The BioPharm Insight™ October Catalyst Monitor Spotlights 13 Key Development and Regulatory Events

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Companies with upcoming events to watch include United Therapeutics, Aegerion Pharmaceuticals and NPS Pharmaceuticals

October Catalyst Monitor

Monthly Catalyst Monitor

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 58-page report, featuring proprietary investigative journalism relevant for each profiled event, sign up for a free demo or trial of BioPharm Insight.

The Catalyst Monitor for October 2012 highlights United Therapeutics’ action review date on October 27 for oral Remodulin. While the drug had positive results in an earlier monotherapy study in pulmonary arterial hypertension (PAH), physicians are disappointed with the results from a combination therapy trial, which is the more likely setting for the drug’s use.

Aegerion Pharmaceuticals and Isis Pharmaceuticals will both likely see FDA approval for their homozygous familial hypercholesterolemia (hoFH) candidates. Aegerion’s lomitapide will compete with ISIS’ Kynamro (mipomersen), but the fatty liver risk associated with lomitapide may lead to stricter FDA monitoring requirements compared to mipomersen. An AdCom will review lomitapide on October 17 and mipomersen on October 18.

Also positive on the FDA approval front is NPS Pharmaceuticals’ prospects for Gattex (teduglutide) in short bowel syndrome (SBS) despite a three-month review delay. If approved, rigorous post-marketing surveillance studies and physician education programs will most likely be requested to settle lingering cancer concerns. An AdCom meeting is scheduled for October 16.

Additional drugs covered in this report include:

  •     GlaxoSmithKlines’ Votrient
  •     Vertex Pharmaceuticals’ VX-809 and Kalydeco
  •     Sarepta Therapeutics’ AVI-4658
  •     Supernus Pharmaceutical’s SPN-804 and SPN-538
  •     Impax Laboratories’ IPX066
  •     Eisai’s Fycompa
  •     Actelion’s Macitentan
  •     Cornerstone Therapeutics’ lixivaptan
  •     Map Pharmaceuticals Levadex

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Kristopher Sarajian
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