Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D; community with critical information on the tools, technologies, and trends that drive the biotech industry.
Issue link: http://gen.epubxp.com/i/155541
Biobusiness for all three indications. Surotomycin (CB-315), an oral lipopeptide, is in Phase III for Clostridium diffcileassociated diarrhea. "C. diffcile is the number-one bacterial threat in the United States. Globally, it accounts for approximately 30 million days of treatment per year," he continued, adding that Cubist expects to fle an NDA in 2015. In July, Tetraphase was granted the Qualifed Infectious Disease Product (QIDP) designation for eravacycline (TP-434) in cIAIs and cUTIs. This designation enables priority review and eligibility for fast-track status, as well as the potential for a fve-year extension of patent exclusivity. The antibiotic is in Phase III trials for cUTIs. This synthetic, intravenously administered tetracycline is a broad-spectrum antibiotic for multidrug-resistant infections. Additional compounds are in preclinical development. The company also is working to create oral antibiotics. Achaogen is focused on multi-drug-resistant, gram-negative bacterial infections. In April, it was awarded a $60 million contract from the Biomedical Advanced Research and Development Authority (BARDA). The funds will be used to conduct a global Phase III study to evaluate the safety and effcacy of plazomicin for patients with gram-negative bacterial infections caused by carbapenemresistant Enterobacteriaceae (CRE). The study is scheduled to begin during the fourth quarter of 2013. Plazomicin (ACHN-490) is a nextgeneration neoglycoside that has demonstrated effcacy against many pathogens. AstraZeneca's ceftaroline/avibactam (CAZ104) is in Phase II studies for cUTIs and cIAIs, and early results indicate potency against MRSA and enterobacteriaceae in vitro. This b-lactamase inhibitor, combined with cephalosporin, is expected to launch in the European Union and Japan the second half of 2014 and in China in 2016. Zinforo, an extended-spectrum ceftaroline for pneumonia and skin infections, already has launched in Europe and is expected to launch in China in the frst half of 2014. part of that contract, Basilea plans combination studies with carbapenems. According to Ronald Scott, CEO, BAL30072 is "a medical countermeasure for a potential biological threat to national security and public health." GlaxoSmithKline has one antibiotic in a Phase III trial, three in Phase II trials, and two in Phase I trials. Four of the six compounds were in-licensed or developed through collaborations. Relenza, an intravenous neuraminidase inhibitor for infuenza, is the most advanced. The targets of the Phase II antibiot- ics are listed as malaria, hepatitis C, and bacterial infections. The Phase I targets are also listed simply as bacterial infections. In May, GlaxoSmithKline was awarded $40 million from HHS for an 18-month agreement, and up to $200 million if the program is renewed for fve years. Second Genome is taking a nonantibiotic approach to treating infection, said Peter DiLaura, CEO. The company is developing microbiome modulators to promote the growth of commensal bacteria, focusing around infammation, metabolic disease, and hospital-acquired infections. "We have built a platform to look at this microbial interaction and are conducting preclinical research on these areas," he explained. Early results suggest that modulating the gut microbiome may reduce the length of time the body is susceptible to C. diffcile infection, and that a healthy microbiome may promote the growth of commensal bacteria to prevent or fght C. diffcile infections. Targeting Pathogenic Toxins Merck has two antibiotic programs in Phase III and fve in Phase II development. In Phase III trials, actoxumab/bezlotoxumab (MK-3415A) combines antibodies targeting two C. diffcile pathogenic toxins (A and B). Merck is developing it with Massachusetts Biological Laboratories and Medarex. Also in Phase III is Merck's vaniprevir (MK-7009), which is being developed as an oral NS3/4A protease inhibitor in combination with pegylated interferon alfa-2b (pegIFN alfa-2b) and ribavirin (RBV) in a clinical trial of Japanese, treatment-naïve participants with chronic hepatitis C genotype 1. Merck's Phase II projects include antibiotics for hepatitis C, HIV, human cytomegalovirus (HCMV) infection in transplant patients, and acute bacterial infections. Basilea Pharmaceutica is in Phase I trials with BAL30072, a siderophore sulfactam with broad-spectrum activity against gramnegative bacteria. The company was awarded an $89 million BARDA contract in June. As Specificity Matters Ki-67, HER2, EGFR, Beta-Catenin & more For research use only. Not intended for diagnostic purposes. UltraMAB is a trademark of OriGene Technologies Inc. 2013 Genetic Engineering & Biotechnology News | GENengnews.com | September 1, 2013 | 17