European Notebook: Industry’s Post-EU Election Goals; IMI2 Gets Under Way; FDA/EMA Tie-Up On Childhood Gaucher Studies
Executive Summary
Worries about science bases drew European politicians to the AstraZeneca/Pfizer merger debate; the European industry calls for EU-wide R&D agenda, standards of care; IMI2 public-private partnership gets under way; FDA and EMA to collaborate on clinical trials for childhood Gaucher disease.
Mega-merger fever returned to Europe in May in the form of Pfizer Inc.’s $117 billion proposal to acquire Britain’s AstraZeneca PLC, alarming politicians over potential job losses in science-based economies there, and their counterparts in the U.S. about the implied loss of tax revenues. Under U.K. law, Pfizer had until May 26 to agree on a deal, or would need to wait for six months before pursuing another tie-up.
The episode was a reminder that political and economic considerations can have a huge influence on even the most carefully constructed financial strategy when it comes to health care. The merger proposal sparked an unprecedented avalanche of questioning of the two CEOs by British politicians (Also see "Pfizer/AstraZeneca: Battleground Shifts To U.K. Parliament" - Pink Sheet, 13 May, 2014.).
Low corporate tax rates in several European countries including Ireland, the U.K. and Switzerland have led to a trickle of companies making local acquisitions and setting up new tax domiciles – the new Allergan PLC is domiciled in Ireland after its acquisition of Warner Chilcott PLClast October, and other companies that have moved their headquarters to Ireland include Alkermes PLC and Perrigo Co. PLC (Also see "M&A Activity Up Year-Over-Year, Driven By Tax-Inversion Deals And Diversification" - Pink Sheet, 11 Apr, 2014.).
European Life Sciences Manifesto
European pharmaceutical companies are usually well versed in putting their views across to politicians, and written reports from the U.K. parliamentary committees in the coming months will show whether Pfizer’s Ian Read and AstraZeneca’s Pascal Soriot were successful. With another group of politicians, the European Parliament, the industry is hoping to hit the ground running after the EU elections May 22-25, by proposing an integrated life sciences strategy for the whole of Europe (Also see "EFPIA Urges Drug Makers To See Value In Mobile Apps" - Pink Sheet, 14 May, 2014.).
A manifesto, released by the European Federation of Pharmaceutical Industries and Associations (EFPIA) on May 5, calls for political leaders to address inequalities in health outcomes and medicines access across the region. There should be EU-wide standards of care, mobile technology should be used to improve adherence to therapies and to allow patients to report adverse events, and fair prices based on ability to pay should be set across Europe, without reference pricing preventing such a system from working, the manifesto says.
Emerging collaborations between countries on health technology assessment should be supported to bring convergence to the assessment of value and patient outcomes, and prevent the pricing of medicines taking a long time, the manifesto continues. EU countries should abandon their fragmented R&D support policies and instead develop a pan-European R&D agenda, in order to develop a thriving and innovative life sciences sector. The European Generics Association also has endorsed the goals of the agenda.
More from Europe
Other European developments covered over the past month include:
- (Also see "German Vaccine Reforms Offer Multiple Tenders; Firms Want Purchase Guarantees" - Pink Sheet, 20 May, 2014.)
- (Also see "Firms May Lose Data Exclusivity Earlier Under Planned EU Adaptive Licensing Regime" - Pink Sheet, 13 May, 2014.)
- (Also see "U.K. Early Access Scheme Now Open To All Comers, But Smaller Firms May Be Scared" - Pink Sheet, 1 May, 2014.)
- (Also see "U.K. Coverage Rejection Of Alimta In NSCLC Increases Concerns About Access To Cancer Drugs" - Pink Sheet, 25 Apr, 2014.)
Unitary Patent Goes To The Vote In Denmark
Denmark is taking the opportunity afforded by the EU elections to ask their electorate whether they accept the setting up of the European Patent Court, part of the implementation of a single European unitary patent, in the same ballot as that for the EU Parliament.
Local companies through their trade association, LIF, are urging voters to say yes, pointing out that LEGO bricks and insulin pens were some of the Danish inventions that have been protected in the past by patents. Patents are vital for the Danish pharmaceutical industry, which accounts for 11.4% of the country’s total exports, LIF said.
IMI Partnership Cleared
One activity that is moving ahead whatever the outcome of the European elections is the Innovative Medicines Initiative, IMI2, the public-private partnership between the EU and the pharmaceutical industry in Europe. EU member states adopted the regulation on IMI2 on May 6.
The 10-year program has a budget of €3.3 billion ($4.5 billion), with the EU contributing €1.6 billion from its Horizon 20/20 research program, and the European Federation of Pharmaceutical Industries and Associations committing €1.6 billion of “in kind” contributions, such as the use of their research facilities and researchers. The first calls for proposals are planned for July 6, and are expected to include research by industrial and academic consortia into new drugs and vaccines for neurodegenerative diseases, metabolic disorders, immune-mediated diseases, infections and translational safety.
IMI2 aims to have lighter financial and intellectual property rules than IMI1, promote open innovation and exploitation, and develop at least two new medicines.
IPOs Take A Back Seat For Now
After an initial flurry of activity earlier this year, there has been a drop-off in the number of companies completing or considering an IPO on a European stock exchange. The U.K. biotech Tiziana Life Sciences PLC raised £2 million ($3.4 million) and began trading on the U.K. Alternative Investment market on April 24 following a reverse merger with Alexander David Investments PLC.
It is developing new drugs for metastatic breast cancer, based on research showing the protein Bcl3 plays a role in metastasis, conducted at the European Cancer Stem Cell Research Institute in Cardiff, Wales.
US company Allied Minds announced on May 20 it plans an IPO and listing on the London Stock Exchange. Allied Minds develops and commercializes science and technology emerging from U.S. universities and government research institutes, and has majority shareholdings in a portfolio of 18 life science and high-tech companies. The company is aiming to raise around $140 million (£83 million). Peer technology transfer companies like IP Group PLC and Imperial Innovations Group PLC are already listed in London.
Transparency Concerns
Europe’s top drug regulator the European Medicines Agency (EMA) has generally been applauded by patient groups for bringing forward plans to improve access to clinical trial data that it possesses, although on May 20 it was accused of back pedaling on some of its commitments.
A draft policy document on transparency would allow pharmaceutical companies to censor documents and will impose strict confidentiality and privacy requirements, according to the Medicines in Europe Forum (MIEF), the Nordic Cochrane Centre, and other patient groups. The European Ombudsman has asked EMA to explain why there has been a change of policy, noting she has conducted dozens of enquiries over the past five years about the agency refusing to make documents available to the public.
Gaucher Disease Trials In Children
EMA already works closely with counterparts in the U.S. and elsewhere, and released a joint proposal May 14 to facilitate clinical trials in children of new therapies for Gaucher disease.
The aim of the proposal is to find a way of evaluating a number of new medicines quickly, when recruitment into clinical trials is difficult due to the small number of subjects likely to be available. The regulators believe models and simulations that extrapolate from adult use might be appropriate in some cases, while in others a multi-arm, multi-company clinical trial might work. The proposal will be discussed at a stakeholder meeting to be held in September 2014, and companies can approach either regulator to express interest in using these innovative approaches.
Austerity Continues
The economies of European countries are still struggling, but several have attracted new pharmaceutical investments. Bari in Southern Italy will be the site of Merck Serono SA’s new €50 million production facilities for filling and packaging liquid drugs into syringes, vials and ampoules.
Pfizer announced May 2 it was opening a new $30 million unit in Ringaskiddy, Cork, to manufacture high-value but small-volume drugs. The new unit will employ only 20 people. And the Spanish blood products company Grifols SA announced the opening in Barcelona of one of the largest plasma fractionation plants in Europe.
Aleotti Passes Away
Alberto Aleotti, the former chairman and CEO of Italy’s private pharmaceutical company Menarini Group, passed away on May 7, aged 91 years. Aleotti served as president of EFPIA from 1986 to 1990, sat on the EFPIA board until 2010, and was president of Italy’s trade association, Farmindustria, from 1978 to 1986; he is best remembered for the successful campaign to get patent protection for innovative medicines in Italy. Menarini, with a turnover of more than €3.2 billion, 72.5% outside Italy, is now chaired by his son Lucia Aleotti; another son, Alberto Giovanni Aleotti, is vice-chairman.