Norwood, MA (PRWEB) December 18, 2012
BioPharm Insight’s monthly Catalyst Monitor analyzes the most material events in the sector during the upcoming month. The Catalyst Monitor tracks significant events and announcements such as FDA approvals, Advisory Committee (AdCom) meetings and expected key clinical results. To access the entire 29-page report, featuring proprietary investigative journalism relevant for each profiled event, sign up for a free demo or trial of BioPharm Insight.
After a three month delay in the drug’s review date, Hyperion’s Ravicti is up for approval in January. Ravicti met its primary endpoints in the Phase II and III trials, indicating it is non-inferior to the treatment standard, Buphenyl (sodium phenylbutyrate), in controlling blood ammonia levels in pediatric and adult patients. Ravicti is nearly tasteless and odorless when compared to Buphenyl. Additionally, about one tablespoon of Ravicti liquid once-daily is equivalent to the FDA-approved maximum daily dose of 40 tablets of Buphenyl. Ravicti’s side-effect profile is also better than Buphenyl.
Another candidate up for approval that experts are saying is a real improvement over existing therapies is Raptor’s cystinosis candidate, RP103. A Phase III trial met its primary endpoint of non-inferiority compared to Cystagon, an immediate-release cysteamine bitartrate. RP103 is superior due to better quality-of-life and lower doses. Experts are strongly optimistic that the FDA will approve the drug, indicating that the labeling will probably be limited to patients with cystinosis and relatively preserved kidney function.
On the drug development side, Threshold’s TH-302-doxorubicin combination therapy has experts split on whether the Phase III soft-tissue sarcoma (STS) trial will be able to demonstrate efficacy and safety benefits. After a 91-patient Phase II study showed median overall survival was 21.5 months compared to 8-13 months with doxorubicin alone, experts still say that conducting the Phase III is a major risk for Threshold, as other previous data in STS does not suggest major benefit for TH-302 added to doxorubicin.
Additional catalysts covered in this report include…
- Santarus’ Uceris likely approval for ulcerative colitis induction
- Gilead’s sofosbuvir Phase III HCV results
- Novo’s IDegLira Phase III data in type 2 diabetes
- Vanda’s Phase III sleep-wake disorder drug
- Anacor’s topical antifungal tavaborole Phase III expectations
- Isis’ chances at US approval for homozygous familial hypercholesterolemia (hoFH) agent
- Impax’s US approval chances for Rytary in advanced Parkinson’s disease
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