PHARMACY

AstraZeneca settles Nexium dispute with Ranbaxy

BY Adam Kraemer

LONDON AstraZeneca has settled a patent dispute with India’s Ranbaxy Laboratories over its top-selling ulcer pill Nexium, securing future sales of the product and boosting its shares 8 percent.

Under the new deal, Ranbaxy will start selling generic Nexium (esomeprazole magnesium) on May 27, 2014, when the first of a series of patents expire, the companies said on Tuesday. Ranbaxy will be the exclusive generic distributor for the first six months, according to Reuters.

AstraZeneca’s shares rose as much as 11 percent after the drugmaker reported the settlement, before settling 8 percent higher at 21.38 pounds ($41.95) by early morning, though AstraZeneca said the settlement would not affect the 2008 earnings outlook.

Ranbaxy chief executive officer Malvinder Singh hailed the deal as “extremely positive” for the Indian group, Reuters reported.

Ranbaxy will also benefit from an agreement—part of AstraZeneca’s outsourcing initiative—allowing it to formulate a portion of AstraZeneca’s U.S. supply of Nexium from May 2010, with the active ingredient being made from May 2009. And it has additional rights to distribute authorized generic versions of two older AstraZeneca products—heart drug Plendil (felodipine) and the 40 mg version of ulcer pill Prilosec (omeprazole).

Only Pfizer’s cholesterol medicine Lipitor, on $12 billion, sells more than Nexium, with its sales of $5.2 billion in 2007.

But AstraZeneca’s future focus had been under cloud with the expiry this week of a 30-month stay period blocking regulatory approval of a generic version. “The agreement allows us to spend more of our time and money in the laboratory and less in the courtroom,” AstraZeneca’s chief executive officer David Brennan told reporters in a conference call.

The deal is also good news for U.S. drug maker Merck, which collects a royalty on U.S. sales of Nexium.

AstraZeneca also faces a generic threat to its second-biggest drug Seroquel, for schizophrenia. Analysts, however, believe the patents protecting this product may be stronger than those surrounding Nexium, according to Reuters.

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Proximity, price outweigh technology in consumers’ choice of pharmacies

BY Jim Frederick

DURHAM, N.C. Fully one in three Americans who take prescription medicines have experienced a prescription error or say they know someone who has, a new consumer survey finds.

 The just-released Parata Prescription Safety 2008 poll appears to bolster the case for pharmacy technology vendors, who assert that robotic dispensing technology and other pharmacy technology can greatly reduce medication errors.

More than half of American adults take at least one prescription daily, according to the Parata survey and other reseaerch. However, researchers argue in a report on the results released Thursday, “increased prescription use has not been accompanied by increased consumer vigilance.”

Instead, consumers “readily admit to choosing their pharmacies for speed and convenience, rather than for safe prescription practices” the company reported. Half of those polled cited “proximity to work or home” as the top reason for choosing one pharmacy over another.

The second most cited reason for choosing a particular pharmacy is price, cited by 23 percent of respondents, Parata reported. “Interestingly, a pharmacy’s use of “automated dispensing equipment,” a proven strategy for reducing prescription errors, ranked last in importance, cited by just 2 percent of respondents,” pollsters noted.

The vast majority of prescription-takers [80 percent] spend less than two minutes speaking to their pharmacists when they pick up their medications, according to Parata, and almost half [45 percent] don’t talk to them at all. And while 91 percent of consumers asked could name the doctors who wrote their last prescriptions, only 36 percent could name the pharmacists who filled them, the survey found.

Nevertheless, far more respondents ranked pharmacists as principally responsible for ensuring their prescriptions are accurate than those who said their doctors mostly filled that role, by a margin of 49 percent to 15 percent for doctors.

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Feds’ new view of multisource drugs draws opposition from NACDS, NCPA

BY Jim Frederick

ALEXANDRIA, Va. The National Association of Chain Drug Stores and the National Community Pharmacists Association today asked the Centers for Medicare and Medicaid Services to withdraw a new and potentially damaging definition of “multiple source drug,” a definition both pharmacy groups say could scramble the prescription payment system for Medicaid and cut further into reimbursements to pharmacies.

The revised definition comes in the form of an interim final rule adopted by CMS. In comments submitted to CMS today, NACDS president and chief executive officer Steve Anderson and NCPA executive vice president Bruce Roberts called attention to two critical legal concerns with the new way the Bush administration is defining multisourced medications.

“The first concern is that the rule was not subject to the normal notice and comment rulemaking process in accordance with the Administrative Procedure Act, which requires public notice and a comment period prior to most rule changes,” the two leaders noted.

The second sticking point is more serious. Anderson and Roberts said the definition of multiple source drugs “is critical for pharmacies because CMS uses Federal Upper Limits (FULs) to cap Medicaid reimbursement to pharmacies that dispense them.”

That said, they told CMS, “the Social Security Act provides that a drug is not a multiple source drug unless two or more equivalent drug products are ‘sold or marketed in the State;’ that is, whether particular drug products are generally available to the public through retail pharmacies in each state. CMS did not comply with this standard in revising the rule.

“While we appreciate CMS’ efforts to redefine ‘multiple source drug’, it is critical that the revisions meet all guidelines and compliance requirements,” said Anderson and Roberts. “Pharmacies are at risk of improper and inadequate Medicaid reimbursements due to the AMP [average manufacturer’s price] rule [for multi-sourced drugs] and the revised definition. As a result, those who will suffer the greatest burden will be the patients and the states.”

The full comments are posted here.

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