CSL Limited

CSL Limited

Type	Public (ASX: CSL)
Industry	medicine
Founded	1994 (privatised), 1916 (government department)
Headquarters	Parkville, Melbourne, Victoria
Key people	Brian A McNamee (CEO)
Products	blood plasma, vaccines, antivenom, other laboratory and medical products
Revenue	A$3,310 million (Y.E. 30 June 2007)
Website	www.csl.com.au

CSL Limited is a global specialty biopharmaceutical company that researches, develops, manufactures and markets products to treat and prevent serious human medical conditions. Our product areas include blood plasma derivatives, vaccines, antivenom, and cell culture reagents used in various medical and genetic research and manufacturing applications.

History

Founded in 1916 the Commonwealth Serum Laboratories, an Australian government body focused on vaccine manufacture. Under the first director, Australian-born William Penfold, CSL commenced operation in the vacant Walter and Eliza Hall Institute building at the Melbourne Hospital in 1918, before moving to its purpose-built Parkville premises in the following year. After ongoing disputes with the Commonwealth Department of Health and its director, (John) Howard Cumpston, Penfold resigned in 1927 and was replaced by Frederic Morgan. Soon after Morgan's appointment, CSL was drawn into a serious public health disaster when a batch of its diphtheria toxin-antitoxin was implicated in the deaths of 12 children in what became known as the 'Bundaberg tragedy' of 1928. Although CSL's manufacturing processes were absolved, its labelling procedures were seen to be in error, leading to an enduring focus on the highest standards across the facility's production. In 1928 CSL also became involved in antivenene (antivenom) manufacture in conjunction with the snake venom research undertaken by Charles Kellaway at the Hall Institute. This led to the successful clinical testing of antivenene against tiger snake Notechis scutatus bite in 1930, and its commercial release in 1931. In 1934 the research on snake venoms was transferred from the Hall Institute to CSL under the direction of former snake showman, Tom 'Pambo' Eades. This represented the initiation of research at the Laboratories – an outcome its directors had been seeking for over a decade. The relationship with the Hall Institute continued until World War II, particularly via joint projects on viral diseases including polio and influenza coordinated by Frank Macfarlane Burnet and Esmond 'Bill' Keogh. Keogh played an important role in the establishment of penicillin production at CSL in 1944 – a critical wartime achievement.

The operation commenced plasma fractionation in 1952. Thereafter the range of antivenoms increased, including those against other snake species such as death adder (Acanthophis antarcticus) and the taipan (Oxyuranus scutellatus), plus spiders including the redback (Latrodectus hasselti) and – after much difficulty – the Sydney funnnel-web (Atrax robustus). Much of this work, including the introduction in 1962 of a polyvalent antivenom against all of the major terrestrial Australian snakes, occurred under the direction of Saul Wiener, while from 1966 until the mid-1990s, venom research was coordinated by the eccentric but dedicated Struan Sutherland.

This former Commonwealth facility was privatised as CSL Ltd in 1994. In 2000 CSL doubled its size through the purchase of a Swiss plasma company, the Bern-based ZLB Bioplasma AG. In 2004, during a period of plasma oversupply, the company expanded again with the purchase of the German medical company Aventis Behring. The company was the 2nd Australian public company to have reached a share price of over $100 per share.

Locations

The company's headquarters remain in Parkville, Victoria, an inner suburb of Melbourne. CSL Behring is headquartered in King of Prussia, Pennsylvania and has manufacturing operations in the Swiss city of Bern, in Marburg in Germany, and Kankakee, Illinois.

Ownership

CSL is a public company whose stock is traded on the Australian Securities Exchange under the stock code CSL. The company completed an Initial Public Offering in June 1994 at A$2.30 per share. Today CSL stock is part of the S&P/ASX 50 Index.

Vaccine for A/H1N1 2009 Pandemic

CSL's vaccine for Swine Flu was approved in September 2009 for use in Australia by people aged 10 and over.^[1] The federal government ordered 21 million doses of vaccine for 2009 A/H1N1 of which 8 million were manufactured by CSL. The Australian government intends to use the CSL Vaccine in one of the largest national vaccine programs in the country's history.

Products

CSL Limited's products can be separated by company division.

Some of the key products produced by each division, have included:

CSL Vaccines

Vaccines

• ADT (acellular diphtheria/tetanus vaccine)
• Comvax (Haemophilus influenzae type B/hepatitis B vaccine)
• Fluvax (influenza vaccine)
• Gardasil (a human papilloma virus vaccine which gained TGA approval in June 2006)
• H-B Vax II (hepatitis B vaccine)
• Liquid PedVaxHIB (Haemophilus influenzae type B vaccine)
• Menjugate (meningococcus group C vaccine)
• Meruvax II (rubella vaccine)
• M-M-R II (MMR vaccine)
• Panvax (H5N1 influenza vaccine)
• Panvax H1N1 (2009 A/H1N1 influenza vaccine)
• Plague vaccine (Yersinia pestis vaccine)
• Pneumovax 23 (pneumococcus vaccine)
• Q Vax (Coxiella burnetii vaccine)
• Tet-Tox (tetanus vaccine)
• Vaqtar (hepatitis A vaccine)
• Varivax (varicella zoster vaccine)

Antivenoms

• Black snake
• Box jellyfish
• Brown snake
• Death adder
• Funnel web spider
• Polyvalent snake antivenom
• Redback spider
• Sea snake
• Stonefish
• Taipan
• Tick
• Tiger snake

CSL Biotherapies

• Angiomax (bivalirudin) – licenced from The Medicines Company
• Austrapen (ampicillin)
• BenPen (benzylpenicillin)
• Burinex (bumetanide) – licenced from LEO Pharma
• Daivonex (calcipotriol) – licenced from LEO Pharma
• Daivobet (calcipotriol/betamethasone) – licenced from LEO Pharma
• EpiPen (epinephrine autoinjector) – licenced from Dey Laboratories
• Flomaxtra (tamsulosin) – licenced from Astellas Pharma
• Flopen (flucloxacillin)
• Fucidin (fusidic acid) – licenced from LEO Pharma
• Minijet system – preparations include: epinephrine, atropine, calcium chloride, furosemide, glucose, lidocaine, naloxone, sodium bicarbonate
• Modavigil (modafinil) – licenced from Cephalon
• Solaraze (diclofenac sodium in hyaluronic acid – licensed from Almirall
• Tramal (tramadol) – licenced from Grünenthal
• Vaniqa (eflornithine) – licensed from Almirall

CSL Behring

Immunology:

• Hizentra®,Human normal immunoglobulin. Liquid 20% immunoglobulin solution, ready-to-use for subcutaneous administration
• Privigen®, human polyvalent immunoglobulin, liquid 10% solution for intravenous injection
• Vivaglobin®, human normal immunoglobulin, liquid 16% solution for subcutaneous administration
• Carimune® NF, Sandoglobulin®, Sanglopor® human normal immunoglobulin, freeze-dried formulations for intravenous administration
• Sandoglobulin ® NF Liquid, Redimune®, Redimune® NF Liquid, human normal immunoglobulin, liquid 12% solution for intravenous administration
• Rhophylac® human anti-D immunoglobulin. Prefilled syringes of highly purified anti-Rhesus factor D IgG for intravenous administration and intramuscular injection.
• Cytogam®, human cytomegalovirus immunoglobulin. Liquid immunoglobulin containing a standardized amount of antibody to cytomegalovirus.
• Berirab® P, human rabies immunoglobulin, liquid 16% solution for intramuscular injection
• Beriglobin® P, human hepatitis A immunoglobulin, liquid 16% solution for intramuscular injection
• Hepatitis B Immunoglobulin P Behring, human hepatitis B immunoglobulin, liquid 16% solution for intramuscular injection
• Tetagam® P, human tetanus immunoglobulin, liquid 16% solution for intramuscular injection
• Varicellon® P, human varicella immunoglobulin, liquid 16% solution for intramuscular injection
• Rhesogamma® P, human anti-D immunoglobulin. Prefilled syringes of highly purified anti-Rhesus factor D IgG for intravenous administration and intramuscular injection.

Coagulation/Bleeding Disorders:

• Beriate®, freeze-dried human coagulation factor VIII concentrate
• Berinin® P, freeze-dried human coagulation factor IX concentrate
• Helixate® FS and Helixate® NexGen, freeze-dried recombinant coagulation factor VIII
• Humate-P® and Haemate® P, freeze-dried human coagulation factor VIII: C and von Willebrand factor concentrate
• Monoclate P®, a freeze-dried monoclonal antibody purified human coagulation factor VIII concentrate
• Mononine®, a freeze-dried human coagulation factor IX that has been purified using monoclonal antibodies
• Stimate®, a synthetic desmopressin acetate nasal spray
• Factor X P Behring, a freeze-dried human coagulation factor IX and factor X concentrate
• Fibrogammin® P and Corifact™, freeze-dried human coagulation factor XIII concentrate
• Octostim®, a synthetic desmopressin acetate nasal spray

Pulmonary:

• Zemaira®, freeze-dried Human Alpha₁-proteinase inhibitor (A₁-PI)

Critical Care:

• Beriplex® P/N, freeze-dried human prothrombin complex concentrate
• Haemocomplettan® P, RiaSTAP™, freeze-dried human fibrinogen (factor I) concentrate
• Kybernin® P, freeze-dried human antithrombin III concentrate
• AlbuRx®, Alburex, Human Albumin Behring, Albuminar® 25, human albumin solution (5%, 20% or 25% human albumin solutions)
• Berinert® P, freeze-dried human C₁-esterase inhibitor (C1-INH) concentrate
• Streptase®, freeze-dried streptokinase

Wound Healing:

• Beriplast® P Combi-Set, fibrin sealant kit, freeze-dried fibrin sealant for topical application
• Fibrogammin® P, freeze-dried human coagulation factor XIII concentrate
• TachoComb®, fibrin sealant fleece-type, fleece-type collagen preparations coated with fibrin glue components

(Note: Product availability varies from country to country, depending on registration status.)

^[2]

CSL Bioplasma

• Albumex (serum albumin)
• Biostate (Factor VIII)
• Carimune, which is immunoglobulin for intravenous administration (IGIV)
• CMV Immunoglobulin-VF (cytomegalovirus immunoglobulin)
• Helixate, which is recombinant Antihemophilic Factor, a blood-clotting factor for the treatment of haemophilia
• Hepatitis B immunoglobulin
• human immunoglobulin – Intragam P, Normal, Rh(D) Immunoglobulin-VF, Sandoglobulin,
• MonoFIX-VF (Factor IX)
• Prothrombinex-HT (prothrombin complex)
• Tetanus Immunoglobulin-VF
• Thrombotrol-VF (antithrombin III)
• Vivaglobin, sub-cutaneous human immune globulin indicated for the treatment of primary immunodeficiency. This product gained FDA approval in January 2006.
• Von Willebrand factor
• Rhophylac (Rh(D) immunoglobulin G)
• Zoster Immunoglobulin-VF (varicella zoster immunoglobulin)

See also

• Australian Red Cross Blood Service

References

• AH Brogan, Committed to Saving Lives: a History of the Commonwealth Serum Laboratories (Melbourne: Hyland House, 1990).
• Dando McCredie, The Fight Against Disease and CSL's Seventy Year Contribution (Richmond: Dando McCredie, c.1986).
• FG Morgan, 'The Commonwealth Serum Laboratories and their work', Collected Proceedings of the Society of Chemical Industry of Victoria, XXXV (1935), 1015–31.
• WJ Penfold, 'The Commonwealth Serum Laboratories', Medical Journal of Australia, 1 (14 April 1923), 396–400.
• Struan K Sutherland, A Venomous Life: the Autobiography of Professor Struan Sutherland (Melbourne: Hyland House, 1998).

Notes

1. ^ "Panvax H1N1 Approval For Registration For Use in Australia by Therapeutic Goods Administration". Melbourne, Australia: CSL Limited. 18 September 2009. Archived from the original on 18 September 2009. http://www.webcitation.org/5jt4RxSfr. Retrieved 26 September 2009. "CSL Biotherapies, a subsidiary of CSL Limited, Australia's leading biopharmaceutical company, can today confirm that its vaccine against the pandemic (H1N1) 200 influenza or 'swine flu' has been approved registration for use in people aged 10 years and over." 
2. ^ http://cslbehring.com/docs/555/221/Global%20Product%20Portfolio_03.11.10.pdf