Merck and Pfizer’s Bavencio approved for renal cell carcinoma

pharmaphorum | May 15, 2019

Merck KGaA and Pfizer’s immunotherapy Bavencio (avelumab) has been approved by the FDA in combination with Pfizer’s Inlyta (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). The accelerated approval was based on positive results from the Phase III JAVELIN Renal 101 study, which showed the combination significantly lowered risk of disease progression or death by 31% and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib. This is good news for a drug that has faced some challenges recently. In March, Merck and Pfizer discontinued an ovarian cancer trial for Bavencio. The decision was based on several emerging factors since the trial’s initiation, including interim results from the separate JAVELIN Ovarian 100 trial announced in December showing that Bavencio was unable to improve progression-free survival when used as a maintenance therapy. That failure came just a few weeks after Merck and Pfizer conceded defeat in another phase III study of Bavencio, the JAVELIN Ovarian 200 trial in platinum-resistant or platinum-refractory ovarian cancer.

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Requirements and rules of good manufacturing practices in pharmaceutical manufacturing. As per FDA and other regulatory agencies, it is mandatory to follow the GMP regulations.

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Requirements and rules of good manufacturing practices in pharmaceutical manufacturing. As per FDA and other regulatory agencies, it is mandatory to follow the GMP regulations.

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PHARMA TECH

Innovation Zed Announce 2022 Launch of InsulCheck DOSE Add-on Technology for Insulin Pens

Zed | November 15, 2021

Innovation Zed, developer of novel diabetes management technologies headquartered at NovaUCD, at University College Dublin, Ireland are delighted to announce today the arrival of the much anticipated InsulCheck DOSE technology that will be coming to market in 2022. "It is with great excitement that we announce the arrival of our InsulCheck DOSE by Innovation Zed. As the third generation product of the InsulCheck family, this technology has been a dream of our company from its very inception and this product is the culmination of over a decade of work to support multiple daily injection (MDI) pen users. We understood the difficult challenges presented by various injection pens and in particular the difficulties in working on a technology to reliably and accurately support low-cost disposable pens. This is the reason we at Innovation Zed took an incremental approach to developing the InsulCheck DOSE product.We have taken a unique approach in developing this technology by working closely with users, caregivers, software developers, medical device specialists and previous generations of InsulCheck products to design and develop a product that bolsters and supports the needs of all stakeholders.'' Dr Dean Minnock, CEO at Innovation Zed Innovation Zed has collaborated with SHL Medical in the development of InsulCheck DOSE. SHL Medical is a world-leading provider of drug delivery solutions and also offers design-to-build and contract manufacturing services for various medical products through its subsidiary, SHL Technologies. What is InsulCheck DOSE? InsulCheck DOSE is a single unit add-on device for pen injectors that automatically captures dose value dialled, injection event time stamp, temperature and mounting/unmounting events. Through Bluetooth® Low Energy (BLE) technology, InsulCheck DOSE transmits these data points to a paired companion software platform in real time for inclusion in diabetes management therapy. "InsulCheck DOSE technology supports MDI users by enhancing their traditional injection pen and transforming it into a smart pen that can optimise their treatment and reduce the stresses caused by MDI therapy. Through this technology we are enabling every MDI user to make their existing injection pen a smart pen without having to compromise or change from their existing HMO or health service provider" - said Dr Minnock. InsulCheck DOSE Features The technology utilises a multi-sensor approach to accurately detect and register the actual dosage dialled and provide an injection event time stamp to log the event. The incorporated temperature sensors constantly monitor the ambient temperature of the area surrounding the injection pen, providing safety notifications to the user if the surrounding temperature may affect the drug housed inside the pen. Using an OLED display, InsulCheck DOSE provides visual information and feedback to the user, helping improve best practice procedures. A rechargeable lithium battery powers the DOSE device and is capable of operating well over 1 week at a time between charges. As a BLE enabled product, all data captured by InsulCheck DOSE is transferred in real time to a paired mobile application. If the user does not wish or is unable to remain connected with a companion software platform, InsulCheck DOSE has built-in memory to store over 40 days' worth of injection history at a time. Through modification of the sleeve component and firmware refinement, InsulCheck DOSE can become applicable to all injection pens for various drug treatments. At launch, it will support a range of reusable and disposable injection pens on the insulin market from Novo Nordisk, Lilly and Sanofi. "Our ability to learn, adapt and improve our technology is one of the key aspects of InsulCheck DOSE and one that separates us greatly from our competitors. The future-proof design of InsulCheck DOSE means that it can be adapted to support the various pen mechanisms in use today, whilst maintaining accuracy and reliability for the patient. Among the numerous unique features of this product is the built in Firmware Over The Air (FOTA) capability which allows continuous optimisation of the device's firmware even when deployed in the field. That future-proofing allows InsulCheck DOSE to adapt to physical injection pen variations from the pen manufacturers and improve on device performance 'on the go' from real world user behaviours" - said Dr Minnock. Value Proposition The InsulCheck DOSE device helps patients, automatically track their daily injection and monitor treatment adherence. The intended use of InsulCheck DOSE is as a supporting component in a management ecosystem for therapy optimisation, remote monitoring and enhanced connected care. Dr Minnock explained, "InsulCheck DOSE is a disruptive technology that will revolutionise an entire market and change the lives of millions of MDI users worldwide. Innovation Zed have entered into discussions with market leaders in the diabetes management sector with the intention of finding a strategic global partner in taking this InsulCheck DOSE technology to the market. InsulCheck DOSE is an attractive offering to any organisation working in this space as it can significantly enhance their existing offering to become more competitive and command new growth and additional market share." Conclusion InsulCheck DOSE enters production at the end of Q2 2022 and will be available as an FDA registered and CE marked product. Manufacturing of InsulCheck DOSE will be handled by Innovation Zed's existing manufacturing partner SHL Technologies, a subsidiary of SHL Medical. If you wish to understand InsulCheck DOSE or any of our technology offerings in greater detail, please feel free to visit our website or reach out to us directly.

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PHARMACY MARKET

Edenbridge Pharmaceuticals Announces the Launch of DARTISLA ODT

Edenbridge Pharmaceuticals | March 01, 2022

Edenbridge Pharmaceuticals, LLC announced that DARTISLA ODT is now available by prescription in the United States through Phil, the commercialization partner and eHub for DARTISLA ODT, as well as in retail pharmacies throughout the country. To ensure access to patients in need, Edenbridge is sponsoring the DARTISLA ODT Copay Program, which allows eligible patients to obtain the product for as little as $0 when filled through Phil or $20 when filled at other pharmacies. “DARTISLA ODT is the first and only FDA-approved orally disintegrating tablet of glycopyrrolate, and we are excited to introduce this novel formulation of glycopyrrolate to patients and healthcare providers,” noted Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and General Counsel. “Further, Edenbridge is committed to ensuring patient access to this product, and we are pleased to be sponsoring the DARTISLA ODT Copay Program to facilitate getting DARTISLA ODT into the hands of people that need it most.” “Phil is proud to support Edenbridge’s commitment to providing broad access to this innovative therapy by simplifying the patient onboarding process allowing affordable, fast, broad-based distribution of Dartisla ODT,” Deepak Thomas, Founder and CEO of Phil The U.S. Food and Drug Administration (FDA) approved Dartisla ODT for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer on December 16, 2021. DARTISLA ODT is manufactured by Catalent using their proprietary Zydis® orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water. Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT. DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. About Edenbridge Edenbridge is a specialty pharmaceutical company focused on identifying, developing, and marketing prescription pharmaceutical products. Edenbridge’s goal is to create a broad portfolio of limited source branded and generic pharmaceutical products that will provide high-quality, affordable, and accessible alternatives in the healthcare market. Edenbridge’s approach is to work with best-in-class and like-minded industry partners to deliver its products to physicians and patients everywhere. Founded in 2008, Edenbridge launched its first product in February 2010 and has sold its commercial products through every major channel of the U.S. prescription pharmaceutical supply chain. In addition, Edenbridge has a robust product development pipeline that includes 505(b)(2) NDAs, ANDAs, and foreign filings. About Phil Phil is a commercialization partner for innovative life sciences companies, offering pharmaceutical manufacturers a modern alternative to traditional access, affordability and distribution options. Through its digital stakeholder experiences, patient access services, market access solutions and distribution models, pharma manufacturers can provide patients with more affordable and timely therapy access.

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BUSINESS INSIGHTS

Fusion Pharmaceuticals and Niowave Announce Actinium-225 Collaboration and Supply Agreement

Fusion Pharmaceuticals Inc. | June 13, 2022

Fusion Pharmaceuticals Inc. a clinical-stage oncology company focused on developing next-generation radio pharmaceuticals as precision medicines, and Niowave, Inc., a manufacturer of medical radioisotopes from radium and uranium, today announced that the companies have entered into a collaboration and supply agreement for the development, production, and supply of actinium-225. Under the agreement, Fusion will invest up to $5 million in Niowave to further develop their technology to increase current production capacity of actinium-225, and in return Fusion will have guaranteed access to a pre-determined percentage of Niowave's capacity of the resulting actinium-225, as well as preferred access to any excess supply produced. As part of the agreement, Fusion will also have an option to invest in future production of actinium-225 to scale with Fusion's needs. "As excitement for the tumor-killing potential of alpha-emitting radio pharmaceuticals increases, we intend to stay at the forefront of actinium development and supply to support our growing pipeline of targeted alpha therapies. We continue to prioritize manufacturing and access to actinium as a critical component of Fusion's platform, and our partnership with Niowave further strengthens and diversifies our supply chain as we advance multiple actinium-based radio pharmaceuticals in the clinic." Fusion Chief Executive Officer John Valliant, Ph.D "The Niowave team has worked hard to scale up our actinium-225 production to the millicurie level and this has allowed us to start working with oncology community partners," said Niowave Chief Executive Officer/Senior Scientist Terry Grimm, Ph.D. "We have been watching Fusion's progress in the development of their pipeline of targeted alpha therapies and we are very excited to partner with them on this journey." Fusion is developing actinium-based TATs leveraging the potency and precision offered by alpha particles. Actinium-225 decay gives off four alpha emissions in relatively rapid succession, maximizing the damage to the DNA of tumor cells, with a 10-day half life that allows for central manufacturing and distribution of products to clinical sites in a ready-to-use form. About Fusion Fusion Pharmaceuticals is a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines. Fusion connects alpha particle emitting isotopes to various targeting molecules in order to selectively deliver the alpha emitting payloads to tumors. Fusion's lead program, FPI-1434 targeting insulin-like growth factor 1 receptor, is currently in a Phase 1 clinical trial. The pipeline includes FPI-1966, targeting the fibroblast growth factor receptor 3 (FGFR3), advancing to a Phase 1 study following the investigational new drug (IND) clearance; and FPI-2059, a small molecule targeting neurotensin receptor 1 (NTSR1). In addition to a robust proprietary pipeline, Fusion has a collaboration with AstraZeneca to jointly develop novel targeted alpha therapies (TATs) and combination programs between Fusion's TATs and AstraZeneca's DNA Damage Repair Inhibitors (DDRis) and immuno-oncology agents. Fusion has also entered into a collaboration with Merck to evaluate FPI-1434 in combination with Merck's KEYTRUDA® (pembrolizumab) in patients with solid tumors expressing IGF-1R. Fusion and Hamilton, Ontario-based McMaster University are building a current Good Manufacturing Practice (GMP) compliant radiopharmaceutical manufacturing facility designed to support manufacturing of the Company's growing pipeline of TATs. About Niowave Niowave manufactures radioisotopes to cure cancer and save lives. Niowave builds and operates superconducting electron linear accelerators and is using that expertise to produce various radioisotopes for nuclear medicine. Niowave is a Cooperative Agreement partner with the National Nuclear Security Administration to develop a domestic supply of molybdenum-99 and currently produces yttrium-90 for use in cancer therapy. Niowave is licensed by the NRC to manufacture radioisotopes from uranium and radium and has partnerships with several universities and national laboratories focused on production and purification of radioisotopes for use in cancer therapy. By using radium targets and electron beams, Niowave is able to produce ultra pure and carrier-free actinium-225. Niowave's R&D facility is currently supplying actinium-225 samples to partners. Production-scale operations are ramping up at a second, FDA-compliant facility capable of meeting the growing actinium-225 market.

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