(Reuters) - Mylan NV (MYL.O) on Friday said it will pay $465 million to settle questions of whether it underpaid U.S. government healthcare programs by misclassifying its EpiPen emergency allergy treatment, which has come under intense scrutiny after a series of drastic price increases.

EpiPen auto-injection epinephrine pens manufactured by Mylan NV pharmaceutical company for use by severe allergy sufferers are seen in Washington, U.S. August 24, 2016. REUTERS/Jim Bourg/File Photo

Mylan has been lambasted by consumers and lawmakers for raising prices on the lifesaving EpiPen sixfold to over $600 for a package of two in less than a decade, making the devices unaffordable for a growing number of families.

Lawmakers were trying to determine whether Mylan made more money on EpiPen than warranted from state Medicaid programs by having it classified as a generic product, resulting in much smaller rebates to the government health plans.

Mylan Chief Executive Heather Bresch was grilled by the House Committee on Oversight and Government Reform for the price increase and they were skeptical of her profit analysis of the product.

The Centers for Medicare and Medicaid Services, in response to a request from U.S. Senator Amy Klobuchar of Minnesota, said this week that the Medicaid plan for the poor spent $797 million on EpiPen between 2011 and 2015, including rebates provided by Mylan, or $960 million before rebates.

Lawmakers have contended that Mylan underpaid Medicaid rebates by misclassifying EpiPen as a generic instead of a branded drug. The Medicaid rebate for a generic is 13 percent compared with a minimum 23.1 percent for a branded drug.

“I am glad the Department of Justice pursued this so quickly,” Klobuchar said in a statement. “If other drugs are misclassified, and surely EpiPen isn’t the only one ... the taxpayers need to get their money back.”

Senator Richard Blumenthal of Connecticut blasted the settlement as too small and said Congress should investigate whether Mylan violated the law. “This settlement is a shadow of what it should be - lacking real accountability for Mylan’s apparent lawbreaking,” he said in a statement.

Mylan said in a regulatory filing on Friday that EpiPen will be classified as a branded drug as of April 1, 2017.

Bresch told lawmakers this week that Mylan plans to launch a $300 generic version of EpiPen as soon as possible this year.

Mylan also lowered its 2016 earnings outlook, but the drugmaker affirmed its 2018 forecast and its shares rose 11 percent to $39.90 after hours.

“Kudos to management for fast action,” AB Bernstein analyst Ronny Gal said in a video message to investors. “This was one of the major risks everyone was focusing on ... now it is essentially off the table.”

Mylan said it will record a pretax charge of about $465 million in the quarter ended Sept. 30. The company, which will make the payment to the Department of Justice and other government agencies, said the settlement does not include any finding of wrongdoing.

Mylan, citing changes to the EpiPen consumer discount program and upcoming launch of a generic version, said it now expects full-year 2016 adjusted earnings per share of $4.70 to $4.90, down from $4.85 to $5.15.

Mylan said it “remains committed” to its target of at least $6.00 in adjusted earnings per share in 2018. </s> The company has come under scrutiny for raising prices on the lifesaving EpiPen sixfold in less than a decade, making the devices unaffordable for a growing number of families.

Mylan, which will make the payment to the Department of Justice and other government agencies, said the settlement does not include any finding of wrongdoing.

Figures released by Centers for Medicare and Medicaid Services on Wednesday showed that U.S. government health plans spent more than $1 billion on Mylan's EpiPen between 2011 and 2015.

U.S. lawmakers have contended that Mylan underpaid rebates to state Medicaid programs by misclassifying EpiPen as a generic instead of a branded drug. The Medicaid rebate for a generic is 13 percent compared with a minimum 23.1 percent for a branded drug.

Mylan said will record a pre-tax charge of about $465 million in the quarter ended Sept. 30.

The company, citing changes to the EpiPen consumer discount program and upcoming launch of a generic version of the treatment, said it now expects full-year 2016 adjusted earnings per share of $4.70 to $4.90, down from a previous range of $4.85 to $5.15 per share. </s> Teva Pharmaceutical Industries Ltd. and federal regulators have reached a tentative agreement to resolve a series of disputes over pacts to delay sale of generic drugs.

The proposed settlement with the Federal Trade Commission, which would resolve three complaints, essentially extends and tightens restrictions under a 2015 settlement and resets the clock so that restrictions remain in place for 10 years from the date of the new agreement.

Teva won't pay any additional money beyond the $1.2 billion in relief for overpayment as part of the 2015 settlement.

So-called "reverse-payment" or "pay-for-delay" settlements involve a branded drug company that pays or gives some kind of inducement to another company to delay sales of a generic. The FTC says such deals cost consumers and taxpayers some $3.5 billion a year. </s> Teva Pharmaceutical Industries Ltd. and federal regulators have reached a tentative agreement to resolve a series of disputes over pacts to delay the sale of cheaper generic drugs.

The proposed settlement with the Federal Trade Commission, which would resolve three complaints, essentially extends and tightens restrictions under a 2015 settlement and resets the clock so that restrictions remain in place for 10 years from the date of the revised agreement.

Teva won't pay any additional money beyond the $1.2 billion in relief for overpayment as part of the 2015 settlement.

"This broad settlement prevents the world's largest manufacturer of generic drugs from entering into collusive agreements that prevent price competition by keeping generic drugs off the market," FTC Chairman Joe Simons said in a statement.

So-called "reverse-payment" or "pay-for-delay" settlements involve a branded drug company that pays or gives some kind of inducement to another company to delay sales of a generic. The FTC says such deals cost consumers and taxpayers some $3.5 billion a year.

Under the terms of the agreement, subject to court approval, the FTC would ask the court to dismiss Teva from two lawsuits over AndroGel, a popular testosterone replacement drug.

The FTC would also ask Teva be dismissed from another lawsuit involving Lidoderm lidocaine patch.

The 2015 settlement agreement over delayed competing versions of sleep-disorder drug Provigil marked the first time the U.S. agency obtained monetary remedies for drug purchasers in a "pay for delay" case. </s> Teva settles with Oklahoma for $85 million in opioid case

NORMAN, Okla. (AP) — One of the drugmakers named in Oklahoma's lawsuit over the opioid crisis has agreed to a settlement in which it will pay the state $85 million.

Israeli-owned Teva Pharmaceuticals and Oklahoma Attorney General Mike Hunter both announced the settlement Sunday in separate statements. Teva, its related affiliates and Johnson & Johnson and several of its subsidiaries were set to go to trial Tuesday in Norman.

Hunter said the case against Johnson & Johnson will proceed on schedule.

He also said the funds from the settlement with Teva will be used to fight the opioid crisis in Oklahoma.

Teva did not admit any wrongdoing under the settlement.

Earlier this year, Oklahoma settled with OxyContin-maker Purdue Pharma for $270 million. </s> Teva Pharmaceutical Industries Ltd. agreed to pay $85 million to settle an Oklahoma lawsuit claiming that illegal marketing of its opioid painkillers contributed to a public health crisis in the state.

The deal, announced Sunday, was reached just as the case was about to go to trial next week. The state had alleged Teva and co-defendant Johnson & Johnson persuaded doctors to boost prescriptions of the powerful medications to treat ailments for which they weren’t approved, causing overdose deaths and drug addiction.

The trial against remaining defendant J&J, which the state has called the “kingpin” of the U.S. opioid crisis, is expected to start on Tuesday.

The terms of the settlement may take up to two weeks to finalize, and the money will be used to “abate the opioid crisis in Oklahoma,” Attorney General Mike Hunter said in a statement.

Oklahoma had been seeking at least $10 billion in damages and penalties. The trial will be the first test of public-nuisance laws against opioid manufacturers and distributors. At least 42 states and more than 1,600 municipalities have sued companies in the industry, demanding billions of dollars in damages.

The last-minute deal in Oklahoma means some of the focus on opioid litigation shifts to Cleveland, where a federal judge has set two test trials for October to allow juries to consider public-nuisance claims over drug-marketing campaigns.

The accord comes about two months after Purdue Pharma LP agreed to pay $270 million to resolve Oklahoma’s claims over sales pitches for its opioid-based painkiller, OxyContin. Purdue sought a deal to ease mounting liabilities that have threatened to push the company into bankruptcy. The money was earmarked for research and treatment.

Oklahoma said J&J and Teva helped create a public-health crisis from opioid abuse that killed thousands of its residents. The state, in its lawsuit, accused the companies of overstating the painkillers’ benefits and understating their risks, which created a “devastating cycle of over-prescription” that was “built on addiction, dependence and a market saturated with misinformation regarding the benefits and safety of those drugs.”

Teva’s settlement doesn’t establish any wrongdoing on the part of the company.

The case is State of Oklahoma v. Purdue Pharma LP, CJ-2017-816, Cleveland County, Oklahoma, District Court (Norman). </s> NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) and Bayer (BAYZF.PK) on Monday said they have agreed to settle more than 25,000 U.S. lawsuits involving their blockbuster blood thinner Xarelto for a total of $775 million.



The settlement will be split evenly between the two companies. The agreement resolves all pending state and federal cases in which plaintiffs sued the companies for failing to warn about potentially fatal bleeding episodes when patients took the drug.



Bayer in a statement on Monday said it continues to believe the claims are without merit. 'However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation,' the company said.



J&J in a statement said it continued to believe in the safety of Xarelto, but that the settlement was the right thing to do for patients and their doctors.



Xarelto is Bayer's best-selling drug. It generated 3.6 billion euros in revenue to the German group's pharmaceutical business last year.



Copyright RTT News/dpa-AFX </s> One of the drugmakers named in Oklahoma's lawsuit over the opioid crisis has agreed to a settlement in which it will pay the state $85 million.

Israeli-owned Teva Pharmaceuticals and Oklahoma Attorney General Mike Hunter both announced the settlement Sunday in separate statements. Teva, its related affiliates and Johnson & Johnson and several of its subsidiaries were set to go to trial Tuesday in Norman.

Hunter said the case against Johnson & Johnson will proceed on schedule.

He also said the funds from the settlement with Teva will be used to fight the opioid crisis in Oklahoma.

Teva did not admit any wrongdoing under the settlement.

Earlier this year, Oklahoma settled with OxyContin-maker Purdue Pharma for $270 million. </s> Two pharmaceutical giants agreed on Monday to settle more than 25,000 lawsuits in the United States in which plaintiffs alleged injuries and death due to taking prescription blood thinner Xarelto. According to Reuters, drug makers Bayer AG and Johnson & Johnson, the two companies that jointly developed the medication, have agreed to settle with plaintiffs for a total of $775 million. Under the terms of the agreement, the companies do not admit liability.

Plaintiffs in the case alleged that Bayer and Johnson & Johnson failed to adequately warn of risks associated with taking the anti-coagulant drug, which is prescribed to prevent and treat blood clots, as well as to possibly lower the risk of deep-vein thrombosis (DVT), pulmonary embolism, and stroke. The plaintiffs’ allegations include that patients taking Xarelto experienced unstoppable bleeding, which led to other severe conditions including fatalities. The pharma giants say these claims are without merit, and in a statement, Bayer said that the “settlement allows the company to avoid the distraction and significant cost of continued litigation.” Some of Bayer’s settlement costs will be offset by liability insurance, according to Reuters.

Xarelto earned (jnj) JNJ $2.47 billion in 2018 alone and has been (bayer-ag) Bayer’s best-selling drug for many years now. A prescription for Xarelto typically costs between $450 and $540 a month. In February, Xarelto was also slated to be the first of Johnson & Johnson’s prescription drugs to be advertised in television commercials.
Mylan pays US$465 million to settle its underpayment to U.S. government healthcare programs by misclassifying its epinephrine autoinjector emergency allergy treatment.