Latest / Making Medicine / UK Pharma Challenges, DTC Ads Debate & 5 New FDA Approvals | Making Medicine

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UK Pharma Challenges, DTC Ads Debate & 5 New FDA Approvals | Making Medicine · Making Medicine

• 0:05
  Speaker 1: Hello everyone, and welcome back to the Making Medicine podcast,
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  Speaker 1: where science, policy and innovation meet. As always, I'm your
• 0:12
  Speaker 1: host John Stanford. This week we're taking a look at
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  Speaker 1: some news across the pond in the United Kingdom, talking
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  Speaker 1: about DTC advertisements and we'll get into the newest medicines
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  Speaker 1: in our FDA approvals corner. With that, let's get into
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  Speaker 1: the show. In today's episode, we're taking a hard look
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  Speaker 1: at the United Kingdom where frankly, there's a dire outlook
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  Speaker 1: on the pharmaceutical industry according to ABPI, the Association of
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  Speaker 1: the British Pharmaceutical Industry in other words, the trade association
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  Speaker 1: representing medicine manufacturers. They put out a new report on
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  Speaker 1: September eleventh, and it pointed to a lot of holes
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  Speaker 1: in the United Kingdom. Richard Torbett, their CEO, noted, the
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  Speaker 1: UK has a world class science base and potential to
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  Speaker 1: lead globally, but without a more competitive environment for investment,
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  Speaker 1: we risk losing out to other countries making bold moves
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  Speaker 1: to attract internationally mobile investment. First and foremost, we need
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  Speaker 1: to create a commercial environment that rewards pharmaceutical innovation fairly
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  Speaker 1: and brings its benefits rapidly to the UK. As Richard
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  Speaker 1: points out, there's great science in the United Kingdom. Sixteen
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  Speaker 1: of the world's top one hundred life science universities are there,
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  Speaker 1: world class R and D infrastructure, strong IP protection, and
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  Speaker 1: a rich ecosystem even of biotech companies. But there are
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  Speaker 1: also some weaknesses that the report points to, the largest
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  Speaker 1: being simply low investment by the country in innovative drugs.
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  Speaker 1: A very small portion. Only nine percent of all of
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  Speaker 1: its healthcare spend is on medicines. That's significantly lower than
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  Speaker 1: when compared to other peer countries like Japan, Spain and Germany.
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  Speaker 1: That leads to poor patient access. The report found that
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  Speaker 1: only thirty seven percent of new medicines are fully available
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  Speaker 1: for use in the United Kingdom, and it also called
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  Speaker 1: out high and quote unpredictable clawback on drug maker's revenue.
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  Speaker 1: In short, it's a recipe for uncomfortable companies and unhappiness
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  Speaker 1: in the system, despite all the right pieces being ready
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  Speaker 1: for the UK to take leadership. It closes by noting
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  Speaker 1: that the UK can hardly achieve its goal of becoming
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  Speaker 1: Europe's top life sciences hub by twenty thirty unless something
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  Speaker 1: changes almost in sync with the report's announcement are proof
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  Speaker 1: points from individual companies. Merk scrapping plans to open a
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  Speaker 1: new headquarters in central London, pointing to a lack of
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  Speaker 1: making meaningful progress in the life science industry. ELI Lilly
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  Speaker 1: is reconsidering plans for its Gateway lab site, Sonofi pausing
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  Speaker 1: potential investment, while quote the UK is a world class
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  Speaker 1: hub for science, but we need to see tangible improvements
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  Speaker 1: in the current commercial environment. AstraZeneca announced and paused investment
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  Speaker 1: in its Cambridge research site. So what can we make
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  Speaker 1: from all these company announcements and an industry association report
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  Speaker 1: saying the UK should do more to invest and value
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  Speaker 1: innovation in the life sciences. I think it is important
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  Speaker 1: points along the way of a constant discussion that we're
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  Speaker 1: always having is what makes a country important in the
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  Speaker 1: global R and D ecosystem for new drugs. The United
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  Speaker 1: States pays the most around the world for drugs. The
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  Speaker 1: United States also has the most access to available drugs,
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  Speaker 1: and it also generates the most drugs. There's a lot
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  Speaker 1: of debate happening of are those things connected. I think
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  Speaker 1: what we're hearing out of the United Kingdom is that
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  Speaker 1: they are connected and that a country that's not valuing
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  Speaker 1: innovation for its patients is going to have a hard
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  Speaker 1: time being a home for that innovation and the ecosystem
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  Speaker 1: that comes with it. We don't know if the UK
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  Speaker 1: can realize its goal of being a life sciences hub
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  Speaker 1: without spending more on pharmaceuticals, but this is certainly a
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  Speaker 1: moment where the companies seem to be making a clear
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  Speaker 1: statement we are going to invest our resources and our
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  Speaker 1: headquarters in places that are valuing the innovation we produce.
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  Speaker 1: It also comes at a time when, of course we're
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  Speaker 1: talking about this because of President Trump's Most Favored Nation announcement,
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  Speaker 1: and so I think there's two ways to look at this.
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  Speaker 1: One is it's clear that pressure is rising around the
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  Speaker 1: world for other countries to pay their fair share. I
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  Speaker 1: think that's what we're seeing from the companies, and I
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  Speaker 1: think the ABPI report shows what will happen if countries
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  Speaker 1: don't start picking up more of the tab for innovation.
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  Speaker 1: But I think we can also look at it the
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  Speaker 1: other way. Let's say we did incorporate an MFN price
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  Speaker 1: controlled structure like the United Kingdom, would we be putting
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  Speaker 1: out bleak reports about lack of interest and maybe looking
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  Speaker 1: to other countries like China as a place where innovation
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  Speaker 1: has gone. There's certainly no interest from policymakers on either
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  Speaker 1: side of the Aisle to make our innovation ecosystem akin
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  Speaker 1: to the United Kingdoms. And so this is a little
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  Speaker 1: bit of a blinking warning sign price control to co
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  Speaker 1: enemies that don't value innovation for whatever reason, don't seem
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  Speaker 1: to be home of the very innovation that they so
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  Speaker 1: anxiously wish to produce. Also in the news this week
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  Speaker 1: is talk about advertisings. It relates to medicines. President Trump
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  Speaker 1: signed a memorandum telling his administration to take a look
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  Speaker 1: at what they can do to cut down on the
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  Speaker 1: number of drugs advertised on the air. And while there
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  Speaker 1: are a lot of debates, papers and everything about whether
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  Speaker 1: or not we have too many ads for drugs in
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  Speaker 1: this country, and we are, along with New Zealand, one
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  Speaker 1: of the few countries that allowed direct to consumer advertising,
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  Speaker 1: there's some interesting perspectives about this from the investment community,
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  Speaker 1: and that's where we'll be spending our time. So as
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  Speaker 1: this plays out with the administration and we might get
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  Speaker 1: new rules, it's worth remembering that speed to market is
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  Speaker 1: an important factor in every investment that venture capitalists make
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  Speaker 1: into a new medicine. Some have been so vocal as
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  Speaker 1: to say, if we remove advertisements, it will slow down
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  Speaker 1: adoption rates and fundamentally change the equation for investing drugs.
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  Speaker 1: Read another way, it'll make investing in drugs harder and
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  Speaker 1: more expensive, and that's certainly not something we need right now.
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  Speaker 1: It'll also potentially impact one of the biggest pitfalls in
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  Speaker 1: US biotech right now, the pill penalty. We've talked on
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  Speaker 1: previous episodes that the pill penalty and giving only nine
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  Speaker 1: years to small molecule drugs is gutting investment in that
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  Speaker 1: important corner of science instead favoring biologics in their thirteen years.
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  Speaker 1: How do these two issues link up, Well, let's think
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  Speaker 1: about it. One of the arguments for more advertisements, or
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  Speaker 1: at least to keep the same number of advertisements, is
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  Speaker 1: they really do work. They make patients ask their doctors
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  Speaker 1: about new drugs. They make doctors look into new drugs
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  Speaker 1: that they might need to provide for their patients, and
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  Speaker 1: over time it plays a meaningful role in people taking
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  Speaker 1: more medicine. Well, from the economic side of this, that
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  Speaker 1: translates to recouping your investment in a drug faster and
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  Speaker 1: being able to spend it more on R and D
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  Speaker 1: on future drugs. And so the argument from some in
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  Speaker 1: the investment community is that by slowing down the uptake
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  Speaker 1: of medicine, we'll need longer to recoup that investment and
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  Speaker 1: of course make a return on that investment. And so
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  Speaker 1: maybe nine years, which we're already seeing isn't enough, becomes
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  Speaker 1: ten years or eleven years or even longer in order
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  Speaker 1: for investors to stay excited about the risky, risky world
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  Speaker 1: of biotech. So everyone probably has a personal opinion. Everyone
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  Speaker 1: probably has a favorite jingle, and they probably have a
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  Speaker 1: lot of drug ads that they'd rather not see. But
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  Speaker 1: it'll be important that we look at the data and
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  Speaker 1: the unintended consequences of making a move against this, and
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  Speaker 1: how it could exacerbate one of the known problems with
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  Speaker 1: the IRA, the pill penalty. Now for one of my
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  Speaker 1: favorite segments, our FDA approval's corner. Each approval represents decades
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  Speaker 1: of work, billions of dollars, risk, and most importantly, hope
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  Speaker 1: for patients. We should really take a moment to think
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  Speaker 1: about each of these drugs. Before the FDA approvals weren't
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  Speaker 1: available in the United States and now, thanks to science
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  Speaker 1: and investment, patients will have a new medicine that potentially
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  Speaker 1: can make a meaningful difference in their life. So here
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  Speaker 1: are the latest wins from August from Jazz Pharmaceuticals. Modeso
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  Speaker 1: was approved for malignant glioma. It's the first and only
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  Speaker 1: treatment option approved by the FDA for this ultra rare
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  Speaker 1: and aggressive brain tumor that affects an estimated two thousand
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  Speaker 1: people in the United States each year, primarily children and
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  Speaker 1: young adults, so this is certainly something to be celebrated.
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  Speaker 1: So is Hernexios from Baringer Engelheim, which was approved for
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  Speaker 1: non small cell lung cancer. It's the first and only
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  Speaker 1: FDA approved once daily oral treatment for adults with her
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  Speaker 1: too mutant metastatic non cell lung cancer. What's interesting about
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  Speaker 1: her Nexios's approval is the move for an oral treatment,
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  Speaker 1: and this gets to some of the conversation about the
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  Speaker 1: pill penalty and just how important it is to patients
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  Speaker 1: that may be given something that is readily available, maybe
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  Speaker 1: at the pharmacy, and potentially means less time spent at
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  Speaker 1: a hospital or in a clinic. It would be exciting
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  Speaker 1: to see so many more cancer drugs move into the
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  Speaker 1: oral space so that patients can have ease of access
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  Speaker 1: and frankly, often a lower cost. Also approved in August
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  Speaker 1: was Brinsupre, which is the first and only treatment for
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  Speaker 1: non cystic fibrosis bronchiic tassis, a long term lum disease
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  Speaker 1: that affects about five hundred thousand people in the US.
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  Speaker 1: Donzera from Ionis Pharmaceuticals is the first and only RNA
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  Speaker 1: targeted treatment to prevent attacks of hereditary angiodema or HAE.
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  Speaker 1: And finally, to close out the month, the FDA approved
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  Speaker 1: wayrills from Snofi. It's the first BTK inhibitor for adults
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  Speaker 1: with ITP. It's an important approval for the more than
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  Speaker 1: twenty five thousand adults living with ITP who may not
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  Speaker 1: have responded well to previous treatments. So August was a
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  Speaker 1: big month for the FDA, particularly for rare drugs as
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  Speaker 1: well as drugs for disease is that didn't have a
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  Speaker 1: drug already on the market. Nothing could be worth more
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  Speaker 1: celebrating than bring something forward. But even the drugs that
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  Speaker 1: now give a different way to take medicine or might
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  Speaker 1: work for people for whom other medicines didn't work. It's
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  Speaker 1: exciting and we should stand back and be proud of
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  Speaker 1: the scientists, companies and regulators that are bringing five new
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  Speaker 1: drugs to the market. That's all from this month's FDA
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  Speaker 1: Approvals Corner. That's all for this week's episode of The
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  Speaker 1: Making Medicine Podcasts. Have a thought or question about today's
• 10:29
  Speaker 1: conversation in the UK or DTC advertising, or maybe you're
• 10:33
  Speaker 1: one of the companies that had a new medicine approved.
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  Speaker 1: Drop us a comment and we'll feature it in next
• 10:38
  Speaker 1: week's episode. Don't forget to subscribe on YouTube and follow
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  Speaker 1: us on LinkedIn, x and Instagram using the links in
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  Speaker 1: the description. Thanks for listening and as always, keep innovating.