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Category: Pharmaceuticals

“Beyond Nicotine”: Tobacco Joins Hands With Pharma.

BY MIKE MAGEE

Connecticut attorney general, William Tong, took a turn in the spotlight this week, representing 33 states and Puerto Rico in announcing that vaping original, Juul, had agreed to pay penalties of $438.5 million to settle lawsuits against the company.

Juul in essence acknowledged that the company’s marketers had targeted young students, used social media to attract underage teens, and had given them free samples. With 45% of the company’s Twitter followers between ages 13 and 17, and an age verification methodology authorities label as “porous”, they were happy to get the nation’s attorney generals out of their hair.

Over the past four years, Juul has lost over 95% of its value. When Altria bought a 35% stake in the company in December, 2018, they paid $12.8 billion. That translates to just $450 million today. What were they thinking? At the time, Juul was fighting to preserve their “flavor pods” – with mango and creme brûlée a favorite among teens. 

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The Licensing Walls Come Tumbling Down

BY KIM BELLARD

Abortion rights continue to be one of the most heated issues in American politics, super-fueled by last week’s leak of a draft Supreme Court opinion that would overturn 1973’s Roe v. Wade and return the issue to the states to decide. 

I’ll leave it to others more qualified than me – women, for example — to weigh in on abortion itself, but I want to talk about how abortion pills are going to force changes to our healthcare system that many may not be ready for.

Although the stereotype of abortions is a procedure done by a physician in an office/clinic, the majority of abortions in the U.S. are now done through the use of abortion pills.  It is a two step process, and the two medications must be prescribed by a physician. Until last December, women were required to see a physician in person, but the FDA permanently lifted those requirements, following a temporary waiver during the pandemic. The pills are considered both highly effective and safe.  There are startups, like Hey Jane and Just the Pill, that specialize in them.

Not surprisingly, since the leak searches for “abortion pills” have hit all-time highs.

The states that have been passing various abortion bans have not ignored the loophole that abortion pills represent. There are a variety of restrictions that have been enacted, such as requiring in-person visits to outright banning use of telehealth for them. In those states, some women have opted to travel out of state to do the telehealth visit and/or to receive the pills via the mail. 

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Matthew’s health care tidbits: #DigitalHealth valuations

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

For my health care tidbits this week, it’s time to bring up the disconnect between the continual collapse of #DigitalHealth stock prices and the continued increase in private sector investment and valuation in the same sector.

All of nine months ago, way way back in March 2021 market leader Teladoc hit a stock price of $308. Last week it hit a low of just under $90. Meanwhile several companies have IPOed or SPACed this year and almost all of them have seen their stock fall dramatically. For example, pioneer online mental health company Talkspace is now at a market cap of under $300m. This week a different mental health company Cerebral which was only founded in January 2020 raised $300m at a private valuation of over $4 billion. Yes they could have bought out Talkspace for that amount! In October Medicare Advantage plan Devoted Health raised money at a $12 billion valuation which exceeded the market cap of rivals Clover, Bright Health and Oscar–each of which has more members.

So what’s going on? Part of this is the wash of money still going into venture funds. Interest rates are historically low, while inflation is picking up, so that money has to go somewhere. Additionally some of the companies that SPACed out were probably unable to get such a good valuation in a private round. But it can’t be that all the 50 or so public companies are lower quality than the private ones. That indicates that either the private valuations aren’t real (because there are so many protections built into the deal for investors), or that the private and public valuations are going to get closer together. There is of course one more possibility–some of the private companies may pursue M&A and buy out some of the public ones. But in any event, this current arbitrage cannot last forever.

It’s not unlikely the public stocks may pick up. But we’ve seen private and public market bubbles before and the aftermath isn’t usually pretty.

Matthew’s health care tidbits: Drug prices

Each week I’ve been adding a brief tidbits section to the THCB Reader, our weekly newsletter that summarizes the best of THCB that week (Sign up here!). Then I had the brainwave to add them to the blog. They’re short and usually not too sweet! –Matthew Holt

For my health care tidbits this week, I am going to talk drug pricing. Anyone who gets basically any health policy newsletter has seen some of the cash PhRMA has splashed trying to make it seem as though the American public is terrified of drug price controls. But as Michael Millenson on a recent THCB Gang pointed out, when Kaiser Health News asked the question in a rational way, those PhRMA supported numbers don’t hold. 85% of Americans want the government to intervene to reduce drug prices.

Big pharma whines about innovation and how they need high prices to justify R&D spending but health care insiders know two things. First, for ever Big Pharma has spent about twice as much on sales and marketing as it’s spent on R&D. This was true when I first started in health care thirty years ago and it’s still true today. Second, the “R” done by big pharma is resulting in fewer breakthrough drugs per $$ spent now compared to past decades. Which means that they should be increasing that share spent on R&D and need to improve the “R” process. But that’s not happening.

Finally, pharma is very good at increasing prices of branded products and extending their patent protection. Lots of dirty games go on here. Look into it and you can expect a lot of discussion about insulin pricing or discover how Humira is still raking in $16bn a year in the US, despite the fact its original patent expired in 2018. With 85% of the American public in favor, you’d think then that a Democratic Congress would leap at the change to pass a bill that might save the taxpayer $50bn a year in drug costs. But of course that’s not going to happen. There is about $30bn a year in savings in the House version of Build Back Better that passed last week, but there’s little chance of much of that being in the Senate version given Joe Manchin’s daughter’s role running a drug company, and Krysten Sinema being a recent recipient of PhRMA’s largesse. And that’s assuming any version of #BBB gets through the Senate.

Instead hope something small happens to help desperate patients, and wonder how we ended up in a political system that apparently disregards what 85% of the public wants.

A Plan to Conquer U.S. Drug Shortages

By JESSICA DALEY and WAYNE RUSSELL

COVID-19 has focused the nation’s attention on the risks associated with complex, global supply chains, particularly related to healthcare products and prescription drugs. While supply disruptions of personal protective equipment (PPE) captured headlines, the pandemic also compromised the drug supply chain. With much of the United States’ generic drugs manufactured overseas, exportation bans coupled with increased global demand created significant challenges for U.S.-based providers to secure basic, life-sustaining and life-saving therapies.

As an “easy” solution, many are now calling for manufacturers to produce medications domestically. While expanding investment in U.S. drug-making capacity is a vital component of a reliable supply strategy, moving the majority of production onshore is unrealistic.

Creating a dependable drug supply chain is a multi-faceted issue that requires a thoughtful, diversified strategy.

Repairing the Market is Job #1

Drug shortages have been pervasive for more than a decade – well before COVID-19’s onset. While shortages are triggered in a number of ways, arecent Food and Drug Administration (FDA) report says economics are a main causative factor.

Almost all shortage drugs are older, low-cost generics costing less than $9/dose. Because these products don’t generate blockbuster profits, manufacturers are less willing to invest capital to improve quality, build redundant capacity or source safety stock. Over time, market competition continues to erode price and further compress profits, leading to a war of attrition where competitive players exit the market – leaving behind as few asone or two manufacturers in many important categories.

Relocating production to the United States will not address generic drugs’ inherent profitability problem. Increased regulations, environmental and otherwise, could lead to higher production costs, which begs the question: will healthcare providers trade the potential for higher costs for predictability in supply?

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Price-Fixing Case Reveals Vulnerability of Generic Drug Policies

By ANDREW MULCAHY

A massive lawsuit filed in May by 44 states accuses 20 major drug makers of colluding for years to inflate prices on more than 100 generic drugs, including those to treat H.I.V., cancer and depression. If true, the alleged behavior is not just a violation of antitrust law, but also a betrayal of the government policies that created and defended the entire generic drug industry. 

Most prescriptions in the U.S. today — 9 in 10 — are filled with generics, which are just as safe and effective as their brand-name equivalent. And yet generics account for only 22 percent of U.S. prescription drug spending. These prices are so low because of competition between makers of different versions of the same generic drug. The more competing generic alternatives, the lower the price, theoretically right down to the marginal cost of manufacturing the pill. 

This success is the result of decades of careful federal and state policymaking, all geared towards introducing competition in prescription drug markets. The entire generic industry has its origins in the Hatch-Waxman Act of 1984. Prior to Hatch-Waxman, a company that wanted to sell a competing version of a drug whose patents had expired had to conduct lengthy and expensive clinical trials to get approval from the U.S. Food and Drug Administration. Hatch-Waxman established a quicker, less-expensive path to FDA approval that leans on the scientific research supporting the already approved brand-name drugs.  

Hatch-Waxman also created incentives for generic drug makers to challenge drug patents that prevent competition. Successful challengers win a 180-day period of exclusivity during which their generic is the only one allowed to compete with the brand-name drug. The floodgates open and additional competition pushes prices down further after the 180-day period.  

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Investment State-of-Play in Big Pharma: Bayer’s Eugene Borukhovich Weighs In

By JESSICA DaMASSA, WTF HEALTH

Bayer’s G4A team launched their 2019 program today, so here’s a little help for anyone curious about the state of pharma startup investment and what it takes to land a deal there these days.

I had the chance to pick the brain of Bayer’s Global Head of Digital Health, Eugene Borukhovich, during JP Morgan Healthcare Week and pulled out these three gloriously thought-provoking soundbites from our conversation to give you some insight as to the mindset over at big Bayer.

  • “Digital therapeutics are shining light on the convoluted, complex mess of digital health”

If you’ve wondered what lies ‘beyond the pill’ for Big Pharma, wonder no more. It seems the answer is digital therapeutics. Eugene predicts that “within the next couple of years, ‘digital health’ as a term will disappear,” and calls out organizations like the Digital Therapeutics Alliance for their efforts to set standards around evidence-base and behavior modification so regulators and strategic investors alike can properly evaluate claims made by health tech startups. As time goes on, it looks like efforts to ‘pharma-lize’ the ways startups take their solutions to market will increase, pushing them into more traditional go-to-market pathways that have familiar and comforting guidelines in place. As Eugene says, “Ultimately, what we say in my team, is that it’s about health in a digital world today.” Sounds like that’s true for both the products he’s seeking AND the way pharma is looking to bring them to market… 

  • “These multi-hundred million [dollar] press releases are great to a certain extent, but what happened to the start-up style mentality?”

When asked about Big Tech getting into Big Health, in the end, it seems, Eugene shakes out to be in favor of the ‘Little Guy’ – or, at least, in their approach. Don’t miss his comments about “cockiness in our healthcare industry” and how Big Tech is working around that by partnering up, but the salient point for startups is that big companies still seem very much interested in buddying with smaller businesses. It’s for all the same reasons as before: agility, the ability to iterate quickly, and the opportunity to do so within reasonable budgets. Eugene offered this telling rhetorical musing: “Just because it’s a combination of two big giants…do you need to do $500 million? Or, do you give some…traction, milestone, [etc.]…to prove it, just like a start-up would?”

  • “In large organizations, transformation equals time, and…we don’t have time.”

“To me,” says Eugene, “the biggest challenge is actually landing these inside the organization.” He’s talking about novel health solutions – digital therapeutics or otherwise – after learning from previous G4A cycles. Culture, precedent, and years of market success loom large in big healthcare companies across the ecosystem, which is one reason why innovation inside them is so challenging. Eugene says he’s “a big believer in a small team – even in large organizations – to take something by the cojones, and get shit done, and move it forward, and push the envelope from the bureaucracy and the process.” There’s a sense of urgency to ‘innovate or die’ in the face of the growing competition in the healthcare industry. “Back to this earlier conversation around whether it’s tech giants or other companies,” he adds, “it is a race to the speed of the organization. How quickly we learn and how quickly we make the decisions. Bottom line, that’s it.”

There’s plenty more great insights and trend predictions where these came from, plus the juicy details behind how G4A itself has pivoted this year. Check out the full interview now.

THCB Spotlights: eyeforPharma

By ZOYA KHAN

Jessica DaMassa interviews Paul Simms, the Chairman of eyeforpharma. Eyeforpharma are the “media moguls” when it comes to the Pharma industry. In order to innovate the industry, they are holding two different conferences this year to bring pharma leaders and health technology startups together to foster relationships and strategic partnerships with one another. Their first conference will be held in Barcelona in March, and the second one will be in Philadelphia in April.

Paul speaks to Jess about how health tech startups are maturing in their ways and realizing that health care is an institutionalized game, causing them to pivot their companies’ directions to fit that model. He also comments on how the pharmaceutical industry is trying to build strong relationships with particular startups to innovate their business practices, whether it be in R&D, drug discovery, or clinical research. Paul argues that the future of Pharma is more akin to a platform model, where pharma companies are not just limited to their internal capacity but are much more reliant on a larger ecosystem of moving parts that will help develop and grow the space. He also mentions that Pharma companies could really benefit from taking a page out of Google’s or Facebook’s business model which allows people to innovate and create their own content on these platforms. He further states that large B2C companies, like Amazon, will change the entire game of how people receive and curate their health insurance plans. 

eyeforphrama’s conference theme is “medicine is just the beginning”. Paul and his team believe if they bring together specific groups of people, it will benefit the pharmaceutical industry in the short term as well as the long term. Paul believes that “Pharma companies need to have a wider portfolio of innovation that goes far beyond medicine, whether that is drug+plus a solution or without the pill at all.”  Currently, Paul states, that the merging of pharma companies with other pharma companies is like having “s*x with your cousins” and believes that Pharma companies need to bridge out of their own space to keep up with the times. If you are a startup in this space, be sure to check out eyeforpharma’s upcoming conferences.

Zoya Khan is the Editor-in-Chief of The Health Care Blog and an Associate at SMACK.health

Increased Payer and Provider Support May Drive Billions of Dollars in Savings from Biosimilars

Sheila Frame, biosimilars

By SHEILA FRAME 

FDA Commissioner Scott Gottlieb has said biosimilars are “key to promoting access and reducing health care costs. And it’s a key to advancing public health.” While the Administration works to reduce barriers to bringing biosimilars to market, payers and providers can help increase adoption of biosimilars in clinical practice and ensure cost savings.

Organizations such as the American College of Rheumatology and the American Society of Clinical Oncology have issued educational documents to help guide providers in incorporating biosimilars into treatment plans, where appropriate. Yet, many doctors remain hesitant to prescribe them due to concerns about safety, efficacy, immunogenicity, effects of switching to a new biosimilar and the economic value to patients.

Biosimilars are developed in a similar way as existing biologics and have the same safety, efficacy, and quality profiles, but are more competitively priced to ensure more patients have access to these important medicines and that the system can afford them. A ten-year growing body of real-world use in the EU shows biosimilar medicines increase usage of biologic medicines, while matching their reference biologics in terms of safety, efficacy and quality.

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Last Month in Oncology with Dr. Bishal Gyawali: November 2018

Keynote speech

There was a very sobering piece in NEJM by the FDA last month in which the authors try to explore what went wrong with the Keynote-183, Keynote-185 and checkmate 602 trials testing PD-1 inhibitors combinations with pomalidomide or lenalidomide and dexamethasone in multiple myeloma. Interim analysis of Keynote 183 and 185 revealed detrimental effects on overall survival (OS) with hazard ratios of 1.61 and 2.06, not explained by differences in toxicities alone. The checkmate 602 trial was also halted in light of these findings and also showed higher mortality in the nivolumab combination arm.

In the thoughtful NEJM piece, the authors make at least three important points. First, they question why these PD-1 inhibitors were tested in combination despite their having limited single-agent activity. In fact, a couple of years ago, Vinay Prasad and I asked the same question: why are novel cancer drugs being tested in combination despite having limited activity as a single agent? We found that these drugs, even when ultimately approved, provide relatively low value and recommended that drugs with poor single agent activity not be tested in combinations unless there are specific reasons to expect synergy.

The second important point in the article is that many cancer drug approvals are lately based on durable response rates in single arm trials without a control group, a situation in which it is difficult to evaluate the safety and efficacy of drug combinations. Indeed, without an RCT, the oncology community would never have known these signals of detrimental effect. If the FDA had approved these PD-1 inhibitors in multiple myeloma on the basis of non-randomized trials, which it often does in other oncology contexts, who knows how long it would have taken to recognize the increased mortality in patients—and at what cost. This is another reason why we need RCTs more now than ever. Finally, the authors point out that these PD-1 inhibitors in multiple myeloma were directly advanced to phase 3 trials after phase 1 trials were completed, without phase 2 information. Indeed, in a recent paper, Alfredo Addeo and I showed that a substantial percentage of drugs that fail in phase 3 trials do not have supporting phase 2 data.
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