Healthcare Industry News: Bayer Schering
News Release - February 14, 2007
Favrille Announces Agreement With Berlex, Inc. Regarding Use of FavId(R) in Combination With Leukine(R) (sargramostim) in B-Cell Non-Hodgkin's LymphomaSAN DIEGO, Feb. 14 (HSMN NewsFeed) -- Favrille, Inc. (Nasdaq: FVRL ), a biopharmaceutical company developing patient-specific, active immunotherapies for the treatment of cancer announced today it has entered into an agreement with Berlex, Inc., a U.S. affiliate of Bayer Schering Pharma AG, Germany. While terms of the agreement are not disclosed, the focus of the agreement will be on studying the use of Favrille's active immunotherapy, FavIdŽ (Id/KLH), in conjunction with Berlex's growth factor LeukineŽ (sargramostim, GM-CSF) in patients with B-cell non-Hodgkin's lymphoma (NHL).
FavId is a patient-specific, active immunotherapy currently in a pivotal Phase 3 clinical trial following RituxanŽ induction therapy for the treatment of follicular B-cell NHL.
Leukine is a recombinant granulocyte-macrophage colony-stimulating factor (GM-CSF), a growth factor that is currently used to help fight infections in appropriate patients by enhancing immune cell function. GM-CSF has also been studied as a means to enhance the immune response in clinical trials of active immunotherapies. GM-CSF was first used in an early study of Id/KLH by the National Cancer Institute and in subsequent studies of Id/KLH and FavId. Patients enrolled in Favrille's pivotal Phase 3 clinical trial of FavId whose disease remained stable or improved following induction treatment with Rituxan were randomized to receive either FavId with GM-CSF or placebo with GM-CSF.
"We are excited to work with the experienced Berlex Oncology team on the development of this novel treatment for lymphoma patients," said David Guy, Chief Commercial Officer of Favrille. "We are confident that FavId, in combination with Leukine, may ultimately provide oncologists with a new treatment option for patients with B-cell NHL. Once the data are available, we look forward to commercial success for both FavId and Leukine in this setting."
About Non-Hodgkin's Lymphoma
The annual prevalence of low-grade NHL is approximately 213,000 patients in the U.S. with 56,000 undergoing treatment annually. Treatment often includes the use of Rituxan, which had sales that exceeded $2 billion in the U.S. in 2006. Despite the widespread use of Rituxan, it is not a cure and patients eventually experience disease progression. As the sixth most common form of cancer, the treatment of NHL remains a significant unmet medical need.
FavId is a patient-specific, Id/KLH, active immunotherapy for the treatment of NHL currently in a pivotal Phase 3 clinical trial. Id/KLH active immunotherapy is a well studied area of investigation and independent Phase 2 studies have suggested delayed disease progression in patients who develop an immune response to the idiotype protein expressed by their lymphoma. The barrier to commercialization of this technology has been the difficulties associated with the production of a patient-specific product at a cost that would make it commercially viable. Favrille has addressed this issue by developing a proprietary baculovirus-insect cell expression system that can rapidly and cost-effectively produce FavId. The Company completed enrollment of patients in its randomized, double-blind, placebo-controlled Phase 3 trial in early 2006 and expects to trigger the analysis of the primary endpoint, time to disease progression, during the fourth quarter of 2007. Favrille has a Special Protocol Assessment from the U.S. Food and Drug Administration (FDA) for its Phase 3 trial. FavId has also received Fast Track designation from the FDA.
LeukineŽ (sargramostim) is a recombinant granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) FDA approved for use following induction chemotherapy in older adults with acute myelogenous leukemia (AML) to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. Leukine is also approved for use in multiple stem cell transplantation settings. In controlled clinical trials across all indications, no significant differences were observed between Leukine- and placebo-treated patients in the type or frequency of adverse events with the exception of an increase in skin-associated events in the Leukine group in the pivotal AML trial. There were occasional reports of fluid retention, dyspnea, supraventricular tachycardia, and laboratory abnormalities (increases in creatinine, bilirubin, and liver enzymes). Other adverse events have been reported. Leukine is marketed by Berlex, Inc.
Favrille, Inc. is a biopharmaceutical company focused on the development and commercialization of targeted immunotherapies for the treatment of cancer and other diseases of the immune system. The Company's lead product candidate, FavId, is based upon unique genetic information extracted from a patient's tumor. FavId is currently under investigation in a pivotal Phase 3 clinical trial for patients with follicular B-cell NHL and Phase 2 clinical trials in other B-cell NHL indications. The Company is developing additional applications based on its immunotherapy expertise and proprietary cost-effective manufacturing technology, including a second product candidate, FAV-201, for the treatment of cutaneous T-cell lymphoma.
Statements in this press release that are not strictly historical in nature constitute "forward-looking statements." Such statements include, but are not limited to, references to Favrille's product candidates, proprietary technologies and research programs. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Favrille's actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements. These factors include, but are not limited to, risks and uncertainties related to progress and timing of clinical trials for FavId, including difficulties or delays in development, testing, manufacturing and marketing FavId or Favrille's other product candidates; Favrille's ability to obtain marketing approval for FavId or Favrille's other product candidates and the timing of any such approvals; Favrille's ability to manufacture sufficient quantities of FavId for use in clinical trials and, if FavId receives marketing approval, for commercialization; risks associated with achieving projected operating metrics and financial performance or the anticipated number of patients using FavId; potential delays in patient enrollment; Favrille's ability to obtain additional financing to support its operations; and additional risks discussed in Favrille's filings with the Securities and Exchange Commission. In addition, conclusions regarding the safety and efficacy of Favrille's product candidates cannot be made until the results of future clinical trials of longer duration in more patients are known. All forward-looking statements are qualified in their entirety by this cautionary statement. Favrille is providing this information as of the date of this release and, except as required by law, does not undertake any obligation to update any forward- looking statements contained in this release as a result of new information, future events or otherwise.
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