TRENTON - An experimental anti-clotting drug that Merck & Co. is developing was found to increase risk of dangerous internal bleeding in a second study, meaning it's unlikely to achieve the blockbuster status once expected, if it's even approved.
Vorapaxar is part of a new generation of anti-clotting drugs meant to prevent the death and disability strokes and heart attacks cause in the millions of people at risk for them. Drugmakers have generally touted their compounds as more effective and safer than Coumadin, known chemically as warfarin, the standard treatment for decades despite the need for frequent blood tests because getting the dosage right is so tricky.
On Tuesday, Merck said top-line results from a 26,000-patient study called TRA-2P show vorapaxar, when added to standard anti-clotting therapy, significantly reduced risk of heart attack, stroke, and death from heart disease or emergency heart surgery.
But the company said there was a significant increase in bleeding, including bleeding inside the skull. That can cause a stroke, brain damage or death. Such intracranial bleeding was less common in patients who had not previously had a stroke.
A year ago, the same bleeding problem led safety monitors to halt a late-stage study of vorapaxar called Tracer. That international study included nearly 13,000 patients who had had a heart attack or severe chest pain from clogged arteries.
At the time, Merck decided to continue the TRA-2P study but to no longer give vorapaxar to about 6,000 patients in that study who had a history of stroke.
"We believe commercialization is unlikely, given the potential safety profile of the drug and negative results from Tracer," Citi analyst John Boris wrote to investors. "If vorapaxar reaches the market, we see a limited commercial" opportunity.
He still has a "Hold" rating on Merck but wrote off any chance of vorapaxar sales in January 2011.
Merck basically conceded the drug's diminished prospects when it took a $1.7 billion charge a little over a year ago to write down the value assigned to vorapaxar when it acquired the compound through its November 2009 purchase of Schering-Plough Corp.
Merck, based in Whitehouse Station, N.J., and with operations in the Philadelphia region, said it will present detailed results from TRA-2P at the March 24-27 meeting of the American College of Cardiology.
"We are pleased that TRA-2P met its primary endpoint, and we look forward to discussing the results with the scientific community," Peter Kim, president of Merck Research Laboratories, said in a statement.
Merck has said it plans to apply for approval of five different drugs between this year and next. Vorapaxar is not on the list, although Merck originally had planned to apply for approval in 2011.
Meanwhile, rival drug companies have gotten new anti-clotting drugs approved recently or expect a ruling on their drug shortly. Those are: Boehringer Ingelheim of Germany, whose Pradaxa was approved in October 2010; partners Johnson & Johnson and Bayer Healthcare, whose Xarelto was approved last July, and partners Pfizer Inc. and Bristol-Myers Squibb Co. Their Eliquis is expected to get a ruling from the Food and Drug Administration by March 28.
None of those drugs has shown such serious bleeding risks, but they are far more expensive than warfarin.
In midday trading, Merck shares were up 28 cents at $38.68.
Summary:
STRIKE TWO: A second study shows Merck's experimental anti-clotting drug vorapaxar increased risk of dangerous internal bleeding, including inside the skull. The study, called TRA-2P, did show vorapaxar lowered risk of heart attack, stroke and death.
DIM FUTURE: Merck's already taken a $1.7 billion charge over vorapaxar after it flopped in the earlier study. It's to release full results of the latest study in late March.
ANALYST VIEW: Citi's John Boris thinks approval is unlikely. If it happens, he writes, vorapaxar has "limited commercial" opportunity.
,,,
Linda A. Johnson can be followed at
http://twitter.com/LindaJ,onPharma
US-based scientists have managed to create artificial brain cells that perfectly replicate those naturally found in Parkinson's patients. Their work could become a platform on which future Parkinson's drugs are based and, according to those involved, it could change the shape of present-day approaches to the condition's treatment.
The scientist's research allows them to study precisely how mutations in the gene responsible for Parkinson's - the parkin gene - bring on the condition.
"This is the first time that human dopamine neurons have ever been generated from Parkinson's disease patients with parkin mutations", head researcher Doctor Jian Feng explained. "Before this, we didn't even think about being able to study the disease in human neurons.
"It's impossible to obtain live human neurons to study", Feng added - so deeply submerged are they in the brain. But modern-day stem cell technology has now made it possible to replicate these neurons under lab conditions.
Parkinson's Cell Research
The Parkinson's cell research saw Feng and his colleagues draw on a process already trialled by others, with successful results. Four skin samples were collected - two from perfectly healthy volunteers and the other two from those with this parkin gene - and transformed into brain tissue.
No drug treatment capable of curing Parkinson's currently exists but, given the number of people the condition affects, such a product is ranked by scientists among the world's most important medical needs.
New Parkinson's Drugs
Therefore, next on the US team's agenda is putting these neurons through trials, in a bid to discover new Parkinson's drugs.
"New stem cell technology which allows nerve cells to be made from adult skin cells is opening doors for research into Parkinson's", charity group Parkinson's UK's research development manager, Doctor Michelle Gardner, said in a statement.
"This study is particularly exciting because it describes for the first time how researchers have successfully generated nerve cells from people with a rare genetic form of Parkinson, linked to the parkin gene."
Pharma News will revisit this Parkinson's drug research in future News Items.
See also:
LOUISVILLE, Ky.
The one-time vice president of a health care company has pleaded guilty to charges of misbranding and altering drugs and to committing health care fraud.
A statement from the U.S. Attorney's Office says 62-year-old Johnny Perry of Mount Washington entered the plea Monday in U.S. District Court in Louisville. Perry served as an executive with National Respiratory Services.
A grand jury charged Perry in August with altering medications that were not FDA approved, but billing them as approved. Perry was also charged with submitting false claims to Medicare for the cost of FDA approved drugs. Prosecutors say Medicare paid the company $2,030,343 from November 2006 through June 2008.
Perry also faced charges of misbranding and altering inhalation drugs.
A sentencing date has not been set.
As a result of increasing concerns associated with the
use of Actos® medication, manufacturer Takeda Pharmaceuticals has been forced to cut its work force. The company announced on January 18, 2011 that 2,800 jobs within the United States and in Europe will be cut as the result of decreasing sales. The company has also purchased Swiss drug company, Nycomed.
The company expects that sales will continue to drop as concerns with Actos increase and the introduction of generic versions of Actos enter the market. They have made plans to cut jobs slowly over the course of four years.
This reduction in Takeda’s workforce will represent about 9% of the company but is expected to help the company save $1.7 billion by March of 2016.
The FDA approved Actos for the treatment of type II diabetes in July of 1999. This once a day pill was designed to aid the body’s sensitivity to insulin and accrued sales of $4.3 billion for Takeda Pharmaceuticals in 2010. However, these sales quickly dropped after concerns associated with Actos were actively reported to the FDA.
Generic versions of Actos medication are expected to be released by August of 2013, further reducing sales dollars for Takeda.
Victims who have taken Actos claim that Actos causes bladder cancer and allege that Takeda failed to properly issue sufficient warnings to patients and the medical community.
In September of 2010, the FDA began to review safety concerns of Actos due to interim data from an ongoing ten year study that revealed a link between
Actos and bladder cancer. The agency mandated updated warning labels for Actos in the U.S. and the health regulating agency in Europe also mandated new warning labels as well.
Actos lawyers continue to pursue compensation for individuals who have suffered bladder cancer injuries after taking Actos.
No comments:
Post a Comment