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Johannesburg: Aspen Pharmacare, South Africa’s leading JSE-listed pharmaceutical company, is pleased to announce the launch of EmdoltenTM, a Dolutegravir-based triple combination anti-retroviral (ARV) treatment option. EmdoltenTM, a once a day triple combination tablet therapy in the form of Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate, is positioned to become a preferred first line ARV and will be available in 50mg, 300mg/300mg dosage strengths. Stavros Nicolaou, Aspen Senior Executive, Strategic Trade, said, “There has been significant excitement at a clinician, funder and patient level about the use of Dolutegravir, a second generation integrase inhibitor, which offers clinical and safety profile benefits. EmdoltenTM enhances Aspen’s HIV product offering in South Africa and has the potential to improve the lives of millions of South Africans presently on ARV treatment. As part of our ARV leadership, we were able to introduce the first Dolutegravir and Dolutegravir-containing combinations into the South African market over 18 months ago.  This represents a further refinement of Dolutegravir-containing combinations.” “Aspen pioneered the development and manufacture of generic ARVs in South Africa in the early 2000s, when our country was grappling with HIV denial and the potentially destructive consequences of an un-arrested HIV pandemic.  Prior to this, ARV’s, which were then patent protected, were inaccessible to the majority of these patients.” Aspen’s pioneering efforts resulted in the accelerated introduction of South Africa’s public ARV programme which has contributed to the successful treatment of hundreds of thousands of patients afflicted with HIV and AIDS. “Since the launch of Aspen Stavudine, our first generic ARV in August 2003, we have continued to be an anchor supplier of ARVs to both the South African public and private sectors, a leadership position we have maintained through extensive manufacturing investment into the local economy and the introduction of an ongoing pipeline of ARV products. This has enabled Aspen to bring the latest ARV innovations to market, providing patients and healthcare professionals with the most advanced ARV treatment options for patients’ specific needs,” added Nicolaou. Issued by: Shauneen Beukes, Aspen Group Communications Manager Tel: +27 12 6618467 Cell: 082 389 8900 On Behalf Of: Stavros Nicolaou, Senior Executive, Aspen Pharmacare Holdings Ltd Cell: 082 458 3135

Aspen was one of the few companies invited by French Prime Minister Edward Philippe to attend the Health Industry Strategic Meeting on 9 July 2018 at the Matignon, Paris – the official office of the Prime Minister. Represented by Stavros Nicolaou and Fabrice Jover, Aspen had an opportunity to hold brief discussions with Prime Minister Philippe; Minister of Health, Dr Agnes Buzyn; French Junior Minister for Economy, Finance and Trade, Delphine Geny-Stephann and other officials. During these discussions Aspen was able to highlight its ongoing French production investment through its Notre Dame de Bondeville manufacturing site and its continued commitment to supplying quality, affordable and accessible medicines, most of which are life-saving, to the citizens of France and the European Union. Aspen has capacity to manufacture over 250 million pre-filled injectable thrombosis syringes for global distribution from this French-based site, and it is in the process of installing new capacity at the same site to manufacture anaesthetic products. During the meeting Minister Philippe also made certain announcements with respect to future pricing of pharmaceutical product in the French market.

Port Elizabeth – JSE Limited-listed Aspen Pharmacare (APN), South Africa’s largest pharmaceutical company, officially opened its R1 billion Port Elizabeth-based high containment facility earlier today. Stephen Saad, Aspen Group Chief Executive said, “Aspen continues its evolution into a global specialty manufacturer of niche products requiring complex technologies. The high potency manufacturing facility we are opening today represents such complex technologies, providing Aspen with the opportunity to expand it exports with products which are used for rare indications.  Initial production in this facility is planned for Alkeran, Leukeran and Purinethol (treatment of late stage cancers), Imuran (prevention of organ tissue rejection in liver and kidney transplants as well as treatment of certain autoimmune diseases) and Benztropine (treatment of Parkinson’s disease).” Saad added, “The commissioning of this facility further cements Aspen’s position as the largest private investor in the South African pharmaceutical industry, with its current manufacturing operations constituting a significant portion of the installed pharmaceutical volume capacity in our country. Aspen’s ongoing investment in its South African manufacturing sites bolsters the introduction of new technologies, the addition of skilled employment opportunities and the enhancement of our country’s export capability.” Officiating at the opening, the Minister of Trade and Industry, Dr Rob Davies, said the investment will significantly strengthen our country’s capacity as a manufacturer of quality pharmaceutical products. “Aspen’s expansion into the High Potency Facility will enable the manufacture of products not previously produced locally and also add to the export capacity of Aspen contributing to the overall growth of the pharmaceutical sector and will potentially have a positive impact on lowering the current trade deficit within this sector,” said Davies. Minister Davies added that the facility will further enhance both South Africa and Aspen’s status in terms of regional and continental trade. “Aspen is a leading global producer of regulated hormonal products and a leader in infant nutrition products in select emerging markets. With this new facility, it is anticipated that around 95% of these new products are to be exported with target markets in Latin America, Europe, Asia and Africa with the first exports expected to Europe as the first regulatory approvals were from Europe.  The new high potency manufacture facility will provide Aspen with niche-type capability to offer the market specialised therapeutics and increase its footprint within the global pharmaceutical environment,” said Minister Davies.” Aspen’s operations in the Eastern Cape employ over 2500 people of which 2000 are at the Port Elizabeth site with more than 90% of these employees being recruited from local communities. The high containment facility, together with the new sterile facility being built at the same site, will provide for some 500 additional jobs. In order to ensure world class training capabilities in its employees, Aspen is in the process of establishing a Training Academy. The intention is to give Aspen employees the opportunity to attain national accredited qualifications in pharmaceutical manufacture. The 23,000m² facility has been audited by the South African Health Products Regulatory Authority and the German regulator, Landesamt für soziale Dienste des Landes Schleswig-Holstein (LAsD) both of which have granted the requested approval. At full capacity, the high containment facility is expected to produce approximately 3.6 billion tablets annually and package some 3 million bottles per month.   Issued jointly by the Department of Trade and Industry and Aspen Pharmacare Download a PDF version of this document here. About Aspen Aspen is a leading global player in specialty, branded and generic pharmaceuticals with an extensive basket of products that provide treatment for a broad spectrum of acute and chronic conditions experienced through all stages of life. With an acknowledged presence of nearly 2 decades in the pharmaceutical sector, Aspen remains committed to its core values of providing quality and effective healthcare solutions to millions of patients in more than 150 countries, with its core focus being in the Thrombosis, Anaesthetic, High Potency & Cytotoxic and Nutritional therapeutic categories. Aspen has a strong presence in both emerging and developed countries. Its emerging market footprint includes Sub-Saharan Africa, Latin America, China, South East Asia, Eastern Europe and the Commonwealth of Independent States, comprising Russia and the former Soviet Republics. It is also a leading pharmaceutical company in developed countries including Australia and most notably in Western Europe. Aspen operates with an established business presence in approximately 50 countries spanning 6 continents and employs more than 10,000 people. The Group operates 25 manufacturing facilities across 17 sites. Aspen holds international manufacturing approvals from some of the most stringent global regulatory agencies including the FDA, TGA and EMA. Aspen’s manufacturing capabilities are scalable to demand and cover a wide variety of product-types including oral solid dose, liquids, semi-solids, steriles, biologicals, APIs and infant nutritionals. With a market capitalisation of approximately $10 billion, Aspen is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and ranks amongst the top 20 listed companies on this exchange.  For more information visit www.aspenpharma.com

Durban – JSE Limited-listed Aspen Pharmacare (APN), a leading pharmaceutical company in the southern hemisphere, has welcomed the statement issued by the Democratic Alliance (“DA”) earlier today in which it has confirmed that it is satisfied that there is no evidence that Aspen has engaged in alleged anti-competitive behavior as per the DA’s statement issued on 19 April 2017. The statement issued by the DA on 29 May follows below: Competition Commission investigates conduct of all pharmaceutical companies operating in South Africa and BRICS The DA welcomes the Competition Commission’s preliminary investigation into the market conduct of all pharmaceutical companies operating in South Africa and in the BRICS (Brazil, Russia, Brazil, India, China and South Africa) consortium. The World Bank has raised concerns about cartel-like practices that tend to drive medicine prices upwards and this requires investigation. Following extensive high-level engagements between Aspen Pharmacare and the Health Portfolio of the Democratic Alliance, necessitated by a previous press release, the DA is satisfied that there is no evidence that Aspen is involved in the same practices that they are accused of having pursued in Europe.

Windhoek, Namibia – JSE Limited listed Aspen Pharmacare (APN), a leading pharmaceutical company in the southern hemisphere, has announced that a memorandum of understanding (“M.O.U”) has been concluded between Aspen’s Russian business and the Vladivostok Far Eastern Federal University (“F.E.F.U”). The Deputy Prime Minister of Russia Mr. Yury Trutnev, who has delegated authority from the Russian President for the Far Eastern Federal Region of Russia, oversaw proceedings and committed the region and university to this collaborative effort. Stavros Nicolaou, Aspen Senior Executive Strategic Trade Development said, “The Group welcomes this latest collaboration with the Russian Federation which further complements existing relations with that country. The M.O.U provides for cooperative efforts to improve the quality of education and contribute towards advanced innovative technology in the fields of thrombosis and anaesthesia through joint training and research efforts with the FEFU. The goal of the programme is to decrease the mortality rate of thrombotic events and to increase the quality of anaesthesia use in the Russian Federation. This will improve the life expectancy of Russian citizens in the medium to long term, as clinicians will have access to some of the newest low molecular weight heparin technology, which has an improved safety profile against older interventions.” Aspen was established in the Russian Federation in 2013 and employs over 150 specialist representatives  detailing critical medicine areas that include anti-thrombosis and anaesthesiology. One of the principle products in Aspen’s thrombosis therapeutic portfolio is Fraxiparine (Nadroparine Calcium), which substantially diminishes the risk of the formation of life-threatening blood clots. This low molecular weight heparin is manufactured through a complex process and provides one of the best in class safety and efficacy anti-thrombotic profiles. Aspen is in discussion with the Ministry of Health for the inclusion of Fraxiparine on the Russian Federation Essential Drug List. The use of anti-thrombotic agents in the Russian Federation is approximately 10% of that of the European Union. In 2015 Aspen commenced technology transfer for the Russian-based manufacture of Fraxiparine through its Russian partner Nanolek L.L.C, which is in the Kirov region of Russia.  Aspen’s products are distributed throughout the Russian Federation.

Having noted the report published in The Times of London on 20 May 2017 titled “Massive price rise for vital drug put pets’ lives at risk”, Aspen wishes to express its disappointment and concern that much of the information and clarification it provided to The Times’ Billy Kenber prior to the report being published has been excluded. In particular, the Times chose to omit the fact that the product in question, fludrocortisone, is not indicated for use in animals and that the original Aspen product, Florinef, continues to trade actively in the United Kingdom under European Union free trade arrangements. To provide a balanced account of the facts, Aspen wishes to communicate the following information which was shared with the Times, in response to questions: 1. Aspen replaced Florinef with a new product formulation with an improved product stability profile. Florinef is a cold chain product, requiring continuous refrigeration, creating challenges for transportation and storage both in the supply chain and by the patient. The new product is a different formulation which is heat stable and no longer requires such refrigeration. It also removes the risk of discard in case of storage temperature change. The price at which the product was launched in the United Kingdom was considered appropriate considering the cost of developing and launching the new formulation. 2. Pricing approval for the new formulation fludrocortisone was obtained via the NHS BSA prior to launch and the price is registered on the NHS DM&D site. 3. Florinef remains available in the United Kingdom through the free trade arrangements of the European Union and continues to be actively sold in the United Kingdom. 4. Neither Florinef nor the new formulation fludrocortisone are indicated for use as a veterinary product and Aspen can accordingly not take accountability for utilisation of these products by pet owners. We do note that the apparently substantial mark-up by others on the price of the product sold to pet owners contributes to the cost of using this product off-label by pet owners, but must point out that Aspen cannot be deemed to be responsible for this mark-up. 5. As Aspen has the rights to register and supply this improved fludrocortisone tablet formulation globally, there may be scope for cost and price reductions as the product is registered in more countries and the volumes of off-take for it increase. Any further queries in this regard may be directed to Aspen via its website at https://www.aspenpharma.com/contact-form.