Hat tip: http://arbroath.blogspot.com/
Friday, July 10, 2009
Merck - Zetia: clinical trials, ain't they a bitch
Merck & Co. fell in New York trading after researchers halted a study comparing Abbott Laboratories’ cholesterol drug Niaspan with Zetia, sold by Merck and Schering- Plough Corp.
The researchers said there were no safety concerns and chose to stop the study, called Arbiter 6 Halts, after a “prespecified, blinded interim analysis,” according to a posting in the National Institutes of Health’s clinical trials database. Abbott doesn’t know why the study was ended early and wasn’t involved in the decision, said Elizabeth Hoff, a spokeswoman for the company, based in Abbott Park, Illinois.
The study may have shown Niaspan was more effective at unclogging arteries than Zetia, according to analysts from Natixis Bleichroeder Inc. and Wells Fargo Securities LLC. A finding favoring Niaspan may further erode sales of Zetia, which fell 22 percent in the U.S. last year after studies, said Jon Paul LeCroy, an analyst with Natixis, who downgraded Merck today.
The researchers said there were no safety concerns and chose to stop the study, called Arbiter 6 Halts, after a “prespecified, blinded interim analysis,” according to a posting in the National Institutes of Health’s clinical trials database. Abbott doesn’t know why the study was ended early and wasn’t involved in the decision, said Elizabeth Hoff, a spokeswoman for the company, based in Abbott Park, Illinois.
The study may have shown Niaspan was more effective at unclogging arteries than Zetia, according to analysts from Natixis Bleichroeder Inc. and Wells Fargo Securities LLC. A finding favoring Niaspan may further erode sales of Zetia, which fell 22 percent in the U.S. last year after studies, said Jon Paul LeCroy, an analyst with Natixis, who downgraded Merck today.
Thursday, July 09, 2009
Onglyza - prepare for launch
AstraZeneca Plc and Bristol-Myers Squibb Co. are preparing to introduce their new diabetes drug Onglyza to the German market in the third quarter as U.S. regulators continue their review of the medicine.
The U.K. and U.S. drugmakers, which plan to jointly market the product as part of a diabetes partnership they began in January 2007, may offer patients a treatment with fewer side effects than current therapies, said Bristol-Myers’s German chief Han Steutel in a press briefing in Frankfurt late yesterday.
“The products which are currently on the market have side effects” such as weight gain and a lower than normal level of glucose in the blood, said Steutel. Onglyza does not have such side effects, he said. The drug won the backing of a European Medicines Agency panel last month, a recommendation that is typically followed by European Commission approval within about three months.
The U.K. and U.S. drugmakers, which plan to jointly market the product as part of a diabetes partnership they began in January 2007, may offer patients a treatment with fewer side effects than current therapies, said Bristol-Myers’s German chief Han Steutel in a press briefing in Frankfurt late yesterday.
“The products which are currently on the market have side effects” such as weight gain and a lower than normal level of glucose in the blood, said Steutel. Onglyza does not have such side effects, he said. The drug won the backing of a European Medicines Agency panel last month, a recommendation that is typically followed by European Commission approval within about three months.
Wednesday, July 08, 2009
EC antitrust report out
The long-awaited European Commission antitrust report following an 18-month investigation of the drugs industry has been published this morning with the authors saying that “shortcomings in the pharmaceutical sector require further action”.
The final report says that market entry of generic drugs is delayed and the EC’s inquiry “suggests that company practices are among the causes”. However, it does not exclude “other factors such as shortcomings in the regulatory framework”. The Commission said it intends to “intensify its scrutiny of the pharmaceutical sector… including continued monitoring of settlements between originator and generic drug companies” and “the first antitrust investigations are already under way”.
Competition Commissioner Neelie Kroes said that “we must have more competition and less red tape in pharmaceuticals”, saying the sector “is too important to the health and finances of Europe's citizens and governments to accept anything less than the best”. She added that “the inquiry has told us what is wrong with the sector, and now it is time to act”, noting that “we will not hesitate to apply the antitrust rules where such delays result from anticompetitive practices”.
More specifically, the Commission has announced an antitrust investigation into Servier, plus the generics firms Teva, Krka, Lupin, Mylan’s Matrix Laboratories unit and Niche Generics, part of Unichem Labs.
PharmaTimes World News will have comprehensive coverage of the report’s findings and reaction in tomorrow’s elert.
By Kevin Grogan
The final report says that market entry of generic drugs is delayed and the EC’s inquiry “suggests that company practices are among the causes”. However, it does not exclude “other factors such as shortcomings in the regulatory framework”. The Commission said it intends to “intensify its scrutiny of the pharmaceutical sector… including continued monitoring of settlements between originator and generic drug companies” and “the first antitrust investigations are already under way”.
Competition Commissioner Neelie Kroes said that “we must have more competition and less red tape in pharmaceuticals”, saying the sector “is too important to the health and finances of Europe's citizens and governments to accept anything less than the best”. She added that “the inquiry has told us what is wrong with the sector, and now it is time to act”, noting that “we will not hesitate to apply the antitrust rules where such delays result from anticompetitive practices”.
More specifically, the Commission has announced an antitrust investigation into Servier, plus the generics firms Teva, Krka, Lupin, Mylan’s Matrix Laboratories unit and Niche Generics, part of Unichem Labs.
PharmaTimes World News will have comprehensive coverage of the report’s findings and reaction in tomorrow’s elert.
By Kevin Grogan
BNP Wives
Watch
A documentary exploring the extraordinary lives of women working for the British National Party.
A documentary exploring the extraordinary lives of women working for the British National Party.
Which Big Pharma execs said these quotes
"Direct-to-consumer promotion was the single worst decision for the industry. When industry says we're spending all the money on R&D but actually it's spending it on TV advertising to preserve margins, it doesn't get much credibility."
And:
"The marginally-different-and-market-it-like-hell model is over."Answer
Tuesday, July 07, 2009
Lundbeck have their wallet out
Lundbeck has hit the acquisition trail and is buying the UK’s LifeHealth Ltd as well as fellow Danish firm NeuronIcon.
First up, the Copenhagen-based firm is shelling out $147 million to buy the Berkshire-headquartered group saying that the deal is “a logical next step” follwing its acquisition in March of the USA’s Ovation Pharmaceuticals. One of the latter’s key products is Xenazine (tetrabenazine) for chorea associated with Huntington's disease, but LifeHealth owns 25% of the sales of the drug in the USA and Canada, less production costs.
LifeHealth also holds about 50% of non-North American sales of the product “to distributors into the territories”, Lundbeck said, so by acquiring the UK firm, it “substantially increases its economic share of the tetrabenazine asset and retains certain rights to all future indications, including the controlled-release formulation currently in development”. Lundbeck chief executive Ulf Wiinberg noted that Xenazine is the only US Food and Drug Administration-approved product for patients suffering from chorea associated with Huntington's disease and it has been doing very well since its US launch in November last year.
Lundbeck believes the sales potential for Xenazine in the USA, where 20,000-25,000 patients suffer from the disease, to be more than $250 million. Mr Wiinberg added that “this new transaction strengthens Lundbeck's US platform and materially improves the earnings outlook” across the Atlantic. The deal will be immediately accretive to profits and is being financed using currently available cash resources.
Meantime Lundbeck is also acquiring the privately-owned biotechnology group NeuronIcon for an undisclosed sum.
Aarhus-based NeuronIcon is developing new therapies for acute brain damage after strokes or skull fractures. The firm has “produced new knowledge about why and how nerve cells in the brain are lost”, said Jan Egebjerg, director of Lundbeck's biologic research unit, and its “promising technologies provide a solid foundation for Lundbeck to develop new pharmaceuticals for improved treatment of the very serious brain disorders that lead to nerve cell destruction," he added.
NeuronIcon was founded by scientists at the University of Aarhus and is based on research conducted there and at the University of Berlin. Lundbeck said that these scientists “have made the world's first discoveries of how the body's own protein, sortilin, kills nerve cells if activated in special situations that arise in connection with disorders such as stroke, spinal cord injuries and Alzheimer's and Parkinson's diseases”
Lundbeck has also signed an agreement with the University of Aarhus, giving it certain rights to any new discoveries made over the next three years.
By Kevin Grogan
First up, the Copenhagen-based firm is shelling out $147 million to buy the Berkshire-headquartered group saying that the deal is “a logical next step” follwing its acquisition in March of the USA’s Ovation Pharmaceuticals. One of the latter’s key products is Xenazine (tetrabenazine) for chorea associated with Huntington's disease, but LifeHealth owns 25% of the sales of the drug in the USA and Canada, less production costs.
LifeHealth also holds about 50% of non-North American sales of the product “to distributors into the territories”, Lundbeck said, so by acquiring the UK firm, it “substantially increases its economic share of the tetrabenazine asset and retains certain rights to all future indications, including the controlled-release formulation currently in development”. Lundbeck chief executive Ulf Wiinberg noted that Xenazine is the only US Food and Drug Administration-approved product for patients suffering from chorea associated with Huntington's disease and it has been doing very well since its US launch in November last year.
Lundbeck believes the sales potential for Xenazine in the USA, where 20,000-25,000 patients suffer from the disease, to be more than $250 million. Mr Wiinberg added that “this new transaction strengthens Lundbeck's US platform and materially improves the earnings outlook” across the Atlantic. The deal will be immediately accretive to profits and is being financed using currently available cash resources.
Meantime Lundbeck is also acquiring the privately-owned biotechnology group NeuronIcon for an undisclosed sum.
Aarhus-based NeuronIcon is developing new therapies for acute brain damage after strokes or skull fractures. The firm has “produced new knowledge about why and how nerve cells in the brain are lost”, said Jan Egebjerg, director of Lundbeck's biologic research unit, and its “promising technologies provide a solid foundation for Lundbeck to develop new pharmaceuticals for improved treatment of the very serious brain disorders that lead to nerve cell destruction," he added.
NeuronIcon was founded by scientists at the University of Aarhus and is based on research conducted there and at the University of Berlin. Lundbeck said that these scientists “have made the world's first discoveries of how the body's own protein, sortilin, kills nerve cells if activated in special situations that arise in connection with disorders such as stroke, spinal cord injuries and Alzheimer's and Parkinson's diseases”
Lundbeck has also signed an agreement with the University of Aarhus, giving it certain rights to any new discoveries made over the next three years.
By Kevin Grogan
Monday, July 06, 2009
A long portrait
Long Portrait: Graciella Longoria from Clayton Cubitt on Vimeo.
Long portrait of Graciella Longoria, on the first anniversary of her father's death in a car accident. Photographed by Clayton Cubitt on his terrace, Brooklyn. June 2009
Caraco cut 350
Caraco Pharmaceutical Laboratories Ltd said it would slash more than half its workforce to align its expenses with the current halt in production, following U.S. health regulators' recent seizure of the company's medicines on repeated manufacturing violations.
The company, which said it would cut 350 jobs, added that JPMorgan Chase Bank has informed the company that its $10 million line of credit was not available to be drawn down upon until the regulatory matter was resolved.
The company, which said it would cut 350 jobs, added that JPMorgan Chase Bank has informed the company that its $10 million line of credit was not available to be drawn down upon until the regulatory matter was resolved.
Introducing Pharma Phacts
Medical students are pledging a lifetime of abstinence - from drug company freebies, hoping to educate fellow students about alleged marketing tactics employed by pharmaceutical companies.
Fearing their future prescribing habits could be shaped by the pens, stethoscopes, and tape measures on offer at sponsored meetings and briefings, the students say their stance brings awareness and extends further than idealism.
They’ve launched Pharma Phacts, a national campaign from healthyskepticism.org to highlight the strong ties the medical industry has with drug manufacturers, including CME. The optional online pledge is to never accept another pharma freebie.
Australian Medical Students Association (AMSA) president Tiffany Fulde says the rationale behind Pharma Phacts was “aspirational”, but whether it was realistic was difficult to determine due to wide exposure in the workforce.
While AMSA does not directly endorse the campaign, it was launched at the AMSA Global Health Conference over the weekend, and it ties in with some of AMSA’s own pharmaceutical sponsorship guidelines, says Ms Fulde.
“There’s been research into pharmaceutical sponsorship of different educational events, that if an event is sponsored by a particular company, students were less likely to be critical of that company later on,” says Ms Fulde.
“Ultimately education of students is all about patient care down the track, and if the way that education is delivered, or funded, impacts upon that quality, Pharma Phacts is designed to try and make students aware of that and help combat that if that’s the case,” she told 6minutes.
Safety first!
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for July 2009 (PDF).
This issue contains advice that the combination of clopidogrel and PPIs should be avoidedunless considered essential due to an interaction that reduces efficacy of the clopidogrel. The evidence of clinical significance is not entirely conclusive but the needs for each of these drugs should be assessed and an alternative used where possible. Clinicians should considerif aspirin might be a suitable antithrombotic or if the PPI is still necessary.
The hot topic reviews the current risk-benefit ratio for long-acting beta agonists (LABA) in chronic obstructive pulmonary disease (COPD) and stop press covers the following:
- Mycophenolate mofetil: pure red cell aplasia
- Hydroxycut range of food supplements: risk of liver damage
- Priadel Liquid: potential for dosing errors
- Clarification: ACE inhibitors and angiotensin II receptor antagonists – use during breastfeeding
Hat tip: http://www.prescriber.org.uk/
Lobbying healthcare - hey big spenders!
The nation's largest insurers, hospitals and medical groups have hired more than 350 former government staff members and retired members of Congress in hopes of influencing their old bosses and colleagues.
The hirings are part of a record-breaking influence campaign by the health-care industry, which is spending more than $1.4 million a day on lobbying in the current fight.
The hirings are part of a record-breaking influence campaign by the health-care industry, which is spending more than $1.4 million a day on lobbying in the current fight.
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