Genentech

• 1. Introduction

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  Genentech was founded in 1976 by a venture capitalist and a biochemist who believed they could turn a laboratory technique into a company. Robert A. Swanson had a hunch, and Herbert Boyer had the science. What Boyer and his colleague Stanley Norman Cohen had demonstrated in 1973 was deceptively simple in concept: restriction enzymes could act as molecular scissors, cutting DNA from one organism and stitching it into another. Nobody had tried to build a business from that idea. Swanson called Boyer and convinced him to try.

  What followed was not just a company. It was the beginning of an entirely new industry. Genentech is widely regarded as the world's first biotechnology company. Its scientists learned to express human genes inside bacteria, turning living cells into miniature drug factories. Within two years of its founding, the company had coaxed bacteria into producing synthetic human insulin. Within a decade, it had drugs on pharmacy shelves.

  The questions the rest of this documentary will pursue: How did a technique developed in an academic laboratory become a billion-dollar medicine? What did Genentech actually build, and at what cost? And what does it mean that a company once celebrated as a homegrown American success story is now a subsidiary of a Swiss pharmaceutical giant?

• 2. Boyer, Swanson, and the Science

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  Herbert Boyer is considered a pioneer in the field of recombinant DNA technology, which is the science of cutting and reassembling genetic material from different organisms. His 1973 experiment with Stanley Norman Cohen showed the world what was possible. Restriction enzymes, proteins found naturally in bacteria, could be used to snip specific sequences from one strand of DNA. Those fragments could then be pasted into a plasmid, a small circular piece of DNA that bacteria use to carry extra genetic instructions. The result was a living cell carrying foreign code, reading it and acting on it.

  When Swanson contacted Boyer, Cohen had returned to academic research. Boyer took the meeting. The two agreed to co-found Genentech, a name that compressed genetic engineering and technology into a single word.

  Boyer brought in Arthur Riggs and Keiichi Itakura from the Beckman Research Institute. Together, the group accomplished something that had never been done before: they expressed a human gene in bacteria. The gene coded for somatostatin, a hormone involved in regulating growth, and the bacteria produced it in 1977. A year later, David Goeddel and Dennis Kleid joined the group. Their contribution was synthetic human insulin, produced in 1978, which would go on to become the first genetically engineered human therapeutic ever approved by the U.S. Food and Drug Administration.

• 3. From Lab to Pharmacy

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  Synthetic human insulin reached the FDA in 1982, approved under the brand name Humulin. Genentech partnered with Eli Lilly and Company, who navigated the product through the approval process and manufactured it under license. It was a landmark. For the first time, a medicine designed at the molecular level using recombinant DNA was legally available to patients.

  Genentech's second commercial drug, Protropin, arrived in 1985. It was a supplementary growth hormone for children with growth hormone deficiency, chemically known as somatrem. Protropin would later become the center of a costly legal fight, but in its early years it established Genentech's position as a company that could move from discovery to prescription.

  Activase followed in 1987. It was a recombinant tissue plasminogen activator, a drug designed to dissolve blood clots in patients experiencing acute heart attacks, and it was also approved for use in non-hemorrhagic stroke. Each new drug demonstrated a different application of the same underlying toolkit: identify a human protein with therapeutic value, find the gene that codes for it, insert that gene into bacteria or another host organism, harvest the protein, and purify it.

  The pipeline that emerged from Genentech's labs over the following decades ranged across oncology, immunology, ophthalmology, and rare diseases. Herceptin, approved in 1998, targeted metastatic breast cancer in patients whose tumors overexpress the HER2 gene. Rituxan, approved in 1997, treated certain non-Hodgkin's lymphomas and was later approved for rheumatoid arthritis. Avastin, approved in 2004, attacked the blood vessel growth that feeds tumors, and eventually received six separate FDA approvals across multiple cancer types, though its approval for advanced breast cancer was later revoked in November 2011.

• 4. Ownership and Independence

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  In 1982, Genentech sold a 6.5 percent equity stake to Corning Glass Works, and the two companies created a joint venture called Genencor to pursue industrial enzymes using recombinant DNA technology. That partnership represented one kind of future: Genentech as a collaborative platform.

  The future that actually arrived looked different. In 1990, F. Hoffmann-La Roche AG acquired a majority stake in the company. The Swiss pharmaceutical giant was making a bet on biotechnology before most of its competitors understood what biotechnology would become. For nearly two decades after that acquisition, Genentech operated with a degree of independence unusual for a majority-owned subsidiary, continuing to conduct research and run clinical trials as if it were still a standalone company.

  That arrangement ended in March 2009, when Roche bought all remaining shares it did not already control for approximately $46.8 billion, making Genentech a wholly owned subsidiary. Genentech Research and Early Development now operates as an independent center within the Roche organization, headquartered in South San Francisco, California, where Genentech was born. As of July 2021, the company employed 13,539 people.

• 5. Disputes and Controversies

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  Protropin, the growth hormone drug Genentech launched in 1985, accumulated $2 billion in sales over its commercial life, making it one of the foundations of the company's financial success. It was also the subject of a legal fight that lasted nearly a decade. The University of California, San Francisco sued Genentech in 1990, claiming the company had taken technology covered by a 1982 UCSF patent and used it without authorization to develop Protropin. UCSF sought $400 million in damages.

  Genentech maintained it had developed the drug independently. A jury in July 1999 found that the university's patent was valid but could not agree on whether Protropin had actually been derived from UCSF research. In November 1999, Genentech agreed to pay $200 million to settle. The settlement was divided among multiple recipients: $30 million went to the University of California General Fund, $85 million went to the three inventors and two collaborating scientists, $50 million funded a new teaching and research campus for UCSF, and $35 million supported university-wide research.

  A different kind of controversy surfaced in 2009, when The New York Times reported that Genentech's talking points on health care reform had appeared verbatim in the official statements of several Members of Congress during the national debate over the Affordable Care Act. Two U.S. Representatives, Joe Wilson and Blaine Luetkemeyer, issued identical written statements that had originally been drafted by lobbyists working for Genentech. The episode drew attention to the close relationship between pharmaceutical industry lobbying and legislative language.

• 6. Research Partnerships

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  Genentech's approach to drug discovery has never been entirely internal. The company entered into a series of collaborations that expanded its scientific reach beyond what its own laboratories could accomplish.

  In 2008, Genentech began working with Roche and its subsidiary GlycArt to develop obinutuzumab, which would eventually reach patients under the brand name Gazyva in 2013 as the first drug with a breakthrough therapy designation to receive FDA approval. In February 2010, Genentech formalized a collaboration with the University of California, San Francisco, building on approximately fifteen prior working relationships to focus on small molecule drug discovery in neurology.

  In January 2015, the company signed a $60 million deal with 23andMe that gave Genentech access to the genomic and patient-reported data the consumer genetics company had gathered from its customers. Nine months earlier, in October 2014, Genentech had paid $150 million upfront to partner with NewLink Genetics of Iowa on checkpoint inhibitors, a class of drugs that help the immune system recognize and attack cancer cells.

  By late 2016, Genentech was running parallel partnerships with Carmot Therapeutics, which was identifying drug candidates that Genentech would then develop, and with the Israeli company BioLineRx on a checkpoint inhibitor intended to work in combination with Genentech's own drug atezolizumab, marketed as Tecentriq. Tecentriq, approved in 2016, was the first anti-PD-L1 antibody approved to treat advanced bladder cancer and metastatic non-small cell lung cancer.

• 7. A Shifting Footprint

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  Genentech's manufacturing footprint has changed substantially over the decades. Its corporate headquarters remain in South San Francisco, but production has spread to Vacaville, Oceanside, and Hillsboro, Oregon, as well as to facilities overseas.

  In December 2006, Genentech sold its facility in Porriño, Spain, to Lonza and acquired an exclusive right to purchase a Lonza mammalian cell culture manufacturing site under construction in Singapore. In June 2007, the company began building a separate facility in Singapore, this one using E. coli rather than mammalian cells, specifically to produce Lucentis in bulk. Lucentis is a treatment for neovascular age-related macular degeneration; Genentech began shipping it on the 30th of June 2006, the day the FDA granted approval after a priority six-month review.

  In 2023, Genentech announced plans to close its manufacturing facility in South San Francisco, the city where the company was founded nearly five decades earlier, while expanding production capacity in Oceanside. In March 2024, Lonza completed the acquisition of Genentech's Vacaville manufacturing site from Roche for $1.2 billion, continuing a commercial relationship between the two companies that stretches back to the 2006 Spain transaction. Hemlibra, a treatment for haemophilia A developed by Chugai Pharmaceutical and approved in 2017, and Ocrevus, the first FDA-approved therapy for both relapsing and primary progressive multiple sclerosis, approved the same year, represent the kinds of products now moving through whatever manufacturing network remains.