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Oncolytics Biotech Inc. (”Oncolytics”) (TSXONC, NASDAQONCY) announced that the Cancer Therapy Research Center at the University of Texas Health Science Center (CTRC) has started patient enrolment in a U.S. Phase 2 clinical trial using intravenous administration of REOLYSIN(R) in combination with paclitaxel and carboplatin in patients with metastatic melanoma. The Principal Investigator is Dr. Devalingam Mahalingam, M.D., Ph.D., MRCP(UK), MRCP(I), clinical investigator in GI/thoracic oncology and drug development at the CTRC.

“We have seen some very encouraging results in our clinical trials using REOLYSIN in combination with other therapies in metastatic melanoma patients,” said Dr. Brad Thompson, President and CEO of Oncolytics. “For example, of nine evaluable melanoma patients treated intravenously in our combination REOLYSIN and chemotherapy trials, five had stable disease or better (two partial responses and three stable disease).

“In our local administration REOLYSIN and radiation studies, all of the evaluable melanoma patients (10) had stable disease or better in the target lesion, (three partial responses, one significant minor response and six stable disease). These results, combined with preclinical work demonstrating that in vivo combination treatment resulted in markedly reduced tumour growth compared to single agent treatments, provided the rationale for our collaborators to explore a Phase 2 combination study for patients with metastatic melanoma.”

“Today, few effective treatment options exist for patients with advanced malignant melanoma,” said Dr. Mahalingam. “We welcome this collaboration with Oncolytics, and are excited to have started patient enrolment for this Phase II investigatorinitiated study at the CTRC. We are hopeful this novel agent will continue to show promising results.”

The trial (REO 020) is a single arm, openlabel, Phase 2 study of REOLYSIN given intravenously with paclitaxel and carboplatin every three weeks. It is anticipated that up to 43 patients will be treated in the study.

Eligible patients include those with metastatic, malignant melanoma who have failed one or more prior therapies, or those who are not considered to be a candidate for standard, firstline treatment.

The primary objective of the Phase 2 trial is to measure the objective response rate (partial response (PR) and complete response (CR)) to the treatment combination. The secondary objectives are to assess progressionfree survival (PFS) and overall survival (OS) for the treatment regimen in the study population, to assess disease control rate (CR + PR + stable disease (SD)) and duration in the study population, and to assess the safety and tolerability of the combination treatment.

This trial is part of a broad preclinical and clinical collaboration with the CTRC that will involve up to five, openlabel, Phase 2 studies exploring the use of REOLYSIN in combination with chemotherapy for various cancer indications.

About Melanoma

Cancer of the skin is the most common of cancers, probably accounting for at least half of all cancers. Melanoma accounts for less than 5% of skin cancer cases but causes a large majority of skin cancer deaths. The American Cancer Society estimates that about 68,720 new melanomas will be diagnosed in the United States during 2009, and 8,650 people will die from the condition. Unlike many other common cancers, melanoma widely occurs in younger as well as older people. Occurrence rates continue to increase with age and are highest among those in their 80s, but melanoma is not uncommon in those younger than 30, and in fact is one of the more common cancers in adolescents and young adults.

About Oncolytics Biotech Inc.

Oncolytics is a Calgarybased biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics. Oncolytics clinical program includes a variety of Phase 1/2 and Phase 2 human trials using REOLYSIN, its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy.

The Cancer Therapy Research Center (CTRC) at The University of Texas Health Science Center at San Antonio is one of the nations leading academic research and treatment centers, serving more than 4.4 million people in the highgrowth corridor of Central and South Texas including Austin, San Antonio, Laredo and the Rio Grande Valley. CTRC is one of a few elite cancer centers in the country to be named a National Cancer Institute (NCI) Designated Cancer Center, and is one of only three in Texas. A world leader in developing new drugs to treat cancer, The CTRC Institute for Drug Development (IDD) is internationally recognized for conducting the largest oncology Phase I clinical drug trials program in the world, and participates in the clinical and/or preclinical development of many of the cancer drugs approved by the U.S. Food Drug Administration.

This press release contains forwardlooking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forwardlooking statements, including the Companys expectations related to the U.S. Phase 2 combination REOLYSIN/paclitaxel and carboplatin clinical trial for patients with metastatic melanoma, and the Companys belief as to the potential of REOLYSIN as a cancer therapeutic, involve known and unknown risks and uncertainties, which could cause the Companys actual results to differ materially from those in the forwardlooking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN as a cancer treatment, the tolerability of REOLYSIN outside a controlled test, the success and timely completion of clinical studies and trials, the Companys ability to successfully commercialize REOLYSIN, uncertainties related to the research and development of pharmaceuticals and uncertainties related to the regulatory process. Investors should consult the Companys quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forwardlooking statements. Investors are cautioned against placing undue reliance on forwardlooking statements. The Company does not undertake to update these forwardlooking statements, except as required by applicable laws.

Bioniche Life Sciences Inc. (”Bioniche”; TSX BNC), a researchbased, technologydriven Canadian biopharmaceutical company, provided an update on its Phase III clinical program evaluating Urocidin(TM) in the treatment of bladder cancer. Recruitment has been completed in its Phase III registration trial evaluating Urocidin in the treatment of nonmuscleinvasive bladder cancer that is refractory (unresponsive) to the current standard immunotherapy Bacillus CalmetteGuerin (BCG).

The Data Monitoring Committee (DMC) held its ninth meeting regarding this clinical trial last week. After its meeting, the Committee has recommended that Bioniche “continue the trial unmodified until the next scheduled or triggered meeting.” The next scheduled meeting of the Committee is scheduled to occur in October.

The DMC is an independent group that acts in an advisory capacity to the Company. Its role is to evaluate the progress of the clinical trial, including monitoring the safety and efficacy data generated in the trial. On a regular basis, the DMC reviews study results, evaluates the incidence of adverse events, determines whether the basic trial assumptions remain valid, and evaluates whether the overall integrity, scientific merit and conduct of the study remain acceptable.

Data from the full cohort of 105 highgrade bladder cancer patients from this trial, coupled with additional safety information to be collected from a second clinical trial that is expected to start later this year, will be used to support regulatory submissions under the FDAs Accelerated Approval program.

Second Phase III Registration Trial

Bioniche is working with its new licensing partner, Endo Pharmaceuticals Inc., on setting up clinical trial sites for a second registration trial that will directly compare the efficacy and safety of Urocidin with BCG in the firstline treatment of nonmuscleinvasive bladder cancer.

In September, 2007, the Company announced that an agreement had been reached with the FDA under the Special Protocol Assessment (SPA) procedure on the design of the trial, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). An SPA gives a clear pathway to registration of Urocidin when the trial endpoints are achieved. This indication for MCC received Fast Track designation by the FDA last year.

About Bladder Cancer

In North America, bladder cancer is the fourth most common cancer in men and in the top ten for women. In the United States, approximately 70,000 patients are newly diagnosed with bladder cancer each year. In addition, the cancers of many previouslydiagnosed patients remain unresolved, sometimes leading to cystectomy (bladder removal) or death. Approximately 70 percent of bladder cancer patients have the nonmuscleinvasive form of bladder cancer at diagnosis and, on appropriate regulatory approvals, might be eligible for multiple treatments with Urocidin.

Nonmuscleinvasive bladder cancer is a form of bladder cancer localized in the surface layers of the bladder that has not yet spread into the deeper muscle layer. This form of bladder cancer is treated predominantly by urologists using surgical resection and intravesical infusion therapy. Urocidin is an intravesical infusion therapy, administered via transurethral catheter into the bladder.

About Urocidin(TM)

Urocidin is a formulation of MCC, a sterile mycobacterial cell wallDNA complex composition that has a dual mode of action immune stimulation and direct anticancer activity. Urocidin is formulated for the treatment of bladder cancer, where it is administered by transurethral catheter directly into the bladder, coming into contact with immune system cells and bladder cancer cells. Industry Canadas Industrial Technologies Office (formerly Technology Partnerships Canada) has contributed to the development of the Companys mycobacterial cell wall technologies by means of a C$9.6 million loan that is recoupable from sales.

About Bioniche Life Sciences Inc.

Bioniche Life Sciences Inc. is a researchbased, technologydriven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fullyintegrated company employs approximately 200 skilled personnel and has three operating divisions Human Health, Animal Health, and Food Safety. The Companys primary goal has been to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of the Top 50 Best Small and MediumSized Employers in Canada for 2009.

Except for historical information, this news release may contain forwardlooking statements that reflect the Companys current expectation regarding future events. These forwardlooking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Companys ongoing quarterly and annual reporting.

OmniComm Systems, Inc. (OTC Bulletin Board OMCM), one of the fastest growing companies in the EDC marketplace, announced that Impax Pharmaceuticals, the brand division of Impax Laboratories, Inc., Hayward, CA, has selected the TrialMaster EDC solution for conducting a Phase III study in patients with Parkinsons Disease. “While managing a global multi site clinical trial there can be significant challenges in getting trial data when you want it and in the format that you need it,” said Suneel Gupta, PhD, Chief Scientific Officer for Impax. “The TrialMaster EDC solution provides us with an intuitive and easy to use export tool that simplifies the process. After considering multiple different EDC solutions, we selected OmniComm Systems based on its customer driven approach and reputation for delivering unparalleled service and support. Additionally, its support of industry standards has enabled us to meet our very tight corporate timelines for this important study.”

“We look forward to working with Impax to assist them in the fight to cure Parkinsons disease,” remarked Stephen Johnson, COO of OmniComm Systems. “We are honored that after an extensive evaluation, OmniComms electronic data capture solution, TrialMaster(TM), was chosen to capture and process their clinical trial data. TrialMaster(TM) will enable them to continue to make informed and strategic decisions that will be vital to their success as a company.”

About Impax Laboratories, Inc.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlledrelease and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities.

About OmniComm

OmniComm Systems, Inc. provides customerdriven Internet solutions to pharmaceutical, biotechnology, research and medical device organizations that conduct life changing clinical trial research. OmniComms growing base of satisfied customers is a direct result of the companys commitment to deliver products and services that ensure ease of use, faster study build, ease of integration and better performance. OmniComms client intuitive pricing model allows companies that range from small, to midsize to large scale institutions to safely and efficiently capitalize on their clinical research investments. OmniComm Systems, Inc. has U.S. headquarters in Fort Lauderdale, FL and European headquarters in Bonn, Germany, with satellite offices in New Jersey, the United Kingdom, and Russia as well as sales offices throughout the U.S. and Europe.

Safe Harbor Disclaimer

Statements made by OmniComm included in this release may constitute forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve a number of risks and uncertainties such as the Companys ability to obtain new contracts and accurately estimate net revenues due to uncertain regulatory guidance, variability in size, scope and duration of projects, and internal issues at the sponsoring client, integration of acquisitions, competitive factors, technological development, and market demand. As a result, actual results may differ materially from any financial outlooks stated herein. Further information on potential factors that could affect the Companys financial results can be found in the Companys Reports on Form 10K and 10Q filed with the Securities and Exchange Commission. The Company undertakes no obligation to publicly update any forwardlooking statement, whether as a result of new information, future events, or otherwise.

Source OmniComm Systems, Inc

VION PHARMACEUTICALS, INC. (OTC Bulletin Board VION) announced the date and location of the Oncologic Drugs Advisory Committee (ODAC) Meeting at which its lead oncology therapeutic Onrigin(TM) (laromustine) Injection will be presented.

The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes appropriate recommendations to the U.S. Food and Drug Administration (FDA).

The meeting will be held on September 1, 2009 at the Hilton Washington DC/Silver Spring, 8727 Colesville Road, Silver Spring, MD. Background materials for the meeting are expected to be made available by the FDA on its website no later than two business days before the meeting.

Alan Kessman, Chief Executive Officer, commented, “We look forward to our meeting with the Oncologic Drugs Advisory Committee in September. It is one more step towards achievement of our main objective which is approval for Onrigin(TM) in its first indication in the United States in 2009.”

The Company announced previously that it had received a standard review classification from the FDA for its New Drug Application (NDA) for Onrigin(TM) and a user fee goal date of December 12, 2009 for a decision by the FDA with respect to approval.

The NDA presents data for Onrigin(TM) as a single agent for remission induction treatment for patients sixty years of age or older with de novo poorrisk acute myeloid leukemia (AML). The NDA is based on the results of an international multicenter pivotal Phase II trial of 85 patients sixty years of age or older with de novo poorrisk AML, supplemented by data from 55 patients in a previous Phase II trial in elderly AML. Eightysix percent of these 140 patients had two or more risk factors that predicted for a poor prognosis.

About Vion Pharmaceuticals

Vion Pharmaceuticals, Inc. is committed to extending the lives and improving the quality of life of cancer patients worldwide by developing and commercializing innovative oncology therapeutics. Vion has two agents in clinical trials, Onrigin(TM) (laromustine) Injection and Triapine((R)). The FDA is reviewing a New Drug Application for Onrigin(TM) for remission induction treatment for patients sixty years of age or older with de novo poorrisk AML. Triapine((R)), a potent inhibitor of a key step in DNA synthesis, is being evaluated in clinical trials sponsored by the National Cancer Institute.

This news release contains forwardlooking statements. Such statements are subject to certain risk factors which may cause Vions plans to differ or results to vary from those expected, including Vions potential inability to obtain regulatory approval for its products, particularly Onrigin(TM) (laromustine) Injection (formerly Cloretazine((R) )(VNP40101M)), delays in the regulatory approval process, particularly for Onrigin(TM) (laromustine) Injection, including possible delays in the FDAs review process beyond our expectation for approval in December 2009, delays or unfavorable results of drug trials, the possibility that favorable results of earlier preclinical studies, clinical trials or interim clinical trial data are not confirmed by safety and efficacy results in later or final clinical trials, the need for additional research and testing, the inability to manufacture product, the potential inability to secure external sources of funding to continue operations, the inability to access capital and funding on favorable terms, continued operating losses and the inability to continue operations as a result, and a variety of other risks set forth from time to time in Vions filings with the Securities and Exchange Commission, including but not limited to the risks attendant to the forwardlooking statements included under Item 1A, “Risk Factors” in Vions Form 10K for the year ended December 31, 2008, Vions Form 10Q for the quarter ended March 31, 2009, and Vions PostEffective Amendments on Form S1 Registration Statement filed on March 23, 2009. Except in special circumstances in which a duty to update arises under law when prior disclosure becomes materially misleading in light of subsequent events, Vion does not intend to update any of these forwardlooking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Source Vion Pharmaceuticals, Inc

Amgen Inc. (Nasdaq AMGN) announced the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for the epidermal growth factor receptor (EGFr) class of antibodies, including Vectibix((R)) (panitumumab). This decision follows the FDAs December 2008 Oncologics Drugs Advisory Committee (ODAC) meeting where the clinical utility of the KRAS gene as a predictive biomarker in patients with metastatic colorectal cancer (mCRC) treated with antiEGFr antibody was discussed.

“We are pleased that the FDA has recognized the clinical importance of KRAS as a predictive biomarker for antiEGFr antibody therapy,” said Sean Harper, M.D., chief medical officer and head of Global Development at Amgen.

The INDICATION AND USAGE section of the prescribing information has been updated to include that retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of colorectal cancer with these mutations.

The CLINICAL STUDIES section of the prescribing information has been updated to reflect results from retrospective analyses across seven randomized clinical trials with agents in this class. This includes the first Phase 3 analysis that showed mCRC patients with mutated KRAS tumors do not respond to monotherapy with an EGFrinhibiting antibody (the Vectibix “408″ trial).

“With this label update, physicians can now eliminate antiEGFr antibodies as a treatment option for patients with mutated KRAS tumors and redirect those patients to alternative therapies, avoiding unnecessary treatments in patients who are unlikely to benefit,” said Sean Harper.

This label update is specific to the utility of KRAS as a biomarker for Vectibix used as a monotherapy. In the combination chemotherapy setting, the Vectibix “181″ and “PRIME (203)” trials will be the first prospective Phase 3 clinical studies testing the clinical utility of KRAS as a predictive biomarker in mCRC patients in earlier lines of therapy. Data from the “181″ and “PRIME (203)” trials are expected in the third quarter of 2009.

This update follows recent KRAS related action from key cancer organizations, including the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN). A Clinical Provisional Opinion (CPO) was issued by ASCO in January, where the organization recommended the use of the KRAS biomarker in selecting the appropriate patients for antiEGFr antibody therapy. In November 2008, the NCCN announced updates to their Guidelines on Colon and Rectal Cancers. The guideline updates included the recommendation that a determination of the KRAS gene status of either the primary tumor or a site of metastasis should be part of the pretreatment workup for patients diagnosed with metastatic colorectal cancer.

About Colorectal Cancer

Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States (U.S.). The American Cancer Society estimates that about 106,100 new cases of colon cancer and 40,870 new cases of rectal cancer will be diagnosed in 2009. Colorectal cancer is the second leading cause of cancer death among men and women in the U.S. and it has been estimated that more than 49,000 people will die from colorectal cancer in 2009. That means that one person in the U.S. dies of colorectal cancer every 9.3 minutes.

About Vectibix

Vectibix is indicated as a single agent for the treatment of patients with epidermal growth factor receptor (EGFr) expressing metastatic colorectal carcinoma after disease progression on, or following fluoropyrimidine, oxaliplatin and irinotecancontaining chemotherapy regimens. The effectiveness of Vectibix as a single agent for the treatment of EGFrexpressing, metastatic colorectal carcinoma is based on progressionfree survival. Currently no data demonstrate an improvement in diseaserelated symptoms or increased survival with Vectibix.

Important Product Safety Information

Dermatologic Toxicity Dermatologic toxicities occurred in 89 percent of patients and were severe (NCICTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to less than or equal to grade 2 within 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported.

Infusion Reactions Severe infusion reactions occurred in approximately 1 percent of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix.

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 sciences 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 peoples lives.

ForwardLooking Statements

This news release contains forwardlooking statements that are based on managements 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 forwardlooking 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. Forwardlooking 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 Amgens most recent annual report on Form 10K and most recent periodic reports on Form 10Q and Form 8K. Please refer to Amgens most recent Forms 10K, 10Q and 8K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of July 17, 2009 and expressly disclaims any duty to update information contained in this news release.

No forwardlooking 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 thirdparty 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 health care 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 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 FDAapproved labeling for the products, and not the information discussed in this news release.

The Wall Street Journal examines the “strategic shift in the $770 billion pharmaceutical industry to target the working poor in the developing world” through the eyes of a Pfizer pharmaceutical representative working in the slums overlooking Caracas, Venezuela. The newspaper writes “For the first time in a halfcentury, sales of prescription drugs are forecast to decline this year in the U.S., historically the industrys biggest and most profitable market … As a result, developing countries … have begun to look more attractive to the industry.”

Pfizer has expanded into China, India, Brazil, Russia and Turkey. GlaxoSmithKline, Novartis and SanofiAventis are also expanding their focus on sales to developing countries. Pfizer, which “brought in $1.4 billion in sales from emerging markets in the first quarter of this year,” is benefiting from a belief in Venezuela and in much of the developing world that branded medicines are worth paying a premium for because theyre safer and more effective than generics,” yet cost 40 to 50 percent more, the newspaper writes. Still, “[s]ome publichealth officials question whether Pfizer is promoting what they say is an unfounded perception that generic drugs arent trustworthy.”

“Pfizer says the problem with generics in Venezuela is that laws requiring them to be equivalent to brandname versions arent uniformly enforced” and “up to 30 percent of drugs sold in the developing world are counterfeit and may not be effective.” To help mitigate costs, Pfizer offers discounts to doctors. The Wall Street Journal writes that Pfizers “program in Venezuela is an exercise in how to reduce prices enough to attract poorer customers while still turning a profit.”

The article also details Pfizers offers of free computers and internet for doctors, creating the opportunity for them to practice telemedicine. “Pfizer says the computers start out as loans and become permanent gifts once the doctors have shown that they are using them for medical purposes and have signed a waiver stating they understand theyre not intended to influence their prescribing,” the newspaper writes.

Carlos Serrano, a Venezuelan doctor featured in the article whose office is set to receive a refurbishment by Pfizer later this month, “says hes increased by 40 percent the number of Pfizer drugs he prescribes since” being contacted by the local Pfizer representative, but says he has not been influenced by the aid hes received from the company. “There are some illnesses that have to be treated with a good product, no matter what the cost,” Serrano said (Johnson, 7/7).

This information was reprinted from globalhealth.kff.org with kind permission from the Henry J. Kaiser Family Foundation. You can view the entire Kaiser Daily Global Health Policy Report, search the archives and sign up for email delivery at globalhealth.kff.org.

© Henry J. Kaiser Family Foundation. All rights reserved.

There are striking differences in treatment regimens for nonsmall cell lung cancer (NSCLC) patients, based on both age and geography, according to a new market research study conducted by Merck KGaA, Darmstadt, Germany, presented as a poster on Saturday at the 2009 ASCO (American Society of Clinical Oncology) meeting in Orlando, Florida (Abstract no. 8053; Poster no. N15). Performed in conjunction with TNS Healthcare, the representative study shows that among patients with advanced NSCLC, monotherapy is used most often among those 70 or older, while combination therapies are administered most frequently to younger patients. Location also is a key factor in determining therapy choice, with a chemotherapy doublet plus a targeted agent far more common in the US than in Europe.

“While chemotherapy doublets remain the standard regimen for firstline treatment of stage IIIB and IV NSCLC, there are substantial differences among regions in the doublets most often chosen and whether a targeted agent is concurrently administered,” says J.F. Vansteenkiste, first author of the poster. “For example, the preferred doublet in Europe is platinum plus gemcitabine, used in 29% of patients. In contrast, in the US and Japan, platinum plus taxanes is predominant, used in more than a quarter of American and more than half of Japanese patients.”

“The most extensive use of doublets plus targeted agent is in the US, in contrast with Europe and Japan. Almost half of nonsquamous cancer patients younger than 70 are being treated with these combinations in the US. Even among those older than 70, more than a quarter of patients are on chemotherapy doublets plus targeted agent.” Randomized phase III studies have shown that adding targeted agents to standard firstline treatments can prolong overall survival.

Almost 5,000 NSCLC Patients Monitored

Merck KGaA already had presented at last years ASCO a landmark study for Erbitux in combination with standard 1stline chemotherapy in advanced NSCLC which showed for the first time in 10 years a significant survival benefit in a broad patient population. In the current study Merck KGaA monitored 4,950 patients from May to midJuly 2008 across Western Europe (Spain, Italy, Germany, France and the UK), the US and Japan. TNS Healthcare recruited oncologists in the US, oncologists, radiotherapists and pulmonologists in Europe and pulmonologists and respiratory surgeons in Japan to participate. Physicians who contributed provided information through online patient record forms.

About Merck

Merck is a global pharmaceutical and chemical company with total revenues of euro 7.6 billion in 2008, a history that began in 1668, and a future shaped by 32,700 employees in 60 countries. Its success is characterized by innovations from entrepreneurial employees. Mercks operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since.

About TNS Healthcare

TNS Healthcare provides market research consulting to the worldwide pharmaceutical, biotech and medical device industries, as well as healthfocused ad agencies, media and analysts. It offers globally consistent solutions and custom advisory services to support product introductions; brand, treatment and sales performance optimization; and physician and DTC promotional assessment.

Informing decisions across the life cycle, TNS Healthcare offers actionready insights for pre launch landscaping, market and opportunity assessment, segmentation, positioning, message and campaign creation, pricing, forecasting, attitude and awareness measurement and postlaunch tracking. It delivers information across stakeholdersincluding physicians, patients and consumersto help companies anticipate and impact customers behaviors. TNS Healthcare provides both qualitative and quantitative offerings, using traditional and on line methodologies, combining worldwide reach with local expertise.

FDA on Tuesday posted on its Web site advertising guidelines for drugmakers and medical device manufacturers, offering suggestions on how to present risk information to health care professionals and consumers, the Wall Street Journal reports. Agency officials said the industry had asked for guidance on how to comply with its rules, which require a balanced presentation of a products risk and effectiveness. Exclusion or minimization of risk information is the most commonly cited violation each year in FDAissued warnings or enforcement letters. The new guidelines include detailed information on how aspects such as font, types of contrast and white space in print materials can appropriately present risk information. According to the Journal, the 24page document is not binding. FDA will accept public comments for 90 days prior to issuing final guidelines (Corbett Dooren, Wall Street Journal, 5/27).

Reprinted with kind permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation.

© 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Cylene Pharmaceuticals, Inc., announced that it will present major advances in the development of their firstinclass, CK2 inhibitor CX4945 at the 2009 BIO International Convention on Wednesday, May 20th at 440 pm. William G. Rice, Ph.D., Cylenes president and CEO, will discuss the mechanism, antitumor properties and tumor selectivity of CX4945, the Companys oral protein kinase inhibitor currently in Phase I clinical trials. This proprietary compound has demonstrated promise as a potent and selective oral inhibitor of protein kinase CK2, a previously unexploited molecular target with well documented roles in many cancers, indicating broad therapeutic potential. Cylenes Serine/Threonine Kinase Inhibitor program has also delivered orally active panPIM inhibitors of the PIM1,2,3 kinases, still in preclinical development.

Cylene Pharmaceuticals, Inc. is a Phase IIstage, smallmolecule Oncology Company designing promising therapeutic agents with its two proprietary product discovery platforms, using novel chemistry and biology capabilities. The company was cofounded by Daniel Von Hoff, MD, one of the worlds leading oncology clinical investigators. In addition to the CK2 inhibitor CX4945, Cylenes Nucleolus Targeting Technology has generated Quarfloxin (CX3543), a small molecule agent that is in Phase II development for the treatment of carcinoid/neuroendocrine tumors (C/NET). Quarfloxin disrupts an essential protein DNA complex in cancer cells, thereby knocking out a critical source of support for tumor cells and selectively causing cancer cell death. Quarfloxin is safe and welltolerated and has completed two separate Phase I trials on different dosing schedules, during which biological activity was observed in several C/NET patients

Evotec AG (Frankfurt Stock Exchange EVT; NASDAQ EVTC) announced that the Company will acquire the zebrafish screening operations of Summit Corporation plc, including operations in Abingdon, UK, and Singapore, for £ 0.5 million in cash.

Summits zebrafish technology is a strong addition to Evotecs industrialized highquality drug discovery platform. This capability is valuable to drug discovery as it provides important whole organism data about the safety and toxicity of druglike molecules at an early stage of lead optimization. It thereby allows prioritization of the most promising compounds early in the drug discovery process, reducing the risk of potential laterstage failure and, ultimately, lowering costs in drug discovery and development.

Founded in 2003, Summit has built the worlds leading zebrafish capability. The company had collaborated with more than 25 pharmaceutical companies worldwide. The alliances include a threeyear research agreement with Johnson & Johnson signed at the end of 2008 to support the development of new assays using the zebrafish platform as well as collaborations with BayerSchering, Merck KGaA, Merz, Roche and Servier. Evotec expects this business to contribute revenue in 2009 (May to December) and to rapidly grow revenue and profitability over the next two years.

Dr Mario Polywka, Chief Operating Officer of Evotec commented “We get access to a portfolio of validated safety pharmacology and toxicology assays and disease models for target validation that enjoy growing interest in our industry. The integration of this business offers significant synergies, including the move of Summits UK operations into our facilities in Abingdon, the integration of this offering into our global sales and marketing network as well as the use of the Singapore facility as a base to target new growth markets in the Far East, expanding our current business reach.”

Dr Werner Lanthaler, Chief Executive Officer of Evotec, added “Through this small acquisition of Summits zebrafish operations we are enhancing our worldclass drug discovery platform. Besides strict cost containment one core element of our Evotec 2012 Action Plan to Focus and Grow is the further investment and expansion of our unique Discovery Alliance Business. This transaction is a first example of how we will continue to develop this business to build on our worldclass leadership role.”

Background information

About zebrafish screening technology

Zebrafish have the potential to accelerate and derisk the drug discovery and development process by reducing attrition rates and lowering the development cost of producing new drugs. Zebrafish are wellcharacterised model organisms and are used in the screening of potential drug candidates to provide invaluable in vivo safety and efficacy data from the earliest stages of drug discovery and throughout the development process. With a significant genetic similarity to humans and the presence of many vital organs including the heart, brain and liver, the larval zebrafish is highly suitable for screening potential drug candidates for efficacy and safety effects. Screening in zebrafish provides many advantages over other established in vivo models by allowing large numbers of compounds to be rapidly profiled using small amounts of compound.

Summit has developed a range of highthroughput safety pharmacology and toxicity screens and also several important zebrafish disease models that can be used to identify and evaluate potential new drug candidates.

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