XOMA - Sector: Healthcare - Industry: Biotechnology & Drugs

[setravis]

XOMA  XOMA Presents XOMA 3AB Data at National Biodefense Meeting...  by GlobeNewswire  Jan 11 2011 8:30AM

BERKELEY, Calif., Jan 11, 2011 (GlobeNewswire via COMTEX) -- XOMA Ltd. (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(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 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.

This news release was distributed by GlobeNewswire, www.globenewswire.com

SOURCE: XOMA Ltd.


CONTACT: XOMA Ltd.
Company and Investor Contact:
Carol DeGuzman
510-204-7270
[email protected]
Canale Communications
Media Contact:
Carolyn Hawley
619-849-5375
[email protected]

[setravis]

Is XOMA a Turnaround Stock?
January 12, 2011 

XOMA Limited (XOMA) has gone through many problems in the past, causing its stock to fall down, down, down. But could XOMA be at a turnaround.

They got $35 million upfront from a French pharmaceutical company. That is 28% of the company's market cap, which is $124 million. Plus, there is up to $470 million in milestone payments. That is about 3.8 times the current value of the stock.

The stock recently has been falling after a sharp rise. I am betting that XOMA will jump back up. The drop seems unwarranted.

Investors seemed to be disappointed on the news from its current study on 052 XOMA. However, the study was designed to evaluate safety, which it did, and "was not designed to show statistically significant differences in measures of biological activity." The study "showed the potential treatment, labeled Xoma 052, was well tolerated" and "the drug showed a clean safety profile and a promising C-reactive protein reduction."
This should be good news, right?

Coming to conclusions about something the study was not designed to test is irrational thinking. Basically, there must be a control, something a study was designed to test so it can be compared, on every study. With the absence of a control, the data is meaningless.

The odds are very high that XOMA will rise either today or tomorrow. The stock has an MFI and RSI of 60. A MFI of 60 is its one-month low, as shown below. So odds are high it will reverse higher.

A real move would be on fundamental analysis noted at the top half of the article.

Day's Range: 5.72 - 5.83
52wk Range: 2.24 - 12.60
Volume: 1,022,428
Avg Vol (3m): 3,750,910
Market Cap: 126.21M
P/E (ttm): N/A
EPS (ttm): -2.88
Div & Yield: N/A (N/A)

Technicals
Last Price Quote is:
2.58%above 13-day EMA
36.79%above 50-day EMA
RS Rating: 96 

[setravis]

Xoma and Elan: A Tale of Two Mismanaged Biotech Companies, Part 2

ELAN

Although investors' fury at Elan's management is understandable and legitimate, the management's mistakes should not blind them to fairly assessing this firm, which has contributed to science and drug development more than most other drug developers, small and large. There is reason to believe that this contribution to science is the main reason behind the firm's financial debacle. Nevertheless, Elan's science, scientists, their discovered disease pathways, and the technologies they created have advanced the understanding of neurological diseases and made possible the management of diseases yet to find treatments. While drug companies design, discover and develop drugs that target validated pathways of diseases, Elan, itself, discovered the pathways of diseases for the drugs it designed and developed. In neuropathology, Elan's research and findings have enriched the medical libraries with breakthrough knowledge about the pathophysiology of diseases such as Alzheimer's disease, Parkinson's disease and multiple sclerosis.

The firm developed several products for Alzheimer's disease based on its understanding of the disease pathways. In addition to its small molecule inhibitors of beta secretase and gamma secretase, the firm developed small molecule drugs that target neurotrophic receptors that could protect vulnerable people's neurons. It identified unusual forms of alpha-synuclein, a major component of Lewy bodies, which is a signature characteristic in the brain tissue of Parkinson's disease patients. This finding has led to therapeutic targets that are the focus of Elan's new drug discovery efforts.

It was Elan's scientists who discovered the role of the selective adhesion molecule, alpha 4 integrin protein, in the etiology of multiple sclerosis and other autoimmune diseases, including Crohn's disease. Alpha 4 integrin has a role in the movement of immune cells from the bloodstream into the tissues in response to inflammation. Elan's breakthrough selective adhesion molecule inhibitor Tysabri® (natalizumab) is approved for the treatment multiple sclerosis and Crohn's disease. Yet, Elan's scientists continue to investigate new small molecule inhibitors that block alpha 4 integrin and may selectively block immune cell traficking. The firm's scientists are also studying signaling molecules that may be involved in the brain inflammation characteristic of secondary progressive MS. The firm aims at disrupting the pathway of chronic inflammation-neurodegeneration that causes permanent disability in advanced MS.

In addition to illuminating the molecular pathological pathways, selecting therapeutic targets, and designing evidence-based drugs, Elan created state-of-the-art technologies that enhance the safety and efficacy of products and, even better, make possible the development of products that lacked the physicochemical requirements of therapeutics. Elan's two important technologies, NanoCrystal technology and drug delivery technology have contributed to improving the actions, effects and side effects of several drugs.

That said, the question remains: does the resentment of the management's mistakes prevent us from trying to determine a fair value for this firm at the current stage?

Final word: Again, we prefer to be objective and do our homework, including taking into consideration the harm that resulted from the management's miscalculations. This harm, which has been financial, has reached a stage where it had to slow, if not halt, the firm's scientific ambitions, which, together with other unexpected circumstances, like the unexpected risk of progressive multifocal leukoencephalopathy (PML) as a side effect of Tysabri, caused the accumulation of large dept. Elan had to downsize. It did. It had to reform. It did. Still finding itself in a disagreeable territory, it had no option left but to relinquish most of its Alzheimer's disease programs. It did. It then thought to dispose of its drug delivery technology to get rid of the rest of its dept. It did not.

This surprising hesitation of Elan to execute its own plan has probably been the firm's belief that Tysabri's sales could do the financial miracle now that the firm has already filed to include the anti-JC Virus antibody status test in Tysabri's product labeling. The decrease, or elimination of the risk of PML, which has prevented the breakthrough drug from becoming a blockbuster drug, will, indeed, produce the miracle that would resurrect this firm.

Elan has marketed products that bring to its coffers over $1.1 billion. Around 60% of this revenues comes from Tysabri, which it partnered 50-50 with Biogen Idec (BIIB). The firm is still offering its services for other firms through its technologies, and will continue to cash in royalties on products that have been approved and marketed for other firms. The latest apparent blockbuster drug Ampyra for MS leg walking difficulties was developed for Acorda (ACOR) Therapeutics with Elan's technology; it had an excellent market penetration.

Tysabri is still the most effective MS drug on the market. Further diminishing the risk of developing PML would lead to sales that would generate between $2.5-$3.0 billion a year. The drug is approved in more than 45 countries; for relapsing forms of multiple sclerosis (MS) in the U.S. and for relapsing-remitting MS in Europe. It is not unrealisted to expect that both the U.S. and EU would expand their approval of the drug to both indications. Elan's current revenue increase was driven by the growth of Tysabri and the launch of Ampyra.

To make the story short, Elan is insured by Tysabri. We believe Elan will either be resurrected by Tysabri, or be taken over because of Tysabri. Either way would be rewarding to the shareholders.