Medical Device Daily Contributing Writer
And MDDs

On the heels of the bold announcement by Daniel Bour, CEO of the French private hospital group Générale de Santé (Paris), that he was hunting for a European acquisition in excess of $1 billion (Medical Device Daily, March 13, 2007), the principal stockholder seized control of the company and sent the CEO packing.

Italian surgeon Antonino Ligresti, company chairman, on March 15 formally submitted to French financial authorities for the Bourse de Paris a plan for a holding company he controls, Santé Développement Europe, to purchase the remaining capital of the company.

Ligresti increased to 60% his holdings in Générale in early March by buying out the shares of the investment group Amber Capital (New York). Ligresti is offering EUR 32.50 for the remaining shares of the company.

Trading in Générale was suspended on March 7, closing at 132 ($43.87) a share, ending a steady rise of 20% over six months. The market capitalization is valued at 11.8 billion ($2.4 billion).

The contract for Bour was due to be renewed March 18, but one week ahead of that date Ligresti thanked Bour for his contribution and said Ross McInnes, a member of the board of his principal holding company Santé Sarl (Luxembourg), would take over until a new president arrives at the end of June.

The Italian financial press said Ligresti was uncomfortable with the aggressive strategy of Bour and what he called the instability of the American shareholders. The total cost of Ligresti's takeover is estimated at 11.3 billion ($1.75 billion).

In a statement Ligresti said: "Taking control of the majority of capital and voting rights definitively brings to the company a stable and committed shareholder."

Générale de Santé is the leading private clinic group in France, with 184 care centers and almost 15,000 beds covering services for general medicine, surgery, obstetrics, mental health, sub-acute care and rehabilitation, oncology-radiotherapy, diagnostics and home care. The company has 12 centers in Italy.

Revenues for 2006 were reported earlier this month at 11.7 billion ($2.2 billion).

Générale was the target for a takeover in 2003 by the Swedish hospital group Capio AB (Stockholm). Bour at that time introduced Ligresti to Générale as a white knight who bought a third of the shares.

1st thoracic aortic treatment with Powerlink DSS

Endologix (Irvine, California) reported the treatment of the first thoracic aortic dissection patient with the company's Powerlink Dissection Stent System (DSS). The procedure was performed by Dieter Raithel, MD, of the Southern Clinic (Nuremberg, Germany).

The Powerlink DSS, a variant of Endologix's Powerlink technology without the ePTFE graft cover, is being used as an investigational device in the European Union and is not currently available in the U.S.

The first treated patient, a 41-year-old woman, underwent cardiothoracic surgery last May for aortic valve replacement and conduit implantation to treat an aortic dissection that originated in the ascending aorta and extended into the iliac artery. She was readmitted earlier this month to treat a symptomatic aortic dissection distal to the surgical conduit.

"Having treated more than 400 patients over the past seven years for abdominal aortic aneurysm [AAA] with the Powerlink, I am excited to use a system based on this innovative stent technology to treat thoracic aortic dissection," Raithel said. "The implantation of the DSS, in combination with a proximal covered stent, was performed without problems."

Paul McCormick, president/CEO of Endologix, said, "We are enthusiastic about the application of our technology to treat thoracic aortic dissection. "The market size for thoracic aortic pathologies is poorly defined in the clinical literature and many fatal events due to this condition may go undiagnosed."

He added: "We believe that we can continue to focus on our core AAA market, while making progress in the early development of a Powerlink variant that leverages our platform technology to address a new and clinically significant market."

Drug approvals accelerating in France

Twenty-four new medications were launched in the French market in 2006 and 33 drugs received an extension of indication, for a total of 58 therapies introduced.

This marks a 21% increase over the 41 therapies introduced in 2005 and beats the average of 51 per year for the five previous years, according to Les Entreprises du Médicament (LEEM), the French pharmaceutical manufacturers association.

France is the only European country to regulate prescriptions with a "positive list" rather than listing drugs that are not allowed. This requires a longer process to introduce a drug to the reimbursement plan.

Each drug is then assigned a rating for its contribution to improving medical effectiveness (Amélioration du Service Médical Rendu, or ASMR) and this rating determines the category of reimbursement from 75% to 15%.

The advance in treatments for cancer in 2006 was characterized as "spectacular," by Catherine Lassale, the medical director at LEEM, who notes five new products considered "major" improvements to existing therapies and 10 that add to the range of already available treatments. Eight therapies received ASMR ratings for treatment of rare diseases.

Responding to pressure to reduce the delay between the approval of a drug for market and the assignment of ASMR ratings that triggers its distribution, the Health Authority (Haute Authorité de Santé) reported last month that it had increased by 92% the number of opinions issued in 2006, compared to 2005. It also said the approval cycle had been shortened by an average of 100 days.

The average delay in France, according to LEEM, is 380 days compared to the European community directive of 180 days, and the approval cycle in Germany and the UK that averages one month.