Genentech Explained

Genentech, Inc.
Type:	Subsidiary
Location:	South San Francisco, California, United States
Industry:	Biotechnology
Products:	Avastin, Herceptin, Rituxan, Perjeta, Kadcyla, Gazyva, Tarceva, Ocrevus, Polivy, Tecentriq, Xofluza, Hemlibra, Venclexta, Esbriet, Cotellic, Alecensa, Zelboraf, Nutropin, Actemra, Lucentis, Xolair, Activase, Cathflo Activase, Xeloda, Boniva, TNKase, CellCept, Pegasys, Pulmozyme, Tamiflu, Valcyte, Anaprox, Cytovene, EC-Naprosyn, Erivedge, Fuzeon, Invirase, Klonopin, Kytril, Naprosyn, Rocephin, Roferon-A, Romazicon, Valium, Xenical, Zenapax
Num Employees:	13,539 (July 2021)
Revenue:	$26.4 billion (2020)^[1]
Parent:	Roche

Genentech, Inc. is an American biotechnology corporation headquartered in South San Francisco, California. It became an independent subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche.^[2] Historically, the company is regarded as the world's first biotechnology company.^[3]

As of July 2021, Genentech employed 13,539 people.^[4]

History

The company was founded in 1976 by venture capitalist Robert A. Swanson and biochemist Herbert Boyer.^{[5] [6]} Boyer is considered to be a pioneer in the field of recombinant DNA technology. In 1973, Boyer and his colleague Stanley Norman Cohen demonstrated that restriction enzymes could be used as "scissors" to cut DNA fragments of interest from one source, to be ligated into a similarly cut plasmid vector.^[7] While Cohen returned to the laboratory in academia, Swanson contacted Boyer to found the company.^{[5] [8]} Boyer worked with Arthur Riggs and Keiichi Itakura from the Beckman Research Institute, and the group became the first to successfully express a human gene in bacteria when they produced the hormone somatostatin in 1977.^[9] David Goeddel and Dennis Kleid were then added to the group, and contributed to its success with synthetic human insulin in 1978.

In 1990 F. Hoffmann-La Roche AG acquired a majority stake in Genentech.^[10]

In 2006 Genentech acquired Tanox in its first acquisition deal. Tanox had started developing Xolair and development was completed in collaboration with Novartis and Genentech; the acquisition allowed Genentech to keep more of the revenue.^[11]

In March 2009 Roche acquired Genentech by buying shares it didn't already control for approximately $46.8 billion.^{[12] [13] [14]}

In July 2014, Genentech/Roche acquired Seragon for its pipeline of small-molecule cancer drug candidates for $725 million cash upfront, with an additional $1 billion of payments dependent on successful development of products in Seragon's pipeline.^[15]

Research

Genentech is a pioneering research-driven biotechnology company^[10] that has continued to conduct R&D internally as well as through collaborations.^{[16] [17]}

Genentech's research collaborations include:

• In 2008 Genentech entered into a collaboration with Roche and its subsidiary GlycArt to develop obinutuzumab.^[18]
• In February 2010 Genentech entered into a collaboration with University of California, San Francisco after having worked with them in about fifteen other collaborations, this time to collaborate on small molecule drug discovery in neurology.^[19]
• In October 2014 Genentech paid $150M upfront to collaborate with Iowa-based NewLink Genetics on checkpoint inhibitors.^[20]
• In June 2015 it entered into a wide-ranging partnership with The Data Incubator to help train and hire the next generation of data scientists at the company.^[21]
• In January 2015 it signed a $60M deal with 23andMe that gave Genentech access to the genomic and patient-reported data held by 23andMe.^[22]
• In October 2015 it started a collaboration with Nimbus Therapeutics to develop leads from Nimbus' in silico drug discovery platform.^[23]
• In June 2016 Genentech partnered Epizyme to conduct clinical trials exploring whether Epizyme's EZH2 inhibitor tazemetostat would be synergistic with Genentech's atezolizumab.^[24]
• In August 2016, the company began a collaboration with Carmot Therapeutics in which Carmot will discover new candidates and Genentech will develop them.^[25]
• In September 2016 Genentech partnered with the Israeli company BioLineRx on a checkpoint inhibitor that Genentech intended to pair with its own atezolizumab.^[26]

Facilities

Genentech's corporate headquarters are in South San Francisco, California, with additional manufacturing facilities in Vacaville, California; Oceanside, California; and Hillsboro, Oregon. In March 2024, it was announced the Swiss pharmaceutical company, Lonza had acquired the Vacaville site from parent-company, Roche for $1.2 billion.^[27]

In December 2006, Genentech sold its Porriño, Spain, facility to Lonza and acquired an exclusive right to purchase Lonza's mammalian cell culture manufacturing facility under construction in Singapore. In June 2007, Genentech began the construction and development of an E. coli manufacturing facility, also in Singapore, for the worldwide production of Lucentis (ranibizumab injection) bulk drug substance.

In 2023, the company announced plans to close down its manufacturing facility in South San Francisco, while expanding its manufacturing capabilities in Oceanside.^{[28] [29]}

Public-private engagement

Political lobbying

Genentech is a donor to the Center for Health Care Strategies, a non-governmental organization that lobbies the United States Government on issues related to Medicaid.^[30]

Genentech Inc Political Action Committee

Genentech Inc Political Action Committee is a U.S. Federal Political Action Committee (PAC), created to "aggregate contributions from members or employees and their families to donate to candidates for federal office".

Controversy

Disputes

In November 1999, Genentech agreed to pay the University of California, San Francisco $200 million to settle a nine-year-old patent dispute. In 1990, UCSF sued Genentech for $400 million in compensation for alleged theft of technology developed at the university and covered by a 1982 patent. Genentech claimed that they developed Protropin (recombinant somatotropin/human growth hormone), independently of UCSF. A jury ruled that the university's patent was valid in July 1999, but wasn't able to decide whether Protropin was based upon UCSF research or not. Protropin, a drug used to treat dwarfism, was Genentech's first marketed drug and its $2 billion in sales has contributed greatly to its position as an industry leader. The settlement was to be divided as follows: $30 million to the University of California General Fund, $85 million to the three inventors and two collaborating scientists, $50 million towards a new teaching and research campus for UCSF, and $35 million to support university-wide research.^[31]

In 2009, The New York Times reported that Genentech's talking points on health care reform appeared verbatim in the official statements of several Members of Congress during the national health care reform debate.^[32] Two U.S. Representatives, Joe Wilson and Blaine Luetkemeyer, both issued the same written statements: "One of the reasons I have long supported the U.S. biotechnology industry is that it is a homegrown success story that has been an engine of job creation in this country. Unfortunately, many of the largest companies that would seek to enter the biosimilar market have made their money by outsourcing their research to foreign countries like India." The statement was originally drafted by lobbyists for Genentech.

Products timeline

• 1982: Synthetic "human" insulin approved by the U.S. Food and Drug Administration (FDA), partnered with insulin manufacturer Eli Lilly and Company, who shepherded the product through the FDA approval process. The product (Humulin) was licensed to and manufactured by Lilly, and was the first-ever approved genetically engineered human therapeutic.
• 1985: Protropin (somatrem): Supplementary growth hormone for children with growth hormone deficiency (ceased manufacturing 2004).
• 1987: Activase (alteplase): A recombinant tissue plasminogen activator (tPa) used to dissolve blood clots in patients with acute myocardial infarction. Also used to treat non-hemorrhagic stroke.
• 1990: Actimmune (interferon gamma 1b): Treatment of chronic granulomatous disease (licensed to Intermune).
• 1993: Nutropin (recombinant somatropin): Growth hormone for children and adults for treatment before kidney transplant due to chronic kidney disease.
• 1993: Pulmozyme (dornase alfa): Inhalation treatment for children and young adults with cystic fibrosis—recombinant DNAse.
• 1997: Rituxan (rituximab): Treatment for specific kinds of non-Hodgkin's lymphomas. In 2006, also approved for rheumatoid arthritis.
• 1998: Herceptin (trastuzumab): Treatment for metastatic breast cancer patients with tumors that overexpress the HER2 gene. Recently approved for adjuvant therapy for breast cancer. FDA also recently approved Trastuzumab for metastatic gastric cancer with HER2 receptor site positive.
• 2000: TNKase (tenecteplase): "Clot-busting" drug to treat acute myocardial infarction.
• 2003: Xolair (omalizumab): Subcutaneous injection for moderate to severe persistent asthma.
• 2003: Raptiva (efalizumab): Antibody designed to block the activation and reactivation of T cells that lead to the development of psoriasis. Developed in partnership with XOMA. In 2009, voluntary U.S. market withdrawal after reports of progressive multifocal leukoencephalopathy.
• 2004: Avastin (bevacizumab): Anti-VEGF monoclonal antibody for the treatment of metastatic cancer of the colon or rectum. In 2006, also approved for locally advanced, recurrent or metastatic non-small cell lung cancer. In 2008, accelerated approval was granted for Avastin in combination with chemotherapy for previously untreated advanced HER2-negative breast cancer. In 2009, Avastin gained its fifth approval for treatment of glioblastoma multiforme, and sixth approval for the treatment of metastatic renal cell carcinoma. It was most publicized for its approval in advanced breast cancer treatment, but the FDA approval for breast cancer treatment was subsequently revoked in November 2011.
• 2004: Tarceva (erlotinib): Treatment for patients with locally advanced or metastatic non-small cell lung cancer, and pancreatic cancer.
• 2006: Lucentis (ranibizumab injection): Treatment of neovascular (wet) age-related macular degeneration (AMD). The FDA approved LUCENTIS after a Priority Review (six-month). Genentech started shipping product on June 30, 2006, the day the product was approved.
• 2010: Actemra (tocilizumab): The first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody approved to treat rheumatoid arthritis.
• 2011: Zelboraf (vemurafenib): For the treatment of metastatic melanoma caused by BRAF mutation.
• 2012: Erivedge (vismodegib): Treatment for advanced basal-cell carcinoma (BCC). A small molecule inhibitor that targets a key protein in the Hedgehog signaling pathway. This is the first approved therapy for advanced BCC.
• 2012: Perjeta (pertuzumab): For use in combination with Herceptin (trastuzumab) and docetaxel chemotherapy for the treatment of patients with previously untreated HER2-positive metastatic breast cancer.
• 2013: Kadcyla (ado-trastuzumab emtansine): The first Genentech antibody-drug conjugate (ADC) to receive FDA approval. It consists of trastuzumab (Herceptin) linked to a cytotoxic agent mertansine (DM1), used in the treatment of HER2-positive metastatic breast cancer.
• 2013: Gazyva (obinutuzumab): For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). Gazyva is the first drug with breakthrough therapy designation to receive FDA approval.
• 2014: Esbriet (pirfenidone): An anti-fibrotic drug for the treatment of idiopathic pulmonary fibrosis (IPF). Developed by Intermune, Inc.
• 2015: Cotellic (cobimetinib): For use in combination with ZELBORAF (vemurafenib), to treat metastatic melanoma caused by BRAF mutation.
• 2015: Alecensa (alectinib): Treatment for non-small cell lung cancer (NSCLC).
• 2016: Venclexta (venetoclax): Treatment for patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy.
• 2016: Tecentriq (atezolizumab): First-in-class anti-PD-L1 antibody for the treatment of advanced bladder cancer or metastatic non-small cell lung cancer (NSCLC), both after failure of platinum-based chemotherapy. Tecentriq was granted accelerated approval for its advanced bladder cancer indication due to promising phase II results.
• 2017: Ocrevus (ocrelizumab): The first FDA-approved therapy that treats both relapsing-remitting multiple sclerosis (RRMS) and primary progressive multiple sclerosis (PPMS). The PPMS form of the disease previously had no approved treatments.
• 2017: Hemlibra (emicizumab): Treatment for haemophilia A. Developed by Chugai Pharmaceutical Co.
• 2018: Xofluza (Baloxavir marboxil): Antiviral medication for treatment of influenza A and influenza B. Developed by Shionogi.
• 2019: Polivy (Polatuzumab vedotin-piiq): Treatment of diffuse large B-cell lymphoma when used in combination with bendamustine and rituximab.

See also

• Evan Morris

Further reading

• Book: Hughes, Sally Smith . Genentech . University of Chicago Press . April 8, 2013 . 978-0-226-04551-1.
• Book: Marsa, Linda . Prescription for Profits . Scribner Book Company . 1997 . 978-0-684-80002-8.

External links

• • Genentech Suppliers, Partners, and Customers
• Corporate chronology (Genentech)
• "A Cancer Drug Shows Promise, at a Price That Many Can't Pay", The New York Times, February 15, 2006, Alex Berenson
• Presentation by Genentech employees about sustainable business January 10, 2007

Notes and References

1. Web site: Genentech .
2. Web site: About Us. Gene.com. August 22, 2014. https://web.archive.org/web/20140804185741/http://www.gene.com/about-us. August 4, 2014. live.
3. Russo . Eugene . Special Report: The birth of biotechnology . Nature . January 2003 . 421 . 6921 . 456–457 . 10.1038/nj6921-456a . 12540923 . 2003Natur.421..456R . 4357773 . free .
4. News: Working at Genentech. Great Place to Work. en-US. November 18, 2021.
5. Russo . E. . Special Report: The birth of biotechnology . 10.1038/nj6921-456a . Nature . 421 . 6921 . 456–457 . 2003 . 12540923. 2003Natur.421..456R . 4357773 . free .
6. Web site: Corporate Overview. Genentech. Genentech was founded by venture capitalist Robert A. Swanson and biochemist Dr. Herbert W. Boyer. After a meeting in 1976, the two decided to start a biotechnology company, Genentech. Although the two confidently assert that it was the first biotech company, others clearly came before, including Cetus Corporation which was founded in 1971.. dead. https://web.archive.org/web/20120418082422/http://www.gene.com/gene/about/corporate/index.jsp?hl=en&q=genentech. April 18, 2012.
7. Cohen . S. . Chang . A. . Boyer . H. . Helling . R. . Construction of biologically functional bacterial plasmids in vitro . Proceedings of the National Academy of Sciences of the United States of America . 70 . 11 . 3240–3244 . 1973 . 4594039 . 427208 . 10.1073/pnas.70.11.3240. 1973PNAS...70.3240C. free .
8. "In January 1976, 28-year-old venture capitalist Robert Swanson entered the picture. A successful cold-call to Boyer's lab led to a couple of beers—and an agreement to start a pharmaceutical company. Investing $500 each, they capitalized a new business, Genentech, to seek practical uses for Boyer and Cohen's engineered proteins. Swanson raised money for staff and labs..."Web site: Who made America? Herbert Boyer. PBS. August 28, 2017. https://web.archive.org/web/20120620215336/http://www.pbs.org/wgbh/theymadeamerica/whomade/boyer_hi.html. June 20, 2012. live.
9. 10.1126/science.412251 . Itakura . K. . Hirose . T. . Crea . R. . Riggs . A. D. . Heyneker . H. L. . Bolivar . F. . Boyer . H. W. . Expression in Escherichia coli of a chemically synthesized gene for the hormone somatostatin . Science . 198 . 4321 . 1056–1063 . 1977 . 412251. 1977Sci...198.1056I.
10. News: Fisher. Lawrence M.. Genentech: Survivor Strutting Its Stuff. The New York Times. October 1, 2000. February 19, 2017. https://web.archive.org/web/20170404185137/http://www.nytimes.com/2000/10/01/business/genentech-survivor-strutting-its-stuff.html?pagewanted=all&_r=0. April 4, 2017. live.
11. News: Genentech strikes $919M deal to buy Tanox. FierceBiotech. November 9, 2006. https://web.archive.org/web/20170404155601/http://www.fiercebiotech.com/biotech/genentech-strikes-919m-deal-to-buy-tanox. April 4, 2017. live.
12. News: Morse . Andrew . May 10, 2006 . Chugai Shares Post Healthy Gain On Prospects for Cancer Drug . The Wall Street Journal . September 26, 2008 .
13. News: Staff writers. July 21, 2008. 1935-472X. September 26, 2008. Roche Makes $43.7B Bid for Genentech. Genetic Engineering & Biotechnology News. https://web.archive.org/web/20090203010727/http://www.genengnews.com/news/bnitem.aspx?name=39080941. February 3, 2009. live.
14. News: Pollack. Andrew. Roche Agrees to Buy Genentech for $46.8 Billion. March 12, 2009. The New York Times. April 3, 2020. en-US. 0362-4331.
15. News: Staff writers. July 2, 2014. July 2, 2014. Genentech acquires Seragon. Genetic Engineering & Biotechnology News. https://web.archive.org/web/20140714133409/http://www.genengnews.com/gen-news-highlights/genentech-acquires-seragon-for-up-to-1-725b/81250056/. July 14, 2014. live.
16. News: Three Years After Merger, Genentech R&D Outshines That of Roche's GEN News Highlights. Genetic Engineering News. July 3, 2012. September 18, 2016. https://web.archive.org/web/20170405023846/http://www.genengnews.com/gen-news-highlights/three-years-after-merger-genentech-r-amp-d-outshines-that-of-roche/81246997?kwrd=Dalcetrapib. April 5, 2017. live.
17. Web site: Living 10 Years in the Future. Genentech. https://web.archive.org/web/20160801073259/http://www.gene.com/scientists. August 1, 2016.
18. News: Carroll. John. Genentech teams with Glycart on antibody program. FierceBiotech. October 3, 2008. September 18, 2016. https://web.archive.org/web/20170404155446/http://www.fiercebiotech.com/biotech/genentech-teams-glycart-on-antibody-program. April 4, 2017. live.
19. News: UCSF enters drug discovery agreement with Genentech. FierceBiotech. February 19, 2010. September 18, 2016. https://web.archive.org/web/20170404155549/http://www.fiercebiotech.com/biotech/ucsf-enters-drug-discovery-agreement-genentech. April 4, 2017. live.
20. News: Carroll. John. Genentech pays $150M upfront to partner on NewLink's immuno-oncology drug. FierceBiotech. October 20, 2014. September 18, 2016. https://web.archive.org/web/20160614043146/http://www.fiercebiotech.com/partnering/genentech-pays-150m-upfront-to-partner-on-newlink-s-immuno-oncology-drug. June 14, 2016. live.
21. News: The Promise and Challenge of Big Data for Pharma . April 5, 2017 . https://web.archive.org/web/20170405171004/https://hbr.org/2016/11/the-promise-and-challenge-of-big-data-for-pharma . April 5, 2017 . live .
22. News: Herper. Matthew. Surprise! With $60 Million Genentech Deal, 23andMe Has A Business Plan. Forbes. August 16, 2017. https://web.archive.org/web/20170816224058/https://www.forbes.com/sites/matthewherper/2015/01/06/surprise-with-60-million-genentech-deal-23andme-has-a-business-plan/#28855bf37927. August 16, 2017. live.
23. News: Garde. Damian. Genentech co-signs Nimbus' computer-aided R&D with an oncology pact. FierceBiotech. October 20, 2015. September 18, 2016. https://web.archive.org/web/20160711042119/http://www.fiercebiotech.com/partnering/genentech-co-signs-nimbus-computer-aided-r-d-an-oncology-pact. July 11, 2016. live.
24. News: Lawrence. Stacy. Epizyme nabs combo trial deal with Genentech for NHL candidate FierceBiotech. www.fiercebiotech.com. June 23, 2016. September 18, 2016. https://web.archive.org/web/20160906121630/http://www.fiercebiotech.com/biotech/epizyme-nabs-combo-trial-deal-genentech-for-nhl-candidate. September 6, 2016. live.
25. . August 2016. Carmot to Use Lead-Identification Technology in Collab with Genentech. News: Discovery & Development. Genetic Engineering & Biotechnology News. Paper. 36. 14. 17.
26. News: Lawrence. Stacy. Genentech, BioLineRx pair up a checkpoint inhibitor combo. FierceBiotech. September 7, 2016. September 18, 2016. https://web.archive.org/web/20160911013920/http://www.fiercebiotech.com/biotech/genentech-biolinerx-pair-up-a-checkpoint-inhibitor-combo. September 11, 2016. live.
27. Web site: 2024-03-20 . Lonza to acquire biologics site in Vacaville, US from Roche for $1.2bn - Pharmafile . 2024-03-20 . pharmafile.com . en-GB.
28. News: Varian . Ethan . March 25, 2023 . Genentech lays off 265 workers in South San Francisco, closes manufacturing plant . The Mercury News.
29. News: Rocha . Natalie . February 21, 2023 . Genentech expands in Oceanside with $450M biotech manufacturing facility and 150 jobs . The San Diego Union-Tribune.
30. Web site: 2021 . History & Funders . live . https://web.archive.org/web/20220712141817/https://www.chcs.org/about-us/history-funders/ . 2022-07-12 . 2022-07-12 . Center for Health Care Strategies . en-US.
31. News: Genentech Press Release. University of California and Genentech Settle Patent Infringement Lawsuits. Genentech, Inc.. November 16, 2015. https://web.archive.org/web/20130822221538/http://www.gene.com/media/press-releases/4887/1999-11-19/university-of-california-and-genentech-s. August 22, 2013. dead.
32. Pear, Robert. "In House, Many Spoke with One Voice: Lobbyists", New York Times, November 15, 2009.