Bristol Reaches $80 Million Deal to Settle Hepatitis C Claims

Report: Bristol-Myers Squibb settles hepatitis C drug claims for $80 million

(Ref: NASDAQ, The Wall Street Journal)
January 24th, 2013
By: Joe Barber

The Wall Street Journal reported Thursday that Bristol-Myers Squibb agreed to pay $80 million to 15 patients who were harmed during clinical trials of the hepatitis C drug BMS-986094. A company spokesperson confirmed that the parties "have an agreement in principle to settle the matters that were in mediation" and that the terms of the deal are confidential.

Bristol-Myers Squibb ended development of the therapy, which it gained through the $2.5-billion acquisition of Inhibitex, last year and took an associated charge of $1.8 billion after one patient died during testing and several others were hospitalised. The company indicated that heart and kidney toxicity was observed among study participants, although the cause of the damage was not definitely identified.

According to a letter reviewed by The Wall Street Journal, the patients and families will have to sign onto the tentative agreement and submit to binding arbitration to determine the size of their settlement payout.

In related news, Bristol-Myers Squibb reported Thursday that fourth-quarter earnings rose to $925 million from $852 million in the prior-year period, partly due to a tax benefit from the purchase of Inhibitex.

http://www.firstwordpharma.com/node/1052805


Bristol Reaches $80 Million Deal to Settle Hepatitis C Claims

By JONATHAN D. ROCKOFF

Bristol-Myers Squibb Co. BMY +2.61% agreed to pay $80 million to settle cases involving 15 patients killed or hurt during company-sponsored testing of an experimental drug for hepatitis C.

Now the patients and families must sign onto the tentative settlement and submit to binding arbitration to determine how much money each will receive, according to a letter, reviewed by The Wall Street Journal, outlining the terms of the deal.

Continue reading @ WSJ


UPDATE 4-Bristol profit tops forecast; outlook is scaled back

Published: Thursday, 24 Jan 2013 | 3:05 PM ET

By: Ransdell Pierson

 

The most spectacular setback came last August, when Bristol-Myers scrapped BMS-986094, a high-profile treatment for hepatitis C, after a patient died of heart failure in a mid-stage trial and others were hospitalized. The company took a charge of $1.8 billion in the 2012 third quarter for the failed medicine. Although the drug would not have reached the market for several years, the failure tarnished the company's research prowess.

Bristol-Myers has agreed to pay $80 million to patients hurt in the hepatitis C study, The Wall Street Journal reported on Thursday. The drugmaker confirmed it had an "agreement in principle" to settle the matter but said terms of the pact were confidential.

Jan 24 (Reuters) - Bristol-Myers Squibb Co reported better-than-expected quarterly results on Thursday, lifting its shares 2.5 percent, but scaled back its 2013 earnings forecast following setbacks for several of its experimental drugs.

The company said it expects earnings this year of $1.78 to $1.88 per share before special items. That would represent a decline of as much as 11 percent from 2012, mainly because of generic competition for its Plavix blood clot preventer and Avapro blood pressure treatment.

Although the 2013 forecast is in line with the average Wall Street estimate of $1.83 per share - thanks in part to a highly favorable tax rate this year - the company conceded it would not reach its more ambitious earlier goals.

In March 2010, riding high from approvals of new medicines and confidence in other ones in development, Bristol-Myers said 2013 earnings would be "at minimum $1.95" per share, adding it was "well positioned to deliver on the promise of our pipeline."

"Bristol today finally owned up to what most analysts were already aware, that they are unlikely to hit the minimum guidance they set a couple of years ago," said Atlantic Equities analyst Richard Purkiss. "Various things have made that unlikely."

In January 2012, U.S. regulators rejected dapaglifozin, a new type of treatment for type 2 diabetes, citing safety concerns. Just months later, the company's experimental brivanib oncology drug failed in a late-stage trial to prolong survival in liver cancer patients.

The most spectacular setback came last August, when Bristol-Myers scrapped BMS-986094, a high-profile treatment for hepatitis C, after a patient died of heart failure in a mid-stage trial and others were hospitalized. The company took a charge of $1.8 billion in the 2012 third quarter for the failed medicine. Although the drug would not have reached the market for several years, the failure tarnished the company's research prowess.

Bristol-Myers has agreed to pay $80 million to patients hurt in the hepatitis C study, The Wall Street Journal reported on Thursday. The drugmaker confirmed it had an "agreement in principle" to settle the matter but said terms of the pact were confidential.

Despite its research setbacks, Bristol-Myers shares are trading at 19 times expected 2013 earnings per share, well above the average multiple of 12.5 for other large drugmakers.

Purkiss said the premium is partly warranted because of huge sales potential of Eliquis, a new type of blood clot preventer developed with Pfizer Inc that was approved by U.S. regulators last month. He said several Bristol-Myers cancer drugs in late-stage trials also have blockbuster sales potential.

"Hopes for those drugs, and Eliquis, could justify a premium, but probably not the current premium," Purkiss said, adding that Bristol-Myers shares could be vulnerable to new setbacks.

The company's new 2013 profit outlook assumes a company tax rate this year of 16 percent, far below a rate of up to 23 percent that some analysts had expected. Bristol-Myers officials said the rate is coming down due to a new federal tax credit for research and development and other factors.

The drugmaker said it earned $925 million, or 56 cents per share, in the fourth quarter, up from $852 million, or 50 cents per share, a year earlier.

Excluding special items, such as a $411 million tax benefit from the write-off of the failed hepatitis C drug, the company earned 47 cents per share. On that basis, analysts' average forecast was 43 cents per share.

Revenue plunged 23 percent to $4.19 billion following U.S. patent expirations last year on Plavix and Avapro. Wall Street had expected $4.12 billion.

Plavix sales plunged 97 percent to $49 million, while Avapro sales fell 57 percent to $84 million. Soaring growth of newer drugs helped cushion those declines.

Sales of arthritis treatment Orencia jumped 26 percent to $325 million, and combined revenue from diabetes drugs Onglyza and Kombiglyze rose 29 percent to $198 million. Leukemia treatment Sprycel rose 24 percent to $281 million. Yervoy, a new treatment for melanoma, grew 47 percent to $211 million.
 

Source

 

 

Bristol-Myers to Hold Talks On Settling Claims of Hepatitis C Patients

Bristol-Myers to Hold Talks On Settling Claims of Hepatitis C Patients

By JONATHAN D. ROCKOFF

Bristol-Myers Corp. BMY +0.26% is scheduled to hold talks starting Wednesday to settle hundreds of millions of dollars in claims of liver-disease patients killed or injured during a company-sponsored drug trial last year, according to court papers and a person familiar with the matter.

Bristol has received requests for medical costs and damages for 14 people injured in the trial that total more than $500 million, according to the person familiar with the matter.

Read More @ WSJ

Bristol-Myers Tries To Settle Hep C Patient Claims
By By Ed Silverman // January 16th, 2013

Talks with a court-sanctioned mediator are expected to begin today in Philadelphia and the outcome is supposed to be reported to a federal court in Texas, where the lawsuits were filed, by the end of the month, according to court documents. Stephen Sheller, lead counsel for the plaintiffs in the litigation, declined to comment, as did a spokeswoman for Bristol-Myers.

Read More @ Pharmalot

Bristol-Myers begins pricey post-mortem cleanup following 094 disaster

January 16, 2013 | By John Carroll

Rockoff's source puts these initial talks in Philadelphia, with a mediator on site to see if the two parties can start to move toward an agreement that would defuse the confrontation ahead of a trial. And Bristol's representatives are not in an enviable position. The plaintiffs are alleging that in the red-hot race to develop a new, leading hep C therapy, the drug developer threw aside caution and rushed pell-mell into the study. Texas nurse Janet Vella was one of several patients who suddenly found themselves in the hospital. In her case, her heart and kidney started to fail.

Read more @ Fierce Biotech
 

 

 

Setbacks in HCV Drug Development Highlight Uncertainties in Treat or Wait Decisions

Setbacks in HCV Drug Development Highlight Uncertainties in Treat or Wait Decisions
Source-
Clinical Care Options

Graham R. Foster FRCP, PhD - 10/22/2012

At the opera, the show isn’t over until the large lady begins her aria. In drug development, licensing and effective treatment of thousands of patients define a successful launch. Following recent problems with emerging drugs for HCV, I am reminded of the difficulties of turning chemicals into drugs and the importance of waiting until the development cycle is complete before claiming success.

I first sensed trouble in April 2012 when it was announced that trials of alisporivir were being suspended. Over 1800 patients had received this cyclophilin antagonist, with impressive virologic responses (Capsule Summary). A phase III trial was moving forward, and I was surprised to learn that a patient receiving alisporivir had died of pancreatitis. The US Food and Drug Administration noted a possible association of pancreatitis with alisporivir and instituted a “clinical hold.” A full evaluation of the alisporivir data set is now under way, and we wait to see whether any possible risks can be managed and whether it is safe to resume testing. Worse news followed in August when unexpected cardiac toxicity was seen with BMS-986094, a nucleotide analogue polymerase inhibitor, leading to the death of a patient and suspension of clinical trials. This nucleotide was just one of a molecular family, and concerns that cardiotoxicity may be a class effect led to studies with related drugs (such as a compound in phase IIb development, IDX184) being placed on full or partial clinical hold. The suspension of this drug family leaves only 1 nucleotide at an advanced stage of development (sofosbuvir, previously known as GS-7977), and I am now crossing my fingers and hoping that its current impressive safety record continues. The failure of drugs in late-stage clinical trials has reminded me that unexpected safety concerns are common, and despite the best efforts of companies and regulators, clinical trials remain challenging.

Safety problems are not restricted to clinical trials. Following the launch of the protease inhibitors telaprevir and boceprevir, data started to accrue in patients with advanced cirrhosis (who were excluded from the clinical trial program). Early results indicate an increase in adverse effects over that seen in clinical trials, particularly with severe anemia and multiple treatment-related deaths, most commonly due to sepsis (Capsule Summary). I certainly find in my practice that patients with advanced cirrhosis are fragile, so it is perhaps not surprising that a small proportion develop serious complications when receiving potent antiviral therapy. However, the unexpected severity of the adverse effects and the associated mortality demonstrate again that a successful phase III trial by no means guarantees the safety of a drug in more challenging patient populations.

The recent concerns with licensed and unlicensed drugs serve as a salutary reminder of the difficulties of drug development. As patients and clinicians who are awaiting the arrival of interferon-free treatment regimes, we should remember that excellent responses in small patient cohorts do not guarantee eventual success. As we wrestle with the decision of whether to treat now or wait for more effective regimens, we need to keep in mind that we still have hurdles to overcome before we can celebrate safe, effective all-oral combination therapy for HCV. In my clinic, I remind my patients that waiting for new drugs is not entirely risk free, and if a decision to wait for better drugs is made, it is important to review the decision in a few months to see if the changing drug development landscape necessitates a review of the original decision. The large lady is on the stage, but the show is not yet over.

Tell me your thoughts: Do these hiccups in drug development alter how you counsel your patients regarding future HCV therapies? Do you discuss the potential safety challenges or focus on the efficacy successes?

Graham R. Foster, FRCP, PhD, is Professor of Hepatology, The Liver Unit, and Consultant Hepatologist, Queen Marys University of London, London, United Kingdom.
 

Graham R. Foster, FRCP, PhD, has disclosed that he has received consulting fees, fees for non-CME services, and funds for research support from Boehringer Ingelheim, Bristol-Myers Squibb, Gilead Sciences, Janssen, Merck, Novartis, and Roche and has served on the on the safety board with Idenix.

Topics: HCV

 

The Top Phase III Disasters of 2012 - BMS-094 - Bristol-Myers

Topics:
Clinical Trials
 
The Top Phase III Disasters of 2012

October 3, 2012 | By John Carroll

Excerpt:

Every year we see a good number of potential blockbusters come down to the pivotal wire. And in Part II of this feature I'll highlight the biggest potential blockbusters in the clinic stirring a buzz. But no review of the latest crop of blockbusters would be complete without an assessment of the biggest failures. And 2012 has seen some of the biggest failures in the history of drug R&D....

Here are my top 5 flops of the year:

BMS-094 - Bristol-Myers Squibb

BMS-094 takes the top position. Not many biopharma companies can lay claim to this kind of failure. Just 7 months after Bristol-Myers Squibb ($BMY) grabbed this hepatitis C treatment in its $2.5 billion buyout of Inhibitex, the drug and the lion's share of the investment went up in smoke after a patient sickened and then died of heart failure. Other patients were laid up in the hospital as well. The initial cost was $1.7 billion in writeoffs, though some analysts are still trying to figure out why Bristol thinks the other programs obtained from Inhibitex could be worth $800 million....

Aside from the money also invested in the short R&D program, Bristol-Myers Squibb is also staring down some personal injury lawyers who are eager to make the case that the company recklessly exposed their clients to lethal side effects. A few insightful experts have been making a case for the attorneys, noting that there were some clear red flags for this treatment before Bristol-Myers got its hands on the drug.....

Read more here....

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Idenix Pharma: Guilty By Association

Idenix Pharma: Guilty By Association

 

By Nathan Sadeghi-Nejad

 

Excerpt:

IDX-184 has had no safety issues to date. Nonetheless, structural similarities between Idenix's IDX-184 and Bristol-Myers Squibb's (BMY) BMS-094 were sufficient to warrant concern. Clinical development of the latter drug, which Bristol-Myers acquired in the $2.5 billion takeover of Inhibitex, has been discontinued because of severe cardiovascular toxicity. 

The FDA's clinical hold -- effectively a "stop work" order triggered by unexpected safety issues -- suggests that regulators are also concerned about the safety of IDX-184. In order to get the clinical hold lifted and continue development, Idenix must now convince the FDA that IDX-184 doesn't put patients' lives at unnecessary risk. (At least one patient in the Bristol-Myers study died.)

Let's start with the good news by diving into some chemistry. IDX-184 and BMS-094 are both nucleotide polymerase inhibitors and, structurally speaking, 2′-methylguanosine (2′-MeG) triphosphates. When BMS-094 breaks down in the body, it produces 1-naphthol, a toxic metabolite possibly responsible for the drug's side effects. However, metabolism of IDX-184 does not produce 1-naphthol. Furthermore, while Bristol-Myers' compound showed evidence of mitochondrial toxicity in cell line studies at relatively low concentrations, IDX-184 has a wide margin of cellular level safety......
 

Continue reading @ The Street 

Casualties of an R&D war? Hep C trial patients accuse Bristol-Myers of recklessness

Casualties of an R&D war? Hep C trial patients accuse Bristol-Myers of recklessness

September 17, 2012 | By John Carroll

 

Brian Starkey didn't have insurance coverage when he was diagnosed with hepatitis C. So when a doctor pointed him to a study of Bristol-Myers Squibb's ($BMY) experimental BMS-094, he leaped at a chance to get free care. And as The Kansas City Star reports in an in-depth profile, that decision may have cost him his life.

Starkey's sudden death after taking the treatment--along with severe heart ailments suffered by a big group of the 113 enrollees in the drug study--scuttled a program that inspired Bristol's $2.5 billion acquisition of Inhibitex. And the attorney representing Starkey's family tells the Midwestern newspaper that the risks of toxicity were already apparent when Bristol rushed into clinical studies, anxious to grab a lead in the frenzied race to develop a new hep C treatment that would not require interferon.

"This was a poorly designed study that caused serious injury," attorney Robert Hilliard told the Star. "I'm convinced that they rushed it into trials in order to get FDA approval." Hilliard's firm represents a half dozen of the injured patients, several with severe heart damage. One of the patients requires a heart transplant. All are suing Bristol.

BMS' response: "Based on our due diligence, we believed that we could develop BMS-986094 at a dose that would provide sufficient viral suppression and resistance coverage while also having an acceptable safety and tolerability profile." Bristol has also promised to help officials and other companies like Idenix ($IDIX) to get to the bottom of the drug reactions as quickly as possible.
The patient reactions in the 094 study have also forced Idenix to slam the brakes on two of its experimental programs as the FDA carefully considers whether patients are being exposed to unnecessary risks.

For Starkey's family, including his 19-month-old son, the exercise in caution came too late.
- here's the story from The Kansas City Star

Related Articles:
Deadly tox threat kills Bristol-Myers' $2.5B hep C prospect
Idenix plunges after FDA puts another hep C treatment on hold
Bristol mulls write-down of key hep C drug
Analyst reads last rites after heart failure scuttles Bristol hep C study

Read more @ Fierce Biotech

BMS-986094 :Trial of hepatitis C drug has deadly outcome

Trial of hepatitis C drug has deadly outcome for area man

Test of experimental hepatitis C remedy turns fatal for area patient, shows risk to volunteers.

By ALAN BAVLEY
The Kansas City Star

When Jessica and Brian Starkey of Leavenworth County were diagnosed with hepatitis C infections last year, they didn’t have insurance coverage for treatment. But Jessica’s doctor said there was still a chance they could get help. Researchers in Kansas City were enrolling hepatitis C patients in a national clinical trial.

They offered powerful drug cocktails featuring a promising new experimental drug to kill the virus. And it was free. The drug, which went by the code name BMS-986094, was among a growing number of experimental antiviral medications being developed to treat hepatitis C, a liver-destroying virus that infects more than 3 million people in the United States and as many as 200 million worldwide.

Any red flags?

Publicly available data on laboratory tests that were run on BMS-986094 before human trials started show that relatively low concentrations of the drug killed human bone marrow cells. Drugs similar to BMS-986094 also are known to be toxic to the kidneys.

But the publicly available information about test-tube and animal tests on BMS-986094, or the preliminary tests on people, remains sketchy. “Was there any signal at all that should have raised a red flag?” asked Michael Carome, a physician and deputy director of Public Citizen’s Health Research Group, a consumer advocacy group involved in drug safety issues.

“We don’t know a lot of important details,” said Carome, who formerly was associate director for regulatory affairs at the Office for Human Research Protections of the Department of Health and Human Services. “I assume they did more studies on animals and did tests of heart and liver tissues. A series would normally be done. The question is what else is out there looking at both short-term and long-term exposure.”

Continue Reading.....

BMS halts the development of BMS-986094 due to patient death

Bristol-Myers halts mid-stage study of promising hepatitis C drug

Published: Thursday, August 23, 2012, 7:25 PM Updated: Thursday, August 23, 2012, 7:36 PM

 By Bloomberg NewsThe Star-Ledger

Bristol-Myers Squibb is abandoning an experimental hepatitis C pill it acquired for $2.5 billion earlier this year after one patient died and others were hospitalized while taking the drug in a clinical trial.

Bristol-Myers suspended mid-stage studies of the drug, which was known only as BMS-986094, earlier this month after a patient developed heart failure.

The drug maker, which is based in New York but has a large presence in New Jersey, said yesterday it had decided to halt development of the drug, part of a class of medicines called nucleotide polymerase inhibitors. The company also said it was consulting with U.S. regulators to assess the treatment’s effects.

The original patient subsequently died and eight others suffered from heart and kidney toxicity, the company said in a statement released last night. Two of the patients remain hospitalized.

The hepatitis C treatment was thought by researchers and analysts to be a key therapy in a push by companies, including Gilead Sciences to replace the standard treatment, a regimen including a year of interferon injections that carry flu-like side-effects.

“The decision to halt development of the BMS-986094 has been guided by our overriding interest in protecting patients,’’ said Elliott Sigal, Bristol’s executive vice president and chief scientific officer. “In the interest of all patients, we will make relevant information available to inform the development of other investigational compounds to treat hepatitis C.’’

Bristol-Myers gained the drug with its acquisition of Inhibitex Inc. for $2.5 billion earlier this year.

The company was among a number of drugmakers racing to develop a new generation of medicines to treat an estimated 170 million patients with hepatitis C.

In a statement released after the close of the financial markets, Bristol Myers said it would continue investigating into the cause of the toxicity. The company will also continue to monitor patients who have received the medicine.

Star-Ledger staffwriter Susan Todd contributed to this report.

Source - http://www.nj.com/business/index.ssf/2012/08/bristol-myers_halts_mid-stage.html


Hepatitis C Drug Proves Dangerous
Nine patients are hospitalized and one is dead after taking an experimental drug for hepatitis C developed by Bristol-Myers Squibb Company (NYSE: BMY). On Thursday the company announced it had halted development of the drug, aimed at treating lever disease.

"The decision to halt development of BMS-986094 has been guided by our overriding interest in protecting patients," said Elliott Sigal, M.D., Ph.D., Executive Vice President and Chief Scientific Officer, Bristol-Myers Squibb.

Two of the original nine patients remain hospitalized and Bristol continues to monitor the health of over 100 patients who participating in the study. The company also notified nearly 150 others who were part of earlier test.
Continue reading....

Bristol Drops Hep C Drug After Patient Death
By Ed Silverman

You could see this coming. Last night, Bristol-Myers Squibb abandoned an experimental hepatitis C compound after one patient died of heart failure and nine others were hospitalized during a Phase II study. The move comes less than a month after the drugmaker suspended the trial due to safety issues among patients and that decision, not surprisingly, immediately raised questions about the future of the medication (back story).

The discontinuation is a huge disappointment for Bristol-Myers Squibb, which earlier this year agreed to pay $2.5 billion in cash for Inhibitex and its experimental compound, a nucelotide polymerase inhibitor that was renamed BMS-986094. The wisdom of that deal drew considerable skepticism, though, because the small drugmaker had completed only Phase I testing up to that point.

Continue reading at Pharmalot

BMS halts the development of BMS-986094 due to patient death

Bristol-Myers Squibb announced that it has discontinued the development of BMS-986094 for the treatment of hepatitis C

BMS-986094, formerly known as INX-189, is a nucleotide polymerase inhibitor that is currently being developed in the phase II clinical studies for the treatment of hepatitis C. The FDA has placed a clinical hold on the development of the compound which has also affected the development of Idenix's IDX184 and tanked Idenix shares.

The phase II trial was initially suspended on August 1, 2012 due to a heart failure case which now has resulted in death. As of now, nine patients have been hospitalized and two remained hospitalized. The company has yet to establish a definitive relation between the compound and kidney and heart toxicity. Hoever, for the interest of the patients, it has decided to halt the development of BMS-986094.