- Judge unseals records from Kentucky’s OxyContin lawsuit (cnbc.com)
A judge has unsealed records from a Kentucky lawsuit against the maker of the prescription painkiller OxyContin, including the secret testimony of a former company president...Pike Circuit Court Judge Steven Combs ordered the records be released in 32 days. But Combs said he would delay his order if Purdue Pharma appealed the decision...OxyContin is a powerfully addictive prescription painkiller that was marketed for its ability to slowly release its effects over a 12-hour period. The company suggested this long-acting formula made it less addictive and safer for patients. But users quickly found the pill lost its time-release qualities if it was crushed, resulting in an instant high...In 2006, the company agreed to plead guilty and pay more than $630 million to settle federal charges that it misled doctors and patients about the risks of its top-selling drug...The judge in the case agreed to seal any records Purdue Pharma marked as confidential. Statnews.com...sued to have the records released once the case was resolved. They are particularly interested in Sackler's testimony, as it could reveal how much the company knew about how addictive OxyContin truly is...Lawyers for Purdue Pharma said the company agreed to hand over documents and give Kentucky's attorneys access to high level company officials because it believed the documents would never be made public. They argued that releasing the documents now would betray that trust and bog down the state's civil court docket.
- J&J Ordered to Pay $55 Million Over Cancer Linked to Talc (bloomberg.com)
Johnson & Johnson must pay $55 million to a 62-year-old South Dakota woman who blamed her ovarian cancer on the company’s talcum powder in the second such trial loss this year...State court jurors in St. Louis...awarded $5 million in compensation and $50 million in punitive damages to Gloria Ristesund, who was diagnosed with cancer in 2011 after using J&J’s talc-based feminine hygiene products for almost 40 years...J&J is accused in more than 1,000 lawsuits in state and federal courts of ignoring studies linking its Shower-to-Shower product and Johnson’s Baby Powder to ovarian cancer. Women contend the company knew the risk and failed to warn customers..."Unfortunately, the jury’s decision goes against 30 years of studies by medical experts around the word (world) that continue to support the safety of cosmetic talc,’’...Ristesund had several risk factors for ovarian cancer...That included a family history of cancer, having endometriosis and the fact she had no children...
- Express Scripts says Anthem negotiated in bad faith -court filing (finance.yahoo.com)
Pharmacy benefit manager Express Scripts Holding Co has accused Anthem Inc of negotiating their contract in bad faith and is seeking a court order that the health insurer has no right to demand lower drug prices...The allegations, made in a filing in federal court...in response to a lawsuit Anthem brought against Express Scripts last month seeking $13 billion in price cuts over the remaining four years of the companies' contract...Express Scripts said...the contract did not require it to offer any specific price cuts, but only to negotiate in good faith...Express Scripts said it had proposed five price cuts "within the range" of Swedish's projections last June, but that all were rejected, suggesting that Anthem was acting in bad faith when it brought its $13 billion lawsuit.
- Detroit Area Doctor Charged with Illegal Distribution of Prescription Drugs and Fraud (dea.gov)
An indictment was unsealed today charging a doctor and three other individuals with conspiracy to illegally distribute prescription drugs...Charged in the indictment are: Dr. Michael Weiss, D.O., Edgarten Howard, Carlos Johnson, and Ricky Easley...The indictment alleges that...Weiss conspired with the other defendants to write a large number of prescriptions for highly addictive controlled substances for supposed patients, who did not have a legitimate medical need for the drugs. Weiss primarily prescribed Roxicodone and its generic equivalent, oxycodone, and promethazine cough syrup. He saw the purported patients in Howard’s home, where Howard, Johnson, and Easley paid Weiss cash for his services. Howard, Johnson, and Easley then obtained the drugs that Weiss authorized through the prescriptions, and sold them on the street...Weiss caused Medicare to pay more than $250,000, and Blue Cross almost $40,000, for the illegitimate prescriptions...also...Weiss submitted about 950 claims to Medicare and Blue Cross for providing services to the supposed patients...received about $65,000 through the fraudulent bills.
- India awards Gilead patent for Sovaldi, disappointing civic groups (fiercepharma.com)
Gilead Sciences has received Indian Patent Office approval for Sovaldi (sofosbuvir), with the U.S. drugmaker saying that the nod for a patent on the blockbuster hepatitis C medicine does not hinder access--even as civic groups such as Médecins Sans Frontières decried the ruling...Gilead has worked with several Indian drug manufacturers to produce licensed versions of the drug for defined emerging markets at a significantly lower cost for the therapy (than) in major reimbursed developed markets in the U.S., Europe and Japan...But the access program has not ended complaints from MSF, and other groups, that the particular decision sends a poor signal on access to a wide variety of generics made by Indian firms--some of which were approved under compulsory licenses in the country. At the same time, Indian officials have denied reports that patent policies are changing in favor of stronger intellectual property rules sought by multinational drug firms...according the Hindu, the drug may not be out of the woods yet in India, with a separate application before the Kolkata patent office with civic groups geared up to offer opposing views.
- Pfizer to pay $784.6 million to resolve Wyeth false claims lawsuit (reuters.com)
Pfizer Inc has agreed to pay $784.6 million to resolve allegations that Wyeth, which it acquired in 2009, underpaid drug rebates to Medicaid, the federal health insurance program...The settlement resolves claims by the U.S. and states that Wyeth knowingly reported false and fraudulent prices on two of its anti-acid drugs, Protonix Oral (pantoprazole) and Protonix IV...Wyeth offered hospitals deep discounts on bundles that included both drugs when made available to staff and patients...Wyeth wanted to induce hospitals to buy and use Protonix Oral, a drug they would otherwise have little incentive to prescribe because of other drugs that were already on the market and competitively priced...Wyeth hid the bundled discounts from Medicaid...
- MS patent challenges put billions in Biogen sales at risk (fiercepharma.com)Cost cutting helps Biogen top Wall Street estimates for quarter (reuters.com)
Biogen, already battling in a patent fight over multiple sclerosis star Tecfidera (dimethyl fumarate), has run into another challenge--this time with fellow MS treatment Tysabri (natalizumab). And with IP pressure mounting, the company may need to revamp its commercial lineup to ensure that the revenue keeps on flowing...India’s Swiss Pharma International has filed a petition for inter partes review of one of Tysabri’s patents--and another two petitions are on the way...The move could potentially put sales of the drug, which tallied $1.89 billion in 2015, in jeopardy... Swiss Pharma’s chances of upturning Biogen’s patents are "relatively modest." The product is "thoroughly protected" when it comes to its IP shields, and the safety flags it carries...Pharma patent challenger Kyle Bass has been trying to bat down Tecfidera’s patents for months now...the company needs to head to the dealmaking table...We believe a strategic acquisition of key products in the neurological diseases field, but outside MS, could potentially mitigate the looming threat to the MS franchise that is on the horizon...
- Federal Jury Convicts Boise Doctor Charged with Controlled Substance Delivery (dea.gov)
A Boise jury...returned guilty verdicts against Michael Minas, 50...on charges that he unlawfully distributed controlled substances outside the usual course of professional practice and not for a legitimate medical purpose…Minas illegally distributed was primarily oxycodone 30 mg, but the jury also found Minas guilty of distributing fentanyl and hydromorphone. The jury heard evidence that Minas wrote prescriptions for extraordinary dosages, such as 240, 300, and even 420 oxycodone 30 mg. They also heard evidence that he often wrote prescriptions at intervals of two or three weeks, but wrote dosage instructions on the prescriptions indicating that it was a month’s supply…Minas faces a maximum prison sentence of up to 20 years in prison, a maximum fine of $1,000,00 ($1,000,000) and at least three years of supervised release on each count of conviction.
- Walgreens Agrees to $500K Settlement for Overcharging Customers (pharmacytimes.com)
Walgreens has agreed to pay $500,000 in penalties, fees, and costs related to misleading advertising practices that led to New York customers being overcharged for products..."Businesses are required to ensure that their advertisements are truthful and not misleading..."When consumers purchase products at retail stores in New York, they should be able to rely on the prices displayed in advertisements and on shelf tags and not have to worry about being overcharged when they get to the register."...Walgreens has agreed to reform its advertising and business practices in New York...It must remove expired shelf tags within 36 hours, restrict the use of "Smart Buy" or "Great Buy," and refrain from using "Last Chance" or "Clearance" tags when the item is available at a reduced price for an extended period of time...Walgreens will also conduct internal and external price check audits in stores. If a store fails 2 consecutive external audits, it will have to pay a $2500 penalty.
- Roche sues Intas Pharma over Mircera anaemia drug patent (economictimes.indiatimes.com)
Swiss biotechnology giant Roche has sued Ahmedabad-based drug maker Intas Pharmaceuticals in Delhi High Court, alleging infringement of its patent rights over Mircera (methoxy polyethylene glycol-epoetin beta), an injectable brand used to treat patients with anaemia in chronic kidney-related ailments...Roche has sought an injunction order against the brand launched by Intas...Roche had close to $500 million in global sales for its Mircera brand...Intas...is contending a non-infringing stand on its product. "We also have strong grounds of invalidation for the enforced patent,"...Roche officials did not comment, saying the case is sub-judice. Intas launched its product under the brand name Erypeg in India at prices to retailer ranging from Rs 4,080 ($62) to Rs 8,200 ($124), depending on the strength of the injection. Roche's product is priced between Rs 5285 ($80) and Rs 10,621 ($160) per injection.