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Daily Brief: Italy in turmoil, Pharma attacks Europe's generics move and more

A rapid round up of news from pharma, biotech and healthcare

Hello and welcome to Pharmaceutical Market Europe's quick spin through some of today's eyecatchings developments.

Italy’s anti-EU populists

While the US and UK return from public holidays today, Europe is already well into its week. Undoubtedly the biggest developing story in the EU is the turmoil in Italy.

After months without a government, two populist and anti-EU parties, Five Star and the League, emerged with the strongest mandates from voters, who have rebelled against established parties, reflecting a trend seen in many other European countries.

The two parties had attempted to form a coalition, and had proposed withdrawing Italy from the Euro currency.  However the coalition has now collapsed after a key appointment was blocked by Italy’s President Sergio Mattarella, who has now asked ex-IMF economist Carlo Cottarelli (pictured below) to form an interim government.

Italy is the EU’s fourth-biggest economy and the turmoil there represents a new threat to Europe,  shaking investor confidence in Italy and the wider Eurozone, which has been showing signs of strong economic growth.

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The Prime Minister-in-waiting says he will hold new elections by early 2019, but populist political sentiment is not expected to wane.

For business in Europe, this is just the kind of instability it doesn’t need. Nathalie Moll, director general of European pharma association EFPIA told PME recently that Europe could move on from Brexit – but needed to ensure no other country made for the exit.

Pharma attacks Europe’s pro-generics tweak

Meanwhile EFPIA has spoken out strongly against plans to make it easier for EU generics firms to compete in global markets.

The European Commission wants to introduce a Supplementary Protection Certificates (SPCs) waiver, which would allow them to produce generic copies of drugs for non-EU markets faster. However EFPIA sees it as an erosion of EU intellectual property, and says it is bad news for long term confidence in Europe’s commitment to R&D. Read more here.

Tecentriq keeps pace with Keytruda in lung cancer

Tecentriq

Roche says its immunotherapy Tecentriq has just hit its progression free survival and overall survival endpoints in a phase III study in non-squamous lung cancer.

This is reassuring news for Roche, as it means Tecentriq is matching its big rival, Merck & Co’s Keytruda in the all-important non-small cell lung cancer market.

Neither company has yet released data from the studies, other than to say they hit their endpoints, but once they do analysts will pore over the details to see who might have the edge.  Read Roche's release here.

China’s Luye Pharma shows global ambitions with Seroquel acquisition

Hong Kong-based Luye Pharma wants to be a player in the global pharma market, and is to pay $546m to AstraZeneca for rights to its former blockbuster Seroquel and Seroquel XR in international markets.

The deal shows AstraZeneca continuing its tactic of selling off rights to older largely off-patent brands in order to keep its revenues healthy as it waits for the next generation of drugs to  replace its former blockbusters.

Luye Pharma’s expansion meanwhile illustrates the boom in China’s pharma and biotech sector, which is being boosted by greater regulation and investment in the sector, plus Hong Kong’s recent decision to allow pre-revenue biotechs to launch on its stock exchange.

The company will acquire rights to Seroquel and Seroquel XR in 51 countries and regions including China, the UK, Brazil, Australia, Saudi Arabia, Mexico, South Korea, Thailand, Argentina, Malaysia and other countries and regions in Asia, Latin America, Africa, Oceania and Eastern Europe.

It believes it can oversee a major increase in Seroquel sales in China.  Luye Pharma says revenues for Seroquel products in Asian countries and regions including China was just S$74m.

It says sales revenue for Seroquel and Seroquel XR in China are expected to exceed RMB 1 billion (around $155m) thanks to changes in reimbursement in the country, and believes there is further space for growth in international markets.

Luye Pharma isn’t just acquiring older products, but is developing new formulations of existing drugs using its microspheres drug delivery technology.

It has as acquired rights to numerous CNS products, and is applying its microsphere technology to the treatments.

Its pipeline includes Risperidone Extended-Release Microspheres for Injection candidate (LY03004) for schizophrenia and bipolar disorder, and plans to launch in China and the US by the end of 2018, while an extended release version of Rotigotine for Parkinson's disease is also on course for a launch in 2019.

The company says it will now build commercial operations in Europe, and sees the Seroquel brands as complementary to its CNS portfolio.

Dr. Yehong Zhang, head of Luye Pharma (International) said: "Central nervous system diseases continue to present a challenge to patients and healthcare systems across the world. This transaction represents another step in our effort to build a portfolio and platform to help address this issue. It is an affirmation of our commitment to accelerate our international presence."

Article by
Andrew McConaghie

29th May 2018

From: Research

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