Analysis: Novartis' Prexige shows promise

WASHINGTON, June 15 (UPI) -- Novartis said a new study shows its COX-2 inhibitor Prexige may be safer than ibuprofen in osteoarthritis patients, but some analysts are not convinced that this will be enough to get it approved by the U.S. Food and Drug Administration.

Novartis presented a study at the European Congress of Rheumatology meeting in Barcelona, Spain, showing Prexige slightly reduced blood pressure in osteoarthritis patients with controlled hypertension, compared to a slight increase in those taking ibuprofen.

Ben Yeoh, an analyst with Dresdner Kleinwort, said the data "looks promising" for Prexige.

"However, given the cautious nature of current FDA we are unsure if the Prexige data package is enough to convince FDA," Yeoh stated in a research report. "Approval possible in 2008 but must be considered risky."

Novartis originally submitted a new drug application to the FDA for Prexige in 2002, but the agency deemed it non-approvable due to liver toxicity concerns. Novartis, which plans to refile the Prexige NDA this year, said the new data are important because the cardiovascular adverse effects associated with other non-steroidal anti-inflammatory drugs may be due to their potential to increase blood pressure.

"NSAIDs, including some COX-2s, have been associated with raised blood pressure, and this effect may be in part responsible for the increased risk of cardiovascular disease associated with this class of medications," Tom MacDonald, professor of clinical pharmacology at the Ninewells Hospital and Medical School's hypertension research centre in Dundee, Scotland, said in a statement issued by Novartis. "These data indicate that (Prexige) may have less impact on blood pressure than the most commonly used NSAID ibuprofen."

The study, which involved 741 hypertensive osteoarthritis patients 50 years of age or older, compared once-daily Prexige with ibuprofen taken three times per day. Patients in the Prexige group showed a decrease in mean systolic blood pressure of 2.7 mmHg compared to an increase of 2.2 mmHg in the ibuprofen arm. Mean diastolic blood pressure decreased by 1.5 mmHg in the Prexige group compared with an increase of 0.5 mmHg in those taking ibuprofen.

Prexige has similar efficacy and adverse events as ibuprofen. Adverse events were mostly mild, with the most common in both treatment groups consisting of upper abdominal pain.

Novartis is also dealing with the loss of a patent on one of its key products. Earlier this week, the U.S. Court for the District of New Jersey removed its temporary restraining order on Teva's generic version of Novartis' hypertension drug, Lotrel, which generated $1.3 billion in sales last year.

"We expect a rapid erosion of the branded Lotrel market -- particularly as Novartis will immediately launch its own generic version of Lotrel in the United States through its Sandoz division, while Teva immediately resumes its supply," Credit Suisse analyst Steve Plag said in a statement.

Teva initially launched its product last month before the restraining order was imposed. About three months supply was shipped and that alone eroded more than 40 percent of Lotrel's franchise since mid-May, Plag stated. The resumption of shipment of Teva's drug will continue that erosion, he added.

Plag reduced his earnings per share forecast for Novartis by 5 percent next year to $3.50, resulting in a drop in EPS growth from 9 percent to 6 percent.

He also speculated that there could be further downside for the company due to a slow start for its new hypertension drug, Tekturna.

"We still are concerned that a further downward revision of medium to long term consensus earnings may be required for Tekturna -- which we expect to undershoot expectations (Credit Suisse forecast Tekturna sales of $585 million by 2011 vs. $1.6 billion Evaluate Pharma consensus)," Plag stated. "It's early days yet -- but we remain unimpressed with initial prescription trends."

Tekturna, the first high blood pressure drug that inhibits the kidney enzyme renin, was approved by the FDA in March.