Key Developments: XOMA Corp (XOMA.W)
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18 Jun 2013
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Latest Key Developments (Source: Significant Developments)
XOMA Corp Announces Perindopril And Amlodipine Fixed-Dose Combination Meets Primary Endpoint In Phase 3 PATH Trial
XOMA Corp announced the 837-patient Phase 3 PATH trial (Perindopril Amlodipine for the Treatment of Hypertension) has demonstrated the fixed-dose combination (FDC) of perindopril arginine combined with amlodipine besylate is statistically significantly superior to either compound alone in reducing both sitting diastolic and sitting systolic blood pressure after six weeks of treatment. This FDC, containing a patent-protected proprietary form of perindopril, was licensed by XOMA as part of a U.S. commercial and development rights agreement signed with Servier for their perindopril franchise. Servier markets the fixed-dose combination product, COVERAM, in 91 countries outside the U.S. Full Article
XOMA Corp Receives Orphan Drug Designation From U.S. Food & Drug Administration for Gevokizumab
XOMA Corp announced that gevokizumab, the company's IL-1 beta modulating antibody, has been granted Orphan Drug Designation by the U.S. Food & Drug Administration (FDA) for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis. The FDA Office of Orphan Products Development (OOPD) mission is to advance the evaluation and development of products (drugs, biologics, devices, or medical foods) that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. In fulfilling that task, OOPD evaluates scientific and clinical data submissions from sponsors to identify and designate products as promising for rare disease and to further advance scientific development of such promising medical products. The office also works on rare disease issues with the medical and research communities, professional organizations, academia, governmental agencies, industry, and rare disease patient groups. Full Article
XOMA Corp Initiates Phase 3 Gevokizumab Trial In Patients With Non-Infectious Uveitis And Phase 2 Gevokizumab Trial in Patients With Erosive Osteoarthritis
XOMA Corp announced it has opened enrollment in two clinical trials to determine gevokizumab's potential to treat interleukin-1 beta-mediated inflammatory diseases. The first trial is XOMA's global Phase 3 study investigating the ability of gevokizumab to reduce signs and symptoms, including vitreous hazein patients with non-infectious uveitis involving the intermediate and/or posterior segment of the eye. The second trial is a Phase 2 study to evaluate potential for gevokizumab to improve pain symptoms, physical function and structural abnormalities in patients with erosive osteoarthritis of the hand. Patients currently are being screened in both trials. In this study, titled A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan-Uveitis, XOMA intends to enroll patients with active non-infectious intermediate, posterior, or pan-uveitis with a vitreous haze score equal to or greater than 2+ on the Standardization of Uveitis Nomenclature / National Eye Institute scale in at least one eye. They will be randomized to receive either one of two doses of gevokizumab or placebo. The study's primary endpoint is proportion of patients demonstrating a significant reduction in vitreous haze score on Day 56. The study also will assess the effect of gevokizumab on additional endpoints, including response rates at other time points and changes from baseline in visual acuity. Full Article
XOMA Corp Comments On Q2 2012 Revenue Guidance-Conference Call
XOMA Corp announced that it is on track for first full quarter of sales in the second quarter of 2012. Full Article
XOMA Corp Sees FY, Q1 2012 Charge Guidance-Conference Call
XOMA Corp announced that it anticipates taking one-time charges for restructuring and related severance costs totaling approximately $6 million to $7 million during fiscal 2012 of which $3.5 million will result in cash charges. In the first quarter of 2012, it expects the charge will be approximately $4.6 million, of which $1.3 million will be in cash. Full Article
XOMA Corp Announces Pricing Of $39.2 Million Public Offering Of Common Stock
XOMA Corp announced the pricing of 29,669,154 shares of its common stock and accompanying warrants to purchase one half of a share of common stock for each share purchased at a price to the public of $1.32. The warrants are exercisable at an exercise price of $1.76 per share beginning on the date of issuance and will expire on the fifth anniversary of the date of issuance. All of the shares and warrants in the offering are to be sold by XOMA. The shares and warrants will be issued pursuant to a prospectus supplement filed as part of a shelf registration statement previously filed with the Securities and Exchange Commission (SEC) on Form S-3. XOMA anticipates that its aggregate net proceeds from the offering will be approximately $36.2 million after deducting the underwriting discount and estimated offering expenses payable by XOMA. The offering is expected to close on or about March 9, 2012, subject to customary closing conditions. RBC Capital Markets and Cowen and Company are acting as joint book-running managers and Roth Capital Partners is acting as co-manager of the offering. Ladenburg Thalmann & Co. Inc. is acting as a financial advisor to XOMA for the offering. Full Article
XOMA Corp Announces Proposed Public Offering Of Common Stock
XOMA Corp announced that it is offering to sell, subject to market and other conditions, shares of its common stock and corresponding warrants to purchase one half of a share of common stock for each share purchased, pursuant to an effective shelf registration statement in an underwritten public offering. All of the shares and warrants in the offering are to be sold by XOMA. RBC Capital Markets and Cowen and Company are acting as joint book-running managers and Roth Capital Partners is acting as co-manager of the proposed offering. The shares of common stock and warrants will be issued pursuant to a prospectus supplement filed as part of a shelf registration statement previously filed with the Securities and Exchange Commission (SEC) on Form S-3. Full Article
XOMA Corp Acquires U.S. Rights To Perindopril Franchise
XOMA Corp announced that it has acquired U.S. rights to the perindopril franchise from Les Laboratoires Servier, XOMA's partner for its lead product candidate, gevokizumab (formerly XOMA 052). The agreement includes the branded product ACEON® (perindopril erbumine), a marketed angiotensin converting enzyme (ACE) inhibitor, and a portfolio of three fixed-dose combination product candidates where perindopril is combined with other active ingredient(s), such as a calcium channel blocker. The proprietary form of perindopril in each of the combination products provides patent protection until 2023. XOMA plans to assume commercialization activities for ACEON on January 23, 2012, following the transfer from Servier's previous licensee. Full Article
XOMA Corp Appoints John Varian As Chief Executive Officer
XOMA Corp announced that its Board of Directors has appointed John Varian as Chief Executive Officer. Mr. Varian has been serving as the Interim Chief Executive since August 31, 2011, and has been a member of the Board since December 2008. The Board's decision followed a full executive search, which identified several additional qualified candidates. Full Article
XOMA Ltd. Announces Name Change
XOMA Ltd. announced that, effective December 31, 2011, it change its name from XOMA Ltd. to XOMA Corporation. Full Article
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