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September 04, 2015 3:28 AM ET

Pharmaceuticals

Company Overview of bioCSL Inc.

Company Overview

bioCSL Inc. manufactures and supplies flu vaccines. The company offers AFLURIA, an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. It provides flu vaccine to Australia, New Zealand, and various countries in Europe, South America, and Asia. The company’s products are available through a network of distributors. bioCSL Inc. was formerly known as CSL Biotherapies, Inc. and changed its name to bioCSL Inc. The company was founded in 1968 and is based in King of Prussia, Pennsylvania. bioCSL Inc. operates as a subsidiary of CSL Ltd.

1020 First Avenue

King of Prussia, PA 19406

United States

Founded in 1968

Phone:

610-878-4000

Fax:

610-878-4009

Key Executives for bioCSL Inc.

Chief Executive Officer, Managing Director and Executive Director
Age: 58
Director and President of CSL Behring
Age: 66
Executive Vice President
Age: 58
Group General Counsel
Age: 54
Director of Public Relations & Communications
Compensation as of Fiscal Year 2015.

bioCSL Inc. Key Developments

ALK and Biocsl Enter into a Partnership

ALK and bioCSL announce a partnership in Australia and New Zealand which grants bioCSL exclusive rights to promote and sell ALK's SLIT-tablets against house dust mite and grass pollen allergy, and ALK's Jext(r) adrenaline auto-injector. ALK and bioCSL have entered into a long-term partnership covering three ALK products in Australia and New Zealand. The agreement grants bioCSL exclusive rights in Australia and New Zealand to ALK's sublingual allergy immunotherapy tablets (SLIT-tablets) for house dust mite (HDM) allergy and grass pollen allergy (marketed as GRAZAX(r) in Europe and GRASTEK(r) in North America), and its adrenaline auto-injector, Jext(r). ALK will be responsible for product supply and bioCSL will undertake registration and commercialisation of the products. As part of the agreement, ALK will receive a minor upfront payment of an undisclosed amount, followed by a milestone payment upon approval of the HDM SLIT-tablet in Australia. ALK will sell products to bioCSL at a pre-agreed price structure ensuring a certain split of the final in-market revenues generated by bioCSL. The partnership with bioCSL advances ALK's strategy of broadening its geographical presence through partnerships, acquisitions or by establishing its own affiliates.

bioCSL Inc. Completes 2014-15 Flu Season Shipment of AFLURIA(R)

bioCSL Inc. announced that it has completed shipment of 16.2 million doses of AFLURIA(R) (Influenza Vaccine) for the 2014-2015 season and is now sold out. The Company's distribution of 16.2 million doses represents a 45% increase in doses compared with the 2013-14 flu season for AFLURIA(R). bioCSL's shipments of AFLURIA(R) influenza vaccine were comprised of pre-filled syringe presentations and multi-dose vials, which are approved for use with a needle and syringe or with the PharmaJet(R) Stratis(R) Needle-Free Injection System. AFLURIA(R), influenza vaccine, is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. Administration of AFLURIA with a needle and syringe is approved for use in persons 5 years of age and older. Administration of AFLURIA with the PharmaJet(R) Stratis(R) Needle-Free Injection System is approved for use in persons 18 through 64 years of age only. AFLURIA is contraindicated in individuals with known severe allergic reactions (eg, anaphylaxis) to any component of the vaccine including egg protein, or to a previous dose of any influenza vaccine. Administration of CSL's 2010 Southern Hemisphere influenza vaccine was associated with postmarketing reports of increased rates of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years; these increased rates were confirmed by postmarketing studies. Febrile events were also observed in children 5 to less than 9 years of age. If Guillain-Barré Syndrome (GBS) has occurred within 6 weeks of previous influenza vaccination, the decision to give AFLURIA should be based on careful consideration of the potential benefits and risks. If AFLURIA is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the immune response may be diminished. AFLURIA should be given to a pregnant woman only if clearly needed. AFLURIA has not been evaluated in nursing mothers. It is not known whether AFLURIA is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when AFLURIA is administered to a nursing woman. Antibody responses in persons 65 years of age and older were lower after administration of AFLURIA as compared to younger adult subjects. In children 5 through 17 years of age, most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were pain, redness, and swelling. The most common systemic adverse events were headache, myalgia, irritability, malaise, and fever. In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness, pain, swelling, and redness, itching. The most common systemic adverse reactions observed were muscle aches, headache and malaise. In adults 18 through 64 years of age, the most common injection-site adverse reactions observed in clinical studies with AFLURIA when administered by the PharmaJet Stratis Needle-Free Injection System up to 7 days post-vaccination were tenderness, swelling, pain, redness, itching and bruising. The most common systemic adverse events within this period were myalgia, malaise, and headache. In adults 65 years of age and older, the most common injection-site adverse reactions observed in clinical studies of AFLURIA when administered by needle and syringe were tenderness and pain. Vaccination with AFLURIA may not protect all individuals.

bioCSL, Inc. to Supply U.S. Market with 16.5 Million Doses

bioCSL Inc. announced it has commenced shipping its seasonal influenza vaccine AFLURIA (Influenza Vaccine) for the 2014-2015 flu season. U.S. providers who ordered AFLURIA may be able to begin vaccinating as early as this month. bioCSL Inc. will deliver about 16.5 million doses of the 2014-2015 formulation of AFLURIA, with approximately 75% of doses in thimerosal-free pre-filled syringes.

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