Date: 2016-02-01
Type of information: Production agreement
Compound: solithromycin
Company: Cempra (USA - NC) Macrolide Pharmaceuticals (USA - MA)
Therapeutic area:
Type agreement: manufacturing - production
Action mechanism:
- antibiotic. Solithromycin is a highly potent next-generation macrolide, the first fluoroketolide, which has potent activity against most macrolide-resistant bacterial strains. In vitro and in vivo studies have shown potent activity against S. pneumoniae as well as an extended spectrum of activity against CA-MRSA, streptococci, Haemophilus, enterococci, Mycobacterium avium and in animal models of malaria. It is also active against atypical bacteria, such as legionella, chlamydia, mycoplasma and ureaplasma, and against gonococci and other organisms that cause genitourinary tract infections. It is 8-16 times more potent than azithromycin and is active against azithromycin-resistant strains. Solithromycin's activity against resistant strains is driven by its ability to interact with three sites on the bacterial ribosome, compared to one for current macrolides. The binding to three ribosomal sites is expected to limit resistance development.
- Solithromycin has completed Phase 3 clinical trials and a New Drug Application (NDA) is in progress for the treatment of community acquired bacterial pneumonia.
Disease:
Details:
- • On February 1, 2016, Cempra and Macrolide Pharmaceuticals announced an agreement where Macrolide will use its novel, proprietary synthesis technology to provide Cempra with a fully synthetic process for its late-stage investigational macrolide antibiotic, solithromycin. Solithromycin is currently manufactured using clarithromycin, a fermentation-derived antibiotic, as the starting material. Based on ground-breaking technology developed by Andrew G. Myers , Ph.D., and colleagues at Harvard University , Macrolide Pharmaceuticals will partner with Cempra with the goal of developing a fully synthetic, cost-competitive manufacturing process for solithromycin. An alternative fully synthetic process could provide manufacturing and supplier flexibility by reducing dependence upon fermentation-derived starting materials.
- Under this agreement, Cempra will support research at Macrolide Pharmaceuticals focused on the optimization, scalability and efficiency of a fully synthetic manufacturing approach to solithromycin. To accomplish this, Macrolide Pharmaceuticals will expand its process chemistry efforts to encompass the synthesis of solithromycin. The initial commercialization of solithromycin, if approved, will utilize the semi-synthetic process that begins with clarithromycin. Sometime later, a shift to a fully synthetic process for solithromycin could occur with validation and approval by the FDA .
Financial terms: Financial terms of the agreement have not been disclosed.
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Is general: Yes
