Orphan Drug Designation Granted to XOMA 358 - Report on XOMA

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

About ACI Association: 

Active Charter Investors Association ("ACI Association") produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. ACI Association has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.

ACI Association has not been compensated; directly or indirectly; for producing or publishing this document.

PRESS RELEASE PROCEDURES:  

The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer"). Rohit Tuli, a CFA® charter holder (the "CFA®"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on sound investment judgment and publicly available information which is believed to be reliable. The Reviewer and the CFA® have not performed any independent investigations or forensic audits to validate the information herein. Unless otherwise noted, any content outside of this document has no association with the Author, the Reviewer, or the CFA® (collectively referred to as the "Production Team") in any way. The Production Team is compensated on a fixed monthly basis and do not hold any positions of interest in any of the securities mentioned herein.

NO WARRANTY 

ACI Association, the Author, the Reviewer and the CFA® (collectively referred to as the "Publishers") are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted by the Publishers whatsoever for any direct, indirect or consequential loss arising from the use of this document. The Publishers expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, the Publishers do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.

NOT AN OFFERING 

This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither ACI Association nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.aciassociation.com/.

RESTRICTIONS 

ACI Association is not available to residents of Belarus, Cuba, Canada, Iran, North Korea, Sudan, Syria or Somalia. Do not send email to robottrap (at) aciassociation.com.

CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.

SOURCE www.aciassociation.com