Merck

Merck plans big vaccine expansion in India

John Carroll — Thu, 20 Nov 2008 08:31:52 -0500

Merck is beefing up its sales and marketing forces in India as it aims at evolving into the country's biggest vaccine supplier by 2013. According to a report by FinancialWire, Merck says it will hire some 1,500 people in India as it expands on the two vaccines it already markets on the subcontinent. The pharma giant is following in the footsteps of GlaxoSmithKline and Sanofi-Aventis, which have already established ambitious vaccine groups in India.

Slightly more than a third of the country's 1 billion citizens are under the age of 14, offering a huge market for pediatric vaccines. One in six Indians are under the age of six. And the government has been conducting mass education campaigns aimed at educating its huge population about the need for vaccines.

India, meanwhile, has already established a reputation as a low-cost center for vaccine manufacturing and research. According to a report from the research firm RNCOS, roughly two thirds of the low-cost vaccines made in India are exported to other countries.

- read the report from Trading Markets

In Phase III, Gardasil prevents HPV in men

Maureen Martino — Thu, 13 Nov 2008 14:28:26 -0500

It looks like Gardasil may not just be for girls anymore: a Phase III study of Merck's HPV vaccine found that the jab prevented 90 percent of external genital lesions caused by the disease men aged 16 to 26. In a study of 4,000 men, only three subjects who got the shot developed lesions; there were 31 cases in the placebo group. Gardasil prevents lesions caused by types 6, 11, 16 and 18

Merck said that the company remains on track to submit an sBLA for Gardasil for use in men by the end of 2008. The findings were presented at the European Research Organization on Genital Infection and Neoplasia (EUROGIN) International Multidisciplinary Conference.

- see Merck's release
- read the WSJ blog post

T-cell HIV vax still promising

Maureen Martino — Wed, 12 Nov 2008 15:39:21 -0500

The disastrous results of Merck's HIV vaccine trial--known as V520-- have called into question whether T-cell-based HIV-1 vaccines are a viable option for preventing the disease. But a study led by Beth Israel Deaconess Medical Center researchers finds that a T-cell-based vaccine should still be pursued by researchers.

"Despite the disappointing setbacks in HIV-1 vaccine development this past year, our findings suggest that we're not at the end of the road when it comes to T-cell vaccines," said the study's lead scientist Dan Barouch, MD, PhD. "Our data show that T-cell vaccines that elicit greater magnitude, breadth and quality of immune responses as compared with the Merck vaccine can result in improved protection in the rhesus monkey model of AIDS."

In 2007, Merck halted development of V520 when the vaccine proved to be ineffective. Further analysis showed that the jab actually increased infection rates in those who received it.

- see the release

HPV researcher calls for vaccination of males

Calisha Myers — Mon, 10 Nov 2008 16:04:14 -0500

Discussion of the benefits of vaccination against the human papilloma virus (HPV) almost always centers around women, especially young women, who are at greater risk of developing cervical cancer. Speaking at an event in Canada late last month, the Nobel Prize winning pioneer of HPV research, Dr. Harald sur Hausen, called for the vaccination of men as well. As in women, the more dangerous strains of the virus, HPV-16 and HPV-18, can contribute to the development of anal and penile cancer.

Studies by the CDC indicate that homosexual men are at an even higher risk than heterosexual men; gay and bisexual men may be up to 17 times more likely to develop anal cancer.

The HPV vaccine Gardasil is not yet approved for men, but the manufacturer, Merck, is currently conducting clinical trials to determine the effectiveness of Gardasil in males. Merck spokeswoman Sheila Murphy says she is hopeful that preliminary data for the study will be available soon. "There is going to be a [peer reviewed] meeting in Europe in November, and I was hoping there would be some data presented there, and I still haven't heard whether that is going to be the case or not," Murphy tells Canada's Xtra.

But, Murphy said, it may be another two years before there is a vaccine for men on the market. Although some countries have allowed boys to be given Gardasil based on initial studies, others, such as Canada, have asked for efficacy studies. "In Canada... they want us to do the efficacy studies, to show in fact that the vaccine, not only does it cause an immune response recognition, but it actually prevents a disease," she said.

- check out Xtra article for more

Merck starts work on vax R&D center

John Carroll — Thu, 06 Nov 2008 08:29:06 -0500

Merck is preparing to launch construction of a €200 million vaccine R&D facility in the southeastern area of Ireland. The pharma giant says that construction will get started next year and should wrap in 2010.

"The new vaccine and biologics facility will bolster our expanding global vaccines business, which includes products to protect against hepatitis, zoster, rubella, measles and haemophilus," said Merck. "The project will create 170- new high-quality jobs by 2011 across all areas of management, quality control, engineering, research and development and administration."

Irish officials lauded the move as another sign of the country's growing role in biotechnology.

- read the story in Medical Laboratory World

HIV vax debacle linked to T-cell activation

John Carroll — Thu, 06 Nov 2008 08:27:51 -0500

The failure of Merck's HIV vaccine caused havoc in the field as the NIH pulled back and tried to find out what went wrong. Now French researchers led by Eric Kremer of the University of Montpellier in France believe they can explain why the crucial Merck HIV vaccine trial had to be stopped last fall after it raised the risk of HIV infection. Injecting an adenovirus 5-based vaccine into people with adenovirus 5 antibodies evidently activated T cells, which are targeted for infection by HIV. And that response--in which the immune system became more receptive to the virus rather than attacking it--created a "target-rich environment favoring successful HIV transmission."

"I think that it outlines a very interesting hypothesis that might explain some of the STEP data," says Larry Corey, leader of the HIV Vaccine Trials Network, which conducted the STEP trial. But he cautions, "One should recognize that the data presented are still largely in vitro and that further experiments to define whether this occurred among vaccines in STEP need to be done."

"They're building on a series of reasonable hypotheses, but there are lots of alternative ways this could be happening," says Jeffrey Ravetch of the Rockefeller University in New York.

- read the article in Nature
- and check out the story in Ivanhoe

Rotavirus vax draws rave review at annual gathering

John Carroll — Tue, 28 Oct 2008 14:41:06 -0400

A new vaccine that targets rotavirus is being credited as a remarkable success. A slate of studies say that RotaTeq has sliced the number of new cases by anywhere from 66 percent to 100 percent. And researchers point to data that indicates that the benefits extend to children who have not been vaccinated.

One study of 61,000 infants funded by the manufacturer, Merck Research Laboratories, concluded that RotaTeq offered 100 percent protection against hospitalization and ER visits. RotaTeq was approved in 2006 and is provided to infants orally at two, four and six months. The new data was presented at the annual meeting of the American Society for Microbiology and the Infectious Diseases Society of America.

"The success of the rotavirus vaccine is a major theme of this meeting," said Michael Scheld, M.D., of the University of Virginia School of Medicine in Charlottesville.

- read the story from WebMD

CDC expands recommendations for Merck's PPV vax

Calisha Myers — Thu, 23 Oct 2008 15:21:43 -0400

Adults smokers ages 19 to 64, or those in that age group with asthma, should receive the pneumococcal polysaccharide vaccine (PPV), according to the CDC's Advisory Committee on Immunization Practices (ACIP). The ACIP voted unanimously to issue the recommendations after examining study data, which demonstrated that the risk for pneumococcal diseases among smokers, such as pneumonia and meningitis, is about four times the rate for non-smokers. Data also revealed an increased risk of pneumococcal diseases among people with asthma.

In addition to the vaccine, the panel also recommended that smokers receive smoking-cessation counseling. It's likely that the CDC will adopt the panel's recommendations, which means an estimated 35 million smokers will be directed to get the jab and counseling.

PPV, marketed in the U.S. by Merck as Pnuemovax 23, is the only pneumococcal vaccine approved in the U.S for adults. Novartis has a a pneumococcal vax expected to begin trials in 2010.

- check out the Merck release
- read the AP article for more

Merck eyes big shares of Indian vax market

John Carroll — Thu, 23 Oct 2008 08:32:35 -0400

Merck is positioning itself to become the largest vaccine player in the Indian market by 2013. And it's concentrating on rolling out vaccines for cancer, rotavirus and shingles as soon as they become available.

"We plan to launch the latest products from our global stable at a relatively faster pace. While the lead time for MNCs to launch their novel drugs in India is 17-20 years after the US or European launch, we will look at near concurrent launch in India," said Anjana Narain, director (vaccine), MSD Pharma, the wholly-owned Indian arm of Merck. According to the Economic Times, Merck has two vaccines in the Indian market--Pneumovax 23 and the recently-launched Gardasil.

The Indian vaccine market has been growing at a rate of 25 percent to 30 percent a year.

- read the report from the Economic Times

ALSO: Construction hasn't even finished at Merck's new Durham, North Carolina vaccine plant and the company's already considering what to do next. The $750 million plant, which is expected to be completed in 2011, will house 400 workers and the production of childhood vaccines and a shingles shot for adults. But Merck has two more experimental vaccines in testing that will need a home. Article

Critics accuse Merck of hyping cervical cancer risk

John Carroll — Thu, 21 Aug 2008 08:29:14 -0400

Just how important Gardasil has become to Merck's top line is underscored by a New York Times article analyzing the impact of what the pharma company calls "educational programs" and just about everyone else refers to as a very effective marketing campaign. In a short period of time cervical cancer has transitioned from obscure killer to what the Times calls the "disease of the moment." And tens of millions of girls in Europe and the U.S. have been vaccinated at a cost ranging from $400 to $1,000.

Merck's aggressive marketing has been criticized for pushing parents of very young girls to get vaccinations even though they were likely years away from any likely exposure to the virus.

"This big push is making people crazy--thinking they're bad moms if they don't get their kids vaccinated," said Dr. Abby Lippman, a professor at McGill University.

--read the article in the New York Times

Study examines cost-effectiveness of Gardasil

John Carroll — Thu, 21 Aug 2008 08:28:06 -0400

A new study in the New England Journal of Medicine questions the cost-effectiveness of Gardasil in older women, saying that the payback is reduced by their increased exposure to the virus that causes cervical cancer. But the team of researchers from Harvard School of Public Health also confirmed that the vaccine is cost-effective among pre-adolescent girls because of their reduced exposure to the virus. Merck, which makes the vaccine and markets it around the world, quickly disputed the study, saying that its own economic models indicate that the vaccine provides a real payback when used for women.

The discussion over cost-effectiveness in the older age bracket is critical for Merck, which wants to expand the use of the cervical cancer vaccine. That expanded use is key to the company's efforts to gain more revenue from the vaccine. It's also an important discussion for GlaxoSmithKline, which has been commercializing Cervarix in various markets and working to gain an FDA approval.

--read the report in the Wall Street Journal

Merck, Dynavax announce Heplisav results

Maureen Martino — Wed, 06 Aug 2008 14:50:21 -0400

Dynavax and Merck announced that their hepatitis B vaccine Heplisav achieved the primary endpoint in a Phase III study. In the study, 95.1 percent of subjects who received Heplisav developed protective antibodies to hepatitis B versus 81.1 percent of subjects who received Engerix-B, a marketed drug. Heplisav is being developed for patients with end-stage renal disease.

Back in April the FDA put a clinical hold on the drug's development because one subject was suspected to have Wegener's granulomatosis, an rare inflammation of blood vessels. The hold is still in effect, and the FDA has requested a review of clinical and preclinical safety data along with all available information about the Wegener's granulomatosis case.

- here's the release

Merck invests $300M in vaccine expansion

John Carroll — Thu, 24 Jul 2008 08:07:09 -0400

Merck's decision to pump $300 million into an expansion of its Durham, NC vaccine facility is seen by analysts as part of a coordinated effort to solidify a leading role in a booming global vaccines market. The work in North Carolina should be completed by 2010, a year before Merck opens a new, $300 million vaccine plant in Ireland.

BCC Research recently estimated that the vaccine business will advance at a blistering pace of 11 percent a year, hitting $34 billion in 2013. And Merck isn't alone in aggressively ramping up new facilities to satisfy the growing demand for vaccines. Sanofi-Aventis recently announced that it would invest more than $6 billion in its vaccine business and Microbix is spending almost $200 million on a new plant in China.

- read the article from In-PharmaTechnologist

Wall Street shrugs off FDA’s Gardasil rejection

John Carroll — Thu, 26 Jun 2008 07:53:31 -0400

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. Most analysts think the key market for the vaccine is already covered by the agency's 2006 approval of the cervical cancer vaccine to protect girls and women aged 9 to 26. The older group was unlikely to deliver any significant new revenue. And Gardasil has captured a significantly larger market than GlaxoSmithKline's Cervarix.

One of the few dissents to that opinion came from James Kelly, an analyst at Goldman Sachs who said the new market is important to Merck because sales of Gardasil are beginning to peak. Merck says it plans to respond to the FDA's decision in about a month.

- read the AP report

Merck’s rotavirus vaccine makes big impact

John Carroll — Thu, 26 Jun 2008 07:51:49 -0400

A new report by the CDC concludes that Merck's new rotavirus vaccine has made a major impact on the disease in the last two years. RotaTeq, designed to prevent diarrhea and vomiting in children, has pushed the start of the rotavirus season back by three months and reduced the severity of the season by half. Incidences of the disease plunged soon after the vaccine was approved and swiftly hit their lowest level since figures were first gathered 15 years ago. Rotavirus is highly contagious and has been blamed for 272,000 ER visits in the U.S. each year.

- read the report in the Philadelphia Inquirer

Planned AIDS vaccine trial raises concerns

Thu, 05 Jun 2008 06:59:56 -0400

The AIDS Vaccine Research Subcommittee of the NIH has OK'd a new AIDS vaccine trial, prompting some skeptics to caution against plunging back into trials so soon after a Merck program misfired.

"We're redesigning the aims of human HIV vaccine research without redesigning the vaccine," said Scripps Research Institute immunologist Dennis Burton. "Let's not go into a human experiment without a clear idea of what we're going to learn."

Emory University's Eric Hunter, though, said the new vaccine was sufficiently different from Merck's to warrant a study. The vaccine is based on the adenovirus type 5 and given after a schedule of three DNA-based immunizations aimed at priming the human immune system. Merck's vaccine was administered without the DNA priming.

- read the article from The Scientist

ALSO: Researchers at Mymetics insists that a new HIV vaccine can be successful by building on the experiences of the past 20 years. Release

FDA orders Merck to fix vaccine plant problems

Thu, 01 May 2008 06:59:57 -0400

The FDA has given Merck 15 days to decide how to fix manufacturing problems at its main vaccine plant in West Point, PA, according to a warning letter dated April 30. The plant hasn't been adhering to manufacturing rules, the FDA stated; agency inspectors found "significant objectionable conditions" during repeated visits to the plant between November and January.

According to the letter, Merck officials didn't thoroughly investigate when vaccine batches failed to meet specifications, even if those batches had been distributed. Some drug components were tainted, and the plant lacked proper procedures and safeguards to ensure purity, the letter said. "We have reviewed the warning letter and are committed to addressing all of the FDA's concerns," a company spokeswoman told the Associated Press.

The plant makes children's vaccines, including PedvaxHIB for Haemophilus influenza type B and ProQuad against measles, mumps, rubella, and chicken pox. It also makes Merck's cervical cancer protectant, Gardisil. Last year, the plant recalled 1.2 million doses of the H. influenza shot because of a sterility problem.

- read the report at Google News
- see the warning letter

Feds steering funds back to basic AIDS vax research

Thu, 27 Mar 2008 07:59:58 -0400

After trying and failing repeatedly to develop an AIDS vaccine, federal officials say they're going back to the drawing board to come up with some new ideas. Anthony Fauci told a summit meeting that "We need to turn the knob toward [basic scientific] discovery--nobody should be unclear about that," according to the Washington Post. And UC San Francisco's Walter Greene backed him up on that point, saying that it's time to execute a mid-course correction in their strategy.

Officials have been forced to rethink strategies after Merck had to halt studies into an experimental vaccine after concluding that its approach likely increased the risk of contracting the lethal virus. The NIH is spending close to half a billion dollars this year on vaccine research. About 38 percent of that money goes to testing experimental vaccines, but Fauci is calling for an even heavier emphasis on funding essential research.

- read the report from the Washington Post

Related Articles:
Long delay seen for Merck's AIDS vaccine. Report
Merck's HIV vaccine linked to higher infections rate. Report
Merck halts study of "ineffective" HIV vaccine. Report
AIDS scientist backed on new vaccine approach. Report