Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Male Otsuka UK Marketing Executive's Behavior Worse Than Bill Cosby's

Male Otsuka UK Marketing Executive's Behavior Worse Than Bill Cosby's | Pharmaguy's Insights Into Drug Industry News | Scoop.it

According to the UK's Prescription Medicines Code of Practice Authority (PMCPA), which oversees the self-regulatory code of the Association of the British Pharmaceutical Industry (ABPI), "An anonymous, non-contactable complainant alleged that a male employee of Otsuka Pharmaceuticals (UK) behaved inappropriately and provided inappropriate hospitality following a dinner at a meeting partly funded by the pharmaceutical industry.

"The complainant stated that he/she went from the private function area at a hotel where dinner had been held to the public hotel bar and noticed three Otsuka employees. Descriptions were provided. A female health professional, who the complainant remembered as being very drunk at the dinner, subsequently entered the bar and started talking to the Otsuka employees. Although she was obviously intoxicated a male Otsuka employee continued to ply her with drinks; his two female colleagues seemed unhappy with this" (see "AUTH/2752/3/15 - Anonymous v Otsuka").

Otsuka did not deny that the senior employee spoke to a woman in the public bar nor that "she was flirtatious and tactile." [You gotta love the pharma industry! It has no problems talking about erections on TV, but sexual encounters in real life must be described in clinical terms such as "tactile."]

The document goes on to describe in some detail what happened that night, which sounds like something straight out of a True Romance comic.


You won't believe what happened next. Read more here: http://bit.ly/1TBmAe8 

Pharma Guy's insight:


It turns out that the Otsuka women managers bought the woman 3 drinks at he behest of their male boss: two glasses of wine and one glass of water. A glass of water? Whaaa? Actually, these women were pissed at the guy's behavior and at least one of them -- probably the one who bought the glass of water -- lodged the complaint with the PMCPA.

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Otsuka to FDA: No Thanks... Orphan Status for Abilify is More Profitable. Generics Can Pound Sand!

Otsuka to FDA: No Thanks... Orphan Status for Abilify is More Profitable. Generics Can Pound Sand! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In a closely watched gambit, a drug maker has taken the highly unusual step of going to court to prevent the FDA from widening the market for its best-selling pill. And the move may not only embolden other companies to follow suit, but also threatens to raise health-care costs for consumers.


The dispute turns on the complexities of regulatory law, but has a familiar refrain—a brand-name drug maker is trying to thwart generic competition and protect a product that rings lots of registers. In this case, Otsuka Pharmaceutical Co. hopes to defend the market for its Abilify antipsychotic, which generated $4.9 billion in U.S. sales last year, but faces the loss of a crucial patent next week.


Here’s the back story: Last December, the FDA approved Abilify for treating children with Tourette syndrome, a neurological disorder that causes tics.


Since Abilify had a so-called orphan designation, which refers to a drug used to treat a rare malady like Tourette’s, Otsuka won another seven years of exclusive marketing rights—through late 2021—before low-cost generics could appear.


But in February, the FDA surprised Otsuka by approving Abilify to treat adults with Tourette syndrome. This widened the market and kicked off the legal battle, because Otsuka contends FDA law would trigger a labeling change that could usher in generics.


In a lawsuit, Otsuka contends the FDA isn’t allowed to approve an indication for which a drug maker didn’t apply and charged the agency was actually attempting to “clear a blocked path” for generics. An FDA spokeswoman wouldn’t comment.


One Wall Street analyst suggests Otsuka may have overreached. “Under Otsuka’s interpretation, having one orphan indication protects the entire [Abilify] franchise from generic entry,” wrote Sanford Bernstein analyst Ronny Gal in an investor note. “Otsuka seized on a putative loophole as a way of protecting its blockbuster franchise.”


He maintains, however, that “Congress did not intend to allow [a] single pediatric orphan indication to provide patent protection for [a drug] beyond the targeted orphan use, and to argue otherwise is shamelessly audacious.” An Otsuka spokesman declined to comment.

Pharma Guy's insight:


As one person familiar with the matter notes, “if Otsuka prevails, you’ll see other [drug makers] look to try something similar.” This just proves how profitable orphan drug status is. For more on that read: Orphan Drugs Now "Where the Money Is," Says Willie Sutton's Ghost- http://bit.ly/pgdaily111113-3A

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