The weekly round-up of failed trials, missed targets, and other business mishaps.
India is planning to cut prices of expensive branded drugs to make them more affordable for its predominantly poor population, according to a top Indian government official, Reuters reported. “A committee has already finalized a proposal and we will put it out in the public domain in a month or so,” Dilsher Singh Kalha, secretary of the Department of Pharmaceuticals, told reporters at an industry conference. “There could be a reference pricing system (for patented drugs) or maybe fixed-pricing, but a final decision has not been taken.” The price controls for branded drugs would follow the announcement earlier this month of India’s $5.4 billion plan to provide free generic medicines to its citizens. As of now, most patented drugs are free of price controls, though restrictions are in place for 348 so-called “essential” drugs. India is hoping to provide drugs at prices more reasonable for a population in which 40 percent of people live on less than $1.25 a day.
The Federal Trade Commission has tried unsuccessfully for years to stop branded drug companies from paying generic competitors to delay introduction of their generic medicines to market. For nearly a decade, generic drugmakers and big-name pharmaceuticals companies have won court rulings that allowed “pay-for-delay” to continue. Now, however, a federal appeals court in Philadelphia ruled that the pay-for-delay arrangement was anticompetitive. The decision by the Philadelphia Third Circuit Court of Appeals directly conflicts with decisions made by at least three other federal courts, likely giving the Supreme Court reason to hear the case. A Supreme Court decision that rules pay-for-delay settlements are anticompetitive would likely have profound effects on the industry. Brand name drug companies could face substantially lower profits as generics penetrate their markets, and insurance companies and patients likely would benefit from significant savings.
A Pennsylvania Superior Court ordered Pfizer to pay $10.4 million in damages to a woman who implicated the company’s Prempro menopause drug as the reason for developing breast cancer. Audrey Singleton sued Pfizer’s Wyeth unit over Prempro and was awarded compensatory and punitive damage due to the company’s marketing of the drug. Wyeth allegedly hid the drug’s health risks and that was enough for the jury to rule in the plaintiffs favor. The ruling comes in the wake of Pfizer settling a multitude of lawsuits over Prempro and related menopause drugs. As of May 2012, Pfizer has settled about 60 percent of the outstanding case over the drugs and paid out $896 million in damages.
Before GlaxoSmithKline struck a deal with Human Genome Sciences to acquire the company for $3 billion in July, Human Genome Sciences had apparently rebuffed a much larger offer. In 2010, sources are reporting, Amgen had offered to acquire the company for $7 billion, or $35 a share. At the time Amgen was aggressively attempting to reinvigorate its product portfolio. According to a filing last week, Human Genome’s board decided not to pursue the sale of the company at the $7 billion price because regulatory approval for Benlysta, the first new treatment for lupus in 50 years, was expected by the latter part of 2010. Of course, the failure of Benlysta to achieve projected sales levels contributed with other factors to a 72 percent fall in the price of Human Genome Sciences’ shares and opened the door for GSK to acquire the company at a far more favorable price.
The U.S. Food and Drug Administration sent complete response letters to Otsuka Pharmaceuticals and Lundbeck, effectively derailing at least temporarily their antipsychotic drug, aripiprazole. The agency noted deficiencies in an inspection of a third-party supplier of sterile water for making the drug as the reason for denying the drug. The setback delays the potential U.S. approval of the drug and shortens Otsuka and Lundbeck’s lead over rival company Alkermes in developing a once-monthly antipsychotic. Despite the setback regarding Otsuka’s third-party vendor, analysts at J.P Morgan believe the drug will still gain approval sometime in 2013.