Friday, Jun 30, 2006
South San Francisco, Calif. -- June 30, 2006 --Genentech, Inc. (NYSE: DNA) announced today that the U.S. Food and Drug Administration (FDA) has approved LUCENTIS (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.
"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."
"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 AMD," 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:
In addition to data from the two pivotal studies, data from the Phase I/II FOCUS and Phase IIIb PIER studies were included in the FDA review.
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 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).
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.
LUCENTIS (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. 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.
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.
Genentech is a leader in research and product development in the area of angiogenesis, the process by which new blood vessels are formed. 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, and the uncontrolled growth of new blood vessels is an important contributor to a number of pathologic conditions, including wet AMD.
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.
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.gene.com.
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 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.