Drugmakers have sometimes been accused of marketing drugs for the elderly that might not be in their best interest. But a new study says doctors in the Southern part of the U.S. are too often prescribing drugs for elderly patients that can have severe side effects and for which there are better alternatives. “We started this study because we know that these medications are likely to have more harms than benefits in older patients,” Dr. Amal Trivedi, told The New York Times . “We have tried to reduce the use of these medications, and it's important to figure out exactly how common they are among the elderly and what types of factors contribute to their use.”? Health experts say that when it comes to prescribing an anti-anxiety drug for an older person, Pfizer's ( $PFE ) Xanax is a better choice that its Valium. That is because Valium is harder to metabolize, meaning older users are sedated longer, which might result in a fall. Doctors have also found that some diabetes drugs and muscle relaxers are better for older people for the same reason.? That information is not really new, but a finding by researchers that in the Southern part of the U.S. more than 1 in 5 patients older than 65 are likely to get one or more medications on a list ?of “110 drugs to avoid in the elderly” compiled by the National Committee for Quality Assurance, The New York Times reports. These are drugs that have such severe side effects in the elderly that health authorities have told doctors they should avoid giving them to their older patients. The study is published in The Journal of General Internal Medicine .? The researchers were not able to pinpoint the reasons that use of these drugs in the elderly is more common in the South but postulate that socioeconomic factors like education and access to quality medical care might be related to some of the regional differences. Researchers evaluated data from Medicare Advantage plans on more than 6 million older men and women across the entire U.S. that found that 1.3 million of them, roughly 20%, had been prescribed at least one high-risk medication in 2009, and 5% had been given two, despite the fact there generally were safe alternatives.? Drugmakers themselves have been accused of pushing some drugs on doctors that are inappropriate for older people. Just last year, Johnson & Johnson ( $JNJ ) settled a bunch of cases tied to the dangers of taking antibiotic Levaquin . It was alleged in some cases that J&J's Ortho-McNeil Pharmaceutical division had downplayed tendon risks in elderly patients in an effort to sell more product, an allegation the company has refuted. – read the New York Times story Related Article: J&J settles a boatload of Levaquin cases EMA database of adverse-event reports opens to public Which psych drugs are most popular?
Thank you, U.S. patent office. Pfizer ( $PFE ) won an extra 18 months of exclusivity for its pain drug Celebrex , in the form of a reissued patent that doesn't expire till the end of 2015. That means a cool couple of billion in extra sales. Celebrex brought in $1.7 billion in the U.S. last year, ranking it among the company's biggest sellers now that Lipitor is off patent. The drug was scheduled to lose market exclusivity on May 30, 2014. With the new method-of-use patent, Celebrex can hang on to that market for another year and a half. Provided, at least, that the courts back Pfizer's exclusive claim. The company immediately sued several generics makers that have asked FDA to approve their Celebrex copies. Teva Pharmaceutical Industries ( $TEVA ), Mylan ( $MYL ), Watson Pharmaceuticals –now Actavis ( $ACT )–and Apotex were aiming to launch their versions beginning next May. The extra revenue would come in handy at Pfizer, which is remaking itself into a streamlined version of its former, more diversified self. Lipitor, once a $9 billion seller, brought in only $3.95 billion last year, thanks to generic competition. Newer drugs are helping to fill the gap, but 2012 sales were down 10% overall. – read the Pfizer release – get more from Reuters Related Article: Fighting the $9B ghost of Lipitor past, Pfizer points to new drugs
Pfizer nabs extra time with blockbuster Celebrex patent
Entitled “Specific Anti-gp41 Antibodies Predict HIV-1 Disease Progression”, this article highlights the protective role of anti-3S antibodies in the progression of HIV infection. Evry, 1st March 2013 – InnaVirVax, a…
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InnaVirVax announces publication of an article in JAIDS (Journal of Acquired Immune Deficiency Syndromes)
Allergan CEO David Pyott–Courtesy of Allergan Allergan ( $AGN ) CEO David Pyott won quite a payday in 2012. In addition to the usual million-dollar-plus salary and bonus, Pyott nabbed a $9.4 million stock award, bringing his total to $21.2 million. When FiercePharma ranks the industry's highest-paid executives in April, Pyott will likely join the club. That $9.4 million stock award was a big pat on the back in financial form–and a bribe to keep him in his job. The “one-time special recognition and retention” compensation vests in 2017, provided performance goals are met, Allergan's preliminary proxy statement says. If Pyott leaves before then, he forfeits the whole shebang. Why is Pyott worth it? Well, the board says, Allergan's market value has grown to more than $30 billion from some $2 billion during his time as CEO. Its annual sales have grown to about $5.7 billion from $1.15 billion over the same time frame. Its shares have risen 24% over the past 12 months. The company has won new product approvals and new medical indications for top-performing Botox . And the company met its 2012 targets for earnings per share and R&D reinvestment (if not revenues). “Mr.?Pyott has delivered exceptional value to our stockholders,” the board said, adding that the compensation committee “wanted to recognize [his] consistently high performance over his tenure at the company.” As for the rest of Pyott's 2012 compensation package, there was $1.3 million in salary, a $1.65 million cash bonus, and $7.01 million in options. Pension and deferred compensation was $1.8 million, and perks amounted to almost $52,000.?In 2011, Pyott's compensation amounted to $13.9 million. So, his $21 million-plus 2012 package represents a 51.4% increase. Allergan shareholders will have their chance to weigh in on Pyott's compensation, albeit only on an advisory basis. The proxy statement sets out the company's case for its pay plans in preparation for that “say-on-pay” vote. Executive pay leans heavily on pay-for-performance measures and “at-risk” compensation, the company says. Like Pyott's special award and its goal-related vesting provisions, for instance. We'll find out what shareholders think at the company's annual meeting. – see the preliminary Allergan proxy – get more from Bloomberg Special Report: Top 10 Pharma CEO Salaries of 2011 Related Article: Who's missing from the CEO pay list? Short answer: Europeans
– Article in Peer-Reviewed Science-Translational Medicine Reports Strong and Durable T Cell Responses from VGX-3100, Which is Designed to Treat Cervical Dysplasias Caused by HPV Infection — On-going phase II efficacy study will determine…
MALVERN, PA.–(BUSINESS WIRE)–Oct 8, 2012 – Researchers at Progenra, Inc. announce the advanced online publication of the article “Selective Dual Inhibitors of the Cancer-related Deubiquitylating Proteases USP7 and USP47”…
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Progenra’s Novel USP7 Inhibitors are Shown to Exert Multiple Anti-Tumor Effects
Mercury Pharma, a U.K.-based specialty drugmaker, has gone from one private equity owner to another. Cinven agreed to pay ?465 million ($732 million) for the company, which HgCapital took private in 2009. The deal follows a couple of years of “streamlining” at Mercury, CEO John Beighton said in a statement. In an echo of Pfizer ( $PFE ) CEO Ian Read , Beighton explained that Mercury has been refocusing on its “core specialty pharmaceutical products” and plowing money into its pipeline. Right now, Mercury sells generic drugs and some branded products, including anesthetics, antipsychotics, cardiovascular drugs, pain meds and arthritis treatments. It's focused mostly on the U.K., but sells its products in more than 50 countries, including Australia and New Zealand, South Africa and Kenya, and a variety of markets in the Middle East and Asia. It launched 15 new products since last January. Apparently, Cinven sees growth in Mercury's essential drugs, many of them cheap generics, even in today's tough economy. Or, perhaps, especially–Cinven Partner Supraj Rajagopalan figures demand for Mercury's essential drugs will continue. “In a number of areas, Mercury is actually able to work with payors to reduce costs,” he said in a statement. Cinven is also eyeing M&A to broaden Mercury's reach. “It is a fantastic platform for further consolidation both in the U.K. and internationally,” he said, adding that Cinven has already identified “a number of compelling acquisition opportunities.” – read the release from Mercury Related Article: Cinven drops out of bidding for Elan division
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Cinven to pay $732M for U.K.’s Mercury Pharma
Amgen's big-selling anemia drugs were first brought in for questioning a few years ago. Studies and side-effect reports cast doubt on their safety. The FDA started a review. Then, in 2007, FDA slapped a “black box” warning on Epogen ?and Aranesp , citing risks of heart problems at higher doses. And the interrogation continues. The Washington Post takes a close look at the drugs, sifting through safety data and government documents to present a play-by-play of the saga. Like Department of Justice investigators who've been probing the company's marketing practices for years, the article rounds up regulatory actions, dosage debates and reimbursement moves. But it also looks past that back-and-forth among regulators, Amgen ( $AMGN ), and Johnson & Johnson ( $JNJ ), which markets an Amgen-made anemia product, Procrit . For instance: Amgen's intensive marketing persuaded doctors to boost dosage levels, and when the risks of those higher doses arose, lobbying in Washington helped fend off dosage limits proposed by Medicare ,?the Post reports. The Justice Department's ongoing probe focuses on that intensive marketing. Whistleblowers have claimed that Amgen promoted the drugs off-label and offered doctors kickbacks to boost Aranesp sales. Late last year, the company set aside $780 million to settle federal investigations and whistleblower claims related to anemia-drug marketing. The reimbursement questions are another thing altogether. As the Post reports, it's not just the political pressure applied to keep Medicare from cracking down on anemia-drug reimbursements. It's also the very structure of those reimbursements, which are set higher than doctors' costs for the drugs, allowing providers to profit off the spread. These drugs are far from the only ones reimbursed in this way. Amgen is also far from the only drugmaker accused of marketing violations. It should be noted that Amgen has denied misleading anyone about its drugs' safety or effectiveness, and says that its salespeople are trained to market drugs responsibly. But as the Post points out, the anemia-drug example underscores flaws in the U.S. healthcare system, and weaknesses in the regulatory and reimbursement framework. And it shows how drugmakers have every incentive to push the envelope. Amgen's proposed $780 million settlement is just a small fraction of its billions in anemia-drug profits. – read the Post analysis Special Report: Pharma's Top 11 Marketing Settlements Related Articles: WSJ: J&J, feds finalize settlement of up to $2.2B J&J to tighten up on oversight in wake of recalls, lawsuits
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Did anemia drug giants game the system to rake in billions?
With the results of an arrhythmia safety study in, the FDA is having GlaxoSmithKline ( $GSK ) expand the labeling changes on its Zofran, which is used in chemotherapy for vomiting and nausea. The clinical study found that a 32mg intravenous dose of the drug “may affect the electrical activity of the heart (QT interval prolongation), which could pre-dispose patients to develop an abnormal and potentially fatal heart rhythm known as Torsades de Pointes,” the FDA says in a safety communication. The notice says the updated label will remove a single 32 mg dosage, leaving in place the lower recommended intravenous dose of 0.15 mg/kg every four hours for three doses with no single intravenous dose to exceed 16 mg. No changes are contemplated at this point for instructions on oral dosing. Currently, oral doses of up to 24 mg are approved, MedPage reports. In September the agency had issued a warning that said the drug could induce dangerous and possibly lethal changes in heart rhythms. The label was changed to include “a warning to avoid use in patients with congenital long QT syndrome.” The agency also asked GSK to do the study. Zofran has been in use for some time. In October, South Korea fined GSK $2.6 million for a 2002 agreement with domestic drugmaker Dong-A Pharmaceutical that kept a generic version of Zofran off the market. Dong-A, which was sued by GSK after launching its copy-cat drug in 1998, was ordered to pay about $1.85 million for its role in the agreement. -?here is the FDA announcement – read the MedPage ? story – here's a Reuters ? piece Related Article: Korean FTC fines Glaxo, Dong-A in generic Zofran delay ?
GSK’s Zofran arrhythmia risk leads to new label change
Japanese drugmaker Astellas Pharma got what it was hoping for and what it badly needs, FDA approval of its new bladder treatment, mirabegron, branded Myrbetriq. The potential market is large. Estimates of Americans suffering from overactive bladders range from 33 million to 44 million. But?Astellas also needs a new source to offset revenue that will peter out when its current bladder treatment, Vesicare falls off patent. That bladder control drug generated $1 billion in sales last year but loses its shield in 2015, points out Bloomberg . Astellas reportedly is aiming to reach $1.9 billion in sales from both Vesicare and Myrbetriq by the end of its fiscal year that ends in March 2015. Myrbetriq goes up against Pfizer's ( $PFE ) Detrol ,?Warner Chilcott's ( $WCRX ) Enablex, and of course Astellas' own Vesicare. The advantage of the once-daily drug is that it helps people with leaky bladders without affecting their ability to urinate, like some competing drugs, Bloomberg reports. That said, the FDA laid out a fairly substantial list of risks in its approval announcement. There is increased blood pressure and heart risk. Also some patients experienced hypersensitivity reactions like anemia and painful rashes. There also is a link to liver disease, some urinary tract infections and even?malignant tumors. The FDA says the reason for the tumor risk is unknown. Myrbetriq is not recommended for anyone with uncontrolled high blood pressure, end-stage kidney disease or severe liver disease. The company says it expects to have the new drug to pharmacies by the fourth quarter. – here's the Bloomberg story – get more from Reuters – see the FDA notice Related Article: Astellas scores FDA panel nod for overactive bladder drug
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Drug OK to boost Astellas in leaky bladder market