Algernon Health Inc (AGNPF)

[Money $hot]

Algernon Pharmaceuticals Lead Compounds Safety History

Annual Information Form

For The Financial Year Ended August 31, 2018

April 11, 2019

Page(s) 16 & 17

NP-120 was developed in France and introduced into the Japanese market in 1987 by a global pharmaceutical company. NP-120 was withdrawn from the French market in 2014 owing to a lack of risk/benefit analysis but is still available in Japan as a generic drug. Since its origin, there have been a number of clinical trials investigating its use in other diseases, as summarized below:

1. 4,821 Patients (1 Year) Circulatory System Related Disorders;
2. 94 Patients (6 Months) Circulatory Issues; and
3. 46 Patients (3 Months) With Alcohol Dependence.

NP-135 was developed in Russia in 1970. NP-135 is currently prescribed for neurological conditions in Russia, where it is genericized, and as a supplement in the Ukraine. Since its origin, there have been a number of clinical trials investigating its use in other diseases, as summarized below:

1. Viral Hepatitis A (148 Patients);
2. Chronic Non-specific Respiratory Diseases (36 Patients);
3. Radiation Sickness (9 Patients);
4. Ischemic Heart Disease (75 Patients);
5. Coronary Artery Bypass Surgery (29 Patients);
6. Prevention Of Hearing Loss (148 Patients);
7. Neuromuscular Diseases (145 Patients);
8. Ischemic Stroke (2 Studies: 53 And 28 Patients);
9. Fetal Hypoxia During Gestosis (157 Patients); and
10. Treatment Of Recurrent Erysipelas (66 Patients)

Note: No significant adverse side effects in any of the above noted studies were identified by the
Company.

NP-160 was developed in Russia in the 1980’s. NP-160 was approved in Russia for the treatment of neurologically related diseases. The Company believes that it was withdrawn from the market in the fourth quarter of 2018 due to declining sales. Since its origin, there have been a number of clinical trials investigating its use in other diseases, as summarized below:

1. Pilot trial (30 patients);
2. Multicenter trial (795 patients);
3. Phase II trial (30 patients, randomized, blinded, placebo-controlled);
4. Non-motor symptoms of Parkinson’s Disease (70 patients, open label); and
5. Irritable Bowel Syndrome (30 patients, open label w/ control group)

Note: No significant adverse side effects in any of the above noted studies were identified by the
Company.

NP-178 was developed in Russia and was first approved in 1986. NP-178 is available in Russia and the Ukraine as a highly genericized prescription medicine. In Russia, NP-178 is one of the top selling drugs and is on the state registry of essential drugs. Since its origin, there have been a number of clinical trials investigating its use in other diseases, as summarized below:

1. Cerebral Ischemia (At Least 26 Trials, 6337 patients);
2. Cardiology (12 trials, 2531 patients);
3. Psychiatry (10 trials, 733 Patients);
4. Ophthalmology (11 trials, 1163 patients);
5. Pancreatitis (6 trials, 505 patients);
6. Epilepsy, Encephalopathy, Pain, Eczema, Dentistry and others; and
7. Phase III registered trial for stroke on going.

Note: No significant adverse effects in any of the above noted studies were identified by the Company.

NP-251 was developed in Japan and approved in 1987. NP-251 is no longer available in Japan where it was initially approved as an anti-allergy medication.

1. Withdrawn from the market in 2014 for sales reasons; and
2. Little reported clinical Information.

Note: The Company did not identify any publically available significant adverse side effect issues related to this compound.

https://webfiles.thecse.com/sedar_filings/00037722/1904160953176150.pdf

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