Most deaths related to childbirth occur in the first 24 hours after birth. One of the most common causes is postpartum hemorrhage (PPH), heavy blood loss that occurs when the uterus does not contract properly after childbirth. The hormone oxytocin, known as the love hormone due to its role in establishing romantic relationships, also plays an important role during labor in causing the uterus to contract.
For this reason, oxytocin has been used as a treatment for PPH. World Health Organization WHO also recommends an injection of oxytocin in the third stage of labor (the postpartum period) to prevent PPH. The treatment is considered effective, but there is a high demand for alternative forms of administration, as it requires expertise to perform the injections and also equipment that is not always available, which is a common problem in developing countries.
New PPH treatment platform in pipeline
Researchers at Monash University The Institute of Pharmaceutical Sciences (MIPS) in Melbourne, Australia, has been working on an alternative formulation of oxytocin that does not require an injection. To speed up the process, MIPS has recently entered into an R&D collaboration with Janssen Pharmaceutica, a company within Johnson & JohnsonGroup, to drive the clinical development of inhaled oxytocin for the prevention of PPH in developing countries.
Iconovo contributes with ICOone
This week, the project received a boost when Monash University announced that they had reached an agreement with the Swedish inhalation company. Iconovo to use the company's ICOoneplatform for administering oxytocin in powder form to the lungs. The dry powder formulation does not require refrigeration and is easy to handle for healthcare professionals, midwives and mothers themselves.
Iconovo CEO Johan Waborg expressed their enthusiasm for the project in a press release:
»We are very happy to be able to contribute ICOone and our inhalation expertise to an incredibly important new medical innovation. There is a great need to simplify the administration of oxytocin so that these unnecessary and tragic deaths can be reduced worldwide. In this project, we all come together to make important things really happen. This project means that Iconovo broadens its experience to innovative development projects and we look forward to working on more similar projects where we can contribute our inhalation expertise. It sends a strong signal to the market that these innovation-focused players see ICOone as a suitable inhaler for innovative applications«
A Phase I clinical trial is planned for the project in 2021 and the agreement involves phased payments of a technology access fee of EUR 900, which will be paid at milestones in the clinical development. The first of three milestone payments will be received as a license fee following a positive outcome in the Phase I trial. In addition, Monash University will pay Iconovo for supporting development work in the project regarding milestones that have not yet been agreed upon. Royalties accrue to Iconovo over a 000-year period from launch and will be in the range of 20 – 5 percent.
ICOone's versatility and strong IP protections
The ICOone platform, which is a user-friendly, single-use dry powder inhaler, can be used in a variety of formulations and can offer faster treatments with high safety for patients. The technology on which the product is based has strong patent protection and in the spring it was announced that intention to grant, from EPO for ICOone.
Thanks to its versatility, PPH is not the only area of use for ICOone, in fact, it is not even the first collaboration for Iconovo regarding ICOone. In 2018, the company signed an agreement with McMaster University in Canada on the development of a vaccine against tuberculosis. The agreement concerns the development of a dry powder formulation of an inhalable vaccine that is administered with Iconovos ICOone. The project was described in more detail in BioStocks article published earlier this year on World Tuberculosis Day.
Contributes to significant market potential
The agreement between Iconovo and Monash University has the potential to address a large unmet medical need among women. Iconovo estimates that approximately 15-20 percent of the expected 115 million births annually in less developed countries, such as rural areas in Africa and Asia, would benefit from an inhaled formulation. It could offer significant advantages over alternatives through its ease of administration, low transportation costs and the management of hazardous waste such as used syringes.
In the future, this potential could also be expanded to the US and Europe, where the need for safer, non-invasive alternatives to injections should not be underestimated.
The content of BioStock's news and analysis is independent, but BioStock's operations are to some extent financed by companies in the industry. This post refers to a company from which BioStock has received funding.