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Aspen Pharmacare Holdings Limited


Head office in Durban, South Africa
Type	Public (JSE: APN) JSE Limited
Industry	Health care, pharmaceutical industry
Predecessor	Lennon Ltd
Founded	1850, public 1997, Durban, South Africa
Headquarters	La Lucia Ridge, uMhlanga, KwaZulu-Natal , South Africa
Key people	Stephen Saad (Group CE)
Products	Specialty branded pharmaceuticals including steriles, injectables, oral solid dose liquids, semi-solids, biologicals, active pharmaceutical ingredients
Revenue	R 38,606,000,000 (FY 2022)^[1]
Net income	R 8,324,000,000 (FY 2022)^[2]
Total assets	R 111,375,000,000 (FY 2022)^[3]^[2]
Total equity	R 70,942,000,000 (FY 2022)^[4]^[2]
Owner	JSE listed
Number of employees	9,100^[5]
Website	www.aspenpharma.com

Aspen Pharmacare Holdings Limited is a public multinational pharmaceutical company headquartered in uMhlanga, South Africa.^[6] Founded in 1997,^[7] it listed on the Johannesburg Stock Exchange (JSE) in 1998^[8] and purchased South African Druggists in 1999 before expanding into international markets.^[9] Currently the largest pharmaceutical company in Africa^[10] through aggressive mergers and expansion,^[6]^[11] with major manufacturing sites in locations such as Gqeberha in South Africa,^[9] Bad Oldesloe in Germany,^[12] Notre-Dame-de-Bondeville in France,^[13] and Oss, Netherlands,^[14] Aspen is known for manufacturing and distributing branded pharmaceuticals as well as generic HIV/AIDS antiretrovirals (ARVs)^[15]^[9] and cancer medications.^[16] Among other products, Aspen has also been involved in manufacturing the Janssen COVID-19 vaccine through «fill and finish»,^[17] and has the rights to sell the product under its own brand name Aspenovax.^[18] The company’s profits in 2021 were US$2.63 billion.^[19] In 2016 Aspen was fined for price gouging on cancer drugs, and after an investigation Aspen committed to reduce prices for 5 years in the European Union.

History[edit]

Founding and acquisitions (1997-2003)[edit]

According to the company website, the legacy company behind Aspen Holdings was founded in 1850 by Berry Grey Lennon, an Irish chemist, who opened a drug store in Gqeberha, South Africa. In 1898, B.G. Lennon & Co. established itself as Lennon Lt, and by 1930 it was the largest pharmaceutical company in the southern hemisphere. Mergers continued throughout the 1950’s and 1960’s. Lennon was listed on the Johannesburg Stock Exchange (JSE) in 1968, and in 1975 it started a research and development department to develop and register generic drugs.^[8] Separate from Lennon, the originating Aspen company was founded in 1997^[7] by South African businesspeople Stephen Saad, Gus Attridge, and Steve Sturlese,^[9] as well as a fourth shareholder. The business was initially located in Durban, South Africa. With backing from Investec, Aspen listed on the JSE^[20] in 1998.^[8] Aspen purchased South African Druggists (SAD) in 1999, the oldest pharmaceutical business in South Africa, for R2.4 billion in a hostile take over.^[20] SAD still owned a large manufacturing facility in Gqeberha^[9] and the Lennon home remedies brand.^[8]

With Saad serving as chief executive and Attridge as deputy chief executive, co-founder Steve Sturlese left the company in 2001,^[9] and that year Aspen expanded into Australia.^[8] Also in 2001, Saad negotiated the «first-ever voluntary» licenses to manufacture generic versions of antiretrovirals (ARVs) to treat HIV, ending a «stand off» between the South African government and various multinational drug companies^[9] over anticompetitive activities.^[21] Also, in 2001, GlaxoSmithKline (GSK) granted Aspen the right to manufacture low-cost generics of three of its ARVs.^[22] By 2003, Aspen was the largest generic medicine distributor in South Africa.^[21] In August 2003, Aspen launched Aspen Stavudine — its first generic ARV drug,^[23] building an Oral Solid Dosage drug facility in Gqeberha to produce what was Africa’s first generic antiretroviral.^[8] Aspen’s efforts led to expanded access to affordable treatments for HIV/AIDS.^[15] In 2003, Boehringer Ingelheim granted Aspen licenses to create generic ARVs for use in the Sub-Saharan portion of Africa.^[21]^{[failed verification]}

International expansion (2004-2019)[edit]

Aspen acquired Fine Chemicals Corporation in Cape Town, South Africa in 2004,^[24] which was the only producer of active pharmaceutical ingredients in South Africa. Also in 2004 it acquired Infacare from Royal Numico.^[8] In 2005, Aspen was granted a license by Merck & Co. to produce efavirenz^[21] and by 2005 Aspen was the largest supplier of ARVs in Africa.^[25] In 2007, Aspen announced it would expand into Latin America in partnership with Strides Pharma Science Limited. At the time, Aspen had operations in South Africa, the United Kingdom, Australia, the United States, India, Kenya, and Tanzania.^[9] In 2009, Aspen purchased the rights to market Melphalan and several other cancer drugs from GSK,^[16] such as levothyroxine, azathioprine, digoxin and allopurinol.^[8] As part of the transaction, GSK purchased 16% of Aspen’s shares^[16] for £268 million, while Aspen acquired GSK’s manufacturing site in Bad Oldesloe, Germany and the rights to market and distribute GSK’s pharmaceutical products in South Africa.^[12] Finalized in 2011,^[26] in late 2010, Aspen announced it would acquire the Australian company Sigma Pharma for US$1.24 billion.^[6]

In 2013 Aspen expanded in Africa by opening businesses in Nigeria, and around that time, also purchased 60% of the company Shelys, which had businesses in Uganda, Tanzania, and Kenya.^[20] That year the company continued to expand globally^[27] and began promoting its products in Russia,^[20] also investing US$215 million in the licenses for various Nestle SA infant nutritional products in Australia, Southern Africa,^[28] and Latin America.^[29] In 2013, Aspen announced it would acquire drug brands from MSD^[8] and an active pharmaceutical ingredient (API) company in the Netherlands^[20] as well as anticoagulant rights. It had expanded into 21 countries in 2014, and built new global headquarters. In 2016 it bought intellectual property and manufacturing rights for Astra Zeneca’s anaesthetics,^[8] and GSK sold its stake in Aspen in October 2016.^[30] In mid-2016, Aspen was unable to supply Thyrax in the Netherlands^[31] due to changing production locations,^[32] with the shortage later extended into 2017. Affected patients were forced to switch medications in the interim and it was reported that 30% risked experiencing side-effects,^[31] with a dose-equivalent switch from Thyrax to other LT4 brands induced overdosing in 24-63% of patients.^[33]

Since 2018 the company admits a «commercial focus on specialised therapies», i.e. specialty drugs.^[8] In August 2018, Aspen stated it was the world’s largest anesthetics company outside of the United States. Also in 2018, Aspen announced plans for a new US$80 million manufacturing facility in Gqeberha for late stage cancer drugs.^[34] That year Aspen sold its infant nutritional business to Lactalis for US$865 million,^[35] and in 2019, it sold its Japanese generics unit to Novartis.^[36] In May 2019, Mylan purchased a portfolio of products from Aspen in Australia.^[37] In 2020, Aspen also sold the intellectual property and commercialization rights of its European thrombosis business to Mylan.^[38]

Corporate developments, new products (2020-2023)[edit]

In 2020, Aspen focused on meeting a demand for dexamethasone pills, a steroid used on extremely ill patients in the COVID-19 pandemic.^[39] Also in 2020, Aspen opened a US$80 million high-containment facility in Gqeberha, and announced a further US$160 million to be spent on two additional sterile plants,^[40] «paving the way for a push into vaccines.»^[41] Aspen Pharmacare has been involved in the manufacturing of Johnson & Johnson’s COVID-19 vaccine, in that it was responsible for «fill and finish» of Janssen COVID-19 vaccine stock made elsewhere.^[42] In February 2021 the South African government had signed a contract for 11 million doses of this vaccine and ordered another 20 million doses in April 2021.^[42] After worries that the vaccine fill stock made by an Emergent BioSolutions plant in Baltimore might have been contaminated, that year Aspen destroyed some of its doses. In August 2021, Aspen filled vaccine stock from a plant in the Netherlands, with 40% of those doses supposed to go to Europe and the remaining 60% to Africa through the end of September.^[42] Aspen agreed to sell several products, all of which were sold in South Africa,^[43] to the Swiss company Acino Pharma AG in October 2021.^[44] Gus Attridge retired at the end of 2021 and was replaced as chief financial officer by Sean Capazorio.^[45]

By 2022, anticoagulants and anaesthetics made up 30% of Aspens business.^[46] In March 2022, Aspen concluded a licensing agreement with Johnson & Johnson to manufacture its own COVID-vaccine, to be named Aspenovax and sold in African countries.^[47] After no Aspenovax orders were placed during a backlog of vaccines in Africa in early 2022, in May 2022 Aspen stated it might repurpose the Gqeberha site’s sterile production line by July for other products.^[18] Aspen concluded an agreement with the Serum Institute of India in August 2022 to manufacture, market and distribute four Aspen-branded routine vaccines for Africa.^[48]

Operations[edit]

A global pharmaceutical company of generic drugs and specialty drugs,^[49] according to Forbes, Aspen Pharmacare Holdings Ltd. supplies both «branded and generic pharmaceutical products.»^[7] Various drug products include sterile products,^[41] tablets, capsules, eye drops, suppositories, liquids, creams, and ointments. The company also develops and manufactures pharmaceutical ingredients.^[7] In 2022, 74% of revenue stemmed from trading commercial drugs, and 26% came from producing drugs. Two thirds of their revenue is from emerging market countries.^[49] In October 2021, Aspen operated «23 manufacturing facilities across 15 sites.»^[43] Seven of those facilities produced active pharmaceutical ingredients and 16 produced «finished dose forms»,^[49] which are drugs «in the final form for delivery to patients with a specific mixture of active- and inactive ingredients, in a particular configuration, and into a particular dose.»^[50]

Pricing investigations[edit]

Price-gouging[edit]

Aspen has been criticized for aggressively increasing the prices of generic drugs it sells, threatening to stop supplying drugs unless the price is paid,^{[citation needed]} leading to a number of investigations and fines.^[51] In October 2016,^[52]^[53] Aspen was fined $5.5 million for price-gouging in Italy^[52]^[53] by order of the Italian Competition Authority for price hikes^[51] initiated between 2012 and 2014^[16] in respect to certain cancer drugs.^[51] Aspen unsuccessfully^[54] appealed the ruling,^[51] arguing that while the hikes appeared large, they resulted from «a very low and unsustainable price base.»^[55] By 2016 Aspen was also being accused of the same practices, including artificially restricting supply, in the UK, Australia, New Zealand, Spain, France, Brazil,^[16] and South Africa.^[56] In a British study, it was found that Aspen’s Busulfan, a cancer treatment used by the British National Health Service, had undergone a price hike of 1,143% between 2011 and 2016. In 2017 in France, three people died after being given cyclophosphamide, an alternative drug to Aspen’s melphalan which had gone up in price.^[16]

In October 2017, the South African Competition Commission dropped its investigation into Aspen’s pricing of various cancer medicines after determining «an excessive pricing case could not be sustained against them.»^[56] That year, The Guardian noted that Aspen’s share value had risen significantly during the period when the price increases had been implemented, and that GSK had profitably sold its Aspen shares in three tranches.^[16] After an investigation by the UK’s Competition and Markets Authority into arrangements Aspen made regarding the UK market for Fludrocortisone, Aspen agreed to pay the National Health Service £8 million in 2019.^[57]

After a three year investigation^[58] into Aspen’s pricing of generic cancer drugs,^[51]^[59] in July 2020 the European Commission announced that Aspen had committed to a price reduction on six cancer drugs of 73% for over 10 years,^[60]^[58] while guaranteeing supply over at least 5 years to the European Economic Area sans Italy.^[58] The investigation was conducted due to rising prices for five drugs (chlorambucil, melphalan, mercaptopurine, tioguanine and busulfan).^[61] The commission found that from 2012 to 2019, Aspen had in the EEA persistently earned high profits with its average prices «exceeding costs by almost 300%» for products that had been off-patent for about 50 year. In order to prevent any further abuse of a dominant position, if Aspen intended to discontinue its supplies, the company must inform any concerned member states at least one year in advance, as well as making EU marketing authorizations for the products available for any interested third party to acquire.^[60] While Aspen had disagreed with the commission’s preliminary assessment, the company «proposed commitments to the commission that would be satisfactory to all the parties involved» to address competition concerns. In February 2021, the 73% price reduction was agreed upon as binding. No fines were levied.^[58]

References[edit]

^ https://www.aspenpharma.com/2021/09/01/aspen-increases-revenue-from-continuing-operations-by-12-to-r378-billion/
^ ^a ^b ^c https://www.aspenpharma.com/wp-content/uploads/2022/08/Aspen-Results-Booklet_YE-June-2022.pdf
^ https://www.wsj.com/market-data/quotes/ZA/XJSE/APN/financials/annual/balance-sheet
^ https://www.wsj.com/market-data/quotes/ZA/XJSE/APN/financials
^ «Group overview – Aspen Pharmacare». Aspen Holdings. 15 May 2022. Retrieved 15 May 2022.
^ ^a ^b ^c Simeon Bennett; Michael Cohen (21 May 2010). «Aspen Pharmacare Offers to Buy Australia’s Sigma Pharma for $1.23 Billion». Bloomberg News.
^ ^a ^b ^c ^d «Aspen Pharmacare Holdings | Company Overview & News». Forbes. Retrieved 10 March 2023.
^ ^a ^b ^c ^d ^e ^f ^g ^h ⁱ ^j ^k «History». Aspen Pharmacare. n.d. Retrieved 15 May 2022.
^ ^a ^b ^c ^d ^e ^f ^g ^h «Pharmaceuticals wizard knows potion for success». Bizcommunity. Retrieved 10 March 2023.
^ https://www.iol.co.za/business-report/companies/aspen-pharmacare-sells-6-prescription-drugs-for-r18-billion-to-swiss-acino-health-group-e1c8efbc-99a0-4753-b907-ba7ca9e44263
^ Tenu Avafia; Jonathan Berger; Trudi Hartzenberg (2009). «8. The ability to utilize TRIPS flexibilities in sub-Saharan African countries». In Ricardo Meléndez-Ortiz; Pedro Roffe (eds.). Intellectual Property and Sustainable Development: Development Agendas in a Changing World. Edward Elgar Publishing. pp. 177–8. ISBN 978-1-84844-645-8.
^ ^a ^b «GSK expands into emerging markets with Aspen deal». www.telegraph.co.uk. Retrieved 10 March 2023.
^ McKee, Selina (2 January 2014). «GSK transfers thrombosis drugs to Aspen». PharmaTimes. Retrieved 10 March 2023.
^ https://www.cbc.ca/news/canada/new-brunswick/aspen-pharmacare-manufacturing-facility-1.3755308
^ ^a ^b Karen Maas; Frank Boons (2010). «7. CSR as a strategic activity». In Céline Louche; Samuel O. Idowu; Walter Leal Filho (eds.). Innovative CSR: From Risk Management to Value Creation. Greenleaf Publishing. p. 158. ISBN 978-1-906093-35-8.
^ ^a ^b ^c ^d ^e ^f ^g Bosley, Sarah (28 January 2017). «Drugs firms are accused of putting cancer patients at risk over price hikes» – via The Guardian.
^ «Vaccines made in South Africa to stay in Africa, says envoy». CBS17.com. 2 September 2021. Retrieved 10 March 2023.
^ ^a ^b Chutel, Lynsey (12 May 2022). «Africa’s First Covid-19 Vaccine Factory Hasn’t Received a Single Order». The New York Times. ISSN 0362-4331. Retrieved 15 May 2022.
^ https://www.nasdaq.com/articles/s.africas-aspen-pharmacare-posts-21-rise-in-annual-profit-resumes-dividend-2021-09-01-0
^ ^a ^b ^c ^d ^e «How A Mouse Ate An Elephant». www.forbesafrica.com. 1 May 2014. Retrieved 10 March 2023.
^ ^a ^b ^c ^d Patrick Lumumba Osewe; Yvonne Korkoi Nkrumah; Emmanuel K. Sackey (2008). Improving Access to HIV/AIDS Medicines in Africa: Trade-Related Aspects of Intellectual Property Rights (TRIPS) Flexibilities Utilization. World Bank Publications. pp. 35–9. ISBN 978-0-8213-7544-0.
^ «African firm wins Aids drug permit». 8 October 2001. Retrieved 10 March 2023.
^ «South Africa’s Aspen launches three-in-one HIV drug». Reuters. 26 November 2018. Retrieved 10 March 2023.
^ «Aspen buyout of FCC OK». Business. Retrieved 10 March 2023.
^ «No bitter pills to swallow at Aspen». The Mail & Guardian. 22 August 2005. Retrieved 10 March 2023.
^ «Aspen completes buyout of Sigma pharma business for $900 million». www.thepharmaletter.com. Retrieved 10 March 2023.
^ «South Africa’s dose of big pharma». Financial Times. 17 November 2013. Retrieved 10 March 2023.
^ Kew, Janice (18 April 2013). «Aspen buys Nestle infant-nutrition licenses in Australia, Africa». mint. Retrieved 10 March 2023.
^ «UPDATE 3-South Africa’s Aspen in talks to sell infant formula unit». Reuters. 11 September 2018. Retrieved 10 March 2023.
^ «South African sell-down: Slaughters leads as GSK exits Aspen Pharmacare». Legal Business. 3 October 2016. Retrieved 10 March 2023.
^ ^a ^b «Report about the effects on patients that had to switch from thyrax» (PDF). Archived from the original (PDF) on 7 November 2017. Retrieved 14 July 2017.
^ https://www.trouw.nl/nieuws/fabrikant-verhuist-pillen-niet-leverbaar~bb60dd33/?referrer=https://www.google.com/
^ Flinterman, Linda E.; Kuiper, Josephina G.; Korevaar, Joke C.; van Dijk, Liset; Hek, Karin; Houben, Eline; Herings, Ron; Franken, Anton A.M.; de Graaf, Johan P.; Horikx, Annemieke; Janssens, Marijke (1 June 2020). «Impact of a Forced Dose-Equivalent Levothyroxine Brand Switch on Plasma Thyrotropin: A Cohort Study». Thyroid. 30 (6): 821–828. doi:10.1089/thy.2019.0414. ISSN 1050-7256.(subscription required)
^ McDougall, Mary (1 August 2018). «Aspen Pharmacare wants to play in the big leagues». CNNMoney. Retrieved 10 March 2023.
^ «Drugmaker Aspen sells baby milk business to dairy giant Lactalis». Reuters. 13 September 2018. Retrieved 10 March 2023.
^ «Novartis buys Aspen’s Japanese generic unit for up to 400 million euros». Reuters. 11 November 2019. Retrieved 10 March 2023.
^ «South Africa’s Aspen sells Australian prescription portfolio to Mylan». Reuters. 20 May 2019. Retrieved 10 March 2023.
^ «Mylan Acquires Aspen’s European Thrombosis Portfolio for $757.3 Million». BioSpace. Retrieved 10 March 2023.
^ «South Africa’s Aspen could supply 10 million dexamethasone pills in COVID-19 crisis». Reuters. 23 June 2020. Retrieved 10 March 2023.
^ «Aspen opens $80mn manufacturing facility in South Africa». manufacturingdigital.com. 16 May 2020. Retrieved 10 March 2023.
^ ^a ^b «Aspen Gets Unsolicited Offers for Pharma Ingredient Unit». Bloomberg.com. 9 September 2021. Retrieved 10 March 2023.
^ ^a ^b ^c Robbins, Rebecca; Mueller, Benjamin (16 August 2021). «Covid Vaccines Produced in Africa Are Being Exported to Europe». The New York Times. ISSN 0362-4331. Retrieved 16 May 2022.
^ ^a ^b «The Capital Quest | Aspen inks $123 mn deal to sell six products to Swiss drugmaker Acino». The Capital Quest. 22 October 2021. Retrieved 10 March 2023.
^ Khumalo, Sibongile. «Aspen’s R1.8 billion sale of its six medicine brands is a ‘decent price’ tag». Business. Retrieved 10 March 2023.
^ «S.Africa’s Aspen names company veteran Capazorio as finance chief». Reuters. 5 August 2021. Retrieved 10 March 2023.
^ «S.African drugmaker Aspen sees no immediate impact of India’s decision to curb drug exports». Reuters. 6 March 2020. Retrieved 22 April 2022.
^ «Aspen signs deal with J&J to launch Aspenovax Covid-19 vaccine». Fin24. Retrieved 15 May 2022.
^ Mukherjee, Promit (31 August 2022). «S.Africa’s Aspen, India’s Serum Institute sign vaccines deal for Africa». Reuters. Retrieved 10 March 2023.
^ ^a ^b ^c «Group overview». Aspen Pharmacare. Retrieved 15 May 2022.
^ «Finished Dosage Forms». Eurofins BioPharma Product Testing NL. n.d. Retrieved 16 May 2022.
^ ^a ^b ^c ^d ^e «Aspen Pharmacare faces EU probe over cancer drug price rises». Financial Times. 15 May 2017. Retrieved 10 March 2023.
^ ^a ^b Ed Silverman: Drug maker fined for shorting supplies of cancer drugs in order to raise prices, STAT News, 17 October 2016
^ ^a ^b Autorità Garante della Concorrenza e del Mercato. Ruling of the session on September 29, 2016, 2016
^ «Italian Antitrust Authority completes pricing compliance investigation». www.thepharmaletter.com. Retrieved 10 March 2023.
^ «Europe faces steep price increases for some old cancer drugs». markets.businessinsider.com. Retrieved 10 March 2023.
^ ^a ^b «Aspen off the hook over cancer drug pricing». Business. Retrieved 10 March 2023.
^ «South Africa’s Aspen to pay 8 million pounds to NHS after UK probe». Reuters. 14 August 2019. Retrieved 10 March 2023.
^ ^a ^b ^c ^d https://www.iol.co.za/business-report/companies/aspen-and-ec-strike-deal-to-cut-prices-of-off-patent-cancer-medicines-081e967e-9616-4852-8ce9-28db438c8895
^ «Aspen under EU antitrust spotlight over excessive cancer drug prices». Reuters. 15 May 2017. Retrieved 19 June 2017.
^ ^a ^b «Communication from the Commission published pursuant to Article 27(4) of Council Regulation (EC) No 1/2003 in Case AT.40394 – Aspen». Official Journal of the European Union. 52020XC0715(01). 15 July 2020. Retrieved 10 November 2020.
^ Wardle, Noel; Wood, Ian. «How drug prices are hiked and what is being done to tackle the problem». The Pharmaceutical Journal. Retrieved 22 April 2022.

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