Contract manufacturing news in brief
recently announced new contract manufacturing news.
DSM Pharmaceuticals and APT Pharmaceuticals have formed a manufacturing pact whereby DSM will produce APT's commercial drug supply as a sterile product for pulmonary delivery, from its commercial facilities in Greenville, North Carolina. APT is a specialty drug development company primarily focused on inhaled treatments for serious lung diseases. "DSM has a superior reputation in sterile manufacturing, experience with similar drug products, and an excellent working relationship with the FDA", said Howard Raff, COO of APT. "In addition to their experience, they also have the capability to provide increased scale through commercialisation." Althea Technologies has commenced a manufacturing supply agreement to provide protein production, purification and aseptic filling services to make clinical trial batches of the first drug candidate of Quintessence Biosciences, QBI-139. The drug, has shown to be effective in fighting pancreatic, non-small cell lung, prostate, and ovarian solid tumours in preclinical studies on human cells and Quintessence plans to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) this quarter. Laureate Pharma has entered into a GMP manufacturing contract with Arius Research for its Trop-2 signal transduction antibody programme which is targeting a novel protein marker that has been linked in the scientific literature to aggressive cancers including pancreatic, colon, breast and prostate cancer. Under the agreement, Laureate will produce Arius' IgG1 humanised antibody so that the firm can begin preclinical studies in the first quarter of this year. Anthera Pharmaceuticals recently announced it has forged manufacturing agreements with Albemarle Corporation and Patheon for the large-scale clinical production of Varespladib (A-002), in preparation for anticipated phase III clinical trials and a subsequent new drug application (NDA) to the FDA. Albemarle will be responsible for the process optimisation and manufacture of GMP quantities of the drug's active pharmaceutical ingredient (API), while Patheon will undertake the finished tablet production. The agreement also provides an option for the commercial production of Varespladib in the future. Financial terms were not disclosed. Varespladib is Anthera's oral drug candidate for the treatment of cardiovascular disease and the firm said it believes that its new relationship with Albermale and Patheon position the company to secure a cost-effective, long-term supply of the product; quickly scale current manufacturing efforts to meet production requirements; and reduce manufacturing related risks to the Varespladib clinical program. "These agreements with Albemarle and Patheon provide Anthera with key supply chain resources for the manufacture of Varespladib," said Paul Truex, president and CEO of Anthera.
