innovation.

Events

All Events

Current issue

All issues

Product of the week

Products