The HIV Disease
ISR’s initial focus is on the HIV market. HIV disease continues to be a serious health issue for parts of the world. Worldwide, there were about 2 million new cases of HIV in 2014. About 37 million people are living with HIV around the world but only around 15 million have access to treatment. In 2014, there were about 1.2 million deaths in persons with AIDS, and nearly 39 million people with AIDS have died worldwide since the epidemic began. Even though sub-Saharan Africa bears the biggest burden of HIV/AIDS, countries in South and Southeast Asia, Eastern Europe and Central Asia, and those in Latin America are significantly affected by HIV and AIDS (CDC’s Global AIDS web site). The lack of a definitive cure is a pressing health problem and results in a high on-going cost to society. For example, in the United States, HIV/AIDS costs the society an estimated $40 billion on an annual basis.
In the seven major markets* the combined sales value of HIV drugs is expected to increase in the next decade, rising from $14bn in 2013 to $15bn in 2023 (CAGR of 0.9%). It is forecast that the market will peak at $17.3bn in 2020 after a strong period of growth stimulated by new drug launches and the increasing prevalence of HIV**. Between the forecast dates, the global patient population for HIV is expected to increase to around 40 million in 2022. Out of the five major EU markets***, the UK will remain largest by patient number over the next decade, with the EU total market patient population estimated to be over 0.5 million by 2022. The projected annual growth rate for the UK is 6.2%, the fastest of all the major markets (*7 major markets = US, Japan and the 5 major EU markets; **GlobalData Pharmapoint September 2015; ***5 major EU markets = France, Germany, Italy, Spain, UK).
The Asian, African and South American regions are developing markets currently contributing less than 20% share in the global HIV market. The recent growth of the market in Asia Pacific is however a positive sign for potential manufacturers, with the rest of the world following a similar pattern. Furthermore the potential for market growth in these regions is substantial due to their population sizes and issues with current treatments.
The unavailability of affordable drugs is often the reason these markets have not been proliferated. Furthermore the leading cause of death in Asia and South America is their poor healthcare standards which make patient compliance and patient care with current treatments difficult. In addition to pharmaceuticals, current treatments of HIV patients also involve dietary modifications and symptomatic relief of conditions presented during the onset of AIDS. Therapeutic treatment is often costly and requires constant supply of energy compounds (sugar/fat) in order for the patient to maintain a standard daily requirement. The affordability of such treatments is a factor of concern in many developing countries of the world. Furthermore, the highest number of HIV-infected people is witnessed in poor countries. There is a majority of the HIV infected population living in sub-Saharan Africa region.
ISR’s Novel Method
The gold standard for the millions already infected with HIV is antiretroviral drugs targeting virus replication, integration and release.
No current treatments exploit the immune system´s potential to treat an established HIV/AIDS infection. ISR´s novel method introduces three key opportunities:
- ISR’s technology will provide a therapy with a unique mechanism of action beyond the risk of viral mutation – an attractive resistance profile which does not require co-dosing with a boosting agent.
- The long-term financial aspects of treating HIV patients with costly dietary supplements and other medical treatments may be reduced – a major health economy impact.
- New patents based on the second generation of ISR048 (ISR049), data protection of the use of ISR048 and existing IP defining the method and means for treating viral disease, will position ISR at the competitive edge at the time many companies will lose market protection.
- HIV continues to be a major global public health issue with a significant burden of disease
- There is no cure for HIV infection
- New and more effective therapies are still needed
- No alternative treatment in cases of ART resistance and ART intolerance representing 8% – 14% receiving ART treatment (Business opportunity $200-300 MUSD)
- Several of the HIV leaders will begin losing patent and market protection in 2017
- In 2016, four of the top 10 best selling HIV drugs will still expand sales
- New international WHO guidelines – early treatment