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XOMA Presents XOMA 3AB Data at National Biodefense Meeting
BERKELEY, Calif., Jan. 11, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced several presentations that highlight advances in the company's biodefense program and particularly in the development of XOMA 3AB, a three antibody formulation that binds to distinct regions of botulinum toxin type A. Among these will be an invited oral presentation describing the successful lyophilization of XOMA 3AB and studies demonstrating the stability of this formulation over time stored at a wide range of temperatures. The presentations will be made at the Fifth Annual Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop and BARDA Industry Day, January 10 to 12, 2011 in Washington, DC.
XOMA 3AB has been shown in preclinical studies to neutralize botulinum toxin type A, which is among the most deadly bioterrorism threats. XOMA 3AB is being developed through funding provided by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. To date, XOMA has entered into more than $100 million in U.S. government contracts for this program.
"The PHEMCE meeting is a leading venue for providing scientists and government leaders with up-to-date information on the excellent progress in our anti-botulinum toxin program. Our presentations at this conference clearly emphasize our expertise and technical leadership position in this strategically important space," said Steve B. Engle, XOMA Chairman and Chief Executive Officer.
The presentations are:
* Development of a High Temperature Stable Lyophilized Formulation for XOMA 3AB, a BoNT/A Triple Antibody Product
* Recombinant Monoclonal Antibody Co-mixture Based Monovalent Antitoxin Development for Treatment of Type A, B and E Botulism
* Nonclinical Safety Evaluation of XOMA 3AB, A Novel Triple Monoclonal Antibody Drug Product Targeting Botulinum Toxin Type A, in Sprague-Dawley Rats
These projects have been funded in whole or in part with funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services under Contract No. HHSN266200600008C, Contract No. HHSN272200800028C, and Contract No. HHSN266200600011C.
About the Public Health Emergency Medical Countermeasures Enterprise
PHEMCE is a coordinated interagency effort that is responsible for defining and prioritizing requirements for public health emergency medical countermeasures; focusing research, development, and procurement activities on the identified requirements; and establishing deployment and use strategies for medical countermeasures in the strategic national stockpile. BARDA is the U.S. government's Biomedical Advanced Research and Development Authority.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
* XOMA 052, a potent anti-IL-1 beta antibody entering Phase 3 clinical development in Behcet's uveitis, for which it has been designated an orphan drug, and in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions. XOMA is developing XOMA 052 in collaboration with Les Laboratoires Servier.
* XOMA 3AB, an antibody candidate in preclinical development to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
* A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory, ophthalmic and oncologic diseases.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering™, affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, 60 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval at its Berkeley, California location. For more information, please visit www.xoma.com.
The XOMA Ltd. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=5960
Forward-Looking Statements
Certain statements contained herein concerning product development or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Among other things, results of early-stage clinical trials may not be supported by later findings, larger trials and/or other actions required for regulatory approval may not be economically feasible, and results of clinical trials may in any event not be consistent with preclinical or interim results.
These and other risks, including the generally unstable nature of current economic and financial market conditions; the results of discovery research and preclinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); changes in the status of existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demands for products; scale-up and marketing capabilities; availability of additional licensing or collaboration opportunities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.
CONTACT: XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.comCanale Communications
Media Contact:
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201101110830primzoneusprx___210821&title=xoma-presents-xoma-3ab-data-at-national-biodefense-meeting#ixzz1AjhCiegu
XOMA Presents XOMA 3AB Data at National Biodefense Meeting
BERKELEY, Calif., Jan. 11, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced several presentations that highlight advances in the company's biodefense program and particularly in the development of XOMA 3AB, a three antibody formulation that binds to distinct regions of botulinum toxin type A. Among these will be an invited oral presentation describing the successful lyophilization of XOMA 3AB and studies demonstrating the stability of this formulation over time stored at a wide range of temperatures. The presentations will be made at the Fifth Annual Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Stakeholders Workshop and BARDA Industry Day, January 10 to 12, 2011 in Washington, DC.
XOMA 3AB has been shown in preclinical studies to neutralize botulinum toxin type A, which is among the most deadly bioterrorism threats. XOMA 3AB is being developed through funding provided by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. To date, XOMA has entered into more than $100 million in U.S. government contracts for this program.
"The PHEMCE meeting is a leading venue for providing scientists and government leaders with up-to-date information on the excellent progress in our anti-botulinum toxin program. Our presentations at this conference clearly emphasize our expertise and technical leadership position in this strategically important space," said Steve B. Engle, XOMA Chairman and Chief Executive Officer.
The presentations are:
* Development of a High Temperature Stable Lyophilized Formulation for XOMA 3AB, a BoNT/A Triple Antibody Product
* Recombinant Monoclonal Antibody Co-mixture Based Monovalent Antitoxin Development for Treatment of Type A, B and E Botulism
* Nonclinical Safety Evaluation of XOMA 3AB, A Novel Triple Monoclonal Antibody Drug Product Targeting Botulinum Toxin Type A, in Sprague-Dawley Rats
These projects have been funded in whole or in part with funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services under Contract No. HHSN266200600008C, Contract No. HHSN272200800028C, and Contract No. HHSN266200600011C.
About the Public Health Emergency Medical Countermeasures Enterprise
PHEMCE is a coordinated interagency effort that is responsible for defining and prioritizing requirements for public health emergency medical countermeasures; focusing research, development, and procurement activities on the identified requirements; and establishing deployment and use strategies for medical countermeasures in the strategic national stockpile. BARDA is the U.S. government's Biomedical Advanced Research and Development Authority.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
* XOMA 052, a potent anti-IL-1 beta antibody entering Phase 3 clinical development in Behcet's uveitis, for which it has been designated an orphan drug, and in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions. XOMA is developing XOMA 052 in collaboration with Les Laboratoires Servier.
* XOMA 3AB, an antibody candidate in preclinical development to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.
* A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory, ophthalmic and oncologic diseases.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering™, affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, 60 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval at its Berkeley, California location. For more information, please visit www.xoma.com.
The XOMA Ltd. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=5960
Forward-Looking Statements
Certain statements contained herein concerning product development or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market. Among other things, results of early-stage clinical trials may not be supported by later findings, larger trials and/or other actions required for regulatory approval may not be economically feasible, and results of clinical trials may in any event not be consistent with preclinical or interim results.
These and other risks, including the generally unstable nature of current economic and financial market conditions; the results of discovery research and preclinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); changes in the status of existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demands for products; scale-up and marketing capabilities; availability of additional licensing or collaboration opportunities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.
CONTACT: XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.comCanale Communications
Media Contact:
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201101110830primzoneusprx___210821&title=xoma-presents-xoma-3ab-data-at-national-biodefense-meeting#ixzz1AjhCiegu
Its not FRA, its Berlin
http://www.boerse-berlin.de/index.php/Aktien?isin=US9282422057
from the Servier-Page
SERVIER announces Joint Development and Commercialization with XOMA on Novel Therapeutics for Orphan Disease
release date: 04/01/2011
Suresnes, France, January 4, 2011 - Servier and XOMA Ltd., a leader in the discovery and development of therapeutic antibodies, today announced the signing of an agreement to jointly develop and commercialize XOMA 052, XOMA’s anti-inflammatory drug candidate, in multiple indications. XOMA 052 is designed to inhibit the pro-inflammatory cytokine interleukin-1 beta that is believed to be a primary trigger of pathologic inflammation in multiple diseases. Servier will fund the first $50 million of XOMA 052 development expenses and 50% of further expenses for the Behcet’s uveitis indication. XOMA 052 is expected to advance into Phase 3 development in Behcet’s uveitis in 2011. Servier will fund development for diabetes and cardiovascular disease indications.
In 2011, Servier and XOMA expect to hold discussions with multiple regulatory agencies to initiate Phase 3 studies of XOMA 052 in Behçet’s uveitis, a debilitating ophthalmic inflammatory condition that often leads to vision-threatening complications including blindness. XOMA 052 has already received orphan drug designations for Behçet’s disease from regulators in the European Union and in the USA.
“XOMA 052 gives us a later-stage asset to develop for diabetes and cardiovascular diseases, which are both areas of strength for us, as well as for rare diseases,” said Emmanuel Canet, M.D., Ph.D., Servier’s President, Research and Development. “With this therapeutic antibody designed to inhibit interleukin-1 beta we are reinforcing our strategy in the field of biologics and developing novel approaches aimed at treating severe diseases. We are especially eager to shepherd the development of XOMA 052 for the treatment of patients with Behçet’s uveitis, a population that has very few options and may face eventual blindness.”
About Behçet’s Disease
Behçet’s disease causes chronic inflammation of the blood vessels, or vasculitis, among other complications. Uveitis is a vasculitis of the blood vessels in the eye which can be vision-threatening. Behcet’s uveitis is one of the most severe forms of uveitis which can lead to blindness and affects approximately 60% of Behcet’s disease patients.
There are at least 250,000 patients diagnosed with Behcet’s disease worldwide. Onset of the disease occurs most commonly in adults in their twenties, thirties and forties, and is typically more severe in men.
Without immediate treatment, major exacerbations of Behçet’s uveitis may lead to retinal detachment, macular edema, vitreous hemorrhage, glaucoma and eventual blindness. The effects of these exacerbations on vision are cumulative. Patients often experience multiple exacerbations per year, requiring treatment to control the frequency and severity of attacks of this chronic disease.
http://www.servier.com/Corporate/NewsView.aspx?idx=1818
She's flying....great
wohooooo comon baby lets rock
UPDATE 2-Xoma in French tie-up for inflammatory drug, shrs soar
BANGALORE, Jan 4 (Reuters) - Xoma Ltd said it partnered with French drugmaker Les Laboratoires Servier to develop and market its anti-inflammatory drug for multiple indications, boosting the company's cash resources.
The company's shares, which have more than doubled in the past one month in anticipation of the drug's interim trial data, jumped as much as 30 percent to a high of $6.88 on Tuesday morning, making it the biggest gainer on Nasdaq.
As per the agreement, Xoma will get about $35 million in upfront payment and up to $470 million in milestone payments and tiered royalties for the drug XOMA 052.
'The XOMA 052 deal is not a blockbuster marquis deal with a huge upfront payment, but it is timely, retains significant commercial rights for XOMA, brings in needed cash, and substantially reduces burn in 2011 and 2012,' RBC Capital Markets analyst Jason Kantor said.
The company estimated cash and cash equivalents of $36-$38 million as of Dec. 31.
The company's auditors had expressed doubts in March 2009 about the drugmaker's ability to function as a going concern.
While the going concern doubts were mostly removed in December 2009, this deal removes substantial financial risk.
However, Kantor said the company will still require additional capital, but other sources such as antibody technology licensing deals and biodefense contracts are likely in 2011-2012.
In June, the company reported promising results from a study of the drug to treat an eye condition related to Behcet's disease, or inflammation of blood vessels. The company now plans to advance the drug for this indication to the late stage this year.
DEAL DYNAMICS
As per the agreement, Xoma retains rights for Behcet's and other inflammatory and oncology indications in the United States and Japan, while Servier will acquire the rights in the rest of the world.
'The largely funded Behcet's disease opportunity is the quickest path to market for XOMA 052 and supports Xoma's valuation,' Kantor who upgraded the stock to 'outperform' from 'sector perform' said in a note.
The drug is also in mid-stage trials for type 2 diabetes, the results of which are expected in the first quarter.
Xoma said Servier will fund development of the drug for diabetes and cardiovascular diseases in exchange for worldwide rights.
The deal also provides Xoma the option to reacquire U.S. and Japan rights to the diabetes and cardiovascular indications.
(Reporting by Krishnakali Sengupta in Bangalore; Editing by Vinu Pilakkott, Roshni Menon) Keywords: XOMA/
(krishnakali.sengupta@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging:krishnakali.sengupta.reuters.com@reuters.)
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The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
XOMA NEWS
XOMA and Servier Sign Development and Commercialization Agreement for XOMA 052
Conference Call and Webcast at 8:30 am ET Today
BERKELEY, Calif., Jan. 4, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, and Les Laboratoires Servier (Servier), France's largest privately-held pharmaceutical company, today announced the signing of a regional agreement to jointly develop and commercialize XOMA 052, XOMA's anti-inflammatory drug candidate, in multiple indications. XOMA 052 is designed to inhibit the pro-inflammatory cytokine interleukin-1 beta that is believed to be a primary trigger of pathologic inflammation in multiple diseases. Key elements of this agreement include:
* XOMA will receive approximately $35 million upfront, up to approximately $470 million in milestone payments and tiered royalties up to a mid-teens percentage rate.
* XOMA retains development and commercialization rights for Behcet's uveitis and other inflammatory and oncology indications in U.S. and Japan. Servier receives similar rights in the rest of the world.
* Servier will fund the first $50 million of XOMA 052 development expenses and 50% of further expenses for the Behcet's uveitis indication. XOMA 052 is expected to advance into Phase 3 development in Behcet's uveitis in 2011.
* Servier will fund development for diabetes and cardiovascular disease indications in exchange for worldwide rights.
* XOMA retains an option to reacquire the development and commercialization rights to the diabetes and cardiovascular indications in the U.S. and Japan by paying an option fee and partial reimbursement of incurred development expenses. If XOMA reacquires these rights, it has the ability to license them to one or more third parties.
"This is an important collaboration for XOMA as we gain a seasoned partner in Servier and it allows us to accelerate XOMA 052 into Phase 3 development this year in Behcet's uveitis, an orphan indication for which we have reported positive proof-of-concept results. The agreement advances our strategy of focusing on opportunities in the U.S. where we can directly participate in the development and commercialization of our novel products," said Steven B. Engle, Chairman and Chief Executive Officer, XOMA. "This agreement substantially increases our cash resources while reducing future cash requirements, provides a pathway to commercialization of XOMA 052 in the near term, and supports development in diabetes and cardiovascular disease while maintaining our ability to participate in these programs. As a result, we can accelerate development of a new approach that targets the inflammatory cause of multiple diseases and has the potential to dramatically improve the lives of patients."
"Servier is a world-class pharmaceutical company with 2010 revenues of 3.7 billion euros and a long history of successful innovation and collaborations, global franchises in diabetes and cardiovascular disease and established operations in the geographical regions where Behcet's disease is most prevalent," Mr. Engle continued. "They are an ideal partner to maximize the clinical and commercial potential of XOMA 052."
"XOMA 052 gives us a later-stage asset to develop for diabetes and cardiovascular diseases, which are both areas of strength for us, as well as for rare diseases," said Emmanuel Canet, M.D., Ph.D., Servier's President, Research and Development. "With this therapeutic antibody designed to inhibit interleukin-1 beta we are reinforcing our strategy in the field of biologics and developing novel approaches aimed at treating severe diseases. We are especially eager to shepherd the development of XOMA 052 for the treatment of patients with Behcet's uveitis, a population that has very few options and may face eventual blindness."
In 2011, XOMA and Servier expect to hold discussions with multiple regulatory agencies to initiate Phase 3 studies of XOMA 052 in Behcet's uveitis, a debilitating ophthalmic inflammatory condition that often leads to vision-threatening complications including blindness. XOMA 052 has already received orphan drug designations for Behcet's disease from regulators in the U.S. and European Union, which support an expedited path to commercialization. XOMA expects to release results from two ongoing Phase 2 studies in patients with Type 2 diabetes in the first quarter of 2011.
XOMA will receive approximately $35 million in an upfront payment consisting of $15 million and a 15 million euro loan, which does not have to be repaid until 2016. Regarding milestone payments, if XOMA reacquires diabetes and cardiovascular rights in the U.S. and Japan, then the milestone payments could be up to $470 million as mentioned above. If XOMA does not reacquire these rights, then the milestone payments could be up to $800 million. XOMA will be responsible for XOMA 052 manufacturing throughout clinical development and launch and anticipates being a long-term manufacturer. This adds to the company's potential profit participation during the life of the commercial product.
Investor Conference Call
XOMA will host a conference call and webcast to discuss its agreement with Servier today, January 4, 2011, at 8:30 am ET. The webcast can be accessed via the Investors section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay until close of business on March 31, 2011.
Behcet'sDisease
Behcet's (pronounced beh-CHETS) disease causes chronic inflammation of the blood vessels, or vasculitis, among other complications. Uveitis is a vasculitis of the blood vessels in the eye which can be vision-threatening. Behcet's uveitis is one of the most severe forms of uveitis which can lead to blindness and affects approximately 50% of Behcet's disease patients.
XOMA estimates that there are 250,000 patients diagnosed with Behcet's disease worldwide including 20,000 in the U.S. Onset of the disease occurs most commonly in adults in their twenties, thirties and forties, and is typically more severe in men.
Without immediate treatment, major exacerbations of Behcet's uveitis may lead to retinal detachment, macular edema, vitreous hemorrhage, glaucoma and eventual blindness. The effects of these exacerbations on vision are cumulative. Patients often experience multiple exacerbations per year, requiring treatment to control the frequency and severity of attacks of this chronic disease. No therapies are approved in the U.S. to treat Behcet's disease. It is treated with corticosteroids and immunosuppressive drugs, which can have significant side effects, including diabetes and hypertension, and can contribute to other eye diseases like glaucoma and the formation of cataracts. These drugs also can adversely affect the neurological, pulmonary, gastrointestinal, hematological and cardiovascular systems.
XOMA has completed a successful proof-of-concept Phase 2 trial of XOMA 052 in patients with Behcet's uveitis. As previously reported, all seven patients displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures after a single treatment with XOMA 052 and following discontinuation of immunosuppressive drugs such as cyclosporine and/or azathioprine. Follow-up results demonstrated that each of the five patients re-treated with XOMA 052 due to a recurring uveitis exacerbation responded again to XOMA 052 treatment and maintained their response for several months. The drug was well-tolerated, and no drug-related adverse events were reported.
XOMA 052 and Interleukin-1 Inhibition
XOMA 052 is a potent monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases and other diseases including cancer. XOMA 052 binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine involved in Behcet's uveitis, diabetes, cardiovascular disease, rheumatoid arthritis, gout, and other auto-inflammatory diseases. IL-1 is a well-validated therapeutic target, with three marketed IL-1 inhibitors that have been used by more than 200,000 patients overall. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.
To date, nearly 600 patients have been enrolled in XOMA 052 clinical trials. XOMA has completed enrollment in two Phase 2 clinical trials in patients with Type 2 diabetes and expects three month interim results from the Phase 2a trial in the first half of January 2011 and six month results from the Phase 2b trial in this quarter. The Phase 2 trials follow a successful 98 patient Phase 1 program in Type 2 diabetes in which XOMA 052 was shown to be well-tolerated, demonstrated evidence of biological activity in diabetes measures and cardiovascular biomarkers, and had a half-life that may provide convenient dosing of once per month or less frequently. The company has also demonstrated the potential for XOMA 052 in in vivo models of cardiovascular disease and in an in vitro model using human myeloma, or plasma cell cancer, cells.
Servier
Servier is the leading independent French pharmaceutical company, established in 1954 by its founder, Dr. Jacques Servier. The group is established in 140 countries and 88% of Servier products are prescribed outside of France. Sales turnover in 2010 reached about 3.7 billion euros. More than 25% of Servier's turnover is invested in Research and Development. Servier R&D counts 19 International Centers of Therapeutic Research, and its principal therapeutic research orientations are cardiovascular diseases, diabetes, neuropsychiatric disorders, cancer and osteoarticular diseases. Servier has an extensive history of more than 150 successful partnerships for product discovery, development, regulatory approval and availability for patients. More information is available at: www.servier.com/.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
* XOMA 052, a potent anti-IL-1 beta antibody entering Phase 3 clinical development in Behcet's uveitis, for which it has been designated an orphan drug, and in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions.
* XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Contract # HHSN266200600008C).
* A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory, ophthalmic and oncologic diseases.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering™, affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, 60 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval at its Berkeley, California location. For more information, please visit www.xoma.com.
The XOMA Ltd. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=5960
Forward-Looking Statements
Certain statements contained herein concerning the receipt of milestone payments and royalties, the timing of availability of clinical results, plans to initiate clinical trials, estimated patient populations and outcomes, and clinical trial results or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.
Among other things, the receipt of milestone payments is contingent on the related development or sales milestone events being achieved; the receipt of royalties is contingent on marketing approval and successful commercial launch, and the percentage of such royalties will vary depending on the level of sales of the product; the results of clinical trials may be delayed or may never become available as a result of complications in the collection or interpretation of statistical data, unavailability of resources, actions or inaction by our present or future collaboration partners, insufficient enrollment in such trials or unanticipated safety issues; our estimates of patient populations and outcomes are internal estimates based on a variety of external sources, which we have not independently verified; and results of clinical trials may in any event not be consistent with preclinical or interim results; plans to initiate new clinical trials may change depending on availability of resources, actions or inaction by our present or future collaboration partners or unanticipated safety issues; and results of early-stage clinical trials may not be supported by later findings, and larger trials and/or other actions required for regulatory approval may not be economically feasible.
These and other risks, including the generally unstable nature of current economic and financial market conditions; the results of discovery research and pre-clinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); availability of additional collaborative and licensing opportunities; changes in the status of existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demand for products; scale-up and marketing capabilities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.
CONTACT: XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.comCanale Communications
Media Contact:
Carolyn Hawley
858-354-3581
carolyn@canalecomm.com
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201101040755primzoneusprx___210216&title=xoma-and-servier-sign-development-and-commercialization-agreement-for-xoma-052#ixzz1A4S2hSuf
XOMA and Servier Sign Development and Commercialization Agreement for XOMA 052
Conference Call and Webcast at 8:30 am ET Today
BERKELEY, Calif., Jan. 4, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, and Les Laboratoires Servier (Servier), France's largest privately-held pharmaceutical company, today announced the signing of a regional agreement to jointly develop and commercialize XOMA 052, XOMA's anti-inflammatory drug candidate, in multiple indications. XOMA 052 is designed to inhibit the pro-inflammatory cytokine interleukin-1 beta that is believed to be a primary trigger of pathologic inflammation in multiple diseases. Key elements of this agreement include:
* XOMA will receive approximately $35 million upfront, up to approximately $470 million in milestone payments and tiered royalties up to a mid-teens percentage rate.
* XOMA retains development and commercialization rights for Behcet's uveitis and other inflammatory and oncology indications in U.S. and Japan. Servier receives similar rights in the rest of the world.
* Servier will fund the first $50 million of XOMA 052 development expenses and 50% of further expenses for the Behcet's uveitis indication. XOMA 052 is expected to advance into Phase 3 development in Behcet's uveitis in 2011.
* Servier will fund development for diabetes and cardiovascular disease indications in exchange for worldwide rights.
* XOMA retains an option to reacquire the development and commercialization rights to the diabetes and cardiovascular indications in the U.S. and Japan by paying an option fee and partial reimbursement of incurred development expenses. If XOMA reacquires these rights, it has the ability to license them to one or more third parties.
"This is an important collaboration for XOMA as we gain a seasoned partner in Servier and it allows us to accelerate XOMA 052 into Phase 3 development this year in Behcet's uveitis, an orphan indication for which we have reported positive proof-of-concept results. The agreement advances our strategy of focusing on opportunities in the U.S. where we can directly participate in the development and commercialization of our novel products," said Steven B. Engle, Chairman and Chief Executive Officer, XOMA. "This agreement substantially increases our cash resources while reducing future cash requirements, provides a pathway to commercialization of XOMA 052 in the near term, and supports development in diabetes and cardiovascular disease while maintaining our ability to participate in these programs. As a result, we can accelerate development of a new approach that targets the inflammatory cause of multiple diseases and has the potential to dramatically improve the lives of patients."
"Servier is a world-class pharmaceutical company with 2010 revenues of 3.7 billion euros and a long history of successful innovation and collaborations, global franchises in diabetes and cardiovascular disease and established operations in the geographical regions where Behcet's disease is most prevalent," Mr. Engle continued. "They are an ideal partner to maximize the clinical and commercial potential of XOMA 052."
"XOMA 052 gives us a later-stage asset to develop for diabetes and cardiovascular diseases, which are both areas of strength for us, as well as for rare diseases," said Emmanuel Canet, M.D., Ph.D., Servier's President, Research and Development. "With this therapeutic antibody designed to inhibit interleukin-1 beta we are reinforcing our strategy in the field of biologics and developing novel approaches aimed at treating severe diseases. We are especially eager to shepherd the development of XOMA 052 for the treatment of patients with Behcet's uveitis, a population that has very few options and may face eventual blindness."
In 2011, XOMA and Servier expect to hold discussions with multiple regulatory agencies to initiate Phase 3 studies of XOMA 052 in Behcet's uveitis, a debilitating ophthalmic inflammatory condition that often leads to vision-threatening complications including blindness. XOMA 052 has already received orphan drug designations for Behcet's disease from regulators in the U.S. and European Union, which support an expedited path to commercialization. XOMA expects to release results from two ongoing Phase 2 studies in patients with Type 2 diabetes in the first quarter of 2011.
XOMA will receive approximately $35 million in an upfront payment consisting of $15 million and a 15 million euro loan, which does not have to be repaid until 2016. Regarding milestone payments, if XOMA reacquires diabetes and cardiovascular rights in the U.S. and Japan, then the milestone payments could be up to $470 million as mentioned above. If XOMA does not reacquire these rights, then the milestone payments could be up to $800 million. XOMA will be responsible for XOMA 052 manufacturing throughout clinical development and launch and anticipates being a long-term manufacturer. This adds to the company's potential profit participation during the life of the commercial product.
Investor Conference Call
XOMA will host a conference call and webcast to discuss its agreement with Servier today, January 4, 2011, at 8:30 am ET. The webcast can be accessed via the Investors section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay until close of business on March 31, 2011.
Behcet'sDisease
Behcet's (pronounced beh-CHETS) disease causes chronic inflammation of the blood vessels, or vasculitis, among other complications. Uveitis is a vasculitis of the blood vessels in the eye which can be vision-threatening. Behcet's uveitis is one of the most severe forms of uveitis which can lead to blindness and affects approximately 50% of Behcet's disease patients.
XOMA estimates that there are 250,000 patients diagnosed with Behcet's disease worldwide including 20,000 in the U.S. Onset of the disease occurs most commonly in adults in their twenties, thirties and forties, and is typically more severe in men.
Without immediate treatment, major exacerbations of Behcet's uveitis may lead to retinal detachment, macular edema, vitreous hemorrhage, glaucoma and eventual blindness. The effects of these exacerbations on vision are cumulative. Patients often experience multiple exacerbations per year, requiring treatment to control the frequency and severity of attacks of this chronic disease. No therapies are approved in the U.S. to treat Behcet's disease. It is treated with corticosteroids and immunosuppressive drugs, which can have significant side effects, including diabetes and hypertension, and can contribute to other eye diseases like glaucoma and the formation of cataracts. These drugs also can adversely affect the neurological, pulmonary, gastrointestinal, hematological and cardiovascular systems.
XOMA has completed a successful proof-of-concept Phase 2 trial of XOMA 052 in patients with Behcet's uveitis. As previously reported, all seven patients displayed rapid reduction of intraocular inflammation and improvement in visual acuity or other ophthalmic measures after a single treatment with XOMA 052 and following discontinuation of immunosuppressive drugs such as cyclosporine and/or azathioprine. Follow-up results demonstrated that each of the five patients re-treated with XOMA 052 due to a recurring uveitis exacerbation responded again to XOMA 052 treatment and maintained their response for several months. The drug was well-tolerated, and no drug-related adverse events were reported.
XOMA 052 and Interleukin-1 Inhibition
XOMA 052 is a potent monoclonal antibody with the potential to improve the treatment of patients with a wide variety of inflammatory diseases and other diseases including cancer. XOMA 052 binds strongly to interleukin-1 beta (IL-1 beta), a pro-inflammatory cytokine involved in Behcet's uveitis, diabetes, cardiovascular disease, rheumatoid arthritis, gout, and other auto-inflammatory diseases. IL-1 is a well-validated therapeutic target, with three marketed IL-1 inhibitors that have been used by more than 200,000 patients overall. By binding to IL-1 beta, XOMA 052 inhibits the activation of the IL-1 receptor, thereby preventing the cellular signaling events that produce inflammation.
To date, nearly 600 patients have been enrolled in XOMA 052 clinical trials. XOMA has completed enrollment in two Phase 2 clinical trials in patients with Type 2 diabetes and expects three month interim results from the Phase 2a trial in the first half of January 2011 and six month results from the Phase 2b trial in this quarter. The Phase 2 trials follow a successful 98 patient Phase 1 program in Type 2 diabetes in which XOMA 052 was shown to be well-tolerated, demonstrated evidence of biological activity in diabetes measures and cardiovascular biomarkers, and had a half-life that may provide convenient dosing of once per month or less frequently. The company has also demonstrated the potential for XOMA 052 in in vivo models of cardiovascular disease and in an in vitro model using human myeloma, or plasma cell cancer, cells.
Servier
Servier is the leading independent French pharmaceutical company, established in 1954 by its founder, Dr. Jacques Servier. The group is established in 140 countries and 88% of Servier products are prescribed outside of France. Sales turnover in 2010 reached about 3.7 billion euros. More than 25% of Servier's turnover is invested in Research and Development. Servier R&D counts 19 International Centers of Therapeutic Research, and its principal therapeutic research orientations are cardiovascular diseases, diabetes, neuropsychiatric disorders, cancer and osteoarticular diseases. Servier has an extensive history of more than 150 successful partnerships for product discovery, development, regulatory approval and availability for patients. More information is available at: www.servier.com/.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
* XOMA 052, a potent anti-IL-1 beta antibody entering Phase 3 clinical development in Behcet's uveitis, for which it has been designated an orphan drug, and in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions.
* XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Contract # HHSN266200600008C).
* A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory, ophthalmic and oncologic diseases.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering™, affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, 60 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval at its Berkeley, California location. For more information, please visit www.xoma.com.
The XOMA Ltd. logo is available at www.globenewswire.com/newsroom/prs/?pkgid=5960
Forward-Looking Statements
Certain statements contained herein concerning the receipt of milestone payments and royalties, the timing of availability of clinical results, plans to initiate clinical trials, estimated patient populations and outcomes, and clinical trial results or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.
Among other things, the receipt of milestone payments is contingent on the related development or sales milestone events being achieved; the receipt of royalties is contingent on marketing approval and successful commercial launch, and the percentage of such royalties will vary depending on the level of sales of the product; the results of clinical trials may be delayed or may never become available as a result of complications in the collection or interpretation of statistical data, unavailability of resources, actions or inaction by our present or future collaboration partners, insufficient enrollment in such trials or unanticipated safety issues; our estimates of patient populations and outcomes are internal estimates based on a variety of external sources, which we have not independently verified; and results of clinical trials may in any event not be consistent with preclinical or interim results; plans to initiate new clinical trials may change depending on availability of resources, actions or inaction by our present or future collaboration partners or unanticipated safety issues; and results of early-stage clinical trials may not be supported by later findings, and larger trials and/or other actions required for regulatory approval may not be economically feasible.
These and other risks, including the generally unstable nature of current economic and financial market conditions; the results of discovery research and pre-clinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); availability of additional collaborative and licensing opportunities; changes in the status of existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demand for products; scale-up and marketing capabilities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.
CONTACT: XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.comCanale Communications
Media Contact:
Carolyn Hawley
858-354-3581
carolyn@canalecomm.com
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201101040755primzoneusprx___210216&title=xoma-and-servier-sign-development-and-commercialization-agreement-for-xoma-052#ixzz1A4S2hSuf
XOMA Presentation:
http://www.xoma.com/media/files/XOMA%20Presentation.pdf
XOMA NEWS and conf. call today
http://www.thestreet.com/_nasdaq/story/10959183/1/xoma-key-diabetes-drug-study-preview.html?&cm_ven=NASDAQ&cm_cat=FREE&cm_ite=NA
Xoma: Key Diabetes Drug Study Preview
BERKELEY, Calif. (TheStreet) -- Most of the market took a breather the Christmas holidays but not Xoma(XOMA_), which saw the value of its shares more than double on extraordinary volume despite the lack of any real news from the company (Unless you count disclosure of another dilutive financing right before the end of the year.)
Investors are looking ahead to when Xoma is expected to release interim results from a small, mid-stage study of an experimental diabetes drug, XOMA 052. The company announced late Monday that it will hold a conference call Tuesday morning to provide a business update. Whether or not that includes XOMA 052 data was not disclosed.
Clearly, investors who've been buying the stock in the past week or so believe strongly that the XOMA 052 data will be positive. What's just as clear is that Xoma's entire future rests on the development of XOMA 052, so the bet investors are making is big -- and risky.
XOMA 052 has the potential to be a blockbuster drug because it aims to attack the root cause of diabetes -- the inability of damaged islet cells in the pancreas to produce insulin. All other diabetes drugs either boost insulin production or help the body to be more sensitive to insulin produced naturally. XOMA 052 could also play a meaningful role in other diseases where inflammation is the culprit -- including cardiovascular disease and rheumatoid arthritis.
The scary, glaring danger is that XOMA 052 is owned by Xoma -- a company with an ignominious reputation in the biotech sector for drug development futility (and a chief executive who was almost named TheStreet's Worst Biotech CEO of 2010.) Over the course of two decades, Xoma has accomplished very little but rack up a mountain of losses amidst a plummeting stock price. Developing XOMA 052 successfully on its own is a feat that Xoma's management team may be incapable of achieving, even if the drug works.
At Monday's close of $5.30, Xoma shares are up 122% since Dec. 21. The stock actually closed above $7 on Dec. 23 before selling off a bit. [Mind you, remember that Xoma instituted a 1-for-15 reverse stock split last August in a last-ditch effort to remain Nasdaq listed.]
With that background, here's a quick FAQ on XOMA 052 and the upcoming phase II study results:
What should investors be looking for in this phase II study of XOMA 052?
The key data point (and the primary endpoint of the study) will be to determine the ability of XOMA 052 to reduce blood glucose (as measured by reductions in HbA1c levels) in patients with Type 2 diabetes.
This phase IIa study enrolled about 70 patients with Type 2 diabetes and randomized them to one of three dose levels of XOMA 052 and a placebo. All patients were also treated with a background regimen of the diabetes medicine metformin.
Xoma will be releasing interim results from the study based on three months of treatment. The study will continue, with patients randomized to XOMA 052 remain under treatment for another three months.
How will we know if the XOMA 052 data are positive or not?
The most immediate thing to look for is a greater reduction in HbA1c levels for XOMA 052-treated patients compared to patients treated with a placebo. It's not unusual in diabetes trials to see placebo patients demonstrate small reductions in blood glucose levels, but of course, the improvement (reduction) in XOMA 052 patients needs to be larger.
What's the magic blood glucose-lowering number that XOMA 052 needs to beat in order for investors to judge the phase II study a success?
That's a tough question to answer. Interim, three-month data from a relatively small study will only provide a snapshot of the drug's potential. With that said, David Kliff of the Diabetic Investor newsletter tells me that a .75% reduction in HbA1c would be a meaningful result worthy of some optimism (assuming the side effect profile is relatively benign.)
RBC Capital Markets analyst Jason Kantor is willing to be a bit more accommodating. In a recent note, he told clients that an HbA1c reduction of around 0.6% after three months should be viewed favorably. That would match results from an earlier, phase I study of XOMA 052.
Previous data on XOMA 052 in diabetes exists? Tell me more.
Xoma conducted a series of small, phase I diabetes studies of XOMA 052 in 2008 and 2009. These studies provided a hint of XOMA 052's efficacy but also raised some questions that cast a shadow over the drug. (These questions are also the reason for why investors and potential Xoma partners have wanted to see more data before getting comfortable with XOMA 052's diabetes potential.)
I won't go through all the previous data, but in a multi-dose study of just five Type 2 diabetes patients, treatment with a 0.03 mg/kg dose of XOMA 052 resulted in a 0.6% reduction in HbA1c and a fasting blood glucose reduction of 27 mg/dl after 56 days. By comparison, the placebo patients reported a 0.1% drop in HbA1c and a 13 mg/dl increase in fasting blood glucose after 56 days.
However, in the same study, another five Type 2 diabetes patients treated with a higher 0.3 mg/kg dose of XOMA 052 reported a 0.2% increase in HbA1c and a 20 mg/dl increase in fasting blood glucose levels. The decidedly worse outcomes for the higher dose of XOMA 052 raised questions about the entire study. Given the small number of patients, the poor high-dose results might just have been a fluke but then again, it also cast some doubt over the more optimistic lower-dose results.
What is XOMA 052 and how does the drug work?
XOMA 052 is an injectable monoclonal antibody that targets interleukin-1 beta, a pro-inflammatory protein that is thought to play a role in diabetes, rheumatoid arthritis and other diseases. XOMA 052 binds to IL-1 beta, thereby preventing inflammation that can damage insulin-producing islet cells in the pancreas.
In a Dec. 21 note that seems to have ignited this most recent wave of Xoma buying, SummerStreet Research Partners noted that while other companies are developing IL-1 beta inhibitors, Xoma's XOMA 052 could be best in class.
"We see an opportunity for significant expansion of the IL-1 class in diabetes. Pending data in diabetes should confirm this thesis during [the first half of 2011.] We believe anti-IL-1 therapy could play an important role in diabetes due to its impact on islet cell function which could allow glucose control with a reduced risk of hypoglycemia or heart attacks. Xoma, which has a minuscule current valuation and a potentially best-in-class compound, offers the biggest leverage to this opportunity," the SummerStreet report stated.
What else can we expect from Xoma on XOMA 052 after the release of the phase IIa results?
Xoma is also running a larger, phase IIb study of XOMA 052 in Type 2 diabetes patients which is expected to yield data in the latter part of the first quarter. This study, which enrolls 440 patients, is studying the same HbA1C endpoint but with a more clinically relevant six months of treatment. Xoma is also conducting a small phase II study in Type 1 diabetes patients.
Will Xoma find a partner for XOMA 052?
That's the plan. Xoma management has generally botched the XOMA 052 partnership expectation game with investors, meaning the company has so far overpromised and under-delivered. The data from the phase IIb study coming at the end of the first quarter, if positive, should be sufficient to garner interest from a larger drug company. Whether Xoma's management team can get a deal done is not a guarantee. Again, XOMA 052 is a potentially valuable drug in the hands of a Keystone Cops management team. Whether or not they can do something right is still an open question.
Competition? Any other IL-1 beta blockers being tested in diabetes?
Yes, as SummerStreet also points out, helpfully, Eli Lilly(LLY_) is conducting an 80-patient phase II study of its anti IL-1 beta antibody Ly2189102 in Type 2 diabetes, with results expected in the first half of the year.
Novartis(NVS_) owns an anti IL-1 beta antibody known as Ilaris (canakinumab), approved as a treatment for the orphan disease cryopyrin-associated periodic syndromes (CAPS) in 2009. Sales are minimal. Novartis is conducting phase II studies of Ilaris in Type 2 diabetes, with data from one of these trials expected later this year.
--Written by Adam Feuerstein in Boston.
------------------------------------------------------------------
CALL
BERKELEY, Calif., Jan. 3, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA - News), a leader in the discovery and development of therapeutic antibodies, announced today that it is hosting a conference call and webcast tomorrow, January 4, at 8:30 AM Eastern time (5:30 AM Pacific time) to provide a business update.
The webcast can be accessed via the Investors section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay approximately two hours after conclusion of the live event until close of business on March 31, 2011. To access the live call, dial 877-369-6589 toll-free or 408-337-0122 outside of the U.S. A telephonic replay will be available approximately two hours after conclusion of the live event until close of business on January 11, 2011 by dialing 800-642-1687 toll-free or 706-645-9291 outside of the U.S. and using conference ID 34051571.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
* XOMA 052, an anti-IL-1 beta antibody entering Phase 3 development in Behcet's uveitis, for which it has been designated an orphan drug, and in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions.
* XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Contract # HHSN266200600008C).
* A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory, ophthalmic and oncologic diseases.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering(TM), affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, 60 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval, and a team of about 225 employees at its Berkeley, California location. For more information, please visit www.xoma.com.
The XOMA Ltd. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5960
Forward-Looking Statements
Certain statements contained herein concerning product development and capabilities of XOMA's technologies or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.
These risks, including the generally unstable nature of current economic and financial market conditions; the results of discovery research and pre-clinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); availability of additional collaborative and licensing opportunities; changes in the status of existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demand for products; scale-up and marketing capabilities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.
Contact:
XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.com
Canale Communications
Media Contact:
Carolyn Hawley
858-354-3581
carolyn@canalecomm.com
------------------------------------------------------------------
Presentation
XOMA Presentation:
http://www.xoma.com/media/files/XOMA%20Presentation.pdf
http://www.thestreet.com/_nasdaq/story/10959183/1/xoma-key-diabetes-drug-study-preview.html?&cm_ven=NASDAQ&cm_cat=FREE&cm_ite=NA
Xoma: Key Diabetes Drug Study Preview
BERKELEY, Calif. (TheStreet) -- Most of the market took a breather the Christmas holidays but not Xoma(XOMA_), which saw the value of its shares more than double on extraordinary volume despite the lack of any real news from the company (Unless you count disclosure of another dilutive financing right before the end of the year.)
Investors are looking ahead to when Xoma is expected to release interim results from a small, mid-stage study of an experimental diabetes drug, XOMA 052. The company announced late Monday that it will hold a conference call Tuesday morning to provide a business update. Whether or not that includes XOMA 052 data was not disclosed.
Clearly, investors who've been buying the stock in the past week or so believe strongly that the XOMA 052 data will be positive. What's just as clear is that Xoma's entire future rests on the development of XOMA 052, so the bet investors are making is big -- and risky.
XOMA 052 has the potential to be a blockbuster drug because it aims to attack the root cause of diabetes -- the inability of damaged islet cells in the pancreas to produce insulin. All other diabetes drugs either boost insulin production or help the body to be more sensitive to insulin produced naturally. XOMA 052 could also play a meaningful role in other diseases where inflammation is the culprit -- including cardiovascular disease and rheumatoid arthritis.
The scary, glaring danger is that XOMA 052 is owned by Xoma -- a company with an ignominious reputation in the biotech sector for drug development futility (and a chief executive who was almost named TheStreet's Worst Biotech CEO of 2010.) Over the course of two decades, Xoma has accomplished very little but rack up a mountain of losses amidst a plummeting stock price. Developing XOMA 052 successfully on its own is a feat that Xoma's management team may be incapable of achieving, even if the drug works.
At Monday's close of $5.30, Xoma shares are up 122% since Dec. 21. The stock actually closed above $7 on Dec. 23 before selling off a bit. [Mind you, remember that Xoma instituted a 1-for-15 reverse stock split last August in a last-ditch effort to remain Nasdaq listed.]
With that background, here's a quick FAQ on XOMA 052 and the upcoming phase II study results:
What should investors be looking for in this phase II study of XOMA 052?
The key data point (and the primary endpoint of the study) will be to determine the ability of XOMA 052 to reduce blood glucose (as measured by reductions in HbA1c levels) in patients with Type 2 diabetes.
This phase IIa study enrolled about 70 patients with Type 2 diabetes and randomized them to one of three dose levels of XOMA 052 and a placebo. All patients were also treated with a background regimen of the diabetes medicine metformin.
Xoma will be releasing interim results from the study based on three months of treatment. The study will continue, with patients randomized to XOMA 052 remain under treatment for another three months.
How will we know if the XOMA 052 data are positive or not?
The most immediate thing to look for is a greater reduction in HbA1c levels for XOMA 052-treated patients compared to patients treated with a placebo. It's not unusual in diabetes trials to see placebo patients demonstrate small reductions in blood glucose levels, but of course, the improvement (reduction) in XOMA 052 patients needs to be larger.
What's the magic blood glucose-lowering number that XOMA 052 needs to beat in order for investors to judge the phase II study a success?
That's a tough question to answer. Interim, three-month data from a relatively small study will only provide a snapshot of the drug's potential. With that said, David Kliff of the Diabetic Investor newsletter tells me that a .75% reduction in HbA1c would be a meaningful result worthy of some optimism (assuming the side effect profile is relatively benign.)
RBC Capital Markets analyst Jason Kantor is willing to be a bit more accommodating. In a recent note, he told clients that an HbA1c reduction of around 0.6% after three months should be viewed favorably. That would match results from an earlier, phase I study of XOMA 052.
Previous data on XOMA 052 in diabetes exists? Tell me more.
Xoma conducted a series of small, phase I diabetes studies of XOMA 052 in 2008 and 2009. These studies provided a hint of XOMA 052's efficacy but also raised some questions that cast a shadow over the drug. (These questions are also the reason for why investors and potential Xoma partners have wanted to see more data before getting comfortable with XOMA 052's diabetes potential.)
I won't go through all the previous data, but in a multi-dose study of just five Type 2 diabetes patients, treatment with a 0.03 mg/kg dose of XOMA 052 resulted in a 0.6% reduction in HbA1c and a fasting blood glucose reduction of 27 mg/dl after 56 days. By comparison, the placebo patients reported a 0.1% drop in HbA1c and a 13 mg/dl increase in fasting blood glucose after 56 days.
However, in the same study, another five Type 2 diabetes patients treated with a higher 0.3 mg/kg dose of XOMA 052 reported a 0.2% increase in HbA1c and a 20 mg/dl increase in fasting blood glucose levels. The decidedly worse outcomes for the higher dose of XOMA 052 raised questions about the entire study. Given the small number of patients, the poor high-dose results might just have been a fluke but then again, it also cast some doubt over the more optimistic lower-dose results.
What is XOMA 052 and how does the drug work?
XOMA 052 is an injectable monoclonal antibody that targets interleukin-1 beta, a pro-inflammatory protein that is thought to play a role in diabetes, rheumatoid arthritis and other diseases. XOMA 052 binds to IL-1 beta, thereby preventing inflammation that can damage insulin-producing islet cells in the pancreas.
In a Dec. 21 note that seems to have ignited this most recent wave of Xoma buying, SummerStreet Research Partners noted that while other companies are developing IL-1 beta inhibitors, Xoma's XOMA 052 could be best in class.
"We see an opportunity for significant expansion of the IL-1 class in diabetes. Pending data in diabetes should confirm this thesis during [the first half of 2011.] We believe anti-IL-1 therapy could play an important role in diabetes due to its impact on islet cell function which could allow glucose control with a reduced risk of hypoglycemia or heart attacks. Xoma, which has a minuscule current valuation and a potentially best-in-class compound, offers the biggest leverage to this opportunity," the SummerStreet report stated.
What else can we expect from Xoma on XOMA 052 after the release of the phase IIa results?
Xoma is also running a larger, phase IIb study of XOMA 052 in Type 2 diabetes patients which is expected to yield data in the latter part of the first quarter. This study, which enrolls 440 patients, is studying the same HbA1C endpoint but with a more clinically relevant six months of treatment. Xoma is also conducting a small phase II study in Type 1 diabetes patients.
Will Xoma find a partner for XOMA 052?
That's the plan. Xoma management has generally botched the XOMA 052 partnership expectation game with investors, meaning the company has so far overpromised and under-delivered. The data from the phase IIb study coming at the end of the first quarter, if positive, should be sufficient to garner interest from a larger drug company. Whether Xoma's management team can get a deal done is not a guarantee. Again, XOMA 052 is a potentially valuable drug in the hands of a Keystone Cops management team. Whether or not they can do something right is still an open question.
Competition? Any other IL-1 beta blockers being tested in diabetes?
Yes, as SummerStreet also points out, helpfully, Eli Lilly(LLY_) is conducting an 80-patient phase II study of its anti IL-1 beta antibody Ly2189102 in Type 2 diabetes, with results expected in the first half of the year.
Novartis(NVS_) owns an anti IL-1 beta antibody known as Ilaris (canakinumab), approved as a treatment for the orphan disease cryopyrin-associated periodic syndromes (CAPS) in 2009. Sales are minimal. Novartis is conducting phase II studies of Ilaris in Type 2 diabetes, with data from one of these trials expected later this year.
--Written by Adam Feuerstein in Boston.
BERKELEY, Calif., Jan. 3, 2011 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA - News), a leader in the discovery and development of therapeutic antibodies, announced today that it is hosting a conference call and webcast tomorrow, January 4, at 8:30 AM Eastern time (5:30 AM Pacific time) to provide a business update.
The webcast can be accessed via the Investors section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay approximately two hours after conclusion of the live event until close of business on March 31, 2011. To access the live call, dial 877-369-6589 toll-free or 408-337-0122 outside of the U.S. A telephonic replay will be available approximately two hours after conclusion of the live event until close of business on January 11, 2011 by dialing 800-642-1687 toll-free or 706-645-9291 outside of the U.S. and using conference ID 34051571.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
* XOMA 052, an anti-IL-1 beta antibody entering Phase 3 development in Behcet's uveitis, for which it has been designated an orphan drug, and in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions.
* XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Contract # HHSN266200600008C).
* A preclinical pipeline with candidates in development for autoimmune, cardio-metabolic, inflammatory, ophthalmic and oncologic diseases.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering(TM), affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, 60 pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval, and a team of about 225 employees at its Berkeley, California location. For more information, please visit www.xoma.com.
The XOMA Ltd. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5960
Forward-Looking Statements
Certain statements contained herein concerning product development and capabilities of XOMA's technologies or that otherwise relate to future periods are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.
These risks, including the generally unstable nature of current economic and financial market conditions; the results of discovery research and pre-clinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); availability of additional collaborative and licensing opportunities; changes in the status of existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; XOMA's ability to meet the demands of the United States government agency with which it has entered into its government contracts; competition; market demand for products; scale-up and marketing capabilities; international operations; share price volatility; XOMA's financing needs and opportunities; uncertainties regarding the status of biotechnology patents; uncertainties as to the costs of protecting intellectual property; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent filing on Form 10-K and in other SEC filings. Consider such risks carefully when considering XOMA's prospects.
Contact:
XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.com
Canale Communications
Media Contact:
Carolyn Hawley
858-354-3581
carolyn@canalecomm.com
great seems XOMA is flying
XOMA Reports Third Quarter 2010 Financial Results
BERKELEY, Calif., Nov. 4, 2010 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced its financial results for the third quarter ended September 30, 2010 and provided a general business update.
"The next several months will see pivotal events in the development of our flagship anti-inflammatory antibody candidate, XOMA 052, for Type 2 diabetes," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "We expect to announce interim results from three months of treatment in our 74 patient Phase 2a clinical trial in early January. During the first quarter of 2011, we plan to release top line results from our 420 patient Phase 2b trial, which is designed to evaluate the activity of XOMA 052 in diabetes patients over six months of treatment. Positive results could bring a potentially disease-modifying therapeutic for the treatment of Type 2 diabetes a major step closer to patients."
Financial Results
XOMA had total revenues of $10.9 million and a net loss of $13.6 million, or $0.69 per share, in the third quarter of 2010, compared with total revenues of $27.4 million and net income of $1.5 million, or $0.13 per share, in the third quarter of 2009. The decrease in revenues in the 2010 period compared with the 2009 period was primarily due to the $25.0 million sale of the company's royalty interest in LUCENTIS® in the third quarter of 2009, partially offset by increased contract revenue related to work performed under a U.S. government biodefense contract and the $4.0 million sale of the company's royalty interest in CIMZIA® in the 2010 third quarter.
XOMA had total operating expenses of $27.5 million in the quarter ended September 30, 2010, compared with $20.6 million in the 2009 third quarter. Research and development expenses were $21.3 million in the 2010 third quarter, compared with $13.4 million in the 2009 third quarter, primarily reflecting increased spending on the XOMA 052 Phase 2 clinical program. Selling, general and administrative expenses were $6.2 million in the 2010 third quarter compared with $7.2 million in the 2009 third quarter.
At September 30, 2010, XOMA had cash and cash equivalents of $16.9 million, compared with $23.9 million at December 31, 2009. Subsequent to September 30, 2010, XOMA's cash position was strengthened by $2.0 million received as final payment under its antibody discovery collaboration with Kaketsuken and $1.5 million in gross proceeds from equity issuances under an At Market Sales Agreement entered into in 2009 which has now been fully utilized. In addition, XOMA was awarded $977,917 in grants under the U.S. government's Patient Protection and Affordable Care Program.
Recent Highlights
Enrollment completed in Phase 2a trial of XOMA 052 in patients with Type 2 diabetes: This randomized, placebo-controlled trial, in which 74 patients were enrolled, is designed to evaluate extended biologic activity and safety of XOMA 052. Outcomes will include diabetes measures such as hemoglobin A1c, or HbA1c, and fasting blood glucose, or FBG, and C-reactive protein, or hsCRP, a biomarker of inflammation associated with cardiovascular risk. Interim results from the first three months of treatment in this six month trial are expected to be announced in the first half of January 2011.
Enrollment completed in Phase 2b trial of XOMA 052 in patients with Type 2 diabetes: This randomized, placebo-controlled dose-ranging trial enrolled 420 patients and is designed to further evaluate the safety and efficacy of XOMA 052 dosed once monthly compared to placebo. The results will include data on measurements of HbA1c, FBG and hsCRP. Top line results are expected to be announced in the first quarter of 2011.
XOMA 052 designated orphan drug in U.S. and European Union for the treatment of Behcet's disease: Orphan drug designation generally provides multi-year marketing exclusivity and other potential advantages for the development of new agents to treat rare diseases. In June 2010, XOMA announced positive results from an open-label pilot study of XOMA 052 in seven patients with Behcet's disease who were suffering from vision-threatening disease exacerbations, known as uveitis, despite maximal doses of immunosuppressive medicines. XOMA 052 was well-tolerated in this trial, and improvements in vision and ocular inflammation were observed in all seven patients following initial treatment, and in each of the five retreated patients.
$4 million received from sale of rights to CIMZIA® royalties and $750,000 milestone payment received from AVEO: The proceeds of the sale and milestone payment provide non-dilutive funding to support the development of XOMA 052 and other programs.
$997,917 in grants awarded under the Patient Protection and Affordable Care program: All four of the applications XOMA submitted under this program were awarded to the maximum allocation, providing non-dilutive capital to advance XOMA's programs to develop XOMA 052, XOMA 3AB, and monoclonal antibody therapeutics for the treatment of metabolic and oncologic diseases. The award payments were authorized on October 29, 2010.
Additional Financial Results
Interest expense for the third quarter of 2010 was $0.1 million compared with $1.3 million for the same period of 2009. The decrease in the 2010 period compared with the 2009 period was primarily due to the repayment in full of the term loan with Goldman Sachs Specialty Lending Holdings, Inc. in September 2009. Other income was $3.1 million in the 2010 third quarter compared with $0.1 million in the third quarter of 2009. This increase was primarily related to revaluation of warrant liabilities in the third quarter of 2010.
Liquidity and Capital Resources
Net cash used in operations during the first nine months of 2010 was $42.9 million compared with cash provided by operations of $11.5 million for the same period in 2009. The decrease in cash provided by operating activities in the 2010 period was primarily due to a decrease in revenue receipts for license and collaborative fees and royalties and an increase in spending on the XOMA 052 Phase 2 clinical program.
In October 2010, XOMA entered into an At Market Issuance Sales Agreement under which XOMA may issue shares from time to time through Wm Smith & Co. and McNicoll, Lewis & Vlak LLC as agents by means of one or more "at the market" offerings or, with XOMA's approval, in negotiated transactions. This agreement replaces the At Market Sales Agreement XOMA entered into in the 2009 third quarter, which has been fully utilized.
Guidance
XOMA will not be providing specific guidance on overall revenues or cash receipts for 2010 so as to best manage its ongoing negotiations for XOMA 052 and technology licensing. Excluding potential revenue from business development activities, the company expects that up to $60 million in cash may be used in operating activities in 2010.
Reverse Stock Split and NASDAQ Compliance
On August 18, 2010, XOMA effected a 1-for-15 share consolidation, or reverse stock split. In September 2010, NASDAQ notified the Company that it regained compliance with the minimum $1.00 per share bid price requirement for continued listing on The NASDAQ Global Market.
Investor Conference Call
XOMA will host a conference call and webcast to discuss its first quarter 2010 financial results today, November 4, 2010, at 4:30 pm ET. The webcast can be accessed via the Investors section of XOMA's website at http://investors.xoma.com/events.cfm and will be available for replay until close of business on February 2, 2011.
About XOMA
XOMA discovers, develops and manufactures novel antibody therapeutics for its own proprietary pipeline as well as through license and collaborative agreements with pharmaceutical and biotechnology companies, and under its contracts with the U.S. government. The company's proprietary product pipeline includes:
XOMA 052, an anti-IL-1 beta antibody in Phase 2 clinical development for Type 2 diabetes with cardiovascular biomarkers, Type 1 diabetes, and with potential for the treatment of a wide range of inflammatory conditions. XOMA 052 also has demonstrated positive clinical benefit in a proof-of-concept trial for the treatment of vision-threatening uveitis of Behcet's disease.
XOMA 3AB, an antibody candidate in pre-IND studies to neutralize the botulinum toxin, among the most deadly potential bioterror threats, under development through funding provided by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (Contract # HHSN266200600008C).
A preclinical pipeline with candidates in development for autoimmune, inflammatory and oncologic diseases.
In addition to its proprietary pipeline, XOMA develops products with premier pharmaceutical companies including Novartis AG, Schering Corporation, a subsidiary of Merck & Co., Inc., and Takeda Pharmaceutical Company Limited.
XOMA's technologies have contributed to the success of marketed antibody products, including LUCENTIS® (ranibizumab injection) for wet age-related macular degeneration and CIMZIA® (certolizumab pegol) for rheumatoid arthritis and Crohn's disease.
The company has a premier antibody discovery and development platform that incorporates an unmatched collection of antibody phage display libraries and proprietary Human Engineering(tm), affinity maturation, Bacterial Cell Expression (BCE) and manufacturing technologies. BCE is a key breakthrough biotechnology for the discovery and manufacturing of antibodies and other proteins. As a result, sixty pharmaceutical and biotechnology companies have signed BCE licenses, and several licensed product candidates are in clinical development.
XOMA has a fully integrated product development infrastructure, extending from pre-clinical science to approval, and a team of about 225 employees at its Berkeley, California location. For more information, please visit http://www.xoma.com.
The XOMA Ltd. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=5960
Safe Harbor Statement
Certain statements contained herein concerning timing of results of clinical trials or other aspects of product development, or that otherwise relate to future periods, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements are based on assumptions that may not prove accurate. Actual results could differ materially from those anticipated due to certain risks inherent in the biotechnology industry and for companies engaged in the development of new products in a regulated market.
Among other things, the timing of results of clinical trials may be delayed or may never become available as a result of complications in the collection or interpretation of statistical data, unavailability of resources, actions or inaction by our present or future collaboration partners, insufficient enrollment in such trials or unanticipated safety issues; and results of clinical trials may in any event not be consistent with preclinical or interim results.
These and other risks, including the generally unstable nature of current economic conditions; the results of discovery research and preclinical testing; the timing or results of pending and future clinical trials (including the design and progress of clinical trials; safety and efficacy of the products being tested; action, inaction or delay by the FDA, European or other regulators or their advisory bodies; and analysis or interpretation by, or submission to, these entities or others of scientific data); uncertainties regarding the status of biotechnology patents; uncertainties as to the cost of protecting intellectual property; changes in the status of the existing collaborative and licensing relationships; the ability of collaborators, licensees and other third parties to meet their obligations; market demand for products; scale up and marketing capabilities; competition; international operations; share price volatility; XOMA's financing needs and opportunities; and risks associated with XOMA's status as a Bermuda company, are described in more detail in XOMA's most recent annual report on Form 10-K and in other SEC filings. Consider such risks carefully in considering XOMA's prospects.
Tables follow —
XOMA Ltd.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)
(in thousands, except per share amounts)
Three months ended
September 30, Nine months ended
September 30,
2010 2009 2010 2009
Revenues:
License and collaborative fees $ 1,410 $1,421 $ 1,749 $29,276
Contract and other revenue 5,733 3,688 18,025 18,662
Royalties 3,754 22,314 4,267 28,895
Total revenues 10,897 27,423 24,041 76,833
Operating expenses:
Research and development 21,345 13,444 58,278 43,472
Selling, general and administrative 6,152 7,197 16,731 18,972
Restructuring 45 2 45 3,603
Total operating expenses 27,542 20,643 75,054 66,047
(Loss) income from operations (16,645) 6,780 (51,013) 10,786
Other income (expense):
Investment and interest income 4 9 13 47
Interest expense (104) (1,339) (281) (4,778)
Loss on debt extinguishment -- (3,645) -- (3,645)
Other income (expense) 3,113 103 300 1,240
Net (loss) income before taxes (13,632) 1,908 (50,981) 3,650
Provision for income tax expense (benefit) 1 370 17 6,083
Net loss $(13,633) $1,538 $(50,998) $ (2,433)
Basic net (loss) income per common share $ (0.69) $ 0.14 $ (2.87) $ (0.24)
Diluted net (loss) income per common share $ (0.69) $ 0.13 $ (2.87) $ (0.24)
Shares used in computing basic net (loss) income per common share 19,802 11,150 17,742 10,211
Shares used in computing diluted net (loss) income per common share 19,802 11,517 17,742 10,211
XOMA Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
September 30,
2010 December 31,
2009
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 16,860 $ 23,909
Trade and other receivables, net 7,944 7,231
Prepaid expenses and other current assets 1,486 1,012
Total current assets 26,290 32,152
Property and equipment, net 16,179 20,270
Other assets 543 402
Total assets $ 43,012 $ 52,824
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 5,706 $ 2,942
Accrued liabilities 8,187 8,639
Deferred revenue 2,152 2,114
Warrant liabilities 1,716 4,760
Other current liabilities -- 223
Total current liabilities 17,761 18,678
Deferred revenue — long-term 1,346 2,894
Interest bearing obligation — long-term 13,505 13,341
Other long-term liabilities 353 385
Total liabilities 32,965 35,298
Shareholders' equity 10,047 17,526
Total liabilities and shareholders' equity $ 43,012 $ 52,824
CONTACT: XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
deguzman@xoma.com
Canale Communications
Media Contact:
Carolyn Hawley
619-849-5375
carolyn@canalecomm.com
XOMA CORP
Daily Commentary
Our system posted a BUY CONFIRMED today. The previous SELL recommendation was issued on 12.28.2010 (2) days ago, when the stock price was 6.0300. Since then XOMA has fallen -11.61% .
BUY-IF is confirmed by a white candlestick with a higher open. The buying price is today's open ( 5.3000 ) according to the Rules of Confirmation.
The recent bullish formation leading to the BUY-IF signal is confirmed today. The market is ready for a new bullish move. It opened today with a gap-up and the day’s activity resulted in a close higher than the open. This is one of our valid confirmation criteria.
We hope that you bought this stock. You should watch the upward gap in the opening, wait a bit, feel the bullish tendency of the market making sure that prices stay over the opening price and then go long. Your benchmark was the opening price of the upward gap.
If you bought, continue to hold this stock until the confirmation of the next SELL-IF signal. You are on safe grounds as long as the future prices continue to trade above the benchmark price. What to do if you did not buy? Maybe, you did not have time to follow the session or you simply delegated the delicate job of confirmation to us. Well it is a bit late, but not too late. You may still find suitable prices for buying in the following sessions.
The market is currently cold for short-sellers. Avoid any short sales and cover the short positions immediately if there are any.
http://www.americanbulls.com/StockPage.asp?CompanyTicker=XOMA&MarketTicker=NASD&TYP=S
Pre-market is looking good so far
hares of XOMA are Moving Higher on 1.9x Above-Average Volume (XOMA)
Written on Wed, 12/29/2010 - 11:06am
By Sarah Hashim-Waris
Shares of XOMA (NASDAQ:XOMA) are trading up 2.7% to $4.88 today on above average volume. Approximately 5 million shares have traded hands today vs. average 30-day volume of 2.6 million shares.
Spikes in volume can validate a breakout or signify a potential turning point. As such, SmarTrend will continue to monitor shares of XOMA to see if this bullish momentum will continue.
SmarTrend is monitoring the recent change of momentum in XOMA. Please refer to our Company Overview for the results of our proprietary technical indicators that have been scanning shares of XOMA in search of a potential trend change.
In the last five trading sessions, the 50-day MA has climbed 7.48% while the 200-day MA has slid 1.03%.
In the past 52 weeks, shares of XOMA have traded between a low of $2.24 and a high of $12.60 and are now at $5.05, which is 125% above that low price.
http://www.mysmartrend.com/news-briefs/news-watch/shares-xoma-are-moving-higher-19x-above-average-volume-xoma
thewall.com: Xoma may have sold $45M in stock recently, says RBC Capital
RBC Capital believes Xoma may have sold up to $45M in stock over the past several days given recent share strength. The firm believes a capital raise may reduce some Xoma's financial risk in 2011 but recommends waiting for initial diabetes results in January before chasing shares. Shares are Sector Perform rated.
i've a buy Limit @ 0.8024 do you think it'll go down to this again?
no...tight SL's and she went down again then. Good new entry points yesterday. What i burned, i got back then...:)
hmmm was on the wrong side. turned into a bull ^^
hmm...downtrend is still intact. I'm short on G/J.
But good luck.
Stockwire.com: CHAT LIVE in the only dedicated CHAT ROOM for Cyberlux Corp. (OTCBB: CYBL) shareholders!
AUSTIN, TX, Jan 17, 2008 (M2 PRESSWIRE via COMTEX) -- STOCKWIRE.com, one of the largest investment websites on the internet, is proud to announce the official launch of the Cyberlux chat room!
Visit the only LIVE CHAT ROOM on the internet dedicated to (OTCBB: CYBL) shareholders, by visiting: http://www.stockwire.com/cybl ----------------------------------------------------------
RESEARCH TRIANGLE PARK, N.C., Jan 16, 2008 - Cyberlux to Provide Task Lighting for New York City's New 911 Public Safety Answering CenterCyberlux Selected as Task Lighting Solution Provider for NYC's High Profile 911 Call Center Project.
Cyberlux Corp. (OTCBB: CYBL), a leading provider of LED lighting solutions, announced today that the Company has been selected to provide portable task lighting for the City of New York's new 911 Public Safety Answering Center. Selected by Evans Consoles, the manufacturer of the new 911 Dispatch Command Consoles, the Cyberlux Portable LED Task Light will illuminate the work environment of the new 911 public safety call taking and dispatching operators. Cyberlux received an initial order from Evans Consoles for 355 units valued at over $64,000.
Evans Consoles (www.evansonline.com), the world leader in the design and manufacture of mission-critical custom control room solutions, selected Cyberlux to develop the LED Task Light in order to meet the energy-efficiency, durability and performance requirements of the new City of New York 911 Public Safety Answering Center (PSAC). Through the Cyberlux military specification (milspec) design/build process, Evans Consoles and Cyberlux collaborated to develop a lighting solution for the public safety call center market. The resulting milspec LED Task Light will replace the traditional fluorescent task lighting fixtures typically used in existing call centers.
The milspec LED Task Light performs for over 50,000 hours without a lighting element replacement, and operates with up to 52% more energy efficiency on low lighting levels and up to 31% more energy efficiency on high lighting levels when compared to traditional fluorescent task lighting. The Cyberlux milspec LED Task Lighting products provide up to 1000 lumens of illumination with 12 watts of power and utilize a patent-pending thermal management system for optimal lighting performance.
In addition, this Cyberlux milspec LED Task Light is the only LED task light available that is compatible with the Johnson Controls Personal Environments control center. The Johnson Control system is typically used by call center operators, including those in New York City, to control lighting, heating and air conditioning within their personal operating environment. The dual-arm milspec LED Task Light is adjustable and adaptable to any call center operator's lighting needs and is dimmed and controlled using the Johnson Controls system to vary the amount of light according to task.
"We are very pleased to partner with Evans Consoles to deliver this world- class milspec LED Task Lighting solution to a significant customer such as the City of New York. The new mission-critical 911 Call Center project is an example of the commercial product design/build capability that Cyberlux Corporation offers to customers such as Evans Consoles and the City of New York," said Mark Schmidt, president of Cyberlux. "Evans Consoles is a market leader, and we look forward to growing our business relationship as well as our distribution of milspec LED Task Lighting solutions as the need for next- generation energy-efficient lighting products continues to accelerate," continued Schmidt.
About Cyberlux Corporation: Cyberlux Corporation (OTCBB: CYBL) has created breakthrough LED lighting technology that provides the most energy efficient and cost effective lighting solutions available today for consumer, commercial and military uses. The Military and Homeland Security products deliver unique, covert, and advanced visible lighting capability for threat detection, force and asset protection, and first responder deployment. Cyberlux uses solid- state semiconductors, trademarked as its diodal(tm) lighting elements, which consume 75% less energy than incandescent lighting elements and perform for over 20 years in contrast to 750 hours for conventional bulbs.
----------------------------------------------------------
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-0-
anyone is trying to holding this thingy down...hummm...why?
very good news imho
time for the weekend sellers :))
yepp, and it seems not so bad
more buying pressure and we'll go through
yepp, if bashers coming back we'll go upwards
totally agree
maybe we see an after-market filling or news?
lol sorry, just skimmed your post because i'm at work
yes, but it's also a confirmation. just my view of things
get your last tickets for this crazy train, now... :))
i'm here lol *eom*
hope not...not a friend of gaps
imho for sure...because of the lawsuit they have to make losses public
as i said:
Posted by: joergstgt
In reply to: None
Date:11/14/2007 12:27:35 PM
Post #of 16079
doesn't matter..i'm a snugly one and have time... i'm young :))