Coeruleus

Insomnia

Repositioned and reformulated the generic flumazenil into a highly concentrated sublingual spray: FLUMUP SL.

  • FLUMUP SL targets several unmet clinical needs for Insomnia and Hepatic Encephalopathy and other GABA related disorders;
  • FLUMUP provides an instant antidote to the drowsiness effect from sleeping pills; and
  • It allows an on-demand, effective, safe self- administered application to achieve immediate withdrawal of sleep drugs & hypnotics residual effect.

Insomnia - Potential

  • 30%-45% of adults and about 50% of the elderly population worldwide suffer from Insomnia;
  • 50-70 million Americans suffer from chronic sleep disorder (fast growing market due to increase in ageing population);
  • Up to 30% of Insomniacs suffer from next day residual effects;
  • In 2011 - 637 million monthly treatments were prescribed in the US, EU and CA (IMS Data). Average growth trend of +2%; and
  • Sleep disorder market was estimated to be $4.1bn in 2007 and expected to grow to $6.8bn by 2017 (90% relates to insomnia).

Insomnia - Current Status

IP Status

Patent pending at National Phase on the new formulation.

Clinical Trails

Successful Human Phase 2 Study.

Success HUman PK BA/BE Cross Over Study.

Competition

There are currently no similar products in exitence. Current treatment are Ritalin, Amphetamines, Modafinnial and Xyrem.

Product

  • Insomnia - time to market 3 years;
  • FLUMUP has been reformulated into a spray to be administered orally to instantly relive the drowsiness effect of sleeping pills;
  • FLUMUP is relatively easy to produce and has an excellent stability profile;
  • Sleep-Wake control in the "combat condition" is an unmet demand;
  • The IDF has supported a study in this topic at carmel medical Centre using FLUMUP; and
  • Efficacy, safety and PK of the new product were already demonstrated in two clinical trail in humans.

Hepatic Encephalopathy

FLUMUP – a repositioned drug for treating Hepatic Encephalopathy

  • Treatment for Hepatic Encephalopathy is improving the quality of life for patients suffering from GABAergic related Overt Hepatic Encephalopathy;
  • A novel approach for H.E. therapy avoiding unnecessary hospitalisation;
  • Allowing chronic patients to use it before falling into unpleasant episodes; and
  • Coeruleus will approach the FDA to receive orphan drug designation.

Hepatic Encephalopathy (HE) - Potential

  • Market size for HE is estimated as $2.115bn in 2019;
  • 7 million People with Chronic Liver Disease in the US;
  • Coeruleus' sublingual new drug will allow chronic therapy for HE in its early phases. Flumazenil is the ONLY drug that treats current episodes; and
  • Our previous success with the sleep-related therapy will serve as a boost for the FDA application.

Hepatic Encephalopathy – Current Status

IP Status

2 patents pending at National Phase.

Clinical Trails

Successful Human Phase II Study. Successful Human PK BA/BE Cross Over Study.

Competition

Orphan Drug designation.

HE Indication Benefits

  • Insomnia - time to market 3 years;
  • Coeruleus' sublingual new drug will allow chronic therapy for HE in its early phases;
  • Returns patient quality of life at illness stage; and
  • Reduces patient's hospitalisation by enabling home care.