Pharmalot

The Risperdal Lawsuits Keep On Coming: Kentucky Sues J&J

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Like a game of whack-a-mole, no matter how many times Johnson & Johnson attempts to put to rest lawsuits over the marketing of its Risperdal antipsychotic, another claim pops up. The latest is a lawsuit filed this week by the Kentucky attorney general, who like others before him in federal and state governments, charge the health care giant with illegally promoting the widely prescribed pill.

The charges are familiar: J&J is accused of hiding and minimizing side effect data about diabetes and weight gain, and concealing evidence that Risperdal causes increased levels in children of a hormone that stimulates breast development and milk production. Last fall, J&J began settling lawsuits charging the pill causes gynecomastia, which is the abnormal development of large mammary glands in males (here is the lawsuit).

In the scheme of things, this is just one more lawsuit that, as noted, covers familiar ground, but underscores the extent to which Risperdal marketing practices continue to haunt the health care giant, which is struggling to overcome the negative impression caused by manufacturing gaffes that led to countless product recalls and a scandal over the safety of its hip replacement devices.

J&J, in fact, is haggling with the feds over the terms of a $2.2 billion settlement. Specifically, the drugmaker is trying to avoid admitting to conduct that could negatively affect the outcome of the personal injury lawsuits involving gynecomastia. The feds want J&J to admit data played down the risks from increased prolactin, while J&J wants the feds to agree not to continue to pursue the allegation (read more here).

As noted, many other states succeeded in forcing J&J to pay for Risperdal marketing practices. Last year, J&J agreed to pay $181 million to resolve claims by 36 states (see this), an Arkansas judge fined the health care giant $1 billion (look here) and J&J (JNJ) agreed to pay $158 million to settle a lawsuit brought by the Texas attorney general (back story). And two years ago, J&J was ordered by a South Carolina judge to pay $327 million for deceptive marketing, which he called detestable (see here).

Risperdal marketing has been a special kind of albatross for J&J ceo Alex Gorsky as well. Last year, the feds tried unsuccessfully to compel him to provide a deposition in a widely publicized kickback case involving the Omnicare nursing home pharmacy. At issue were charges Omnicare received kickbacks – in the form of rebates, educational grants and payments for marketing data – so that Risperdal would be prescribed more often. As we wrote last year, from October 1998 to October 2001, Gorsky was vp of marketing at the Janssen unit that sold the drug, and from October 2001 to early 2003 he was the Janssen president. During that time, he was responsible for selling Risperdal, and Omnicare was the biggest Risperdal customer.

Moreover, according to the feds, his resume noted that Gorsky instituted a Janssen compliance program for regulatory and legal issues. He also regularly received monthly reports on J&J’s Long Term Care Group, including reports which had details about Omnicare efforts to promote Risperdal prescribing of Risperdal. And Gorsky met repeatedly with senior Omnicare execs to discuss those efforts (read more here).

Conway, by the way, has raised the ire of drugmakers in...

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Flushing Sound: PhRMA Threatens Another County Over Take-Back Plan

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For the second time in the past year, the pharmaceutical industry trade group is threatening to sue a county government for wanting drugmakers to help pay disposing of unused and expired prescription medicines. The latest episode is unfolding in King County, Washington, where the Board of Health has proposed a regulation that would require drugmakers to provide and promote secure return systems, KOMO News reports. A vote could come as soon as next month.

Last December, you may recall, the Pharmaceutical Research & Manufacturers of America filed a lawsuit against Alameda County in California after passing what was the first local regulation in the US to require drugmakers to pay for a disposal plan.

Officials in both counties have maintained that safe disposal should be a shared responsibility since the pharmaceutical industry profits from the sale of its medicines, but PhRMA argues the cost of compliance is prohibitive. In discussing the King County proposal before local officials, PhRMA senior assistant general counsel Marjorie Powell made clear that the industry trade group is likely to file another lawsuit if local officials do not back down.

"I see no difference from the things we objected to in Alameda so I see no reason why, when asked, my board would not vote to do the same in King County," she said. “I would be quite surprised if my board did not sue King County," Powell said. "I was trying to tell the board that if they pass this they are likely to face legal action. That is not a threat, it's a statement of fact."

The issue has been closely watched because such regulations could pop up across the country, forcing the pharmaceutical industry to cope with a patchwork of regulations and encounter rising costs. Local officials maintain their budgets simply cannot shoulder the entire cost of such efforts.

Alameda County residents, for instance, can drop off their medications at 28 different locations at a cost of about $330,000 annually, according to official estimates (back story). A recent study in Wisconsin found that just 2 percent of unused household medicines were collected in the state in 2011 and the estimated cost of take-back programs ranged from $8.05 to $10.07 per pound. By comparison, programs in Canada and France, where drugmakers provide funding, average $3.50 per pound and $0.23 per pound, respectively (read more here).

In Alameda, though, drugmakers are upset that the ordinance forbids them from imposing any local point-of-sale fee to recoup the costs of the program, which they maintain violates the dormant commerce clause in the US Constitution. By allegedly "off-loading" the expense, they argue that their customers from other parts of the country will be forced to absorb the costs. PhRMA has singled out seniors who will shoulder these costs (here is the lawsuit).

In King County, the local Hazardous Waste Management Program will initially pay for 200 uniform boxes to be placed in pharmacies and police stations where consumers can drop off unwanted medicines. But drugmakers will absorb most costs, such as collection supplies at drop-off sites; prepaid mailers for disabled or homebound residents; collection events; transportation to incinerators, and program promotion and evaluation, administrative costs and fees to Public Health to cover annual review and oversight, KOMO News writes. Failure to comply will cost up to $2,000 a day.

As for the PhRMA threat, King County Councilmember Joe McDermott, who also chairs the Board of Health...

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Up And Down The Ladder... Job Changes

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone?

And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that Achillion Pharmaceuticals hired David Apelian as executive vp and chief medical officer. Most recently, he was sr vp of R&D and chief medical officer at GlobeImmune. Before that, Apelian was clinical director in the infectious diseases group at Bristol-Myers Squibb and clinical director in the department of hepatology and gastroenterology at Schering Plough.

Generic Pharmaceutical Association promoted Jason Money to assoc vp, federal gov’t affairs;

AbbVie says chief scientist John Leonard is retiring;

Breast Cancer Action says former executive director Barbara Brenner passed away;

American Psychiatric Association named Saul Levin as ceo and medical director;

Achillion Pharmaceuticals hired Kevin Kucharski as sr vp of clinical operations;

Zosano Pharma hired Nandan Oza as chief operations officer;

Vivus added J. Martin Carroll to its board;

Vivus added Jorge Plutzky to its board;

Optimer Pharmaceuticals named Eric Sirota as chief operating officer;

Bayer AG hired Herbert Heitmann to head communications and government relations;

Harvard Bioscience says ceo Chane Graziano is retiring;

Harvard Bioscience named David Green as interim ceo;

Durata Therapeutics added Paul Friedman to its board;

LIST ENDS HERE

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Pharmalot... Pharmalittle... The Weekend Nears

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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, as you know, our treasured signal to daydream about weekend plans. Already, we envision spending time with assorted short people, one of whom must be escorted to a big date this evening; puttering around the castle; foraging for treasures in nearby villages and taking a few well-deserved naps. But what about you? Have anything special planned? Maybe spending time with a special someone? Enjoying the great outdoors? Or perhaps you could simply plan the rest of your life? Whatever you do, have a grand time, but be safe. Meanwhile, see you soon...

Sanofi And French Government Squabble Over Fate Of R&D Site (Bloomberg News)

J&J To Discontinue Sale Of Metal-On-Metal Hip Implants (Bloomberg News)

Novartis Has No Intention Of Buying Actavis (Reuters)

One In Five Children Have A Mental Health Disorder (Health Day)

Amgen And Novartis Partner With Biotech Venture Capital Firm (PM Live)

Australian Judge Refuses To Approve Vioxx Settlement (Sydney Morning Herald)

New Drug Pricing In India Goes Into Effect (Pharma Times)

Bayer Buys Herbal Remedy Supplier (PM Live)

Hikma Ends Phenobarbitol Sales To Arkansas Over Execution Use (BBC)

J&J Will Look Beyond Tasmania For Poppy Supplies (ABC)

Bayer Prostate Cancer Drug Wins FDA Approval (GenEnNews)

FDA Warning Did Not Change For-Profit Dialysis Drug Use (Reuters)

J&J Wins Expanded Approval Of Simponi For Disease (Bloomberg News)

EDITOR'S NOTE: Please check this post for additional stories during the day

cherry tree pic thx to taylora on flickr

 

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A Batch Of Melanoma Treatments Harness The Immune System

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In a closely watched preview to an upcoming cancer conference, several big drugmakers late yesterday released abstracts showing promise for a new batch of drugs that harness the immune system to fight melanoma and other cancers. And the big winner, so far at least, is Bristol-Myers Squibb.

A combination of its existing Yervoy melanoma treatment and an experimental medication called nivolumab, which targets the immune system differently, shrank tumors in about 41 percent of 52 patients with advanced melanoma. Tumors disappeared entirely in 10 percent of patients.

The combination treatment generated faster patient responses and shrunk tumors more thoroughly than either drug alone, according to Jedd Wolchok, an oncologist at Memorial Sloan-Kettering Cancer Center and the lead study author, in a briefing organized by the American Society of Clinical Oncology.

The new Bristol-Myers treatment, which is known as a PD-1, or programmed death therapy, is not the only such drug that is generating considerable interest. Both Merck and Roche are also testing such medications and reported encouraging results.

“We think the programmed death therapies are highly likely to steal the show” at the annual ASCO meeting to be held early next month in Chicago, wrote Sanford Bernstein analyst Tim Anderson in an investor note today. And for the moment, he believes Bristol-Myers is in the lead.

There was considerable anticipation, in fact, over the Bristol-Myers combination and the stock rose 5 percent yesterday, even though the abstract was not released for two hours after trading officially halted. ASCO says there was no indication that an embargo was broken or news released prematurely.

The stock gave up some gains today, prompting speculation that some investors may have been looking for better results from the combination treatment. But ISI Group analyst Mark Schoenebaum wrote in an investor note “this is a ‘near’ complete response and is quite impressive, in our opinion.”

And he released a survey of 104 large investors showing 42 percent believed the results met expectations, while another 29 percent believed the outcome was a bit better than expected. Only 9 percent expected the results to be much better.

But Roche is not far behind. The drugmaker released results of an early stage study showing its own drug, which works slightly differently, showed significant shrinkage in 29 of 140 patients who had not only melanoma, but also lung and kidney cancer (you can search the abstracts here).

“We are on the cusp of immunotherapy breaking into several different tumors,” wrote Leerink Swann analyst Seamus Fernandez in an investor note. But “Bristol-Myers is extremely well-positioned for long-term leadership in a transformational class of drugs.”

And big sales are projected. Bernstein, for instance, looks for Bristol-Myers (BMY) to notch about $3.2 billion in annual revenue by 2020, while both the Merck (MRK) and Roche drugs should generate roughly $1.5 billion by then.

STORY ENDS HERE

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The Most Serious Kind Of Drug Recall Is Increasing

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Amid an FDA crackdown on manufacturing violations and a rising shortage of many prescription drugs, it may not be surprising to learn that there were also more recalls during the first quarter of this year.

Specifically, there were 107 recalls, which amounted to a 32 percent increase from the previous quarter and a higher number, on average, according to a report from Expert Recall, a consulting firm.

And given the increased scrutiny placed on compounding pharmacies by the FDA in the wake of the nationwide outbreak of fungal meningitis last fall, a compounder set the record for most recalls in this year’s first quarter with a total of 13.

Overall, there more than 13.1 million unit recalls, up from 11.7 million in the fourth quarter of 2012. The bulk were due to several large recalls, including that involved more than 1 million units each.

Interestingly, there were 14 Class I recalls this past quarter, which was more was document in each quarter of 2012. This is the most serious because these suggest what the FDA calls a reasonable probability that use or exposure will cause serious adverse consequences or death.

Similarly, there were more Class II and Class III recalls in the recently ended quarter than in each quarter during 2012. The number of Class II recalls amounted to 62 and the number of Class III recalls totaled 31.

In a further breakdown, six recalls involved over-the-counter medicines and three “high volume” products accounted for 85 percent of the total. The drugs, however, were not named.

The remainder of the 107 recalls involved prescription drugs, including 14 that were documented as Class I, 61 were Class II and 26 were Class III. And 67 recalls affected US customers nationwide. Only one recall affected customers outside the US.

HERE IS THE REPORT

STORY ENDS HERE

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Trade Deal Extension Generates Support From Congress

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Five Democratic members of Congress are urging the US Trade Representative to support an extension of World Trade Organization rules for poor countries because such a move could affect the prices of prescription medicines for countless millions of people.

At issue is a provision of the WTO’s Trade-Related aspects of Intellectual Property agreement, or TRIPS, that requires all of the signatories to adopt its measures, which include enforcing patents. But waivers were granted to the 1994 law that extended the deadline in different ways.

A provision pertaining specifically to pharmaceuticals extended the deadline until 2016, but another waiver covering all TRIPS provisions expires on July. Haiti proposed extend this transition period for implementing all TRIPS rules until countries “graduate” from less-developed country, or LDC, status.

Haiti has, in effect, sought an indefinite extension. And the members of Congress argue that if the request is denied, the prices of essential medicines – notably, for AIDS, tuberculosis and malaria – could rise dramatically in these countries, which already suffer from inadequate health systems.

Patient advocacy groups argue that the pharmaceutical industry may take the decision as a signal to abandon patent enforcement in LDC’s or grant voluntary licenses, which widen access to medicines. However, they fear the calculus may be altered if the WTO ends the extension, and so far, a handful of Congressional Democrats agree.

“We are concerned that if LDC’s are required to fully implement TRIPS while still ‘least developed,’ this could limit access to quality, affordable medicines to fight HIV, malaria and other diseases; educational and informational resources; and agricultural goods and green technology,” they wrote to acting US Trade Rep Demetrios Marantis.

“The Haiti proposal does not, in any way, prevent countries from implementing elements of the TRIPS intellectual property rules if desired, but the application would give LDC’s the flexibility to structure intellectual property rules to support development,” wrote Henry Waxman, a California Democrat, and four others (here is the letter).

The transition period would not exempt less-developed countries from applying TRIPS rules, but would give them flexibility in choosing whether or not to protect patents and other intellectual property.

A spokeswoman for the US Trade Rep sends us this: “The US government supports an extension of the transition period for LDC’s. We were a key player in securing the previous extension and we’re ready to support another one. The proposal about which we’re expressing questions is from some of the LDC’s requesting a permanent exclusion for LDC’s from TRIPS obligations.”

STORY ENDS HERE

pill pix thx to anolobb on flickr

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J&J Faces Criminal Charges In South Korea Over Tylenol Production

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A new Johnson & Johnson manufacturing scandal – this one in South Korea – is worsening. Two weeks after the drugmaker was ordered to halt production of two types of Children’s Tylenol syrup because some bottles contained higher amounts of the active ingredient, regulators now plan to bring criminal charges against the Janssen unit there and ban production of five products over the next few months. And Jannsen Korea unit ceo Kim Oak-Yeon may face three years behind bars.

The Ministry of Food and Drug Safety had already ordered Janssen Korea to recall and discard nearly 1.7 million Children’s Tylenol bottles that were produced after May 2011, and now wants to hold the health care giant accountable for “producing and selling products that were a threat to public health.” The excess amounts of acetaminophen can potentially cause liver damage.

The regulator, meanwhile, also ordered production of Children’s Tylenol Suspension to be halted for five months. Similarly, production of Nizoral was banned for four months; and production of Ultracet tabs, another pain reliever; the Pariet 10mg acid reflux tabs and Concerta Oros ADHD 18mg tabs were banned for one month.

The production ban is not surprising. Earlier this month, a ministry spokesman noted that drugmakers are typically prohibited from producing medicines for several months when manufacturing problems are detected and, in this case, production was likely to be suspended for up to six months.

The problems purportedly began when Janssen employees manually placed Tylenol syrup into bottles as new automated facilities installed in May 2011 could not completely fill the bottles toward the end of the manufacturing process at the Hyang Nam facility, according to the Yon Hap News Agency.

“Despite being aware of the anomalies in March, it was a month before Janssen Korea notified us. During that period, the company sold about 38,000 bottles of Children’s Tylenol Suspension 100ml and 500ml, though they potentially could cause liver damage,” Lee Dong-hee, the ministry’s director, told a news conference, The Korea Times reports.

As we noted previously, this is only the latest manufacturing embarrassment for J&J. The health care giant is still trying to remediate a key plant in Fort Washington, Pennsylvania, where its McNeil Consumer Healthcare unit is headquartered, after the facility contributed to a spate of recalls. J&J (JNJ) consequently signed a consent decree with the FDA.

Ironically, J&J last month launched its first new corporate image campaign in more than a decade in hopes of restoring consumer confidence in its products after the huge laundry list of recalls – Tylenol; Motrin; Rolaids; Sudafed; Benadryl; syringes; K-Y Jelly; Accuvue contact lenses; hip replacement devices; and the Topamax epilepsy drug, among many others.

The campaign is also designed to deflect attention away from ongoing investigations and litigation surrounding a scandal over failure data for its hip replacement devices and marketing practices for promoting its Risperdal antipsychotic. In fact, a $2.2 billion settlement with the US Department of Justice is in the pipeline.

Kim Oak-Yeon, the Janssen Korea ceo, tells the news agency that the health care giant will use the latest incident as an occasion to make better medicines and improve quality control. "We will cooperate with the investigation by related authorities to try to regain the confidence of consumers, patients, medical professionals and the government," she said in a statement.

STORY ENDS HERE

jail pic thx to timpearce on flickr

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