ALK-Abelló

ALK-Abelló A/S (Nasdaq Copenhagen: ALK B), also commonly known as ALK, is a Denmark-based pharmaceutical company which specializes in the development and manufacture of allergy immunotherapy (AIT) products for the prevention and treatment of allergy. It is one of the world’s largest makers of allergy immunotherapy products (also known as ‘allergy vaccines’)[3] with 81% of its revenue coming from sales in Europe.[2]

ALK-Abelló A/S
Aktieselskab
Traded asNasdaq Copenhagen: ALK B
ISINDK0060027142 
IndustryPharmaceuticals
Founded1923 Copenhagen[1]
HeadquartersHørsholm, Denmark
Key people
Steen Riisgaard (Chairman)
Carsten Hellmann (CEO)
ProductsAcarizax, Grazax, SlitOneUltra, Alutard SQ, Jext
Revenue DKK 3,005 million (2016)[2]
Number of employees
2,300 (2016)[2]
Websitewww.alk.net

History

ALK-Abello dates back to 1923[1] when Denmark’s first allergen extracts were produced at the pharmacy of the Copenhagen University Hospital.[4] The company was subsequently established as Allergologisk Laboratorium København. The company has since focused on mapping the mechanisms of allergic impact on the immune system in order to develop new and improved allergy therapies. The research focuses on prevention, treatment, and management of allergies, especially hay fever and asthma. In 1925 Juan Abello Pascual founded Abello Pharmaceuticals in Spain.

In 1978, ALK released the first standardized line of products for the treatment of allergies. In 1992 ALK and Abello merged. In the 1990s, ALK was the first company to launch sublingual immunotherapy drops (allergy immunotherapy administered as droplets under the tongue). In recent years, ALK’s research and development strategy has been focused on introducing a range of sublingual immunotherapy tablets (SLIT-tablets). The first, for grass pollen allergy, was launched in 2006, and was followed by SLIT-tablets for ragweed pollen allergy in 2014 and house dust mite allergy in 2016. The company is part-owned by the Lundbeck Foundation, however is also a publicly traded entity.

Corporate information

ALK’s stock is listed on the NASDAQ OMX Copenhagen Stock Exchange.

As of February 7, 2017, the current members of ALK’s board of directors are:[2]
Steen Riisgaard (chairman of the board, chairman of the remuneration committee and chairman of the nomination committee)
Jacob Kastrup (employee elected)
Lars Holmqvist (member of the remuneration committee)
Andreas Slyngborg Holst (employee elected)
Anders Gersel Pedersen (chairman of the scientific committee, member of the remuneration committee)
Jakob Riis (chairman of the audit committee)
Lene Skole (member of the audit committee and the nomination committee)
Katja Barnkob Thalund (employee elected)
Per Valstorp (member of the audit committee)

As of February 7, 2017, the members of ALK’s board of management are:[2]
Carsten Hellmann (President and Chief Executive Officer)
Henrik Jacobi (Executive Vice President, Research and Development)
Søren Niegel (Executive Vice President, Commercial Operations)
Flemming Pedersen (Chief Financial Officer and Executive Vice President)
Helle Skov, Executive Vice President, Product Supply

Operations

ALK employs 2,300 people worldwide.[2] The company’s global headquarters and its main research and development center are on the Scion DTU science and technology park in Hørsholm, Denmark, in the Capital Region of Denmark.

The company is present in 32 countries, either directly or via partnerships, and works with distributors in a number of other markets.[2]

Other ALK facilities include:

Products

Allergy immunotherapy products account for 89% of ALK’s revenues[2] and comprise three types of product:

  • Sublingual immunotherapy tablets (SLIT-tablets) covering grass pollen, ragweed pollen and house dust mite allergies.
  • Sublingual immunotherapy drops (SLIT-drops). A droplet-based allergy vaccine marketed under various brand names and covering approximately 40 different allergens and combinations of allergens, including pollens, molds, mites and pets.[5]
  • Subcutaneous immunotherapy (SCIT). An injection-based allergy vaccine marketed under various brand names and covering the most common allergens such as pollens, molds, mites, pets, bees and wasps.[6]

The aforementioned allergy immunotherapy products are purified from natural allergen sources then combined with excipients during formulation.[7]

Other ALK products include an emergency adrenaline autoinjector for people who experience anaphylaxis,[8] allergy diagnostic kits, for example, skin prick tests, and bulk allergen extracts, mostly sold in the US to allergy specialists for use in their practices.[9]

Partnerships and collaborations

From 2006 until 2016, ALK had a strategic alliance with Merck & Co to develop and commercialize ALK’s SLIT-tablet products in the United States, Canada and Mexico, granting Merck exclusive rights to develop, market and distribute the tablets for grass pollen allergy, house dust mite allergy and ragweed allergy in those markets.[10][11] In June 2016, ALK and Merck & Co announced that the partnership would end by the end of 2016. "All rights to ALK's SLIT-tablets in North America to revert to ALK from MSD". Archived from the original on 2016-08-17. Retrieved 2016-07-31.

The company also has an alliance with Torii Pharmaceutical Co. Ltd to develop and commercialize ALK’s house dust mite allergy immunotherapy products in Japan. The agreement covers the house dust mite SLIT-tablet, an injection-based immunotherapy product, and diagnostic products for house dust mite allergy. In addition, it established a research and development collaboration to develop a SLIT-tablet product for Japanese cedar pollen allergy.[10][12]

In China, ALK had a collaboration with Eddingpharm which covered ALK’s diagnostic skin prick test for house dust mite allergy, and a subcutaneous immunotherapy (SCIT) product, also for house dust mite allergy. Under the agreement, Eddingpharm handled sales and distribution, while ALK provided medical and scientific expertise. Announced in April 2014, the collaboration was to run for an initial seven years, provided certain performance targets were met.[13] However, the agreement was terminated by ALK in 2016 in favor of a collaboration with a new distributor.[2]

ALK also has a collaboration with Abbott covering Russia and selected emerging markets, under which Abbott gains rights to distribute and commercialize ALK's SLIT-tablets for grass, ragweed, tree and house dust mite allergies.[14] The agreement with Abbott was expanded in 2016 allowing Abbott to register and sell ALK’s house dust mite SLIT-tablet in seven markets in South-East Asia: Hong Kong, Malaysia, the Philippines, Singapore, South Korea, Taiwan and Thailand.[15]

ALK also signed a collaboration with bioCSL (now name Seqirus) covering Australia and New Zealand which grants it exclusive rights to promote and sell ALK’s SLIT-tablets against house dust mite and grass pollen allergy and its adrenaline auto-injector.[16]

Sponsorships

ALK is one of the founder sponsors of the European Academy of Allergy and Clinical Immunology (EAACI).[17] It also sponsors and organizes an invitation-only biennial scientific symposium, the Symposium on Specific Allergy (SOSA).[18] Since 2000, the company has sponsored the WAO Henning Løwenstein Research Award[19] which is awarded to a young scientist who has shown excellence within the field of allergy.[20] Since 2005, the award has been made every two years. The 2013 winner received €10,000 (or an educational grant of corresponding value) and a travel grant to attend the 2013 European Academy of Allergy and Clinical Immunology (EAACI)/World Allergy Organization (WAO) Congress in Milan, Italy.

Timeline

1923: Doctor Kaj Baagøe and pharmacist Peter Barfod produce Denmark’s first pharmaceutically manufactured allergen extract at Copenhagen University Hospital (Rigshospitalet)[1]
1949: Production of allergy vaccines and diagnostics is centered at an independent unit called Allergologisk Laboratorium (Allergology Laboratory)[1]
1972: The technique to accurately identify the proteins that provoke allergies in individual patients is developed[1]
1976: The first standardized process for allergen extracts (DAS 76) is developed[1]
1978: The world's first standardized allergy immunotherapy product is launched[1]
1984: ALK begins a period of global expansion by establishing a presence in several new markets and through strategic acquisitions[1]
1990: The world's first product for sublingual immunotherapy drops (SLIT-drops) (droplets administered under the tongue) is launched[1]
1990: The PAT (Preventative Allergy Treatment) study is initiated in collaboration with leading European allergy specialists. The study finds that allergy immunotherapy decreases the risk of the development of asthma in children with allergic rhinitis[1]
1992: ALK acquires Alergia e Immunologia Abello S.A. (Abello), a Spanish company based in Madrid (with additional locations in Italy and Germany), its largest competitor at the time. Abello Pharmaceuticals was founded in 1925 by pharmacist Juan Abello Pascual and specialized in manufacturing oxygen- and alkaline-based therapeutics as well as synthetic hormones, among other processes and products.
2000: Acquires Center Laboratories, one of the leading suppliers of allergenic extracts in the U.S.
2006: The world’s first registered sublingual immunotherapy tablet (SLIT-tablet), for grass pollen allergy, is launched[1]
2007: An agreement is signed with Schering-Plough (which merged with Merck & Co. in November 2009) to develop, register and commercialize in North America a portfolio of SLIT-tablet treatments for grass, ragweed and house dust mite allergy[1]
2009: The Grazax Asthma Prevention (GAP) trial, investigating the potential for preventing the development of asthma in children and adolescents is initiated.[21]
2011: A new ALK-developed adrenaline auto-injector for the treatment of acute anaphylaxis is launched[22]
2011: An agreement with Torii Pharmaceutical Co., Ltd. to develop, register and commercialize a number of SLIT-tablet products in Japan is signed. The agreement also covers selected existing ALK products and diagnostics against house dust mite allergy. It also covers a research and development contract to develop a sublingual immunotherapy tablet against Japanese cedar pollen allergy.[1]
2014: The grass and ragweed SLIT-tablets are launched in the US.[23][24]
2014: ALK signs collaboration agreements with Eddingpharm for China and Abbott for Russia and selected emerging markets.[13][14]
2015: ALK signs a collaboration agreement with bioCSL (now Seqirus) covering Australia and New Zealand.[16]
2016: ALK expands its partnership with Abbott to cover seven markets in South-East Asia [15] and terminates its partnerships with Merck and EddingPharm.[2]
2016: The house dust mite SLIT-tablet is launched in Europe and Japan.[25][26]

Research and development

Since launching the first SLIT-tablet (for grass allergy) in 2006, ALK has been developing tablets for other allergies, including tree, ragweed and house dust mite. Its strategy is to develop more patient-friendly treatments based on the approach of 're-educating' the immune system.

Notes and references
  1. "History, ALK website". Retrieved 2013-06-27.
  2. "ALK Annual Report 2016" (PDF). Retrieved 2017-05-30.
  3. "Stallergenes Annual Report 2012". Retrieved 2013-06-17.
  4. "Jacobsen K. "From Goose Feathers to Grazax- The History of ALK"". Retrieved 2014-02-20.
  5. "Sublingual vaccines, ALK website". Retrieved 2013-06-27.
  6. "Subcutaneous vaccines, ALK website". Retrieved 2013-06-27.
  7. "Raw Materials". Retrieved 1 May 2014.
  8. "Allergy emergency treatment, ALK website". Retrieved 2013-06-27.
  9. "Allergy diagnostics, ALK website". Retrieved 2013-06-27.
  10. "Partnerships, ALK website". Retrieved 2013-06-27.
  11. "Worldwide Alliances, Merck & Co website". Archived from the original on 2015-07-07. Retrieved 2013-06-27.
  12. "Torii media release (28 January 2011)". Archived from the original on 2014-02-23. Retrieved 2014-02-20.
  13. "ALK media release (25 April 2014)". Retrieved 2014-06-12.
  14. "ALK R&D and business briefing, slide 59 (21 May 2014)" (PDF). Retrieved 2014-06-12.
  15. "ALK media release (28 January 2016)". Retrieved 2017-05-30.
  16. "ALK media release (09 February 2015)". Retrieved 2015-02-23.
  17. "Organization, EAACI website". Retrieved 2014-02-20.
  18. "Congresses, ALK website". Retrieved 2013-06-27.
  19. "Research award, ALK website". Retrieved 2014-02-20.
  20. "Former recipients, ALK website". Retrieved 2014-02-20.
  21. "ALK media release (16 November 2009)". Retrieved 2014-02-20.
  22. "ALK media release (06 September 2011)". Retrieved 2014-04-08.
  23. "Merck Media release (14 April 2014)". Retrieved 2017-05-30.
  24. "Merck Media release (17 April 2014)". Retrieved 2017-05-30.
  25. "ALK media release (27 January 2016)". Retrieved 2017-06-20.
  26. "ALK media release (28 Sep 2015)". Retrieved 2017-06-20.
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