Author: Kudyba, Karl ; Stayton, Patrick S ; Pottenger, Ayumi E ; Roy, Debashish ; Roth, Alison ; Zhang, Jing ; Rochford, Rosemary ; Ho, Duy-Khiet ; Livingston, Vincent C ; Vlaskin, Vladmir ; Chavas, Thomas E J ; Huber, Hans E ; Tyson, George ; Pybus, Brandon ; Burke, Paul A ; Lin, Hsiuling ; Maktabi, Mahdi ; Senter, Peter ; Srinivasan, Selvi ; Wesche, David

Approximately 3.3 billion people live with the threat of Plasmodium vivax malaria. Infection can result in liver-localized hypnozoites, which when reactivated cause relapsing malaria. This work demonstrates that an enzyme-cleavable polymeric prodrug of tafenoquine addresses key requirements for a mass administration, eradication campaign: excellent subcutaneous bioavailability, complete parasite control after a single dose, improved therapeutic window compared to the parent oral drug, and low cost of goods sold (COGS) at less than $1.50 per dose. Liver targeting and subcutaneous dosing resulted in improved liver:plasma exposure profiles, with increased efficacy and reduced glucose 6-phosphate dehydrogenase–dependent hemotoxicity in validated preclinical models. A COGS and manufacturability analysis demonstrated global scalability, affordability, and the ability to redesign this fully synthetic polymeric prodrug specifically to increase global equity and access. Together, this polymer prodrug platform is a candidate for evaluation in human patients and shows potential for P. vivax eradication campaigns.

01 Sep 2014·Nature Reviews Drug DiscoveryQ1 · MEDICINE

Overcoming the challenges in administering biopharmaceuticals: formulation and delivery strategies

Q1 · MEDICINE

Review

Author: Burke, Paul A ; Langer, Robert ; Mitragotri, Samir

The formulation and delivery of biopharmaceutical drugs, such as monoclonal antibodies and recombinant proteins, poses substantial challenges owing to their large size and susceptibility to degradation. In this Review we highlight recent advances in formulation and delivery strategies--such as the use of microsphere-based controlled-release technologies, protein modification methods that make use of polyethylene glycol and other polymers, and genetic manipulation of biopharmaceutical drugs--and discuss their advantages and limitations. We also highlight current and emerging delivery routes that provide an alternative to injection, including transdermal, oral and pulmonary delivery routes. In addition, the potential of targeted and intracellular protein delivery is discussed.

Therapeutic Delivery

Industry Update: The latest developments in therapeutic delivery

Author: Burke, Paul A.

A review.The time period 6 Nov. 2011 to 5 Dec. 2011 included the following developments.Roche completed its exit from RNAi through the sale of its Kulbach, Germany facility to some of the original site founders.Arrowhead Research Corporation detailed siRNA delivery advances made by Roche Madison Inc., which they acquired in Oct. 2011.Pfizer purchased an antisense company with an anti-scarring treatment, Isis spin-off Excaliard Pharmaceuticals.The competitive GLP-1 agonist field saw the split of Amylin, developer of Byetta^, and long-time partner Eli Lilly.Meanwhile GSK''s long-acting GLP-1 agonist albiglutide failed to meet a non-inferiority end point when compared with Novo Nordisk''s Victoza^.Unigene provided updates on two oral peptide programs.Phase III results from a trial of oral calcitonin, conducted by partner Novartis, failed to meet efficacy end points.In contrast, a Phase II study of oral parathyroid hormone, conducted as part of an agreement with GSK, hit its primary end point, but shortly thereafter GSK returned their rights in the product.Stem cell therapy saw mixed news.Geron, a leading embryonic stem cell company, completed a Phase I in spine patients, and then announced it was abandoning all stem cell work to focus on other areas.Sep., AlloCure and Mesoblast both announced pos. results from clin. studies utilizing mesenchymal stem cells obtained from donated bone marrow.Finally, Amgen surprised would-be developers of biosimilars of blockbuster Enbrel when it announced issuance of a patent, filed in 1995, covering the product through 2028, approx. 16 years beyond what Enbrel''s period of exclusivity had been generally considered to be.

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