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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Digital Abilify for Improving Adherence. Is it a Solution for a Non-Problem?

Digital Abilify for Improving Adherence. Is it a Solution for a Non-Problem? | Pharmaguy's Insights Into Drug Industry News |
Is this technology really the best fit for patients who are mentally ill?

GETTING PEOPLE TO take their pills is hard, especially with mental illnesses like schizophrenia and bipolar disorder. But to use the language of techno-optimism: “There’s an app for that!”

No, really. This month, the Food and Drug Administration accepted an application to evaluate a new drug-sensor-app system that tracks when a pill’s been taken. The app comes connected to a Band Aid-like sensor, worn on the body, that knows when a tiny chip hidden inside a pill is swallowed—so if patients aren’t keeping up with their meds, the program can alert their doctors.

The drug here is Abilify, a popular antipsychotic from the pharmaceutical giant Otsuka, and the sensor and the app come from Proteus Digital Health, a California-based health technology company. The FDA has already approved the drug and the sensor system separately—now, they’ll be evaluated together under a whole new category of “digital medicines.” If approved, the ingestible sensor can actually be used in the pill.

Their sensor is primarily aimed at people who want to take their meds but forget. Taking a pill every day is a hassle, which can get in the way of adherence, and the drugs can have side effects that can be more than minor. 

Pharma Guy's insight:

A whopping 93% of physicians feel that "worry about side effects" was a moderate or significant reason for non-adherence (see here).

IMHO, To improve adherence drug companies should change THEIR behavior - such as focusing more on creating drugs with fewer side effects.

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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 |

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-

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