Gates Foundation Funds Refillable Birth Control Development

VitalDose

To understand the plan for developing this prototype, Brand and Rahe gave a brief overview of VitalDose drug delivery system — the platform Celanese has been working on.

According to a Celanese solutions showcase, “Vitaldose EVA is an enabling technology formulators can leverage to create effective implants for long-acting controlled release therapeutics.”

The Timeline

The Celanese press release highlighted an 18-month projection for the prototype development, which will be done in the Celanese Pharmaceutical Development and Feasibility Lab.

When asked about the projected project time frame, Brand said, “Celanese works to the needs of the customer, so it's not a standard cookie cutter process. I want to make sure that that's clear. In this case, the company is working to prove a hypothetical system designed with the Gates Foundation. It will involve looking at the release profile, specific materials within our VitalDose platform, and how to fine-tune those to get to a drug release profile that makes sense. The company will also look at how the refillable implant will work.”

“Celanese is working iteratively on the design for what the Gates Foundation certainly believes will work for this client group. It'll need to be small, discreet, and, as Laura said, delivered subcutaneously. The team will work together to determine the best design,” added Rahe.

“Celanese is just, right now, working on getting the prototype into the hands of the Gates Foundation so that they can choose what they want to do with it next,” said Brand.

The Team

“The team is a mix of scientists and commercially focused people working on the project. The scientists run the feasibility lab, the VitalDose lab, in the Florence, Kentucky, facility. There's a team of scientists working on this and several other projects that Celanese has in its portfolio. They work on, really, the feasibility in this lab. Then, on the commercial side, there are a group of folks called field development engineers, which are engineers who work with customers.”

The engineering team works to determine what is or isn't working. There is also a marketing team that contributes to the overall strategy by focusing on women’s health.

Contraceptives for child-bearing individuals come in many forms, and understanding the form of this device will be essential to patients or providers looking to integrate this contraceptive option.

When prompted, Brand explained, “VitalDose could take a different form factor. It could be an intravaginal ring. It could be an implant, like a rod. It could be this refillable implant that we're talking about with the Bill and Melinda Gates Foundation. It can really take on several different form factors. But the objective is to have an implant where there's sustained release of a drug. It could be an existing drug administered subcutaneously or intravenously.”

“It will be a refillable implant administered subcutaneously, so it's relatively easy and straightforward to get into the body. There’s a lot of standard development work to get to that 18-month point,” Brand told PharmaNewsIntelligence.

Why This Refillable Form?

With other forms of contraceptives on the market, medical providers and patients should recognize what would make this device different from other contraceptive methods.

Among other benefits anticipated by Celanese, the main advantage of a refillable form is the flexibility of the device.

“An IUD requires a highly skilled physician to insert it. I believe it's usually a commitment of around three to five years [depending on brand]. Then, patients can have it removed and get a new one. With this system, though, people can opt not to get it refilled every year if wanting to get pregnant,” explained Brand.

“The benefit there is just the flexibility and the level of physician required to administer it. For the implant, a much lower-level skilled physician or nurse practitioner could insert it. Then, with the pill, that involves a rigorous adherence or compliance regimen of taking it at the same time every day. Anyone who's taken the pill is familiar with that. If one pill is missed, the efficacy can go down significantly. This guarantees patients will get the outcome they are going after,” expanded Brand.

Additionally, “this would reduce the number of physician visits, let's say, or clinic visits to get a shot or an IV administration because it would be implanted. It has a sustained release profile over time that's monitored and tested so that patients have the outcomes that they want to have: the efficacy and safety profiles that are desirable.”

Rahe spoke on the benefits of discretion with this device, saying, “obviously, the IUD is discreet. But as Laura mentioned, it will last for the three-to-five-year time. It's not flexible. But the pill is not discreet. Many times, this population needs something discrete to the woman who’s using the particular device.”

Looking Ahead

The potential benefits of a device like this are extraordinary for patients and providers. While the apparatus and grant are intended to create a prototype for use in low- or middle-income countries, there is speculation that it can be implemented globally.

Despite the potential benefits of this product, the company is only in the early stages of development. At this point, a prototype has yet to be created, and there is not quite an understanding of how this will be implemented and distributed practically.

Additionally, after the creation of this prototype, rigorous testing will need to be performed to determine efficacy, side effects, clinical restrictions, and implications of use.

“I think that will largely be up to whoever in the Bill and Melinda Gates Foundation chooses to partner to commercialize this product. That will be up to them in terms of monitoring side effects and all the stuff a typical pharmaceutical company would need to do in terms of maintaining that, coming up with a treatment regimen for those things, [etc.],” stated Brand.

As the development of this device continues to progress, multiple stakeholders in the healthcare industry, such as providers and pharmaceutical companies, will need to be involved in device testing, improvement, and distribution.

Editors Note: This article has been updated to reflect details on the device and process.