A discovery by scientists at deCODE genetics (Nasdaq DCGN) and academic colleagues from Iceland, the Netherlands and Denmark has pointed to a common biological mechanism contributing to both kidney stones and decreased bone mineral density (BMD). About 60% of the population carry two copies of a singleletter variation in the human genome (SNP) on chromosome 21, putting them at roughly 65% greater likelihood of developing kidney stones than those who carry no copies. This single variant may thus account for more than a quarter of the incidence of kidney stones, and in women carriers it is also associated with decreased BMD at the hip and spine.

The SNP is in the gene encoding claudin 14 (CLDN14), a protein expressed in the kidney and one of a family of membrane proteins that regulate the passage of ions and small solutes between cells. As calcium is a key component both of most kidney stones and of bone, the deCODE team examined the relationship between CLDN14 and the metabolism of calcium. The results suggest that the SNP may be contributing to increased calcium excretion in urine, a major risk factor for kidney stones and also a sign of bone loss.

“This is an exciting finding because it uncovers a highly plausible common biological mechanism leading to two diseases. This offers a potentially attractive new pathway for drug discovery, and the next task is to build on our understanding of how this SNP increases risk of these diseases and how this pathway could be targeted therapeutically to address this risk. As ever, deCODEme subscribers will see this new variant in their profiles, and we look forward building on this discovery,” said Kari Stefansson, CEO of deCODE.

About kidney stones

Kidney stones are small crystals formed of dissolved minerals, mainly calcium, that form in the kidneys. Smaller stones can simply be passed through urination, though larger ones can block the urinary tract, causing considerable pain and bleeding. Kidney stones affect some 5% of women and 10% of men in the industrialized world. Larger stones can be detected with ultrasound screening and broken up to facilitate passage, though the recurrence rate is high.

deCODE would like to thank all those who participated in this study, as well as the collaborating clinicians and scientists from the Landspitali University Hospital in Reykjavik, Iceland; Radboud University Nijmegen Medical Centre in Nijmegen, Netherlands; Nordic Bioscience A/S in Herlev, Denmark; and the Center for Clinical and Basic Research A/S in Ballerup, Denmark.

About deCODE

deCODE is a biopharmaceutical company developing drugs and DNAbased tests to improve the treatment, diagnosis and prevention of common diseases. Its lead therapeutic programs, which leverage the companys expertise in chemistry and structural biology, include DG041, an antiplatelet compound being developed for the prevention of arterial thrombosis; DG051 and DG031, compounds targeting the leukotriene pathway for the prevention of heart attack; and DG071 and a platform for other PDE4 modulators with therapeutic applications in Alzheimers disease and other conditions. deCODE is a global leader in human genetics, and has identified key variations in the genome (SNPs) conferring increased risk of major public health challenges from cardiovascular disease to cancer. Based upon these discoveries deCODE has brought to market a growing range of DNAbased tests for gauging risk and empowering prevention of common diseases. Through its CLIAregistered laboratory, deCODE offers deCODE T2(TM) for type 2 diabetes; deCODE AF(TM) for atrial fibrillation and stroke; deCODE MI(TM) for heart attack; deCODE ProstateCancer(TM) for prostate cancer; deCODE Glaucoma(TM) for a major type of glaucoma; and deCODE BreastCancer, for the common forms of breast cancer

Any statements contained in this presentation that relate to future plans, events or performance are forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forwardlooking statements are subject to a number of risks and uncertainties that could cause actual results, and the timing of events, to differ materially from those described in the forwardlooking statements. These risks and uncertainties include, among others, those relating to our ability to obtain sufficient financing to continue as a going concern, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, our ability to form collaborative relationships, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODEs filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10Q or Current Reports on Form 8K. deCODE undertakes no obligation to update or alter these forwardlooking statements as a result of new information, future events or otherwise.

Source deCODE genetics

CuraGen Corporation (Nasdaq CRGN) announced that its Phase I/II Trial evaluating CR011vcMMAE for the treatment of patients with advanced breast cancer has met the efficacy criteria for advancement to the second stage of enrollment. To date, 29 patients have been enrolled in this trial, including 15 in the Phase II portion. Two of the first four evaluable Phase II patients were progressionfree at 12 weeks, therefore, as part of the Simon 2Stage design, the Phase II trial will now advance to the second stage and enroll a total of approximately 25 patients. The principal investigator of the study is Dr. Linda Vahdat, Medical Director of the Breast Cancer Research Program and Associate Professor of Clinical Medicine, /Weill Cornell. CuraGen anticipates presenting updated results from this study during the second half of 2009.

About CR011vcMMAE

CR011vcMMAE is an antibodydrug conjugate (ADC) being developed by CuraGen that consists of a fullyhuman monoclonal antibody, CR011, linked to a potent cellkilling drug, monomethylauristatin E (MMAE). The ADC technology, comprised of MMAE and a stable linker system for attaching it to CR011, was licensed from Seattle Genetics, Inc. The ADC is designed to be stable in the bloodstream. Following intravenous administration, CR011vcMMAE targets and binds to GPNMB, a specific protein that is predominantly expressed on the surface of cancer cells, including melanoma, breast cancer and glioma. Upon internalization by the targeted cell, CR011vcMMAE is designed to release MMAE from CR011 to produce a cellkilling effect. CR011vcMMAE is currently in two Phase II trials assessing its safety and efficacy in the treatment of melanoma and for the treatment of metastatic breast cancer, and in a Phase I trial to evaluate the safety and activity of alternate dosing schedules.

About Breast Cancer

Breast cancer is the most common cancer in women and a leading cause of death in the United States. According to the American Cancer Society, more than 180,000 women will be diagnosed with invasive breast cancer in 2009 with more than 40,000 deaths attributed to this disease. Despite recent advances in therapy, the median survival of patients with metastatic breast cancer is 2 to 3 years, while patients with “triplenegative” or “basallike” breast cancer have limited treatment options and poorer outcomes. Therefore, a significant unmet need remains for novel therapeutic approaches for patients with locally advanced and metastatic breast cancer who have failed other therapies.

About CuraGenCuraGen Corporation (Nasdaq CRGN) is a clinicalstage biopharmaceutical company developing promising approaches for the treatment of cancer. CuraGen Corporation is headquartered in Branford, Connecticut.

Forward Looking Statements

Statements in this press release regarding managements future expectations, beliefs, intentions, goals, strategies, plans or prospects, including statements relating to CuraGens development program for CR011vcMMAE, including CuraGens ability to advance CR011vcMMAE through Phase II clinical trials for melanoma and metastatic breast cancer, to explore additional doses and schedules of this antibodydrug conjugate, and to explore the potential of CR011vcMMAE in a patient population in need of new therapies may constitute forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forwardlooking statements can be identified by terminology such as “anticipate,” “believe,” “could,” “could increase the likelihood,” “estimate,” “expect,” “intend,” “is planned,” “may,” “should,” “will,” “will enable,” “would be expected,” “look forward,” “may provide,” “would” or similar terms, variations of such terms or the negative of those terms. Such forwardlooking statements involve known and unknown risks, uncertainties and other factors including the risk that any one or more of CuraGens drug development programs will not proceed as planned for technical, scientific or commercial reasons or due to patient enrollment issues or based on new information from nonclinical or clinical studies or from other sources, the success of competing products and technologies, CuraGens stage of development as a biopharmaceutical company, government regulation and healthcare reform, technological uncertainty and product development risks, product liability exposure, uncertainty of additional funding, CuraGens history of incurring losses and the uncertainty of achieving profitability, reliance on research collaborations and strategic alliances, competition, patent infringement claims against CuraGens products, processes and technologies, CuraGens ability to protect its patents and proprietary rights and uncertainties relating to commercialization rights, as well as those risks, uncertainties and factors referred to in CuraGens Quarterly Report on Form 10Q for the period ended March 31, 2009 filed with the Securities and Exchange Commission under the section “Risk Factors,” as well as other documents that may be filed by CuraGen from time to time with the Securities and Exchange Commission. As a result of such risks, uncertainties and factors, CuraGens actual results may differ materially from any future results, performance or achievements discussed in or implied by the forwardlooking statements contained herein. CuraGen is providing the information in this press release as of this date and assumes no obligations to update the information included in this press release or revise any forwardlooking statements, whether as a result of new information, future events or otherwise.

Source CuraGen Corporation

Six scientists from The University of Queensland have received Smart Future Fellowships to help further their research into areas such as disease detection and clean energy.

The Queensland Government sponsored Fellowships provide funding for early or midcareer researchers to undertake innovative research in Queensland and receive up to $300,000 from the Government over three years.

Acting Deputy ViceChancellor (Research) Professor Max Lu congratulated the Fellows and thanked the Queensland Government for continuing to back talented young researchers.

“This is a wise investment by the Government in researchers whose work could lead to advances in health, the environment and sustainable energy, and also generate economic returns for Queensland.

“UQ has received half of all the Fellowships in this category, which is a great endorsement of the quality of our researchers and their records of delivering productive research outcomes.”

The six recipients are

Dr Simon Corrie, from UQs Australian Institute for Bioengineering & Nanotechnology (AIBN), is working on a new, noninvasive microdevice that can painlessly extract material from the skin for early detection of diseases. If successful this device will reduce the reliance on expensive, painful and invasive tissue extraction methods such as scrapings and excisional biopsies, and will also advance our understanding of the fundamental physiology of the skin epithelia.

Dr Zhen Li, from the AIBN, is pursuing new contrasting agents for the existing technologies of magnetic resonance imaging (MRI) and fluorescence mediated imaging (FMI) for early detection of cancers. It is anticipated these contrast agents will be based on magnetic and fluorescent nanocrystals prepared using an environmentally friendly aqueous method. Not only do these nanocrystals have the potential to extend the capabilities of MRI and FMI, they might also act as drug delivery molecules.

Dr Chengua Sun, from the AIBN, aims to improve the performance of solar cells by increasing the reactivity of titanium oxide crystals. The potential benefits include greater utilisation of solar energy and new materials to break down air and water pollutants.

Dr Marcel Dinger, from UQs Institute for Molecular Bioscience, will examine stretches of the genome that dont contain genes, called noncoding RNA. It is believed noncoding RNA plays a role in directing development in complex organisms such as humans. The research has the potential to greatly improve our knowledge about the molecular basis of development and disease, which will in turn provide targets for drugs to treat genetic diseases and cancer.

Dr Kazuhiro Nogita, from the School of Engineering, aims to create a viable magnesiumbased way to store hydrogen. Hydrogen has the potential to power much of the modern world with only water as the byproduct, but storing hydrogen safely and efficiently remains a major problem. A magnesiumbased storage system could solve this problem as well as generate a new market for Queensland rich magnesite reserves.

Associate Professor Helen Cooper, from UQs Queensland Brain Institute, is working on an effective and efficient nanoparticlebased drug delivery system for the treatment of diseases such as Alzheimers and Huntingtons. While powerful new drugs have been developed recently, their failure to enter the brain and target damaged neurons has limited their clinical use. This project hops to overcome those hurdles.

Bayer HealthCare Pharmaceuticals, Inc. announced that new data on Bayers novel anticancer development candidate BAY 734506 (DASTInhibitor) will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, May 29 June 2.

“Bayer is committed to expanding our oncology franchise, and the oral multikinase inhibitor BAY 734506 is one of the promising compounds in the companys pipeline,” said Kemal Malik, MD, member of the Board of Management and Chief Medical Officer and Head of Global Development at Bayer HealthCare. “We look forward to determining the role of BAY 734506, along with other compounds in our franchise, in creating potential treatment options for patients afflicted with various cancers.”

The BAY 734506 data being presented are

BAY 734506

Phase I study of BAY 734506, an inhibitor of oncogenic and angiogenic kinases, in patients with advanced refractory colorectal carcinoma

Dirk Strumberg, MD, Department of Hematology and Medical Oncology, Marienhospital Herne, University Medical School of Bochum, Germany

Abstract 3560, Poster, Saturday, May 30, 2009, 8001100 a.m., Level 2, West Hall C

Phase II study of BAY 734506, a multikinase inhibitor, in previously untreated patients with metastatic or unresectable renal cell cancer

Professor Tim Eisen, PhD, Addenbrookes Hospital and the University of Cambridge, UK

Abstract 5033, Poster Discussion, Friday, May 29, 2009, 200600 p.m., Level 2, W230A

About BAY 734506 (DASTInhibitor)

BAY 734506 is a novel oral multikinase inhibitor with a kinase inhibition profile targeting angiogenic, stromal and oncogenic receptor tyrosine kinases (TK). BAY 734506 has been shown to inhibit tumor growth in preclinical models by hitting targets along a spectrum of angiogenic pathways, including VEGFR and TIE2. BAY 734506 has also been shown to prevent the proliferation of tumor cell lines while promoting apoptosis (cell death) by directly targeting several oncogenic TK receptors. The mechanism may offer promise to treat a broad spectrum of tumors.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.based pharmaceuticals unit of Bayer HealthCare LLC, a subsidiary of Bayer Corporation. One of the worlds leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units Diagnostic Imaging, General Medicine, Specialty Medicine and Womens Healthcare. The companys aim is to provide products that will improve human health worldwide by diagnosing, preventing and treating diseases.

ForwardLooking Statements

This release may contain forwardlooking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA CTIC) announced that data from CTIs pivotal phase III EXTEND (PIX301) trial of pixantrone in patients with advanced, relapsed aggressive nonHodgkins lymphoma (NHL) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 29 to June 2, 2009 in Orlando, Florida.

Ruth Pettengell, M.D. of St. Georges Hospital, University of London, an investigator on the study, is scheduled to present the data on Monday, June 1, 2009 during the Lymphoma and Plasma Cell Disorders session that will be held from 200 PM600 PM Eastern Time. The presentation, abstract #8523, is titled, “Randomized Phase III trial of pixantrone compared with other chemotherapeutic agents for thirdline singleagent treatment of relapsed aggressive nonHodgkins lymphoma.”

CTI expects to complete the submission of a New Drug Application (”NDA”) for pixantrone this quarter and will request priority review which if granted could lead to an approval decision from the U.S. Food and Drug Administration (”FDA”) during the fourth quarter of 2009.

About Pixantrone

Pixantrone (BBR 2778), is a novel major groove binder with an azaanthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as firstline (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anticancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.

About Pixantrone

Pixantrone (BBR 2778), is a novel major groove binder with an azaanthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as firstline (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anticancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class.

About Cell Therapeutics, Inc.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.

This press release includes forwardlooking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that the New Drug Application submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, the companys ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Companys filings with the Securities and Exchange Commission including, without limitation, the Companys most recent filings on Forms 10K, 8K, and 10Q. Except as may be required by law, CTI does not intend to update or alter its forwardlooking statements whether as a result of new information, future events, or otherwise.

Source Cell Therapeutics, Inc

New picture released demonstrate that the adjoining of Zometa(R) (zoledronic acid) injection to normal chemotherapy before breast cancer surgery reduces the size of breast tumors more effectively than chemotherapy alone in women with earlystage disease.

These neoadjuvant subset results from the retrospective exploratory analysis of the foreign AZURE (Adjuvant Zoledronic acid to redUce REcurrence) trial are the first to pageant the direct effect of Zometa in combination with chemotherapy to guidance shrink cancerous breast tumors, potentially resulting in lacking radical surgery for some women. The materials were presented at the 31st Annual CTRCAACR San Antonio Breast Cancer Symposium.

“These results support a prepatent antitumor benefit of combining Zometa with chemotherapy in the neoadjuvant treatment of breast cancer,” said Matthew Winter, MBChB MSc, Clinical Research Fellow, University of Sheffield, UK, a comfort investigator of that subset analysis. “Adding Zometa to chemotherapy prior to surgery increased tumor shrinkage in that analysis. When breast cancer treatment is addicted prior to surgery, the goal is to reduce the size of the tumor and in doing so potentially improve breast conservation progressions and longerterm outcomes.”

In the analysis, pre and postmenopausal women who received Zometa in attachment to chemotherapy before surgery (neoadjuvant use) experienced a significant 33% reduction in the size of their primary tumor (14.1 mm reduction in tumor size) compared with patients who received chemotherapy alone (P=0.002)(1). The proportion of patients requiring mastectomy was higher (77.9%) in the chemotherapyalone group than in the Zometa group (65.3%).

“Clinical evidence continues to demonstrate that Zometa may play a role in protecting patients from the return and spread of earlystage breast cancer,” said David Epstein, President and CEO, Novartis Oncology. “We are encouraged by these latest results, which flash Zometa may favor some women elude mastectomies, and we hold over committed to further exploring the benefit of Zometa as an anticancer treatment.”

Zometa is the universes leading treatment to reduce or delay bone complications in patients with forward cancer that has spread to the bones crosswise a broad range of solid tumors, including breast cancer.

The undeveloped anticancer properties of Zometa were previously observed in premenopausal women with earlystage breast cancer from the Austrian Breast & Colorectal Cancer Study Group12 (ABCSG12) study, which was presented at the American Society of Clinical Oncology annual meeting (ASCO) earlier that year. Final results from the AZURE trial are expected in the next two to three years.

Novartis is further exploring the anticancer effect of Zometa in a broad clinical program in breast, lung and prostate cancers with the results expected up the next two to three years. Laboratory research has suggested that Zometa may hand protect patients with earlystage breast cancer from the return or spread of the cancer to other parts of the body (distant metastatic sites) through several incommensurable pathways, including inhibiting angiogenesis (formation of blood vessels that grow and fatten cancer cells), stimulating cancerfighting Tcells, inducing tumor cell apoptosis (programmed cell repose) and accretion the activity of anticancer agents that target tumor cell metastases(2).

Study details

AZURE is a randomized, openlabel, multicenter, parallel group trial with a fiveyear treatment phase and a subsequent fiveyear followup phase designed to determine whether Zometa, added to recognized therapy (chemotherapy and/or hormonal therapy) before (neoadjuvant) or after (adjuvant) surgery, is superior to each therapy alone in improving diseasefree survival in pre and postmenopausal women with earlystage breast cancer. The trial includes 3,360 patients from 174 centers in seven countries and is coordinated by the Cancer Research Centre, Weston Park Hospital, Sheffield, England with support from Novartis(1).

The neoadjuvant subset in the prevailing analysis included 205 participants who received either chemotherapy alone or in combination with Zometa once ever and anon three to four weeks for six months prior to breast cancer surgery. Following adjustment for other prognostic factors, the adjusted mean tumor size after treatment was 28.2 millimeters in the Zometa group and 42.4 millimeters in the chemotherapy group, a significant reduction of 33%(1). The pathologic complete response rate (no evidence of residual cancer in the breast or lymph nodes) increased to 10.9% in the Zometa group from 5.8% in the chemotherapy group (P=0.033). The proportion of women needing a mastectomy was reduced by 16% in patients taking Zometa (65.3% in the Zometa group versus 77.9% in the chemotherapyalone group)(1).

About Zometa

Zometa is indicated for patients with multiple myeloma and documented bone metastases from solid tumors in conjunction with garden variety antineoplastic therapy; prostate cancer should have progressed after treatment with at least one hormonal therapy.

weighty safety notice

Zometa is contraindicated in patients with hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of Zometa. Hypersensitivity reactions, including rare cases of urticaria and angioedema and very rare cases of anaphylactic reaction/shock, have oldchronology reported.

Due to the risk of clinically significant deterioration in renal affair, which may progress to renal bomb, unshared doses of Zometa should not exceed 4 mg, and the duration of infusion should be no beneath than 15 minutes. Risk factors for the deterioration of renal responsibility allow for impaired baseline renal task and multiple cycles of bisphosphonate treatment.

Zometa is not recommended in patients with bone metastases with severe renal impairment. In patients with mild to moderate renal impairment at baseline, lower doses of Zometa are recommended based on calculated creatinine clearance. Before each Zometa dose, serum creatinine should be measured and treatment should be withheld for renal deterioration until serum creatinine has returned to within 10% of the baseline value.

Zometa should not be used while pregnancy. Women of childbearing future should be advised to evade becoming pregnant. If the patient becomes pregnant while taking that drug, the patient should be apprised of the implied harm to the fetus.

Osteonecrosis of the jaw (ONJ) has oldera reported predominantly in cancer patients treated with intravenous bisphosphonates, including Zometa. bounteous of these patients were in sync with receiving chemotherapy and corticosteroids, which may be risk factors for ONJ. Postmarketing judgment and the literature suggest a greater oscillation of reports of ONJ based on tumor stripe (first breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, restricted trauma, including poorly fitting dentures). crowded reports of ONJ involved patients with signs of town infection, including osteomyelitis. Cancer patients should maintain super oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should shy invasive dental procedures, if hopeful. No dope are available as to whether discontinuation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures. A causal relationship among bisphosphonate use and ONJ has not out established. Clinical judgment of the treating physician should guide the management plan of each patient based on peculiar benefit/risk assessment.

In postmarketing proof, severe and occasionally incapacitating bone, joint and/or muscle pain has old hat reported infrequently in patients taking bisphosphonates.

The ultimate common adverse events (greater than or equal to 15%) in bone metastases clinical trials, regardless of causality, with Zometa 4 mg (n=1031) were as gos after bone pain (55%), nausea (46%), fatigue (39%), anemia (33%), pyrexia (32%), vomiting (32%), constipation (31%), dyspnea (27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough (22%), arthralgia (21%), lowerlimb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%) and paresthesia (15%).

Caution is advised when bisphosphonates are administered with aminoglycosides, loop diuretics and potentially nephrotoxic drugs.

Zometa contains the lookalike active ingredient as institute in Reclast(R) (zoledronic acid). Patients being treated with Zometa should not be treated with Reclast.

Patients should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Please see full Prescribing illumination.

Disclaimer

The foregoing release contains forwardappearing statements that can be identified by terminology such as “implied,” “potentially,” “may,” “encouraged,” “committed,” “exploring,” “expected,” “suggested,” “risk,” “should,” “suggest,” or similar expressions, or by express or implied discussions regarding implied new indications or labelling for Zometa or regarding believable future revenues from Zometa. You should not nail undue reliance on these statements. Such forwardappearing statements reflect the mod views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Zometa to be materially otherwise from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Zometa will be submitted or approved for any additional indications or labeling in any emporium. Nor can there be any guarantee that Zometa will achieve any particular levels of split in the future. In particular, managements expectations regarding Zometa could be affected by, among other thoughts, unexpected clinical trial results, including unexpected new clinical materials and unexpected additional analysis of existing clinical conclusions; unexpected regulatory alertnesses or delays or government regulation popularly; the aggregations ability to obtain or maintain patent or other proprietary intellectual freehold protection; competition in general; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Novartis Groups assets and liabilities as recorded in the Groups consolidated balance sheet, and other risks and factors referred to in Novartis AGs existent framework 20F on folder with the US Securities and interdependence Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the instruction in that press release as of that quarter and does not undertake any obligation to update any forwardappearing statements selfsufficient in that press release as a emanation of new dirt, future events or otherwise.

About Novartis Pharmaceuticals Corporation

Novartis Pharmaceuticals Corporation researches, develops, manufactures and generals store leading innovative prescription drugs used to treat a representation of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous setup, dermatological, GI and respiratory areas. The troops mission is to improve personss lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an branch of Novartis AG (NYSE NVS), which provides healthcare solutions that address the evolving requirements of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to foremost meet these requirements innovative medicines, costsaving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer state merchandises. Novartis is the only assemblage with leading positions in these areas. In 2007, the Groups continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1 billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in R&D activities around the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 97,000 fullcontinuance associates and operate in grooved 140 countries all completed the creation. For more clue, please see novartis.com.

For more data

Additional scholarship regarding Zometa and Novartis Oncology can be constitute on the websites novartisoncologyvpo.com/zometa, us.zometa.com and us.novartisoncology.com.

References

1. Winter, M.C., et al. The accession of Zoledronic Acid to Neoadjuvant Chemotherapy May Influence Pathological Response Exploratory Evidence for Direct Antitumor Activity in Breast Cancer. Presented at the 31 Annual Meeting of the CTRCAACR San Antonio Breast Cancer Symposium (SABCS), 1014 December 2008. Abstract No. 5101.

2. Gnant, M. et al. Efficacy of Zoledronic Acid in Premenopausal Women With Breast Cancer Receiving Adjuvant Endocrine Therapy The ABCSG12 trial. Presented at the 44th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Ill., 31 May 2 June, 2008. Abstract LBA4.

Novartis Pharmaceuticals Corporation
novartis.com

The pharmaceutical industry that week is expected to call voluntary restrictions on directtoconsumer drug blasting, the Wall Street Journal reports. The Pharmaceutical Research and Manufacturers Association will disclose restrictions that accommodate suggesting drugmakers contemplate implementing a minimum clock period before launching proclamation for newly approved drugs. According to the Journal, the new recommendations will update guidelines the sales group adopted in 2005, which were intended to ensure drug ads were accurate and provided balanced news regarding safety and effectiveness.

According to the Journal, the new restrictions come after scrutiny from the layout Energy and Commerce Committee, which had said that ads for the cholesterol drugs Vytorin, comarketed by Merck and ScheringPlough, and Lipitor, manufactured by Pfizer, and a Johnson & Johnson anemia drug were potentially misleading and deceptive.

The Journal reports that some companies responded to the congressional pressure by agreeing to some restrictions, such as a moratorium on ads within the first six months of a drugs launch. The Journal notes that “such concessions are viewed partly as a move to stave off potential new regulations on drug ads.” Jon Swallen, senior vice president of research at TNS Media Intelligence, said, “There arent crowded industries out there that yearning government involved in their occupation in a restrictive manner, not when it breeze ins to the puff and vending lump of the trade.”

Ad Spending Declining
The Journal reports that the drugmakers concessions come amid an overall decline in spending on ads. U.S. pharmaceutical ad spending declined by 6% to $3.2 billion in the first eight months of 2008, following a decline of 3% in 2007 to $5.3 billion, according to TNS.

TNS said lots of the decline resulted from secondary nonbranded buildup, such as corporate favoring messages and diseaseawareness ads. According to the Journal, other factors have contributed to the continuing spending money in the industrys squib spending, such as an swelling in the scrutiny of drug ads by Congress and a decline in the amount of new drugs approved in recent years. According to TNS, the decline in FDA approval led to a 7% decrease in ad spending on new qualitys in 2007. Spending on established varietys rose by 5%, TNS reported.

Meanwhile, the recession has resulted in some companies seeking a more targeted announcing approach to reduce costs, according to the Journal. In adjoining, some companies are seemingly waiting longer after drugs are approved to begin hard sell, the Journal reports (Loftus, Wall Street Journal, 12/10).

Reprinted with kind permission from kaisernetwork.org. You can view the entire Kaiser Daily pink design Report, search the archives, or proof up for subscription delivery at kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily haleness red tape Report is published for kaisernetwork.org, a free aid of The Henry J. Kaiser people Foundation.

&mimeograph; 2008 Advisory Board jungle and Kaiser generations Foundation. All rights restrained.

Alfacell Corporation (Nasdaq ACEL) announced that American Society of Hematology (ASH) annual meeting abstracts in Blood (2008 112 Abstract 4205 & 2008 112 Abstract 4010) report that ONCONASE (ranpirnase) and RAmphinase (RAmph) spectacle antitumor activity in chronic lymphocytic leukemia (CLL) and acute myeloblastic leukemia (AML) cells alone as well as in combination with canonical chemotherapeutic agents, expanding the spectrum of malignancies for which Alfacells proprietary ribonucleases expo promising activity.

The abstracts are the corollary of research conducted by collaborators at the parish of Hematology, Medical University of Lodz in Poland, Alfacell and the Brander Cancer Research Institute and parish of Pathology at New York Medical College. ONCONASE and RAmph are amphibian endoribonucleases with unrepeated mechanisms of inhibiting the growth and causing apoptosis (programmed cell parting) of malignant cells. Previously, ONCONASE has extinct shown to upset multiple cellular pathways involved in these mechanisms, and has dead validated in prevalent solid tumor cell lines, as well as a Tcell leukemia cell line. These reports now broaden ONCONASEs activity into CLL and AML, and count a joint endoribonuclease, RAmph.

For the study in CLL, leukemic cells were isolated from 36 untreated patients with CLL and were cultured for 2472 hours with either ONCONASE or RAmph alone and in combination with the purine analogues cladribine (2CdA) and fludarabine (FA), as well as with doxorubicin. A significant cytotoxic effect of ONCONASE and RAmph was evident after 48 and 72 hours of treatment, respectively. Synergistic activity was seen in the combination of the endonuclease plus either purine analogue. The combination of doxorubicin with ONCONASE or RAmph demonstrated an maximization in proapoptotic activity when compared to exceptional agent treatment, although the effect was not statistically significant. that is the first study showing cytotoxic, proapoptotic effects of ONCONASE and RAmph in CLL, and synergism with the big end widely used CLL therapies.

For the study in AML, leukemic cells isolated from 22 patients with newly diagnosed AML were cultured for 2472 hours with either ONCONASE or RAmph alone and in combination with doxorubicin or cytarabine arabinoside. In these experiments, both endoribonucleases showed significant activity against AML cells. The main innards of that power was shown to be the triggering of caspasedependent apoptosis by activation of the mitochondrial pathway. The combination of ONCONASE or RAmph with doxorubicin in AML exhibited significant synergistic cytotoxicity, and offers insights into the inherent therapeutic enhancement for doxorubicin, from a class of drugs commonly used as first line therapy in AML.

“These ex vivo studies expand the duck soup of ONCONASE as a inherent treatment for various leukemias,” said Kuslima Shogen, Alfacells chief executive officer. “Based on our knowledge of the impact of ONCONASE on cellular pathways involved in tumor cell growth, and further in resistance to chemotherapy, additional studies may further demonstrate ONCONASEs promising antileukemic activity.”

About AML

AML (acute myeloblastic leukemia) is a cancer of the myeloid line of white blood cells, characterized by the rapid proliferation of abnormal cells which accumulate in the bone marrow and interfere with the production of normal blood cells. AML is a potentially curable disease; but only a minority of patients are cured with in therapy. AML is treated initially with chemotherapy aimed at inducing a remission; some patients may go on to receive a hematopoietic stem cell transplant. Although cure progressions have superannuated reported to be 2045%, that is conjecturable to be lots lower for elderly patients and those who cannot tolerate aggressive therapy.

About CLL

CLL(chronic lymphocytic leukemia) is a cancer of the lymphocytic line of white blood cells. CLL affects a particular lymphocyte, the B cell, which originates in the bone marrow, develops in the lymph nodes, and normally fights infection. In CLL, the DNA of a B cell is damaged, so that it cant fight infection, but it grows out of authority and crowds out the healthy blood cells that can fight infection. While typically considered incurable, CLL progresses slowly in largest cases. Determining when to start treatment and by what means is regularly difficult. In attachment, several drugs are used to treat CLL, however Fludarabine is the utmost extensively studied and is currently the lions share commonly used firstline therapy in that disease.

About ONCONASE(R)

ONCONASE is a firstinclass therapeutic product candidate based on Alfacells proprietary ribonuclease (RNase) technology. A congenital protein isolated from the leopard frog, ONCONASE has extinct shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the usual extermination of cells, via multiple molecular mechanisms of energy.

Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc. Strategic negotiating and distribution agreements for ONCONASE have outofstyle secured with Megapharm Ltd. for Israel, BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an branch of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe.

ONCONASE has back decimal granted fast track status and orphandrug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has superseded granted orphandrug designation in the European Union and Australia.

About Alfacell Corporation

Alfacell Corporation is the first band to advance a biopharmaceutical product candidate that works in a manner similar to RNA interference (RNAi) through hung upstage clinical trials. The product candidate, ONCONASE, is an RNase that overcomes the challenges of targeting RNA for therapeutic whyfors while enabling the development of a new class of targeted therapies for cancer and other lifethreatening diseases. For more scoop, see alfacell.com.

Safe Harbor

that press release includes statements that may constitute “forwardappearing” statements, commonly containing the words “believe,” “estimate,” “project,” “foresee” or similar expressions. Forwardappearing statements involve risks and uncertainties that could cause actual results to differ materially from the forwardseeing statements. Factors that would cause or contribute to such differences consist of, but are not limited to, uncertainty whether the clinical trial results will allow the band to complete submission of a New Drug Application and if a New Drug Application submission is completed, uncertainty whether FDA will canon or lump it such application, uncertainties involved in transitioning from concept to product, uncertainties involving the ability of the congregation to finance research and development activities, abeyant challenges to or violations of patents, uncertainties regarding the outcome of clinical trials or differences of opinion in interpreting the results of clinical trials, the mobs ability to secure necessary approvals from regulatory agencies, dependence upon thirdparty vendors, and other risks discussed in the communitys periodic filings with the Securities and supplantment Commission. By making these forwardappearing statements, the group undertakes no obligation to update these statements for revisions or changes after the quarter of that release.

Alfacell Corporation
alfacell.com

In an examination of unintentional overdose deaths in the state of West Virginia, a bulk of these have unusable begin to be associated with the nonmedical use and diversion of prescription drugs, eminently pain relievers, according to an scoop released on December 9, 2008 in JAMA.

In the management of chronic pain, guidelines were introduced in 1997 encouraging the expanded use of opioid pain relievers, pending stringent patient evaluation and full counseling, if other treatments are inadequate. Since before faraway, the retail purchases of dependable such analgesics, including methadone, hydrocodone, and oxycodone, increased enormously, according to the paper. that was accompanied by a parallel inflation in emergency office visits and deaths attributed to opioid pain reliever overdoses. According to the piece, West Virginia has suffered one of the highestincreases in these types of deaths in the United States, having a 550% upsurge in euthanasia from unintentional poisoning medially 1999 and 2004.

To investigate the association at intervals these deaths and use of prescription opioids, Aron J. Hall, D.V.M., M.S.P.H., of the Centers for Disease drivers seat and Prevention, Atlanta, and colleagues, examined risk characteristics associated with patients dying of unintentional pharmaceutical overdose in West Virginia in 2006. input was collected from medical examiners, prescription drug monitoring program, and opiate treatment program records. All state residents who died of unintentional pharmaceutical overdoses in West Virginia that year.

Of the 295 who died, 67.1% (198) were men, and 91.9% (271) were mid the ages of 18 and 54. Of the deceased, 63.1% had used pharmaceuticals which contributed to euthanasia outwardly documented prescriptions, and 21.4% had received prescriptions from five or more clinicians in the previous year. Women were more anticipated to have “shopped” for multiple clinicians than men, with 30.9% of them performing that act while only 16.7% of men did. Meanwhile, use of the drugs after documented prescriptions was more common for those two died mid 18 and 24 years of age. Of the total population, 94.6% had at least one indicator of substance abuse.

Deaths incident to illegal prescription use were routinely associated with a history of substance abuse, nonmedical pharmaceutical administration, and illicit drugs. Deaths with prescriptions from multiple doctors were more rational to have had previous overdoses, and diminished credible to have alcohol contributing to un.

Of the total, 79.3% (234) of deaths were linked to multiple contributory substances. The utmost prevalent class of drugs was the opioid analgesics, contributing to 93.2% of deaths, and of these, 44.4% showed evidence of prescription documentation. Methadone was the lions share commonly identified drug, and it was involved in 40% of all of the deaths. Fewer of the deceased had prescriptions for methadone than for other drugs such as hydrocodone or oxycodone.

The authors note the of substance role of doctors themselves in the use of prescription opioids. “Clinicians have a critical role to play in preventing the diversion of prescription drugs. Clinicians and pharmacists be externally to counsel patients who are prescribed opioids not only about the risk of overdose to themselves but likewise about the risk to others with whom they might share their medication. In accession, clinicians should follow recent published guidelines for the management of chronic pain and refer patients as needed to pain management specialists. Clinicians should and dash off use of state prescription drug monitoring programs to determine whether their patients are getting scheduled drugs from other clinicians. Clinicians can now obtain such scoop about their patients from prescription drug monitoring programs in largest states,” they write.

A. Thomas McLellan, Ph.D., of the Treatment Research Institute, and Barbara Turner, M.D., Ms.Ed., of the University of Pennsylvania School of Medicine, Philadelphia, contributed an accompanying editorial in which they state several steps physicians should take to remedy reduce the likelihood of inappropriate prescription opioid use.

“When deciding whether to prescribe an opioid, physicians should ask patients about their prior and accepted histories of alcohol and other drug use. Patients with histories of substance use, mental wellbeing predicaments, or both should receive special heed and comanagement from pain management specialists when expedient. Treatment of mental prime disorders should be considered scrap of rewarding pain management.”

“Physicians as well should scrutinize an opioid treatment agreement (contract) with the patient stipulating the pulsation of obtaining medications, timely refills but no early replacements for lost prescriptions, safe storage, no sharing, unrivaledsource prescribing, monitoring through urine screens, and adherence to monitoring visits. The agreement should be presented as a way of simultaneously protecting the patient from adverse events and promoting a collaborative, responsible relationship,” they write. 

Patterns of Abuse Among Unintentional Pharmaceutical Overdose Fatalities
Aron J. Hall, DVM, MSPH; Joseph E. Logan, PhD; Robin L. Toblin, PhD, MPH; James A. Kaplan, MD; James C. Kraner, PhD; Danae Bixler, MD, MPH; Alex E. Crosby, MD, MPH; Leonard J. Paulozzi, MD, MPH
JAMA. 2008;300(22)26132620.
surf Here For Abstract

Prescription Opioids, Overdose Deaths, and Physician Responsibility
A. Thomas McLellan, PhD; Barbara Turner, MD, MsEd
JAMA. 2008;300(22)26722673.
have a look at Here For Abstract

Drug Safety Alliance (DSA) a global leader in pharmaceutical safety and pharmacovigilance offered details at the recent Seventh Annual intercontinental prospects Conference in San Francisco, CA on how a welldesigned signal management program and chosen tools can support pharmaceutical companies with early detection of new safety scoop.

In her session, “Pragmatic Solutions and dispositions for Proactive Signal Detection” DSAs Chief Safety Officer, Elizabeth Garrard, PharmD, RPh, offered insight into how early detection of pushover associations bounded by an adverse event and a drug can sustenance companies recognize and mitigate product risk sooner. Dr. Garrard shared realapple experiences from clients utilizing DSAs enhanced proactive signal detection services while her address to approximately 50 drug safety professionals.

“Were seeing a push within the pharmaceutical industry to become more knowledgeable about viable adverse effects earlier in the drug development process,” Dr. Garrard said. According to Dr. Garrard, that is due in piece to patient and consumer pressure on the industry and regulatory agencies to realize the positive financial and public pink impacts of proactive pharmacovigilance such as signal detection.

Drug Safety Alliance utilizes Empirica Signal by Phase Forward as scrap of its overall traditional and automated signal detection services to succor drug developers detect risk earlier and react faster in deploying effective mitigation strategies. Empirica Signal is a experiments mining and knowledge management machine providing detection and quantification of safety signals for safety professionals. Drug Safety Alliance of late announced major hardware and software upgrades to support the implementation of database mining, collection and reporting software such as Empirica Signal.

“We are improving our IT infrastructure, software, and processes to ensure that drug developers of any size who have safety concerns can have access to a comprehensive signal management program that includes stateoftheart reports mining and risk management tools,” Cathy Stokes, CEO of Drug Safety Alliance said. “In inclusion to our strong IT bureau, DSA employs highly skilled program managers that carefully use these tools. DSA program managers have an average of five years participation in the pharmaceutical industry, which is a lot in a relatively new industry equal pharmacovigilance. At Drug Safety Alliance, our ultimate goal to aid drug developers ensure regulatory compliance and better serve the public pink.”

Drug Safety Alliances risk management strategy complies with uptodate regulation and guidance and is customizable to conform to client hanker, with services including signal detection; trend analysis; Risk Management Plan and Pharmacovigilance Plan development; Product label review; and development of Risk communication materials.

About Drug Safety Alliance

Founded in 2000, Drug Safety Alliance (DSA) provides pharmacovigilance expertise to hefty and pitiful pharmaceutical and biotechnology companies to balm them grow up safe drugs and improve patient safety. DSAs mission is to partner with clients to mitigate their drug safety risks and to maximize product longevity and value. Driven by the highest ethical standards, DSA is uniquely focused to provide formidablequality pre and postsquare drug safety services including domestic and ecumenical regulatory compliance, safety database support and mastering options, risk management and adverse event case management. DSA is headquartered in the Research Triangle Park region