Gardasil

PhRMA honors Gardasil(r) researchers with Discoverers Award

Source: sev.prnewswire.com/medical-pharmaceuticals Author: press release The Pharmaceutical Research and Manufacturers of America (PhRMA) will honor recipients of its 2009 Discoverers Award and 2009 Clinical Trial Exceptional Service Award tonight at PhRMA's annual meeting in San Antonio, TX. The awards will be presented to biopharmaceutical company scientists and other researchers who helped discover, develop and advance Gardasil(r), a breakthrough vaccine from Merck & Co., Inc. that can help prevent cervical cancer. (See footnote for more detailed description.) Cancer vaccines represent an emerging type of biological therapy. With 500,000 new cases of cervical cancer and 250,000 deaths from it each year worldwide, human papillomavirus (HPV) infections and the resulting cancers are a major human health threat. HPV infection typically occurs in adolescent and young adult women. "The recipients of these awards should all be proud that they have played such an incredible role in advancing healthcare here in America and around the world. Millions of patients will live healthier, longer lives because of the critical research that was done by these dedicated researchers," says PhRMA President and CEO Billy Tauzin. "These extraordinary honorees certainly deserve this recognition because they are the heroes behind a medicine that helps patients prevent a life-threatening cancer before it can get started." PhRMA's Discoverers Award recognizes scientists whose research and development of medicines have greatly benefited mankind, and whose dedication to improving the quality of patients' lives exemplifies the best among research-based company scientists today. Discoverers Award recipients are Merck's Eliav Barr, M.D., Vice President, Oncology Clinical [...]

Oral Cancer Foundation News Team - A2009-04-07T18:14:04-07:00April, 2009|Oral Cancer News|

HPV data may aid vaccine’s effectiveness

Source: health.usnews.com Author: staff The majority of invasive cervical cancers in New Mexico in the 1980s and 1990s contained DNA from human papillomavirus type 16 (HPV16) and HPV type 18 (HPV18), says a new study. It also found that women diagnosed with HPV16- or HPV18-positive cancers were an average of five years younger than those diagnosed with cancers associated with other HPV types. The HPV vaccine (Gardasil) protects against infections caused by HPV16 and HPV18, so the new findings may have implications for future cancer screening programs, the researchers said. The researchers analyzed U.S. data in the Surveillance, Epidemiology and End Results registry and identified 1,213 cases of in situ cervical cancer diagnosed between 1980 and 1999, as well as 808 cases of invasive cervical cancer diagnosed between 1980 and 1999 in New Mexico. HPV16 DNA was found in 53.2 percent of invasive cervical cancers, HPV18 DNA was found in 13.1 percent, and HPV45 DNA in 6.1 percent. HPV16 DNA was found in 56.3 percent of in situ cervical cancers, HPV31 DNA in 12.6 percent, and HPV33 DNA in 8 percent. Patients' median age at diagnosis of invasive cancer with HPV16 and HPV18 was 48.1 years, and 45.9 years, respectively. Median age at diagnosis of invasive cancer with other HPV genotypes was 52.3 years. The study is in the March 24 online issue of the Journal of the National Cancer Institute. "To our knowledge, this is the largest study of its kind conducted in a U.S. population," wrote a team [...]

Oral Cancer Foundation News Team - A2009-04-07T18:18:36-07:00March, 2009|Oral Cancer News|

A vaccine debate once focused on sex shifts as boys join the target market

Source: www.washingtonpost.com Author: Rob Stein When a vaccine designed to protect girls against a sexually transmitted virus arrived three years ago, the debate centered on one question: Would the shots make young girls more likely to have sex? Now the vaccine's maker is trying to get approval to sell the vaccine for boys, and the debate is focusing on something else entirely: Is it worth the money, and is it safe and effective enough? "We are still more worried about the promiscuity of girls than the promiscuity of boys," said Susan M. Reverby, a professor of women's studies and medical history at Wellesley College. "There's still that double standard." The shift in the discussion about Gardasil illustrates the complex interplay of political, economic, scientific, regulatory and social factors that increasingly influence decisions about new types of medical care. For the vaccine, the new dynamic reflects a strategic tack by Gardasil's critics, growing concern about health-care costs, fears about whether medical treatments are being vetted adequately and stubborn biases about gender, experts say. "There is the cost, the safety, the boys versus girls," said Susan F. Wood, a professor of public health at George Washington University. "These are some of the complexities that are going to have to be addressed one way or the other with this vaccine." Gardasil protects against the human papillomavirus, the most common sexually transmitted infection. HPV causes genital warts and, in women, can lead to cervical cancer -- a disease that strikes about 10,000 American women [...]

Oral Cancer Foundation News Team - A2009-03-27T08:30:59-07:00March, 2009|Oral Cancer News|

Drugmaker Merck seeks Gardasil approval for boys

Source: www.forbes.com Author: Linda A. Johnson Drugmaker Merck & Co. has asked federal regulators to approve use in males for its vaccine against the human papillomavirus, which causes cervical and other sexually transmitted cancers. The application was submitted in late December, Merck spokeswoman Amy Rose said Tuesday. It was long planned as part of Whitehouse Station, N.J.-based Merck's strategy to increase the market for Gardasil. It prevents infection with the sexually transmitted virus and thus cancers of the genital organs. Gardasil, launched in 2006 for girls and young women, quickly became one of Merck's top-selling vaccines, thanks to aggressive marketing and attempts to get states to require girls to get the vaccine as a requirement for school attendance. However, it is one of the priciest vaccines on the market, typically costing $360 for a three-dose regimen. Gardasil had 2007 sales of $1.5 billion, but sales began slowing in the second half of 2008, after a government-funded Harvard study concluded it was cost-effective for girls but not for women in their 20s. The U.S. Food and Drug Administration has two months to decide whether the application for use in males meets its standards. Reviews can then take 10 months or more. The application includes research data from a Merck study including about 4,000 males, ages 16 to 26; Gardasil prevented 90 percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine. The agency approved use of Gardasil in females ages 9 [...]

Oral Cancer Foundation News Team - A2009-01-07T07:17:35-07:00January, 2009|Oral Cancer News|

What to expect: HPV vaccine Gardasil for men

Source: www.vaccinerx.com Author: written by Vaccind Rx Daily Staff The four-type (6,11,16,18) human papillomavirus (HPV) vaccine Gardasil® is also effective in men according to the primary analysis from a pivotal phase III clinical study. In previously uninfected men aged 16 to 26 years*, Gardasil® prevented 90% (95%CI: 69, 98) of external genital lesions caused by HPV types 6, 11, 16 or 18. The data were presented this week at the congress of the European Research Organisation on Genital Infection and Neoplasia (EUROGIN) in Nice, France.1 The study was designed to determine the efficacy of Gardasil® in preventing HPV 6,11,16 or 18- related 'external genital lesions' a composite endpoint that included genital warts, penile / perineal / perianal lesions† (PIN, PIN2/3; potential pre-cursors to cancer) and penile / perineal / perianal cancer. In the study, Gardasil was 90.4% effective in reducing external genital lesions (3 cases in the vaccine group vs 31 cases in the placebo group; 95% CI:69.2, 98.1). All three cases observed in the HPV vaccinated group were of genital warts, resulting in a vaccine efficacy of 89.4% (95% CI [65.5, 97.9]) in preventing genital warts in men. There were no cases of penile / perineal / perianal lesions in the vaccinated group vs. 3 cases in the placebo group. There were no cases of penile / perineal / perianal cancer in either group. At the time of this analysis, the study had a mean duration of about 29 months. No HPV vaccine-related serious adverse events were reported. A [...]

Oral Cancer Foundation News Team - A2008-11-25T22:12:42-07:00November, 2008|Oral Cancer News|

7 Facts you need to know about HPV and Gardasil

Source: www.usnews.com Author: Bernadine Healy M.D. As women—and soon men—gain access to the new Merck vaccine Gardasil, which targets the sexually transmitted human papillomavirus, the Centers for Disease Control and Prevention has stepped up efforts to identify the 25,000 or more cancers primarily associated with HPV that increase the burden of cancer in the United States each year. As reported in the November 15 supplement to the journal Cancer, the latest figures include 10,846 patients with invasive cancer of the cervix, followed by 7,360 with cancers of the mouth, particularly the tonsils and the back of the tongue. In addition, there are 3,018 cancers of the anus, 2,266 of the vulva, and 828 of the penis. To the CDC, these are baseline numbers to track the life-threatening consequences of HPV infection. To sexually active young people, this report should be a wake-up call. The hows and whys of catching contagious warts and cancer through sex should be part of every parent's birds-and-bees talk, every school's sex-ed curriculum, and—most of all—all young people's thinking about their own sexual vulnerability. Here are seven need-to-know facts: 1. Infected boys and men are silent carriers of HPV, spewing out their contagion in body fluids. With some strains, visible warts on the genitals bud off fresh virus. 2. Infected girls and young women (particularly vulnerable to infection because of a still-developing cervix) also shed abnormal cells bearing virus into Pap smears, tests that sexually active women should have yearly. The atypical cells usually clear in [...]

Oral Cancer Foundation News Team - A2008-11-18T03:34:59-07:00November, 2008|Oral Cancer News|

Study suggests Merck’s Gardasil is effective in males

Source: money.cnn.com Author: Peter Loftus A new study suggests Merck & Co.'s (MRK) Gardasil vaccine, which is primarily given to prevent cervical cancer in girls and women, may also be effective in preventing genital warts and penile cancer when given to males. Merck hopes the company-funded study will support roughly doubling the target population for the vaccine, which could help jump-start sagging sales. The Whitehouse Station, N.J., company said it remains on track to apply by year end for Food and Drug Administration approval to market Gardasil to boys and men ages 9 to 26 for prevention of external genital lesions caused by certain viral strains. "This is groundbreaking data," said Anna Giuliano, professor of medicine and epidemiology at University of South Florida, who co-authored the study. "To demonstrate that Gardasil prevents infection and disease at a very high level in males - that's the other half of the world." It was the first study to demonstrate Gardasil's effectiveness in males - prior studies had shown it could produce a positive immune response in males. The vaccine, which was launched in 2006, is currently approved in the U.S. for girls and women ages 9 through 26 to prevent cervical, vulvar and vaginal cancers, as well as genital warts and other lesions caused by certain viral strains. These diseases, in both males and females, share the same cause: Human papillomavirus, or HPV, which is transmitted through sexual contact. The cancers in men caused by HPV, however, are rarer than cervical cancer. [...]

Oral Cancer Foundation News Team - A2008-11-13T16:09:00-07:00November, 2008|Oral Cancer News|

Gardasil Vaccine honoured with International Galien Prize for pharmaceutical research

Source: www.medicalnewstoday.com Author: staff Gardasil®, the four-type (6,11,16,18) human papillomavirus (HPV) vaccine, has been awarded the 2008 International Galien Prize, a prestigious award for recognising and promoting significant advances in pharmaceutical research which is considered the pharmaceutical industry equivalent of the Nobel Prize. "It is gratifying to be part of the transformation of scientific breakthrough into actual benefits for people's health," says Didier Hoch, President of Sanofi Pasteur MSD. "Only 30 years after the discovery that HPV can cause cervical cancer and many other diseases we hold today a vaccine in our hands that can save lives and prevent the suffering of thousands and millions of women. This is unprecedented progress in medical and pharmaceutical research." From 2006 to 2008, Gardasil® has won national Galien Prizes in Belgium, France, Netherlands, Switzerland, the US and the UK (the two HPV vaccines currently licensed for use in the UK were jointly awarded the Galien prize in the palace of Westminster, in September 2008). Additionally, Gardasil® has garnered a number of other prizes, including the 2006 Scrip Award by the British pharmaceutical newsletter Scrip for "Best new biological product" and 2007 Medec Prize by the French general practitioners for "Medicine of the year." During the 1970s, Professor Harald zur Hausen, the Co-Laureate of this year's Nobel Prize in Physiology or Medicine, postulated the role of HPV in causing cervical cancer. He pursued this idea for more than 10 years by searching for different HPV types, which culminated in the discovery in 1983 of [...]

Oral Cancer Foundation News Team - A2008-11-04T13:40:33-07:00November, 2008|Oral Cancer News|

Nobel laureate calls for HPV vaccine for boys

Source: ww.xtra.ca Author: Andrew Innis The Nobel Prize winning pioneer of human papilloma virus (HPV) research is calling for the vaccination of boys against HPV. Speaking at the MaRS Centre in Toronto on Oct 21, Dr Harald zur Hausen argued that vaccination against the viruses, which can lead to cervical cancer in women, is also important to men since they too are susceptible to developing cancers related to HPV. Zur Hausen said men, like women, need to be protected from the more dangerous strains of the virus, HPV-16 and -18, which can contribute to the development of anal and penile cancer. The announcement came hours before the release of a report by the US Centers for Disease Control and Prevention (CDC), which confirmed that after two years of clinical usage Gardasil remains safe for human use, citing no elevated risk for neurological complications. The vaccine was approved for use in both Canada and the United States two years ago. Philippe Brideau, media relations officer for Public Health Agency Canada, said Gardasil has been found to be, “effective and the vaccine is safe, and should be used.” He said there have been no major reactions reported. Health Canada estimates nearly 75 percent of sexually active men and women will be infected with HPV at least once in their lifetime. While most strains of the virus are of little danger, mainly producing genital warts, it can lead to the development of cancer in both males and females. Men who have sex with [...]

Oral Cancer Foundation News Team - A2008-10-29T20:36:27-07:00October, 2008|Oral Cancer News|

Cervical cancer vaccine called safe

Source: www.washingtonpost.com Author: staff Gardasil, the two-year-old vaccine that's designed to prevent cervical cancer, is safe, U.S. officials said Wednesday. The U.S. Centers for Disease Control and Prevention's Immunization Safety Office said a study of 370,000 doses given to girls and young women over the past two years found no evidence that the vaccine causes an increased risk of blood clots or other serious conditions, Bloomberg News reported. The CDC, which recommends the vaccine for girls starting at ages 11 and 12, based its findings on statistics from the Vaccine Safety Datalink, which uses medical data to test hypotheses about vaccine safety, the news service said. "There were no associations found that suggested an elevated risk," said John Iskander, acting director for the Immunization Safety Office, toldBloomberg. Critics of the vaccine, including some groups that worry that the inoculation could promote promiscuity, have contended that Gardasil may not be safe and could give women a false sense of security about sexually transmitted diseases. Gardasil protects against four types of genital human papillomavirus, HPV, which is spread through sexual contact and can cause cervical cancer in women. The U.S. study covered 190,000 girls and young women who received at least one dose of the vaccine's three-shot regimen. The CDC researchers compared medical data on those girls who got the vaccine with data for girls and young women who received other vaccines or none. "The results are really reassuring," said Dr. Paul Offit, chief of the infectious diseases division at Children's Hospital [...]

Oral Cancer Foundation News Team - A2008-10-24T08:55:32-07:00October, 2008|Oral Cancer News|