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AMD treatment: towards authorization of Avastin, the cheaper drug (rapporteur Safely budget)

 

Paris, June 30 2014 (AFP) - Use of the drug Avastin may be authorized to treat an eye disease, AMD, currently treated by the only Lucentis, although more expensive, said Monday AFP reporter (PS ) amending budget of Social Security in the Assembly, Gérard Bapt.

This authorization to treat related macular degeneration (AMD) should pass through a government amendment to the bill funding the Social Security Amendment (PLFSSR) for 2014, the examination begins Monday. Mr Bapt expects "an economy for Social Security euros 200 million per year at least."

While a draft decree had been raised to achieve this goal, "since it appears that the legislation is preferable, when a decree was legally challenged," said Mr Bapt.

The only drug approved in France for the treatment of AMD is Lucentis (molecule: ranibizumab, Novartis laboratory), the most expensive, while Avastin (molecule: bevacizumab, Roche Laboratories) is only permitted as anti-cancer The laboratory did not request authorization for AMD.

The high cost of Lucentis (800 euros per monthly injection) led hospital practitioners prescribe Avastin cancer (30 50 in euros per injection), with similar properties, but the Directorate General for Health (DGS) has banned this practice in July 2012 "to preserve the safety requirements", causing a stir of many specialists.

The Minister of Health and Social Affair, Marisol Touraine, had hoped in April that the least costly treatment can be used in France. Negotiations since 2012 his request with the laboratory via the Economic Committee for Health Products (CEPS), did allow for lower prices for Lucentis (10 2012,11% in% in% in 2013 and 9 2014), as the department.

In early April, the Competition Authority has ordered raids on Roche and Novartis, suspected anticompetitive practices in this folder.

The Italian Competition Authority imposed a fine of EUR 182,5 million in March to two laboratories for "unlawful agreement".

 

 

Pharmacy: shareholders approve the merger of BioAlliance Pharma and TopoTarget

 

Paris, June 30 2014 (AFP) - The shareholders of the French biopharmaceutical company BioAlliance Pharma and its Danish competitor TopoTarget have approved their final fusion and thus the birth of Onxeo group, expected to become a major player in Orphan Diseases in Oncology according to a statement Monday.

All resolutions on border merger between BioAlliance Pharma SA and TopoTarget A / S, by the shareholders of both companies, the 27 2014 June and June 30 2014 were approved "over 99%," the statement said the new group.

The merger is expected to close in July, says it does.

The date of the last trading day of TopoTarget the Copenhagen Stock Exchange, and the first trading day of BioAlliance Pharma (renamed Onxeo) also in Copenhagen, will be announced later ..

Shareholders will receive two TopoTarget BioAlliance for newly issued shares held 27 TopoTarget.

After the merger, the shareholders of BioAlliance hold about two thirds of the new entity, against about one-third for those TopoTarget.

Onxeo will be led by the current CEO of the French company, Judith Greciet, while Patrick Langlois remain chairman.

1997 created and introduced to the Euronext Paris in 2005, BioAlliance has widened its net loss last year to € 15,3 2013 million, against 11,5 2012 million, mainly because of spending on research and development increased.

 

 

European green light for the daclatasvir, a new drug for hepatitis C

 

Paris, June 27 2014 (AFP) - The daclatasvir a new drug against chronic hepatitis C, the U.S. pharmaceutical company Bristol-Myers Squibb (BMS) has received initial approval for marketing in Europe, said Friday the European Agency drug (EMA).

The Committee for Medicinal Products for Human Use (CHMP) of the EMA "recommended approval of the authorization on the market for Daklinza (daclatasvir) in combination with other medicines for the treatment of chronic hepatitis C in adults, "according to a statement from the EMA.

This medication belongs to a new class of molecules, the direct-acting antiviral (DAA), whose very expensive sofosbuvir (the American Gilead). The AAD are revolutionizing the treatment of hepatitis C, says EMA which states that it "actively supports the development of these new treatment options."

Hepatitis C is a liver disease caused by HCV, which can cause cirrhosis or liver cancer: 185 million people are infected worldwide and die 350.000 his liver complications, according to WHO.

The current standard is based on two drugs, Peg-interferon plus ribavirin. The problem is that its effectiveness is not optimal (in 50 75%) and there are many side effects: fatigue, eating disorders, sleep, anxiety, psychological disorders and dysfunction of the thyroid gland. The green light should now be formally approved by the European Commission.

 

 

Roche: CHMP positive opinion on Avastin for cancer of the ovary

 

Zurich, June 27 2014 (AFP) - The Swiss pharmaceutical group Roche said it had received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on Avastin, one of its key drugs for cancer of the ovarian difficult to treat.

This instance of the European Union (EU) in favor of the use of this drug in combination with chemotherapy for the treatment of ovarian cancer resistant to platinum-based chemotherapy, the group said Basel in a statement.

The ovarian cancer is one that has the highest among gynecological cancers mortality rates.

On 230.000 women diagnosed each year worldwide, many suffer from advanced disease who reoffend after initial treatment, said the Swiss group.

"The women with ovarian cancer resistant to platinum have few treatment options for difficult to treat their disease," said Sandra Horning, Chief Medical Officer and Director of Global Development at Roche products cited in the statement.

Approval of Avastin for this indication would be an important step for patients in Europe, allowing them to live longer without disease progression, has she said.

The CHMP positive opinion is based on a Phase III study showing that adding Avastin to chemotherapy 62% reduced risk of disease progression or death.

The European Commission generally follows the CHMP opinion within two months after the committee issued its opinion.

Paulson's fund invites in market battle Valeant / Allergan

 

New York, June 26 2014 (AFP) - The hedge fund investor John Paulson was invited in market battle between the Canadian drugmaker Valeant in the U.S. Allergan acquiring 1 billion shares this last wrote Wednesday Wall Street Journal.

Valeant launched June 1 18 hostile takeover bid for rival, having failed to convince the interest of reconciliation Allergan, maker of Botox anti-wrinkle treatment.

Paulson gold fund supports the operation, said the business daily, citing a source familiar with the matter.

He joins the battle of Pershing fund billionaire Bill Ackman, who vehemently argues for several months the idea of ​​a takeover by Valeant Allergan.

Pershing holds 9,7% of Allergan shares but must obtain total support 25% of the shareholders of the American manufacturer to convene an extraordinary meeting of the council in which he would replace a majority of the Board of Directors by favorable to his views officials.

Paulson holds for its part 6 million shares, or about 2% of Allergan shares, says the Wall Street Journal. It possessed no end of March.

Valeant had proposed for the first time in April Allergan to redeem for 45,6 billion. He then raised its bid to 49,4 billion, then 53,5 billion there two weeks.

Allergan has consistently refused to engage in discussions with Valeant, a laboratory which aims to integrate the global platoon blows acquisitions.

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