ALK Abelló

History

ALK-Abello dates back to 1923 when Denmark’s first allergen extracts were produced at the pharmacy of the Copenhagen University Hospital. The company was established as Allergologisk Laboratorium København by Dr. Barfod in 1928. 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 1978, ALK released the first standardized line of products for the treatment of allergies. 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, Grazax, was launched in 2006, becoming the first SLIT-tablets to be proven effective in the treatment of hay fever, or more specifically “showing a disease-modifying effect on grass pollen-induced allergic rhinoconjunctivitis.” A SLIT-tablet for ragweed allergy was launched in 2014. 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 12 March 2015, the current members of ALK’s board of directors are:
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)
Katja Barnkob Thalund (employee elected)
Per Valstorp (member of the audit committee)

As of 13 February 2015, the members of ALK’s board of management are:
Jens Bager (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, Finance, Information Technology, Investor Relations and Business Development)
Helle Skov, Executive Vice President, Product Supply

Operations

ALK employs 1,844 people worldwide. 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 has subsidiaries in Austria, Canada, Denmark (which also serves as the headquarters for the Nordic region), France, Germany, Italy, the Netherlands, Poland, Slovakia, Spain, Switzerland, Turkey, the United Kingdom and the United States, as well as sales offices in China, the Czech Republic, Finland, Norway and Sweden. In several other countries, including Australia, Brazil, Greece, Israel, Malaysia, Mexico, New Zealand, Portugal, South Africa, Thailand and across much of central and southern Europe, ALK products are available via distributors.

Other ALK facilities include:

Products

Allergy immunotherapy products account for 91% of ALK’s revenues and comprise three types of product:

The aforementioned allergy immunotherapy products are purified from natural allergen sources harvested in the US branch of ALK's raw materials production facility, then combined with excipients during formulation.

Other ALK products include an emergency adrenaline autoinjector for patients who experience anaphylaxis, marketed under the brand name Jext, allergy diagnostic kits, for example, skin prick tests, marketed under various brand names including Soluprick SQ, and bulk allergen extracts, mostly sold in the USA to allergy specialists for use in their practices.

Partnerships and collaborations

ALK has a strategic alliance with Merck & Co to develop and commercialize ALK’s SLIT-tablet products in the United States, Canada and Mexico. The alliance grants Merck exclusive rights to develop, market and distribute the tablets for grass pollen allergy, house dust mite allergy and ragweed allergy in those markets. Grass SLIT-tablets have been approved and launched in the US and Canada under the trade name Grastek, while ragweed SLIT-tablets have been approved and launched in the US and Canada under the trade name Ragwitek. In June 2016 ALK and Merck & Co reported that the partnership will end by the end of 2016. The reason of the termination of the strategic alliance goes back to the missing market success of the tablet program in the USA. Due to the ending of the strategic alliance ALK won't receive further 290 million Euro in milestone payments, which are needed for the clinical development program of the tablet immunotherapy. "All rights to ALK's SLIT-tablets in North America to revert to ALK from MSD". 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 for asthma and allergic rhinitis in Japan. The agreement also covers injection-based immunotherapy product, Alutard, and diagnostic products for house dust mite allergy. In addition, it establishes a research and development collaboration to develop a SLIT-tablet product for Japanese cedar pollen allergy.

In China, ALK has a collaboration with Eddingpharm which covers ALK’s diagnostic skin prick test, Soluprick SQ, for house dust mite allergy, and the subcutaneous immunotherapy (SCIT) product, Alutard SQ, also for house dust mite allergy. Under the agreement, Eddingpharm handles sales and distribution, while ALK provides medical and scientific expertise. Announced in April 2014, the collaboration runs for an initial seven years, provided certain performance targets are met.

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, and a collaboration with bioCSL which grants it exclusive rights to promote and sell ALK’s SLIT-tablets against house dust mite and grass pollen allergy and the Jext adrenaline auto-injector.

Sponsorships

ALK is one of the founder sponsors of the European Academy of Allergy and Clinical Immunology (EAACI). It also sponsors and organizes an invitation-only biennial scientific symposium, the Symposium on Specific Allergy (SOSA). Since 2000, the company has sponsored the WAO Henning Løwenstein Research Award which is awarded to a young scientist who has shown excellence within the field of allergy. 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 Poul Barfod produce Denmark’s first pharmaceutically manufactured allergen extract at Copenhagen University Hospital (Rigshospitalet)
1949: Production of allergy vaccines and diagnostics is centered at an independent unit called Allergologisk Laboratorium (Allergology Laboratory)
1972: The technique to accurately identify the proteins that provoke allergies in individual patients is developed
1976: The first standardized process for allergen extracts (DAS 76) is developed
1978: The world's first standardized allergy immunotherapy product under the Alutard SQ brand (SQ is short for Standardized Quality) is launched
1984: ALK begins a period of global expansion by establishing a presence in several new markets and through strategic acquisitions
1990: The world's first product for sublingual immunotherapy drops (SLIT-drops) (droplets administered under the tongue) is launched
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
1992: ALK acquires "Alergia e Immunologia Abello S.A." Abello, the 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: Grazax, the world’s first registered sublingual immunotherapy tablet (SLIT-tablet) is launched
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
2009: The disease modifying effect of Grazax is recognized by regulatory authorities in Europe
2009: The Grazax Asthma Prevention (GAP) trial, investigating the potential of Grazax in preventing the development of asthma in children and adolescents is initiated. Results are expected in 2015
2011: Jext, a new ALK-developed adrenaline auto-injector for the treatment of acute anaphylaxis is launched
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.
2013: ALK's partner Merck files applications to market grass and ragweed SLIT-tablets in the US.
2014: ALK signs collaboration agreements with Eddingpharm for China and Abbott for Russia and selected emerging markets.
2015: A collaboration with bioCSL adds Australia and New Zealand to ALK’s global footprint.

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.