Pfizer’ Talzenna leads latest CHMP highlights

pharmatimes | April 29, 2019

Pfizer’s PARP inhibitor, Talzenna (talazoparib), has been given a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for adults with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, heading up April’s recommendations list. Thirteen medicines were recommended for approval at the Committee’s April 2019 meeting, including two orphan medicines; Novo Nordisk’s Esperoct (turoctocog alfa pegol), for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A; and Alexion’s Ultomiris (ravulizumab), for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.

Spotlight

There is an upward trend for pharmaceutical companies to ask their contract development and manufacturing organisations (CDMO) to support the conversion.

Spotlight

There is an upward trend for pharmaceutical companies to ask their contract development and manufacturing organisations (CDMO) to support the conversion.

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PHARMA TECH

Sirona Biochem Signs International Partnership Agreement with Wanbang Biopharmaceuticals

Sirona Biochem Corp. | November 28, 2022

Sirona Biochem Corp. announces that, subsequent to the LOI, Sirona and Wanbang Biopharmaceuticals have signed an expanded, international partnership agreement to collaborate on licencing Sirona’s SGLT2 inhibitor, TFC-039, as a pharmaceutical treatment in both animal and human health. The agreement adds human health to the partnership as a result of new licencing opportunities currently in due diligence. Wanbang and Sirona initially signed a licensing agreement for TFC-039, whereby Wanbang obtained the rights to develop the compound as a diabetes treatment in China and Sirona retained the global rights. Sirona has since been in discussions with animal health companies to advance TFC-039 as a treatment for diabetes and chronic kidney disease in companion animals. SGLT2 inhibitors provide an opportunity to treat inflicted animals with an oral medication as opposed to the traditional method of daily insulin injections. More recently, Sirona has entered into due diligence with a large pharmaceutical company with a regional interest in developing the compound for human diabetes. Together, Sirona and Wanbang share extensive knowledge and scientific results of TFC-039. Partnering will significantly increase the speed to third-party partnerships and commercialization. The shared data spans over 12 years of research and development, and includes in vitro and in vivo preclinical work, multiple clinical studies, advanced manufacturing process development and the ability to commercially manufacture TFC-039. “We have a long-standing relationship with Wanbang and are excited to combine our two companies’ expertise to license TFC-039. Wanbang has invested millions of dollars into the clinical stage research and development of the manufacturing processes for TFC-039. These pieces of data are critical to large organizations and will greatly increase the opportunities to move forward. The probability of a successful licensing agreement has been made much stronger by leveraging our alliance with Wanbang. We have had a successful year building Sirona’s pipeline, with positive movement on all projects and we’re looking forward to continuing this success with our SGLT2 inhibitor as well as our antiviral and anti-aging projects in 2023.” Dr. Howard Verrico, CEO About Wanbang Biopharmaceuticals and Fosun Pharmaceuticals Wanbang Biopharmaceuticals develops, manufactures, and markets drugs with indications for chronic disease treatment, antibiotics, and other endocrine diseases in China. Founded in 1981, the company is headquartered in Xuzhou, China, and is a subsidiary of Shanghai Fosun Pharmaceutical Group. Fosun is a leader in the pharmaceutical industry and is regarded as one of the top five domestic pharmaceutical companies in China. About Sirona Biochem Corp. Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential. Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants.

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BUSINESS INSIGHTS, PHARMACY MARKET

Xeris Pharmaceuticals Announces USFDA Approval of Recorlev

Xeris Pharmaceuticals, Inc. | January 31, 2023

On January 30, 2023, Xeris Biopharma Holdings, Inc., a leading biopharmaceutical company, announced that the Food and Drug Administration (FDA) granted orphan-drug exclusivity (ODE) to its subsidiary Xeris Pharmaceuticals, Inc. for Recorlev® (levoketoconazole) a cortisol synthesis inhibitor for the treatment of endogenous Cushing's syndrome in adult patients for whom surgery is not viable or has not been effective. levoketoconazole (Recorlev) being the first FDA-approved therapeutic for the treatment of endogenous hypercortisolemia, Xeris Pharmaceutical is permitted to have seven years of orphan-drug market exclusivity beginning from December 30, 2021. The FDA's Orphan Drug Designation program intends to accelerate the development of medications that treat a disease that affects 200,000 or fewer people in the United States each year. This regulatory exclusivity with the patent exclusivity under Xeris' U.S. patents for Recorlev is valid until at least March 2040. To serve and assist this community, Xeris is dedicated to ensuring that everyone who needs access to their medications receives them. Xeris has developed Xeris CareConnection™ to provide patients and caregivers with a comprehensive program that includes financial support, one-on-one assistance, and educational materials throughout the treatment journey. Additionally, Xeris CareConnection assists healthcare providers and their teams with education on access and reimbursement. About Xeris Pharmaceuticals, Inc. Founded in 2005, Xeris is a growth-oriented biopharmaceutical firm dedicated to improving patients' lives via the development and commercialization of novel products in a range of therapies. Its unique technology makes medicines easier to use for patients & caregivers. The company has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for treating severe hypoglycemia (very low blood sugar); Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis; and Recorlev® for the treatment of endogenous hypercortisolemia. In addition, it has an increasingly broad pipeline of research and partnered projects utilizing its unique formulation technology platforms, XeriSol™ and XeriJect™, bringing forward innovative products for the firm and its partners.

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BUSINESS INSIGHTS, PHARMA TECH

Certara Acquires AI Company Vyasa to Boost Scientific Innovation

Certara | January 05, 2023

Certara, Inc. announced the acquisition of Vyasa Analytics, LLC, which offers scalable deep-learning software that enables life sciences enterprises to make predictions and answer complicated queries across structured and unstructured bio-medical data. The acquisition will improve Certara's software by giving its end-to-end platform cutting-edge artificial intelligence (AI) features. Certara said it was excited to announce that it had bought Vyasa, a cutting-edge company that would improve its software platforms and give it more options across many product lines. It went on to say that by introducing AI into its product line, the company is establishing capabilities that will allow it to maintain its leadership in biosimulation use cases in drug research and development. Established in 2017, Vyasa software offers businesses a revolutionary artificial intelligence-powered platform that allows them to integrate and analyze material across their company data landscape. LAYAR is a flexible, modular data fabric that can be used to analyze numbers, words, and pictures. It is Vyasa's most important product. It uses artificial intelligence to help people make better decisions during all stages of drug development. About Certara Certara, a pharmaceutical manufacturing firm with headquarters in Princeton, is focused on accelerating the creation of medications by transforming the traditional drug discovery and development process utilizing its biosimulation software, technology, and services. There are around 2,000 biopharmaceutical businesses, academic institutions, and regulatory bodies from 62 countries among its clientele.

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