Staying Healthy

Cell Therapeutics, Inc. (“CTI”) (Nasdaq and MTA: CTIC) announced that CTI’s Marketing Authorization Application (“MAA”) seeking approval for Pixuvri™ (pixantrone dimaleate) for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”) was validated and accepted for review by the European Medicines Agency (“EMA”). Validation indicates that the application is complete and that the EMA’s review process has begun.

“We look forward to working with our rapporteurs and the EMA during their review process in an effort to bring pixantrone to patients for whom there are currently no available drugs in this setting,” said James A. Bianco, M.D., CEO of CTI.

The EMA’s review of the MAA will follow the centralized marketing authorization procedure and, if the MAA is approved, Pixuvri expects to receive marketing authorization in the E.U. member states.

The Company also plans, in 2011, to submit a marketing application in selected other countries beginning with Switzerland.

Pixantrone was initially granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma (DLBCL), but based on the expansion of the current MAA to the broader aggressive NHL population, CTI has agreed to withdraw the orphan designation from the E.U. register.

About Pixantrone

Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines–rather than intercalation with DNA–pixantrone alkylates DNA–forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. We believe that these structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, we believe the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide production–both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI’s securities. 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 and/or less toxic and effective for the treatment of relapsed or refractory, aggressive NHL and/or other tumors as determined by the EMA, that the EMA may not approve CTI’s MAA after review, that Pixuvri may not prove effective as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL, that CTI may not submit a marketing application in selected other countries in 2011, and CTI’s 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 CTI’s filings with the Securities and Exchange Commission including, without limitation, CTI’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Source: Cell Therapeutics, Inc

Sihuan Pharmaceutical Holdings Group Ltd. (HKEx: 0460), a leading pharmaceutical company with the largest cardio-cerebral vascular drug franchise in China by market share, today announced that its wholly-owned subsidiary Hainan Sihuan Pharmaceutical Co., Ltd. has entered a distributorship agreement with Benxi Leilong Pharmaceutical Co., Ltd. with regard to Alprostadil Injection, one of the best-selling cardio-cerebral vascular drugs in China.

According to the agreement, the Company will have exclusive distribution rights for the drug for 30 years from 16 November, 2010 in Sihuan Pharmaceutical’s distribution network of close to 10,000 hospitals in China. Benxi Leilong will sell the drug to the Company at a fixed wholesale price. Alprostadil Injection by Benxi Leilong is a leading intravenous injectable lipid emulsion for treatment of peripheral vascular diseases, cardio-cerebral microcirculation disorders and post-surgery thrombosis, which has better function and is more competitive than the traditional alprostadil products. According to MENET’s data, currently the general alprostadil drugs rank as one of the best selling prescriptions for cardio-vascular disease in China; while the total sales of general alprostadil products were approximately RMB700 million in 2007 in China, according to Biao Dian Medical Data Company Limited (PICO).

Dr. Che Fengsheng, Chairman and CEO of the Company, said, “We believe that the obtaining of the distribution rights of Alprostadil Injection will further expand our existing product portfolio. It will also enable us to consolidate our strong market position and brand reputation. With the capability to effectively market and distribute the drug through our unique nationwide network, Sihuan Pharmaceutical should be able to generate a stable and substantial revenue stream from this distribution agreement.”

Source: Sihuan Pharmaceutical Holdings Group Ltd

1. Infiltrating Microglia and Neuropathic Pain

Ji Zhang, Xiang Qun Shi, Stefania Echeverry, Jeffrey S. Mogil, Yves De Koninck, and Serge Rivest

Microglia are everywhere these days. This week, it’s neuropathic pain and the spinal cord. Zhang et al. report that resident CNS microglia, as well as those derived from hematogenous macrophages/monocytes that infiltrate the spinal cord, participate in neuropathic pain. The authors tested mice after a partial ligation injury of the sciatic nerve. The authors tracked the two microglia populations using chimeric mice in which bone marrow stem cells expressing green fluorescent protein were transplanted into irradiated mice. The microglial signaling pathway involved chemokine monocyte chemoattractant protein 1 (MCP-1; also called CCL2) and its receptor, CCR2. MCP-1 is not normally present in the nervous system, but it is induced by injury. The authors report that intrathecal injection of MCP-1 activated microglia in the spinal cord, whereas a neutralizing antibody prevented the injury-induced infiltration of bone marrow-derived microglia. Microglia were not activated in mice lacking CCR2, and these mice did not show mechanical allodynia.

2. Spine Shrinkage Does Not Equal LTD

Xiao-bin Wang, Yunlei Yang, and Qiang Zhou

The functional significance of morphological changes that accompany synaptic plasticity has long been debated. Remember “twitching” spines” This week, Wang et al. revisited this issue by examining dendritic spine size after long-term potentiation (LTP) and long-term depression (LTD). Using electrophysiological recordings and simultaneous two-photon time-lapse imaging in rat hippocampal slices, the authors report that spine remodeling and synaptic plasticity are not indelibly linked and can occur independently. Low-frequency stimulation induced LTD and reduced the diameter of dendritic spines. However, a peptide that competes with the endogenous phosphatase substrate p-cofilin inhibited spine shrinkage but did not affect the expression of LTD. Conversely, block of LTD did not prevent spine shrinkage. Pharmacological block of exocytosis prevented the constitutive replacement of internalized AMPA receptors. As a result, synaptic responses were reduced, but spine size was unchanged. Actin remodeling, however, was required for LTD.

3. Mapping Vibrissal Pathways in Thalamic Barreloids

Nadia Urbain and Martin DeschГЄnes

What can pass through the head of a barreloid” According to Urbain et al., the answer is a newly discovered pathway for ascending information in the rat vibrissal system. The low-threshold mechanoreceptors on the array of vibrissa on the rodent snout respond only to a single whisker. The afferent fibers from these mechanoreceptors then maintain the array arrangement in sets of cells in the brainstem (barrelettes), thalamus (barreloids), and, of course, in somatosensory cortex (barrels). The authors used extra-cellular recording to sample whisker-sensitive cells in the thalamus. Cells in the head of barreloids received input from the principal trigeminal nucleus and were sensitive to multiple whiskers. These thalamic cells also received corticothalamic input from the vibrissa motor cortex. The new pathway is thus in position to get those five rows of whiskers in synch during whisking.

4. Parkin Rescue of PINK1 Deficiency

Nicole Exner, Bettina Treske, Dominik Paquet, Kira Holmström, Carola Schiesling, Suzana Gispert, Iria Carballo-Carbajal, Daniela Berg, Thomas Gasser, Rejko Krüger, Konstanze F. Winklhofer, Frank Vogel, Andreas S. Reichert, Georg Auburger, Philipp J. Kahle, Bettina Schmid, and Christian Haass

Although most Parkinson’ disease (PD) cases are sporadic, the genes involved in the rare familial cases continue to be instructive. Exner et al. focused on PD-related mitochondrial abnormalities. Mutations in phosphatase and tensin homolog (PTEN)-induced kinase 1 (PINK1) have been linked to juvenile parkinsonism, but the substrates for this kinase remain unknown. PINK1 does contain a mitochondrial targeting sequence, providing a putative link to PD. The authors report that RNAi knockdown of PINK1 in human cell lines resulted in fragmented mitochondria with reduced membrane potential. Low glucose reversibly worsened the condition. Two PINK1 mutations, Q126P and G309D, did not rescue the phenotype. However, expression of wild-type but not mutant parkin did overcome the mitochondrial morphological changes. Cultured primary fibroblasts from patients with the two PINK1 mutations also contained fragmented mitochondria. The authors suggest that parkin may act as a stress-protection mechanism in the face of a PINK1 deficiency.

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Source: Sara Harris
Society for Neuroscience

Alkermes, Inc. (NASDAQ: ALKS) today announced the presentation of promising preclinical results for its proprietary opioid modulator, ALKS 33, showing the drug candidate’s potential in multiple disease indications. The data demonstrated ALKS 33 was effective in preventing olanzapine-associated weight gain and could potentially offer an adjunct therapy to patients with weight gain related to antipsychotic drug regimens. An additional data presentation showed that ALKS 33, regardless of the route of administration, effectively blocked elevations in nucleus accumbens dopamine following cocaine and amphetamine administration. A third presentation on ALKS 33 described the relationship between binge eating and reward disorders and the clinical rationale and endpoints of the ongoing clinical trial of ALKS 33 for the treatment of binge eating disorder. The data were presented at the 40th Annual Meeting of the Society for Neuroscience in San Diego.

“We are excited to present data on ALKS 33, which demonstrate this drug candidate’s broad utility,” stated Elliot Ehrich, M.D., Chief Medical Officer of Alkermes. “ALKS 33, which is moving forward in clinical trials in three disease indications, exemplifies Alkermes’ strategy to advance its pipeline of next-generation therapeutics to address diseases in major markets, including central nervous system disorders and brain reward disorders, such as addiction, obesity and other impulse-control disorders.”

Presentations given at the symposium include:

– A preclinical study evaluated the effects of ALKS 33 co-administered with olanzapine on olanzapine-induced weight gain in rodents. Results showed that ALKS 33 was effective in preventing olanzapine-induced weight gain while not inhibiting olanzapine’s antipsychotic activity. Olanzapine, also known as ZYPREXA®, is one of the most commonly prescribed antipsychotic medications, but it is also associated with clinically significant weight gain.

– A second preclinical study evaluated the efficacy of ALKS 33 on attenuating cocaine- and amphetamine-induced elevations of dopamine in the nucleus accumbens, a key region in the brain’s reward pathway, and showed that both oral and subcutaneous administration of ALKS 33 were effective.

– A third presentation outlined the clinical rationale and endpoints of ALKS 33 for the treatment of binge eating disorder and detailed the design of the ongoing phase 2 proof-of-concept clinical study of ALKS 33 in 60 patients with binge eating disorder. Results from the phase 2 study are expected in the first half of calendar year 2011.

About ALKS 33

ALKS 33 is an oral opioid modulator that builds on Alkermes’ scientific expertise in opioid biology and pharmacology, as well as the company’s clinical and commercial knowledge in the field of addiction. Data from previous studies of ALKS 33 showed that it is generally well tolerated and successfully blocked the effects of an opioid, with a duration of action that supports once daily dosing. Previous findings have also shown that ALKS 33 has limited or no metabolism by the liver, which differs from existing oral therapies for addiction. ALKS 33 is currently in development for the treatment of alcohol dependence, binge eating disorder and as a combination therapy with buprenorphine for the treatment of cocaine addiction.

Note Regarding Forward-Looking Statements

Certain statements set forth above may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential therapeutic value of ALKS 33 and Alkermes’ plans to continue development of ALKS 33. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and the company’s business is subject to significant risk and uncertainties, and there can be no assurance that its actual results will not differ materially from its expectations. These risks and uncertainties include, among others: whether results of early stage clinical trials will be predictive of later stage clinical trial results; the outcome of clinical and preclinical work the company is pursuing; decisions by the FDA or foreign regulatory authorities regarding the company’s products; potential changes in cost, scope and duration of clinical trials. For further information with respect to factors that could cause the company’s actual results to differ materially from expectations, reference is made to the reports the company filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as amended. The forward-looking statements made in this release are made only as of the date hereof and the company disclaims any intention or responsibility for updating predictions or financial expectations contained in this release.

VIVITROL® is a trademark of Alkermes, Inc.; RISPERDAL® CONSTA® is a trademark of Janssen-Cilag group of companies. ZYPREXA® is a trademark of Eli Lilly and Company.

Source: Alkermes

View drug information on Risperdal Oral Formulation; Vivitrol; Zyprexa.

Amgen Inc. (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved XGEVA(TM) (denosumab), the first and only RANK Ligand inhibitorfor the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. XGEVA was approved following a 6 month priority review by the FDA, a designation reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists. XGEVA is not indicated for the prevention of SREs in patients with multiple myeloma.

“Today’s approval of XGEVA illustrates what is possible when scientific innovation, commitment and investment come together to advance medicine,” said Kevin Sharer, chairman and chief executive officer of Amgen. “A diagnosis of bone metastases is a major event for patients living with cancer, and the consequences can be devastating. We are pleased to offer this new advance to patients and their healthcare providers.”

Bone metastases, the spread of cancer to the bones, are a serious concern for patients with advanced cancer and present a considerable burden to the healthcare system. Weakened bones due to metastases can lead to fractures and compression of the spinal cord and necessitate procedures like major surgery and radiation, designed to prevent or manage bone complications. The primary goal of treatment for bone metastases is to prevent the occurrence of debilitating and costly bone complications, which can disrupt a patient’s life and cause disability, pain and hospitalization.

“As many as 3 out of 4 patients with advanced prostate, lung, and breast cancer will experience spread to their bones. Despite the availability of current treatments, a significant proportion of these patients still experience bone complications or are not candidates for existing treatment,” said David H. Henry, M.D., clinical professor of medicine, and vice chair, Department of Medicine, Pennsylvania Hospital, University of Pennsylvania Healthcare System. “Based on the compelling science and robust clinical evidence seen with XGEVA, I expect this new option to quickly become a mainstay of cancer care and to play an important role in reducing the incidence of debilitating bone complications in patients with advanced cancer.”

The RANK Ligand pathway, first discovered by Amgen scientists in the mid-1990s, is believed to play a central role in cancer-induced bone destruction, regardless of cancer type. XGEVA is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone). XGEVA prevents RANK Ligand fromactivating its receptor, RANK on the surface of osteoclasts, thereby decreasing bone destruction.

XGEVA Clinical Trial Experience

The FDA approval of XGEVA is based on the results of three pivotal, Phase 3 head-to-head trials that evaluated XGEVA delivered every four weeks as a 120 mg subcutaneous injection versus Zometa(R) (zoledronic acid) delivered every four weeks via a 15-minute intravenous infusion, adjusted for kidney function per the labeled instructions. The clinical program for XGEVA spanned more than 50 tumor types in over 5,700 patients. In the Phase 3 trials, XGEVA demonstrated a clinically meaningful improvement in preventing SREs compared to Zometa. Specifically, in patients with breast or prostate cancer and bone metastases, XGEVA was superior to Zometa in reducing the risk of SREs. In patients with bone metastasis due to other solid tumors or bone lesions due to multiple myeloma, XGEVA was noninferior (trending towards superiority) to Zometa in reducing the risk of SREs. Superiority was also seen in the integrated analysis of the Phase 3 studies.

Overall rates of adverse events and serious adverse events were generally similar between XGEVA and Zometa. Osteonecrosis of the jaw (ONJ) was infrequent, with no statistically significant difference between treatment arms. Hypocalcemia was more frequent in the XGEVA arm. Overall survival and progression-free survival were similar between arms in all three trials.

“As many as 70 percent of patients with prostate cancer that have metastasized to the bone are not currently receiving therapy to prevent complications from these bone metastases. This may be secondary to urologists lacking comfort or facilities to provide infusion treatment,” said Neal D. Shore, M.D., FACS, medical director, Carolina Urologic Research Center. “XGEVA could provide increased treatment care options and accessibility for urologist’s who treat advanced prostate cancer; as XGEVA is administered as a subcutaneous injection on a monthly basis. Also, XGEVA does not require dose adjustment for changes in renal function.”

ECONOMIC IMPACT OF SREs

The total economic burden of patients with bone metastases in the U.S. alone estimated to be $12.6 billion annually.(i) Patients who experience an SRE as a result of bone metastases incur significantly higher medical costs compared with those who do not experience such events. (ii, iii, iv) In addition, once patients experience an SRE, the risk of a subsequent SRE is increased. The costs of SREs vary by type and severity, ranging from relatively low costs for minor fractures to high cost events like spinal cord compression associated with hospitalization. Studies have shown that the costs of treating SREs are a significant cost burden.

XGEVA is an innovative therapy that significantly reduces debilitating and costly SREs. This can result in cost offsets due to the reduced incidence of SREs and related medical costs. XGEVA will cost $1,650 monthly based on wholesale acquisition cost.

XGEVA FIRST STEP(TM) COUPON PROGRAM

Amgen is committed to supporting patient access to important medicines through innovative programs including our newly established commercial co-pay program for XGEVA, financial support to independent third party co-pay foundations, and the Safety Net Foundation, which provides free products to uninsured patients who qualify. The XGEVA FIRST STEP(TM) Coupon Program is a landmark program among oncology commercial co-pay programs, as it is the first program under the medical benefit with no income eligibility requirement. The program is intended to provide assistance to eligible patients who need help meeting their deductible, co-insurance, and/or co-payment requirements under the medical benefit for XGEVA. Under this program, eligible patients will incur no out of pocket costs for their initial XGEVA injection and pay a maximum of $25 for subsequent injections.

XGEVA Regulatory Status

Amgen has also submitted marketing applications for XGEVA in the European Union, Australia, Canada and Switzerland. In Japan, Amgen is working with its licensing partner, Daiichi-Sankyo Company, Limited and a marketing application was submitted in August.

XGEVA Important Safety Information

XGEVA can cause severe hypocalcemia. Correct pre-existing hypocalcemia prior to XGEVA treatment. Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary. Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

Osteonecrosis of the jaw can occur in patients receiving XGEVA. Patients who are suspected of having or who develop ONJ while on XGEVA should receive care by a dentist or an oral surgeon. In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.

The most common adverse reactions in patients receiving XGEVA were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction in patients receiving XGEVA was dyspnea. The most common adverse reactions resulting in discontinuation of XGEVA were osteonecrosis and hypocalcemia.

Denosumab is also marketed as Prolia(TM) in other indications.

Bone Metastases and SREs: Prevalence and Impact

Bone metastases occur in more than 1.5 million patients with cancer worldwide and are most commonly associated with cancers of the prostate, lung, and breast, with incidence rates as high as 75 percent of patients with metastatic disease.(v)

Approximately 50-70 percent of cancer patients with bone metastases will experience debilitating SREs.(vi, vii, viii) Events considered to be SREs include fractures, spinal cord compression, and severe bone pain that may require surgery or radiation.(ix) Such events can profoundly disrupt a patient’s life and can cause disability and pain.(x, xi, xii)

Denosumab and Amgen’s Research in Bone Biology

The denosumab development program demonstrates Amgen’s commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-related bone diseases. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials. In addition to this newly approved indication, XGEVA is also being investigated for its potential to delay bone metastases in prostate and breast cancer.

About Amgen

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science’s promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people’s lives.

Forward-Looking Statements

This news release contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Nov.18, 2010 and expressly disclaims any duty to update information contained in this news release.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.

In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others’ regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.

References

(i) Schulman KL, Kohles J. Economic burden of metastic bone disease in the U.S. American Cancer Society 2007:2334-2342.

(ii) Delea T, Langer C, McKiernan J, et al. The cost of treatment of skeletal-related events in patients with bone metastases from lung cancer. Oncology 2004;67:390-396.

(iii) Schulman KL, Kohles J. Economic burden of metastic bone disease in the U.S. American Cancer Society 2007:2334-2342.

(iv) GVD/2007:2334-2342.Barber ISPOR 2008 Poster

(v) Coleman RE. Skeletal complications of malignancy. Cancer. 1997; 80(suppl): 1588-1594.

(vi) Lipton A, Theriault RL, Hortobagyi GN. Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases. Cancer 2000;88:1082-1090.

(vii) Saad F, Lipton A, Cook R, Chen YM, Smith M, Coleman R. Pathologic fractures correlated with reduced survival in patients with malignant bone disease. Cancer. 2007;110:1860-1867.

(viii) Rosen LS, Gordon D, Tchekmedyian NS, et al. Nonsmall cell lung carcinoma and other solid tumors. Cancer. 2004;100:2613-2621.

(ix) Costa L, Badia X, Chow E, Lipton A, Wardley A. Impact of skeletal complications on patients’ quality of life, mobility, and functional independence. Support Care Cancer. 2008; 16: 879-889.

(x) Norgaard M, Jensen AO, Jacobsen JB, Cetin K, Fryzek JP, Sorensen HT. Skeletal related events, bone metastasis and survival of prostate cancer: a population based cohort study in Denmark (1999 to 2007).J Urol 2010; 184:162-167.

(xi) Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int 2006;17:1726-1733.

(xii) Saad F, Gleason DM, Murray R, et al. A Randomized, Placebo-Controlled Trial of Zoledronic Acid in Patients With Hormone-Refractory MetastaticProstate Carcinoma. Journal Ntl Cancer Inst 2002;19:1458-1468.

Source: Amgen

View drug information on Xgeva; Zometa.

Bayer today announced the results from the pivotal, double-blind Phase III, ROCKET AF trial. In the study, rivaroxaban demonstrated superiority to warfarin in reducing the risk of stroke and non-CNS systemic embolism in patients with atrial fibrillation (AF). Importantly, rates of bleeding were similar to warfarin, and bleeding events most concerning to physicians and patients, including intracranial hemorrhage, critical organ bleed, and bleeding-related death, were significantly lower in the rivaroxaban group. The results were presented today as a late-breaker at the American Heart Association Scientific Sessions 2010 in Chicago, USA.

“Atrial fibrillation and stroke devastate the lives of millions of patients and their families worldwide every year. Anticoagulation with warfarin is effective in preventing strokes in patients with atrial fibrillation and has been the standard of care for more than half a century. However, its use in clinical practice is associated with many limitations”, said Professor Werner Hacke, Chair of the Department of Neurology at the University of Heidelberg, Germany, and member of the ROCKET AF Executive Steering Committee. “The ROCKET AF study has shown that once-daily rivaroxaban promises patients improved protection from stroke, with good safety and added convenience.”

With 14,264 patients randomized, ROCKET AF is the largest double-blind study undertaken in the prevention of stroke in patients with AF, comparing once-daily rivaroxaban to dose-adjusted warfarin. For the primary efficacy endpoint, rivaroxaban was superior to warfarin, delivering a 21% relative risk reduction in stroke and non-CNS systemic embolism in the pre-specified on treatment population (1.70% vs. 2.15%, p=0.015). Additionally, in the intent to treat (ITT) population which followed all patients randomised in the trial until its completion, whether or not they completed the full course of therapy or switched to other options, rivaroxaban showed comparable benefits to warfarin (2.12% vs. 2.42%, p

The improved protection of patients provided by rivaroxaban in ROCKET AF was not associated with an increase in bleeding. On the principal safety measure of major and non-major clinically relevant bleeding events, rivaroxaban was similar compared with warfarin (14.91% vs. 14.52%, p=0.442). Rates of major bleeding were also comparable between rivaroxaban and warfarin (3.60% vs. 3.45%, p=0.576). Importantly, patients treated with rivaroxaban had fewer intracranial hemorrhages (0.49% vs. 0.74%, p=0.019), fewer critical organ bleeds (0.82% vs. 1.18%, p=0.007) and lower bleeding-related deaths (0.24% vs. 0.48%, p=0.003) than those on warfarin. Rates of hemoglobin drop (2.77% vs. 2.26%, p=0.019) and transfusion requirements (1.65% vs. 1.32%, p=0.044) were increased when compared to patients who received warfarin.

The frequency of abnormal laboratory values of liver function was balanced between the treatment groups and there was no signal for serious liver damage attributable to rivaroxaban observed in the trial.

Rivaroxaban was well tolerated in the study, and rates of discontinuation due to adverse events were similar to those seen for patients on warfarin. Rivaroxaban, administered once daily, without the need for routine laboratory coagulation monitoring delivered improved protection, simplified dosing and good tolerability.

“Given the prevalence and morbidity associated with atrial fibrillation, and the well-known difficulties with warfarin use, it is exciting to have an alternative which was documented in this study to be effective with no increase in significant bleeding,” said Robert M. Califf, M.D., study co-chairman and Vice Chancellor for Clinical Research from Duke University.

ROCKET AF is the seventh consecutive Phase III trial in the ongoing rivaroxaban global development program that has demonstrated either superiority (RECORD1, 2, 3, 4, EINSTEIN-EXTENSION and ROCKET AF), or non-inferiority (EINSTEIN-DVT). The RECORD trial program compared rivaroxaban to enoxaparin in the prevention of venous thromboembolism in more than 12,500 patients undergoing elective hip or knee replacement surgery. The multinational Phase III EINSTEIN-DVT study investigated a new single-drug approach with rivaroxaban compared with initial enoxaparin treatment, followed by a vitamin K antagonist in a randomized, open-label non-inferiority study involving more than 3,400 patients with acute symptomatic DVT, but without any symptoms of PE. EINSTEIN-Extension evaluated the efficacy and safety of rivaroxaban compared to placebo in the secondary prevention of recurrent symptomatic venous blood clots, by extending preventative treatment by 6 or 12 months beyond a previously completed regimen of 6 or 12 months of therapy, and enrolled approximately 1,200 patients with symptomatic DVT or PE.

About Atrial Fibrillation

AF is the most common sustained cardiac rhythm disorder and affects more than 2.3 million people in the U.S. and up to 6 million people in Europe. In patients with AF, the irregular heartbeat makes them vulnerable to the formation of a blood clot in the atria, which can travel to the brain, potentially resulting in a stroke. Strokes cause damage to the brain, and can lead to physical and behavioral impairment, or even death. People with AF are at a five-fold increased risk for stroke compared with the general population about one-third of them will suffer from a stroke.

About ROCKET AF

ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) was a prospective, randomized, double-blind, double-dummy parallel group outcomes study comparing once-daily rivaroxaban (20 mg, or 15 mg for patients with moderate renal impairment) with dose-adjusted warfarin in 14,264 patients with non-valvular atrial fibrillation who were at risk for stroke or non-CNS systemic embolism.

This was an event-driven trial, which ended when the pre-specified number of efficacy events was accumulated. The primary objective of ROCKET AF was to demonstrate the efficacy of once-daily rivaroxaban as non-inferior to well controlled warfarin in the prevention of stroke and non-CNS systemic embolism in patients with non-valvular AF. The principal safety measure of ROCKET AF was the composite of major plus non-major clinically relevant bleeding events. The patients with AF evaluated in ROCKET AF typify those who are treated today by physicians with an anticoagulant to help reduce the risk of stroke.

About Rivaroxaban

Rivaroxaban is a novel oral anticoagulant that was invented in Bayer HealthCare’s Wuppertal laboratories in Germany, and is being jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. It has a rapid onset of action with a predictable dose response and high bioavailability, no requirement for coagulation monitoring, as well as a limited potential for food and drug interactions.

Rivaroxaban is marketed under the brand name Xarelto® for VTE prevention in adult patients following elective hip or knee replacement surgery, and it is the only new oral anticoagulant that has consistently demonstrated superior efficacy over enoxaparin for this indication. Xarelto® is approved in more than 100 countries worldwide and has been successfully launched in more than 75 countries by Bayer HealthCare.

The extensive clinical trial program supporting rivaroxaban makes it the most studied oral, direct Factor Xa inhibitor in the world today. More than 65,000 patients are participating in the rivaroxaban clinical development program evaluating the product in the prevention and treatment of a broad range of acute and chronic blood-clotting disorders, including VTE treatment, secondary prevention of acute coronary syndrome, and VTE prevention in hospitalized, medically ill patients.

If approved by the FDA, Ortho-McNeil, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company), will commercialize rivaroxaban in the U.S. The U.S. Bayer HealthCare sales force will support the Ortho-McNeil sales force by detailing rivaroxaban in designated hospital accounts. Bayer HealthCare is exclusively responsible for the marketing of rivaroxaban in countries outside the U.S.

Source: Bayer

View drug information on Warfarin Sodium tablets; Xarelto.

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer (NYSE: PFE) today reported that the companies have discontinued the Phase 3 APPRAISE-2 clinical trial in patients with recent Acute Coronary Syndrome (ACS) treated with apixaban or placebo in addition to mono or dual antiplatelet therapy. The study was stopped early based on the recommendation of an independent Data Monitoring Committee (DMC). There was clear evidence of a clinically important increase in bleeding among patients randomized to apixaban. This increase in bleeding was not offset by clinically meaningful reductions in ischemic events.

The APPRAISE-2 Trial (Apixaban for Prevention of Acute Ischemic Events – 2), one of nine clinical trials evaluating apixaban in patients at risk of ischemic events, was designed to include approximately 10,800 patients with a recent Acute Coronary Syndrome. Patients were randomized to apixaban 5 mg twice daily or placebo. The study was conducted in 40 countries and was coordinated by Duke Clinical Research Institute in the U.S. and Uppsala Clinical Research Center in Sweden.

The companies have informed the APPRAISE-2 investigators, ethics review boards and regulatory health authorities of the decision to stop the study. Enrollment will be stopped and patients will be taken off of the study drug. The lead investigators will complete a full evaluation of the available data set and the results will be made public.

“We remain committed to the development of apixaban in other patient populations,” said Brian Daniels, M.D., senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “We are focused on the rolling submission of data for the prevention of stroke in patients with atrial fibrillation who are expected or demonstrated to be unsuitable for treatment with warfarin to the Food and Drug Administration and the application to the European Medicines Agency for venous thromboembolism (VTE) prevention. Other ongoing studies investigating apixaban in different patient populations are being monitored by independent data monitoring committees and are continuing.”

“Our recommendation to discontinue APPRAISE-2 concerns only the population of high-risk ACS patients receiving anti-platelet therapy enrolled in APPRAISE-2,” said Robert Harrington, M.D., Duke Clinical Research Institute, and co-chair of the APPRAISE-2 Steering Committee. “Recent Phase 3 clinical trials of apixaban have demonstrated promising results in patients with VTE and atrial fibrillation. We look forward to reviewing the complete APPRAISE-2 data, when it is available, to better understand this apparently different risk profile in patients with ACS.”

Based on the APPRAISE-2 recommendation, the DMC for APPRAISE Japan, a Phase 2 study in ACS patients, has also recommended discontinuation for APPRAISE Japan.

About the Apixaban Clinical Trial Program

Apixaban, which is currently being developed by Bristol-Myers Squibb and Pfizer, is an investigational oral factor Xa inhibitor, a new class of agents being studied for the prevention and treatment of blood clots. Apixaban is being investigated within the EXPANSE Clinical Trials Program, which is projected to include nearly 60,000 patients worldwide across multiple indications and patient populations and includes a total of eight completed or ongoing, randomized, double-blind Phase 3 trials.

The apixaban Phase 3 trial program is evaluating the prevention of venous thromboembolism, prevention of stroke and other thromboembolic events in patients with atrial fibrillation and the treatment of venous thromboembolism.

About the Bristol-Myers Squibb/Pfizer Collaboration

In 2007, Pfizer and Bristol-Myers Squibb entered into a worldwide collaboration to develop and commercialize apixaban, an investigational oral anticoagulant discovered by Bristol-Myers Squibb. This global alliance combines Bristol-Myers Squibb’s long-standing strengths in cardiovascular drug development and commercialization with Pfizer’s global scale and expertise in this field.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that apixaban will receive regulatory approval or, if approved, that it will become a commercially successful product. There is also no guarantee that other ongoing clinical trials of apixaban will proceed unchanged. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2009, in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

PFIZER DISCLOSURE NOTICE:

The information contained in this release is as of November 18, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about potential indications for a product candidate, apixaban, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial completion dates and regulatory submission dates; decisions by regulatory authorities regarding whether and when to approve any drug applications that are being or may be filed for such indications as well as their decisions regarding labeling and other matters that could affect their availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

Source: Bristol-Myers Squibb

View drug information on Warfarin Sodium tablets.

Could terrorists of the future use a swarm of tiny robots – less an a quarter-inch high – to attack their targets? Will new bio materials be able to target individuals carrying specific genetic markers? Could cyber-attackers melt down a nuclear facility with the press of a “return” key, or implant chips to control our minds?

These scenarios may sound like science fiction, but according to Dr. Yair Sharan, Director of the Interdisciplinary Center for Technological Analysis and Forecasting (ICTAF) at Tel Aviv University, they’re all within the realm of possibility in the next few decades. That’s why it’s critical for nations to be aware of the risks, and primed to mitigate them to avert another 9/11 or Mumbai terror attack.

As head of a pan-European project called FESTOS (Foresight of Evolving Security Threats Posed by Emerging Technologies, Dr. Sharan and his colleagues are looking 30 years into the future to determine what our real technological threats will be. At the end of their three-year project, already underway, they’ll issue a detailed task report to describe the threats and suggest to leaders of democratic nations how they can avoid them.

Forecasting disaster

Part of ICTAF’s work looks for “signals” in politics, news reports, and advanced high-tech coverage to assess what technologies and applications could be used for future crime and terror. “While America did not foresee the scale of 9/11, the signs were there that such an act was a possible event,” says Dr. Sharan. He calls 9/11 an example of a “wild card” – an event or scenario with a low probability and a very high impact. “Our mission is to forecast wild card calamities, natural and manmade, so that nations can be alert and poised to avoid human casualties.”

The FESTOS team’s method also uses questionnaires and interviews with 250 experts from the United States and Europe in a variety of disciplines including chemistry, robotics and computer sciences. The research team analyzes the data to determine and classify future threats, and proposes strategies to mitigate the risks.

At Tel Aviv University, researchers dig into the numbers to estimate threat probabilities. With the input of technology pioneers and scientists, they are exploring what inventions might be available that are meant to improve our lives, but have the potential to be used for malicious purposes. They are “technology mapping,” looking into possibilities such as robot terrorists, dangerous new chemicals, and pioneering materials born of biotech and nanotech.

The probability is that tomorrow’s terror attacks will be information technology-related, Dr. Sharan predicts. Forecasters envision an attack on a country’s energy supply, or a cyber attack on a major airport, especially since hackers of the White House and the Iran nuclear facility have shown how vulnerable critical infrastructure systems can be.

Experience with terrorism provides an advantage

Unfortunately, Dr. Sharan observes, democratic nations like the United States, the United Kingdom, and Spain have learned over the last decade that threats from terror are not limited to Israel. But Israel’s unrelenting experience with terrorism, and Tel Aviv University’s demonstrated expertise in forecasting, have created a laboratory for work that can have a profound impact on Western policy making and planning. And knowing what’s possible will arm future leaders with the tools to protect their citizens.

After the forecasts in the FESTOS study are collected, the results will be shared with decision and policy makers in governments in Europe, Israel, the USA and other democratic nations. Policy makers will then be able to prepare for “foreseen” surprises.

Source:
George Hunka

American Friends of Tel Aviv University

Results from the VeriStrat analysis of a phase II trial of first line erlotinib in combination with sorafenib in patients with advanced non-small cell lung cancer (NSCLC) were presented today at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets in Cancer Therapeutics being held in Berlin, Germany by Egbert Smit, MD, PhD of the VU Medical Center, Amsterdam, The Netherlands. The intention of the biomarker analysis was to evaluate the ability of the blood-based test, VeriStrat, to predict patient outcomes with the erlotinib plus sorafenib combination regimen.

Forty-nine of 50 patients from the study had pretreatment serum samples available for analysis. VeriStrat analysis classified 33 (67%) as likely to have “good” outcomes and 15 (31%) as likely to have “poor” outcomes. Only one sample was classified as indeterminate. VeriStrat Good patients had a significant improvement in overall survival compared with VeriStrat Poor patients (Hazard ratio= 0.30; CI: 0.12-0.74). The median overall survival for VeriStrat Good patients was 13.7 months compared to 5.6 months for VeriStrat Poor patients.

Researchers concluded that the proteomic test, VeriStrat, may identify a subset of patients that derive significant clinical benefit from first- line treatment of advanced NSCLC with dual targeted therapies. Prospective studies are planned.

“This is the first study to demonstrate that a biomarker can identify patients who are likely to benefit from the erlotinib plus sorafenib combination,” stated Egbert Smit, MD, PhD. “This is exciting for lung cancer patients as the all-oral combination may be more tolerable than traditional platinum-based regimens, with similar efficacy. More research is needed to fully define the role of this biomarker and identify the specific groups of patients that this combination may benefit.”

This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.

Source: Biodesix

Pfizer Inc. (NYSE: PFE) announced that the Phase 3 AXIS 1032 trial (A4061032), studying the investigational compound axitinib in previously treated patients with metastatic renal cell carcinoma (mRCC), has met its primary endpoint, demonstrating that axitinib significantly extended progression-free survival (PFS) when compared to sorafenib, in the study population. Consistent with previous analyses, axitinib demonstrated a generally manageable safety profile in this study.

“It is gratifying that in this trial axitinib provided significant benefit to patients with advanced RCC whose disease had progressed after 1st-line therapy,” said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer’s Oncology Business Unit. “These results provide insight into the potential value of axitinib as part of a sequential treatment approach in patients with advanced RCC. We will work with health authorities to determine possible filing options for axitinib for use in patients with advanced RCC.”

Each year, approximately 210,000 people worldwide are diagnosed with kidney cancer and nearly 102,000 people are expected to die from the disease. Within the last five years, great advances have been made in the treatment of patients with advanced RCC, the most prevalent form of kidney cancer. However, five-year survival rates for patients with advanced RCC remain low, at around 20 percent.

About the Investigational Agent Axitinib

Axitinib is an oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3. VEGF receptors 1, 2 and 3 appear to have roles in tumor growth, vascular angiogenesis and metastatic progression of cancer (the spread of tumors). Axitinib is an investigational agent and has not been approved by regulatory agencies.

Axitinib Clinical Research Program

Pfizer continues to investigate the potential role of axitinib across several tumor types, including a Phase 3 study of treatment-naive and previously treated patients with mRCC.

About Sutent® (sunitinib malate)

Sutent is an oral multi-kinase inhibitor approved for the treatment of advanced RCC and for the treatment of GIST after disease progression on or intolerance to imatinib mesylate.

Sutent works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two important Sutent targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR), are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. Sutent also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Important Sutent® (sunitinib malate) Safety Information

Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. It is recommended to monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. Sutent should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. Sutent should not be restarted if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.

Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on Sutent.

Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. Complete blood counts (CBCs) with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with Sutent.

The most common adverse reactions in GIST and RCC clinical trials were diarrhea, fatigue, asthenia, nausea, mucositis/stomatitis, anorexia, vomiting, hypertension, dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin discoloration, altered taste and bleeding.

About Torisel® (temsirolimus)

Torisel is the only intravenous mammalian target of rapamycin (mTOR) inhibitor approved for the treatment of advanced renal cell carcinoma (RCC).

Based on preclinical studies, Torisel inhibits the activity of mTOR, an intracellular protein implicated in multiple growth-related cellular functions including proliferation, growth and survival. The inhibition of mTOR also reduces levels of certain growth factors, such as vascular endothelial growth factor (VEGF), which are overexpressed in solid tumors like kidney cancer and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, nutrients and oxygen needed for growth.

Important Torisel® (temsirolimus) Safety Information

Torisel is contraindicated in patients with bilirubin >1.5 times the upper limit of normal (ULN). If Torisel must be given to patients with mild hepatic impairment, it should be used with caution and at a reduced dose.

Torisel has been associated with serious and sometimes fatal side effects including: hypersensitivity reactions, hyperglycemia/glucose intolerance, infections, interstitial lung disease, hyperlipidemia, bowel perforation, renal failure, wound healing complications, and intracerebral hemorrhage.

Live vaccines and close contact with those who received live vaccines should be avoided. Women of childbearing potential should be advised of the potential hazard to the fetus and avoid becoming pregnant.

The most common adverse reactions (incidence greater than or equal to 30%) are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common laboratory abnormalities (incidence greater than or equal to 30%) are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, elevated alkaline phosphatase, elevated serum creatinine, lymphopenia, hypophosphatemia, thrombocytopenia, elevated AST, and leucopenia.

Strong inducers of CYP3A4/5 and inhibitors of CYP3A4 may affect concentrations of the primary metabolite of Torisel. If alternatives cannot be used, dose modifications of Torisel are recommended.

DISCLOSURE NOTICE: The information contained in this release is as of November 19, 2010. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about potential indications for axitinib, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any drug applications that may be filed for such indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of such indications; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2009 and in its reports on Form 10-Q and Form 8-K.

Source: Pfizer Inc

View drug information on Sutent; Torisel.