Tuesday, February 23, 2010

GlaxoSmithKline shares drop 2,5%

Is really Avandia that bad or is it just a game of GSK's competitors? I'd love to know the truth.

Monday, February 22, 2010

Poll: will Avandia be eventually pulled off the market?

Decided to try SurveyMonkey and at the same time figure out what people think of the possible end of the story with GSK's Avandia.
Here's the link to the poll, it's very simple (yes/no)

Sunday, February 21, 2010

Why I love Sunday

Day with no major breaking news! Such a relief.

Heard the news?

Take a deep breath... everything is not so bad

So upsetting to read the news about such vital meds - when life is going to get better and taking meds from asthma won't cause death?

Saturday, February 20, 2010

Remove Diabetes Drug Avandia From Market: FDA Reports

The blockbuster type 2 diabetes drug Avandia raises users' odds for heart attack and heart failure and should be removed from the market, according to confidential government reports.
The New York Times on Saturday reported on documents from the U.S. Food and Drug Administration that find that if people now taking (rosiglitazone) Avandia switched to a similar medication, Actos, about 500 heart attacks and 300 cases of heart failure would be eliminated each month. And in a report from the Institute for Safe Medication Practice, Avandia was linked to 304 deaths in the third quarter of 2009 alone, the highest for any prescribed drug in that time period, the Times reported.
In one of the FDA documents, dated October 2008, Drs. David Graham and Kate Gelperin -- drug safety officials at the agency -- agreed that "rosiglitazone should be removed from the market."
The reports, obtained early by the Times, are yet another chapter in Avandia's checkered history. The drug was once taken by millions worldwide, but that changed after a study released in early May of 2007 by the Cleveland Clinic suggested that Avandia carried cardiovascular risks. That study, which included more than 28,000 people, found that Avandia increased a user's odds of heart attack by 43 percent compared to those not taking the medicine.
At the time, Dr. Bruce M. Psaty of the University of Washington -- who also co-wrote an accompanying editorial in the New England Journal of Medicine -- urged the FDA to restrict access to Avandia and cited both the agency and the drug's maker, GlaxoSmithKline, for poor oversight.
"The primary problem here is that studies that were needed early on about the health benefits of this drug were never done," Psaty told HealthDay. "As a result of the failure of the sponsor to do long-term clinical trials to show health benefits, as a result of the failure of the FDA to insist on it, we have data that are weak."
Following on the Cleveland Clinic study, the FDA demanded "black box" warnings on labeling for both Avandia and Actos, warning of a potentially heightened risks for heart failure. However, other studies found no raised level of heart risk, and at the time the agency said it had not reached a definitive conclusion on the data.
In November of the same year, the FDA updated Avandia's labeling to include a caution regarding heart attack risk. At the time, Dr. Janet Woodcock, acting director of the FDA's Center for Drug Evaluation and Research, said that, "we are keeping Avandia on the market because we have concluded there isn't enough evidence to indicate that the risk of heart attack is higher for Avandia than other type 2 diabetes treatments."
The story got more complicated in 2008, as a number of studies emerged tying the use of Avandia to increased bone fracture risk.
Throughout 2009, more studies reiterating the drug's heart risks also came to light, including one published in the BMJ suggesting that Avandia's risk for heart failure seemed to outstrip those of its related rival, Actos.
By that point, "most clinicians [had] stopped using Avandia -- some will use Actos instead or go to another class completely," Dr. Carl J. Lavie, medical director of cardiac rehabilitation at the Ochsner Heart and Vascular Institute in New Orleans, told HealthDay at the time.
The emergence of the leaked documents on Saturday comes at a time when officials within the FDA seem to be at loggerheads over whether to ban Avandia or not, the Times reported. The newspaper said that some officials believe that safer alternatives exist, while others say the evidence on Avandia's safety is conflicted and the drug should remain available as a treatment option.
Trying to sort things out, in December of 2009 Woodcock asked officials at the FDA to convene another advisory committee to determine whether Avandia should remain on the market, with a decision expected this summer.
In the meantime, a bipartisan Senate investigation -- overseen by Sen. Max Baucus (D-Mont.) and Sen. Charles E. Grassley(R-Iowa) -- has pored over 250,00 internal documents from GlaxoSmithKline. The investigation has placed much of the blame for the Avandia debacle on the company, contending that it neglected to warn patients for years of the drug's dangers.
"G.S.K. executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk," according to the Senate investigation report, which is slated for release Monday but was obtained early by the Times.
Speaking to the newspaper Friday night, agency commissioner Dr. Margaret Hamburg said that, "I await the recommendations of the advisory committee. Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved."
For its part, GlaxoSmithKline continued to assert that "scientific evidence simply does not establish" that Avandia heightens heart attack risk, and it disagrees with the Senate investigation findings.
In the wake of the controversy, the drug company had been directed by the FDA to conduct a trial comparing rates of heart attacks, strokes and heart-linked deaths among users of Avandia, Actos or a placebo. But according to internal documents accessed by the Times, Graham and Gelperin characterized the study, called TIDE, as "unethical and exploitive," with patients being given Avandia despite the fact that it appears to come with greater risks and no added benefit over Actos.
One of the Graham/Gelperin reports -- dated October 2008 -- concludes that, "Although the proposed TIDE trial is motivated by a desire for definitive answers regarding the cardiovascular safety of the drug rosiglitazone, the safety of the study itself cannot be assured and is not acceptable."
However, other FDA officials overruled those concerns and TIDE is still enrolling patients, with preliminary results expected by 2014.
The ongoing controversy has dampened patients' and physicians' enthusiasm for Avandia. According to the Times, while sales of the drug topped $3.2 billion in 2006, those numbers plummeted soon after the first studies suggesting risk emerged a year later.
Still, "hundreds of thousands" of people still take Avandia, the Times noted. GlaxoSmithKline's patent on the drug expires in 2012.

Source: Drugs.com

Thursday, February 18, 2010

OTC shopping destination: Japan

Boehringer Ingelheim’s buyout of the remaining stake in Japanese over-the-counter drugs maker SSP Co Ltd. is a bet on a recovery in Japan’s (OTC) sector. That may mean more buying opportunities.
The liberalization in 2009 of OTC drug sales in Japan may prove to be the turning point for a return to health. Pharma companies with an established interest in consumer brands - Novartis, for example, which is pushing Japanese growth - should take a close look.
Relatively unchallenging current valuations of two local players, Taisho Pharmaceutical Co and Lion Corp., could spur bite-sized M&A if acquirers take as bullish a view as Boehringer.
Sanofi-Aventis, which last year bought Chattem Inc. in the U.S., and GlaxoSmithKline, an established consumer health player with a strong focus beyond its traditional markets, might also be looking to buy. Outside big pharma, interest could come from cash-rich Reckitt Benckiser.
Taisho is Japan’s largest OTC player, and last year bought Bristol-Myers Squibb’s Asia-Pacific OTC business. It expects its self-medication division, which includes energy drinks as well as OTC cold remedies, to post full-year 2009/10 sales of Y159 billion, down 2% on the year, with operating margins squeezed well below the 18% seen the previous year.
Okay, that’s not bullish, but it isn’t worse than most other Japanese OTC firms. Acquirers could follow the example of Boehringer, which has hinted at cutting costs out of SSP and using the group to sell additional switch-OTC products.
Although Taisho’s EV multiple of 8.6x reported Ebitda is at the top of the OTC sector, this likely reflects its smaller, but growing, prescription pharma unit. This business could be integrated into a pharma firm’s operations or, for a non-pharma player like Reckitt, divested.
As a comparison, Boehringer is buying the 40% SSP stake at an 8.8x multiple, but that puts a 34% premium on SSP’s share price.
Meanwhile, Lion trades at a more modest multiple, and an 18% premium to the current price would see an acquirer pay Y143 billion, an EV of 8.8x Ebitda. Lion’s healthcare business, including cosmetics as well as OTCs, accounted for 42% of Y228 billion nine-month group sales, which feature its struggling household and chemical products divisions.
Turning around these non-healthcare assets might be of particular interest to Reckitt, a major player in household detergents, which needs more OTC drugs to plug the gap left by patent expiry for its heroin addiction treatment Suboxone.
Another strategy for an acquirer could be a buyout of an OTC business of one of Japan’s larger pharma groups, say Takeda Pharmaceutical or Daiichi Sankyo, if these companies see more sense in focusing on their higher-margin prescription drug operations.
Takeda had nine-month OTC sales of Y47 billion, while Daiichi Sankyo’s were Y35 billion, roughly on a par with SSP. Sales at both firm’s OTC businesses were down by 6% year on year, and the divisions comprised 4-5% of each group’s revenue.
Japan’s OTC drug sector is worth a little over $1 billion a year in sales, and lack of growth has spurred internal consolidation, such as Lion’s purchase of the local OTC businesses of Bristol-Myers Squibb and Chugai, and Astellas Pharma Inc.’s divestment of OTCs to Daiichi Sankyo.
The change last year to Japan’s Pharmaceutical Affairs Act, which allowed general retailers to start selling many non-prescription drugs, may mean increased competition for pharmacies from supermarkets but could stimulate overall growth in OTC sales.
That’s what Boehringer is banking on.

Source: The Wall Street Journal