Orphan Drug Designation Granted to XOMA 358 - Report on XOMA

Jul 23, 2015, 09:50 ET from www.aciassociation.com

NEW YORK, July 23, 2015 /PRNewswire/ --

ACI Association has initiated research coverage on XOMA Corporation (NASDAQ: XOMA). Select highlights from the internally released reports are being made available to the general public (included below), with access to the entirety of the research available to new members.

Today, membership is open to readers on a complementary basis at the following URL: http://www.aciassociation.com/?c=XOMA

Highlights from our XOMA Report include:

  • Grant of Orphan Drug Designation - On June 16, 2015, XOMA Corporation reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XOMA 358, a fully human allosteric monoclonal antibody that reduces both the binding of insulin to its receptor and downstream insulin signaling, for the treatment of congenital hyperinsulinism (HI).
  • Benefits to the Drug Developer - The Company informed that the FDA Office of Orphan Products Development (OOPD) grants Orphan drug designation to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the United States. The designation provides benefits to the drug developer in form of seven years period of U.S. marketing exclusivity, tax credits for clinical research costs, clinical research trial design assistance, the ability to apply for annual grant funding, and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.
  • Views of Management - Commenting on the development, Paul Rubin, M.D., Senior Vice President, Research and Development, and Chief Medical Officer at XOMA said, "The orphan drug designation for XOMA 358 recognizes its potential to address a significant unmet medical need for patients with congenital hyperinsulinism. Patients with hyperinsulinism, a rare and devastating disease, secrete inappropriate and excessive insulin, which cause dangerously low blood sugar levels that can lead to brain damage or, in rare cases, death."
  • Study Results - The Company had presented positive phase 1 data on XOMA 358 at the Endocrine Society's Annual meeting (ENDO 2015) in March 2015. Results of the study, in which 14 healthy volunteers received XOMA 358 and 5 received placebo, showed XOMA 358 reduced insulin receptor signaling and increased glucose production after exogenous insulin injection. In the study, XOMA 358 appeared to be well tolerated, with no serious adverse events observed. Discussing the results of the study, Rubin said, "We recently completed a positive Phase 1 study, results of which suggest XOMA 358 is active against the insulin receptor and shows potential in treating patients who experience an endogenous over-production of insulin. Congenital hyperinsulinism is one of the indications we are considering for a Phase 2 study, which we expect to initiate later this year."

To find out how this influences our rating on XOMA Corporation read the full report in its entirety here: http://www.aciassociation.com/?c=XOMA

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