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How Would One Go About Building a Company to Bring Cheap Senolytics to the World?


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Posted 21 February 2018 - 08:27 PM


Let us for a moment choose to believe that the dasatinib and quercetin combination is a senolytic treatment that does as well in humans as it does in mice. This is to say it kills about 25-50% of senescent cells in the tissues usually most affected by oral medications, meaning the kidney, liver, and cardiovascular system, and some unknown but lower fraction elsewhere. Whether or not this is the case has yet to be determined; the first pilot studies are still running at Betterhumans, and they likely won't tell us the size of the effect in terms of fraction of cells removed. Viable assays for cellular senescence that can be used in human medicine are in short supply - there is only the one that I know of that is ready to go, and even that has just reached the final stage of laboratory proof of concept. If it is the case, however, that treatment with dasatinib and quercetin works in much the same way in humans, then it should have a notably positive effect on the state of health for older individuals, given that the accumulation of senescent cells is one of the causes of aging.

The distinguishing feature of dasatinib and quercetin are that they are cheap. A senolytic therapy would be undergone perhaps once every few years at most; it kills the unwanted cells it can kill, and it is pointless to do it again before there has been enough time for new senescent cells to emerge at their slow pace. Quercetin is a widely used supplement, and enough of it for a single treatment costs less than a dollar. Dasatinib can be purchased from manufacturers for between $20 and $150 for a single dose suitable for senolytic therapy, depending on where the manufacturer is based. The FDA approved packaging of dasatinib, called Sprycel, costs $300-600 for the same amount, assuming you can find someone willing to break down a bottle of tablets to sell you the small amount needed. It is certainly possible to purchase Sprycel for less than this by ordering from outside the US.

If this pharmaceutical does work in humans as imagined above, then at these prices it is a therapy that would be affordable for a sizable portion of the world's population. But like all such matters, it is tied up by patents and regulation. No-one can build a large-scale business selling a pharmaceutical where the intellectual property and regulatory approval are owned by a large and influential concern - in this case Bristol-Myers Squibb (BMS). It is certainly the case that there is a healthy marketplace of scofflaws outside the US who sell directly from manufacturers, but they are not a single target, and it is hardly worth BMS's time to try to squash them while dasatinib is generating only the level of revenue possible for a cancer drug. That economic calculus may well change if it suddenly becomes a viable treatment for every older individual, and physicians show interest in off-label use - that is a vastly larger potential market. Certainly, BMS exerted their influence to block attempts to produce a cheaper generic version in India. That was associated with the Indian government and thus had a convenient single point of attack, unlike the manufacturer marketplace.

Dasatinib is still patent protected, at least until 2020, which means that any earnest effort to make dasatinib a household term in the near future would have to engage with BMS and gain at last tacit approval in order to grow. After 2020, no permission is needed. BMS will continue to tinker with their formula to extend patent protection on the versions of Sprycel that they sell, but they will no longer be able to directly make life difficult for those who wish to manufacture and sell dasatinib per the original formulation. The price will likely drop considerably at that point.

The Non-Profit Approach

The most obvious option is to build a non-profit that focuses on education and partnership. The goal would be to deliver low-cost dasatinib and the understanding needed for widespread use to less wealthy regions of the world. The non-profit would focus on building relationships with physicians, medical organizations, manufacturers, and the product owner, BMS. There is considerable precedent for this sort of endeavor, and many larger pharmaceutical companies carry out in-house programs of this nature. It can benefit the pharmaceutical company considerably even if they make little to no revenue from the use of their product in those markets. It is usually the case that they wouldn't have been able to sell at profitable prices there anyway, and the program can be very good for their public image - something that Big Pharma entities are always in need of, for some strange reason.

The For-Profit Scofflaw Approach

Prior to 2020, one would require deep pockets and to be based outside the US, preferably in a country that doesn't regard the US with any great favor, in order to build something large that undercuts BMS, or even simply to sell into markets that BMS chooses not to serve. Being a small company that ships dasatinib at low cost from China to other parts of the world is probably viable, but growth to any significant size would bring a quick end to the endeavor. As mentioned, an attempt was made in India, where there is a history of threatening to break international intellectual property agreements in order to bring low-cost medications to that part of the world. That failed, and I'd say that India is probably the most likely region to successfully host a defensible patent breaking exercise.

The For-Profit BMS Enabler Approach

The enabler approach runs something like this: establish a path to obtain Sprycel in bulk at a workably low cost, and in an approved manner for the regulatory framework, and then build a revenue stream based on selling wrapped packages of services and Sprycel to physicians, nursing home operators, and other interested groups. Businesses and other organizations are better customers to start with in less wealthy regions, as there is a greater chance of being able to gain sufficient revenue to expand. Optionally, partner with BMS, though this is typically hard to do without connections.

The packages sold might include: educational materials and classes; professional services to assist with insurance and other regulatory concerns for prescribing off-label usage; membership of a network that helps bring in patients interested in the treatment and thus contributes to a physician's bottom line; tests and organization of testing services to evaluation results; and so forth. Everything is carried out in a such a way that it benefits BMS, such that the company has incentives to allow the business to grow. There are many possible variations on this theme, some of which are similar to the promotional activities carried out by the pharmaceutical companies themselves, while others look more like patient or physician associations or service organizations.

The Wait Until 2020 Approach

In either non-profit or for-profit models by which dasatinib might be distributed to the less wealthy regions of the world in volume, the prospects look a lot better once BMS is no longer the gatekeeper. The price of manufacture will fall precipitously, and an enterprising group with a good approach and competent execution might be able to do quite well in markets traditionally neglected by large pharmaceutical concerns. "Quite well" in this case would mean - under the assumptions at the top of this post - a significant number of people living incrementally longer in better health at a cost that is reasonable for them, considering the benefits achieved. That seems a worthwhile goal to aim for.


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