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Takeda Pharma says Japan approves two flu vaccine drugs

TOKYO Mon Mar 31, 2014 3:40am EDT

TOKYO (Reuters) - Takeda Pharmaceutical Co Ltd said on Monday it had received approval to manufacture and supply two vaccines for prevention of pandemic influenza from the Japanese health ministry.

The New Drug Application for the vaccines, H5N1 "Takeda" and "Takeda", was submitted in March 2013.

Takeda had entered a development, licensing and technology transfer agreement with Baxter International Inc in 2010 in which Baxter licensed exclusive rights to its cell culture-based pandemic flu vaccine technology for the Japanese market.

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Injured Gasquet out of Davis Cup quarter-finals

PARIS Mon Mar 31, 2014 5:42am EDT

PARIS (Reuters) - Richard Gasquet has pulled out of France's Davis Cup quarter-final tie against Germany this week with a lower back injury, the French federation said on Monday.

The FFT said in a statement that captain Arnaud Clement called up Edouard Roger-Vasselin and Michael Llodra to make up for the absence of Gasquet, who requires eight days of rest.

Clement, who also called up Jo-Wilfried Tsonga, Julien Benneteau and Gael Monfils, has until Thursday's draw to name his final team.

Germany are already without Tommy Haas and Florian Mayer, who are both injured, for the tie taking place in Nancy, Eastern France from Friday.

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Czech PPF buys stake in French cancer treatment research firm

PRAGUE, March 31 Mon Mar 31, 2014 6:28am EDT

PRAGUE, March 31 (Reuters) - Czech investment group PPF has acquired a minority stake French biotech company OriBase Pharma, PPF said on Monday.

PPF, owned by Czech businessman Petr Kellner, said it had committed to funding the group's drug development portfolio with investments that will enable it to increase its stake to a majority in the short-term.

New financial details were released. OriBase Pharma specialises in the development of new therapy treatments in oncology, PPF said. (Reporting by Jason Hovet, editing by Jan Lopatka)

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Straumann buys convertible bonds in South Korean implant maker

Mon Mar 31, 2014 6:18am EDT

* Spends $30 million on convertible bonds in MegaGen

* Bonds include option to obtain a majority stake

* Part of drive to expand in growing, low-cost implants

ZURICH, March 31 (Reuters) - Swiss dental implants maker Straumann has bought $30 million of bonds that can convert into shares of South Korean company MegaGen, as part of a drive to strengthen its position in the growing market for low-priced implants.

The world's largest maker of dental implants said on Monday the bonds, which bear 3 percent annual interest, included the option to be converted into shares in 2016, as well as an option to obtain a majority stake in MegaGen.

Faced with sluggish demand for premium implants in Europe as cash-strapped consumers cut back on expensive dental treatment, Straumann is expanding in the lower priced market, which makes up roughly 60 percent of industry volumes.

Chief Executive Marco Gadola said last year the company had up to 400 million Swiss francs ($450 million) available to spend on buying low-cost players in growing markets. The Basel-based firm already owns a 49 percent stake in Brazil's Neodent.

"Some dentists are willing to pay for lower standards than those offered by premium brands, which has fuelled growth in the value segment," Gadola said in a statement on Monday.

"To address their requirements and to capture this significant business opportunity, we are building a platform of value brands, in which MegaGen will have an important role."

Founded in 2002, privately-owned MegaGen is a fast-growing dental implants maker with sales volumes of more than 30 million last year, of which two thirds were in Asia/Pacific, Straumann said.

The Daegu-based company will spend the proceeds of the bonds on expanding its domestic and international implant business as well as promoting its digital dentistry platform.

By 0945 GMT, shares in Straumann were trading up 1.1 percent at 191.00 Swiss francs, outperforming a 0.3 percent firmer European healthcare sector index.

($1 = 0.8870 Swiss Francs) (Reporting by Caroline Copley; Editing by Mark Potter)

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China hardens medical device sector regulation, fines

SHANGHAI, March 31 Mon Mar 31, 2014 6:08am EDT

SHANGHAI, March 31 (Reuters) - China will increase fines and toughen oversight of the country's fast-growing medical device sector as it overhauls decade-old laws to stamp out corporate malpractice.

The new rules, which will come into effect from June, raise the top fine for illegal manufacturing or selling of medical equipment to 20 times the value of the goods, according to a document published on the website of the State Council, or cabinet, on Monday. The original law, established in 2000, set a cap at five times the value.

China's medical device market may double to more than $50 billion by 2020, according to research firm Global Data, and is a magnet for international firms looking to target the country's population of nearly 1.4 billion.

Medical device makers in China have drawn the glare of regulators before, hit by allegations of corruption and bribery. Some firms were also targeted last year for overpricing.

U.S. authorities have fined AGA Medical Corp and Biomet Inc millions of dollars for corporate malpractice in China, while Germany's Siemens AG had faced a lawsuit in the United States over its China operations, a case which was dismissed last year.

"The new rules increase the range of possible punishments, and the level of fines for the most serious violations," government officials said in a Q&A published on the State Council's website. Violations include operating without relevant licences or misleading regulators.

Under the new regulations, authorities will categorise medical devices into three segments, depending on the level of potential risk to consumers, with the highest risk products being put under the greatest scrutiny. Systems to monitor the industry and recall products will be reinforced.

"In recent years we've seen some issues of illegal behaviour, and the legal foundation for striking back has not been clear enough. To resolve the problem, we needed a complete revision of the existing legislation," the officials added.

In cases where the illegal equipment is valued at less than 10,000 yuan ($1,600), the fine can be up to 100,000 yuan. If the value of the devices is above 10,000 yuan, the fine can be between 10 and 20 times the value the goods involved.

In the most serious cases, firms which sell products illegally could be banned from applying for an operating license for up to five years. ($1 = 6.2122 yuan) (Reporting by Adam Jourdan; Editing by Ryan Woo)