PHARMACY

Roche, Ipsen note positive results in diabetes drug trial

BY Alaric DeArment

PARIS An investigational diabetes drug developed by Roche and Ipsen offers glycemic control comparable to that of an insulin produced by Sanofi-Aventis, according to results of two late-stage clinical trials announced Thursday.

An investigational diabetes drug developed by Roche and Ipsen offers glycemic control comparable to that of an insulin produced by Sanofi-Aventis, according to results of two late-stage clinical trials announced Thursday. Roche has disclosed results of the fourth and fifth phase 3 trials of an eight-trial program comparing taspoglutide with Sanofi’s Lantus (insulin glargine [rDNA origin]) and placebo in patients with Type 2 diabetes, indicating that taspoglutide lowered HbA1c levels in patients as effectively as Lantus.

One study, involving 1,049 patients, compared patients who took taspoglutide with those who took Lantus and metformin who had previously taken a combination of metformin and sulfonylurea but had failed to lower HbA1c levels. The other gave taspoglutide or placebo to 305 overweight or obese patients.

Earlier this month, Ipsen released results from two other trials in the program, indicating that taspoglutide provided better glycemic control than Merck & Co.’s Januvia (sitagliptin).

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Sanofi Pasteur enters licensing agreement with Syntiron

BY Alaric DeArment

ARDEE, Ireland Sanofi Pasteur has entered a licensing agreement for a vaccine to prevent Staphylococcus bacterial infections, the vaccine maker announced Wednesday.

Sanofi Pasteur obtained the license from St. Paul, Minn.-based biotech company Syntiron to develop and commercialize the vaccine, which also protects against the dangerous methicillin-resistant Staphylococcus aureas, or MRSA. MRSA causes a large number of difficult-to-treat infections in people due to its resistance to most antibiotics.

Under the agreement, Sanofi Pasteur will support preclinical development with Syntiron and be responsible for future development, regulatory approval and commercialization. Financial terms of the deal were not disclosed.

“The agreement with Syntiron is just another example of Sanofi Pasteur’s interest in partnering with biotechs to produce innovative vaccines to address public health needs,” Sanofi Pasteur president and CEO Wayne Pisano said. “Along with our development of a vaccine to prevent Clostridium difficile infection, the successful development of a vaccine to prevent MRSA would be a major achievement in combating hospital-associated infections.”

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Senate quashes drug importation proposals, draws response from industry groups

BY Jim Frederick

WASHINGTON Bowing to concerns over drug safety and to a deal struck earlier between the Obama administration and U.S. drug makers, the Senate defeated legislation Tuesday that would have opened the way for Americans to directly import pharmaceuticals from Canada and other nations.

A proposal to allow importation, long opposed by the drug industry and retail pharmacy advocates in the United States, failed to win passage by a vote of 51-48, according to reports. The measure needed a 60-vote majority to pass.

The defeat came despite strong backing from some prominent Democrats and Republicans who saw it as a relief measure for seniors hit by rising drug costs and the recession. The Senate also nixed a counter-proposal that would have opened direct importation to medicines certified as safe by the Food and Drug Administration.

The National Association of Chain Drug Stores, an organization representing the nation’s drug stores, said that while it supported the goal of reducing prescription drug costs, it believes importation would put patients’ and consumers’ health and safety at risk, minimize the role of pharmacists in the dispensing of medication and counseling of patients, and adversely disrupt patient care and service.

“The U.S. distribution system is already one of the safest in the world and we are pleased that the Senate acted to preserve the system,” said NACDS president and CEO Steve Anderson. “NACDS has worked to defeat legislation that would compromise the safety of prescription drug distribution channels.”

The trade group Pharmaceutical Research and Manufacturers of America issued a statement Tuesday praising the defeat of both importation proposals. “We continue to support comprehensive healthcare reform so that millions of uninsured Americans can access high-quality and affordable healthcare coverage and services,” said PhRMA SVP Ken Johnson. “We believe that if health reform is done in a smart way, prescription drug importation is not necessary because most Americans will finally have health insurance and access to safe and secure prescription medicines.”

Some consumer advocacy groups, however, sharply criticized lawmakers for failing to allow importation as part of health-reform legislation. AARP EVP Nancy LeaMond expressed the group’s disappointment “that the Senate rejected this smart, bipartisan legislation to help bring down prescription drug prices for millions of Americans.

“For more than 50 years, AARP has been fighting to make health care and prescription drugs more affordable for older Americans,” LeaMond added. “Safe and legal importation is one step toward affordability that we have long supported, and we will continue to work with lawmakers to implement this provision without unnecessary roadblocks.

By contrast, AARP lauded Senate majority leader Harry Reid, D-Nev., and Democratic Sens. Max Baucus of Montana and Chris Dodd of Connecticut for their support Monday of legislation to close the Medicare prescription drug doughnut hole during a House-Senate conference committee on health reform legislation. “AARP sincerely thanks Majority Leader Reid and Sens. Baucus and Dodd for the commitment they made tonight to close the dreaded Medicare doughnut hole, a dangerous gap in prescription drug coverage that leaves more than three million seniors without affordable medications each year,” said AARP CEO A. Barry Rand. “No American should ever be forced to choose between filling their prescriptions or buying their groceries.”

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