Spectrum picks up orphan cancer drug with stabilized delivery

With a 2015 commercial launch in mind, Spectrum Pharmaceuticals ($SPPI) hopes to file an NDA next year for an orphan-designated cancer drug it snagged from Ligand Pharmaceuticals ($LGND). The compound has a specialized delivery component that increases the stability and solubility of the treatment.

Captisol-enabled melphalan is a conditioning treatment for patients undergoing stem cell transplant for myeloma, a cancer of the plasma cells, and is commonly used to combat the disease. But Phase II clinical trials showed that Captisol can allow for longer administration and higher intensity of chemotherapy, according to a Spectrum release.

Captisol is a chemically modified version of cyclodextrin, which has a ring structure that protects the melphalan and allows it to remain active in the body for a longer amount of time. Also, because the compound avoids the use of propylene glycol, the drug doesn't come with the renal and cardiac side effects normally associated with melphalan.

Other companies have had success using the Captisol delivery mechanism, including Onyx Pharmaceuticals ($ONXX), Baxter ($BAX) and Pfizer ($PFE), and more than 30 products are in clinical development making use of the technology. Its orphan status expedites the regulatory process, allowing it to move more quickly through the FDA's hoops and giving market exclusivity to Ligand, and now Spectrum.

- here's the release

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