Cetus Corporation

Last updated
Cetus Corporation
Company type Public
Nasdaq: CTUS
Industry Biotechnology
Founded1971
Defunct1991
FateMerged with Chiron Corporation
Headquarters Emeryville, California
Products Betaseron, Proleukin, PCR

Cetus Corporation was one of the first biotechnology companies. [1] It was established in Berkeley, California, in 1971, but conducted most of its operations in nearby Emeryville. Before merging with Chiron Corporation in 1991 (now a part of Novartis), it developed several significant pharmaceutical drugs as well as a revolutionary DNA amplification technique.

Contents

History

Cetus was founded in 1971 by Ronald E. Cape, Peter Farley, and Nobelist Donald A. Glaser. Its early efforts involved automated methods to select for industrial microorganisms that could produce greater amounts of chemical feedstocks, antibiotics, or vaccine components. By the late 1970s, however, three new revolutionary techniques had been developed: recombinant DNA, monoclonal antibodies, and gene expression, the foundations of the biotechnology industry. In order to enter these new fields, Cetus raised $108 million in an initial public offering (IPO) in 1981, the largest IPO to that date.

Its first large development project, in conjunction with Triton Biosciences, was the successful cloning, expression, modification, and production of beta-interferon. Unfortunately, the resultant protein did not live up to its expectations as a broad-spectrum anti-cancer drug, and only much later was it approved for use to treat symptoms of multiple sclerosis. [2] The product is now sold under the name Betaseron.

The company's flagship product was Interleukin-2 (IL-2), an important modifier of the immune system. In the early 1980s, an intense competition to clone the gene for IL-2 was underway among Cetus, Genentech, Immunex, and the Japanese researcher, Tadatsugu Taniguchi, and in 1982 Taniguchi was the first to succeed. [3] :76 By 1983 Cetus created a proprietary recombinant version of IL2 and collaborated with Steven Rosenberg to begin clinical trials. [3] :76–77 The drug showed promising effects in treating renal cancer, but also had significant side effects on patients. In 1990 the U.S. Food and Drug Administration (FDA) refused to approve the drug for clinical use, asking for additional information. [4] It wasn't until two years later, after Cetus had been sold, that IL-2 was approved. It is now distributed under the name Proleukin.

The company also had a broad effort to research and develop techniques for DNA diagnostics. Collaborations were made with Perkin-Elmer for diagnostic instruments, and with Kodak for commercial diagnostic kits. It was here that the technique of polymerase chain reaction (PCR) DNA amplification was conceived by Kary Mullis. The technique has been widely used in DNA research, forensics, and genetic disease diagnostics. Its inventor received the Nobel Prize in 1993, the only one awarded for research performed at a biotechnology company.

The delay in FDA approval for IL-2 created a major funding crisis at Cetus, which had been spending a considerable fraction of its investments to produce and test the drug. [5] [6] The company's CEO resigned six weeks later, and patent rights to the PCR process were sold to Hoffman-La Roche. Losses continued, and in 1991 the company was sold to Chiron Corporation. [7] Chiron continued the development of IL-2, which was finally approved by the FDA in 1992. Chiron also collected the scattered rights for the production of beta-interferon, which was approved for clinical use in 1993.

Related Research Articles

<span class="mw-page-title-main">Kary Mullis</span> American biochemist (1944–2019)

Kary Banks Mullis was an American biochemist. In recognition of his role in the invention of the polymerase chain reaction (PCR) technique, he shared the 1993 Nobel Prize in Chemistry with Michael Smith and was awarded the Japan Prize in the same year. PCR became a central technique in biochemistry and molecular biology, described by The New York Times as "highly original and significant, virtually dividing biology into the two epochs of before PCR and after PCR."

Samuel D. Waksal is the founder and former CEO of the biopharmaceutical company ImClone Systems. He is also the founder of Kadmon Pharmaceuticals, which was financed with private capital and commenced operations in New York City in 2010. At ImClone, Waksal led the company to develop the cancer drug Erbitux (cetuximab). During the course of its review process with the Food and Drug Administration (FDA) Waksal became involved in an insider trading scandal revolving around improper communications with personal friends and family members. He was convicted of several securities violations, served time in federal prison, and was released.

Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California, wholly owned by the Swiss multinational pharmaceutical company, the Roche Group. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche. Historically, the company is regarded as the world's first biotechnology company.

<span class="mw-page-title-main">Biogen</span> Pharmaceutical company

Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, United States specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide. Biogen operates in Argentina, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Mexico, Netherlands, Poland, Sweden, and Switzerland.

<span class="mw-page-title-main">Interferon beta-1a</span> Cytokine in the interferon family

Interferon beta-1a is a cytokine in the interferon family used to treat multiple sclerosis (MS). It is produced by mammalian cells, while interferon beta-1b is produced in modified E. coli. Some research indicates that interferon injections may result in an 18–38% reduction in the rate of MS relapses.

Daclizumab is a therapeutic humanized monoclonal antibody which was used for the treatment of adults with relapsing forms of multiple sclerosis (MS). Daclizumab works by binding to CD25, the alpha subunit of the IL-2 receptor of T-cells.

<span class="mw-page-title-main">Roche</span> Swiss multinational healthcare company

F. Hoffmann-La Roche AG, commonly known as Roche, is a Swiss multinational holding healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel. Roche is the fifth-largest pharmaceutical company in the world by revenue and the leading provider of cancer treatments globally. In 2023, the company’s seat in Forbes Global 2000 was 76.

<span class="mw-page-title-main">Interleukin 2</span> Mammalian protein found in humans

Interleukin-2 (IL-2) is an interleukin, which is a type of cytokine signaling molecule forming part of the immune system. It is a 15.5–16 kDa protein that regulates the activities of white blood cells (leukocytes, often lymphocytes) that are responsible for immunity. IL-2 is part of the body's natural response to microbial infection, and in discriminating between foreign ("non-self") and "self". IL-2 mediates its effects by binding to IL-2 receptors, which are expressed by lymphocytes. The major sources of IL-2 are activated CD4+ T cells and activated CD8+ T cells. Put shortly the function of IL-2 is to stimulate the growth of helper, cytotoxic and regulatory T cells.

<span class="mw-page-title-main">Chiron Corporation</span> American biotechnology firm (1981-2006)

Chiron Corporation was an American multinational biotechnology firm founded in 1981, based in Emeryville, California, that was acquired by Novartis on April 20, 2006. It had offices and facilities in eighteen countries on five continents. Chiron's business and research was in three main areas: biopharmaceuticals, vaccines, and blood testing. Chiron's vaccines and blood testing units were combined to form Novartis Vaccines and Diagnostics, while Chiron BioPharmaceuticals was integrated into Novartis Pharmaceuticals. In 2014, Novartis completed the sale of its blood transfusion diagnostics unit to Grifols and announced agreements for the sale of its vaccines unit to GlaxoSmithKline.

<span class="mw-page-title-main">Thermo Fisher Scientific</span> Provisioner of scientific consumables, equipment, and services

Thermo Fisher Scientific Inc. is an American life, science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services. Based in Waltham, Massachusetts, Thermo Fisher was formed through the merger of Thermo Electron and Fisher Scientific in 2006. Thermo Fisher Scientific has acquired other reagent, consumable, instrumentation, and service providers, including Life Technologies Corporation (2013), Alfa Aesar (2015), Affymetrix (2016), FEI Company (2016), BD Advanced Bioprocessing (2018), and PPD (2021).

Biomolecular engineering is the application of engineering principles and practices to the purposeful manipulation of molecules of biological origin. Biomolecular engineers integrate knowledge of biological processes with the core knowledge of chemical engineering in order to focus on molecular level solutions to issues and problems in the life sciences related to the environment, agriculture, energy, industry, food production, biotechnology and medicine.

Laboratory Corporation of America Holdings (Labcorp), headquartered in Burlington, North Carolina, provides laboratory services used for diagnosis and healthcare decisions. It operates one of the largest clinical laboratory networks in the world and has operations in over 100 countries; although its operations are primarily in the U.S.

<span class="mw-page-title-main">History of polymerase chain reaction</span>

The history of the polymerase chain reaction (PCR) has variously been described as a classic "Eureka!" moment, or as an example of cooperative teamwork between disparate researchers. Following is a list of events before, during, and after its development:

Gualberto Ruaño is a pioneer in the field of personalized medicine and the inventor of molecular diagnostic systems used worldwide for the management of viral diseases. Ruaño is President and Founder of Genomas, a genetics-related company and now the bio-tech anchor of Hartford Hospital’s Genetic Research Center; he also serves as Director of genetics research at the Center.

<span class="mw-page-title-main">Allozyne</span>

Allozyne was a clinical stage biotechnology company headquartered in Seattle's biotech and high tech innovation corridor. Allozyne was founded in 2005 by California Institute of Technology researchers, and was incubated by Accelerator Corporation. Its lead product candidate, AZ01, is a long acting interferon beta for the treatment of the relapsing remitting form of multiple sclerosis, a chronic degenerative disease characterized by demyelination of nerve fibers leading to severe nerve damage and increasing disability. Multiple sclerosis is estimated to affect 400,000 individuals in the US alone and 2.5 million worldwide. AZ01 is currently undergoing Phase I clinical trials in the US. Preclinical data indicates that AZ01 has the potential to be dosed once monthly compared to the current standard of care dosed anywhere from once daily to once per week.

<span class="mw-page-title-main">Pablo DT Valenzuela</span> Chilean biochemist

Pablo Valenzuela is a Chilean biochemist dedicated to biotechnology development. He is known for his genetic studies of hepatitis viruses; participated as R&D Director in the discovery of hepatitis C virus and the invention of the world's first recombinant vaccine. He is one of the cofounders of the biotechnology company Chiron Corporation and of Fundacion Ciencia para la Vida, a private non profit institution where he is currently working.

SynCo Bio Partners B.V. is a biopharmaceutical good manufacturing practices (GMP) contract manufacturing organization (CMO) located in Amsterdam, the Netherlands, licensed for clinical and commercial GMP manufacturing of bulk drug substances and drug products. SynCo offers a fully integrated range of biopharmaceutical development and manufacturing services supporting small biotech to large pharmaceutical organizations worldwide from the earliest stages in process development, through preclinical and clinical trials, approval and market supply.

<span class="mw-page-title-main">Molecular diagnostics</span> Collection of techniques used to analyze biological markers in the genome and proteome

Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients, and in agricultural biosecurity similarly to monitor crop- and livestock disease, estimate risk, and decide what quarantine measures must be taken.

<span class="mw-page-title-main">Cepheid (company)</span> American molecular diagnostics company

Cepheid is an American molecular diagnostics company that is a wholly owned subsidiary of Danaher Corporation. Its systems automate traditional nucleic acid tests. The tests can be used to identify and analyze pathogens and genetic disorders. Cepheid sells clinical tests for healthcare-associated infections, infectious diseases, sexual health, oncology and genetics.

<span class="mw-page-title-main">Ozanimod</span> Medication

Ozanimod, sold under the brand name Zeposia, is an immunomodulatory medication for the treatment of relapsing multiple sclerosis and ulcerative colitis. It acts as a sphingosine-1-phosphate receptor (S1PR) agonist, sequestering lymphocytes to peripheral lymphoid organs and away from their sites of chronic inflammation.

References

  1. "First-Hand:Starting Up Cetus, the First Biotechnology Company - 1973 to 1982 - Engineering and Technology History Wiki". ethw.org. Retrieved 2020-08-04.
  2. FDA Approves a Multiple Sclerosis Drug, New York Times, July 24, 1993.
  3. 1 2 Paul Rabinow. Making PCR: A Story of Biotechnology. University of Chicago Press, 1996 ISBN   978-0226701479
  4. Andrew Pollack for the New York Times. Cetus Drug is Blocked by FDA July 31, 1990.
  5. Detailed history of Cetus and the commercial aspects of PCR
  6. Sally Lehrman for The Scientist. January 20, 1992 Cetus: A Collision Course With Failure
  7. Andrew Pollack for the New York Times. July 23, 1991 Two Biotech Pioneers To Merge

Further reading