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Bayer extends antacid line with fruit chews

BY Michael Johnsen

There can’t be too many tried-and-true, immediate-action calcium carbonate formulations among heartburn remedies, no matter how many proton-pump inhibitors dot that shelf’s landscape. At least that’s what Bayer Consumer is counting on with its line extension of Alka Seltzer Fruit Chews.

And it’s not a bad bet. GlaxoSmithKline’s Tums brand recently won accolades for its latest line extension; Tums Freshers was named 2013 Product of the Year in the OTC Relief category as part of a survey of more than 50,000 people conducted by global research firm TNS. The brand also was voted the most innovative OTC product launch in the past year as part of DSN’s 2012 Innovies awards.

Tums represents the No. 2 brand in the heartburn category, behind Prilosec OTC. Further, Tums continues to grow at a 4.1% clip, even as the category is down 1.6% across total U.S. multi-outlets for the 12 weeks ended April 21, according to IRI. In fact, sales of all PPIs have been trending down for that 12-week period.

Bayer and GSK may have another PPI switch to contend with in the near future. Pfizer has been shepherding Nexium through the Rx-to-OTC switch process since it bought OTC sales rights to the brand in August.

The article above is part of the DSN Category Review Series. For the complete Digestives Sell-Through Report, including extensive charts, data and more analysis, click here.

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Liability of harmful side effects questioned

BY Alaric DeArment

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

The case, Mutual Pharmaceutical v. Bartlett, involves Karen Bartlett, who took Mutual’s sulindac, a generic version of Merck’s Clinoril. After taking the drug, Bartlett developed and suffered near-blindness, esophageal burns and lung damage, as well as the skin disorders Stevens-Johnson syndrome and toxic epidermal necrolysis. A jury awarded Bartlett $21 million for her injuries, and the Supreme Court heard the case in mid-March.

The issue is, while Bartlett suffered the injuries after taking Mutual’s drug, under federal regulations governing generic drugs, a generic drug company typically does not have to conduct clinical trials — only demonstrate that its product is identical to the branded drug. It relies on the safety and efficacy data collected by the developer of the original branded drug.

"The previous court suggested that the manufacturer in this case, Mutual Pharmaceutical, could comply with the law by simply halting production of the Food and Drug Administration-approved drug in question, sulindac," Generic Pharmaceutical Association president and CEO Ralph Neas said. "This pain drug has been available since 1979, has been dispensed more than 300 million times from 2007 to 2012, and has exhibited a typical safety profile. We cannot confer to unqualified juries the power to undermine FDA rulings and potentially deprive millions of patients the medicines they need. Decisions about the safety and efficacy of drugs belong in the capable hands of the FDA."

In PLIVA v. Mensing, a 2011 case cited by Mutual, the Supreme Court determined that because generic drugs and their labeling are required to be identical to their branded counterparts, generic drug companies cannot be responsible for inadequate labeling.

The case closely follows a ruling by the Alabama state Supreme Court in January in a similar case. The Alabama court ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports. According to the New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer’s acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis make generic versions. Weeks had originally filed the suit in federal court, but the court asked the Alabama Supreme Court to determine if Weeks could sue the branded drug makers.

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States consider ‘carve-out’-style laws for biosimilars

BY Alaric DeArment

While the passage of the Patient Protection and Affordable Care Act of 2010 was a milestone in a number of respects, it also was one of the biggest moments in the history of the generic drug industry since the 1984 passage of the Hatch-Waxman Act, which created an abbreviated regulatory approval pathway for generic pharmaceutical drugs.

The healthcare reform law created a similar, abbreviated pathway for biosimilars, and while the Food and Drug Administration has yet to put regulations in place, many analysts foresee significant growth in the industry when that happens. According to Visiongain, a British market-research firm, the global market for biosimilars will see rapid growth over the next 10 years as biosimilars hit the market in the United States. Indeed, companies ranging from generic drug manufacturers that already make biosimilars for the European market — including U.S.-based Hospira, Israel-based Teva Pharmaceutical Industries and Switzerland-based Sandoz — to those looking to enter the market, such as Actavis and Mylan, and large pharmaceutical companies, including Merck and Boehringer Ingelheim, all hope to claim their piece of the market.

But one major obstacle to biosimilars has been the biotechnology industry. Biotech companies have supported bills in numerous states that, while not banning substitution of biosimilars for branded biotech drugs, would certainly get in the way, saying they are necessary to promote patient safety. Unlike generic drugs, which are required to be identical to their branded counterparts, they say, it is much harder to avoid differences between branded biotech drugs and biosimilars due to the likelihood of genetic differences between the cell lines used to make them, which can dramatically change a biosimilar’s properties and therefore its safety and efficacy profile.

In March, Virginia Gov. Bob McDonnell signed into law a bill that would prohibit a pharmacist from dispensing a biosimilar to substitute for a branded biotech drug if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product. It also would require the pharmacist to inform the patient before dispensing and record the name of the product and its manufacturer on the dispensing record and prescription label. Pharmacists would further be required to provide cost information to the patient for the branded product and the biosimilar. The Generic Pharmaceutical Association, a Washington trade group that represents generic drug manufacturers, criticized the bill, but the bill contains a two-year sunset clause, meaning it will expire in 2015, before biosimilars are likely to hit the market in significant numbers. A similar bill failed in Maryland’s legislature.

Meanwhile state legislators in Florida passed a bill last month that would allow for substitution of a biosimilar for a branded biologic when they were determined to be interchangeable, and also required the state board of pharmacy to maintain a current list of interchangeable products — drawing praise from the GPhA. An earlier version of the bill also contained restrictions on substitution, but the final version was waiting for the governor’s signature, at press time, with none of them attached.

All of these bills might be moot, though. President Barack Obama’s $3.8 trillion 2014 budget proposal sent to Congress in April would ban state laws to restrict biosimilar substitution, if passed.

"Biotech companies have supported bills in numerous states that, while not banning substitution of biosimilars for branded biotech drugs, would certainly get in the way."

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