Remember when Theranos was making huge waves in the med device market just months ago? They’ve taken a pretty awful bludgeoning since then. In a move to regain footing, the company recently debuted a new technology, “miniLab,” at the American Association of Clinical Chemistry’s annual meeting. However, in addition to the fact that miniLab’s technology already exists, the debut was a surprise to the expert attendees who were expecting a straight-up explanation about the company’s original (and completely unrelated) blood-testing device that got CEO and founder Elizabeth Holmes banned from running a clinical testing company. It is still under fire concerning its highly inaccurate test results. Some daresay the miniLab release was a distraction from Theranos’ looming woes, but “forgive and forget” isn’t big on the scientific scene.
In creating its 2017 formulary, the pharmacy benefits manager CVS Health, said “Hit the road, Jack,” to a number of drugs. Some products like Sanofi’s insulin blockbuster Lantus and Amgen’s Neupogen were given the boot in favor of biosimilar counterparts. Ten other drugs were left high and dry for being “hyperinflationary,” including several drugs made by Valeant, Concordia, and Novum Pharma. Some rare disease and cancer drugs were also nixed. These formulary cuts should translate to cost savings for CVS Health but are worrisome for patients who may no longer have access to needed products. This is also concerning for drug makers, particularly if other PBMs follow suit.
Researchers at Johns Hopkins Bloomberg School of Public Health found that biosimilar drugs perform as well as the brand-name biologics. They analyzed data from 19 studies of biosimilars that treat rheumatoid arthritis, inflammatory bowel disease and psoriasis to reach their conclusion. Many drug innovators, on the other hand, argue that biosimilars are not equivalent to their reference products and shouldn’t be used willy-nilly as a substitute. It’s complicated so don’t expect this argument to be solved definitively any time soon (or ever?). There are currently more than 50 biosimilars in development and the Johns Hopkins study could be weighty in terms of future product adoption.
Teva has announced plans to purchase Anda, Allergan’s generics distributor. This comes on the heels of Teva having purchased roughly $40 billion worth of Allergan’s generic drugs, aka the Actavis Generics division. Anda’s reach goes beyond Actavis, however. According to the release, they distribute “generic, brand, specialty and over-the-counter pharmaceutical products from more than 300 manufacturers.” Teva projects Anda to bring in over $1 billon in third party revenue this year, and the deal is set to be completed in the second half of 2016. Hey Teva, don’t go filling up on candy or you won’t have any room for a main course of innovative pharmaceutical products…am I right? Anyone? Too much? Sorry.
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Source: “Clinical Trials” – Memorial Sloan Kettering Cancer Center;
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In most major pharma markets the role of the drug rep has changed significantly in the past 15 years. 15 years from now, how much of a role do you believe drug reps will play in the adoption of new medicines?
The UK recently released the first set of data for Disclosure UK, which is akin to the Open Payments data in the US (A.K.A, the “Sunshine Act”). Just to recap, pharmaceutical manufacturers made $6.5B in payments to US physicians for general (i.e., non-research related) and research purposes in 2015. Figures released by The Association of the British Pharmaceutical Industry show drug companies disclosed payments to UK doctors and other health professionals totaling £340m (~$450M USD) in 2015. So what’s the difference? Well, compliance with the UK version is not mandatory. Seriously. Financial Times reports that “doctors receiving the largest share of the money are opting out.” Shocker. That said, we were surprised that 70% of doctors participated. Well done, indeed. Cheerio.
One year to the day since Teva announced the acquisition of Allergan’s generics business it finally has the thumbs-up from the Federal Trade Commission (FTC) to move forward. However, the proposed $40.5B acquisition comes with some strings attached—Teva must divest 79 of its own products to appease the FTC and keep the US pharma market competitive. But it doesn’t stop there. Teva is also required to provide long-term supply contracts to several of their API customers to prevent any anticompetitive backlash stemming from the agreement. As the largest generics producer in the world, Teva’s portfolio just grew substantially, but so did Allergan’s bank account. What’s Allergan going to do with all that moolah?