BARKAN PHARMA ISRAEL LTD

Barkan-Farma SRL

Business Brief – January 2014

 

 

Company Overview

 

Barkan-Farma S.R.L. specializes in the development, production

and marketing of ethical drugs and dermo-cosmetics in the Eastern

European and Central Asia regions.

 

Barkan-Farma is a privately held pharmaceutical company established in 2007 in Moldova. The Company was started by Mr. Rafi Barkan, the founder of Aminolab Ltd., the Israel's leading analytical laboratory service company, and Meditor Pharmaceuticals Ltd., the renowned R&D Company that has developed a true breakthrough in Migraine treatment and hypotension related disorders. The leading drug Ravimig brings to market a new and innovative mechanism of action for the treatment of Migraine that works also for

no-responders to current migraine drugs.  Ravimig has proved to be safe and effective with not known side effects thus bringing to market  an overall superior solution over Triptans.

 

Barkan-Farma was established as a unique ethical drug company. The Company's mission is to serve the unmet needs of the chosen Eastern European and Central Asia pharmaceutical markets while capitalizing on their untapped market opportunity and outstanding market growth.

 The Company's goals and long-term objectives are:

• To establish corporate identity and build the image of a trusted ethical drug company

• To develop a highly reputable, well-recognized brand for its ethical anti-migraine drug

• To develop distinctive local brands for other hypotension related disorders therapies

• To build a robust and well-developed distribution network in each of the target countries

• To develop a distinctive portfolio of generic drugs, cosmeceuticals and unique dietary supplement products. By doing so the Company will further grow its sales and profitability, utilizing the established distribution network and capitalizing on the image of the highly reputable ethical drug company. 

 

Barkan-Farma obtained exclusive distribution rights for Ravimig from Meditor Pharmaceuticals Ltd. (Israel) for its commercialization in the Eastern European and Central Asia territories.

Meditor Pharmaceuticals is an Israeli biopharmaceutical company dedicated to the development and commercialization of novel small-molecule therapies for the treatment of hypotension related disorders and migraine management therapy.

 

 

Barkan-Farma's innovative therapies have been clinically tested and proved to be highly effective and safe in a variety of clinical indications; a unique pipeline of products that includes Ravimig® 50mg, 2 tablets/box: oral formulation indicated for migraine

 

Ravimig ®

50 mg tablets for Migraine

 

Ravimig® a 50 mg., novel anti-migraine drug offers many sufferers safe, rapid and lasting treatment. As opposed to other therapies available on the market, Ravimig® features outstanding abilities in treating migraine attacks with not known adverse effects.

 

Indication: Fast-acting pain relief for Acute Migraine attacks.

 

Package: Ravimig® 50mg, 2 tablets p/box

oral formulation tablet indicated for Migraine.

Prescription drug.

 

 

 

Clinical Trials:

Clinical trials carried in Eastern Europe demonstrated the efficacy of Ravimig®  tablets in alleviating migraine attacks by standard end points routinely used for other state of the art medications. Headache relief was obtained within less than two hours, and no recurrent headaches were observed. The effect on blood pressure and heart rate did not demonstrate any adverse reactions. 

 

Ravimig®  shows advantages over the existing anti-migraine agents including:

¨     Faster response to treatment

¨     Very low recurrence rate

¨     Different mechanism of action have positive effect on no responders as compared to current therapies

 

 

Vasoactive substances such as nitric oxide are believed to play a role in the process of migraine generation. Ravimig®, a novel immediate release oral tablet formulation inhibits NO overproduction and safely and effectively migraine attacks. 

 

A preliminary open label study on 100 patients, demonstrated the efficacy of Ravimig tablets in alleviating migraine attacks by standard end points routinely used for other state of the art medications. In the high doses group the headache relief was obtained within less than two hours, and no recurrent headaches were observed. The effect on blood pressure and heart rate did not demonstrate any adverse reactions.  The study proved that Ravimig was effective in 73% of the patients. It is remarkable that similar studies conducted with various triptans reported a lower efficacy level.[1]

 

Based on this study, a new oral formulation has been developed. A cGCP Phase II Randomized Double Blind, Placebo-Controlled Dose-Escalating Stud was successfully completed  for this new formulation. The study was performed on 40 migraine patients. The aim of the study was to assess the pharmacokinetics and pharmacodynamics of Ravimig tablets for the treatment of acute migraine attacks without aura in women.

 

Data analysis of all the subjects showed that at 2 hours post-treatment periods, statistically significant greater number of subjects treated with Ravimig had pain relief compared to those receiving placebo.

 

A post-marketing survey was conducted on 75 patients in Moldova by Prof. Moldovanu.

The results of the study showed the effectiveness of Ravimig. Two thirds (68%) of patients with migraine responden positively,experiencing pain-relief  within 30-60 minutes of administration of Ravimig tablets. Additionally, no adverse events or side effects were reported.  It was concluded that Ravimig is well tolerated and has a high degree of safety.

 

 

 

[1] “Nitric Oxide Synthase Inhibitors: a new principle in the treatment of migraine attacks.” LH Lassen, M Ashina, I Christiansen, V Ulrich, R Grover, J Donaldson, J Olesen. (1998)

 

 

[1] “Nitric Oxide Synthase Inhibitors: a new principle in the treatment of migraine attacks.

” LH Lassen, M Ashina, I Christiansen, V Ulrich, R Grover, J Donaldson, J Olesen. (1998)

 

 

Intellectual Property:

Both Barkan Farma and Meditor Pharmaceuticals allocate significant human and financial resources to build and maintain a strong IP portfolio. Meditor owns the intellectual property worldwide and granted an exclusive license to Barkan Farma for the commercialization of Ravimig in Eastern Europe and Central Asia.

A patent for "Pharmaceuticals Compositions for Headache, Migraine, Nausea and Emesis”, entered PCT phase in August 2001 and so far was granted in 30 countries including the US in 2006. Additional patent covering a  different formulation for Migraine tablets is being pursued for "taste masked pharmaceutical compositions for -alkylisothiouronium derivatives" .

 

Market:

Migraine is a serious neurological disease that affects approximately 15% of the population and adversely influences the quality of life of patients who suffer from it, mostly young or middle-aged women.

Barkan-Farma commercializes Ravimig ® in Moldova where the drug is already registered and has marketing approval. The company will gradually expand Ravimig ® sales to the six main countries Moldova, Romania, Ukraine, Russia, Kazahstan and Uzbekistan. Geographical expansion will continue in additional countries of the rapidly growing, developing markets of the Eastern Europe and Central Asia regions.

Ravimig offers many sufferers safe, rapid and lasting treatment. As opposed to other therapies available on the market, Ravimig features outstanding abilities in treating migraine attacks with not known adverse effects. Over-the-counter (OTC) non-specific therapies (aspirin, ibuprofen, and other analgesics sometimes combined with caffeine) are widely available on the local markets at very low prices (20-50 cents per tablet). These agents, suited for low-severity migraine, do not help patients with more disabling attacks. These patients are prescribed migraine-specific therapies. Local markets offer a relatively wide choice of triptans including:  Eletriptan by Pfizer; Sumatriptan by Glaxo-Wellcome, Veropharm, and Indian manufacturers, Naratriptan by Glaxo-Wellcome, Zolmitriptan by Astra Zeneca. Prices for these agents range between US$ 3.5-4 per tablet of Sumatriptan manufactured in India, US$ 6-8 for a single tablet of Sumatriptan 50mg/Elitriptan 40mg/Zolmitriptan 2.5 mg produced by Western manufactures. Most expensive are: Sumatriptan 100mg by GSK (Glaxo-Smith-Klein) priced at US$ 14-15 per unit or US$ 28-30 per a pack of two tablets (US$ 11 and US$ 22 respectively in Moldova). Sumatriptan 20mg Nasal Spray by GSK priced at US$ 17-18 per unit. 

 

 

Many patients treated with triptans report adverse side effects. As compared to these agents, Ravimig has shown to have a better safety profile. The Company believes that Ravimig 50mg will be best adopted by the Moldavian, Ukrainian and Central Asia region markets at prices that are lower than those of the branded triptans. The estimated selling price of a pack of Ravimig (50mg #2 oral tablets) is US$ 17-18. Distributor price is estimated at US$ 12-12.5 per a single pack. In Russia and Romania these prices are expected to be 15-20% higher.

 

Ravimig market penetration will be challenged by intense market competition and well-budgeted advertising campaigns run by the Western manufacturers of triptans. For these reasons, the Company assumes that Ravimig market penetration rate will be relatively moderate. However, in Moldova, Ravimig is expected to reach 22% of the potential target patients (primarily triptan non-responders) in five years from its introduction in 2011.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales assumptions: 

• Ravimig® will be sold in a pack of 2 tablets. Projected distribution price per a tablet is US$ 6, and per a pack of two - US$ 12.

Figures from the World Health Organization (WHO) show that in Western countries 6–8% of men and 15–18% of women experience at least one migraine attack each year (the difference is believed to be hormonally driven). In Asian countries the prevalence is lower, but still significant: approximately 3% of men and 10% of women suffer an attack in any given year. Population of 18-64 years old was considered. It was further considered, that on the average a migraine affected person experiences one attack per 

month (yet, some experience as much as five). It is assumed that annual consumption is at least 12 tabs per person. In fact, consumption can be much higher.

• It is assumed that only 30% of all the migraine affected who can afford paying for the treatment will be prescribed Ravimig®.