Gardasil

GSK, Sanofi lobby Irish for HPV shots

Tracy Staton — Tue, 02 Dec 2008 10:51:52 -0500

Drugmakers are dispatching experts to the Emerald Isle to lobby for their human papillomavirus vaccines. That's because the Irish government has opted out of a comprehensive program to vaccinate young women against HPV, which can cause cervical cancer and genital warts. Instead, Ireland plans a screening program for cervical cancer in hopes of catching the disease early--and saving money in the process.

GlaxoSmithKline, which makes the Cervarix HPV shot, and Sanofi Pasteur, which markets Merck's Gardasil in Europe, say screening isn't enough. They're sending cervical cancer experts to speak to consultants and healthcare types about the benefits of vaccination. For instance, Sanofi dispatched Margaret Stanley of Cambridge University last week, and GSK is hoping to get Dr. Anne Szarewski, a clinical consultant at the Wolfson Institute of Preventive Medicine, in front of Ireland's health minister later this week.

A spokesperson for Minister Mary Harney told the London Times that an HPV vaccine program would play a role in Ireland's overall response to cervical cancer, but that vaccinating all young women isn't practical right now. "The decision not to proceed... is not based on the scientific evidence," the spokesperson said, "but is related to the need to prioritize scarce resources given the current state of the public finances."

But GSK takes issue with the Minister's cost estimates for a vaccine program, too. Claire Taaffe, a GSK spokeswoman, told the Times that the company thinks the cost would be lower than the 10 million euros government is quoting. Competitive bidding would cut that cost considerably, she said.

- read the story in The Times

Study: Gardasil for boys works, too

Tracy Staton — Thu, 13 Nov 2008 11:12:51 -0500

You can't accuse Merck of failing to claim new territory. The drugmaker is already trotting out research that supports using its human papillomavirus vaccine in young men and boys, as well as girls and young women. Merck aims to ask the FDA by year's end for permission to market the shot to males.

The Merck-funded study showed that Gardasil prevented 90 percent of external genital lesions caused by the strains of HPV the shot covers. The shot also was 85.6 percent effective at cutting persistent infection, the research showed. "This is groundbreaking data," one of the study's co-authors told Dow Jones.

Doubling the potential market for Gardasil in one fell swoop--that's ambitious. But it could be necessary to goose sales of the shot upward again. Gardasil has been sagging a bit lately, though it has managed to work its way through about one-third of eligible females in the U.S. The problem is that success cuts into the number of potential shot recipients, and those numbers can't be replaced by the girls aging their way into Gardasil eligibility.

- read Merck's release
- check out the WSJ Health Blog's take

CDC: Side effects not linked to Gardasil

Tracy Staton — Thu, 23 Oct 2008 10:37:32 -0400

Merck appears to be having a few difficulties marketing Gardasil--but now it may have one less. In their first post-marketing review of the human papillomavirus vaccine, U.S. health regulators conclude that reported side effects likely weren't caused by Gardasil. Data from that post-marketing safety study, along with stats from the vaccine adverse events reporting system, together showed that there was no increased risk of certain potential side effects, including Guillain-Barre Syndrome, stroke, blood clots, anaphylaxis, and more. "Based on all of the information we have today, CDC and FDA have determined that the HPV vaccine is safe to use and effective," the CDC said.

Meanwhile, BNet and the Pharma Marketing Blog have pointed out that Gardasil could end up as a victim of its own success. "As more girls get the shot, its remaining market declines--and thus Merck must target increasingly marginally profitable populations" BNet notes, commenting on the company's aim at 19-to-26-year-olds who have been less likely to get the shot thus far.

Why not simply target the three-quarters of teenagers who haven't been vaccinated against HPV yet? For one thing, Merck is hamstrung by marketing rules; it needs parental permissions to direct promotional mail and email to kids who aren't of age. And it has to do something to reverse the shot's 33 percent decline in sales.

- check out the side effects report in the WSJ
- read BNet's take
- see the post at the Marketing Blog

Dutch probe GSK, Sanofi over HPV shots

Tracy Staton — Mon, 20 Oct 2008 10:17:33 -0400

Government officials in the Netherlands are investigating accusations that Sanofi-Aventis and GlaxoSmithKline were providing research funding to members of the country's Health Council, which advises the government on public health issues, at a time when the group was considering whether to have girls vaccinated against the human papillomavirus.

As you know, Sanofi-Aventis markets the HPV vaccine Gardasil in Europe in a joint venture with Merck. Glaxo sells Cervarix, its HPV vaccine, which hasn't yet received U.S. approval.

The Health Council recently recommended that girls should get shots to prevent HPV infection, which can cause cervical cancer and genital warts. But now, the Dutch Socialist Party wants Parliament to debate the issue. Party Chair Agnes Kant says the drugmakers have been too aggressive at marketing their vaccines. And she suggests that they've tried to influence the council's decision-making via funding.

Glaxo told Pharmalot that it's cooperating with the Dutch authorities, and that a lot of misinformation is going around in the Dutch media about the issue. The company is "taking steps to correct the false information." Stay tuned.

- read the post at Pharmalot

HPV vaccine makes inroads, CDC says

Tracy Staton — Fri, 10 Oct 2008 10:31:51 -0400

Merck's Gardasil has quickly taken hold among teenage girls, the CDC reports. According to the health agency's teen vaccine survey, at least one in four girls has received at least one dose of the human papillomavirus vaccine, which is designed to stave off four strains of the virus that's linked with cervical cancer and genital warts.

That's pretty quick uptake for a vaccine just approved in June 2006. "For a new vaccine, 25 percent coverage is really very good," the CDC's vaccine services chief said.

There are several hindrances to new immunizations, experts told the Wall Street Journal. For one thing, parents tend to be cautious about vaccine safety. Plus, in Gardasil's case, protection can be expensive. The three-shot course costs about $375, and it's unclear whether it offers lifetime immunity or will require boosting in the future. And because Gardasil protects against a sexually transmitted virus, some parents feel free to wait a year or two beyond the recommended administration age of 11 to 12 years, which could be inhibiting uptake numbers.

- see the CDC release
- check out the story in the New York Times
- see the WSJ's article

FDA grants Gardasil two new indications

Tracy Staton — Mon, 15 Sep 2008 11:01:18 -0400

Some good news for Merck's Gardasil: The FDA says the human papillomavirus vaccine is approved for prevention of vulvar and vaginal cancers, in addition to its current use as a cervical cancer shot. The new indications come at a good time, when Gardasil was faltering on lower-than-expected use among women 19 to 26. And Merck lost its FDA bid for approval in older women, so it couldn't mount a marketing push for that segment of the market.

Now, the company can tout increased protection. "This is fabulous stuff," said Rick Haupt, Merck's program leader for Gardasil.

Next up: data on the use of Gardasil in men. The company hopes to submit a study in support of that new indication by year's end.

- read the FDA release
- check out the story in the New York Times

Analyst gloomy on Merck trends

Tracy Staton — Thu, 11 Sep 2008 11:22:30 -0400

An influential pharma analyst downgraded Merck shares, saying they've hit their price ceiling. Why? The reasons can be summed up in four drugs: Singulair, Gardasil, taranabant, and Vytorin.

Sanford Bernstein's Tim Anderson wrote to investors that Singulair scrips are sluggish, and an ongoing FDA safety review could depress them further when it wraps up at year's end. Plus, Teva might launch a generic competitor next year even though it would be on shaky patent ground. Gardasil sales trends have been weak, too, Anderson says. Vytorin--and its sister cholesterol drug Zetia--have been suffering under controversy since the beginning of this year.

And then there are pipeline troubles, symbolized by the obesity drug taranabant's psychiatric side effects. Anderson thinks there's a good chance the med won't be approved. But, he says, Merck could turn this pipeline perception around in December with some good news at its annual R&D update. Guess we'll have to wait and see.

- see the Pharmalot post

Gardasil "remarkably safe," despite anaphylaxis

Christe Bruderlin-Nelson — Wed, 03 Sep 2008 03:35:55 -0400

Gardasil is "remarkably safe," according to a new study by Australian researchers published in the Canadian Medical Association Journal, even though the study found that the receiving the vaccine meant girls had between a five and 20 times higher risk of developing allergic reactions compared to other vaccines. The drug has been approved in the United States since 2006.

Twelve in the sample of 114,000 Australian girls and women had an anaphylactic reaction during the study period, and eight of those had received the vaccination. The rate anaphylaxis was 2.6 per 100,000 doses (269,680 doses given), which compares unfavorably to a rate of 0.1 per 100,000 doses seen in the C-conjugate meningitis vaccine. Gardasil aims to prevent some of the strains of human papilloma virus (HPV), which is often associated with later development of cervical cancer.

The researchers admitted the rate of serious allergic reactions is much higher for Gardasil than for other vaccinations that children receive and while the girls received prompt treatment, the reactions were potentially serious and could have been life threatening.

As with any medication or vaccine, a thorough risk-benefit analysis is always a smart idea. Patients should consider the immediate risk of contracting HPV, allergies, side effect profile, Pap smear compliance, cost and tolerance to pain before deciding on the Gardasil vaccine.

The Journal of the American Medical Association's editor-in-chief, Pediatrician Catherine DeAngelis, does not give the vaccine carte blanche, saying that we don't yet know how long the vaccine will last or what the true risks are down the road.

- check out the Washington Post article
- read the U.S. News & World Report article
- here is what PharmaTimes says
- see the CMAJ study

Pfizer, Merck go for indirect ads

Tracy Staton — Fri, 29 Aug 2008 12:22:29 -0400

The new trend in drug marketing isn't drug marketing at all. New commercials from Pfizer and Sanofi-Aventis, plus what can only be called a "jewelry campaign" from Merck, show that pharma companies are again turning to disease awareness to sell their products.

Pfizer unveiled a new "My Time to Quit" commercial during the Olympics, which encouraged people to quit smoking, but didn't mention the company's stop-smoking med Chantix at all. By leaving out the drug's name, the drugmaker also got to leave out that unwieldy recitation of side effects that can eat up 20 seconds or more. Instead, the ad sent viewers to mytimetoquit.com, a site that links to a Chantix website.

Likewise, Sanofi-Aventis' latest marketing ploy for insomnia med Ambien involves a 15-second ad and an annoying rooster. The commercials refer viewers to silenceyourrooster.com, a site that promotes the drug. The idea seems to be working, traffic-wise: The site got 400,000 hits in the commercial's first seven days on the air.

Meanwhile, Merck has been promoting Gardasil via its Charm4Life campaign women's magazines. The ads promote "limited edition" bangle bracelets (pictured here) designed by the jewelry company Alex and Ani (magazine ad). Pay $32 for four of them, and the proceeds will go to the Prevent Cancer Foundation. The charm4life.com website, where women can order the bracelets, offers information about the human papilloma virus that can cause cervical cancer. "Talk to your doctor," the site suggests. "Or find out more for yourself right now." The "find out more" is hyperlinked to a Gardasil website.

Why the sudden turn to awareness campaigns? Some experts theorize that it's the intense scrutiny Congress has been offering product-oriented ads. But others wonder whether the awareness approach might backfire, attracting the very critique they may be designed to prevent.

- read the Wall Street Journal article
- see the story at CNBC
- check out the Pharmalot item

Is Gardasil worth the cost?

Tracy Staton — Thu, 21 Aug 2008 10:35:17 -0400

Are HPV vaccines worth the cost? A study in the New England Journal of Medicine concludes that they aren't--at least not for women over 18. They'll only be cost-effective, the resesarchers decided, if they're given to pre-adolescent girls, if they prove to protect girls for a lifetime (so far, they've only been studied for six and half years, so the jury's out) and if current methods of screening for cervical cancer using Pap smears can be adjusted to reduce costs, so that the $400 price tag for the shots can be recouped.

The study could be a blow to Merck's Gardasil and GlaxoSmithKline's Cervarix. Merck has already had some difficulty getting college-age and older women to get the vaccines, contributing to a slowdown in sales for Gardasil. And GSK, which hopes to introduce Cervarix in the U.S. this year, could find doctors and patients slow on the uptake. Plus, one of the companies' strategies has been persuading governments to push the shots, even make them mandatory, and in countries where governments control drug reimbursements, cost-effectiveness often comes into play.

In developed countries, Pap smear screening and treatment have cut cervical cancer deaths to very low levels already. And because the vaccines only protect against two of the cancer-causing strains, that sort of screening still needs to continue even in vaccinated patients. In fact, some women's health advocates have publicly worried that vaccinated women might get lax about their Pap smears, thinking they're in the free and clear because of the shot.

--read the story in the New York Times
--see the Wall Street Journal article

Will Gardasil special help Merck?

Christe Bruderlin-Nelson — Wed, 20 Aug 2008 02:34:42 -0400

Merck isn't having the best week in the news (and is the subject of quite a few pharma jokes), but revenues on its cervical cancer vaccine were behind before the week started. Now the Gardasil vaccine maker is working diligently to help its lagging vaccine pick up steam again. It appears that physicians are checking insurance coverage before administering Gardasil shots, and that means fewer sales for Merck.

Of course, the shot costs more than $100 a pop and physicians foot the bill if insurers don't pay, so it makes sense for docs to verify coverage first.

To help out, the company offered to give replacement dosages of the vaccine to physicians, under certain circumstances.

According to several reports, Barbara Ryan of Deutsche Bank hosted a conference call with Merck during which the head of its vaccine business, Maggie McGlynn, mentioned that the company will give physicians a free dosage of the vaccine if an insurer refuses coverage--in the hopes that more physicians "will convert to same-day vaccination." The deal only applies to women between 19 and 26 years old who have private health insurance. It also has quite a few other contingencies, including stipulations for "proper" claim submission and proof that the private plan does not reimburse even a penny.

This is in addition to Merck's efforts to make the vaccine mandatory for young U.S. girls, with many wondering if the rise in cervical cancer vaccines are due to increased awareness or to Merck's aggressive, award winning and highly controversial marketing schemes.

--see the New York Times story
--find what they're saying at the Pharmalot blog
--get Merck's program details

Gardasil side effects prompt CDC study

Christe Bruderlin-Nelson — Wed, 13 Aug 2008 06:06:03 -0400

Merck is likely quite displeased with the barrage of negative press about its cervical cancer vaccine's side effects, especially after a public interest group, Judicial Watch, released a report at the end of last month saying there were 9,749 adverse reactions and 21 reported deaths related to Gardasil in the last two years.

According to the report, there have been 78 severe outbreaks of genital warts, six cases of Guillain-Barré syndrome and at least 10 miscarriages reported to the Vaccine Adverse Event Reporting System (VAERS) since the approval of Gardasil. However, a study in the New England Journal of Medicine found that clinicians, patients and drug companies report only about 10 percent of side effects to VAERS, so the actual number of Gardasil side effects could be much higher.

Some experts say Merck has also overstated the vaccine's effectiveness and that the evidence just isn't there yet. In light of the potential side effects and the drugs' young female target audience, many also are questioning Merck's continual push to place the drug on state mandatory vaccine lists.

For its part, Merck says there is no evidence that the vaccine and the reported side effects and deaths are related, and the CDC plans to release a study in October that will help determine whether a true linkage between Gardasil and the reported adverse reactions exists.

- see more at News Inferno
- read the story at ABC
- get an alternative view at Natural News

Gardasil: Some good news for Merck

Christe Bruderlin-Nelson — Wed, 23 Jul 2008 10:32:50 -0400

Here's some news that Merck can really use: FDA and CDC gave its Gardasil a (re)seal of approval, saying the vaccine is safe and effective for the prevention of some of the strains of genital warts that can lead to cervical cancer. The vaccine had already received FDA approval for use in females, ages 9 through 26 years.

Agency officials reviewed nearly 10,000 reports of health problems (including 20 deaths) that followed injections with the vaccine, but both the FDA and CDC said in a statement, "There was not a common pattern to the deaths that would suggest they were caused by the vaccine." The agencies also did not find an association between the uncommon neurological disorder, Guillain-Barre Syndrome, and the vaccine, despite patient reports and found that 94 percent of the reported side effects were not serious.

Merck decreased its projections of Gardasil sales on Monday, which was the first of two major hits to its stock prices this week.

- see the official FDA statement
- read the story at the Scientific American
- check out this Pharmalot blog post
- find out more at The Guardian

Flat Gardasil sales trigger Merck sell-off

Tracy Staton — Tue, 08 Jul 2008 09:44:43 -0400

A one-two punch for Merck's Gardasil yesterday: First, a market analyst downgraded the company's stock largely because of flat sales of the human papilloma virus vaccine. Gardasil sales have fallen short of expectations, in fact, for the past two quarters; Merck blamed the slowing growth on seasonal issues. But, says UBS's Roopesh Patel, the second quarter ought to be different, and so sales ought to take a leap upward. But he's calculated Gardasil revenues at $300 million this quarter, just slightly more than $293 million in the first quarter. The sales trends "don't look encouraging," he says. Discouraged investors triggered a sizable drop for Merck's shares.

Second, CBS News ran a piece about reported side effects. The story cited some 8,000 adverse event reports and offered details of a few serious ones--seizures, chronic pain, paralysis, and death from blood clots. Of course these reports are anecdotal; there's no proven causal link between the vaccine and the medical problems girls subsequently developed. But publicity about them can be enough to throw nervous parents off--and the story is already proliferating on other TV news programs and across the web.

- see the market story at Pharmalot
- check out the Wall Street Journal article
- read the CBS News report

One up, two down for Merck's vaccines

Tracy Staton — Thu, 26 Jun 2008 09:41:02 -0400

One out of three ain't bad? Out of a trio of Merck vaccine news today, one story was a clear thumbs-up for the company: Its RotaTeq vaccine delayed the onset of the usual rotavirus season by about three months--from November to February--compared with the usual schedule. You'll recall that Rotateq was recommended for routine use in infants two years ago; now that's it's in use, the number of lab tests for the virus dropped by 37 percent from January to May 2008, and positive tests fell by 79 percent. The CDC says it's possible that widespread use of the vaccine is actually staving off the spread of rotavirus to unvaccinated kids, too.

And now for the bad news. First, the FDA said it's not ready to approve Merck's HPV vaccine Gardasil for use in older women. The company says the agency has "issues" that it will respond to next month. It could just be a temporary setback. Merck certainly hopes so; expanding the use of Gardasil first to older women and next to male carriers is a key growth strategy.

Second, the company is having a tough time getting a crucial ingredient for its Zostavax shot, Merck's anti-shingles product. The company will continue to accept orders, but shipments could be delayed by up to six weeks. The problems stem from a manufacturing problem at Merck that led to shortages of another varicella vaccine product last year.

- see Merck's release
- read the Pharmalot item on Rotateq
- check out the Gardasil news at Seeking Alpha
- see the Wall Street Journal's story on Zostavax

PLUS: Many Wall Street analysts greeted the FDA's decision to reject Merck's bid to expand the use of Gardasil to 27 to 45-year-old women with a yawn. Report

ALSO: A U.S. advisory panel added GlaxoSmithKline's two-dose rotavirus vaccine to the recommended list for infants, where it will join Merck's three-dose product Rotateq. Report

Merck's Gardasil goes to the movies

Tracy Staton — Mon, 23 Jun 2008 11:12:31 -0400

Seems like a match made in marketing heaven. Merck has been pushing its Gardasil vaccine--designed to prevent cervical cancer and genital warts by fending off the human papilloma virus--via ads in movie theaters showing Sex and the City. The ads are ostensibly aimed at the 19-to-26-year-old females likely to see the movie, which is, not incidentally, a clear target for the HPV shot. The vaccine is approved for girls and young women age nine to 26.

The ads also will be shown in tandem with other summer releases, such as Get Smart and The Incredible Hulk, two films not so focused on the young female audience. The speculation? That Merck is building up awareness of Gardasil among young males, who can also carry the HPV virus--and might be Gardasil customers if the company gets FDA approval to market it directly to them.

- read the article in Time

U.K. inks HPV vaccine deal with Glaxo

Tracy Staton — Thu, 19 Jun 2008 10:39:40 -0400

Chalk up a vaccine win for GlaxoSmithKline. U.K. health officials have tapped GSK’s Cervarix as their official HPV preventative, passing over Gardasil, a longer-on-the-market shot marketed by Sanofi Pasteur and developed by Merck. Cervarix will be given to girls 12 and 13 years of age beginning in September.

But while GSK might be celebrating, some patient advocates aren’t. They’d been lobbying for Gardasil, which guards against two other strains of the cancer-causing human papilloma virus and also protects girls from genital warts. “Genital warts is the second most common sexually transmitted infection in the U.K. after Chlamydia,” said the Family Planning Association. “Selecting the Gardasil vaccine would've been a huge preventative measure in terms of health and financial costs to the NHS.”

But the government defended its choice, saying that it awarded the contract based on Cervarix’s score “against a number of pre-agreed criteria.” The GSK product, moreover, "offers best overall value to the NHS," officials said.

- read the story in The Times
- check out the BBC's coverage
- see the article for more

ALSO NOTED: FDA mulls Gardasil use in 45-and-unders; Inverness to close three plants, cut 395

Thu, 20 Mar 2008 07:59:50 -0400

> The FDA will consider approving Merck's HPV vaccine Gardasil for cancer prevention in women up to 45 years. Release

> Restructuring under the gun of new generics and after being slammed by regulatory defeats, Novartis is bidding adieu to James Shannon, its chief of global drug development. Report

> Device maker Inverness Medical plans to shutter three plants that employ 395 people. Report

> Republican presidential candidate John McCain would cost pharma $40 billion if he gets his way on reimportation, critics say. Report

> The FDA gave its blessing to Baxter's new tissue sealant, Artiss, a slow-setting fibrin product designed for use in skin grafts. Report

> Hormone therapy is often overkill for prostate cancer patients, a new study suggests. Report

> AstraZeneca and Bristol-Myers Squibb may face multiple class-action lawsuits that allege they overcharged for meds that have to be administered by doctors. Report

> A New York Times editorial supports the creation of a government-funded "sales force" to counter one-sided pitches from company reps. Report

> Epix Pharmaceuticals has pulled the plug on its depression drug, saying that a mid-stage trial of PRX-00023 failed to demonstrate sufficient efficacy for major depression. Report

And Finally.. Women who complain of memory loss and fuzzy thinking after chemotherapy may have experienced changes in the brain's "white matter." Report

France picks Gardasil over GSK upstart

Tue, 15 Jan 2008 06:59:58 -0500

Gardasil captured more territory for Merck and Sanofi-Aventis yesterday when French health officials recommended that vaccine against Human Papilloma Virus, or HPV. The French authority recommended that girls of 14 be vaccinated against four strains of the virus, which Gardasil does; its rival Cervarix, made by GlaxoSmithKline, protects against only two. Cervarix targets two HPV strains that cause cancer; Gardasil aims at two cancer strains and two that cause genital warts.

It's just one more victory for Gardasil, which made it to market first, and gained all the attendant early-bird advantages. Though Cervarix is approved in a multitude of countries, it's not for sale in the U.S.; the FDA recently asked GSK for more info about the product. But GSK has been so confident in its product that it launched a head-to-head study pitting Cervarix against Gardasil. Results are expected later this year.

- get the report from CNN Money
- read about the U.S. CDC's recent purchase of 10 million Gardasil doses
- here's GSK's release about its Cervarix vs. Gardasil study

It's Crestor vs. Lipitor in AZ trial

Tue, 15 Jan 2008 06:59:55 -0500

If GlaxoSmithKline can challenge Merck to a head-to-head trial (Cervarix versus Gardasil), then AstraZeneca can throw down the gauntlet before Pfizer. In this case, the products in question are statins--AstraZeneca's Crestor and Pfizer's Lipitor. And the study, dubbed Saturn, will compare the two for their ability to decrease progression or induce regression of atherosclerosis over a two-year period. By the time the results are in, Lipitor will be going off patent, and the still-protected Crestor will need a performance edge to tout against cheap, copycat Lipitors.

Who knows, maybe the gamble will pay off. Maybe Crestor will trounce Lipitor and everyone at AstraZeneca will dance joyfully around the exec who came up with the idea for this trial. But the risks are considerable. For a cautionary tale, just consider Merck and Schering-Plough's roll of the Vytorin dice. Presumably, however, AstraZeneca won't hold back the trial results if they don't look good. At least we hope not.

- see this release from AstraZeneca
- read the article at MarketWatch

Related Articles:
Lipitor patent gets U.S. thumbs-down. Report
Lipitor is No. 1, but faces generic threat. Report
AZ hits back at Crestor imitators. Report