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Medicines Patent Pool Centers On Consolidation In Its New Three-Year Strategy

Organization Aims To Conclude 10 Licenses, Develop Five Products And Transfer mRNA Tech To 10 Manufacturers

Executive Summary

The Medicines Patent Pool’s new strategy could open the door to significant new opportunities for generic drug suppliers across low- and middle-income countries, as it explores its remit in new fields such as biologics, early-stage drug development and even – possibly – antimicrobial resistance.

“This is my last job,” said Medicines Patent Pool executive director Charles Gore. “I’ve worked in global public health for the last 20 plus years and I am only interested in what difference we can make as an organization. I’m not interested in empire building or the whole kind of ego trip that there’s unfortunately a bit too much of in public health. It’s about just seeing where we can make a difference.”

Charles Gore Charles Gore

The MPP has recently announced its new strategy, which will span from this year through to 2025, opting for a shorter plan of action than it might have done otherwise – the organization would typically work to a five-year strategy, Gore explained to Generics Bulletin.

The past few years have seen it expand its remit significantly, from focusing solely on HIV, malaria, tuberculosis and hepatitis C to include non-communicable diseases, COVID-19 treatments and vaccines, as well as long-acting technologies. (Also see "MPP Strikes Deal For Long-Acting Injectable HIV Candidate" - Generics Bulletin, 13 Dec, 2021.)

The organization has also doubled in size and welcomed Gore as its executive director in 2018. As such, it has opted to focus on a shorter strategy where it can “do a certain amount of consolidation.”

“With any organization, managing a lot of growth is always a challenge,” said Gore. “Then, on top of that, a lot of our funding cycles end at the end of 2025. Thirdly, the environment is so changeable at the moment, and hence the potential requirements on us are changing.”

He continued: “Finally, our next strategy will be 2026 to 2030 and that will coincide with the end of the Sustainable Development Goals period, so it was much better to do a relatively short strategy that’s more about consolidation, beginning to examine some of the other areas that we could go into that we still don’t know whether we have a role in.”

Between 2023 and 2025 MPP has set itself the goals of establishing 10 new licenses, developing five new products and transferring mRNA vaccine technology to 10 additional manufacturers. It has set itself five strategic goals through which to achieve this:

  1. Expand access to innovative medicines for infectious diseases

  2. Establish voluntary licensing as an impactful access mechanism for other diseases and conditions

  3. Facilitate development and access to novel medical technologies

  4. Accelerate equitable access to countermeasures for pandemics and other international health emergencies

  5. Support diversified and sustainable manufacturing capacity

This will involve continuing the infectious disease focus upon which it was founded, as well as facilitating access to medicines for additional infectious diseases. It also plans to expand its focus into non-communicable diseases and maternal health, as well as novel medical technologies such as long-acting medicines, biologics and mRNA vaccines, which it has already worked with as part of its COVID-19 technology transfer hub. (Also see "Calls For COVID Patent Waivers Persist As Pooling Initiatives Plough Ahead" - In Vivo, 21 Feb, 2022.) Additionally, it plans to focus further on COVID-19 countermeasures as well as pandemic preparedness and other health emergencies.

Underpinning all of this will be its support for sustainable manufacturing, focusing on licensing to local and regional manufacturers as well as technology transfer to support manufacturers in lower middle income countries with vaccines and biologics, as well as complex small molecules and formulations.

Gore also tells Generics Bulletin that the MPP is interested in exploring the problem of antimicrobial resistance and how to make investment in the space appealing to the off-patent industry.

“We’re going to have to see how we can make that interesting for generics,” he said, “because particularly with new second- or third-line antimicrobials you’re trying to limit their usage, which is not per se of interest to generics as it’s not the same kind of high-volume product.”

MPP is now starting work with the Global Antibiotic Research & Development Partnership, to see what its role could be in this arena.

Tech Transfer Unit Branches Out To Biologics

Key to MPP’s strategy are the ongoing operations of its tech transfer unit, which was established during the COVID-19 pandemic to enable suppliers across LMICs to manufacture mRNA vaccines. The unit will also be used, Gore explained, to “facilitate some support for a biologic license.”

One of the key impediments to establishing such a license in the field of biologics, Gore said, is that “originators will say to us ‘we can do a tech transfer to one other company, a bilateral deal with a generic or a contract manufacturing organization or whatever, but your model is problematic because it’s based on competition and we just don’t have the manpower to do that.’ So it’s about providing the support to do the tech transfer.”

MPP plans to initially trial this model with a non-biologic, cabotegravir, which is nonetheless very complex to manufacture as a suspension injectable that requires nano-milling. This will function as an early test of how tech transfer of a highly complex nature could function, as well as MPP’s ability to provide support for this.

“Biologics are different from small molecules, however complex the small molecules, and there will be different aspects of it, but it’s about working out the resources required,” said Gore. “How much demand is there going to be on our time? How many players can we manage? We try to select enough so that we’re never going to have supply problems, but not so many that it’s not an interesting market anymore. How many we can realistically do a tech transfer to is also something of a limiting factor, depending on demand.”

The organization will be working on identifying biotherapeutics that could meet critical public health gaps in LMICs, exploring models and partnerships that could enable the development of and access to biosimilars in these settings and negotiating licensing and technology transfer agreements that could expedite the availability to affordable biotherapeutics in resource-limited countries.

Swimming Upstream

As well as adopting a new focus on biotherapeutics, MPP will also be looking into licensing products at earlier stages in the development pipeline, rather than just those at or after Phase III of development. This, Gore said, has in part been prompted by a “change in expectations” about when drugs should be available in LMICs.

Shortly after announcing the sub-licenses for molnupiravir, Gore spoke with a journalist who expressed dismay that patients in LMICs would still need to wait up to a year before the drug became available to them, rather than seeing this as a positive outcome. “Typically, it takes about three years from a generic company getting a license to then get to the market. Under COVID, we cut that down to a year,” he said.

“I still think a year is fantastic, but even to get to a year we’re going to have to license earlier. We can’t license at the end of Phase III, or it’ll be another three years by the time we negotiate the license and have done the sub-licensing. The only way to do it is to go earlier, because there are limits to how fast a company can develop a product.”

Gore also explained that it could be easier to negotiate a license for a product with a pharmaceutical company before the product has become a commercial asset. “In the early stages, they’re really thinking about selling a product as widely as possible and may find it harder to entertain the idea at that point that they’re never going to sell in certain countries.”

"Typically, it takes about three years from a generic company getting a license to then get to the market. Under COVID, we cut that down to a year."

Of course, this will add a certain element of uncertainty to MPP’s operations, as both the organization itself and the sub-licensees it partners with will have to reckon with the reality that many clinical trials – over half, by some estimates – drop out at Phase III. Gore reckoned, however, that there is an appetite within the industry to take these risks, as “the patent life is longer and therefore there’s more of a market that wouldn’t be there normally for generics.”

MPP will also need to assess how to de-risk investment from the generics side when licensing Phase II or even Phase I products, something it has had experience with in the past when working in conjunction with Unitaid to secure a $75 per-patient-per-year price guarantee for anti-HIV medication dolutegravir in LMICs.

A real difficulty, Gore noted, comes when attempting to license products in upper-middle income countries, as pharmaceutical companies can be reluctant to include them in a license alongside LMICs when they see them as viable commercial markets. “Not always very big ones,” he explained, “but nonetheless serious commercial markets. So they are loath to put them into a license where even if there are royalties they’ll be the same kind of low royalties that, say, Mali are paying.”

In 2021, MPP struck a deal with originator ViiV to supply dolutegravir to four UMICs – Azerbaijan, Belarus, Kazakhstan and Malaysia – as the company was charging a price at which the four governments felt unable to switch their HIV population from efavirenz-base treatment to dolutegravir-based treatment. (Also see "MPP Celebrates First UMIC Dolutegravir Shipments" - Generics Bulletin, 14 Sep, 2021.)

Gore said: “We were able to go in there and talk to the governments and find out what they would be prepared to pay, and then come back to ViiV and structure a deal where the royalty was sufficiently high to make it very commercially attractive, but sufficiently low that the governments could get a price at which they would switch people on to dolutegravir, and so everybody won. We really want to expand that model.”

Failure To Supply LMICs No Longer Publicly Acceptable

As it begins to dip its toes into new areas of life sciences, MPP will have to continue to strike a careful balance between patient need and commercial feasibility.

“What’s the public health impact?” Gore said. “Is it a really good drug that really makes a difference from where we are and do enough people in LMICs need it? If it’s just a few thousand people we’re never going to get a generic company to take a license for it. It’s got to have a serious public health impact, what we do, and then there’s got to be enough patent life left for us to make it worthwhile because otherwise generics will enter anyway.”

Post-pandemic, he opined, it is no longer considered acceptable for a pharmaceutical company to consider LMIC access programs as an afterthought. Public opinion has shifted to be that of Gore’s disheartened journalist, with the expectation that if a medicine is available in high-income countries, it should also be available everywhere else.

Gore said: “That means that pharma companies really need to come to market when they launched in the US and Europe and Japan and Australia, etc., with a fully worked out access plan, and I think and hope that we will be a part of many of those plans.”

“I honestly believe,” he added, “that if pharma wants to protect their intellectual property they need to be prepared to share it through licensing. If you look at the draft of the Intergovernmental Negotiating Body’s pandemic treaty, it’s got a couple of clauses in there that are really coercive for industry.”

“One talks about waivers, committing countries to supporting that, and the second is making use of TRIPS flexibilities, although they don’t say it they’re talking about compulsory licensing. The originator industry needs to take a look at that and realize that it needs to be seen to be doing access. It’s a question of how, rather than should, how can we do this in the best way that gets to the most people at affordable prices.”

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