The Race for Data Exclusivity
The share of revenues drug companies devoted to R&D almost doubled between 2000 and 2019 in the US, with the number of patents also skyrocketing. Yet, this exponential increase in R&D spending has had no corresponding increase in the number of new drugs on the market or revenues generated.
In the case of Spravato, also known as esketamine, 29 clinical studies over eight years were required to establish safety and efficacy and yet the developer Johnson &Johnson’s Janssen was denied data protection rights in Canada, while the UK’s National Institute for Health and Care Excellence (NICE) rejected its coverage. This is a big blow to psychedelic companies as many are looking to develop variations of known psychedelic drugs.
Drug discovery and development are extremely expensive, and drug developers need to be able to recoup that investment to be viable businesses. Patenting, a form of government-granted monopoly, is the most common route drug developers protect their revenues. However, it does not guarantee a competition-free market.
Spravato is protected by patents, but without data protection, Jannsen could face tough competition from rivals such as Clexio and Eleusis, which are developing treatments based on ketamine.
Patenting is also a less available route to many psychedelic drug developers, since the requirements for securing a patent (i.e. novelty and non-obviousness) exclude naturally occurring psychedelics, the plants and fungi that produce them and potentially the “setting” they are administered in from patent eligibility.
Drug developers can overcome this problem by altering the structure of psychedelic compounds to create new chemical entities which can be protected by 'product patents'. They can also create new formulations or novel ways of synthesising the product, and claim intellectual property (IP) over these.
Understanding data exclusivity
Another form of IP protection that psychedelic drug developers can benefit from is data exclusivity rights. While a patent excludes others from making, using or selling a specific drug, data exclusivity prevents others from using a drug’s non-clinical and clinical data to gain approval for similar products, by securing the ownership of data that is provided to regulators.
If drug companies generate the data to show that a psychedelic drug, including naturally occurring compounds, treats a specific indication, they can get data exclusivity for 8 years in Europe. This number is different in different jurisdictions, for instance, 8 years in Canada and 5 in the US with opportunities for extension especially if looking at orphan indications.
But there is a catch. Different companies cannot get data exclusivity for the same product and indication. For instance, both Compass Pathways and Braxia Scientific are doing clinical trials with psilocybin for treatment-resistant depression. Unless there is a significant difference in terms of these treatments’ efficacy due to the nature of the source material or manufacturing process, only one of these companies will be able to secure data exclusivity.
This creates a footrace to get clinical trials approved and delivered in a time-efficient way as numerous companies are currently researching the same conditions.
Adapted from European Medicines Agency’s presentation on data exclusivity.
Obtaining data exclusivity
It is crucial to understand which treatments are eligible for data exclusivity before investing in clinical trials, especially when patent protection is not an option. For this, what is meant by “new active substance” and “new indications” should be carefully defined.
The European Medicines Agency (EMA) defines substances that are not previously market-authorised as new active substances. Substances that are previously authorised can also be included in this definition if they are significantly different from the authorised substance in terms of efficacy and/or safety, because they have a different molecular structure, source material or manufacturing process, or they are an isomer, complex, derivative or salt of the authorised substance.
An indication is defined as new if it is a new target disease or a different stage or severity of a disease. However, a new indication can also extend the target population or change the course of the treatment for the same disease. In this context, it doesn’t count if the active substance is simply a different strength, form, administration route, presentation, variation or extension.
Although the criteria are quite strict, the good news is that the benefits of the data exclusivity period can be enjoyed for an additional 2 + 1 years through market protection offering a total of 11 years to protect returns on investment. During the first 2 additional years, regulators can accept submissions for generic drugs, and even give market authorisation, but these generic drugs cannot be placed on the market. The 1-year extension is granted if authorisation for at least one new indication is obtained during the first 8-year period, with the condition that the treatment brings significant clinical benefit compared to existing therapies for this indication.
Accelerating drug development with Clerkenwell Health
We help psychedelic drug developers run their trials at pace and collect the data they need. Our focus is on shortening the submission, approval and delivery timelines to minimise the time it takes to bring psychedelic drugs to market.
The processes Clerkenwell Health can accelerate for drug developers.
In addition to supporting drug developers in their Innovative Licensing and Access Pathway (ILAP) application, we also specialise in designing integrated and adaptive trials.
Trials with an adaptive design are often more efficient, informative and ethical, make better use of resources, and may even require fewer participants. By introducing pre-specified modifications in the design of an on-going trial depending on the data generated, adaptive designs can allow developers to cover multiple phases of a trial in one protocol, saving time and money spent on multiple submissions.
Although identifying sites outside a small number of hospitals that are already familiar with psychedelics is a challenge, our model allows us to work with a much broader set of hospitals. We focus on building long-term relationships in which we deliver packages to upskill sites and ensure they can be set up with speed when needed.
Our patient recruitment process uses an innovative multi-channel recruitment strategy while our decentralised delivery model minimises patient dropout rates by improving patients’ experience throughout the trial. This model avoids requiring patients to travel for procedures that can be carried out closer to where they live. Patients can also be kept engaged remotely throughout the process with patient-facing technological solutions.
Costly dropouts due to being in a placebo group can be mostly avoided through designs such as wait-list or cross-over trials. Using evidence-based psychotherapy models such as the Acceptance and Commitment Therapy model our therapists are trained with, incentivises participants to continue the trial despite being on placebo, as they’re likely to benefit from therapy alone, especially in a context where receiving psychotherapy through the NHS is difficult.
Speak with our team of clinical, psychiatric and psychedelic specialists to find out how we can accelerate your drug development processes.
