Avista Pharma Solutions, Inc.

Readouts from the EAGLE-2 and EAGLE-3 phase 3 trials last year showed gepotidacin held its own against nitrofurantoin as a UTI treatment. GSK may have pushed back plans to secure approval for gepotidacin as the first new urinary tract infection (UTI) treatment in 20 years, but fresh phase 3 results have lined up the antibiotic for a separate filing to treat gonorrhea. In the late-stage EAGLE-1 trial of around 600 patients, two 3,000-mg daily doses of oral gepotidacin for five days demonstrated noninferiority to the most common treatment for gonorrhea—an injection of the antibiotic ceftriaxone and oral dose of the antibiotic azithromycin—when assessed by microbiological response between three and seven days later. This hit the study’s primary endpoint. The safety and tolerability profile of gepotidacin was consistent with phase 1 and 2 results of the drug, said GSK, which plans to share detailed results “at an upcoming scientific meeting and with global health authorities.” “With rising incidence rates and concern around growing resistance to existing treatments, gonorrhea poses a threat to public health globally,” Chris Corsico, GSK’s senior vice president, development, said in the Feb. 26 release.  Gepotidacin had already turned heads by its ability to show “statistical superiority” as a treatment for uncomplicated UTI compared to the commonly used UTI antibiotic nitrofurantoin in an in-depth readout of the EAGLE-3 phase 3 trial in April 2023, while the late-stage EAGLE-2 trial also showed that gepotidacin held its own against nitrofurantoin. At the time, GSK stated plans to submit gepotidacin for regulatory approval for UTI by June 2023. But the company revealed in its full-year earnings report (PDF) at the end of January 2024 that the deadline has been pushed all the way back to the second half of this year, with an FDA decision now expected in 2025. GSK is currently working with the FDA to provide nonclinical data for review ahead of the submission, a spokesperson told Fierce Biotech this morning. The company is also working in parallel with the FDA to prepare a gonorrhea application in the wake of an approval in UTI. Despite the delayed timeline, today’s gonorrhea data were further affirmation for GSK’s decision to continue to persevere in the antibiotics space even as most Big Pharma peers have long since checked out. Gepotidacin is the first in a new class of chemical antibiotics called triazaacenaphthylene bacterial topoisomerase inhibitors. While the company has been tinkering with the asset since 2007, the story really begins in 2013 with a public-private partnership between the Big Pharma and the U.S. government’s Biomedical Advanced Research and Development Authority to develop new weapons in the fight against antibiotic resistance and bioterrorism. While the relatively low return on investment has deterred plenty of larger drug developers from the space, GSK has continued to weave antibiotics into its business development plans, including paying $66 million upfront in September 2022 to license Spero Therapeutics' tebipenem HBr oral tablets, followed by $90 million to Scynexis in March 2023 to license an FDA-approved antifungal called Brexafemme for the treatment of vulvovaginal candidiasis. GSK's antibiotic for tuberculosis is also set to read out further phase 2 data later this year. Talking to Fierce Biotech a year ago, Melanie Paff, who heads up GSK's hepatitis B program, said antibiotics are “a really hard space to play in because the science and the biology is so difficult.” “When you see the data coming out from gepo[tidacin], for instance—that was hard fought,” she said at the time. “The chemists wouldn't give up, the biologists wouldn't give up, the clinical people wouldn't give up. And I'm really pleased to see that go forward and get the recognition that it deserves.”

FORT LEE, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, today announced the hiring of Brian Cunningham as vice president of sales and Kenneth Rankin as vice president of market access. "The additions of Brian Cunningham and Kenneth Rankin come at an important and exciting time for Elevar, as we position the company for a potential commercial launch in the coming year,” said Elevar Chief Commercial Officer Paul Friel. “Both possess a wealth of sales and management acumen, and a great understanding of the road ahead for our company. We welcome them to our growing team.” In May 2023, Elevar submitted a new drug application for rivoceranib and Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) submitted a biologics license application for camrelizumab to the U.S. Food and Drug Administration (FDA) for the combination of the two drugs as a first-line therapy for unresectable hepatocellular carcinoma (uHCC). The FDA accepted the submissions, assigning Prescription Drug User Fee Act (PDUFA) target action dates in May 2024. Elevar and Hengrui Pharma earlier this month announced a global commercialization licensing agreement that gives Elevar rights to commercialize and develop camrelizumab in combination with rivoceranib for uHCC worldwide, excluding the Greater China Region and Korea. Cunningham joins Elevar from global oncology company Novocure, where he served as the national sales and operations lead for its Central Nervous System Cancers Franchise. From August 2019 to December 2021, Cunningham oversaw the national sales team that launched Novocure’s Tumor Treating Fields therapy for malignant pleural mesothelioma. “Brian is a driven sales professional who has continuously demonstrated leadership skills and great understanding of the pharmaceutical landscape, both at launch and for established therapies,” said Friel. “As we work toward the possible commercial debut of a vital new HCC therapy in the coming year, he will help to put Elevar in a stronger position for rapid success.” Prior to working at Novocure, Cunningham was senior regional business director at Array Biopharma. He spent the previous 14 years in several roles with Pfizer Inc., most recently as North American director of strategic planning and innovation. He holds a bachelor’s degree from Kutztown University and a Master of Business Administration degree from the University of Pittsburgh. Rankin joins Elevar from CTI Biopharma Corp., where he was responsible for developing the pre-commercial company’s “go to market” strategy in the rare oncology marketplace as vice president of market access, distribution, and reimbursement. He brings more than three decades of health care industry sales and market access experience. “Elevar is highly focused on positioning rivoceranib for expeditious market success should its combination with camrelizumab receive FDA approval,” said Friel. “Throughout his career, Kenny has demonstrated a strong ability to navigate the complexities of the rapidly changing health care landscape, overseeing teams and implementing programs that ensure the successful launch of new products.” Prior to working at CTI Biopharma, Rankin was senior director of national accounts and payer/patient access at Incyte. He was previously vice president of sales for rare commercial services at Dohmen Life Science Services, and director of Eisai Inc.’s government payer team. Rankin holds a bachelor’s degree in interpersonal and public communication from Bowling Green State University, where he was also captain of the football and track & field teams. About Elevar Therapeutics Elevar Therapeutics, Inc. is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidate is rivoceranib. Rivoceranib, under the name apatinib in China, is commercialized by Hengrui Pharma in China and was approved in China as a single agent for the treatment of gastric cancer (2014), a second-line treatment for advanced HCC (2020) and first-line treatment in combination with Hengrui Pharma’s camrelizumab for unresectable HCC (January 2023). Rivoceranib has been granted Orphan Drug Designation in the U.S., Europe and South Korea and has been clinically tested in more than 6,000 patients worldwide in numerous cancer indications. Elevar also has rights to commercialize and develop camrelizumab in combination with rivoceranib for uHCC worldwide, excluding Greater China Region and Korea (October 2023). Elevar is headquartered in New Jersey, with offices in Ireland and South Korea. Additional information is available at ElevarTherapeutics.com. Media Contact: Rosemary Ostmann Phone: 201-615-7751 Email: rostmann@rosecomm.com Investor Relations Contact: LifeSci Advisors, LLC Ashley R. Robinson Email: arr@lifesciadvisors.com

Pfizer said Thursday that the FDA has approved Braftovi (encorafenib) plus Mektovi (binimetinib) to treat metastatic non-small-cell lung cancer (NSCLC) in adults with a BRAF V600E mutation. Initially approved by the FDA in 2018, the combination of Braftovi and Mektovi has "helped thousands of people living with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma," remarked chief oncology R&D officer Chris Boshoff, adding "we look forward to helping even more patients with our…targeted combination therapy."For the latest decision, US regulators reviewed data from the ongoing, single-arm Phase II PHAROS trial evaluating Braftovi plus Mektovi in 98 patients, including treatment-naïve and previously treated individuals, with BRAF V600E-mutant metastatic NSCLC. According to results presented earlier this year at the American Society of Clinical Oncology (ASCO) annual meeting, the study met its major efficacy outcome measures of objective response rate (ORR), with an ORR of 75% among treatment-naïve patients and 46% for those who have been previously treated.Serious adverse reactions occurred in 38% of patients, with some of the more common events being haemorrhage, diarrhoea, anaemia, dyspnoea and pneumonia. Further, a total of 17% of patients experienced an adverse reaction that resulted in discontinuation of Mektovi, while 16% experienced an adverse event that resulted in stoppage of Braftovi.Pfizer, which gained access to Braftovi and Mektovi through its $11.4-billion acquisition of Array Biopharma in 2019, has exclusive rights to both products in the US, Canada, and all countries in Latin America, Africa, and the Middle East. Meanwhile, Ono Pharmaceutical holds exclusive rights to sell both drugs in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific, not counting the territories covered by Ono.