Genentech NEWS RELEASE
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`Media Contact:
`Investor Contact:
`
`Dawn Kalmar 650-225-5873
`Kathee Littrell 650-225-1034
`
`FDA APPROVES LUCENTIS FOR THE TREATMENT OF
`WET AGE-RELATED MACULAR DEGENERATION
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`Up to 40% of Patients Treated with LUCENTIS in Pivotal Studies Gained at Least Three
`Lines of Vision on the Study Eye Chart at One Year
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`Wet AMD is a Leading Cause of Blindness in People Over 55
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`SOUTH SAN FRANCISCO, Calif. — June 30, 2006 -- Genentech, Inc. (NYSE: DNA)
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`announced today that the U.S. Food and Drug Administration (FDA) has approved
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`LUCENTISTM (ranibizumab injection) for the treatment of neovascular (wet) age-related
`macular degeneration (AMD). The FDA approved LUCENTIS after a Priority Review (six-
`month). Genentech will ship product today.
`Nearly all patients (95 percent) treated with LUCENTIS maintained their vision in the
`Phase III clinical trials. Vision improved by at least three lines (or 15 letters) on the study eye
`chart in up to 40 percent of these patients at one year. LUCENTIS is designed to inhibit the
`formation and leakage of new blood vessels in the back of the eye, the primary cause of
`central vision loss associated with this disease.
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`"Lucentis provides new hope for patients with wet AMD because it is the first therapy
`to provide a benefit in vision for a significant number of patients," said Arthur D. Levinson,
`Ph.D., Genentech's chairman and chief executive officer. "We are proud that the seminal
`work in angiogenesis conducted at Genentech, years of clinical study, and the dedication and
`commitment of thousands of patients and retina specialists have all contributed to this
`important approval."
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`"In my opinion, the Lucentis approval stands out as one of the most important medical
`developments in ophthalmology during my 25 years in the field because it has the potential to
`reverse vision loss associated with wet AM D," said Eugene de Juan, M.D., president,
`American Society of Retina Specialists. "We are pleased that Lucentis has been approved
`by the FDA and look forward to working with Genentech to provide retina specialists in the
`United States with access to Lucentis for patients as quickly and smoothly as possible."
`The FDA approval of LUCENTIS is based on data from two large Phase III clinical
`trials (MARINA and ANCHOR). In these studies:
`■ Nearly all patients (approximately 95 percent) treated with LUCENTIS (0.5 mg)
`maintained (defined as the loss of less than 15 letters in visual acuity) and up to 40
`percent improved (defined as the gain of 15 letters or more in visual acuity) vision
`at one year, as measured on the Early Treatment of Diabetic Retinopathy (ETDRS)
`eye chart.
`On average, patients treated with LUCENTIS in the MARINA study experienced an
`improvement from baseline of 6.6 letters at two years compared to a loss of 14.9
`letters in the sham group. In the ANCHOR study, patients treated with LUCENTIS,
`on average, experienced an 11.3 letter gain from baseline at one year compared to
`a loss of 9.5 letters in the Visudyne® photodynamic therapy (PDT) control group.
`Up to 40 percent of patients treated with LUCENTIS achieved vision of 20/40 or
`better.
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`■
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`■
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`In addition to data from the two pivotal studies, data from the Phase I/II FOCUS and Phase
`IIlb PIER studies were included in the FDA review.
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`LUCENTIS 0.5 mg is recommended for intravitreal injection once a month. If monthly
`injections are not feasible, treatments can be reduced to one injection every three months
`after the first four monthly injections. Compared to continued monthly dosing, dosing every
`three months will lead to an approximate five-letter (one-line) loss of visual acuity benefit, on
`average, over the following nine months. Patients should be evaluated regularly.
`"Now that Lucentis is approved, we will continue to work with the retina community to
`evaluate how patients may be able to benefit from less frequent dosing, as emerging clinical
`data indicate that dosing may need to be tailored to individual patient needs," said Levinson.
`In clinical trials, the most common adverse reactions among patients treated with
`LUCENTIS (reported in at least 6 percent more patients than in the control groups in at least
`one study) included conjunctival hemorrhage, eye pain, vitreous floaters, increased
`intraocular pressure and intraocular inflammation. Although there was a low rate (less than 4
`percent) of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials
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`that was not statistically different between the LUCENTIS and control groups, there is a
`theoretical risk of ATEs following intravitreal use of inhibitors of VEGF. Serious adverse
`events related to the injection procedure occurred in less than 0.1 percent of intravitreal
`injections, including endophthalmitis, retinal detachments and traumatic cataracts. Other
`serious ocular adverse events observed among LUCENTIS-treated patients (that occurred in
`less than 2 percent of patients) included intraocular inflammation and increased intraocular
`pressure. LUCENTIS is contraindicated in patients with hypersensitivity and ocular or
`periocular infections.
`"The impact of wet AMD goes beyond vision loss and can affect a person's ability to
`interact with family and friends, conduct daily activities and, overall, maintain their
`independence," said Dr. Stephen Rose, chief research officer at the Foundation Fighting
`Blindness. "As an organization dedicated to research for preventions, treatments and cures
`for people affected by retinal degenerative diseases, we applaud the FDA's approval of
`Lucentis as an important advancement in the treatment of wet AMD."
`LUCENTIS was specifically developed for intraocular use in the eye to treat the
`underlying cause of wet AMD by targeting the molecular pathway that controls the formation
`of new blood vessels. LUCENTIS is designed to bind and inhibit VEGF-A, a protein that is
`believed to play a critical role in angiogenesis (the formation of new blood vessels).
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`Webcast Discussion of LUCENTIS FDA Approval
`Genentech will be offering a live webcast of a discussion by Genentech management on
`Friday, June 30, 2006 at 12:00 p.m. Pacific Time. The webcast can be accessed on
`Genentech's website at http://www.gene.com and will be archived and available for replay
`until 5:00 p.m. Pacific Time on July 7, 2006. A telephonic replay will also be available
`beginning at 3:00 p.m. Pacific Time on June 30, 2006 through 5:00 p.m. Pacific Time on July
`7, 2006. Access numbers for this replay are: 1-800-642-1687 (U.S./Canada) and 1-706-645-
`9291 (international); Conference ID number is 1794492.
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`About LUCENTIS
`LUCENTISTM (ranibizumab injection) (0.5 mg) is approved for the treatment of patients with
`neovascular (wet) AMD. LUCENTIS is a recombinant humanized IgG1 kappa isotype
`therapeutic antibody fragment developed for intraocular use.
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`LUCENTIS binds to and inhibits the biologic activity of human vascular endothelial growth
`factor A (VEGF-A), a protein that is believed to play a critical role in angiogenesis (the
`formation of new blood vessels). VEGF-A has been shown to lead to wet AMD disease
`progression and central vision loss. LUCENTIS was developed by Genentech and the
`Novartis Ophthalmics Business Unit for diseases or disorders of the eye. Genentech retains
`commercial rights in the United States and Novartis has exclusive commercial rights for the
`rest of the world. For LUCENTIS prescribing information, please call 1-866-LUCENTIS or visit
`http://www.lucentis.com.
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`About AMD
`AMD is a major cause of painless central vision loss and is a leading cause of blindness in
`people over 55. The National Eye Institute estimates that there are 1.7 million people with
`the advanced form of AMD in the United States alone and that this prevalence will grow to
`2.95 million by 2020. AMD occurs in two forms: dry and wet.
`The dry form is associated with atrophic cell death of the central retina or macula,
`which is required for fine vision used for activities such as reading, driving or recognizing
`faces. The wet form is caused by growth of abnormal blood vessels, also known as choroidal
`neovascularization (CNV) or ocular angiogenesis, under the macula. These vessels leak
`fluid and blood and cause scar tissue that destroys the central retina. This process results in
`a deterioration of sight over a period of months to years.
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`About Angiogenesis
`Genentech is a leader in research and product development in the area of angiogenesis, the
`process by which new blood vessels are formed.
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`In 1989, Napoleone Ferrara, M.D., and a team of scientists at Genentech conducted seminal
`work in the field, which resulted in the identification and cloning of a gene termed Vascular
`Endothelial Growth Factor (VEGF), now known as VEGF-A. The VEGF-A protein is believed
`to play a critical role in angiogenesis and serves as one of the key contributors to
`physiological or pathological conditions that can stimulate the formation of new blood vessels.
`The process of angiogenesis is normally regulated throughout development and adult life,
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`and the uncontrolled growth of new blood vessels is an important contributor to a number of
`pathologic conditions, including wet AMD.
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`Genentech's Commitment to Patient Access
`Genentech is committed to assisting eligible patients in accessing our therapies for approved
`indications, regardless of their ability to pay. Although Genentech's products are covered by
`most government and private insurance, Genentech established the Genentech® Access to
`Care Foundation (GATCF) in 1990 for its marketed products, and donates free product to
`eligible uninsured patients in the United States, except for Pulmozyme® (dornase alfa,
`recombinant), which is covered by the Genentech Endowment for Cystic Fibrosis. In 2005
`alone, GATCF supported over 18,000 patients by providing approximately $200 million of free
`product. Genentech recently donated more than $27 million to several independent public
`charities that provide financial assistance to eligible patients who cannot access needed
`medical treatment due to co-pay costs. To learn more about these independent, public
`charities and potential financial assistance options, patients can speak with an Alternative
`Funding Specialist from Genentech's Single Point of Contact (SPOC) group by calling 866-
`724-9394 or visiting http://www.SPOConline.com.
`
`About Genentech
`Founded 30 years ago, Genentech is a leading biotechnology company that discovers,
`develops, manufactures and commercializes biotherapeutics for significant unmet medical
`needs. A considerable number of the currently approved biotechnology products originated
`from or are based on Genentech science. Genentech manufactures and commercializes
`multiple biotechnology products and licenses several additional products to other companies.
`The company has headquarters in South San Francisco, California and is listed on the New
`York Stock Exchange under the symbol DNA. For additional information about the company,
`please visit http://www.qene.corn.
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`111111
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`This press release contains a forward-looking statement regarding the shipping timeframe for
`LUCENTIS. Such statement is a prediction and involves risks and uncertainties such that the
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`Exhibit 2121
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`actual result may differ materially. Among other things, the shipping timeframe for
`LUCENTIS could be affected by unexpected delays in preparation of finished product for
`shipping or in delivery of finished product to shippers. Please also refer to Genentech's
`periodic reports filed with the Securities and Exchange
`Commission. Genentech disclaims, and does not undertake, any obligation to update or
`revise any forward-looking statement in this press release.
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`Exhibit 2121
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