“We need an open debate on medicines pricing. When it is covered by commercial secrets, it creates mistrust in society,” EU Health Commissioner Vytenis Andriukaitis argued during the annual Gastein Forum on European Health, held in Austria on Oct. 2.

As an example of an open debate, he noted Luxembourg’s move to join the Dutch-Belgian initiative on exploring the joint negotiation by the countries with industry on expensive drug prices Also see "European Notebook: Drug Pricing Collaborations; Biosimilar Switching; Scientific Advice" - Pink Sheet, 27 April, 2015..

Coming up with new health policies for Europe may be taking some time, but the cogs are moving, albeit slowly: Andriukaitis confirmed at the Gastein meeting that access to safe and effective medicines were one of three areas on his agenda for action, the others being planning for an effective health work force, and implementing the cross-border health care Directive. The directive explains in what circumstances a patient from one European country can receive health care in another country and have it reimbursed by their home country. As of July 2015 all but four EU countries had transposed the directive into local law.

The European Commission has also set up an expert group on Safe and Timely Access of Medicines to Patients (STAMP), to discuss the issues, with the group’s latest meeting held Oct. 20. ([A#14151016001]).

Indeed, the European Commission’s position on improving access to medicines for patients in developing countries may be undergoing a renaissance: the previously critical activist group Health Action International conceded the EU’s recent move to support exemption of the world’s poorest countries from IP rules until they were no longer classified as least-developed countries has merit. Still, some of the health care policy positions held by the European Commission were “empty gestures” as they clash with new trade policies being pursued by the EU Trade Commissioner Cecilia Malmström, the HAI said in a report released Oct. 14.

Rasi Close To Heading EMA Again

The Health Commissioner has oversight of the European Medicines Agency, and in early October Guido Rasi came ever closer to being re-appointed as the agency’s executive director, having been stood down in 2014 because of procedural mistakes in his initial appointment Also see "EMA Leadership Goes To Pott After Rasi Retroactively Unhired" - Pink Sheet, 14 November, 2014..

EMA’s management board nominated Rasi for the executive director post Oct. 1, and on Oct. 13 he addressed the European Parliament’s public health committee (ENVI), and will shortly answer questions from members of the European Parliament. The agency is being cautious about when his new stint in charge will begin: “Pending the finalization of the recruitment process, Professor Rasi is expected to take up his duties as EMA executive director within the next month,” the agency said on Oct. 20.

Earlier Advice, More Kinds Of Data

Europe's top drug regulator has continued to look at new ways of regulating medicines this month, including piloting the use of “real world” data in the shape of patient registries to support its work. Some registries are already available from doctors’ or patient organizations and could be used by regulators, but the data may not be structured or formatted the right way, the agency noted. Companies are sometimes urged by regulators to set up a registry to monitor the safety and efficacy of a new medicine, and a more comprehensive strategy on the use of registries is to be developed over the next two years.

The constant urging by EMA for companies to take advice before they embark on a clinical development plan appears to be bearing fruit: 77% of new molecular entities and biosimilar marketing applications submitted during the first six months of 2015 received scientific advice, the agency reported. In the first half of 2015, 21 companies also requested parallel scientific advice from regulators and health technology assessment bodies, a three-fold increase on the first six months of 2014.

During October the agency said it was extending its pilot on involving patients in Committee for Medicinal Products for Human Use discussions to 2016, “allowing more patients to participate” ([A#00140825002]). EMA also expects its clinical trial portal and database to be available for testing by the third quarter of 2016 and operational for all clinical trial applications by the end of 2017.

More From Europe

Other European developments covered over the past month include:

[A#14151016001]
[A#14151013002]
Also see "Italian Move Plugs Big Gap In Future EU Patent System" - Pink Sheet, 7 October, 2015.
[A#14151005001]
Also see "French Industry Rages Over €1.7bn Drug Savings Plan" - Pink Sheet, 28 September, 2015.

Among changes made by regulators in individual European countries during October, Portugal’s government reported the annual review of pharmaceutical prices had saved the country’s national health service more than €21.6m ($24.5m) – prices in Portugal are compared with those in Spain, France and Slovenia, and cut if they are higher than the average of prices in the three countries.

And in Spain, a similar review of prices of pharmaceuticals in its reference price system was expected to lead to savings of €91m for drugs dispensed by pharmacies, the government said Oct. 17.

In Denmark, four new health regulator bodies have been set up under a restructuring ordered by the health ministry to “strengthen their focus on core tasks.” The four new bodies are the Danish Medicines Agency, Danish Health Authority, Danish Patient Safety Authority and Danish Health Data Authority. The Medicines Agency is still searching for a director-general to lead it.

Market Turmoil Hinders IPOs, Big Pharma M&A

Just a month after announcing its intention to float on the London Stock Exchange, the UK’s Acacia Pharma Ltd. said Oct. 16 it was withdrawing its IPO to institutional investors because of market volatility in global equity markets, in the pharmaceutical sector in particular. Acacia is developing cancer supportive care products and has four lead products in the clinic, including APD421 in Phase III for the management of post-operative nausea and vomiting, expected to file in the second half of 2016. The potential IPO garnered interest from investors in Europe and the US but coincided with a period of market uncertainty, the company said.

However, Switzerland’s Basilea Pharmaceutica Ltd. has apparently had no qualms so far about a public offering of its shares on NASDAQ in the US via American Depositary Shares (ADS), announced Oct. 16. The company’s shares are already listed on the SIX Swiss Exchange, and the filing of the registration document at the SEC came on the same day its new antifungal Cresemba (isavuconazole) was approved for marketing in Europe. The product is already marketed in the US by co-developer Astellas Pharma Inc..

Market volatility also led to the IPO in Germany of Bayer AG’s former performance materials business, CovestroAG, being pitched to raise €1.5bn instead of the €2.5bn originally planned. By spinning out Covestro, Bayer is now a “life sciences” business focused on pharmaceuticals, consumer health and crop science. Much of the market turmoil was due to the emissions scandal linked to another German multinational, Volkswagen AG.

The second-largest publicly listed pharmaceutical business in Germany, Merck KGAA, was shaken up in October with a new “merck” logo and the appointment of Stefan Oschmann to replace Karl-Ludwig Kley, who is retiring as CEO of Merck KGaA and chairman of the executive board. Only in the US and Canada will the company continue to be known as EMD Serono, the company said. Merck has almost completed the $17bn acquisition of MilliporeSigma, more than a year after it was announced – Merck divested parts of its solvents and inorganics business in Europe to Honeywell International Inc. on Oct. 20 to win antitrust approval from the EU authorities, one of the last remaining steps before finalization of the Sigma-Aldrich acquisition.

New Facilities For Big Pharma

Merck confirmed Oct. 1 it was also investing €1bn in its HQ site in Darmstadt, Germany. It has just opened a €17m Innovation Center, and is spending another €69m on another Innovation Center, due to be completed in 2018, where Merck researchers will be able to work and interact with external innovators

Europe continues to attract capital to invest in the pharmaceutical sector. Tarrytown, NY-based Regeneron Pharmaceuticals Inc. said Oct. 19 it would invest an additional $350m in its manufacturing and processing facilities in Limerick, Ireland, and add another 200 jobs by the end of 2017. It started work on the plant in 2014, with an investment of $300m and 300 jobs. When completed, the facility will be the largest bulk biologics manufacturing facility in Ireland.

In Spain, the biotech subsidiary mAbxience of the Spanish multinational Chemo Group opened its first European biosimilar monoclonal antibody manufacturing facility in León, Northern Spain, on Oct. 16, where it will start developing biosimilar versions of Roche’s Mabthera (rituximab) and Avastin (bevacizumab). The company already markets a biosimilar rituximab in Argentina, where it has another manufacturing facility.

The UK government-supported Cell Therapy Catapult announced Oct. 9 it was to build a £55m ($85m) large-scale manufacturing center in Stevenage, UK. And Oxford-based UK biotech Adaptimmune Therapeutics PLC said it was expanding its R&D facilities with a new 67,000sq ft building, due for completion in late 2016. The company raised $176 million in an IPO on NASDAQ in May 2015.

AstraZeneca PLC announced Oct. 20 the opening of a new manufacturing and packaging facility in Kaluga, Russia, with a $224m investment, one of the largest for a pharma facility in the country. It will be fully operational in 2017 and will produce 40 million packs and 850 million tablets every year.

European Notebook: Pricing Mistrust Needs Open Debate; Rasi Nears EMA Return; Market Turmoil Affects IPOs

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