A History of Firsts
Genentech was founded in 1976 by venture capitalist Robert A. Swanson and biochemist Dr. Herbert W. Boyer. In the early 1970s, Boyer and geneticist Stanley Cohen pioneered a new scientific field called recombinant DNA technology.
After hearing about Boyer and Cohen's breakthrough, Swanson placed a call to Boyer and requested a meeting. Boyer agreed to give the young entrepreneur 10 minutes of his time. Swanson's enthusiasm for the technology and his faith in its commercial viability was contagious, and the meeting extended from 10 minutes to three hours; by its conclusion, Genentech was born.
Though Swanson and Boyer faced skepticism from both the academic and business communities, they forged ahead with their idea. Within a few short years, they successfully demonstrated the viability of using recombinant DNA technology to develop products with practical applications and, in so doing, launched a whole new industry.
- Robert Swanson and Dr. Herbert Boyer founded Genentech on April 7.
- Genentech produced the first human protein (somatostatin) in a microorganism (E. coli bacteria).
- Human insulin cloned by Genentech scientists.
- Human growth hormone cloned by Genentech scientists.
- Genentech went public and raised $35 million with an offering that leapt from $35 a share to a high of $88 after less than an hour on the market. The event was one of the largest stock run-ups ever.
- First recombinant DNA drug marketed: human insulin (licensed to Eli Lilly and Company).
- First laboratory production of Factor VIII, a clotting factor for bleeding in hemophiliacs. Genentech announced agreement to grant license of worldwide production and marketing of Factor VIII to Cutter Biological.
- Genentech received approval from the U.S. Food and Drug Administration (FDA) to market its first product, Protropin® (somatrem for injection) growth hormone for children with growth hormone deficiency the first recombinant pharmaceutical product to be manufactured and marketed by a biotechnology company.
- Genentech's interferon alpha-2a licensed to Hoffmann-La Roche, Inc. as Roferon®-A received approval from the FDA for the treatment of hairy cell leukemia.
- Genentech instituted the Uninsured Patients Program, providing free growth hormone for financially needy, uninsured patients in the United States. The program was later expanded to include future products.
- Genentech received FDA approval to market Activase® (Alteplase, recombinant), a tissue-plasminogen activator (t-PA), to dissolve blood clots in patients with acute myocardial infarction (heart attack).
- Genentech opened its day-care center, Genentech's Second Generation, one of the largest corporate-sponsored day-care centers in the United States at the time.
- Roche Holding Ltd. of Basel, Switzerland acquires a majority holding in Genentech.
- Genentech's Hepatitis B vaccine licensed to SmithKline Beecham Biologicals S.A. received FDA approval.
- Genentech received FDA approval to market Activase® for the management of acute massive pulmonary embolism (blood clots in the lungs).
- Genentech opened the Founders Research Center, dedicated to founders Robert Swanson and Dr. Herbert Boyer in appreciation of their vision and determination to pursue the promise of biotechnology.
- Genentech received FDA approval to market Nutropin® [somatropin (rDNA origin) for injection] for treating growth failure in children with chronic renal insufficiency before they undergo kidney transplantation.
- Genentech received approval to market Pulmozyme® (dornase alfa) for treating cystic fibrosis from regulatory agencies in the United States, Canada, Sweden, Austria and New Zealand.
- Genentech's Factor VIII licensed to Miles Inc. (formerly Cutter Biological) in 1984 received FDA approval for the treatment of hemophilia-A.
- Genentech announced it would locate its new manufacturing facility in Vacaville, California.
- Genentech received FDA approval to market Nutropin® for the treatment of children with growth failure due to inadequate levels of the natural growth hormone in their bodies.
- Genentech announced an agreement with Roche Holding, Ltd. to extend for four years Roche's option to purchase the outstanding redeemable common stock of the company at a predetermined price that escalates quarterly up to $82.50 a share. As part of the agreement, Genentech began receiving royalties rather than recording sales on European sales of Pulmozyme® and Canadian sales of all Genentech products as Roche assumed responsibility for those sales.
- Genentech received FDA approval to market an accelerated infusion regimen of Activase® for the management of acute myocardial infarction.
- Genentech celebrated the 20-year anniversary of its founding.
- Genentech received FDA approval to market Nutropin AQ® [somatropin (rDNA origin) injection] for the treatment of growth failure in children with chronic renal insufficiency before they undergo kidney transplantation and for the treatment of growth hormone deficiency in children.
- Genentech received FDA approval to market Activase® for the treatment of acute ischemic stroke or brain attack.
- Genentech received FDA approval to market Pulmozyme® for treating cystic fibrosis patients with advanced disease.
- Genentech and partner IDEC Pharmaceuticals (now Biogen Idec Inc.) received FDA approval to market Rituxan® (Rituximab) for the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkins lymphoma.
- Genentech received FDA approval to market Nutropin AQ® for the treatment of short stature associated with Turner syndrome.
- Genentech received FDA approval to market Nutropin® and Nutropin AQ® for the treatment of growth hormone deficiency in adults.
- Genentech launched a service for patients and their physicians called SPOC Single Point of Contact to provide customer-focused reimbursement assistance. The program became Genentech Access Solutions in 2008.
- In recognition of the importance of Genentech in establishing the biotechnology industry in South San Francisco, the city renamed the 400 block of Point San Bruno Boulevard to DNA Way, giving Genentech the new street address 1 DNA Way.
- Genentech received approval from the FDA to market the humanized antibody Herceptin® (Trastuzumab) as a first-line therapy in combination with paclitaxel and as a single agent in second- and third-line therapy for patients with metastatic breast cancer who have tumors that overexpress the HER2 (human epidermal growth factor receptor2) protein.
- Genentech dedicated its new $250 million manufacturing facility in Vacaville.
- Genentech co-founder Robert Swanson was awarded (posthumously) the National Medal of Technology for his foresight and leadership in recognizing the commercial promise of recombinant DNA technology and his seminal role in the establishment and development of the biotechnology industry.
- Genentech reached a settlement agreement with the U.S. Attorney for the Northern District of California regarding Genentech's promotion of human growth hormone in the late 1980s and early 1990s.
- Roche exercised its option to cause Genentech to redeem all of its outstanding special common shares not owned by Roche. Roche announced its intent to publicly sell up to 19 percent of Genentech shares and continue Genentech as a publicly traded company with independent directors.
- Genentech received FDA approval of additional efficacy results for its growth hormone products — Nutropin® and Nutropin AQ® — on the effects of growth hormone replacement therapy on spine bone mineral density in young adults with childhood-onset growth hormone deficiency (GHD).
- On July 20, after about a month-long hiatus due to the Roche redemption, Genentech returned to the New York Stock Exchange (NYSE) with a public reoffering of 22 million shares by Roche, in what is considered the largest public offering in the history of the U.S. healthcare industry. The stock closed the first day of trading at $127, over 31 percent above the public offering price of $97. This was also the first introduction of Genentech's new NYSE trading symbol, DNA.
- Roche conducted a secondary offering of 20 million Genentech shares on October 20. The shares were priced at $143.50 per share, making it the largest secondary offering in U.S. history.
- Genentech and the University of California (UC) agreed to a settlement of the patent infringement lawsuit brought by UC relating to the company's human growth hormone product, Protropin. Both parties agreed that this settlement was not an admission that Genentech infringed UC's patent or used the genetic material in question.
- Genentech and partner Alkermes, Inc. received FDA approval to market Nutropin Depot®[somatropin (rDNA origin) for injectable suspension] for the long-term treatment of growth failure due to a lack of adequate endogenous GH secretion.
- Roche conducted a third offering of up to 19 million shares of Genentech stock at $163 per share.
- Genentech announced the purchase of a cell culture manufacturing facility in Porriño, Spain. Genentech sold the facility to Lonza in 2006.
- Genentech's state-of-the-art manufacturing facility in Vacaville, California, received FDA licensure as a multi-product facility.
- Genentech received FDA approval of TNKase® (Tenecteplase), a modified form of t-PA, for use in mortality reduction associated with acute myocardial infarction (AMI), or heart attack; treatment should be initiated as soon as possible after the onset of AMI symptoms.
- Genentech celebrated the 25th anniversary of its founding.
- Cathflo® Activase® (Alteplase) was approved by the FDA for the restoration of function to central venous access devices (CVADs).
- The FDA approved Nutropin AQ PEN® for delivery of Nutropin AQ recombinant growth hormone.
- A Los Angeles County Superior Court jury voted to award the City of Hope (COH) $300 million in additional royalties and $200 million in punitive damages in the retrial of a contract dispute lawsuit brought by COH against Genentech. Genentech announced it would appeal the judgment in the case to the California Court of Appeal.
- Genentech received FDA approval to include HER2 gene detection test in Herceptin® product labeling.
- Genentech received FDA approval for Xolair® (Omalizumab) for Subcutaneous Use in adults and adolescents (age 12 or older) with moderate-to-severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Xolair is the first humanized therapeutic antibody for the treatment of asthma and the first approved therapy designed to target the antibody IgE, a key underlying cause of the symptoms of asthma that has an allergic component.
- Genentech received FDA approval for Raptiva® (efalizumab) for the treatment of chronic moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy. In April 2009, Genentech announced the voluntary withdrawal from the U.S. market of Raptiva.
- Genentech received FDA approval for Avastin® (bevacizumab) for use in combination with 5-Fluorourcil-based chemotherapy in the treatment of first-line metastatic cancer of the colon or rectum. Avastin is the first FDA-approved therapy designed to inhibit angiogenesis, a process fundamental to cancer growth and metastasis.
- Genentech broke ground on an expansion of the Vacaville site. When completed, the new facility will be configured with an additional eight 25,000-liter fermentation tanks and, when combined with our existing facility, will be the largest biotechnology cell culture manufacturing site of its kind in the world.
- OSI Pharmaceuticals and Genentech announced that the FDA approved, after priority review, Tarceva® (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Tarceva is an oral tablet indicated for daily administration.
- Genentech purchased Biogen Idec's Oceanside, California, biologics manufacturing facility.
- Genentech received FDA approval for Tarceva (100 mg) in combination with gemcitabine chemotherapy for the treatment of locally advanced, inoperable or metastatic pancreatic cancer in patients who have not received previous chemotherapy.
- Genentech celebrated the 30th anniversary of its founding.
- Genentech received approval from the FDA for Lucentis® (ranibizumab injection) for the treatment of neovascular (wet) age-related macular degeneration.
- Genentech received FDA approval for Rituxan for use in combination with methotrexate for the treatment of adult patients with moderately- to severely-active rheumatoid arthritis who have had an inadequate response to one or more TNF antagonist therapies.
- Genentech received FDA approval for Herceptin as part of a treatment regimen containing doxorubicin, cyclophosphamide and paclitaxel, for the adjuvant treatment of patients with HER 2-positive, node-positive breast cancer.
- Genentech received FDA approval for Avastin in combination with carboplatin and paclitaxel for the first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC.
- Genentech and Lonza finalized an agreement for Lonza to purchase Genentech's manufacturing facility in Porriño and to continue to supply Avastin for Genentech under a supply agreement. Concurrently, Genentech entered into a supply agreement for the manufacture of certain Genentech products at Lonza's facility currently under construction in Singapore, with the right to exercise an exclusive option to purchase the facility between 2007 and 2012.
- Genentech finalized its acquisition of Tanox, enabling Genentech to improve the Xolair business and acquire Tanox's product pipeline.
- In January 2008, Genentech received FDA approval for Herceptin® (Trastuzumab) as a single agent, for the adjuvant treatment of HER2-overexpressing node-negative (ER/PR-negative or with one high risk feature) or node-positive breast cancer, following multi-modality anthracycline-based therapy.
- In February 2008, Genentech received accelerated approval from the FDA for Avastin® (bevacizumab), in combination with paclitaxel chemotherapy, for the treatment of patients who have not received chemotherapy for their metastatic HER2-negative breast cancer.
- In April 2008, The California Supreme Court overturned the award of $200 million in punitive damages resulting from the contract dispute lawsuit brought by City of Hope against Genentech.
- In May 2008, Genentech received FDA approval for Herceptin® (trastuzumab) as part of a treatment regimen containing doxorubicin, cyclophosphamide, and docetaxel, and also as part of another regimen containing docetaxel and carboplatin, for the adjuvant treatment of HER2 overexpressing, node-positive, or high-risk node-negative breast cancer.
- In July 2008, Genentech received a proposal from Roche to acquire all of the outstanding shares of Genentech stock not owned by Roche.
- In March 2009, Roche and Genentech announced that they have signed a merger agreement under which Roche will acquire the outstanding publicly held interest in Genentech for US$95.00 per share in cash, or a total payment of approximately US$46.8 billion to equity holders of Genentech other than Roche.
- In May 2009, Genentech received accelerated approval by the FDA for Avastin® (bevacizumab) for people with glioblastoma with progressive disease following prior therapy.
- In August 2009, Genentech received FDA approval for Avastin® (bevacizumab) plus interferon-alfa for people with metastatic renal cell carcinoma, the most common type of kidney cancer.
- In January 2010, Genentech received FDA approval for Actemra® (tocilizumab) to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well.
- In February 2012. Genentech received FDA approval for Rituxan® (Rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).
- In April 2010, Genentech received FDA approval for Tarceva® (erlotinib) as a maintenance treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
- In June 2010, Genentech received FDA approval for Lucentis® (ranibizumab injection) for the treatment of macular edema following retinal vein occlusion (RVO).
- In June 2010, Richard Scheller, Ph.D., Executive Vice President, Research and Early Development (gRED), won the 2010 Kavli Prize in Neuroscience, awarded for outstanding achievement in advancing our knowledge and understanding of the brain and nervous system.
- In August 2010, Genentech received FDA approval for longer use of Valcyte (valganciclovir hydrochloride) in adult kidney transplant patients at high risk for cytomegalovirus (CMV) disease.
- In October 2010, Genentech received FDA approval for Herceptin® (Trastuzumab) was approved, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
- In October 2010, Genentech launched Faces of MBC, to raise awareness about metastatic breast cancer and help support those living with the disease
- 2010 marks the 25th anniversary of Genentech's first product approval. 25 years ago, on October 18, 1985, Genentech received FDA approval to market its first product, a growth hormone for children with growth hormone deficiency. It was the first recombinant biotech drug to be manufactured and marketed by a biotechnology company.
- Genentech celebrated the 35th anniversary of its founding.
- In January 2011, Genentech received FDA approval Actemra® (tocilizumab) for inhibition and slowing of structural joint damage, improvement of physical function, and achievement of major clinical response in adult patients with moderately to severely active rheumatoid arthritis (RA), when given in combination with methotrexate (MTX).
- In January 2011, Genentech received FDA approval Rituxan® (rituximab) as a maintenance treatment for patients with advanced follicular lymphoma who responded to initial treatment with Rituxan plus chemotherapy (induction treatment).
- In April 2011, Genentech received FDA approval ACTEMRA (tocilizumab) for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older.
- In April 2011, Genentech received FDA approval Rituxan® (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).
- In August 2011, Genentech received FDA approval for Zelboraf® (vemurafenib) for the treatment of BRAF V600E mutation-positive, inoperable or metastatic melanoma, as determined by an FDA-approved test.
- In November 2011, the FDA revoked approval of Avastin® (bevacizumab) for treatment of metastatic breast cancer (mBC) in the United States.
- In January 2012, Genentech received FDA approval for Erivedge® (vismodegib) for the treatment of adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.
- In May 2012, Genentech launched Faces of Skin Cancer, to learn more about and better support the advanced skin cancer community.
- In June 2012, Genentech received FDA approval for Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
- In August 2012, Genentech received FDA approval for Lucentis® (ranibizumab injection) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness.
- In September 2012, Genentech launched the Lung Cancer Project. The Lung Cancer Project aims to determine if subconscious biases exist for lung cancer, and if so, to understand why people are biased, how those biases impact lung cancer care and to address misperceptions of lung cancer.
- In October 2012, Genentech received FDA approval for Actemra® (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs).
- Ian Clark was selected as the San Francisco Business Times 2012 Most Admired CEO in the Public Companies category.
- 2012 marked the 20th Anniversary of the Genentech Goes to Town program in South San Francisco. The program supports neighboring communities by encouraging employees to take a break from work and get to know local businesses.
- Genentech, the Banner Alzheimer's Institute, and the National Institutes of Health are collaborating on the first-ever prevention trial in cognitively healthy individuals who are likely to develop Alzheimer's disease due to their genetic history.
- In December 2012, Genentech received FDA approval for Tamiflu® (oseltamivir phosphate) for the treatment of acute, uncomplicated influenza to include infants two weeks of age and older. The approval makes Tamiflu the only prescription oral antiviral medicine approved to treat people of all ages, from infants two weeks of age to elderly people.
- Working Mother magazine named Genentech one of the "100 Best Companies for Working Mothers." This is the 19th year Genentech has appeared on the list.
- Genentech was named one of the "top employers in the biopharmaceutical industry" by Science magazine. This is the twelfth year Genentech has appeared on the list. We have been ranked the #1 company eight times.
- In January 2013, Genentech received FDA approval for Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
- In February 2013, Genentech received FDA approval for Kadcyla™ (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. Kadcyla is the fourth medicine from Genentech to receive FDA approval for people with advanced cancers within the past two years.
- In April 2013, Genentech received FDA approval for Actemra® (tocilizumab) for the treatment of polyarticular juvenile idiopathic arthritis. The medicine can be used in children two years of age and older with active disease.
- In May 2013, Genentech received FDA approval of Tarceva® (erlotinib) for the initial (first-line) treatment of people with metastatic non-small cell lung cancer whose tumors have certain epidermal growth factor receptor (EGFR) activating mutations as detected by an FDA-approved test. The FDA also approved the cobas® EGFR Mutation Test, which was developed by Roche and validated in the pivotal EURTAC study.
- In September 2013, Richard Scheller, Ph.D., Executive Vice President, Research and Early Development (gRED), was named a winner of the 2013 Albert Lasker Basic Medical Research Award, which is given annually to a scientist whose fundamental investigations have provided techniques, information, and concepts contributing to the elimination of major causes of disability and death.
- In September 2013, the FDA granted accelerated approval for Genentech’s Perjeta® (pertuzumab) regimen for neoadjuvant treatment (use before surgery) in people with high-risk, HER-2 positive early stage breast cancer. The Perjeta regimen is the first neoadjuvant breast cancer treatment approved by the FDA and also the first to be approved based on pCR data.
- In October 2013, Genentech announced plans to invest more than $285 million for the expansion of its biologics manufacturing facilities in Vacaville and Oceanside. The Vacaville facility will become the largest producer of biologic medicines for the Roche Group, but also the largest biotech manufacturing facility in the world.
- In October 2013, Genentech received FDA approval for the subcutaneous formulation of Actemra® (tocilizumab) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX) that did not provide enough relief.
- In October 24, 2013, the Smithsonian’s National Museum of American History unveiled the “Birth of Biotech” showcase display, which commemorates breakthrough scientific discoveries and the use of genetic engineering to make medicines that improve patients’ lives. The display features more than 130 artifacts related to Genentech’s history and role in the creation of the biotechnology industry.
- In December 2013, Ian Clark, CEO, accepted The Economist Innovation Award on behalf of Genentech, which recognized Genentech for its impressive track record in research and scientific innovation.
- In November 2013, Genentech received FDA approval for Gazyva™ (obinutuzumab) in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia. Gazyva is the first medicine approved with the FDA’s Breakthrough Therapy Designation and the fifth cancer medicine from Genentech approved by the FDA in the past three years.
- FORTUNE named Genentech one of the "100 Best Companies to Work For" for the 16th consecutive year.
- In March 2014, Genentech received FDA approval for Xolair® (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy.