PHARMACY

Jazz Pharmaceuticals, Azur Pharma combine

BY Allison Cerra

DUBLIN — Jazz Pharmaceuticals and Azur Pharma will become one company, the two drug makers said.

The two said the it now will be a specialty biopharmaceutical company called Jazz Pharmaceuticals plc and will be based in Dublin.

"As Jazz Pharmaceuticals plc, we are a growing, profitable specialty biopharmaceutical company with a diverse portfolio of products in the central nervous system and women’s health areas," said Bruce Cozadd, chairman and CEO at Jazz Pharmaceuticals. "We now have a strengthened management team, a broader commercial organization and an efficient platform for further growth, with resources to build our product portfolio and a future pipeline."

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Frost & Sullivan forecasts strong growth in generic drug market through 2017

BY Alaric DeArment

LONDON — Patent expirations of key blockbuster drugs and efforts by payers to contain costs are likely to bring strong growth to the global generic drug market in the next few years as market-earned revenues grow by more than $100 billion, according to an analysis by research firm Frost & Sullivan.

The report, titled "Generic Pharmaceuticals Market — A Global Analysis" and focusing on the United States and Europe, also found that healthcare expenditure and sales revenues are poised to shift to India, China, Brazil, Turkey and South Korea.

Meanwhile, market-earned revenues are likely to grow from 2010’s $123.85 billion to $231 billion in 2017 at a compound-annual growth rate of 9.29% between 2011 and 2018.

"The patent expiry of several major blockbuster drugs worth $150 billion between 2010 and 2017 will fuel the growth of the global generic pharmaceuticals market," Frost & Sullivan research analyst Aiswariya Chidambaram said. "The trend is shifting towards less competitive, yet commercially attractive segments such as difficult-to-produce generics, specialty generics and biosimilars."

The report noted a growth in strategic alliances between branded and generic drug companies for marketing rights and exclusivity for generic versions of such drugs as Pfizer’s cholesterol-lowering drug Lipitor (atorvastatin), Merck’s blood pressure drug Cozaar (losartan) and AstraZeneca’s cholesterol drug Crestor (rosuvastatin). Meanwhile, Teva, Sandoz and Mylan increasingly are focused on biosimilars.

Still, strengthening regulations and price control measures could have a dampening effect.

"The increase in the prevalence of chronic disorders, newly reported diseases and aging populations have resulted in tremendous pressure placed on governments to implement cost-containment measures and curb rampant healthcare expenditure," Aiswariya said.


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Provectus receives FDA guidance for late-stage trial of melanoma drug

BY Alaric DeArment

KNOXVILLE, Tenn. — The Food and Drug Administration has provided guidance to Provectus Pharmaceuticals as the drug maker prepares to apply with the agency for approval to start a late-stage clinical trial of a drug for skin cancer, Provectus said Wednesday.

Provectus is planning to start a phase-3 trial of the investigational drug PV-10 for melanoma that has spread to other parts of the body, and said the FDA told the company that a meeting with the agency in addition to the one they had in October would not be required.

"Following our third meeting with the agency in October, we believed that significant progress had been achieved in defining the threshold the FDA will require for approval in melanoma, which is a rapidly evolving therapeutic area," Provectus CEO Craig Dees said.

 


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