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Genentech

Official History & Timeline 2002 capture

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. Excited by the 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 had proved their detractors wrong and invented a whole new industry.

1976

Robert Swanson and Dr. Herbert Boyer founded Genentech on April 7.

1977

Genentech produced the first human protein (somatostatin) in a microorganism (E. coli bacteria).

1978

Human insulin cloned by Genentech scientists.

1979

Human growth hormone cloned by Genentech scientists.

1980

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.

1982

First recombinant DNA drug marketed: human insulin (licensed to Eli Lilly and Company).

1984

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.

(side note Cutter is the same company who had killed millions w pooled Factor VIII tainted blood)

1985

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.

1986

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.

1987

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).

1988

Genentech's Uninsured Patients Program expanded to cover Activase®.

1989

Genentech opened its day-care center, Genentech's Second Generation, one of the largest corporate-sponsored day-care centers in the U.S.

1990

Genentech received FDA approval to market Actimmune® (Interferon gamma-1b) for the treatment of chronic granulomatous disease, a rare, inherited deficiency of the immune system resulting in frequent and severe infections. Actimmune® was added to the Uninsured Patients Program.

Genentech received FDA approval to market Activase® for the management of acute massive pulmonary embolism (blood clots in the lungs).

Genentech and Roche Holding Ltd. of Basel, Switzerland completed a $2.1 billion merger. Genentech's Hepatitis B vaccine - licensed to SmithKline Beecham Biologicals S.A. - received FDA approval.

1991

Two licensees received approval to market t-PA in Japan and began selling it there.

1992

Genentech and Roche announced a collaborative agreement for the development, registration and marketing of Pulmozyme® (dornase alfa, recombinant) Inhalation Solution in all major countries in Europe.

Genentech entered into research and development collaborations with Roche for- biotechnology-based automated screening of Roche's chemical library to identify new small-molecule drug candidates; a custom immunoadhesin protein based on the tumor necrosis factor (TNF) receptor.

Genentech opened the Founders Research Center, the largest biotechnology research facility in the world. The center was dedicated to founders Robert Swanson and Dr. Herbert Boyer in appreciation of their vision and determination to pursue the promise of biotechnology.

1993

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 introduced the Genentech Foundation for Growth and Development, an independent non-profit organization to advance the understanding of growth and development of children and to encourage and create research opportunities for practicing physicians and nurses who often have not had such opportunities in the past.

Genentech received approval to market Pulmozyme® 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's bovine growth hormone - licensed to Monsanto Corporation and distributed under the name Posilac - received FDA approval.

The 41,000 patient GUSTO trial (Global Utilization of Streptokinase and t-PA for Occluded Coronary Arteries) showed that an accelerated infusion of Activase® combined with IV heparin reduced heart attack patient mortality by nearly 14 percent over streptokinase (a brand of Kabikinase).

Genentech was granted a permanent injunction against the Wellcome Foundation that prevents Wellcome from marketing t-PA in the United States until Genentech's patent expires in 2005.

Genentech launched Access Excellence, a $10 million nationwide communications network program designed to enable high school biology teachers across the country to access their peers as well as experts.

1994

Genentech introduced the Pulmozyme Patient Pledge to ensure that every qualified cystic fibrosis patient in the United States who needs Pulmozyme® and its related equipment can obtain it and that Genentech's research in cystic fibrosis will continue at an aggressive pace.

Genentech received approval from regulatory agencies in the United Kingdom to market Pulmozyme® for treating cystic fibrosis.

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 it would locate its new $150 million manufacturing facility in Vacaville, California.

1995

Genentech and Eli Lilly and Company settled all pending patent infringement, breach of contract, and related claims, ending a long-standing dispute regarding recombinant human growth hormone.

Genentech entered into an agreement with Alkermes, Inc. to develop sustained release formulations of up to two Genentech proteins utilizing Alkermes' proprietary ProLease® microencapsulation technology.

Genentech entered into an agreement with IDEC Pharmaceuticals for the development of IDEC's anti-CD20 monoclonal antibody, C2B8, for the treatment of non-Hodgkin's B-cell lymphomas.

Genentech received FDA approval to market an accelerated infusion regimen of Activase® for the management of acute myocardial infarction.

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.

1996

Genentech celebrated the 20-year anniversary of its founding.

Genentech received FDA approval to market Nutropin AQ® [somatropin (rDNA origin) injection], the first and only liquid (aqueous) recombinant human growth hormone, for treating 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 Nutropin® for the treatment of short stature associated with Turner syndrome.

Genentech received FDA approval to market Pulmozyme® for treating cystic fibrosis patients with advanced disease.

1997

Genentech and partner IDEC Pharmaceuticals, 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 to growth hormone patients, oncology patients and their physicians called SPOC - Single Point of Contact - to provide customer-focused reimbursement assistance.

Genentech was granted patents for methods of treating hemophiliacs with recombinant human Factor VIII and recombinant human Factor VIII as a pharmaceutical product. A corresponding European patent was granted in 1991.

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.

1998

Genentech received approval from the FDA to market the humanized monoclonal 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 entered into an agreement with Roche providing Roche exclusive ex-U.S. marketing rights for Herceptin®.

Genentech's and IDEC Pharmaceutical Corporation's international partner Roche received approval from the European Commission in the European Union to market MabThera (known as Rituxan® in the United States). MabThera was approved for treating non-Hodgkin's lymphoma (NHL) patients who have had two or more relapses or are resistant to chemotherapy.

Genentech received FDA approval for a change in labeling for Pulmozyme®, which includes the safety and alternative administration of Pulmozyme® in cystic fibrosis patients under the age of five.

Genentech received FDA approval for the large-scale (12,000-liter) manufacture of Rituxan, enabling Genentech to supplement the Rituxan® manufactured by partner IDEC.

Genentech dedicated its new $250 million manufacturing facility in Vacaville. The 310,000-square-foot operation is the world's largest biotech manufacturing facility for the large-scale production of pharmaceutical proteins.

Genentech settled patent litigation on Novo Nordisk A/S and Genentech patents relating to human growth hormone and insulin. Novo Nordisk and Genentech cross-licensed worldwide certain patents relating to human growth hormone. Novo Nordisk received a worldwide license under Genentech patents relating to insulin and Genentech received certain payments.

Genentech signed multiparty agreements with Schering-Plough Corporation, Biogen, Inc. and Roche, settling a 1996 lawsuit that Biogen filed against Roche and Genentech related to a disputed alpha interferon invention. As a result of the settlement, the U.S. Patent Office is expected to issue a patent to Genentech/Roche for the disputed interferon alpha claim. Genentech expects to receive certain future payments.

1999

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 was named one of Fortune's “100 Best Companies to Work for in America.”

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 1980's and early 1990's. The $50 million settlement amount was recorded as a special charge to Genentech's first-quarter 1999 earnings.

Genentech entered into an agreement with Immunex to grant rights under Genentech's immunoadhesin patent portfolio to Immunex for its product ENBREL®.

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 filed with the Securities and Exchange Commission a registration statement relating to a proposed public offering of Genentech shares owned by Roche Holdings, Inc.

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. health care 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.

For the ninth time, Genentech was named one of the “100 Best Companies for Working Mothers” by Working Mother magazine.

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 CEO Art Levinson received the 1999 Corporate Leadership Award from the National Breast Cancer Coalition (NBCC) in recognition for the company's groundbreaking partnership with breast cancer advocates in the research process for Herceptin®.

Genentech and IDEC Pharmaceuticals, Corp. were honored with the 1999 Trailblazers Award from the Cure for Lymphoma Foundation for their groundbreaking research and development of Rituxan®.

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®. Under the terms of the settlement agreement, Genentech will pay the University of California $150 million and make a contribution in the amount of $50 million toward construction of the first biological sciences research building at Mission Bay, a new 43-acre research and teaching campus of the University of California, San Francisco (UCSF). Both parties agree that this settlement is not an admission that Genentech infringed UC's patent or used the genetic material in question.

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).

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.

2000

Genentech was named to Fortune Magazine's list of “100 Best Companies to Work for in America.” In the 2000 list, Genentech rose to number 32 from its number 52 ranking the previous year.

Roche conducted a third offering of up to 19 million shares of Genentech stock at $163 per share.

Genentech received the Multiple Myeloma Research Foundation (MMRF) Corporate Leadership Award.

Genentech was presented with the 5th Annual Helix Award at the BIO 2000 International Meeting and Exhibition in Boston. The Helix Award is the highest award of excellence for the biotechnology industry.

Genentech announced the purchase of a cell culture manufacturing facility in Porriño, Spain. The facility has been established as a wholly-owned subsidiary company, “Genentech España S.L.,” and will supplement Genentech's existing bulk cell culture production capacity in South San Francisco and Vacaville.

Genentech's new state-of-the-art manufacturing facility in Vacaville, CA received FDA licensure as a multi-product facility.

Genentech received FDA approval of TNKase™ for the treatment of acute myocardial infarction (heart attack). TNKase™ is the first “clot-buster” that can be administered over five seconds in a single dose. With TNKase™, Genentech set a company shipping record for newly-approved products: The first package was shipped 9 days and 21 hours after FDA approval.

Herbert W. Boyer and the late Robert A. Swanson of Genentech were named recipients of the 2nd Annual Biotechnology Heritage Award (sponsored by BIO and the Chemical Heritage Foundation) for their contributions in shaping the biotechnology revolution.

2001

Genentech celebrated the 25th anniversary of its founding.

For the third consecutive year, Genentech was named one of Fortune's “100 Best Companies to Work For in America.”

Cathflo™ Activase® (Alteplase), a tissue plasminogen activator (t-PA), was approved by the FDA for the restoration of function to central venous access devices (CVADs). Cathflo Activase is the only marketed thrombolytic available for this indication and offers medical professionals a viable treatment option for a CVAD complication that can hinder patient care.

The U.S. Patent and Trademark Office granted Genentech and the City of Hope a patent relating to fundamental methods and compositions used to produce antibodies by recombinant DNA technology. The decision follows almost 10 years of proceedings in the Patent Office and in the U.S. District Court to determine whether the invention covered by the patent was invented first by scientists at Genentech and City of Hope National Medical Center or by scientists at Celltech in England.

Genentech was named one of the “100 Best Companies for Working Mothers,” in the October issue of Working Mother Magazine. This was the 10th time the company has made the list.

The Genentech Foundation for Biomedical Sciences was recognized by the U. S. House of Representatives for its contributions to the education of the students in San Mateo County.

2002

For the fourth consecutive year, Genentech was named one of Fortune's “100 Best Companies to Work For in America.”

For the second year in a row, Red Herring magazine named Genentech to its “Red Herring 100” list of companies most likely to change the world.

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 will appeal the judgment in the case to the California Court of Appeal.

Genentech was named “Biotechnology Company of the Year” by Med Ad News in the magazine's July 2002 issue.

The San Francisco Business Times ranked Genentech #12 on its first annual list of corporate philanthropists in the Bay Area. 1)

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