In the land of the frowning sun
08-09-2011
by Jeffrey Bouley  |  Email the author

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OSAKA, Japan—While the news hasn't been disastrous, there have been at least three news stories since Friday featuring Takeda Pharmaceutical Co. Ltd. that bear bad tidings for the company.  
 
First came word on Aug. 5 that Takeda and San Diego-based Amylin Pharmaceuticals Inc. were discontinuing development of an investigational combination therapy for the treatment of obesity that comprises pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin. Market-watchers had speculated that might happen after Takeda and Amylin suspended a clinical trial examining the safety and effectiveness of the compound back in March.  
 
However, the company is officially denying the March decision led directly to the current one, saying that the joint decision to discontinue the formulation instead was based "on a commercial reassessment of the pramlintide/metreleptin program, which had been in Phase II development as a twice-a-day injection formulation. The commercial assessment took into account a revised development plan as well as evolving dynamics within the obesity therapeutic area."  
 
Reportedly, the companies will continue to evaluate other assets for potential obesity treatment and related indications under the terms of their existing collaboration agreement.
 
"The interplay of hormonal signals, such as amylin and leptin, plays a crucial role in the regulation of body weight," said Dr. Christian Weyer, senior vice president of research and development at Amylin in an official statement. "Advances in peptide engineering and delivery may help us leverage this biology to develop a therapy with less frequent dosing. With our partner, Takeda, we look forward to continuing to explore new options for the obesity market."  
 
Also affirming the two companies' commitment to the treatment of obesity, if not this specific product, was Dr. David Recker, senior vice president of clinical science for the Takeda Global Research & Development Center, who said, "As the prevalence of obesity continues to rise in the U.S., it is important to develop innovative weight loss therapies for patients with this condition."  
 
Amylin and Takeda will continue to investigate the previously announced antibody-related laboratory finding with metreleptin treatment in patients who participated in a previously completed clinical study of obesity. Neither Amylin nor Takeda expect to revise the latest financial guidance for their respective 2011 fiscal years in connection with the discontinuation of this program.  
 
The next bit of bad news for Takeda came Aug. 8 with the U.S. Food and Drug Administration (FDA) approving updated drug labels for pioglitazone-containing diabetes medicines to include a safety warning that the use of pioglitazone for more than one year may be associated with an increased risk for bladder cancer.
 
According to the new drug label, healthcare professionals should:
  • Not use pioglitazone in patients with active bladder cancer.
  •  Use pioglitazone with caution in patients with a prior history of bladder cancer.  
The updated drug labels recommend that patients should:
  • Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain on urination since starting pioglitazone, as these may be due to bladder cancer.  
Those pioglitazone- containing medicines, all of which come from Takeda, are Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin extended-release) and Duetact (pioglitazone/glimepiride)  
 
That news was accompanied by reports on Aug. 5 and Aug. 8 that Takeda is now facing hundreds of lawsuits and possibly a large drop in sales for Actos, after already having halted sales in Germany and France after pressure from regulators.  
 
Takeda declined to comment on the coming and possibly fast-growing number of lawsuits, though it has noted it is committed to keeping Actos available for patients who need it. Spokeswoman Elissa Johnsen noted that an April study in the journal Diabetes Care found Actos "use for more than two years was weakly associated with increased risk" although the FDA, in analyzing data from the first five years of a 10-year Actos safety study Takeda began in 2002, said the risk was 40 percent higher than that for patients taking the drug for at least a year.  
 
That still doesn't amount to huge numbers—an extra 28 cases a year for every 100,000 people taking Actos—but some analysts see this as a big blow for Takeda. The company loses patent protection for Actos next year, and now not only will lose income in the final stretch but also face an uphill battle for two experimental drugs that were expected to succeed Actos. One has been hung up due to safety concerns by the FDA and the other combines alogliptin and Actos, which makes it unlikely to get approval, much less take off if it does. 

Code: E08101102

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