Genentech

Genentech, Inc.

Type	Wholly owned subsidiary of Roche
Industry	Biotechnology
Founded	1976
Headquarters	South San Francisco, California, United States
Key people	Ian T. Clark, CEO Sandra J. Horning, M.D. Michael D. Varney, Ph.D. Frederick C. Kentz, III, Legal Timothy L. Moore Nancy Vitale, HR Severin Schwan, Chairman of Genentech Board of Directors, CEO of Roche Group
Products	Avastin, Herceptin, Rituxan, Perjeta, Kadcyla, Gazyva, Tarceva, Esbriet, Cotellic, Alecensa, Zelboraf, Nutropin, ACTEMRA, Lucentis, Xolair, Activase, Xeloda, Boniva, Cathflo Activase, TNKase, CellCept, Pegasys, Pulmozyme, Tamiflu, Valcyte, Anaprox, Cytovene, EC-Naprosyn, Erivedge, Fuzeon, Invirase, Klonopin, Kytril, Naprosyn, Rocephin, Roferon-A, Romazicon, Valium, Xenical, Zenapax
Owner	Hoffmann-La Roche
Number of employees	13,720 (August 21, 2015)
Website	www.gene.com

Genentech, Inc., is a biotechnology corporation which became a subsidiary of Roche in 2009. Genentech Research and Early Development operates as an independent center within Roche.^[1]

As of August 2015, Genentech employed 13,720 people.^[2]

History

The company was founded in 1976 by venture capitalist Robert A. Swanson and biochemist Herbert Boyer.^[3][4] 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.^[5] While Cohen returned to the laboratory in academia, Swanson contacted Boyer to found the company.^[3][6] 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.^[7] 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.^[8]

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.^[9]

in March 2009 Roche acquired Genentech by buying shares it didn't already control for approximately $46.8 billion.^[10][11]

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.^[12]

Research

Genentech was a pioneering research-driven biotechnology company^[8] has continued to conduct R&D internally as well as through collaborations.^[13][14]

Some of its research collaborations include:

• In 2008 Genentech entered into a collaboration with Roche and its subsidiary GlycArt to develop obinutuzumab.^[15]

• 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.^[16]

• In October 2014 Genentech paid $150M upfront to collaborate with Iowa-based NewLink Genetics on checkpoint inhibitors.^[17]

• In January 2015 it signed a $60M deal with 23andMe that gave Genentech access to the genomic and patient-reported data held by 23andMe.^[18]

• In October 2015 it started a collaboration with Nimbus Therapeutics to develop leads from Nimbus' in silico drug discovery platform.^[19]

• In June 2016 Genentech partnered Epizyme to conduct clinical trials exploring whether Epizyme’s EZH2 inhibitor tazemetostat would be synergistic with Genentech's atezolizumab.^[20]

• In August 2016, the company began a collaboration with Carmot Therapeutics in which Carmot will discover new candidates and Genentech will develop them.^[21]

• In September 2016 Genentech partnered with the Israeli company BioLineRx on a checkpoint inhibitor that Genentech intended to pair with its own atezolizumab.^[22]

Facilities

Building 32, one of the Genentech headquarters' newer buildings

Genentech's corporate headquarters are in South San Francisco, California, with additional manufacturing facilities in Vacaville, California; Oceanside, California; and Hillsboro, Oregon.

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.

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."^[23]

Controversy

Disputes

In 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 last July, 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.^[24]

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.^[25]

Products timeline

• 1982 – Synthetic "human" insulin approved by the U.S. Food and Drug Administration (FDA), thanks largely to its partnership 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 renal insufficiency.
• 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-Hodgkins 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 (RA).
• 2011 – Zelboraf (vemurafenib): For the treatment of a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal BRAF gene.
• 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 a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene.
• 2015 – Alecensa (alectinib): Treatment for non-small cell lung cancer (NSCLC).
• Ongoing work: Genentech is working on DR6 blocking and anti-N-APP monoclonal antibodies as a potential treatment to delay progression of neuronal destruction in early Alzheimer's disease. To the extent that prevention of neuronal destruction via DR-6 and N-APP would require ongoing intervention, the effective half-life of any monoclonal antibody treatment would have to be substantial. An siRNA approach against DR-6, or vaccine against N-APP may circumvent these limitations.

Awards and recognitions

• Fortune Magazine named Genentech number one on its 2006 list of the "100 Best Companies To Work For." This was the first number one ranking for the company, which has now been on the list for 18 consecutive years. In 2007, it dropped to second place, behind Google. The company ranked 5th in 2008, 7th in 2009, 19th in 2010, 35th in 2011, 68th in 2012, 36th in 2013, 6th in 2014, 9th in 2015, and 11th in 2016. The ranking is based on anonymous employee responses to a survey as well as an evaluation of the company's policies and culture.
• Genentech was named one of the 100 Best Companies for Working Mothers in 2004, 2006-8 and 2010-11 by Working Mother Magazine.^[26]
• It was named as one of the 100 best corporate citizens 2006 by the Business Ethics Magazine. The company participates in various policy and civic leadership groups, such as TechNet,^[27] and sponsors independent third-party research and publications, such as the journal Nature.^[28]
• Genentech was named Top Employer by Science Magazine on October 7, 2010, where it has been recognized for nine consecutive years.^[29]
• In March 2008, Genentech was named Most Admired Pharmaceutical Company by Fortune for the second consecutive year.
• In July 2010, Genentech was named on the "Top 100 Best Places to Work in IT" list by ComputerWorld magazine.^[30]
• In December 2008, Glassdoor.com rated the Genentech CEO Arthur D. Levinson as the "nicest" CEO of 2008 with a 93% approval rating.^[31]
• Genentech was featured in the documentary film Something Ventured which premiered in 2011.
• The Economist rated Genentech as the Most Innovative Corporation of 2013.^[32]

References

Further reading

• Sally Smith Hughes. Genentech: The Beginnings of Biotech (University of Chicago Press; 2011).
• GenenLab Notebook: "Biotech's Beginnings" - New Genentech Employee Booklet (1996)
• * "Prescription for Profits: How the Pharmaceutical Industry Bankrolled the Unholy Marriage Between Science and Business" by Linda Marsa, Scribner (1997)

External links

Wikimedia Commons has media related to Genentech.

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