Allergan plc Ordinary Shares (NYSE: AGN) is one of the world's largest pharmaceutical companies that produces branded and generic drugs, and performs pharmaceutical research and development.
Benzinga had the privilege of chatting with Allergan Chief R&D Officer David Nicholson about the company's recent acquisition of Zeltiq Aesthetics, Avycaz and other pipeline developments.
Allergan announced in late January that the U.S. Food and Drug Administration has approved the company's supplemental New Drug Application (sNDA) to update the label for AVYCAZ (ceftazidime and avibactam) with clinical data from two Phase 3 trials supporting the indication to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms.
Nicholson told Benzinga that it was a "great move" from the FDA to give the company approval as it was based on a relatively small number of patients.
The approval is significant because it removes any restrictions regarding the use of Avycaz in patients with susceptible Gram-negative infections. The executive emphasized the fact that Avycaz can now be used more as a first line antibiotic as it is approved without restrictions for use in patients with challenging pathogens.
Nicholson added that the company is presently working to get approval for Avycaz to be used for the treatment of pneumonia.
Allergan announced in early January that it has entered into a research, development, collaboration and license agreement for the worldwide rights to Assembly Biosciences' microbiome gastrointestinal (GI) development programs.
Nicholson noted that Allergan's GI is one of the company's top four therapeutic areas given its active presence in IBD and in IBS. Nevertheless, management is always looking for new venues to boost its GI pipeline and one of the areas of research which Nicholson spent many years is the impact of the gut flora (the bacteria we all have in our gut) on human health.
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Now some people speculate that differences in the gut microbiome could play a role in development of all sorts of disorders, autism, depression, CNS disorders," he said. "For me, the low hanging fruit that we should be investigating is changes in gut flora on gastrointestinal diseases such as indeed, IBD and IBS, and that is the focus of our collaboration with Assembly."
Nicholson added that he is "very impressed" with Assembly Biosciences and its ability to evaluate the microbiome and differentiate between the microbiome in healthy individuals and individuals with GI disorders.
The executive further emphasized that the objective of the company's partnership is to introduce products to the market.
Nicholson touted the fact that Allergan has around 70 ongoing projects that are currently undergoing early phase 2 through to late phase 3 stages. Of those, the executive highlighted six products that are either in phase 3 or about to enter phase 3 all of which have "significant blockbuster potential."
The 6 Products
- Abicipar (phase 3) is in development for advanced macular degeneration (AMD).
- Rapastinel (phase 3) for the treatment of major depressive disorder (MDD). Of particular note, during the phase 2 study the therapy showed an onset of action within hours in patients who had insufficiently responded to existing antidepressants.
- Cenicriviroc (will enter phase 3 this year) for the treatment of non-alcoholic steatohepatitis (NASH). During the phase 2 study the therapy showed a reduction in reduction in fibrosis in patients.
- Relamorelin (should enter phase 3 this year) is an agent for diabetic gastroparesis.
- Ubrogepant (phase 3) and Olcegepant (phase 2B) for the prophylactic and acute treatment of migraines.
- Esmya or ulipristal (completed phase 3) for the treatment of uterine fibroids. During a phase 2 trial Esmya showed a very significant reduction of bleeding associated with uterine fibroids and also showed a very clear improvement in quality of life of women suffering from this disorder.
At last check, ordinary share of Allergan were up 0.42 percent at $247.40.
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