“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.

A HealthyDose™ of Biosimilars

Did you know that 9 of the top 10 best-selling US biologics will have fallen out of patent protection by 2020? No?

Maybe you should talk to your doctor to see if a HealthyDose™ of biosimilars is right for you. Side effects include: euphoria caused by an acute awareness of feeling yourself getting smarter, accusations of being a know-it-all by your colleagues, and more euphoria due to objectively knowing you are in fact smarter than your colleagues.

Click the picture or click here to see it in high resolution.

4. Good week for biosimilars

This week, United Health announced a proposal to drop Sanofi’s insulin Lantus and Amgen’s bone marrow stimulant Neupogen in favor of their biosimilars. AND THEN, the FDA approved Amgen’s biosimilar version of Humira. Good week for biosimilars, bad week for Lantus, and meh week for Amgen (especially since AbbVie is still suing for patent infringement). This is only the fourth biosimilar licensed by the FDA under the Biologics Price Competition and Innovation Act, but the true test will come if more payers, like United, drop the branded products completely. ICYMI: Biosimilar safety and interchangeability are still questioned by some.

3. Big week for biosimilars

The FDA’s advisory committee had a busy week last week recommending approval for two separate biosimilar products, both of which received unanimous support.  Amgen’s proposed biosimilar for AbbVie’s Humira, ABP 501, received a nod from the committee while Sandoz’ etanercept got a thumbs up as a biosimilar to Amgen’s Enbrel.  With consumers demanding lower drug prices and pharma fighting for longer exclusivity, marketing these biosimilars is another discussion…at least in the US.  These reference products are still under patent in the US, but the EMA has already accepted Sandoz’ Marketing Authorization Application and Amgen just struck a deal with Daiichi Sankyo to begin commercializing ABP 501 and eight other biosimilars in Japan.