Sun Pharma says US court denies motion on Protonix

July 19 (Reuters) – Sun Pharmaceutical (SUN.BO) said a U.S. court had denied its motion to reverse a jury verdict of infringement against the Indian firm on Pfizer’s (PFE.N) Protonix acid reflux drug patent that the jury had said was valid.

In a statement dated July 17, Sun said it was not prohibited from selling the drug before the expiry of Pfizer’s marketing exclusivity in January 2011, as its other claims concerning the validity of the patents, including patent misuse, were still pending.

In April, a jury in the U.S. District Court for New Jersey had rejected allegations by Teva and Sun Pharmaceutical that the patent on the widely used drug was obvious and should be declared invalid. [ID:nN23219271]

The original patent on Protonix, known chemically as pantoprazole, is held by Swiss drugmaker Nycomed [NYCMD.UL] and was licensed to Wyeth, which is now owned by Pfizer.

Nycomed and Wyeth filed their patent infringement lawsuit against Teva and Sun in May 2004. (Reporting by Bharghavi Nagaraju; Editing by Ranjit Gangadharan)

Popular stomach acid reducer ups patients’ risk of developing pneumonia threefold

Washington, September 15 (ANI): Researchers at Wake Forest University School of Medicine have found that a popular stomach-acid reducer, which is used to prevent stress ulcers in critically ill patients who need breathing machine support, triples the likelihood of contracting pneumonia among such patients.

Hospital-acquired pneumonia-the leading cause of infection-related deaths in critically ill patients-increases hospital stays by an average of seven to nine days, cost of care, and the risk of other complications.

“As best we can tell, patients who develop hospital-acquired pneumonia or ventilator-acquired pneumonia have about a 20 to 30 percent chance of dying from that pneumonia. It’s a significant event,” said senior study author Dr. David L. Bowton, professor and head of the Section on Critical Care in the Department of Anesthesiology.

During the study, the researchers compared treatment with two drugs that decrease stomach acid: ranitidine, marketed under the name ZantacTM, and pantoprazole, marketed under the name ProtonixTM or PrilosecTM.

Both drugs decrease stomach acid, but the newer pantoprazole is considered more powerful, and has become the drug of choice in many hospitals.

However, upon the analysis of 834 patient charts, the researchers came to the conclusion that the risk of developing pneumonia was thee times more in the hospitalised cardiothoracic surgery patients who had been treated with pantoprazole.

“We conducted this study, in part, because we thought we were seeing more pneumonias than we were used to having,” said study co-author Marc G. Reichert, pharmacy coordinator for surgery at Wake Forest University Baptist Medical Center.

The researchers say that their study suggests some other steps to keep critically ill patients from developing ventilator-associated pneumonia.

Bowton suggests that doctors consider whether an acid reducer is needed at all, and, in cases where it is needed, ranitidine is recommended because of the apparent decreased risk in developing pneumonia.

Doctors should stop using the drug as soon as the risk of bleeding passes – once the patient is off the breathing machine and eating, either on his/her own or through a feeding tube.

“Stopping the drugs earlier appears to be the best thing for patients,” Reichert said.

The study has been published in a recent issue of CHEST. (ANI)

Common heartburn drugs may reduce anti-clotting medications’ benefits

Washington, May 7 (ANI): Scientists have found that the medicines used for the treatment of heartburn and ulcers can reduce the anti-clotting action of the medication clopidogrel, thereby resulting in about 50 per cent increase in the combined risk of hospitalisation for heart attack, stroke, and other serious cardiovascular illnesses.

This finding is based on a new study that was presented on May 6 at the Society for Cardiovascular Angiography and Interventions (SCAI) 32nd Annual Scientific Sessions.

The study specifically focused on the effects of proton pump inhibitors (PPI) omeprazole (Prilosec), esomeprazole (Nexium), pantoprazole (Protonix), and lansoprazole (Prevacid), which together accounted for about 96 per cent of PPI use in the study.

“Given the large number of patients who undergo coronary stent procedures each year, and the recommended and wide use of clopidogrel following this procedure, our findings have implications for many thousands of patients across the United States,” said Eric J. Stanek, PharmD, senior director of research, personalized medicine research and development, Medco Health Solutions, Franklin Lakes, NJ, and the study’s principal investigator.

“Clopidogrel should continue to be taken as prescribed, and the need for PPI therapy should be carefully evaluated to ensure that it is prescribed only when clearly indicated,” the researcher added.

The research team analysed integrated data on pharmacy and medical claims from more than 10 million patients, including 16,690 patients taking clopidogrel for a full year following coronary stenting. On average, 41 per cent of those patients also took a PPI for more than nine months of the year.

Over the 12-month period when patients took clopidogrel, the researchers evaluated the risk of hospitalisation for major adverse cardiovascular events (MACE), which they defined as a combination of heart attack, unstable angina, stroke or temporary stroke-like symptoms, repeat coronary procedures, or cardiovascular death.

The researchers observed that the overall MACE risk was 51 per cent higher among patients taking any PPI.

According to them, the findings were equally concerning when the effects of individual PPIs were analysed.

Omeprazole correlated with a 39 per cent increased risk of MACE, esomeprazole to a 57 per cent increased risk, pantoprazole to a 61 per cent increased risk, and lansoprazole to a 39 per cent increased risk.

Overall, the incidence of hospitalisation for upper gastrointestinal bleeding was only 1.1 per cent among patients taking a PPI and 0.07 per cent among those not taking a PPI.

However, the researchers concede that further studies are required to determine whether newer, less widely used PPIs-such as rabeprazole (Aciphex) and dexlansoprazole (Kapidex)-are also associated with increased cardiovascular risk in patients taking clopidogrel.

They also have plans to study how genetic variations in the liver enzymes that activate clopidogrel might alter the impact of PPIs on clopidogrel effectiveness, the potential influence of the timing of PPI administration, the effect of alternate dosing of clopidogrel, and the comparative effectiveness of other anti-clotting medications. (ANI)