Take a look at Novartis' second-quarter results for reasons why it engineered that big asset swap-and-sale with GlaxoSmithKline and Eli Lilly. The two units Novartis is unloading, vaccines and animal health, delivered weak sales for the quarter, dragging the company's top line below expectations.
Last month, Japanese authorities arrested an ex-Novartis employee who allegedly manipulated trial data later used to promote the blockbuster blood pressure med Diovan. But now, it looks as if he may not be the only one paying the price.
Both the active pharmaceutical and the formulation plants in India that Ranbaxy Laboratories planned to use to manufacture the long-delayed generic of Novartis' blood pressure drug Diovan are under FDA import alerts. But the Indian drugmaker has finessed a manufacturing workaround with the agency to make the heart drug at its Ohm Laboratories plant in New Jersey.
The long-delayed and highly anticipated launch of generic Diovan is on the way, which is a bummer for Novartis and a huge boost for Indian drugmaker Ranbaxy Laboratories. It is also validation for the decision by Sun Pharmaceutical's owner, billionaire Dilip Shanghvi, who struck a $3.2 billion deal to buy Ranbaxy despite its years of FDA entanglements over quality issues.
After Japanese authorities arrested an ex-Novartis employee Wednesday, prosecutors raided the company's Tokyo office to continue their probe into data manipulation. The move comes six months after Japan's health ministry first filed a complaint to prosecutors alleging that the company used exaggerated advertising to market the blood pressure drug Diovan.
Japanese police brought in Nobuo Shiraishi, a former Novartis worker linked to discredited studies of the company's blood pressure drug Diovan. Shiraishi is suspected of violating the country's pharma laws by providing false data to researchers, Tokyo prosecutors said in a statement.
Novartis is facing yet another investigation in Japan. Little more than a month after a panel of Japanese lawyers uncovered serious misconduct during a trial of its leukemia drug, Tasigna, the Japanese government is probing whether the company broke the law by failing to report side effects of the product.
The pharma giant announced that the data monitoring committee has hit the green light for any early close to the pivotal study for its new blood pressure treatment LCZ696 after investigators tracked delays in cardiovascular deaths and fewer hospitalizations resulting from heart failure in comparison to Vasotec, a generic blood pressure medicine that has been around for years.
In an effort to get itself into a place where it can again ship from its FDA-approved plants in India, Ranbaxy Laboratories says it is taking a hard look at how it runs its API operations.
Novartis' productivity program saved the company $2.8 billion last year, CEO Joe Jimenez said Wednesday as he discussed the company's tepid fourth quarter and 2013 financial results. The most recent target for manufacturing cuts, he said, is a plant in Suffern, NY, which produces Diovan for the U.S.