The Company intends to conclude phase II studies on its own in the prioritized indication RVO, in order to increase the possibility that an agreement of partnership, licensing or sale can be reached with favorable terms for the Company.
RVO is a disease of the eye and one of the most common causes of vision loss worldwide, affecting over 16 million people globally with approximately 500,000 RVO patients in the United States and about 1.2 million RVO patients in Europe. RVO can be further grouped into “Branch Retinal Vein Occlusion (BRVO)” (about 14 million patients in the world) and “Central Retinal Vein Occlusion (CRVO)” (approximately 2.5 million patients worldwide).
As far as the Company is aware, ANXV is the only product under development that can remove the blockage in the vein that causes RVO and which can also offer a new mechanism of action. At present there are no drugs that treat the cause of RVO. Only complications from RVO are treated with so-called anti-VEGF agents for the purpose of preventing growth of new interfering blood vessels in the retina, or corticosteroids against inflammation, injected or implanted directly into the eye. The cost of an anti-VEGF injection amounts to approximately SEK 9,000. It is also being tested for laser treatment, for example. These treatments have increased the chances of visual improvement. Neither, however, has shown positive effects in the acute situation. The RVO market is projected to increase by 11.2% per annum to 2023 and valued at $7 billion by 2016.
Sickle Cell Disease (SCD)
In parallel with its own development of ANXV in the treatment of RVO, the Company is open to collaboration with development partners also for other indications, such as SCD. Annexin is continuously evaluating opportunities for collaboration but presents no forecasts for when a potential partnership could be established.
Sickle cell disease is a hereditary disease that affects the red blood cells, which in turn results in impaired blood supply, damages to organs and premature death. Sickle cell patients are regularly affected by painful sickle cell crises that occur when sickle cells block blood vessels in different parts of the body. Such crises require intensive care with pain relief.
There are currently no treatments that can prevent or break these attacks. Annexin A5 has been shown to break the ongoing sickle cell crisis in animal models of the disease. If ANXV shows an effect in SCD patients with sickle cell crisis, it would fill a major medical need.