Patient Centricity by Prodrug Design

pharmexec | May 02, 2019

The biopharmaceutical industry has brought on many aspects of patient centricity, ranging from clinical trial design to incorporating digital health in outcomes. Some companies, however, are taking patient centricity to another level by utilizing prodrug technology to design better drugs. Elegant in concept, the therapeutic rationale of a prodrug is to improve the physicochemical, biopharmaceutical, or pharmacokinetic properties of an active pharmaceutical ingredient (API). One such company, KemPharm, Inc., has built its business on the significant opportunity that prodrugs offer, both in the development of improved versions of FDA-approved drugs as well as the ability to generate prodrug versions of existing compounds that may have applications for new disease indications. Travis Mickle, CEO of KemPharm, will discuss his company’s use of prodrugs, the business opportunities prodrugs represent, and how prodrugs are helping to improve patient centricity.

Spotlight

This course will provide an overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residues.

Spotlight

This course will provide an overview of clean-in-place (CIP) systems including design, integration, and selection of cleaning chemicals. Participants will discuss engineering concepts, principles, and integration of CIP systems, clean-out-of-place (COP) systems, or immersion parts washers. While there will be some discussion of manual cleaning practices, cleaning principles will be primarily introduced as they relate to the dynamics of CIP and COP technologies, with an emphasis on selecting the right cleaning chemistries for specific soil residues.

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RESEARCH

NRx Pharmaceuticals Announces New Finding from ZYESAMI™ (aviptadil) Phase 2b/3 Clinical Trial

NRx Pharmaceuticals | August 30, 2021

NRx Pharmaceuticals announced an additional finding in its phase 2b/3 clinical trial investigating ZYESAMI™ (aviptadil) for the treatment of patients with acute Respiratory Failure due to Critical COVID-19. Previously announced results have focused on survival and recovery from respiratory failure at 60 days, and ZYESAMI's apparent role in preventing rise in the inflammatory cytokine IL-6, known as "Cytokine Storm." NRx's new analysis shows that patients treated with ZYESAMI demonstrated improvement in blood oxygen, indicative of improved lung function, within a day of starting treatment. The average difference in Respiratory Distress Ratio between those treated with aviptadil and placebo was both clinically meaningful and statistically significant. Moreover, the difference is comparable to that reported a year ago from an open label study at Houston Methodist Hospital by Dr. J Georges Yousef. "With the conclusion of the analysis of primary and secondary endpoints, we are able to focus on prespecified endpoints that confirm mechanism of action," said Prof Jonathan Javitt, MD, MPH, Chairman and CEO of NRx. "COVID-19 attacks the cells that line the lung in a manner that prevents them from transmitting oxygen to the body. It is this respiratory failure that starts the lethal process of COVID," This latest analysis provides confirmatory evidence that aviptadil improves the lung's ability to transmit oxygen within a day of initiating treatment. The benefit was seen across all patients, all baseline severities, and all types of hospitals. We believe this new finding illustrates ZYESAMI's mechanism of action in a placebo-controlled trial and supports our application for Breakthrough Therapy Designation to the FDA." Prior data regarding reduced respiratory distress were reported by Dr. J. Georges Youssef, Head of Academic Pulmonary Medicine at Houston Methodist Hospital one year ago. Dr. Youssef and colleagues reported the results in 21 patients treated with ZYESAMI, compared to 24 patients who received best-available standard of care. This latest analysis also supports NRx's application for Breakthrough Therapy Designation (BTD) to the FDA for ZYESAMI. BTD is a process designed to expedite the development and review of medicines intended to treat a serious condition and is supported by preliminary clinical evidence showing the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint(s). https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy About ZYESAMI™/VIP in COVID-19 ZYESAMI (aviptadil) is a synthetic form of Vasoactive Intestinal Polypeptide (VIP) first discovered by the late Prof. Sami Said in 1970, and ZYESAMI™ is named in his honor. Although primarily concentrated in the lung, it was first purified from the intestinal tract. VIP binds specifically to the alveolar type II cell (ATII) in the air sac (alveolus) of the lung, where it has been shown have potent anti-inflammatory/anti-cytokine activity in animal models of respiratory distress, acute lung injury, and inflammation. Most importantly, VIP stimulates ATII cells to make the surfactant that must coat the lining of the lungs in order for them to exchange oxygen with the blood. Loss of surfactant causes respiratory failure and alveolar collapse, which are hallmarks of COVID-19. About NRx Pharmaceuticals NRx Pharmaceuticals draws upon more than 300 years of collective, scientific and drug-development experience to bring improved health to patients. Its investigational product, ZYESAMI™ (aviptadil) for patients with COVID-19, has been granted Fast Track designation by the US Food and Drug Administration (FDA) and is currently undergoing phase 3 trials funded by the US National Institutes of Health, the Biomedical Advanced Research and Development Authority, a part of the US Department of Health and Human Services, and the Medical Countermeasures program, part of the US Department of Defense. The FDA has additionally granted Breakthrough Therapy Designation, a Special Protocol Agreement, and a Biomarker Letter of Support to NRx for NRX-101, an investigational medicine to treat suicidal bipolar depression. NRX-101 is currently in Phase 3 trials, with readouts expected in 2022. NRx currently has the BriLife for COVID-19 in phase 3 trials, and holds the exclusive worldwide license to commercialize the vaccine. The BriLife vaccine was first developed by the Israel Institute for Biological Research.

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BUSINESS INSIGHTS

CordenPharma Completes Acquisition of Three Manufacturing Facilities from Vifor Pharma

CordenPharma | February 01, 2022

CordenPharma, a leading, full-service Contract Development & Manufacturing Organization supplying APIs, Excipients, Drug Products, and associated Packaging services, announced today the completion of the acquisition of three manufacturing facilities from Vifor Pharma, to be ultimately renamed Corden Pharma Fribourg S.A. in Switzerland, and Corden Pharma Lisbon S.A. in Portugal. "We welcome the three sites and their employees as new members to the CordenPharma Group and look forward to working with Vifor in the future to supply Vifor Pharma's finished drug products, including to their already existing customers. The acquired pharma sites have a well-trained workforce with great cultural fit, state-of-the art infrastructure, and a strong compliance track record. This excellent opportunity aligns well with our strategy to broaden our CDMO capabilities." Dr. Michael Quirmbach, Chief Executive Officer & President of CordenPharma The acquisition of the Vifor Pharma manufacturing sites will expand CordenPharma's capabilities and capacities in the manufacturing of non-sterile drug product dosage forms, including but not limited to, Oral Solid Dosage (OSD) forms such as tablets and capsules. With the addition of these three new facilities, CordenPharma's global network now consists of twelve locations (11 GMP sites and 1 R&D laboratory), supported by > 2,600 employees generating expected sales of over 800 Mio € in 2022. About CordenPharma CordenPharma, the global pharmaceutical service & manufacturing platform of International Chemical Investors Group (ICIG), is a full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Excipients, Drug Products, and associated Packaging Services. Through a growing network of cGMP facilities across Europe and the US organized under five Technology Platforms – Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, and Small Molecules – CordenPharma experts translate complex processes and projects at any stage of development into high-value products.

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PHARMACY MARKET

Novartis' Sandoz spotlights importance of generic drugs in new social campaign

Novartis | December 17, 2020

Did you realize that 90% of remedies are composed for nonexclusive medications? Novartis' Sandoz is getting the news out about nonexclusive medication with such realities in its as of late dispatched "Request Generics" crusade. It's Sandoz's first significant instruction and mindfulness crusade via online media to advance the estimation of generics. The intended interest group is key partners—patients, clinicians, policymakers and payers—with messages running on LinkedIn and Twitter. Sandoz plans to run the mission through the finish of the principal quarter, perhaps more, contingent upon results. It's as of now chipping away at a second stage that will move center to biosimilar adaptations of marked biologic medications. "Generics are assuming a truly significant job, and I believe it's ideal planning currently to discuss the significant job generics play in a well-working medical care framework," said Carol Lynch, Sandoz's U.S. president and head of North America. Other than featuring the pervasiveness of generics, the online media posts promote their reasonableness and their status as firmly directed items—as protected and powerful as their image name partners. The moderateness and security messages are significant, alongside the general token of the opposition generics give in the commercial center. The duplicates of costlier marked medications help to make "a sound serious market that is directed to patients having expanded admittance to the prescriptions they need," Lynch said. Nonexclusive medications saved the U.S. medical services framework $313 billion a year ago, as per the 2020 yearly report of conventional and biosimilar access and reserve funds in the U.S. from the Association for Accessible Medicines, a generics industry exchange gathering.

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