CDC advisory committee recommends Cervarix HPV vaccine for girls, young women to prevent cervical cancer

Philadelphia, PA

GlaxoSmithKline
announced today that the U.S. Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommended that CERVARIX® [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] be given to girls and young women to protect against cervical pre-cancers and cervical cancer caused by oncogenic HPV 16 and 18. The ACIP specifically recommended CERVARIX for routine administration among 11 and 12 year old girls. In addition, the recommendation includes a catch up for girls and young women who have not previously been vaccinated, which for the approved age range for CERVARIX includes 13-25 year old girls and young women.

On October 16, 2009, the Food and Drug Administration (FDA) approved CERVARIX for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

"It's estimated that this year, ten women will die every day from cervical cancer in the U.S.," said Barbara Howe, M.D., Vice President and Director, North American Vaccine Development, GlaxoSmithKline. "The ACIP recommendation for CERVARIX underscores how important it is for girls and young women to be vaccinated to help reduce the burden of this devastating cancer."

Additionally, the ACIP unanimously recommended to provide funding for CERVARIX from the Vaccines for Children (VFC) program. The federally funded program provides vaccines at no cost to children up through 18 years of age who might not otherwise be vaccinated because of inability to pay. Children who are eligible for VFC vaccines are entitled to receive pediatric vaccines that are recommended by the ACIP.

CERVARIX is expected to be commercially available in the U.S. in late 2009.

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Cervical cancer vaccine Cervarix wins support from Japan Health Ministry panel

Tokyo, Japan

GlaxoSmithKline (GSK.L) won support for its cervical cancer vaccine from an advisory panel to Japan's Health Ministry on Tuesday, putting it on track to be the first to offer such a vaccine in the world's second-biggest drug market.

The ministry should give its final stamp of approval within a month, said Takehiro Kimura, a health ministry official.

On Monday, British health officials said a teenage girl died after receiving a cervical cancer vaccine made by Glaxo, though no link could be made between the death and the drug until all facts were known and a post-mortem conducted. [ID:nLT165573]

Approval in Japan could help clear the way for Merck & Co (MRK.N), which has also applied for approval for its Gardasil vaccine. Both Glaxo's Cervarix and Merck's Gardasil vaccines protect against infection from the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

About 2,500 women die each year in Japan from cervical cancer. Worldwide deaths from the disease total about 280,000, mostly in developing countries with inadequate screening.

Glaxo's Cervarix has already been approved in 98 countries, with sales in January-June nearly matching its annual sales of 125 million pounds ($199 million) last year.

A U.S. panel has also backed the vaccine for approval and a final decision could come this month, though Cervarix's launch in the world's largest drug market will lag Gardasil, which won approval three years ago. [ID:nN09323683]

Merck's Gardasil vaccine has been approved for use in 112 countries, and logged $1.4 billion in sales in 2008.

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Clash of the Titans for the HPV Vaccine Market

New York City, NY

wo pharmaceutical giants are vying for the billions of dollars up for grabs in the market for vaccines against the human papillomavirus, or HPV, a sexually transmitted infection that can cause cervical cancer and genital warts.

Merck, which has had a monopoly on HPV vaccines in the United States with its Gardasil for young women, has asked the Food and Drug Administration to approve the drug to protect against genital warts in young men. In 2006, the agency approved Gardasil to protect girls and women ages 9 to 26 against certain strains of the virus that can cause genital warts, pre-cancerous genital lesions and cervical cancer.

Meanwhile, GlaxoSmithKline, which currently markets its Cervarix vaccine to young women in about 100 countries, is seeking to have the vaccine approved in the United States to protect girls and women ages 10 to 25 against certain HPV strains that can cause cervical cancer. Cervarix does not offer protection against strains of the virus that can cause genital warts.

On Wednesday, an advisory panel of the Food and Drug Administration voted that research data from Glaxo had demonstrated the safety and efficacy of Cervarix to protect young women against cervical cancer. The panel, composed of outside experts, also voted in favor of the safety and efficacy of Gardasil to inhibit genital warts in boys and men ages 9 to 26.

The F.D.A. typically follows the recommendations of such panels on drug approvals.

Glaxo shares were up about half a percent to $39.22 at the end of trading on Wednesday; shares of Merck were up about 1.9 percent to $31.55.

But industry analysts said that the drug companies faced a battle to expand the target audience in America for such vaccines because the drugs have limited effectiveness and unknown duration. They also have possible side effects like dizziness and fainting.

Both vaccines also require a series of three shots over six months. Both are most protective in young people who have not yet been exposed to the virus because they are either not sexually active or have just become sexually active and have had few romantic partners.

Indeed, because of the limited audience of young women, American sales of Gardasil have recently stalled, said Tim Anderson, an analyst with Sanford C. Bernstein. In the first half of this year, Gardasil had sales in the United States of $363 million, a decrease of 34 percent compared with the same period in 2008, according to a Merck financial statement.

Mr. Anderson said that Merck will find it harder to persuade parents and health insurers to pay for Gardasil shots to reduce the chance of developing a nonfatal condition like genital warts in boys than to market the vaccine to reduce a potentially deadly disease like cervical cancer in young women.

“You are asking a healthy teen to come to the doctor three times in six months,” Mr. Anderson said in an interview Wednesday. “Pretty much no healthy teen would ever do that, let alone to come back and get a shot, a shot that can cause a lot of pain.”

In a note to investors on Friday, Mr. Anderson forecast that in 2015, Gardasil would have 65 percent of an estimated $3.7 billion worldwide market for vaccines against the human papilloma virus, with Cervarix accounting for the rest.

If the agency ultimately approves Cervarix for use in young women, Glaxo will have to distinguish the drug as a longer-lasting and more comprehensive vaccine to gain a foothold in the United States market owned by Merck, analysts said.

Since the advent in the 1950s of the Pap test to detect precancerous cells in the cervix, death rates from cervical cancer in the United States have dropped by about 70 percent, said Dr. Debbie Saslow, the director of breast and gynecological cancers at the American Cancer Society. An estimated 11,000 women in the United States will develop invasive cervical cancer this year and about 4,000 women will die from the disease, most of whom have never had a pap test, Dr. Saslow said.

The Food and Drug Administration has approved Gardasil to protect against two strains of the virus, 6 and 11, which can cause genital warts, as well as two strains, 16 and 18, which are responsible for the development of about 70 percent of cervical cancers.

Now, Glaxo has submitted data to the agency, suggesting that its vaccine also provided cross-protection against several other strains responsible in total for about 86 percent of cervical cancers, the company said.

“Cervarix will prevent more cancers and save more lives than a vaccine without cross protection,” Dr. Barbara Howe, director of North American vaccine development for Glaxo, told the F.D.A. panel on Wednesday.

But an F.D.A. expert told the panel that it was difficult to measure protection against addition strains that cause cervical cancer.

The panel also examined safety questions about whether Cervarix could increase a woman’s risk of miscarriage or of autoimmune diseases, rare problems which Glaxo said it would follow in post-marketing studies.

Merck is also hoping for approval from the F.D.A. to protect boys and young men against the strains of the virus that can cause venereal warts.

But, although the F.D.A. panelists voted that Merck had demonstrated the safety and efficacy of Gardasil for boys, skepticism among a few panelists suggested that Merck may find it difficult to persuade boys to have shots for an uncomfortable but non-life-threatening problem that often resolves itself without medical intervention.

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FDA approval for Cervarix and Gardasil recommended by committees

Washington, D.C.

Last week, the FDA received recommendations to approve two vaccines against the human papillomavirus (HPV) that causes cervical cancer.

The vaccine Cervarix is licensed in nearly 100 countries worldwide and approved by the World Health Organization, but it has been awaiting FDA approval since its initial application in 2007 raised concerns about possible side effects. Though structured as a bivalent vaccine to protect only against HPV types 16 and 18, Cervarix has been shown in a recent trial to provide cross-protection against three other HPV types and may also produce a higher degree of protection against precancerous lesions known as grade II cervical intraepithelial neoplasias (CIN2+) than the vaccine Gardasil.

Gardasil has been approved for cervical cancer protection in females aged 9 to 26 since 2006, and targets two additional HPV types that are linked to genital warts, which can occur in males, as well. A second expert committee recommended FDA approval be extended to males in that same age group. The clinical trials on which the committee based its recommendation showed that Gardasil was 89 percent effective in preventing genital warts and had no side effects, though it was less effective in those who had already been exposed to HPV.

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FDA panel backs Glaxo's Cervarix cervical cancer vaccine

Gaithersburg, MD

GlaxoSmithKline PLC's proposed cervical cancer vaccine is safe and effective for girls and young women ages 10 to 25, a U.S. advisory panel said on Wednesday.

The endorsement from Food and Drug Administration advisers moves the Cervarix vaccine closer to the U.S. market to compete with Merck & Co's Gardasil shot.

The panel will vote later Wednesday on whether Merck should be allowed to widen its potential market by promoting Gardasil for men and boys as young as 9 for prevention of genital warts.

Both vaccines are designed to protect against infection with the sexually transmitted human papillomavirus (HPV), which causes cervical cancer and genital warts.

FDA advisers, in an 11-1 vote, said Cervarix appeared safe. Some urged monitoring of miscarriages, which were reported at a higher rate around the time of vaccination compared with a hepatitis A shot. Others urged tracking of muscle and neurological problems seen in a small number of patients.

"The data we have seen to date are reassuring, said Dr. LisaRider, a panel member and official at the National Institutes of Health, adding "I think we do need very strong post-marketing studies" of autoimmune conditions that could cause neurological harm.

The committee voted 12-1 that Cervarix was effective.

The FDA usually follows panel recommendations. Glaxo said a final decision on Cervarix may come as early as this month.

The vaccine already is approved in 98 countries, but some analysts say it will be hard for Glaxo to compete against Gardasil's three-year headstart in the U.S. market. Gardasil won FDA clearance in 2006, while Cervarix stalled following Glaxo's initial application in 2007.

The delays mean Cervarix is no longer the mega blockbuster hope it once was, although FDA approval could still be a minor positive catalyst for Glaxo shares, Citigroup analysts said.

Four years ago, previous chief executive Jean-Pierre Garnier touted the vaccine as Glaxo's most important new product. But the British drugmaker missed the opportunity to vaccinate the initial group of eligible teenage girls in the United States, ceding that business to Gardasil.

Consensus forecasts ahead of the panel decision suggest Cervarix will generate worldwide sales of about $1.2 billion in 2013, equivalent to some 2.5 percent of expected Glaxo sales for that year, according to Thomson Reuters I/B/E/S.

Cervical cancer is often caught early in the United States through Pap smears while the disease is treatable. Still, about 4,000 U.S. women die each year from the disease. Worldwide deaths from the disease total about 280,000, mostly in developing countries where screening is lacking.

"If approved, Cervarix will help provide protection against cervical cancer, a devastating disease that is responsible for thousands of deaths in U.S. women each year," said Barbara Howe, director of Glaxo's North American vaccine development.

The company promised to track potential complications and miscarriages after approval. Neither Cervarix nor Gardasil is recommended for pregnant women.

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FDA says Cervarix vaccine blocks cancer-causing HPV virus

Washington, D.C.

A vaccine from GlaxoSmithKline successfully blocks the virus that causes most cases of cervical cancer, the Food and Drug Administration said Friday.

In documents posted online, the FDA said Cervarix — Glaxo's vaccine against human papilloma virus or HPV — successfully blocked the two most cancerous strains of the virus nearly 93 percent of the time.

The main study of the vaccine enrolled more than 18,000 women who either received Cervarix or a sham treatment. The FDA said the vaccine appears to fight the HPV virus for more than six years, based on company data. Side effects were minor, such as pain and swelling at the injection site.

The agency will ask a panel of vaccine experts next week whether Cervarix should be approved for girls and women ages 10 to 25. The FDA is not required to follow the group's advice, though it usually does.

A positive review from the agency will clear the British drugmaker's vaccine to compete in the U.S., though it could face an uphill battle against Merck's blockbuster vaccine Gardasil, which has been on the market here since 2006.

Besides having a three-year head start, Gardasil also defends against two more HPV types that cause 90 percent of genital warts, something Cervarix does not target.

Cervarix already is approved in nearly 100 other countries, but has been delayed in the U.S. since 2007 when the FDA said it needed additional data.

Earlier studies of Cervarix showed a higher number of muscular and neurological problems among patients who used the vaccine compared with the alternate treatment.

The FDA said Friday it asked outside experts to examine more recent data from the company to see if Cervarix could have caused those problems.

"The conclusion in the case of each of these efforts was that the data are not sufficient to establish a link," the agency said in its review.

The FDA said it would ask Glaxo to report any continuing problems in a follow-up study planned for after the vaccine's launch.

About 6 million people in the U.S. each year contract HPV, which usually causes no symptoms and clears up by itself. While there are about 40 strains of the virus that are spread through sexual contact, only about 15 cause cancer in men and women.

Last year nearly 4,000 women died of cervical cancer.

"Protection against cervical cancer is a very important health need for girls and young women, and we believe Cervarix has an important role to play in addressing this," said Glaxo spokeswoman Lisa Behrens.

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World Health Organization approves Cervarix cervical cancer vaccine

London, UK

The World Health Organization approved a second cervical cancer vaccine, this one made by GlaxoSmithKline PLC, meaning U.N. agencies and partners can now officially buy millions of doses of the vaccine for poor countries world-wide.

Glaxo said in a statement Thursday the approval would help speed access to Cervarix. WHO had previously approved Gardasil, a competing cervical cancer vaccine made by Merck & Co. With two cervical cancer vaccines now ready to be bought by donor agencies, officials estimate that tens of thousands of lives might be saved.

More than 80% of the estimated 280,000 cervical cancer deaths a year occur in developing countries. In the West, early diagnosis and treatment has slashed the disease's incidence.

Last year, the global health association GAVI, formerly known as the Global Alliance for Vaccines and Immunization, prioritized the purchase of cervical-cancer vaccines for the world's 73 poorest countries. GAVI includes U.N. agencies, the World Bank and the Bill & Melinda Gates foundation and is a major buyer of vaccines for the developing world.

"We're very eager to offer women in developing countries these vaccines because without early screening, they are arguably more vulnerable to cervical cancer," said Dan Thomas, a GAVI spokesman. Mr. Thomas said the vaccine's price was essential to making it available to poor countries.

In the West, the vaccines typically cost about $360 for a three-shot dose -- which is far too expensive for poor countries, Mr. Thomas said.

Mr. Thomas said GAVI is in talks with drug makers, but that it still isn't clear whether either Merck or Glaxo might sell their vaccines to donor agencies at a cheaper price.

Cervarix hasn't been approved for use in the U.S. or Japan, but is available in 97 other countries. In the U.S., the cervical cancer vaccine market has been cornered by Gardasil since its approval in 2006.

The FDA is expected to decide within the next few months whether to approve Cervarix. Gardasil racked up $426 million in global sales in the most recent quarter, versus $69 million for Cervarix, which has won more contracts from government health programs beyond the U.S.

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Glaxo study shows Cervarix fights protects against the five most common cervical cancer-causing viruses

London, UK

GlaxoSmithKline Plc's (GSK.L) Cervarix is the first product of its kind to show it protects against the five most common cervical cancer-causing viruses, Europe's biggest drug company said in a statement on Tuesday.

A study, published in Tuesday's issue of The Lancet, said that as well as protecting against the two most common virus types, the vaccine also provides protection against the next three most common cancer-causing virus types.

Glaxo said the additional efficacy could translate into approximately 11 to 16 percent extra protection against cervical cancer over and above the protection afforded by efficacy against the two most common types alone.

It is the first time for any cervical cancer vaccine that significant protection has been shown against pre-cancerous lesions not containing the two most common virus types, Glaxo said in a statement.

"This is really good news for primary prevention of cervical cancer as it indicates the vaccine could offer women additional protection ... beyond what had at first been anticipated," said Thomas Breuer, head of global clinical R&D at GSK Biologicals.

BOYS AND MEN

Cervarix and its rival Gardasil, produced by Merck & Co Inc's (MRK.N), are only approved for use in girls and women, but the companies are seeking new markets and some experts say it should be used in boys and men, to protect them and their future sexual partners.

In comments accompanying the Cervarix study, the researchers said the only efficient way to stop the virus is to also vaccinate boys and men because they make up the other half of the sexually active population.

"Women have shouldered responsibility for contraception since its inception. The goal to eradicate sexually transmitted carcinogenic viruses can be jointly carried by women and men and could be accomplished within a few decades," said Karin Michels from the Harvard Medical School in Boston and Harald zur Hausen from the German Cancer Research Centre in Heidelberg.

Glaxo is waiting for approval in the U.S. market for Cervarix. U.S. approval was delayed in June last year after Glaxo said it would augment its application with results from a further study after responding to outstanding questions over the product from the Food and Drug Administration.

Cervarix is already approved in more than 90 countries including major European markets. (Reporting by Ben Deighton; Editing by David Holmes and Jon Loades-Carter)

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Glaxo's cervical cancer vaccine faces US battle

Trenton, NJ

New studies show GlaxoSmithKline PLC's vaccine Cervarix blocks the virus that causes cervical cancer, but if it wins approval for U.S. sales, it will face an uphill battle against Gardasil, which has owned the market here for three years.

Cervarix, Glaxo's vaccine against human papilloma virus or HPV, already is approved in more than 90 other countries, but has been held up by delays in the United States. Several years ago, the British drugmaker was in a neck-and-neck race with rival Merck & Co., Gardasil's maker, to be first on the U.S. market, but it lost when Gardasil got approved in June 2006.

Late in 2007, the Food and Drug Administration declined to approve approve Cervarix. GlaxoSmithKline submitted a new application on March 30 that included final data from an 18,000-woman study recently completed.

Final results from that study and two others are being presented this weekend at a conference in Sweden on papillomavirus. FDA is expected to decide whether to approve Cervarix within several months.

If it does, analyst Erik Gordon, a professor at the University of Michigan's Ross School of Business, said doctors who have prescribed Gardasil for a few years may see no reason to switch -- unless GlaxoSmithKline convinces them its product is much more effective or has fewer side effects.

Both vaccines target the two types of HPV that cause about 70 percent of cervical cancers, types 16 and 18, and data indicate both are about 98 percent effective. But Merck also has data showing Gardasil blocks two other HPV types that cause most cases of genital warts that Cervarix does not target.

That will be a key factor for doctors, experts said.

"All else being equal, it's a no-brainer for the doctor, (who) wants to give the most efficacious treatment," Gordon said.

Gardasil racked up only $426 million in global sales in the most recent quarter, versus $69 million for Cervarix, which has won more contracts from government health programs in other countries.

Partial results of the new Cervarix studies released to The Associated Press indicate it also offers good protection against 12 other HPV types.

One of the studies, which looked at looked at levels of antibodies to some HPV types after study participants were vaccinated with Cervarix or Gardasil, found higher antibody levels induced by Cervarix. But Dr. Gary Dubin, head of one of Glaxo's clinical development centers, said that doesn't prove Cervarix is more effective.

New data will be presented at the same conference on Gardasil, indicating it blocks HPV 16 for at least 9 1/2 years, according to Merck. Glaxo has followed women for up to 7 1/2 years and continues to test some to see if they develop cervical lesions or cancer.

Dr. Cynthia Rand, a researcher, pediatrician and associate professor at the University of Rochester Medical School, said Cervarix appears to be effective. But she said the higher antibody levels triggered by Cervarix, compared with Gardasil, might be meaningless. She said doctors don't know if they will have to give booster shots years from now for either vaccine.

"It won't change my practice" of giving Gardasil and likely won't do so for other doctors, said Rand, whose university has patent claims and receives some royalties related to both vaccines. "Pediatricians prefer in general to also protect against genital warts."

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Glaxo’s cervical cancer vaccine will take longer to get to U.S.

Washington, D.C.

Just when we were talking about delays keeping drug makers’ products from the U.S. market, GlaxoSmithKline announced that its cervical-cancer vaccine Cervarix may take even longer to get to the U.S. than expected.

The company said today that it wants to submit additional data to the FDA, and it now doesn’t expect an FDA decision before late 2009. The FDA had already delayed Cervarix, asking Glaxo for more information.

Now, Glaxo says it has answered the FDA’s questions, but wants to submit more data from a clinical trial that should finish by the end of this year. The clinical trial is measuring Cervarix’s safety and efficacy in thousands of women. Glaxo submitted interim data from the trial with its initial application to the FDA in March 2007.

The development means more profit for Merck, whose blockbuster Gardasil is the only cervical cancer vaccine on the U.S. market. Cervarix is on the market in Europe, Mexico, Australia and parts of Asia.

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GSK Cervical Cancer HPV Vaccine Cervarix Reported Effective for More Than Six Years

Falls Church, VA

GlaxoSmithKline (GSK) has new data that it says shows that its experimental cervical vaccine Cervarix protects women against the four most common types of the human papillomavirus known to cause cervical cancer for nearly six and a half years.

Over this period, which is the longest for protection reported to date, Cervarix “showed 100 percent efficacy in preventing precancerous lesions due to cancer-causing virus Types 16 and 18 and also provided substantial protection against infection caused by virus Types 31 and 45,” the company said.

The data came from an extended follow-up analysis of 776 women ages 15–25 in the U.S., Canada and Brazil who had participated in an initial efficacy study of the vaccine. Nearly 100 percent of the women in the study maintained high levels of antibodies against virus Types 16 and 18 at all times for close to six and half years, GSK said.

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