07.11.16
Headquarters: London, UK
twitter.com/astrazeneca
www.astrazeneca.com
Headcount: 61,500
Year Established: 1999
Revenues: $24,708 (-5%)
Net Income: $2,826 (+129%)
R&D: $5,997 (+7%)
TOP SELLING DRUGS
Continuing to support is growing biologics portfolio, AstraZeneca, which reported sales of $24.7 billion in 2015, made several significant transactions during the year to bolster its biologics growth strategy. The company laid out plans to invest approximately $285 million in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden. The new plant will be focused on filling and packaging of protein therapeutics. It is anticipated that the new facility will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm, from the end of 2018, and will deliver finished products for commercial use once fully operational by 2019.
Södertälje is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organization.
Biotech medicines make up 50% of the company’s pipeline with more than 120 ongoing programs, including more than 30 in clinical development. The new manufacturing facility in Sweden will support the progression of drug candidates across the main therapy areas and be aligned with investments being made in the current biologics manufacturing centers, such as the expansion in Frederick, MD, announced in November 2014.
Expanding its biologics footprint further, AstraZeneca purchased a high-tech biologics bulk manufacturing facility from Amgen, growing its biologics manufacturing capability in the U.S. The Lake Center facility, located in Boulder, CO, is expected to be operational and licensed for commercial production by late 2017. Down the road, the company said this site will eventually double the biologics manufacturing capacity in the U.S. to accommodate its maturing pipeline.
Further supporting its push into biologics, AstraZeneca, through MedImmune, entered into a license agreement and collaboration with Inovio Pharmaceuticals, a biotechnology company developing DNA-based immunotherapies for cancer and infectious diseases. MedImmune acquired exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in Phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumours. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.
MedImmune made an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales. MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumour-specific T-cells.
During the year MedImmune also formed a strategic alliance with WuXi AppTec to bring research and technical capability for biologics to China. AstraZeneca will have the option to acquire WuXi’s biologics manufacturing facility in Wuxi city in the next few years. Prior to that, WuXi Biologics remains the exclusive partner for R&D manufacturing for MedImmune’s innovative biologics in China. The alliance builds on the existing joint venture between the companies formed in 2012 to develop and commercialize MEDI5117, a biologic for autoimmune and inflammatory diseases. The IND application was subsequently accepted by CFDA for review in March 2015.
WuXi will continue manufacturing for the program at its cGMP facilities. WuXi is building its largest biomanufacturing facility using 14 2000L and two 1000L disposable bioreactors to support late-phase clinical and commercial manufacturing. The first phase of the facility will be operational in January 2017.
AstraZeneca also formed a three-year collaboration with Orca Pharmaceuticals, a UK-based biopharmaceutical company, to develop inhibitors of retinoic acid–related orphan nuclear receptor gamma (RORγ). Inhibitors of this receptor are believed to have potential against a wide range of autoimmune diseases for which there is currently no safe, orally available and effective treatment.
RORγ plays a key role in the immune system. Specifically, it helps to convert a population of immune cells called CD4+ T cells into T-helper 17 (TH17) cells, which, in turn, produce chemicals (cytokines) that drive the immune response. However, excessive activity of TH17 cells and other RORγ+ immune cells have been implicated in a wide range of autoimmune conditions such as inflammatory bowel disease, psoriasis, arthritis and multiple sclerosis.
AstraZeneca gains access to RORγ inhibitors developed by Orca Pharmaceuticals and will integrate these into its in-house program. Working together, scientists from AstraZeneca and Orca Pharmaceuticals will identify lead compounds from this program for progression and characterize the autoimmune condition to which the lead compounds are best suited. Orca Pharmaceuticals received an upfront payment with potential future milestone payments from AstraZeneca dependent on the success of their RORγ inhibitors in the program with a potential total value of $122.5 million. AstraZeneca has the option to acquire the Orca compounds at the end of the collaboration.
AstraZeneca formed some other collaborations of note in 2015. Together with Pelago Bioscience AB, it entered into a 2-year strategic research collaboration and license agreement. The companies will collaborate on specified joint projects and AstraZeneca will also be granted a license to use and apply the Cellular Thermal Shift Assay (CETSA) for determination and quantification of drug–target interactions in other AstraZeneca discovery projects.
Peregrine Pharmaceuticals expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca to include a second, late-stage trial. The companies will now evaluate the combination of Peregrine’s phosphatidylserine (PS)-targeted immune-activator, bavituximab, and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in a global Phase II study in previously treated squamous or non-squamous non-small cell lung cancer (NSCLC). Peregrine will conduct the randomized Phase II trial.
Valeant Pharmaceuticals’ affiliate entered into a collaboration agreement with AstraZeneca under which Valeant was granted an exclusive license to develop and commercialize brodalumab, an IL-17 receptor monoclonal antibody in development for moderate-to-severe plaque psoriasis and psoriatic arthritis.
Lastly, Charles River Laboratories and AstraZeneca extended their initial three-year partnership for an additional five-year period through 2020. Charles River retains its position as AstraZenca’s preferred strategic partner for outsourced regulated safety assessment and development DMPK (drug metabolism and pharmacokinetics).
twitter.com/astrazeneca
www.astrazeneca.com
Headcount: 61,500
Year Established: 1999
Revenues: $24,708 (-5%)
Net Income: $2,826 (+129%)
R&D: $5,997 (+7%)
TOP SELLING DRUGS
Drug | Indication | 2015 Sales | (+/-%) |
Crestor | cholesterol | $5,017 | -9% |
Symbicort | asthma | $3,394 | -11% |
Nexium | acid reflux | $2,496 | -32% |
Seroquel XR | anti-psychotic | $1,025 | -16% |
Pulmicor | asthma | $1,014 | 7% |
Zoladex | cancer | $816 | -12% |
Onglyza | type 2 diabetes | $786 | -4% |
Seloken/Toprol-XL | hypertention | $710 | -6% |
Faslodex | breast cancer | $704 | -2% |
Synagis | RSV | $662 | -26% |
Continuing to support is growing biologics portfolio, AstraZeneca, which reported sales of $24.7 billion in 2015, made several significant transactions during the year to bolster its biologics growth strategy. The company laid out plans to invest approximately $285 million in a new high-tech facility for manufacturing of biological medicines in Södertälje, Sweden. The new plant will be focused on filling and packaging of protein therapeutics. It is anticipated that the new facility will supply medicines for clinical trial programs of AstraZeneca and MedImmune, the company’s global biologics research and development arm, from the end of 2018, and will deliver finished products for commercial use once fully operational by 2019.
Södertälje is currently home to AstraZeneca’s largest global tablets and capsules manufacturing facility and is also a launch platform site for the company, with specialist capabilities on-site that allow large-scale production of new medicines, working closely with the research and development organization.
Biotech medicines make up 50% of the company’s pipeline with more than 120 ongoing programs, including more than 30 in clinical development. The new manufacturing facility in Sweden will support the progression of drug candidates across the main therapy areas and be aligned with investments being made in the current biologics manufacturing centers, such as the expansion in Frederick, MD, announced in November 2014.
Expanding its biologics footprint further, AstraZeneca purchased a high-tech biologics bulk manufacturing facility from Amgen, growing its biologics manufacturing capability in the U.S. The Lake Center facility, located in Boulder, CO, is expected to be operational and licensed for commercial production by late 2017. Down the road, the company said this site will eventually double the biologics manufacturing capacity in the U.S. to accommodate its maturing pipeline.
Further supporting its push into biologics, AstraZeneca, through MedImmune, entered into a license agreement and collaboration with Inovio Pharmaceuticals, a biotechnology company developing DNA-based immunotherapies for cancer and infectious diseases. MedImmune acquired exclusive rights to Inovio’s INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in Phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumours. These HPV types are responsible for more than 70 percent of cervical pre-cancers and cancers.
MedImmune made an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales. MedImmune intends to study INO-3112 in combination with selected immunotherapy molecules within its pipeline in HPV-driven cancers. Emerging evidence suggests that the benefits from immuno-oncology molecules, such as those in MedImmune’s portfolio, can be enhanced when they are used in combination with cancer vaccines that generate tumour-specific T-cells.
During the year MedImmune also formed a strategic alliance with WuXi AppTec to bring research and technical capability for biologics to China. AstraZeneca will have the option to acquire WuXi’s biologics manufacturing facility in Wuxi city in the next few years. Prior to that, WuXi Biologics remains the exclusive partner for R&D manufacturing for MedImmune’s innovative biologics in China. The alliance builds on the existing joint venture between the companies formed in 2012 to develop and commercialize MEDI5117, a biologic for autoimmune and inflammatory diseases. The IND application was subsequently accepted by CFDA for review in March 2015.
WuXi will continue manufacturing for the program at its cGMP facilities. WuXi is building its largest biomanufacturing facility using 14 2000L and two 1000L disposable bioreactors to support late-phase clinical and commercial manufacturing. The first phase of the facility will be operational in January 2017.
AstraZeneca also formed a three-year collaboration with Orca Pharmaceuticals, a UK-based biopharmaceutical company, to develop inhibitors of retinoic acid–related orphan nuclear receptor gamma (RORγ). Inhibitors of this receptor are believed to have potential against a wide range of autoimmune diseases for which there is currently no safe, orally available and effective treatment.
RORγ plays a key role in the immune system. Specifically, it helps to convert a population of immune cells called CD4+ T cells into T-helper 17 (TH17) cells, which, in turn, produce chemicals (cytokines) that drive the immune response. However, excessive activity of TH17 cells and other RORγ+ immune cells have been implicated in a wide range of autoimmune conditions such as inflammatory bowel disease, psoriasis, arthritis and multiple sclerosis.
AstraZeneca gains access to RORγ inhibitors developed by Orca Pharmaceuticals and will integrate these into its in-house program. Working together, scientists from AstraZeneca and Orca Pharmaceuticals will identify lead compounds from this program for progression and characterize the autoimmune condition to which the lead compounds are best suited. Orca Pharmaceuticals received an upfront payment with potential future milestone payments from AstraZeneca dependent on the success of their RORγ inhibitors in the program with a potential total value of $122.5 million. AstraZeneca has the option to acquire the Orca compounds at the end of the collaboration.
AstraZeneca formed some other collaborations of note in 2015. Together with Pelago Bioscience AB, it entered into a 2-year strategic research collaboration and license agreement. The companies will collaborate on specified joint projects and AstraZeneca will also be granted a license to use and apply the Cellular Thermal Shift Assay (CETSA) for determination and quantification of drug–target interactions in other AstraZeneca discovery projects.
Peregrine Pharmaceuticals expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca to include a second, late-stage trial. The companies will now evaluate the combination of Peregrine’s phosphatidylserine (PS)-targeted immune-activator, bavituximab, and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in a global Phase II study in previously treated squamous or non-squamous non-small cell lung cancer (NSCLC). Peregrine will conduct the randomized Phase II trial.
Valeant Pharmaceuticals’ affiliate entered into a collaboration agreement with AstraZeneca under which Valeant was granted an exclusive license to develop and commercialize brodalumab, an IL-17 receptor monoclonal antibody in development for moderate-to-severe plaque psoriasis and psoriatic arthritis.
Lastly, Charles River Laboratories and AstraZeneca extended their initial three-year partnership for an additional five-year period through 2020. Charles River retains its position as AstraZenca’s preferred strategic partner for outsourced regulated safety assessment and development DMPK (drug metabolism and pharmacokinetics).