Pharma news highlights: Roche, Sanofi and more

Ed Silverman

Pharmalot

This afternoon, pharmaphorum’s monthly contributor, Ed Silverman, provides his highlights on some of the top pharma news stories from the past four weeks.

(Continued from “Pharma news highlights: Eli Lilly, Abbott and more”)

The past few weeks have been filled with interesting and, sometimes, contentious developments in the greater pharmaceutical world. And so, here are a few of the highlights that have captured attention for various reasons…

Call for clinical trial data of Roche’s flu drug

Increasing pressure is being placed on Roche to release clinical trial data on its Tamiflu flu medication. The latest example is a call by a researcher from the Nordic Cochrane Centre in Copenhagen to European governments to boycott Roche products and file lawsuits against the drugmaker until complete data is released.

The suggestion came just one week after the influential British Medical Journal, which published the missive from Peter Gotzsche, announced a new policy in which it will no longer publish studies unless the relevant patient-level data is made available upon “reasonable request”. The policy goes into effect in January 2013.In explaining its decision, the journal pointed to a widely publicized episode last year in which researchers at the Cochrane Collaboration say they were repeatedly stymied by Roche in their efforts to fully assess up-to-date efficacy information for the Tamiflu influenza treatment. The data was sought as part of an evaluation of the efficacy of the medication.

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“Increasing pressure is being placed on Roche to release clinical trial data on its Tamiflu flu medication.”

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Concerns had been raised over the extent to which Tamiflu is effective and a follow-up effort by the Cochrane Collaboration determined that Tamiflu may not prevent complications from influenza in healthy adults. This position reversed a previous finding that the pill defended against and other deadly conditions linked to the disease.

Sanofi to lower price of cancer medication

The rising cost of medicine – notably, expensive cancer treatments – was on radar screens again after Sanofi made the unusual decision to lower the price of its Zaltrap colorectal cancer medication in the US. The move came in response to physicians at Memorial Sloan-Kettering Cancer Center who had written a blistering op-ed last in The New York Times to say they would not use the newly approved medication because an older, less expensive drug was equally useful.

The drugmaker is now offering discounts that amount to a 50 percent price cut for Zaltrap, which had cost about $11,000 per month before this week. The physicians complained that the price was twice as high for Avastin, a competing drug sold by Roche, but was actually no better in treating patients. In effect, Sanofi caved in to pressure and the implications were hard to miss.

The price discount signals a potential shift in how the pharmaceutical industry may respond to increasing complaints about the rising prices of new medications, some of which cost tens of thousands of dollars a year or more. The move is also noteworthy because a major cancer center successfully achieved its goal with public criticism, rather than behind-the-scenes negotiating.

There was one caveat, though. Sanofi is not changing the official list price, which would continue to be used to calculate Medicare reimbursement, as well as patient co-payments. By offering discounts, Sanofi gives healthcare providers an incentive to use Zaltrap, because physicians and hospitals could profit from the spread between the discount and the reimbursement rate.

FDA’s new effort in monitoring communications

In the US, FDA warning letters are often scrutinized for tell-tale signs of regulatory leanings and one recent example has public relations specialists concerned. A letter was issued to Cornerstone Therapeutics for omitting safety information and minimizing risks of its drug for treating neonatal Respiratory Distress Syndrome. Specifically, the FDA chastised the drugmaker for running afoul of regulations in a so-called pitch letter that was prepared by Fleishman-Hillard public relations firm.

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“In the US, FDA warning letters are often scrutinized for tell-tale signs of regulatory leanings…”

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This letter is significant because this marks the first instance in which public relations specialists can recall seeing non-public communication with a journalist targeted by the agency. As one specialist lamented, if they are only allowed to pitch journalists with the full prescribing information and the additional language is vetted by a lawyer, the communications are unlikely to make much of an impression on the media. The letter signals a new effort by the FDA to monitor communications.

US research centre affected by Hurricane Sandy

In the wake of Hurricane Sandy, which hit the New York metropolitan region rather hard, yet another tragic ending was uncovered. As many as 10,000 rodents perished in the basement of a research center run by NYU Langone Medical Center and the People for the Ethical Treatment of Animals, the activist group, has asked the US National Institutes of Health to investigate the hospital for failing to ensure the safety of the rats and mice.

The reason the drowning drew widespread attention is because the rodents were being used for research for studying heart disease, cancer, autism and schizophrenia, among other ailments. And they were reportedly carefully bred, which made them quite valuable. But the NYU hospital, which is located on the east side of midtown Manhattan, thought its basement could withstand surges 20 percent higher than what occurred historically. That proved to be a miscalculation and PETA claims NYU was negligent.

Novartis’ vaccines business experiences setbacks

Novartis experienced both another setback and some gains with its troubled manufacturing facilities. First, the drugmaker acknowledged that a key facility in Lincoln, Nebraska, which makes various over-the-counter and animal health medications, but was cited for a slew of embarrassing manufacturing violations, will not open later this year, after all.

Then, distribution of flu vaccines made in Italy was halted in several countries after small particles were found in some batches. However, within a couple of weeks, the Italian Medicines Authority reversed itself and other countries followed suit. At the same time, FDA indicated the Sandoz manufacturing plant Broomfield, Colorado, which was one of three sites referenced in a November 2011 warning letter, had finally achieved positive compliance status following a re-inspection in August.

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“Novartis experienced both another setback and some gains with its troubled manufacturing facilities.”

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The regulatory endorsements marked the first sign of progress for the drugmaker, which shook up some of its OTC and manufacturing teams in response to the ongoing problems. Nonetheless, sales have declined and Novartis lost some credibility when executives predicted earlier this year that the Lincoln, Nebraska, plant would be open before year’s end.

US pharmacies scandal

Without question, the biggest story – at least in the US – over the past month has been a scandal over compounding pharmacies. A meningitis outbreak traced to one compounder has resulted in 438 cases, including 32 deaths, which have been reported in nearly two dozen states. The episode has cast a harsh spotlight on the FDA and state regulators, and the extent to which they properly exercise their available authority.

There is controversy, however, over the responsibility the FDA has to oversee compounders thanks to US Supreme Court rulings that the agency maintains has tied its hands, unless a compounder engages in the equivalent of large-scale drug manufacturing and ships large amounts of products beyond its state border. Traditional compounding involves a pharmacy making a specific medication for an individual patient who is unable to obtain the treatment elsewhere.

The FDA has since inspected the facilities run by the compounder at the center of the controversy and found a host of violations, including greenish-black foreign matter and air conditioning systems that were turned off at night. An inspection of another nearby compounder owned by the same executive turned up the same sort of problems. Both have halted operations and Congress has begun investigations.

Meanwhile, the FDA is asking Congress to pass legislation that would spell out its authority and create a new designation for so-called non-traditional compounders – those that engage in bulk production – in order to increase its purview. And officials in Massachusetts – where the compounders are based – have fired one state pharmacy board official for failing to act on a complaint.

The next ‘Pharma news highlights’ will be published in December.

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About the author:

Ed Silverman is a prize-winning journalist who has covered the pharmaceutical industry for the past 16 years. In addition to editing Pharmalot, he is currently an editor-at-large for Med Ad News.

Previously, he was a bureau chief for The Pink Sheet, the venerable industry newsletter, and a contributor to its sister publication, In Vivo magazine. Before that, Silverman worked as a business writer for The Star-Ledger of New Jersey, one of the nation’s largest daily newspapers, where he conceived and launched Pharmalot. During his 13-year tenure, he closely followed a variety of topics of concern to those who work for, and with, drug makers – drug development, mergers and acquisitions, regulatory oversight, safety and pricing controversies, and marketing issues.

Prior to joining The Star-Ledger, Silverman spent six years at New York Newsday and previously worked at Investor’s Business Daily, among other newspapers. He has a master’s degree in journalism from New York University and a bachelor’s degree in accounting from Binghamton University. Tethered to his laptop and Blackberry, Silverman lives in suburban New Jersey with his wife, three children, a sizeable Labrador retriever and a sneaky beagle.

What do you think about November’s pharma news?