On July 13, 2016 Amgen (NASDAQ:AMGN) and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo; TSE: 4568) reported the execution of an exclusive agreement to commercialize nine biosimilars in Japan (Press release, Amgen, JUL 13, 2016, View Source [SID:1234513874]). The deal includes several biosimilars in late-stage development, including biosimilars of adalimumab, bevacizumab and trastuzumab. Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, Amgen will remain responsible for the development and manufacturing of the biosimilars. Daiichi Sankyo will file for marketing approval and be responsible for distribution and commercialization in Japan, while Amgen will have a limited right to co-promote the products.
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"Amgen is excited to collaborate with Daiichi Sankyo as we seek to drive adoption and build confidence in biosimilars as a means of enhancing patient access to more affordable therapeutic options worldwide," said Scott Foraker, vice president and general manager of Biosimilars at Amgen.
Amgen will retain all additional distribution and commercialization rights for the biosimilar programs outside of Japan. Specific financial terms of the agreement were not disclosed.
Month: July 2016
TARIS Biomedical® Initiates Phase 1b Clinical Trial of TAR-200 (GemRIS™) in Patients with Muscle-Invasive Bladder Cancer
On July 13, 2016 TARIS Biomedical LLC, a company developing powerful and targeted new treatments for millions of patients suffering from difficult-to-treat bladder diseases, reported the initiation of a Phase 1b clinical trial of TAR-200 (GemRIS) in patients with muscle-invasive bladder cancer (MIBC) (Press release, TARIS Biomedical, JUL 13, 2016, View Source [SID:1234513867]). TAR-200, a drug-device combination product utilizing the TARIS System, is designed to release gemcitabine continuously into the bladder over 7 days. TARIS also announced that Christopher J. Cutie, M.D., MBA, has been promoted to Chief Medical Officer to oversee all of TARIS’ clinical programs. Schedule your 30 min Free 1stOncology Demo! "Patients diagnosed with muscle-invasive bladder cancer often require complex treatment regimens, including systemic chemotherapy and radical cystectomy (complete surgical removal of the urinary bladder), a life-altering operation associated with significant morbidity and, in some cases, death. Unfortunately, one or both of these treatments are not suitable for many patients suffering from this potentially lethal disease," said Dr. Cutie. "TAR-200 has the potential to address patients underserved by the current standard of care."
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"To our knowledge, this is the first time any drug has ever been continuously delivered into the bladder to treat a bladder tumor over such an extended period. We are excited about this novel treatment approach and look forward to seeing the results of this study," said Purnanand Sarma, Ph.D., President and Chief Executive Officer of TARIS. "Launching our first clinical trial in oncology is a significant milestone for TARIS. Building on the momentum from our Allergan transaction announced in 2014, we are rapidly expanding the organization and plan to move multiple programs into the clinic in the coming 12-18 months. We are pleased to recognize Dr. Cutie’s superb leadership of our clinical programs with his promotion to Chief Medical Officer."
About the TAR-200 Phase 1b Trial
The Phase 1b open-label study will assess whether continuous, local exposure to gemcitabine using TAR-200 is safe and tolerable in patients with MIBC. The study will also assess the preliminary efficacy in this patient population. The study will be conducted at multiple sites in the U.S. and expects to enroll up to 20 patients after the diagnosis of MIBC and before radical cystectomy.
About TAR-200
TAR-200 (GemRIS) is TARIS’ first program in bladder cancer. TAR-200 is a drug-device combination product designed to release gemcitabine continuously into the bladder over 7 days. Gemcitabine is commonly used to treat multiple cancers alone and in combination with other chemotherapeutic drugs.1 TARIS believes TAR-200 has the potential to set a new standard of care in bladder cancer, with enhanced efficacy and minimal systemic side effects compared to current approaches. TARIS is developing TAR-200 to address unmet needs in both muscle invasive and non-muscle invasive bladder cancer.
About Muscle Invasive Bladder Cancer
Bladder cancer affects roughly 2.7 million people worldwide, including nearly 600,000 in the United States.2 The National Cancer Institute estimates that there will be a total of nearly 77,000 new cases and 16,000 deaths due to this disease in 2016.3 When measured as a cumulative lifetime per patient cost, the expense to treat bladder cancer exceeds all other forms of cancer.4 The estimated U.S. national expenditure on bladder cancer was $4.3 billion in 2014.5
Muscle Invasive Bladder Cancer (MIBC) is an advanced form of the disease, representing 25-30% of the newly diagnosed cases. MIBC tumors, which have progressed into the muscle of the bladder wall and potentially beyond, may lead to metastases and death. The standard of care for treatment of MIBC includes radical cystectomy, or complete removal of the bladder, with or without neoadjuvant chemotherapy. Radical cystectomy is a major, life changing procedure and many patients are medically unfit and/or unwilling to undergo the procedure.
Loxo Oncology Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-101
On July 13, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), "for the treatment of unresectable or metastatic solid tumors with NTRK-fusion proteins in adult and pediatric patients who require systemic therapy and who have either progressed following prior treatment or who have no acceptable alternative treatments (Press release, Loxo Oncology, JUL 13, 2016, View Source [SID:1234513860]). Schedule your 30 min Free 1stOncology Demo! "We’re pleased to have been granted Breakthrough Therapy Designation for LOXO-101 and look forward to working more closely with the FDA to bring this therapy to patients with TRK fusion cancers," said Josh Bilenker, M.D., chief executive officer at Loxo Oncology. "Data presented to date from the ongoing adult and pediatric studies of LOXO-101 have demonstrated durable anti-tumor activity across TRK fusion cancers, further validating LOXO-101’s potential to address the unmet medical need among patients with these genetically defined cancers. We remain on track to provide an enrollment update regarding the LOXO-101 Phase 2 trial in the second half of 2016."
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The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a drug candidate that is planned for use to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
The LOXO-101 Breakthrough Therapy Designation application included data from the ongoing Phase 1 dose-escalation study of LOXO-101 in adult patients with advanced solid tumors, the ongoing Phase 1 pediatric study of LOXO-101 in patients with advanced solid tumors or primary CNS tumors, and the ongoing Phase 2 basket trial of LOXO-101 in adult cancer patients whose tumors harbor TRK fusions.
About LOXO-101
LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in a global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions and a Phase 1 trial in pediatric patients. For additional information about the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov or www.loxooncologytrials.com. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123.
Spectrum Pharmaceuticals Settles FOLOTYN® (pralatrexate injection) ANDA Patent Litigation
On July 13, 2016 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in Hematology and Oncology, reported that it has settled its ANDA patent litigation relating to FOLOTYN (Press release, Spectrum Pharmaceuticals, JUL 13, 2016, View Source [SID:1234513855]). Schedule your 30 min Free 1stOncology Demo! As a result of the settlement with the last remaining ANDA filer, Fresenius Kabi USA, LLC, and the previously reported settlements with Teva Pharmaceuticals USA, Inc., Dr. Reddy’s Laboratories, Ltd. & Dr. Reddy’s Laboratories, Inc. and Sandoz Inc., absent certain circumstances, generic versions of FOLOTYN will not be permitted to be marketed in the United States until November 15, 2022. The Company will submit the settlement agreement to the Federal Trade Commission and the Department of Justice. Details of the settlement are confidential.
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Geron Announces Issuance of U.S. Patents Related to Imetelstat
On July 13, 2016 Geron Corporation (Nasdaq:GERN) reported the recent issuance of three U.S. patents related to the company’s telomerase inhibitor, imetelstat (Press release, Geron, JUL 13, 2016, View Source [SID:1234513854]). Schedule your 30 min Free 1stOncology Demo! The first patent, U.S. 9,375,485, has claims covering the use of telomerase inhibitor compounds, including imetelstat, for alleviating at least one symptom of myelofibrosis or myelodysplastic syndromes, including chronic myelomonocytic leukemia. This patent is expected to remain in force until at least March 2033. The other two patents, U.S. 9,388,415 and U.S. 9,388,416, have claims covering methods for using imetelstat to inhibit the activity of telomerase and using imetelstat to inhibit cancer cell proliferation, as well as methods for using imetelstat to treat cancer, and are expected to remain in force until at least September 2024. These patents are related to Geron’s existing imetelstat composition of matter patent U.S. 7,494,982, which issued in 2009 and is expected to remain in force until at least December 2025. Further extensions of patent term may be available for regulatory review periods. Full text patents are available on the United States Patent and Trademark Office website at www.uspto.gov.
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Geron’s portfolio of patents related to imetelstat and related products whose mechanism of action is telomerase inhibition have been licensed to Janssen Biotech Inc., (Janssen) under an exclusive worldwide license and collaboration agreement for all human disorders or medical conditions.
Clinical Trials of Imetelstat
Janssen is conducting two clinical trials of imetelstat under the terms of the collaboration agreement between Geron and Janssen:
IMbarkTM, a Phase 2 clinical trial evaluating two dosing levels of imetelstat in patients with Dynamic International Prognostic Scoring System (DIPSS) Intermediate-2 or High risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a Janus Kinase (Jak) inhibitor. Further information about this clinical trial can be found at View Source; and
IMergeTM, a Phase 2/3 clinical trial evaluating imetelstat in transfusion dependent patients with International Prognostic Scoring System (IPSS) Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent (ESA). Further information about this clinical trial can be found at View Source
About Imetelstat
Imetelstat (GRN163L; JNJ-63935937) is a potent and specific inhibitor of telomerase that is administered by intravenous infusion. This first-in-class compound, discovered by Geron, is a specially designed and modified short oligonucleotide, which targets and binds directly with high affinity to the active site of telomerase. Preliminary clinical data suggest imetelstat has disease-modifying activity by inhibiting the progenitor cells of the malignant clones associated with hematologic malignancies in a relatively select manner. Most commonly reported adverse events in imetelstat clinical studies include fatigue, gastrointestinal symptoms and cytopenias. Patients in these studies also experienced elevated liver enzymes, which resolved to normal or baseline in the majority of patients followed after imetelstat treatment was withdrawn. Imetelstat has not been approved for marketing by any regulatory authority.