I have in the past harped on about Oxy abuse and the $634 Million payout Purdue Pharma made to settle with US Regulators (That's about $0.82 cents per POH share by the way). King Phramaceuticals has also just settled on 17 March 2010 for $42 Million according to the extract I have posted in the remainder of this commentary. This settlement follows on from the FDA's efforts to clamp down on abuse and how quickly a anti abuse Oxy opiod will dominate the market.
Purdue and King are the biggest players in the Oxy and Pain management Market.
A good POH business development manager would be value adding to an Oxypatch product by developing a risk management plan which big pharma can simply rubber stamp as its own. That risk management plan can also be released to shareholders and the market.
FDA extract states.....................
Makers of Powerful Painkillers Present Safety Plans FRIDAY, Dec. 4 -- The makers of 24 different prescription painkillers on Friday presented federal regulators with plans to curb the abuse of these opioid drugs. The pharmaceutical companies have been under pressure from U.S. Food and Drug Administration officials to find a way to stop the hundreds of fatal overdoses that occur with these medications each year, the Associated Press reported. Executives from Johnson & Johnson, King Pharmaceuticals and other drug makers proposed using patient medication guides, letters to doctors and additional physician training to end the misuse and inappropriate prescribing of painkillers, according to the wire service. In February, FDA officials sent letters to 16 companies ordering them to design risk-management plans for their drugs. The drug makers presented their joint proposal to the agency after several months of discussion. The painkillers in question include morphine, oxycodone and methadone. This marks the first time the agency has required a risk-management plan for an entire class of drugs, the AP reported. However, the problem is significant: a 2007 survey found 5.2 million people in the United States reported using prescription painkillers inappropriately. Such drugs are typically approved for people requiring round-the-clock treatment for moderate to severe chronic pain, such as cancer patients. But, significant harm can occur if patients are uninformed about how to properly take the drugs, doctors inappropriately prescribe the drugs, or if legitimate prescriptions get into the hands of people other than the intended patient, Dr. John Jenkins, director of the FDA's Office of New Drugs, part of the Center for Drug Evaluation and Research, said during a news conference back in February. Jenkins said then that the agency was taking this step to implement "a relatively massive new program," because "the rates of misuse and abuse [of opiates] have risen over the past decade." He also said the FDA was better able to address the problem, because the Food and Drug Administration Amendments Act of 2007 gave the agency the authority to regulate opioids. This is "our attempt to try and ensure that the benefits of the products outweigh their risks," Jenkins said in February. In addition to patient misuse, the FDA has documented many cases of physicians prescribing the potent painkillers for people with migraines, an unapproved use. The FDA said patients also sometimes chew extended-release pills that are designed to be swallowed, causing an accidental overdose of the drug.
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King Pharmaceuticals extract...................
King Pharmaceuticals Announces US Department of Justice Settlement March 17, 2010 BRISTOL, TENNESSEE, March 17, 2010 King Pharmaceuticals, Inc. (NYSE:KG) today announced that its subsidiaries, Alpharma Inc. and Alpharma Pharmaceuticals LLC (Alpharma), have finalized a civil settlement with the United States Department of Justice and the Office of the United States Attorney for the District of Maryland resolving a previously disclosed investigation into Alpharmas sales and marketing activities. As part of the overall resolution of the investigation, Alpharma also agreed to enter into separate civil settlement agreements with states that decide to participate in the settlement. The investigation related to Alpharmas sales and marketing of the pharmaceutical product Kadian (morphine sulfate extended-release) Capsules prior to Alpharmas December 2008 acquisition by King. King divested Kadian at the time of the Alpharma acquisition. The settlement does not constitute an admission by Alpharma or King of any liability or wrongdoing. Under the terms of the settlement agreement, Alpharma has agreed to pay federal and state authorities $42.5 million plus accrued interest, the full amount of which has been reserved. No criminal charges were brought against Alpharma as part of this resolution. Alpharma agreed to settle this matter to avoid the time, uncertainty and expense of litigation. About King Pharmaceuticals, Inc. King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products and technologies that complement the Companys focus in specialty-driven markets, particularly neuroscience and hospital. Kings wholly-owned subsidiary, Alpharma, Inc., is also a leader in the development, registration, manufacture and marketing of pharmaceutical products for food producing animals.
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Background on the Kadian Drug ...................
What is Kadian? Kadian belongs to a class of drugs called narcotic pain relievers. Kadian is used to treat moderate to severe pain. Extended-release Kadian capsules are used when around-the-clock pain relief is needed. Kadian may also be used for purposes other than those listed in this medication guide. Important information about Kadian You may not be able to take Kadian unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant. Kadian may be habit-forming and should be used only by the person it was prescribed for. Kadian should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Do not drink alcohol while you are using Kadian. Dangerous side effects or death can occur when alcohol is combined with Kadian. Check your food and medicine labels to be sure these products do not contain alcohol. Never take more than your prescribed dose of Kadian. Tell your doctor if the medicine seems to stop working as well in relieving your pain. Do not stop taking Kadian suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
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POH Price at posting:
9.5¢ Sentiment: LT Buy Disclosure: Held
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