Pharma news highlights: June

Ed Silverman

Pharmalot

(Continued from “Pharma news highlights: May”)

This afternoon, Ed Silverman shares his thoughts on the latest goings-on within the pharmaceutical and healthcare industry in his monthly pharma news highlights opinion piece. Throughout the last month we’ve seen the landmark ruling in favour of “Obamacare”, controversy over Merck’s new Claritin campaign and the launch of a new policy that will save the lives of many in India.

There is good reason that many in the pharmaceutical industry look forward to the summer doldrums – the preceding weeks can be crammed with too much to do. Just consider the barrage of gatherings for oncologists and biotechs. Of course, there was a great deal of news and so here are a few highlights…

Forest Laboratories management battle

For those who consider M&amp,A to be a worthy blood sport, there is nothing more interesting than tracking the comings and goings of Carl Icahn who, once again, is hounding Forest Laboratories and its 84-year-old chairman, Howard Solomon. The two sides are openly sniping at one another as Icahn, who owns 9 % of the drugmaker, attempts to place four nominees on the Forest board. Meanwhile, the billionaire raider is openly disparaging the credentials of Solomon’s son, to ascend the throne, although the Forest management team insists a credible succession plan is under way. But nothing Forest can say will dissuade Icahn from digging in. He now hopes to spur some kind of investigation into $500 million in stock sales by the older Solomon.

Ruling of ‘Obamacare’

Then, there was that a landmark ruling by the US Supreme Court, which upheld the individual insurance mandate at the heart of the Affordable Care Act, which was the centerpiece of healthcare reform. For drugmakers and biotechs, the outcome means a degree of predictability, even though they will face billions of dollars in price cuts and fees. The industry can continue to expect to pay fees and rebates that were agreed to help fund the Affordable Care Act over a 10-year period.

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“…there was that a landmark ruling by the US Supreme Court…”

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One consulting firm expects as much as $105 billion in fees and other costs, which would include provisions for biosimilars, although so-called reference product sponsors, or those selling original biologics, will have 12 years of market exclusivity. And Moody’s Investor Services says the ruling is negative because the costs are high and the industry may not recoup that much in new revenue once the uninsured enter the system in 2014. The fees were $2.5 billion last year and will be $2.8 billion this year, Moody’s notes.

India’s ban on branded drugs

While Americans were debating the aftermath of the ruling, Indian Prime Minister Manmohan Singh announced that medicines will be available free to everyone who needs them starting in October, and that $17.5 million has so far been set aside to finance the program through 2013. The government will fund 75 % of the cost, which could run in the billions of dollars over five years, and individual states will finance the rest. The National List of Essential Medicines, which cites 348 drugs, will be used as a reference, although states will be required to establish their own lists based on local needs. About 5 % of the funding will be available to purchase drugs that are not on these lists. And docs working in the public sector will be required to prescribe only generics.

FDA weight-loss drug approval

Meanwhile, for the first time in more than a decade, the FDA approved a prescription drug for weight loss, a move that ushers in a potentially new era in combating obesity, which has been repeatedly cited as a crucial public health problem. Renamed Belviq, the Arena Pharmaceuticals pill was approved as an addition to a reduced-calorie diet and exercise for managing chronic weight issues. The approval came after two years of delay in which a trio of new diet pills were debated by regulators, physicians and investors. The FDA endorsement suggests that the other drugs – Qnexa from Vivus and Orexigen Therapeutics – may also stand a better chance of reaching medicine cabinets following a series of hurdles in which a cautious FDA examined various side effects. A decision on the Vivus drug is expected by July 17.

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“…for the first time in more than a decade, the FDA approved a prescription drug for weight loss…”

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Arena will be required to conduct post-marketing studies. Just the same, the arrival of a prescription diet drug is likely to become an immensely popular pill, given the tendency among many people to see such medications as a quick fix. This was noticeable during the fen-phen craze in the late 1990?s, when the weight-loss combination became widely available through so-called pill mills before one of the two drugs comprising the combination was withdrawn in 1997 over serious heart and lung concerns. For these reasons, the US Preventive Services Task Force suggested that doctors instruct obese patients to diet, exercise and seek weight-loss counseling, but did not recommend the use of diet drugs. Consequently, the reception given Belviq in the medical community may be mitigated, although the American Society of Bariatric Physicians released a statement applauding the FDA approval.

EMA investigate Roche

The European Medicines Agency (EMA) is investigating whether Roche failed to report tens of thousands of adverse events in connection with its various drugs, including 15,161 patient deaths. The probe comes after UK regulators identified deficiencies in reporting adverse events after recently conducting review procedures that were actually part of a coordinated European program to inspect safety reporting systems in the pharmaceutical industry, according to the EMA. At the time of the inspection, Roche identified some 80,000 reports for medicines marketed in the US that had been collected through its patient support program, the EMA states, but these had not been evaluated to determine whether they should have been reported as suspected adverse reactions to EU authorities. There were also questions about 23,000 adverse events related to evaluating and reporting to national regulators and 600 pertaining to clinical trials.

Merck’s cartoon controversy

Nearly a dozen consumer advocacy groups wrote to the US Federal Trade Commission to demand an investigation into Merck for using cartoon characters from the latest Madagascar animated film in an “inherently unfair”, “deceptive” and “dangerous” way to promote its grape-flavored Children’s Claritin allergy medicine. The tie-in pertains to both tablet and syrup forms of the over-the-counter medication.

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“The advocacy groups worry the combined campaigns may induce children to “over-consume” Claritin…”

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By using the animated characters from ‘Madagascar 3: Europe’s Most Wanted,’ the groups claim that children may confuse the medicine with candy and food that are also part of a promotional campaign undertaken by the Dreamworks film studio. These products include fruit-flavored gummy snacks, Airhead candy, Blue Bunny ice cream bars, McDonald’s Happy Meals and Lance sandwich crackers. The advocacy groups worry the combined campaigns may induce children to “over-consume” Claritin and, in arguing their case, they maintain the Merck effort violates an FTC precedent that was set in 1977 regarding marketing to children.

Pfizer end clinical trial recruitment efforts

Pfizer ended a closely watched effort to use social media almost exclusively to recruit patients for a clinical trial. One year after launching its so-called clinical-trial-in-a-box, the drugmaker discontinued enrollment in the first such study that was designed to allow patients to participate from home by using computers and smartphones instead of going to a clinic or doctor’s office for medicine and check-ups. The drugmaker hoped to create a model for saving money that would rely on personal technology to more easily recruit patients and monitor their progress. But while the gambit generated substantive traffic to the web site that offered information about the trial, the drugmaker was unable to convert that interest into significant numbers of people who were willing to participate in the study, which was testing the Detrol overactive bladder drug.

The next ‘Pharma news highlights’ can be viewed here.

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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.

Which pharma news story from June interested you the most?