Doré Pharmaceuticals. prospectus

Transcription

1 Doré Pharmaceuticals prospectus

2 CONTENT 1. Company history 2. Who are we? 3. Market access Public Market ZAZIBONA 4. Existing partnerships 5. Manufacturing facility 6. Quality Control laboratory 7. Strategy Contract manufacturing Supplier partnerships Direct investments 8. Strong existing foundations

3 company history Doré Pharmaceuticals is a pharmaceutical manufacturer and distributor based in Windhoek, Namibia and was originally established in 1997, where the company specialised in healthcarerelated consumables, pharmaceuticals and medical disposable products. For the past 20 years, Doré Pharmaceuticals has been a local regulatory representative of several highly reputable pharmaceutical manufacturers such as; Aspen Pharmacare, Fresenius Kabi, Sandoz, Gilead and Ascendis Health. The company has established a world-class pharmaceutical manufacturing facility, which was built on EU standards, to cater for the private and public sectors. Quality, reliability and efficiency are the three cornerstones which drives the company to provide high quality and affordable medicine.

4 who are we? Doré Pharmaceuticals is an independent 100% Namibian-owned company with the ability to source from, and supply prospective clients locally and internationally. Therefore, in 2014 the company made a significant investment by establishing a pharmaceutical manufacturing plant in Namibia. Our modular cleanroom and production machinery are all from German pharmaceutical-industry companies which include; BMF, Octanorm and Uhlmann. The quality of the facility was designed on EU GMP and WHO GMP standards, which is on par with the most advanced pharmaceutical manufacturers across the globe. These levels of superior standards are akin with our sister company, Commodity Exchange (Comex), which is the only condom manufacturing company in Namibia. Comex bears ISO 9001:2008, ISO 13485:2012 and SANS 4074 (SABS) certifications. Doré Pharmaceuticals has the capacity to operate as a contract manufacturer in the Southern Africa regions for respective clients who are seeking the highest standards in current good manufacturing practices (cgmp).

5 market access Namibian Market size: Public Market: NAD 2.54bn (USD 173mn) in 2016 to NAD 2.76bn (USD 212mn) in 2017; +8.7% in local currency and 22.9% in US dollar terms. Forecast in US dollar terms increased compared to last quarter. (Namibia Pharmaceuticals & Healthcare Report - BMI Research, Q3 2017). The Public Market is divided into the Essential Medicines Market and the ARV Market, which is roughly at a 2:1 ratio. These figures concur with our market data over the past 20 years, as we have been actively participating in government tenders over these years. Private Market: NAD 1.36bn (USD 92.6mn) in 2016 (Impact Rx Namibia Total Market Report; 2015/ /07). Impact Rx is a Quintiles IMS company (now known as IQVIA), which possess very reliable market data. Total Namibian Market: NAD 3.9bn (USD 265.7mn) in 2017 Population: 2.3 million Pharmaceutical consumption per capita: NAD (USD 116) compared to the United States at USD in 2016 statista.com/statistics/266141/pharmaceutical-spendingper-capita-in-selected-countries/

6 market access Public market As per the Namibian Government Gazette: Exclusive preference is granted to local suppliers (Government Gazette of The Republic of Namibia, No. 5922, 72 (1), Windhoek - 31 December 2015). Thus, the Namibian government has put policies in place where procurement officers for government tenders must look to local manufacturers first. This preference can be witnessed with a company called Fabupharm, who produces creams, ointments and syrups, where the Namibian government looks to procure from them first. The effects of these policies can be seen with our sister company, Comex, which has 100% market share in the public condom market. Comex designed and is locally manufacturing the Smile condom for the Namibian government and owns the copyright and intellectual property of the Smile brand.

7 Market Access - ZAZIBONA ZAZIBONA is a collaborative medicines registration initiative for the Southern African Development Community (SADC). Pharmaceutical trade within SADC is currently limited to: Local manufacture-licensing registration of a pharmaceutical company with the Health Professionals Council. Import and Export licenses. Product registration in country of export. In essence, ZAZIBONA would provide a similar function as what the EMA provides to the EU. Companies such as Sandoz and Fresenius Kabi are currently in the process of registering products via ZAZIBONA. A pharmaceutical company must register their products with at least 2 member states from ZAZIBONA in order to have their products eligible for marketing in all other participating SADC countries. These member states include; Namibia, Zimbabwe, Botswana and Zambia. This means that gaining access to these SADC member markets would be vastly easier. (eg. Product registration in South Africa takes up to 5 years). Other participating countries include: South Africa, Mozambique, Swaziland, Malawi, Seychelles, Angola and DRC

8 existing partnerships We have existing multinational partners which include: Aspen Pharmacare Fresenius Kabi Gilead Sciences Sandoz Ascendis Health The scope of these partnerships include; Warehousing, Distribution, Regulatory and Pharmacovigilance. We also, in large, provide our partners with access to big government tenders for general pharmaceuticals and ARVs. Access which is attained by preference for local manufacturers in Namibia (This is described more in detail under Public Market Access).

9 manufacturing facility Our facility is production-ready, having received our GMP license from the Namibian Medicines Regulatory Council (NMRC). Our next main objective is to acquire an EU GMP license to export to different African markets initially. Our production, regulatory and corporate teams are extremely skilled and have all received EU GMP training certificates from GemLog: Society for Medical and Pharmaceutical Logistics mbh, based in Dresden, Germany. Our Quality Management System (QMS) was designed on EU GMP, WHO, FDA and ICH standards.

10 quality control laboratory We are currently in the design stage of our Quality Control (QC) Laboratory, which we aim to complete by the end of Q4 of The validation and certifications aimed for the QC laboratory is of EU Good Laboratory Practices (GLP) and WHO standards. This will allow us to locally release, not only our own products, but the products of existing and future partners as well. In Namibia, pharmaceutical products must undergo final release testing before entering the markets. Many pharmaceutical companies have to send their finished pharmaceutical products (FPPs) to South Africa (or abroad in some cases) for local release testing, which is a lengthy process due to massive backlogs. Thus, our QC laboratory will be well positioned to capitalise in a very undersubscribed sector, as Namibia does not currently have any qualified QC laboratories.

11 STRATEGY THREE-PRONGED APPROACH TO GROWTH 1. Contract Manufacturing 2. Supply Partnerships 3. Direct Investments We have a 3-Phase Development Plan to optimise our levels of success. Each phase will be completed by gaining expertise and proficiency, which will be added to our existing QMS. timeline ? Blister Packaging Tablet Pressing Granulation API Formulation PHASE I PHASE II PHASE III PHASE IV

12 strategy - contract manufacturing Currently, we can offer Primary (Blister) and Secondary (Cartoning) packaging for prospective partners upon receiving bulk tablets. In the near future, we aim to move on to Tablet Production for prospective partners upon receiving bulk granules. This objective is calculated to start at the beginning of Q4 in When our QC Laboratory is completed and validated, we will be able to offer Local Release Testing of imported pharmaceutical products for prospective partners. The completion of this objective is calculated to be at the end of Q4 in The Namibian market is relatively big and we have preferential access to local tender markets for existing and prospective partner. Our advantageous position, coupled with the advent of ZAZIBONA, makes us an ideal hub for prospective partners who seek to penetrate the SADC markets. This can easily be facilitated with our vast experience with existing multinational partners. Essential medicines lists in SADC countries are particularly important when targeting products to market. These listed medicines are sanctioned for procurement by SADC governments in local tenders. Vaccines, ARVs, TB and Malaria medication are also high volume medications which these governments procure, although WHO pre-qualification is a necessary requirement.

13 strategy - supplier partnerships We have designed a Three-Phase Development Plan for prospective partners which includes: PHASE I: Suppliers of dossiers (CTD format) and bulk tablets for blister packaging. For each pharmaceutical product, a format part with or without, a feeder system, depending on existing parts, must be acquired for primary and secondary packaging. PHASE II: Suppliers of bulk granules for tablet pressing. The production of these granules must be in line with existing dossiers or existing dossiers need to be updated. PHASE III: Supplier of Active Pharmaceutical Ingredients (APIs) and excipients for mass granulation. The production of these APIs and excipients must be in line with existing dossiers or existing dossiers need to be updated. At every phase, a prospective partner can benefit immensely from sales in supply of semifinished to finished pharmaceutical products. We have the capacity to operate as a CMO for prospective partners, as well as purchasing dossiers to market products under the Dore brand. Target products include solid-dose regimens for communicable and non-communicable diseases.

14 strategy - direct investments Our facility has already been built, validated, qualified and licensed for pharmaceutical production in Namibia. Application for EU GMP is our next main priority after completing the production of at least 3 successful batches and a mock product recall exercise. For prospective partners who prefer direct capital investments, funds are still needed for expansion to complete all 3 phases of production. These investments will directly fund the following: New bigger warehouse Tablet pressing machine (FETTE Compacting) Granulation machinery (GLATT) (We mention FETTE and GLATT because these are companies we have had extensive interactions with. Apart from being high-quality manufacturers, these companies provide excellent technical support, all of which has already been discussed and mapped out in our User Requirement Specifications).

15 strong existing foundations GMP-ready production facility built to EU standards by German firms, using German Equipment. Comprehensive QMS. Qualified and highly skilled staff. 20 years of experience winning tenders in the Namibian public market with imported multinational partner products. A small capital investment from Baobab Capital Investments (Pty) Ltd in Windhoek, Namibia. A relatively large public market with advantages for being a local supplier. Direct access to the rest of the Southern African markets, including South Africa, via SADC and ZAZIBONA.

16 Doré Pharmaceuticals Team