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Novartis faces probes on Tekturna tactics, Iran sales

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Jan 242013

Novartis ( $NVS ) may be looking at another trial of its troubled blood pressure drug Tekturna . This would not be a clinical trial, however, but more of the civil or criminal kind. As The Wall Street Journal reports, the Swiss drugmaker's annual report filing with the Securities and Exchange Commission this week included this tidbit. Last year it received a subpoena from the U.S. Attorney for the Western District of Kentucky “requesting the production of documents relating to marketing practices, including remuneration of healthcare providers, in connection with certain NPC products (including Tekturna and its combination products).” The company said it is “cooperating with the investigation, which is civil and criminal in nature.” In late 2011, Novartis halted a clinical trial of Tekturna on safety concerns. The company was testing Tekturna, also sold under the Rasilez brand, in diabetes patients with kidney problems. The hope was that Tekturna would protect the kidneys and heart from damage. But an increase in unwanted side effects–including nonfatal strokes and kidney complications–was seen in the Tekturna arm of the trial. Last year, Novartis added warnings to the drug's European label. Then in April, the FDA issued a warning against using the drug along with ACE inhibitors and angiotensin receptor blockers, both commonly used cardiovascular drugs, in patients with diabetes or kidney problems. The upshot for Novartis was that the diminished outlook for the drug led it to take a $900 million charge last year and contributed to its decision to whack 2,000 jobs, most of them in sales. The pending patent loss at the time for its blockbuster Diovan also figured in there, of course. In addition to that probe, Novartis filed a special Iran Notice with the SEC indicating that its Alcon eye care unit, which is based in Texas, is being investigated. The feds are looking at whether it violated sanctions against sales to Iran and other pariah nations. The company said a “grand-jury subpoena” asked for documents dating back to 2005. The company told WSJ it is cooperating but had nothing more to say.? Those were just a couple of bits of bad news the company laid on investors this week. After issuing its earnings report Wednesday, it told investors to expect flat revenues and slimmer profits this year as generics steal as much as $3.5 billion from 2013 sales.? – read the Wall Street Journal ? story (sub. req.) – here's the SEC? filing – and the Novartis? Iran Notice Related Articles: Novartis braces for $3.5B hit to 2013 sales Novartis to slash 2,000 US jobs, mostly in sales Novartis to revamp Rasilez label with safety risks ?

Armed with diagnostic, Biogen files for first-line Tysabri use

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Jan 162013

Tysabri–courtesy of Biogen Idec If persistence is a virtue, then Biogen Idec ( $BIIB ) is about as virtuous as they come. After years of safety problems, warnings, testing and retesting, the company has asked U.S. and European authorities to approve its multiple sclerosis drug Tysabri for first-line use. Tysabri, an injectable treatment, is now approved for use in patients who've failed on other therapies. Last year, Biogen's share of Tysabri sales amounted to $840 million for the first 9 months. Winning the right to market Tysabri to newly diagnosed patients–a bigger pool–could be very lucrative for Biogen and its partner Elan ( $ELN ). The applications are complicated, however, because of Tysabri's history. First approved in 2004, Tysabri was pulled from the market after patients died from an unusual brain infection, progressive multifocal leukoencephalopathy, or PML. But the drug was quite effective, so FDA allowed Tysabri to re-enter the marketplace in 2006 under a strict risk-management program. Patients did continue to die from PML, at about the rate Biogen predicted, and the company publicly updated those statistics on a regular basis. Despite the risks, patients continued to choose Tysabri; according to Biogen's latest quarterly filing with securities regulators, about 71,000 patients are now using the drug. Meanwhile, Biogen has been working on a diagnostic test that can identify patients who have antibodies to the JC virus, which causes PML. The company won FDA approval for that diagnostic last year. The agency also allowed revisions to Tysabri's label noting the ability to identify virus carriers. All of that built a foundation for the new drug-approval apps. Basically, Biogen and Elan are asking regulators to approve Tysabri for use in those who test negative for those antibodies, an estimated 45% of MS patients. Right now, Reuters notes, Tysabri is limited to 10% to 12% of treated MS patients. As Biogen has forged ahead on Tysabri, it's also been developing another MS treatment, BG-12, administered orally. Meanwhile, Novartis ( $NVS ) won approval for its MS pill Gilenya . So, Tysabri wouldn't be without new competition in the MS market. But according to Reuters , analysts have said Tysabri's market share could grow to 15% by 2015 with the new approval. In that case sales could amount to $2.9 billion. – read the release from Biogen – get the Reuters story – see the Boston Business Journal piece Related Articles: Tysabri label change could add $1B to sales FDA: Tysabri risks greatest during year 3 Biogen reports 11th PML case for Tysabri Teva tries to slow arrival of Biogen's competing MS blockbuster

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Armed with diagnostic, Biogen files for first-line Tysabri use

Critics pillory Sanofi for pulling cheap Campath

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Oct 182012

Sanofi's critics have launched a new offensive. After months of protesting yielded big reductions in the French drugmaker's layoff plans in its home country, those less-than-pleased with Sanofi ( $SNY ) are zeroing in on its decision to swap cheap Campath for the (presumably) much pricier, soon-to-be-approved multiple sclerosis drug Lemtrada . Lemtrada was one of the allures when Sanofi decided to buy the U.S.-based Genzyme . A repurposed version of Campath–approved for years to treat leukemia –Lemtrada is in line for approval in the U.S. and Europe next year. Campath has been selling for a respectable $60,000 per year, but for MS treatment, much smaller doses are used. How could Sanofi expect to charge a premium price for Lemtrada when Campath could be used off-label much more cheaply? In August, Sanofi said it would pull Campath from the market. It would remain available to leukemia patients through access programs in 50 countries, often for free. The withdrawal was expected to be effective in the U.S. last month. So, the field is clear for a higher price on Lemtrada, when and if it wins regulatory approval. Now, Sanofi's French detractors are pointing to the Campath move as further evidence of money-grubbing. The Campath withdrawal was “dictated only by the logic of profit,” the French business publication Challenges contended in a Sanofi critique. Some U.K. doctors have taken their disapproval to a higher level, by writing to Health Secretary Jeremy Hunt to protest Sanofi's cutting off Campath supplies. The drug is currently used off-label in MS patients, who now may not be able to get their next courses of treatment, the neurologists wrote, putting them at risk of “progressive, severe disability.” “It shows little regard for patients whose opportunity to alter the course of their disease is time-limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation,” the letter states (as quoted by The Independent ). And Lemtrada is expected to launch at prices 15 to 20 times higher than Campath's cost, the doctors said. In The Independent , Genzyme said its goal is to get Lemtrada to market ASAP, and that using the drug for MS shouldn't be happening outside clinical trials. “In the U.K., our price for Lemtrada and the value it brings to patients will be subject to the usual health economic valuation by the National Institute for Health and Clinical Excellence.” We'll have to wait and see what the notoriously price-sensitive agency has to say. – read the Independent piece – read the Challenges piece ?(in French) Related Articles: Sanofi hits a speed bump on blockbuster Lemtrada application Sanofi pulls Campath to clear way for higher-priced Lemtrada

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Critics pillory Sanofi for pulling cheap Campath

Facing Monday trial, Pfizer settles bellwether Chantix case

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Oct 182012

Pfizer ( $PFE ) settled its first lawsuit over Chantix 's links to suicide, Alabama media reports. After failing to win a postponement earlier this week, the drugmaker made a deal with the plaintiff, a Minnesota woman whose husband killed himself while using the stop-smoking drug. The terms were undisclosed. It's the first of the Chantix bellwether suits, the leading edge of the litigation over the drug's psychiatric risks. Some 2,600 claims were filed nationwide linking Chantix with suicides, attempted suicides, and other serious psychiatric problems, but all those cases are now consolidated in an Alabama court. Pfizer had asked Judge Inge Johnson to put off the trial until January to give the company time to work in new data from a trial of Chantix in depressive patients. That data made its debut Tuesday. Johnson rejected Pfizer's motion; the settlement followed. Attorneys in the case had also asked the judge to compel Pfizer CEO Ian Read to take the stand. The next case up for litigation was filed by Billy G. Bedsole, Jr., an Alabama man who claims that Chantix triggered suicidal thoughts, erratic behavior, mood swings, anxiety and memory loss. He says he was hospitalized for psychiatric reasons after using the drug. – read the AL.com story Related Articles: Pfizer's bid to forestall Chantix trial fails Pfizer aims to keep CEO off the stand in Chantix trial FDA: Chantix doesn't boost risk of psych hospitalization Study: Pfizer's Chantix raises heart risks 72%

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Facing Monday trial, Pfizer settles bellwether Chantix case

FDA flags cataract risk in kids using Vertex's Kalydeco

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Aug 302012

Vertex Pharmaceuticals ( $VRTX ) has hit an unexpected snag with its cystic fibrosis pill Kalydeco . The FDA is raising questions about a potential risk of cataracts in children using the drug, and asked the drugmaker to conduct a two-year study to assess that risk. The FDA's worries arose after a study in juvenile rats. After receiving a dose of Kalydeco about one-tenth the maximum recommended for humans, the young rodents developed cataracts. Whether the rat results mean similar risks apply to humans is unclear, the agency said. And that's why FDA asked Vertex to follow kids who are already taking Kalydeco, which targets cystic fibrosis in patients with a particular genetic mutation. The study would involve kids up to 11 years old, and would monitor participants for at least two years by providing eye exams every 6 months. In the meantime, the agency is adding information about the rat study to Kalydeco's label. Vertex said that it hasn't received complaints about cataracts from any patients who used the drug during clinical trials or since its launch in January. The drug is approved for use in kids 6 years and older, but Vertex plans to expand that range to patients as young as 2 years. – read the Reuters news Related Articles: Europeans notch approvals for Vertex, Novartis drugs EU OKs Vertex cystic fibrosis drug Kalydeco Vertex stock sales questioned after CF data gaffe Like what you're reading? Click here to get more news delivered to your inbox everyday > >

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FDA flags cataract risk in kids using Vertex’s Kalydeco

Xarelto, Pradaxa find reprieve in Eliquis delay

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Jun 252012

So much for a speedy review of Eliquis , the new anticoagulant from Bristol-Myers Squibb ( $BMY ) and Pfizer ( $PFE ). After putting the drug on its fast track in November, the FDA first put off its decision date by three months, and now has issued a complete response letter looking for more data-crunching (but no new studies). Best expectation for an approval? Next spring. That may be a setback for Bristol-Myers and Pfizer, but for Eliquis' rivals, it's a breather. Boehringer Ingelheim 's Pradaxa and Johnson & Johnson's ( $JNJ ) Xarelto now have the warfarin -alternatives field to themeslves for the near term. And given the data on Eliquis–which suggests it could beat both drugs on efficacy and safety–that reprieve must be a welcome one. And all the more welcome because it's unexpected. “All of this (delay) is surprising given the widespread perception that Eliquis is a best-in-class product relative to already-approved novel oral anticoagulants Pradaxa and Xarelto, ” Sanford Bernstein analyst Tim Anderson said in a note to investors. It's particularly helpful for Xarelto. The J&J drug, developed in partnership with Bayer , just lost out on a new indication in patients with acute coronary syndrome, which includes those who've had a heart attack or suffer from chest pain. That could have been a lucrative market, one that Pradaxa and Eliquis couldn't compete in directly, unlikely as they were to win a similar indication. So, the Eliquis delay gives J&J more time to grab market share in atrial fibrillation patients. Approved?in 2010, a year ahead of Xarelto, Pradaxa has the lead in those patients, at least for now. Reports of bleeding-related deaths among Pradaxa users, including one highly publicized case of a patient who died after striking her head in a fall, have some doctors wary of using the drug. Statistically, the numbers aren't out of the realm predicted by clinical trials, Boehringer maintains, and millions of patients have used Pradaxa. But unlike warfarin, the old standard, there's no quick antidote to Pradaxa, or for any of its new rivals, for that matter. – see the release from Bristol-Myers and Pfizer – check out the Reuters news Related Articles: FDA rejects blockbuster Eliquis bid, asks Pfizer, BMS for trial clarification FDA delivers Xarelto bad news to J&J, Bayer EMA supports Pradaxa but seeks sharper warnings for bleeding

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Xarelto, Pradaxa find reprieve in Eliquis delay

New use for Humira delayed as Abbott preps for spinoff

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May 232012

No new colitis indication for Abbott Laboratories' ( $ABT ) Humira –yet. The FDA has asked for more information from Abbott, postponing its decision on the new indication for several more months. With 500,000 patients in the U.S., ulcerative colitis would be a big new market for Humira to target. The timing for the delay isn't ideal: Abbott Laboratories is preparing to spin off its pharma division into a new company called AbbVie. The keystone of that new company is Humira and its $7.9 billion in 2011 sales, so the bigger Humira's prospects at IPO time, the better. Analysts had predicted an increase in 2012 sales to $9 billion with the colitis use, PM Live says. Plus, Humira doesn't have an eternity of exclusivity left; its patent expires in 2016. So, Abbott/AbbVie needs to capture as much revenue from it as possible. An Abbott spokeswoman told Bloomberg that the company has already handed over more information to FDA. The complete response letter came “several months ago,” Abbott's Elizabeth Hoff told the news service. “We're anticipating a decision by the end of the year.” Humira wouldn't have the colitis market to itself; Johnson & Johnson's ( $JNJ ) Remicade is approved for that use in patients who fail on first-line drugs. Meanwhile, Johnson & Johnson is developing Simponi –a follow-up to Remicade–for ulcerative colitis. The company just reported data from a new study, showing symptom relief in a majority of patients using the drug, compared with about 29% of placebo; all the patients had failed on standard therapy. – see the Bloomberg news – get more from MarketWatch – read the PM Live article Related Articles: Abbott tries to throw up roadblock to Humira biosim Humira sales leap helps power Abbott earnings Abbott prevails as Supremes pass on J&J patent suit

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New use for Humira delayed as Abbott preps for spinoff

Merck notches a win in Vioxx litigation

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May 112012

Merck ( $MRK ) won a legal victory in Australia in its ongoing litigation over painkiller Vioxx outside of the U.S. A court in Australia upheld a lower court decision that Vioxx did not contribute to a heart attack of a man there, who earlier had won a $290,000 award. This is only one small piece of the long legal saga involving Merck and Vioxx. Merck pulled the drug in 2004 when a study indicated that it doubled the risk of heart attacks and strokes, Bloomberg reports. The company in 2007 set up a $4.85 billion settlement fund in the?face of thousands of lawsuits claiming a connection to heart ailments, even though Merck had won 11 of 16 cases in the U.S. The fund did not pertain to claims outside the U.S. In March, Merck began wrapping class action litigation in Canada by pledging to pay up to $37 million to Vioxx patients who developed heart problems after using the drug. The settlement includes $10 million in costs and fees, and will total between $21.8 million and $37 million depending upon the number of eligible claims. – read the Bloomberg story Related Articles: Merck to pay up to $37M in Canadian Vioxx case Merck to appeal Aussie Vioxx ruling

New Zytiga use could double sales potential

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Mar 092012

Analysts are rejigging their sales estimates for Johnson & Johnson's prostate cancer pill Zytiga , on the promise that it could target a much larger set of patients. Yesterday, J&J ( $JNJ ) said it unblinded a study of the drug in patients who'd never had chemotherapy, on indications that Zytiga slowed the cancer's growth and might improve survival. If Zytiga can win a new indication in that patient group, that would more than double its target market, analysts say. And with pre-chemo patients using the drug for a longer timeframe, the gain in sales could be even larger. Wells Fargo's Larry Biegelsen told Bloomberg that, thanks to this news, he's reviewing his current sales forecast of $914 million by 2013. “There are roughly twice as many pre-chemotherapy prostate-cancer patients as there are post-chemo patients,” Biegelsen said. And right now, Zytiga is only FDA-approved for that post-chemo group. A broader approval would put Zytiga in head-to-head competition with Dendreon's ( $DNDN ) vaccine, Provenge . But Christopher Raymond, a Robert W. Baird analyst, told Bloomberg that his survey found that most oncologists would prescribe Zytiga. Meanwhile, Citi analyst Bryan Huang ran the numbers on the potential size of the pre-chemo market; at $5,000 a month for Zytiga–and accounting for competition from an experimental Medivation ( $MDVN ) drug at about the same price–the pre-chemo market in the U.S. would be $2.5 billion a year, he found. Post-chemo he puts at $800 million. – read the Bloomberg story – get more from The New York Times Related Articles: Zytiga data presents new threat to Provenge Surveyed docs see need for new prostate-cancer meds, Medivation says J&J's Zytiga's pain relief, ease of use beat Provenge J&J's prostate drug Zytiga gets final nod in Europe

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New Zytiga use could double sales potential

Gilenya market share drops after FDA review

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Mar 072012

An FDA safety review is taking its toll on Gilenya sales. The Novartis ( $NVS ) multiple sclerosis pill, the first oral therapy for the debilitating disease, lost market share in January after reports that some patients died while using the drug, one of them soon after taking his first dose. Some doctors say they're being more cautious about prescribing the drug, but Novartis says Gilenya's “potential is seen as unchanged.” As Bloomberg reports, the decline was small–to 6.1% of the market for immunomodulatory drugs, from 6.2%–but it came after 15 months of growth at a median rate of 15% per month. Meanwhile, analysts have cut their sales forecasts for the pill?an average of 10%. As a group, they now expect about $2.1 billion in sales by 2016. Novartis counters the market-share figures from the market resesarchers at Wolters Kluwer by saying that it has seen an uptick in U.S. scripts over the past few weeks. The company said a record number of new prescriptions have recently rolled in. “Some uncertainty is to be expected … as some physicians wait for final review and potential label changes” from the FDA, the company told Bloomberg . “Overall, we see Gilenya continuing to grow in volume.” Martin Voegtli of Kepler Capital Markets told the news service that he's cut his Gilenya sales forecasts to $1.96 billion by 2016. But he expects the safety concerns to wear off. “We still expect Gilenya to remain on the market and return to growth once the review has been completed,” he said. – read the Bloomberg story Related Articles: New death reports prompt EMA review of Gilenya FDA joins probe into Gilenya patient's sudden death Gilenya study results reveal no new safety issues New Novartis MS pill racks up 10,000 U.S. users

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Gilenya market share drops after FDA review

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MSL WORLD BLOG

Novartis faces probes on Tekturna tactics, Iran sales

Armed with diagnostic, Biogen files for first-line Tysabri use

Critics pillory Sanofi for pulling cheap Campath

Facing Monday trial, Pfizer settles bellwether Chantix case

FDA flags cataract risk in kids using Vertex's Kalydeco

Xarelto, Pradaxa find reprieve in Eliquis delay

New use for Humira delayed as Abbott preps for spinoff

Merck notches a win in Vioxx litigation

New Zytiga use could double sales potential

Gilenya market share drops after FDA review

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