Overview of Key Milestones Expected Over the Next 12 Months: REVLIMID: Approval expected by the U.S. Food and Drug Administration on the supplemental New Drug Application for REVLIMID in combination with rituximab in relapsed/refractory indolent lymphoma. Approval expected by the European Medicines Agency’s Committee for Medicinal Products for Human Use for REVLIMID in combination with bortezomib and dexamethasone in newly diagnosed multiple myeloma. Data expected from the phase III ROBUST trial with REVLIMID in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone in patients with first-line ABC-subtype diffuse large B-cell lymphoma. POMALYST/ IMNOVID: Approval expected by the EMA CHMP and Japan Pharmaceuticals and Medical Devices Agency for POMALYST/IMNOVID in combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma. OTEZLA: Approval expected by the U.S. FDA for the sNDA in Behet’s disease with a Prescription Drug User Fee Act action date of July 21, 2019. Approval by the PMDA in Japan is expected in H2:2019. Submission of the sNDA with label update for moderate to severe scalp psoriasis to the U.S. FDA expected in Q2:2019. ABRAXANE: Data from the phase III apact trial with ABRAXANE as adjuvant therapy in patients with surgically resected pancreatic cancer. PDUFA action date of March 12, 2019 for the supplemental Biologics License Application submission filed by Roche of Tecentriq in combination with ABRAXANE for the initial treatment of patients with PD-L1-positive, metastatic triple-negative breast cancer. Milestones Expected for Key Pivotal Assets: Ozanimod: U.S. NDA and EU Marketing Authorization Application submissions in relapsing multiple sclerosis on-track for Q1:2019. Phase III TRUE NORTH trial in ulcerative colitis expected to complete enrollment in H1:2019. Fedratinib: U.S. FDA approval expected by year-end 2019. EU MAA submission planned in H1:2019. Phase I/II combination trial with luspatercept planned. Luspatercept: U.S. and EU regulatory applications for transfusion-dependent, lower-risk myelodysplastic syndromes with ring sideroblasts and transfusion-dependent beta-thalassemia planned for H1:2019. Data expected from the phase II myelofibrosis trial in H2:2019. Liso-cel: Data from the pivotal TRANSCEND trial in relapsed/refractory DLBCL expected in 2019. U.S. BLA submission expected in H2:2019. Pivotal phase II trial in relapsed/refractory chronic lymphocytic leukemia to be initiated in H1:2019. bb2121: Data from the KarMMa pivotal trial in RRMM expected in H2:2019: Phase II trial in NDMM to be initiated in H2:2019.
Monday, January 7, 2019
CytoReason, Pfizer sign collaboration agreement for machine learning model
CytoReason announced that it has entered into a collaboration agreement with Pfizer that will leverage CytoReason’s cell-centered models of the immune system. CytoReason will receive from Pfizer payments potentially equaling up to low double digit millions of US$ for technology access fees, research support and certain success-based payments. CytoReason’s proprietary platform helps rebuild lost cellular information from gene expression data and associates genes to specific cells. This information is then integrated with additional omics and literature data to create a cell-based model of the trial-specific immune response. Integration with the CytoReason disease model empowers the study analytics and allows the model to learn and improve, leading to robust target discovery, drug response biomarkers and indication selection
BioTime enters into research option agreement with Orbit Biomedical
BioTime announced that it has entered into a research and option agreement with Orbit Biomedical Limited. Orbit Biomedical, based in London, UK and Ambler, PA, was founded in 2018 to develop a surgical device and training platform for the delivery of cell and gene therapies to the sub-retinal space. Under the terms of the agreement, BioTime and Orbit Biomedical will collaborate on the use of Orbit Biomedical’s proprietary injection technology to deliver OpRegen for the treatment of dry age-related macular degeneration. Under the terms of the exclusive 12 month agreement, BioTime and Orbit Biomedical plan to investigate the safety and utility of Orbit Biomedical’s surgical delivery technology in the ongoing Phase I/II clinical study of OpRegen for the treatment of dry-AMD.
Alnylam announces unaudited Q4 ONPATTRO revenues of $11M-$12M
Alnylam Pharmaceuticals pre-announced its unaudited fourth quarter 2018 global net product revenues for ONPATTRO and provided additional updates on the product’s commercial launch. ONPATTRO global net product revenues for the fourth quarter of 2018 were $11M-12M. As of year-end 2018, over 200 patients in the U.S. and EU were receiving commercial ONPATTRO treatment, and approximately 550 total patients worldwide, including patients on commercial drug and patients in clinical studies and in the Company’s global Expanded Access Program, were being treated with patisiran. In the U.S., a total of 250 Start Forms were submitted as of year-end 2018. Of these, approximately 50% were from patients previously treated on the ONPATTRO EAP. The Start Forms came from a diverse range of prescribing physician specialties, including 44% neurologists, 35% cardiologists, and 21% from other specialties. For Start Forms received, 62% of patients were covered by Medicare, 32% were covered by commercial insurers, and 6% were covered by other government insurers. Significant progress has been made with value-based agreements in the U.S. and with market access efforts in the EU. Since launch, Alnylam has completed full VBAs with Harvard Pilgrim Healthcare, Humana, and another top five U.S. payer. Additional VBAs are under negotiation with over 15 other commercial payers with the potential to cover over 90% of commercial lives in the U.S. In addition, the Company today reported that at December 31, 2018, it had cash, cash equivalents and marketable debt securities, and restricted investments, excluding equity securities, of approximately $1.1B. The Company intends to provide 2019 financial guidance on non-GAAP R&D and SG&A expenses and year-end cash balance in connection with its full, audited fourth quarter and year-end 2018 financial results in February 2019.
Immutep enters into clinical trial collaboration agreement with Cytlimic
Immutep Limited announced that it has entered into a clinical trial collaboration agreement, a supply agreement and a service agreement with CYTLIMIC Inc. for its lead product candidate eftilagimod alpha as part of a cancer vaccine. The agreements enable the two parties to collaborate on clinical trials to evaluate efti as part of a therapeutic cancer vaccine containing CYTLIMIC’s innovative cancer peptide vaccine, called CYT001. The trials will be conducted by and are under the control of CYTLIMIC who will fully fund all development costs. Under the collaboration agreement, Immutep will receive an upfront payment of $500,000 and is eligible to receive up to $4.5M in milestone payments upon the achievement of milestones by CYTLIMIC. https://thefly.com/landingPageNews.php?id=2844487
Endologix backs FY19 revenue guidance of at least $140, consensus $140.82M
Endologix reaffirms its previously issued annual guidance and continues to expect 2019 revenue of at least $140 million. The Company anticipates revenue for the first quarter ending March 31, 2019 of approximately $35 million. The Company continues to expect 2019 operating expenses in the range of $130 million to $140 million. The Company’s 2019 financial guidance contemplates the anticipated impact of the voluntary recall of the Nellix System and issuance of its January 4, 2019 field safety notice.
CareDx sees FY18 revenue $76.2M-$76.5M, consensus $74.84M
https://thefly.com/landingPageNews.php?id=284449
Subscribe to:
Posts (Atom)