Industry | pharmaceutical industry; contract manufacturing industry |
---|---|
Founded | 1984Winnipeg, Manitoba, Canada | in
Defunct | 2014 |
Fate | Acquired by Emergent BioSolutions |
Divisions | Cangene bioPharma (CMO) |
Cangene Corporation was a biopharmaceutical company based in Winnipeg, Manitoba, Canada. It was founded in 1984 and specialized in hyperimmunes, contract manufacturing, biopharmaceuticals and biodefense. Cangene was 61% owned by Canadian pharmaceutical giant Apotex and was publicly listed on the TSX under the symbol CNJ.
Cangene's business model shifted several times during its existence. There is some consensus that the company came to rely on revenue from United States stockpiling and bioterrorism contracts and did not adequately prepare for the disappearance of this revenue. [1] At one point, the company attempted a shift away from contract manufacturing to research & development, but abandoned this track after about two years and subsequently moved to marketing of ready-for-launch products developed by other companies. [1]
Cangene was founded in 1984 and had an employee count of 650 in 2004. [2] In 2009, the number of personnel in the Winnipeg facilities alone was 550, with another 100 in Cangene bioPharma, 35 in its sales force, and about 100 across its plasma collection facilities. [1] By the end of 2011, the overall number of employees was about 700, but significant cuts in personnel were conducted early in 2012. [1] [3] Such cuts were a continuation of a set of personnel reductions which began in mid-2010. [4]
In 2010, Cangene obtained United States distribution rights for WinRho from Baxter, which had held them since 2005. [5] This was in part to counter declining sales of the product under Baxter, but also as part of the corporate strategy, which called for development its own IVIG product. [6] As both WinRho and the newly conceived product were dependent upon human plasma as source material, Cangene expanded their plasma collection facilities in 2010. [6]
Development of the new IVIG product was subsequently cancelled in 2012, representing a strategic turn away from R&D toward marketing in an attempt to return to profitability. [1] Decline in profitability had come in part due to decreased cash flow from a US$ 500,000,000 bioterrorism-related program of work with the U.S. Biomedical Advanced Research and Development Authority. [1]
In 2012, the company obtained exclusive United States distribution rights for Episil. [1]
In 2013, the company purchased rights to development and commercialization of three drug candidates, recombinant blood clotting factors VIIa, VIII and IX, the latter of which is in clinical trials. [7]
In February 2014, the company was acquired by Emergent BioSolutions. [8]
As of 2010, Paul Brisebois served as the company's vice president for commercial development. [5] At the time, the company was in the process of expanding its sales force and shifting focus from contract manufacturing to a "strategy to optimize our commercial assets." [5]
In 2011, the company's "longtime CEO", John Langstaff of Winnipeg, resigned and leadership went to John Sedor of Philadelphia as president and CEO. [9] [10]
Cangene's two manufacturing and plasma collection facilities were located in Winnipeg, Manitoba, Canada. [2] [10] The contract manufacturing subdivision, Celegene bioPharma, maintains facilities in Baltimore, Maryland, United States. [10] The sales and marketing office was located in Philadelphia, Pennsylvania, United States. [10] Most of the company's senior leadership were also based in Philadelphia by the time the company was sold in early 2014. [9]
As a result of their biodefense focus, Cangene had three products included in the U.S. Strategic National Stockpile: Heptavalent botulism antitoxin, Vaccinia immune globulin, Anthrax immune globulin. [10] 2012 revenue from the biodefense products amounted to US$ 50,000,000. [10] Cangene also had four approved commercial specialty products: WinRho, HepaGam B, VARIZIG, and episil. [10] 2012 commercial product revenue was US$ 44,000,000, while their contract manufacturing revenue was US$ 33,000,000. [10]
Cangene bioPharma is the Baltimore-based contract manufacturing division of Cangene. [11] As of November 2010, Cangen bioPharma had 100 employees in two facilities, [2] and 30 customers. [11]
From May 2008 to at least November 2010, Cangene bioPharma supplied assembled Fusilev product to Spectrum Pharmaceuticals under a supply agreement. [11] The agreement was slated to end in May 2013. [11]
Blood plasma is a light amber-colored liquid component of blood in which blood cells are absent, but which contains proteins and other constituents of whole blood in suspension. It makes up about 55% of the body's total blood volume. It is the intravascular part of extracellular fluid. It is mostly water, and contains important dissolved proteins, glucose, clotting factors, electrolytes, hormones, carbon dioxide, and oxygen. It plays a vital role in an intravascular osmotic effect that keeps electrolyte concentration balanced and protects the body from infection and other blood-related disorders.
Baxter International Inc. is an American multinational healthcare company with headquarters in Deerfield, Illinois.
Sarepta Therapeutics, Inc. is a medical research and drug development company with corporate offices and research facilities in Cambridge, Massachusetts, United States. Incorporated in 1980 as AntiVirals, shortly before going public the company changed its name from AntiVirals to AVI BioPharma soon with stock symbol AVII and in July 2012 changed name from AVI BioPharma to Sarepta Therapeutics and SRPT respectively. As of 2023, the company has four approved drugs.
The Biodefense and Pandemic Vaccine and Drug Development Act of 2005, nicknamed "Bioshield Two" and sponsored by Senator Richard Burr, aims to shorten the pharmaceutical development process for new vaccines and drugs in case of a pandemic, and to protect vaccine makers and the pharmaceutical industry from legal liability for vaccine injuries. The proposed bill would create a new federal agency, the Biomedical Advanced Research and Development Agency (BARDA), that would act "as the single point of authority" to promote advanced research and development of drugs and vaccines in response to bioterrorism and natural disease outbreaks, while shielding the agency from public Freedom of Information Act (FOIA) requests. BARDA would be exempt from long-standing open records and meetings laws that apply to most government departments.
Rho(D) immune globulin (RhIG) is a medication used to prevent RhD isoimmunization in mothers who are RhD negative and to treat idiopathic thrombocytopenic purpura (ITP) in people who are Rh positive. It is often given both during and following pregnancy. It may also be used when RhD-negative people are given RhD-positive blood. It is given by injection into muscle or a vein. A single dose lasts 12 weeks. It is made from human blood plasma.
The pharmaceutical industry in India was valued at an estimated US$42 billion in 2021 and is estimated to reach $130 billion by 2030. India is the world's largest provider of generic medicines by volume, with a 20% share of total global pharmaceutical exports. It is also the largest vaccine supplier in the world by volume, accounting for more than 60% of all vaccines manufactured in the world. Indian pharmaceutical products are exported to various regulated markets including the US, UK, European Union and Canada.
Apotex Inc. is a Canadian pharmaceutical corporation. Founded in 1974 by Barry Sherman, the company is the largest producer of generic drugs in Canada, with annual sales exceeding CA$2.5 billion. By 2023, Apotex employed close to 8,000 people as Canada's largest drug manufacturer, with over 300 products selling in over 115 countries. Apotex manufactures and distributes generic medications for a range of diseases and health conditions that include cancer, diabetes, high cholesterol, glaucoma, infections and blood pressure.
Actavis Generics is a global pharmaceutical company focused on acquiring, developing, manufacturing and marketing branded pharmaceuticals, generic and over-the-counter medicines, and biologic products. Actavis has a commercial presence across approximately 100 countries. The company has global headquarters in Dublin, Ireland and administrative headquarters in Parsippany-Troy Hills, New Jersey, United States.
Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides medical devices for biodefense purposes.
Grifols, S.A. is a Spanish multinational pharmaceutical and chemical manufacturer. Principally a producer of blood plasma-based products, a field in which it is the European leader and largest worldwide, the company also supplies devices, instruments, and reagents for clinical testing laboratories.
The Biomedical Advanced Research and Development Authority(BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases. BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA) and reports to the Office of the Assistant Secretary for Preparedness and Response (ASPR). The office manages Project BioShield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks.
Ajanta Pharma Limited, also known by the acronym APL, is a multinational company based in India engaged in development, manufacturing, and marketing of pharmaceutical formulations. It has a presence in India, the United States, and about 30 other countries in Africa, South East Asia, West Asia, and CIS. It was established in 1973.
Aspen Pharmacare Holdings Limited is a public multinational pharmaceutical company headquartered in uMhlanga, South Africa. Founded in 1997, it listed on the Johannesburg Stock Exchange (JSE) in 1998 and purchased South African Druggists in 1999 before expanding into international markets. Currently the largest pharmaceutical company in Africa through aggressive mergers and expansion, with major manufacturing sites in locations such as Gqeberha in South Africa, Bad Oldesloe in Germany, Notre-Dame-de-Bondeville in France, and Oss, Netherlands, Aspen is known for manufacturing and distributing branded pharmaceuticals as well as generic HIV/AIDS antiretrovirals (ARVs) and cancer medications. Among other products, Aspen has also been involved in manufacturing the Janssen COVID-19 vaccine through "fill and finish", and has the rights to sell the product under its own brand name Aspenovax. The company's revenue in 2022 was R38.6 billion. In 2016 Aspen was fined for high prices on cancer drugs, and after an investigation Aspen committed to reduce prices for 5 years in the European Union.
The Botulism Antitoxin Heptavalent - (Equine) – BAT, made by Emergent BioSolutions Canada Inc. – is a licensed, commercially available botulism anti-toxin that effectively neutralizes all seven known botulinum nerve toxin serotypes. It is indicated for sporadic cases of life-threatening botulism and is also stockpiled for the eventuality of botulinum nerve toxins being used in a future bioterrorist attack.
Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians. In fiscal year 2020, it generated over $3 billion in annual revenue.
Biotechnology in India is a sunrise sector within the Indian economy. Agencies of the Government of India concerned with the biotechnology industry include the Department of Biotechnology and the proposed Biotechnology Regulatory Authority of India. As of 2022, the sector is valued at $80 billion. Biotechnology in India is in a growth phase and the sector is expected to be valued at $150 billion by 2025 and surpass $300 billion in value by 2030.
Immunoglobulin therapy is the use of a mixture of antibodies to treat several health conditions. These conditions include primary immunodeficiency, immune thrombocytopenic purpura, chronic inflammatory demyelinating polyneuropathy, Kawasaki disease, certain cases of HIV/AIDS and measles, Guillain-Barré syndrome, and certain other infections when a more specific immunoglobulin is not available. Depending on the formulation it can be given by injection into muscle, a vein, or under the skin. The effects last a few weeks.
Canadian Plasma Resources (CPR) is a private, for-profit bio-pharmaceutical company and a licensed blood establishment based in Saskatoon, Saskatchewan, Canada. It was founded in 2012 and specializes in the collection of source plasma for further manufacturing and contract-manufacturing of plasma-based bio-pharmaceuticals with operations in Saskatoon (Saskatchewan), Moncton, Calgary, Edmonton (Alberta), Winnipeg (Manitoba) and administrative office in Oakville, Ontario. CPR is one of the only four establishments in Canada that are licensed to collect plasma. The others are Canadian Blood Services (CBS), Hema-Quebec and Cangene, now owned by ProMetic Life Sciences Inc.
Robert Peter Kadlec is an American physician and career officer in the United States Air Force who served as Assistant Secretary of Health and Human Services from August 2017 until January 2021. He is responsible for the creation of the COVID-19 vaccine development program Operation Warp Speed.
WuXi Biologics is a global Contract Research Development and Manufacturing Organization (CRDMO) that provides open-access, integrated technology platforms for biologics drug development.