Repligen

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).{{sfn|Repligen 2013 10-K|2014|p=1}} A decision was made in 2012 to focus on the bioprocessing business and reduce research and development expenditures.{{sfn|Repligen 2013 10-K|2014|p=4}} In the period of 2010 to 2013, the majority of sales by the company were concentrated in the single Protein A product line.{{sfn|Repligen 2013 10-K|2014|p=3}}

Repligen employs a direct sales model to users of its products in the United States, with some sales through intermediaries in "certain foreign markets".{{sfn|Repligen 2013 10-K|2014|p=5}} More than 80% of sales have been to customers in the United States and Sweden during the 2010-2013 period.{{sfn|Repligen 2013 10-K|2014|p=5}} 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.{{sfn|Repligen 2013 10-K|2014|p=7}}

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.{{sfn|Repligen 2013 10-K|2014|p=6}}

As a consequence of current operations, about one-third each of revenue and cost and expenses are denominated in Swedish krona currency, the remaining two-thirds denominated in United States dollars; this presents a risk to the business based on unpredictable fluctuations in currency exchange rates.{{sfn|Repligen 2013 10-K|2014|p=18}}

The company's Protein A-related offerings are supported by proprietary technology, trade secrets and patent filings.{{sfn|Repligen 2013 10-K|2014|p=6}} One patent was granted in April 2010 and has been extended so that it remains in effect until 2028.{{sfn|Repligen 2013 10-K|2014|p=6}}{{Patent|US|7691608 B2|"Nucleic Acids Encoding Recombinant Protein A"}} Patents are pending on elements of the OPUS chromatography product line,{{sfn|Repligen 2013 10-K|2014|p=6}} and enabling technology has been licensed from BioFlash Partners.{{sfn|Repligen 2013 10-K|2014|p=3}} Repligen retains an exclusive license to intellectual property owned by the University of Michigan in relation to the Orencia product divested to Bristol-Myers Squibb.{{sfn|Repligen 2013 10-K|2014|p=5}}{{patent|US|6685941|"Methods of treating autoimmune disease via CTLA-4Ig"}}

Repligen's company headquarters are housed together with its manufacturing facility in Waltham, Massachusetts.{{sfn|Repligen 2013 10-K|2014|p=19}}

Repligen maintains manufacturing facilities in Waltham, Massachusetts and Lund, Sweden.{{sfn|Repligen 2013 10-K|2014|p=2}} 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.{{sfn|Repligen 2013 10-K|2014|p=7}}

The lease on the main Waltham facility extends through 2023.{{sfn|Repligen 2013 10-K|2014|p=19}} A second, smaller Waltham facility was leased through the end of 2012 and is now rented on a monthly basis.{{sfn|Repligen 2013 10-K|2014|p=20}} In Lund, four buildings are under lease, three expiring in mid-2017 and the fourth extending to late 2019.{{sfn|Repligen 2013 10-K|2014|p=20}}

Alexander Rich was a co-founder of Repligen and served as Chairman Emeritus{{sfn|Motley Fool|2014}} of Repligen's board of directors. Rich had been a member of the Board since 1981.{{sfn|Forbes|2014}} Paul Schimmel is also a co-founder of Repligen, and he is the Ernest and Jean Hahn Professor at The Skaggs Institute for Chemical Biology at The Scripps Research Institute. He used to be the John D. and Catherine T. MacArthur Professor of Biochemistry and Biophysics in the Department of Biology at MIT.

{{As of|2015}}, the company's President and Chief Executive Officer is Tony J. Hunt.

In early 2010, Repligen licensed technology from BioFlash which it subsequently incorporated into the OPUS line of pre-packed chromatography columns.{{sfn|Repligen 2013 10-K|2014|p=3}}

In 2011, Repligen acquired bioproduction assets from Novozymes for $26.4 million, which doubled the company's bioprocessing capabilities.{{sfn|Repligen 2013 10-K|2014|p=1}}

In December 2016 the company acquired TangenX for $39 million{{Cite web|url=http://www.genengnews.com/gen-news-highlights/repligen-acquires-tangenx-for-39m/81253558|title = Repligen Acquires TangenX for $39M|date = 15 December 2016}}

In September 2023, Repligen acquired a fluid management company, Metenova.{{Cite news |date=September 27, 2023 |title=Repligen (RGEN) to Acquire Fluid Management Company Metenova |work=Nasdaq.com |url=https://www.nasdaq.com/articles/repligen-rgen-to-acquire-fluid-management-company-metenova}}

In 2008, an agreement was struck to divest certain intellectual property rights to Bristol-Myers Squibb around the drug Orencia in exchange for ongoing royalty payments through the end of 2013.{{sfn|Repligen 2013 10-K|2014|p=1}}

At the end of 2012, Repligen out-licensed its spinal muscular atrophy program, in particular the small molecule candidate drug RG3039, to Pfizer.{{sfn|Repligen 2013 10-K|2014|p=1}} This divestment included licensing rights to two patents to Pfizer.{{sfn|Repligen 2013 10-K|2014|p=7}}{{Patent|US|7888366|"2,4-diaminoquinazolines for spinal muscular atrophy"}}{{Patent|US|7985755|"2,4-DIAMINOQUINAZOLINES FOR SPINAL MUSCULAR ATROPHY"}}

At the start of 2014, the company out-licensed its Friedreich's ataxia program, including a library of histone deacetylase inhibitor compounds, to BioMarin Pharmaceutical for {{currency|2 million}} and future milestone and royalty payments.{{sfn|Repligen 2013 10-K|2014|p=2}}{{sfn|Gen. Eng. Biotechnol. News|2014}}

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.{{sfn|Repligen 2013 10-K|2014|p=2}}

Repligen is a major supplier of Protein A, both native and recombinant forms, to the pharmaceutical industry.{{sfn|Repligen 2013 10-K|2014|p=1}} In 2010-2013, Protein A accounted for the majority of the company's product sales.{{sfn|Repligen 2013 10-K|2014|p=3}} The company also provides growth factors 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.{{sfn|Repligen 2013 10-K|2014|p=1}}

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".{{sfn|Repligen 2013 10-K|2014|p=4}} The smaller sizes of columns depend upon proprietary technology licensed from BioFlash Partners, while the larger sizes are based on Repligen-developed proprietary technology.{{sfn|Repligen 2013 10-K|2014|p=3}}

{{Reflist|30em}}

• {{cite web | author=Forbes | year=2014 | url=https://www.forbes.com/profile/alexander-rich/ | title=Alexander Rich | work=Forbes | access-date=15 March 2014 | department=Profiles | url-status=dead | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315192553/http://www.forbes.com/profile/alexander-rich/ }}
• {{Cite news | author=Gen. Eng. Biotechnol. News | title=BioMarin Nabs Repligen's HDACi Compound Library | date=February 15, 2014 | volume=34 | issue=4 | page=14| department=News: Discovery & Development | work=Gen. Eng. Biotechnol. News | type=paper }}
• {{cite web | author=International New York Times | year=2014 | title=Repligen Corporation | work=International New York Times | url=http://topics.nytimes.com/top/news/business/companies/repligen-corporation/ | access-date=15 March 2014 | department=Business Day | at=Company Information | url-status=live | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315184535/http://topics.nytimes.com/top/news/business/companies/repligen-corporation/ }}
• {{cite web | author=Motley Fool | year=2014 | url=http://www.fool.com/quote/nasdaq/repligen-corp/rgen/key-executives | title=Repligen Corp Key Executives RGEN | work=The Motley Fool | access-date=15 March 2014 | url-status=live | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315194147/http://www.fool.com/quote/nasdaq/repligen-corp/rgen/key-executives }}
• {{citation | ref={{harvid|Repligen 2013 10-K|2014}} | year=2014 | title=Repligen Corporation, Form 10-K, 2013 | id=Commission File Number 000-14656 | url=http://corporate.repligen.com/file.aspx?IID=4325751&FID=22568361&O=3&OSID=9 | publisher=Repligen | access-date=16 March 2014 | website=SEC Documents | series=Form 10-K }}
• {{cite news | author=Street Insider | title=Repligen (RGEN) Replaces Board Member Alex Rich with Alfred Goldberg | work=Street Insider | date=19 September 2011 | access-date=15 March 2014 | url=http://www.streetinsider.com/Management+Changes/Repligen+(RGEN)+Replaces+Board+Member+Alex+Rich+with+Alfred+Goldberg/6796218.html | url-status=live | archive-date=15 March 2014 | archive-url=https://web.archive.org/web/20140315195141/http://www.streetinsider.com/Management+Changes/Repligen+(RGEN)+Replaces+Board+Member+Alex+Rich+with+Alfred+Goldberg/6796218.html }}

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