Parents pissed at poor production

Chinese parents are understandably angry after the emergence of a third vaccine safety scandal in about as many years. Regulators announced last Friday that Changsheng Bio-tech (which ironically means “long life” in Chinese) had sold over 250k low-quality DPT vaccines to a Chinese public health agency responsible for 100M citizens. Hey, at least that’s better than the over 400k subpar DPT vaccines produced by a different Chinese manufacturer which authorities uncovered last November. Or the spoiled vaccines illegally sold in 24 provinces in 2016. Authorities are also sick of the scandals, so on Wednesday they announced an audit of China’s entire vaccine production system. Until that’s done, you might not see consumers springing for vaccines Made in China for a bit.

Hearts two sizes too small

No, it’s not The Grinch, but organoids are a great Christmas in July gift for the preclinical researchers in your life. Drugmakers spend tons just to get their drugs to Phase I research but could lose big if too many side effects occur in these first rounds of human trials. For instance, only 6.6% of Phase I cardiovascular INDs make it to Phase II. Wouldn’t it be nice if we could test a drug’s effects on say, a model of the human heart? Some biotech companies have recently developed the means to create 3D assays known as organoids—artificially-grown cell structures that can actually mimic organ functions instead of just the compositions of those organs (i.e. older 3D assays.) Watch out for more companies contracting their services to cut down on investment and—more importantly—patient risk.

Right to try bankruptcy?

The first case concerning the recent Right to Try legislation has come along and it involves Matt Bellina, one of the patients who pushed to pass the legislation in the first place. Before diving in this writer just wants to say—damn this guy is really a fighter. He’s not only a veteran battling ALS, but he also got legislation passed in freaking Congress, which isn’t easy. His case involves a cell therapy being developed by BrainStorm Cell Therapeutics, a biotech with no currently marketable treatments. It’s planning on addressing Right to Try applicants in a semicommercial model that they say won’t exploit patients. But since the company is pre-revenue there’s some big ethics concerns about how to charge vulnerable patients for the expensive treatments, which the law may not address.

Now we’re not going to begrudge anyone at the end of their rope looking for anything that can help, but we do have some strong opinions on the subject. Listen to our recent discussion on Right to Try here in our second InsightCity podcast.

Good question, bad optics

A report released by Goldman Sachs asks a question that the biotech industry has been starting to grapple with: “Is curing patients a sustainable business model?” It’s a fair question, and an easy answer: no. The GS analysts use another GS, Gilead Sciences, as a case study to explain this. A few years ago Gilead came out with their Hepatitis C cure, and US sales of that peaked in 2015 at about $12.5B. This year it’s projected to make less than $4B in the US. So the obvious conclusion is that curing patients with “one-shot” gene therapies makes less money over time than chronic therapies, makes sense. But jeeeeeeez when you take off your impartial industry analyst hat and think about how this kind of report looks to non-industry people… it’s just bad optics.

Massive fraud roundup

Theranos founder Elizabeth Holmes has settled the “massive fraud” charges levied against her by the SEC. A little refresher, Theranos was that company that was going to revolutionize the world of laboratory blood testing and then didn’t deliver. That sent Forbes’ evaluation of her to plummet from ~$4.5B to ~$0.0B, and brought a lot of scrutiny from federal agencies, which eventually culminated in this deal. As part of the stipulations, Holmes can no longer run Theranos, nor be an officer or director of a public company for 10 years.

Shout out to fellow massive fraud Martin Shkreli who was sentenced to 7 years in prison last week. We didn’t feel like giving the jerk a full story, but you’ll be happy to know he cried at his sentencing.

2. For the love of power and money

With every ending comes a new beginning. Sorry for the Hallmark introduction. The US Presidential election is over and whether you wore red, wore blue or were just plain wore out, it is over. But do you know what is not over? The rally in healthcare stocks, that’s what. Regardless of whether the rally is based on past perceptions or future projections, the facts are quite interesting. Between the start of the week and the time this article was written, the Dow Jones Industrial Average is +4.2%, the iShares NASDAQ Biotechnology Index (IBB) is +13.3%, and the NYSE Pharmaceutical Index (DRG) is +5.9%. Sooooo, there’s that.

3. Move over mAbs, stem cell therapies are (almost) here

Great news for individuals suffering from rheumatoid arthritis and not so great news for pharma companies holding patents on the monoclonal antibody-based biologics currently used to treat RA. An Australian biotech, Mesoblast, completed Phase II clinical trials on its stem cell treatment for rheumatoid arthritis to astounding results (some have inserted the word “cure” here). In a test designed to identify whether the stem cell treatment is efficient—by achieving 20% relief of signs and symptoms—researchers instead saw a 70% improvement among more than one-third of the patients who received MPC-300-IV. Since some RA patients are unable to take biologics, a stem cell therapy could benefit wider audiences.

5. Pfizer’s new pop-up manufacturing facility

Pfizer announced this past week that they are developing a Global Biotechnology Center in Hangzhou, China.  This $350M investment will be Pfizer’s newest addition to their portfolio of biotechnology centers and reinforces China as a leading area for growth in the healthcare space.  Integral to it all is GE Healthcare’s KUBio modular facility.  GE’s prefabricated modules reportedly cut the build time in half and help the facility reduce CO2, H2O and energy consumption by 75%.  Will these savings be reflected in the pricing of Pfizer’s future novel biologics and biosimilars?  That could help to lessen some of the recent shade thrown on pharma for its pricing strategies.  Not that it’s Pfizer’s responsibility to rescue the industry’s reputation but come on, it’s Pfizer.