Bendeka (bendamustine rapid infusion) / Eagle Pharma, Teva, SymBio Pharma - LARVOL DELTA

Teva Delivers Second Consecutive Year of Growth; Announces Strong Financial Results in Fourth Quarter and Full Year 2024, Led by Generics Performance and Innovative Portfolio Growth (GlobeNewswire) - "BENDEKA and TREANDA (bendamustine) combined revenues in our United States segment in the fourth quarter of 2024 were $41 million, a decrease of 21% compared to the fourth quarter of 2023, mainly due to competition from alternative therapies, as well as the entry of generic bendamustine products into the market."

Commercial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Indolent Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Solid Tumor

FDA-Approved Drugs: New Drug Application (NDA): 208194 (FDA) - Labeling-Package Insert for Eagle Pharms' Bendeka approved on 11th January 2024

sNDA • Chronic Lymphocytic Leukemia • Non-Hodgkin’s Lymphoma

Teva Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance (Businesswire) - "BENDEKA and TREANDA combined revenues in our North America segment in the third quarter of 2023 decreased by 26% to $57 million, compared to the third quarter of 2022, mainly due to generic bendamustine products entry into the market."

Sales • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Chronic Lymphocytic Leukemia (CLL) real world data form UnitedArabEmirates (LLM Congress 2023) - P=NA | N=37 | "This is the first report on CLL seen in a large tertiary care center in UAE over a period of 5 years. The number of patients is significantly less (3%) as compared to incidence in western hemisphere (35%) of all leukemia cases. Median age (59 years) is at least a decade earlier than western hemisphere with a preponderance in males. Treatment patterns are being rapidly revised with the availability of BTK inhibitors, Venetoclax and anti-CD 20monoclonal antibodies to conform with current guidelines. More epidemiologic investigation is needed to understand the low numbers of patients with CLL reported in this UAE cancer center."

Retrospective data

Phase I/II Study of SyB L-0501RI in Combination With Rituximab to Treat Lymphoma (clinicaltrials.gov) - P1/2 | N=37 | Completed | Sponsor: SymBio Pharmaceuticals | Unknown status ➔ Completed

Combination therapy • Trial completion • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

"#EaglePharmaceuticals World-Wide Sales for #BENDEKA was 41.38m USD in Q4 2022 (Up 1279%) https://t.co/WRNUBCXs5N" (@1stOncology)

Eagle Pharmaceuticals Reaches Settlement Agreement with Accord Healthcare, Inc. Related to BENDEKA (bendamustine hydrochloride) (GlobeNewswire) - "Eagle Pharmaceuticals, Inc...announced that it has reached a settlement agreement with Accord Healthcare, Inc. ('Accord'). Eagle had asserted its Orange Book-listed patents against Accord related to Accord’s new drug application ('NDA') referencing BENDEKA^®. The settlement agreement provides that Accord has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances. The settlement agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice."

Patent • Oncology

A phase I/II study of 10-min dosing of bendamustine hydrochloride (rapid infusion formulation) in patients with previously untreated indolent B-cell non-Hodgkin lymphoma, mantle cell lymphoma, or relapsed/refractory diffuse large B-cell lymphoma in Japan. (PubMed, Cancer Chemother Pharmacol) - P1/2 | "This study showed that bendamustine is safe, well-tolerated and effective for patients with previously untreated iNHL, MCL or rrDLBCL. Pharmacokinetic data were equivalent to those obtained outside of Japan."

Journal • P1/2 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

CPI-613 in Combination With Bendamustine in Patients With Relapsed/Refractory T-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=12 | Recruiting | Sponsor: Wake Forest University Health Sciences | Trial primary completion date: Jun 2022 ➔ Sep 2022

Combination therapy • Trial primary completion date • Cutaneous T-cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma

Eagle Pharmaceuticals Reaches Settlement Agreement with Hospira Related to BENDEKA (bendamustine hydrochloride) until January 17, 2028 (GlobeNewswire) - "Eagle Pharmaceuticals, Inc...today announced that it has reached a settlement agreement with Hospira, Inc ('Hospira'). Eagle had asserted two Orange Book-listed patents against Hospira related to its new drug application ('NDA') referencing BENDEKA®. The settlement agreement provides that Hospira has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances."

Patent • Hematological Malignancies • Oncology

"$EGRX Eagle Pharmaceuticals Reaches Settlement Agreement with Hospira Related to BENDEKA® (bendamustine hydrochloride) until January 17, 2028 https://t.co/BKFzapP0oJ" (@stock_titan)

M&A

Eagle Pharmaceuticals Granted Additional Patent for Bendamustine Franchise (Businesswire) - “Eagle Pharmaceuticals, Inc…announced that the U.S. Patent and Trademark Office has granted the Company U.S. Patent No. 11,103,483, entitled “Formulations of Bendamustine.' Eagle is submitting the ‘483 patent for listing in the U.S. Food and Drug Administration’s Orange Book for both BENDEKA® and BELRAPZO®…Both the asserted patents and the ‘483 patent expire in 2031.”

Patent • Oncology