Oversight is over it

Taking direction from the White House’s recent and ongoing actions towards drug pricing, Congress has begun its latest investigation into prescription drug pricing. It starts with letters sent to 12 companies with products Congress views as either too costly or too price-hiked. As you might expect, that list is filled with blockbusters. Like America used to be. While the list is filled with pharma household names, three names you won’t see on the list—Amgen, Merck, and Gilead—were recently lauded by Health and Human Services Secretary Alex Azar for curbing drug prices. So maybe some progress is being made? The House Oversight Committee will hold hearings on Jan. 29 for experts and patients to weigh in, but no word on whether execs will be expected to make an appearance.

Generally mad with generics

Seven organizations representing about 500 U.S. hospitals are joining up to make their own generics. Sick of high prices and drug shortages, the group is forming a non-profit, FDA-approved manufacturer by the name of Civica Rx. It’ll be headed up by former Amgen chief quality officer Martin Van Trieste, and its initial goal is to manufacture 14 generics for hospital patients. The exact generics Civica will focus on haven’t been named yet, but they’ll either produce them themselves, or outsource the work. You know what they say, if you want something done right, delegate it yourself.

Pfizer calls out peers

Pfizer filed a Citizen Petition with the FDA requesting regulators issue guidance to “…ensure truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars….” With lagging performance from its Remicade copy, Inflectra, as the backdrop, Pfizer is calling BS on innovators’ communications regarding biosimilars, which Pfizer believes intentionally confuse consumers and prescribers and erode confidence biosimilars. Specifically, Pfizer notes how J&J describes that biosimilars act in a “similar” way to Remicade when, in fact, they employ the same mechanism of action. Amgen claims that switching to a biosimilar “carries risk” if your current product is working. And Genentech states that biosimilars are “highly similar but not identical” to branded products. Pfizer claims that’s only half the story. While Pfizer’s motives are almost certainly not altruistic in nature, they probably have a point about intentional marketing half-truths.

“But wait, there’s more”

Order now and we’ll ship you the Thighmaster…and if you’re not satisfied, just return it within 14 days for a full refund. Money-back guarantees are almost a necessity for TV products, but what about for medications? Certainly not the norm, there have been some value-based contracts popping up in the pharma world. There’s a very interesting Forbes article written by former Pfizer global R&D President John LaMattina that lobbies for two major trade organizations (BIO and PhRMA) to pass resolutions that money-back guarantees become a formal practice with member companies. Wow, that would Shake Weight things up. LaMattina points to Amgen’s Repatha (LDL-C lowering) and Novartis’ new gene therapy Kymriah (CAR-T therapy), priced at $475,000/patient. Keep this on your radar, few things could change the healthcare landscape like widespread adoption of value-based pricing.

Tax haven troubles

Puerto Rico’s status of not really being a United State but still being part of the United States (explained here) has made it very attractive for medical manufacturing. For instance, companies there can create “US-made” products from factories incorporated as foreign subsidiaries, which means paying a 4 percent excise tax instead of US income tax. This has saved a lot of money for companies like Amgen, AZ and AbbVie, but the US tax overhaul may change that. The proposed bill would place a 20 percent excise tax on all offshore transactions. That may incentivize companies to change their offshore tax avoidance policies, perhaps choosing a different island to do business on. All of this while Puerto Ricans are facing $100 billion in storm damage. Click here to help with that.

You give $1M and you give $1M and you give $1M (say it like Oprah would)

And soon it starts to add up. This week the NIH announced a pretty cool partnership with the private pharma industry. The Partnership for Accelerating Cancer Therapies (PACT) is a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot project. 11 pharma companies (AbbVie, Amgen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Genentech, Gilead Sciences, GlaxoSmithKline, Johnson & Johnson, Novartis, Pfizer) will contribute $1M each for five years. The NIH will contribute $160 million. The goal: “to identify, develop and validate robust biomarkers — standardized biological markers of disease and treatment response — to advance new immunotherapy treatments.” Sweet. If you want to read what pharma PR folks have been up to you can read their responses here. For the top 10 private-public immuno-oncology collaborations, look here.

One word, “plastics”

Way back in August of 2015 the FDA approved the first 3D-printed drug, Spritam. 3D printing is so prevalent in the medical device industry that even the FDA has a webpage on it. Recently, GE Healthcare announced it is trying to take 3D printing to the biopharmaceutical manufacturing space. Located in Uppsala, Sweden, the Innovative Design and Advanced Manufacturing Technology Center features both metal and polymer (Dustin Hoffman would call them plastics) 3D printers as well as collaborative robots. You had me at robots. The goal is to improve the manufacturing side of pharma (think lighter parts, faster production, improved design flexibility) and, by the way, Amgen is in. InsightCity recently penned another article on 3D printing. Definitely something to keep on your radar.

LDL, PCSK9 and the billion-dollar clinical trial

It will take more than $1 billion dollars for Amgen to determine whether their PCSK9 inhibitor (Repatha) is worth the money (list price = $14,523 per year). PCSK9 inhibitors have been hailed as a way to help people at risk of cardiac events lower their LDL levels. In a clinical trial with ~27,000 patients, Repatha worked, lowering LDL levels. Great, but Amgen’s stock dropped 6% when the results were released. Why? While LDL decreased, the reduction in cardiac events was mild. The math: 50 patients would have to be treated for 3 years to prevent 1 heart attack/stroke/death. BTW, 50 people at $14,523 per year for 3 years = ~$2.2 million to prevent 1 heart attack/stroke/death. May the odds be ever in your favor.