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BMY suspends hep c trial
Bristol-Myers Squibb Co. (BMY) (BMY) lost ground in the race to develop a stand-alone hepatitis C pill after the company suspended testing of an experimental drug for the disease that cost it $2.5 billion to buy earlier this year.
The shares fell as much as 5.9 percent in early trading today after Bristol said yesterday it wouldn’t continue to administer the compound, known as BMS-986094, after a patient developed heart failure, what the company called a “serious safety issue” in a statement.
The therapy was a key player for Bristol in a race among companies, including Gilead Sciences Inc. (GILD) (GILD), to replace the standard treatment, a year-long regimen of interferon injections that carry flu-like side-effects. Two analysts called the news a major setback blunting the New York-based drugmaker’s reputation as having the industry’s best pipeline.
“We recommend that investors assume BMY’s nuc is dead,” said Mark Schoenebaum, an analyst with ISI Group in New York, using industry slang for nucleotide polymerase inhibitor, a family of compounds designed to stop the virus from replicating.
Bristol’s shares fell 5.9 percent to $33.50 at 7:43 a.m. New York time in trading before the market opened, after gaining (BMY) 27 percent in the last 12 months before today. Gilead jumped 10 percent to $59.
Inhibitex Purchase
Bristol gained the compound in January with the acquisition of Inhibitex Inc. for $2.5 billion. The purchase was designed to put the company in a lead role in gaining approval of a new generation of medicines to treat the estimated 170 million patients with hepatitis C.
The hepatitis C market is estimated at $20 billion for the new pills designed to work more quickly with fewer side effects for those with the liver infection.
The setback is the latest bad news for Bristol-Myers.
Another of the company’s top prospects, the blood thinner Eliquis that is being developed with Pfizer Inc., was rejected by U.S. regulators last month, who asked for more data from existing trials. Approval of the drug may be pushed into next year, according to the company. And the diabetes drug dapagliflozin was rejected in January when the Food and Drug Administration asked for more safety information.
Timothy Anderson, an analyst with Sanford C. Bernstein & Co. in New York, said in a note to clients today that he was cutting his estimate (BMY) of 2016 sales of Bristol-Myers’ hepatitis C franchise from $2 billion to $1.2 billion.
‘Conservative Step’
Anderson also cautioned that the heart failure could prove to be a red herring, and that more information was needed.
“Sometimes companies take the conservative step of suspending dosing when new safety issues arise until the data can be analyzed and excessive harm can be ruled out,” he said.
Bristol-Myers’ strategy has been focused on buying companies with promising experimental assets and focusing internally on areas of unmet medical need. The goal has been to rebuild a diversified company that no longer relies as heavily on Plavix, a cardiology drug that lost patent protection this year after selling $7.09 billion in 2011 and making up a third of the company’s revenue.
“This is perhaps yet another chink in the armor of a relatively expensive stock that has earned its multiple via R&D and business development successes,” Schoenebaum said in a note to clients. He predicted the stock would drop. “We expect to continue to see BMY lag the group as it has much if this year.”
30 Patients
Administration of the drug to about 30 patients enrolled in a so-called Phase 2b study has been stopped pending an investigation, Sonia Choi, a Bristol-Myers spokeswoman, said in a telephone interview yesterday.
Heart failure occurred in one patient receiving the highest daily dose of 200 milligrams, Choi said.
“Although the issue presented in a patient receiving that dose, it doesn’t preclude the possibility of issues with other patients at other doses,” she said. “At this point, we don’t know what the cause of the safety issue is. We are taking the time to evaluate information on all patients receiving this compound.”
To contact the reporter on this story: Drew Armstrong in New York at ***@****;
To contact the editor responsible for this story: Reg Gale at ***@****
The shares fell as much as 5.9 percent in early trading today after Bristol said yesterday it wouldn’t continue to administer the compound, known as BMS-986094, after a patient developed heart failure, what the company called a “serious safety issue” in a statement.
The therapy was a key player for Bristol in a race among companies, including Gilead Sciences Inc. (GILD) (GILD), to replace the standard treatment, a year-long regimen of interferon injections that carry flu-like side-effects. Two analysts called the news a major setback blunting the New York-based drugmaker’s reputation as having the industry’s best pipeline.
“We recommend that investors assume BMY’s nuc is dead,” said Mark Schoenebaum, an analyst with ISI Group in New York, using industry slang for nucleotide polymerase inhibitor, a family of compounds designed to stop the virus from replicating.
Bristol’s shares fell 5.9 percent to $33.50 at 7:43 a.m. New York time in trading before the market opened, after gaining (BMY) 27 percent in the last 12 months before today. Gilead jumped 10 percent to $59.
Inhibitex Purchase
Bristol gained the compound in January with the acquisition of Inhibitex Inc. for $2.5 billion. The purchase was designed to put the company in a lead role in gaining approval of a new generation of medicines to treat the estimated 170 million patients with hepatitis C.
The hepatitis C market is estimated at $20 billion for the new pills designed to work more quickly with fewer side effects for those with the liver infection.
The setback is the latest bad news for Bristol-Myers.
Another of the company’s top prospects, the blood thinner Eliquis that is being developed with Pfizer Inc., was rejected by U.S. regulators last month, who asked for more data from existing trials. Approval of the drug may be pushed into next year, according to the company. And the diabetes drug dapagliflozin was rejected in January when the Food and Drug Administration asked for more safety information.
Timothy Anderson, an analyst with Sanford C. Bernstein & Co. in New York, said in a note to clients today that he was cutting his estimate (BMY) of 2016 sales of Bristol-Myers’ hepatitis C franchise from $2 billion to $1.2 billion.
‘Conservative Step’
Anderson also cautioned that the heart failure could prove to be a red herring, and that more information was needed.
“Sometimes companies take the conservative step of suspending dosing when new safety issues arise until the data can be analyzed and excessive harm can be ruled out,” he said.
Bristol-Myers’ strategy has been focused on buying companies with promising experimental assets and focusing internally on areas of unmet medical need. The goal has been to rebuild a diversified company that no longer relies as heavily on Plavix, a cardiology drug that lost patent protection this year after selling $7.09 billion in 2011 and making up a third of the company’s revenue.
“This is perhaps yet another chink in the armor of a relatively expensive stock that has earned its multiple via R&D and business development successes,” Schoenebaum said in a note to clients. He predicted the stock would drop. “We expect to continue to see BMY lag the group as it has much if this year.”
30 Patients
Administration of the drug to about 30 patients enrolled in a so-called Phase 2b study has been stopped pending an investigation, Sonia Choi, a Bristol-Myers spokeswoman, said in a telephone interview yesterday.
Heart failure occurred in one patient receiving the highest daily dose of 200 milligrams, Choi said.
“Although the issue presented in a patient receiving that dose, it doesn’t preclude the possibility of issues with other patients at other doses,” she said. “At this point, we don’t know what the cause of the safety issue is. We are taking the time to evaluate information on all patients receiving this compound.”
To contact the reporter on this story: Drew Armstrong in New York at ***@****;
To contact the editor responsible for this story: Reg Gale at ***@****
Hi UK, just finished Abt 450r over a week ago; 2 weeks post is on this Monday. Labs at 24 week still undetected. Just had to do Riba reduction at week 12, if I had the 12 week study, I could have finished the whole med regime.
They shouldn't have jumped to 200 mgs!!! Looks like more people will be sticking with Gilead and Abbott. Abbott should be doing a phase 3 in October.
Wow. I was going to trial this next month. I don't know what to think about that, but I am very bummed out.
This is a shame. I remember reading an article about this drug back when it was INX-189 back in March of this year. It was when the drug was administered at 100 mg dose rather than the 200mg that happened with the patient who apparently had heart failure. This isn't the article but it was one like it
http://www.hemophilianevada.org/hemophilia-medication/new-hepatitis-drug-inx-189-successful-trials-bbc-wales-today
....But Proffesor McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.
“The drug is safe, with no drug-related side effects at all in a single dose of 100mg”
Proffesor Chris McGuigan Welsh School of Pharmacy :
“Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg,” he said.
He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.
Second trial
In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.
http://www.hemophilianevada.org/hemophilia-medication/new-hepatitis-drug-inx-189-successful-trials-bbc-wales-today
....But Proffesor McGuigan said the INX-189 trials process, though still at a very early stage, represented a significant development.
“The drug is safe, with no drug-related side effects at all in a single dose of 100mg”
Proffesor Chris McGuigan Welsh School of Pharmacy :
“Successfully completing phase 1a demonstrates that the drug is safe, with no drug-related side effects at all in a single dose of 100mg,” he said.
He said the study, which began in May, had also confirmed that one single dose of the drug a day was most likely to be enough in treating the virus.
Second trial
In 2008, laboratory tests showed INX-189 killed 90% of the virus at very low concentration, making it the most potent compound of its kind developed to date.
Just to clarify-- This is not daclatasvir (bms 790052), the drug that is combined with gilead. This is a completely different drug.
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