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Repligen is an American company devoted to the development and production of materials used in the manufacture of biological drugs. The company is based in
Waltham, Massachusetts Waltham ( ) is a city in Middlesex County, Massachusetts, United States, and was an early center for the labor movement as well as a major contributor to the American Industrial Revolution. The original home of the Boston Manufacturing Company, ...
, and incorporated in
Delaware Delaware ( ) is a state in the Mid-Atlantic region of the United States, bordering Maryland to its south and west; Pennsylvania to its north; and New Jersey and the Atlantic Ocean to its east. The state takes its name from the adjacen ...
in 1981. A
public company A public company is a company whose ownership is organized via shares of stock which are intended to be freely traded on a stock exchange or in over-the-counter markets. A public (publicly traded) company can be listed on a stock exchange ( l ...
, Repligen is listed on the
NASDAQ The Nasdaq Stock Market () (National Association of Securities Dealers Automated Quotations Stock Market) is an American stock exchange based in New York City. It is the most active stock trading venue in the US by volume, and ranked second ...
exchange under the symbol RGEN. , Repligen employed 116 people, about 50% of these based in Sweden.


Business model

Before 2012, Repligen maintained dual capabilities in developing pharmaceutical therapeutics (drug discovery and development) and the development of materials supporting biological drug manufacture (bioprocessing business). A decision was made in 2012 to focus on the bioprocessing business and reduce research and development expenditures. In the period of 2010 to 2013, the majority of sales by the company were concentrated in the single
Protein A Protein A is a 42 kDa surface protein originally found in the cell wall of the bacteria ''Staphylococcus aureus''. It is encoded by the ''spa'' gene and its regulation is controlled by DNA topology, cellular osmolarity, and a two-component syste ...
product line.


Sales and revenue

Repligen employs a direct sales model to users of its products in the United States, with some sales through
intermediaries An intermediary (or go-between) is a third party that offers intermediation services between two parties, which involves conveying messages between principals in a dispute, preventing direct contact and potential escalation of the issue. In la ...
in "certain foreign markets". More than 80% of sales have been to customers in the United States and Sweden during the 2010-2013 period. Long-term supply agreements have been established with major customers of the Protein A products, agreements which expire between 2016 and 2021 barring re-negotiation. As a result of royalty-generating out-licensing, royalty revenue from Bristol-Myers Squibb has been in the 27% to 37% range as a proportion of total revenue during the 2010-2013 period; in comparison to revenue from sales, the largest customer accounted for 35% to 45% of revenue during the same period. As a consequence of current operations, about one-third each of revenue and cost and expenses are denominated in
Swedish krona The krona (; plural: ''kronor''; sign: kr; code: SEK) is the official currency of the Kingdom of Sweden. Both the ISO code "SEK" and currency sign "kr" are in common use; the former precedes or follows the value, the latter usually follows it ...
currency, the remaining two-thirds denominated in
United States dollar The United States dollar (symbol: $; code: USD; also abbreviated US$ or U.S. Dollar, to distinguish it from other dollar-denominated currencies; referred to as the dollar, U.S. dollar, American dollar, or colloquially buck) is the official ...
s; this presents an element risk to the business based on unpredictable fluctuations in currency exchange rates.


Intellectual property

The company's Protein A-related offerings are supported by proprietary technology, trade secrets and patent filings. One patent was granted in April 2010 and has been extended so that it remains in effect until 2028., Patents are pending on elements of the OPUS chromatography product line, and enabling technology has been licensed from BioFlash Partners. Repligen retains an exclusive license to intellectual property owned by the
University of Michigan , mottoeng = "Arts, Knowledge, Truth" , former_names = Catholepistemiad, or University of Michigania (1817–1821) , budget = $10.3 billion (2021) , endowment = $17 billion (2021)As o ...
in relation to the
Orencia Abatacept, sold under the brand name Orencia, is a medication used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the immune activity of T cells. It is a modified antibody. Abatacept is a fusion protein composed o ...
product divested to Bristol-Myers Squibb.,


Facilities

Repligen's company headquarters are housed together with its manufacturing facility in Waltham, Massachusetts. Repligen maintains manufacturing facilities in
Waltham, Massachusetts Waltham ( ) is a city in Middlesex County, Massachusetts, United States, and was an early center for the labor movement as well as a major contributor to the American Industrial Revolution. The original home of the Boston Manufacturing Company, ...
and
Lund, Sweden Lund (, , ) is a city in the southern Swedish province of Scania, across the Öresund strait from Copenhagen. The town had 91,940 inhabitants out of a municipal total of 121,510 . It is the seat of Lund Municipality, Scania County. The Öresu ...
. Growth factor products and the native form of Protein A are manufactured in Sweden; recombinant forms of Protein A are manufactured in both the United States and Sweden; assembly of the OPUS chromatography product line is done in the United States. The lease on the main Waltham facility extends through 2023. A second, smaller Waltham facility was leased through the end of 2012 and is now rented on a monthly basis. In Lund, four buildings are under lease, three expiring in mid-2017 and the fourth extending to late 2019.


Corporate history and governance

Alexander Rich Alexander Rich (15 November 1924 – 27 April 2015) was an American biologist and biophysicist. He was the William Thompson Sedgwick Professor of Biophysics at MIT (since 1958) and Harvard Medical School. Rich earned an A.B. (''magna cum l ...
was a co-founder of Repligen; in 2014 at the age of 87, Dr. Rich is "Chairman
Emeritus ''Emeritus'' (; female: ''emerita'') is an adjective used to designate a retired chair, professor, pastor, bishop, pope, director, president, prime minister, rabbi, emperor, or other person who has been "permitted to retain as an honorary title ...
".of Repligen's Board of Directors. Dr. Rich had been a member of the Board since 1981. Paul Schimmel is also a co-founder of Repligen; in 2014 at the age of 74, he is the Ernest and Jean Hahn Professor at The Skaggs Institute for Chemical Biology at
The Scripps Research Institute Scripps Research, previously known as The Scripps Research Institute (TSRI), is a nonprofit American medical research facility that focuses on research and education in the biomedical sciences. Headquartered in San Diego, California, the institu ...
. He used to be the John D. and Catherine T. MacArthur Professor of Biochemistry and Biophysics in the Department of Biology at MIT. , the company's
President President most commonly refers to: *President (corporate title) * President (education), a leader of a college or university *President (government title) President may also refer to: Automobiles * Nissan President, a 1966–2010 Japanese f ...
and
Chief Executive Officer A chief executive officer (CEO), also known as a central executive officer (CEO), chief administrator officer (CAO) or just chief executive (CE), is one of a number of corporate executives charged with the management of an organization especial ...
is Tony J. Hunt.


Acquisitions and in-licensing

In early 2010, Repligen licensed technology from BioFlash which it subsequently incorporated into the OPUS line of pre-packaged chromatography columns. In 2011, Repligen acquired bioproduction assets from
Novozymes Novozymes A/S is a global biotechnology company headquartered in Bagsværd outside of Copenhagen, Denmark. The company's focus is the research, development and production of industrial enzymes, microorganisms, and biopharmaceutical ingredients. ...
for $26.4 million, which doubled the company's bioprocessing capabilities. In December 2016 the company acquired TangenX for $39 million


Divestments and out-licensing

In 2008, an agreement was struck to divest certain intellectual property rights to
Bristol-Myers Squibb The Bristol Myers Squibb Company (BMS) is an American multinational pharmaceutical company. Headquartered in New York City, BMS is one of the world's largest pharmaceutical companies and consistently ranks on the ''Fortune'' 500 list of the l ...
around the drug
Orencia Abatacept, sold under the brand name Orencia, is a medication used to treat autoimmune diseases like rheumatoid arthritis, by interfering with the immune activity of T cells. It is a modified antibody. Abatacept is a fusion protein composed o ...
in exchange for ongoing
royalty Royalty may refer to: * Any individual monarch, such as a king, queen, emperor, empress, etc. * Royal family, the immediate family of a king or queen regnant, and sometimes his or her extended family * Royalty payment for use of such things as int ...
payments through the end of 2013. At the end of 2012, Repligen out-licensed its
spinal muscular atrophy Spinal muscular atrophy (SMA) is a rare neuromuscular disorder that results in the loss of motor neurons and progressive muscle wasting. It is usually diagnosed in infancy or early childhood and if left untreated it is the most common genet ...
program, in particular the small molecule candidate drug RG3039, to
Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfize ...
. This divestment included licensing rights to two patents to Pfizer.,, At the start of 2014, the company out-licensed its
Friedreich's ataxia Friedreich's ataxia (FRDA or FA) is an autosomal-recessive genetic disease that causes difficulty walking, a loss of sensation in the arms and legs, and impaired speech that worsens over time. Symptoms generally start between 5 and 20 year ...
program, including a library of histone deacetylase inhibitor compounds, to BioMarin Pharmaceutical for and future milestone and royalty payments.,


Terminations and moth-balling

Development of an imaging agent, designated RG1068, based on a synthetic human hormone was halted in 2012 following a request by the USFDA for additional safety and efficacy data beyond that provided in a New Drug Application (NDA) submission; a Marketing Authorization Application had been submitted in parallel to the EMA.


Products and services

Repligen is a major supplier of
Protein A Protein A is a 42 kDa surface protein originally found in the cell wall of the bacteria ''Staphylococcus aureus''. It is encoded by the ''spa'' gene and its regulation is controlled by DNA topology, cellular osmolarity, and a two-component syste ...
, both native and recombinant forms, to the pharmaceutical industry. In 2010-2013, Protein A accounted for the majority of the company's product sales. The company also provides
growth factor A growth factor is a naturally occurring substance capable of stimulating cell proliferation, wound healing, and occasionally cellular differentiation. Usually it is a secreted protein or a steroid hormone. Growth factors are important for r ...
s to increase the productivity of cell-based bioproduction, multiple alternating tangential flow (ATF) systems, and a line (OPUS) of chromatography columns scaled to manufacture of product for testing in
clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
. The OPUS product line contains a range of column sizes, the size and composition of which are dependent upon customer requirements, thus the full name of "Open Platform, User Specified". The smaller sizes of columns depend upon proprietary technology licensed from BioFlash Partners, while the larger sizes are based on Repligen-developed proprietary technology.


Notes


References

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External links

{{Authority control Manufacturing support companies Companies based in Massachusetts Companies listed on the Nasdaq 1981 establishments in Massachusetts