Key Developments For Cephalon, Inc.
Cephalon, Inc. (CEPH.O) (Nasdaq)
Ception Therapeutics, Inc. And Cephalon, Inc. Provide Initial Results Of Phase IIb/III Study of CINQUIL in Pediatric Eosinophilic Esophagitis
Ception Therapeutics, Inc. and Cephalon, Inc., announced results from a Phase IIb/III clinical trial for CINQUIL (reslizumab) as a treatment for pediatric eosinophilic esophagitis (EoE). The study was designed to evaluate improvement in the co-primary endpoints of changes in esophageal eosinophil levels and clinical symptoms. Analyses of the data indicated that patients treated with CINQUIL showed a statistically significant reduction in esophageal eosinophil levels versus placebo. In the second co-primary endpoint, patients treated with CINQUIL showed an improvement in their clinical symptoms; however, placebo treated patients also experienced an unexpectedly large improvement in their symptoms. Therefore, the study did not achieve statistical significance for this endpoint. CINQUIL was well tolerated in the study, with an adverse event profile comparable to placebo. Ception and Cephalon continue to fully analyze the data and are planning to perform an analysis of an ongoing open-label extension study to help further assess the clinical results.
Cephalon, Inc. And Teva Pharmaceuticals Industries Limited's Barr Settle Patent Infringement Suit-Reuters
Reuters reported that Cephalon, Inc. said it has come to an agreement to settle its patent infringement dispute with Barr Pharmaceuticals over the pain drug Fentora. Under the agreement, Cephalon, Inc. will grant Barr a non- exclusive, royalty-free right to market and sell a generic version of Fentora in the United States. The license will become effective in October 2018. another generic version of Fentora enters the United States market before that date, Barr will be allowed to enter the market at the same time, assuming no other company has won a period of marketing exclusivity. Cephalon, Inc. had claimed Barr infringed Fentora patents that do not expire until 2019. Under the settlement Barr will not attempt to enter the market earlier than October 2018. Barr is owned by the generic drug maker Teva Pharmaceutical Industries Ltd.
Cephalon, Inc. Announces Data Demonstrating TREANDA Induced Durable Responses in Relapsed Indolent Non-Hodgkin's Lymphoma
Cephalon, Inc. announced data from a pivotal study demonstrating that TREANDA (bendamustine HCl) for Injection induced durable responses in patients with indolent B-cell non-Hodgkin's lymphoma (NHL) whose disease had progressed during or within six months of treatment with rituximab. The findings from this study confirm and expand upon previous investigations with bendamustine. In this multicenter, open-label, single-arm study, 100 patients received TREANDA intravenously at a dose of 120 mg per meter squared over 60 minutes on days one and two every 21 days for up to eight cycles. There were two primary endpoints in the study: the overall response rate (ORR) defined as the percentage of patients who responded to treatment, and the duration of response. In the published results, 75% of patients had a response to treatment with TREANDA, including 14% who had a complete response and three percent who had an unconfirmed complete response. The patient response to treatment lasted a median of 9.2 months. The most common adverse events in this study included myelosuppression, nausea, infection, fatigue, diarrhea, vomiting and fever; serious adverse events included febrile neutropenia and pneumonia.
Cephalon, Inc. Announces Mayo Clinic Proceedings Publishes Study of NUVIGIL In Patients With Shift Work Disorder
Cephalon, Inc. announced that the November issue of Mayo Clinic Proceedings has published data from a pivotal Phase III trial demonstrating that NUVIGIL (armodafinil) Tablets [C-IV] significantly improved wakefulness throughout the shift in patients with excessive sleepiness associated with shift work disorder (SWD). NUVIGIL, the longer-lasting isomer of modafinil, is indicated to improve wakefulness in patients with excessive sleepiness associated with shift work disorder, treated obstructive sleep apnea and narcolepsy. These data were part of the new drug application approved by the FDA in 2007. This Phase III 12-week, randomized, double-blind, placebo-controlled study evaluated 254 permanent or rotating shift workers with shift work disorder at 42 sleep research centers in the United States and Canada. Study patients received NUVIGIL (150 mg) or a placebo at approximately one hour before each night shift. During weeks four, eight and 12, patients spent a night shift in the sleep laboratory, where investigators assessed patients' physiological propensity to fall sleep during night shift hours and clinicians' impression of disease severity, and patient-reported level of sleepiness. The study showed that patients wakefulness significantly improved over the course of the trial in patients taking NUVIGIL (by 3.1 minutes) versus those on placebo (by 0.4 minutes) (P<0.001).
Cephalon, Inc. Lowers FY 2009 Revenue Outlook; Reiterates FY 2009 Earnings Outlook; Issues FY 2010 Mixed Outlook
Cephalon, Inc. updated its fiscal 2009 outlook and expects net sales of $2.125-$2.175 billion. This includes CNS franchise net sales of $1.150-$1.170 billion, pain franchise net sales of $480-$500 million, oncology franchise net sales of $315-$335 million, and other product net sales of $160-$175 million. Adjusted net income outlook remains unchanged at $457-$464 million. Basic adjusted income per common share (EPS) outlook also remains unchanged at $6.30-$6.40. For fiscal 2010, it expects net sales of $2.325-$2.400 billion. This includes CNS franchise net sales of $1.180-$1.220 billion, pain franchise net sales of $535-$570 million, oncology franchise net sales of $400-$430 million, and other product net sales of $200-$220 million. Adjusted net income for fiscal 2010 of $495-$510 million and adjusted EPS of $6.50-$6.70. According to Reuters Estimates, analysts were expecting the Company to report revenues of $2.216 billion for fiscal 2009 and revenues of $2.416 billion, net profit of $508 million and EPS of $6.21 for fiscal 2010.
