Vaccine

CDC hails Merck's Rotateq for efficacy

Tracy Staton — Mon, 27 Oct 2008 10:57:51 -0400

Merck has yet another validation of its childhood vaccine Rotateq, designed to prevent rotavirus in infants and children: The CDC says the shot has led to a dramatic drop in hospitalization and ER visits since its debut two years ago, and even seems to be preventing illness in unvaccinated children. Report

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

Patients clamor for scarce Merck vaccine

Tracy Staton — Mon, 13 Oct 2008 10:34:57 -0400

High demand for Merck's Zostavax shingles vaccine is causing shortages across the country. Doctors are putting patients on waiting lists; some physicians report hundreds of people in line for the shot. And this despite the fact that the vaccine is approved just for patients 60-plus (Merck is testing it now for the 50- to 59-year-olds)

The drugmaker didn't expect demand for Zostavax to shoot up so quickly, but that's not the only reason why production is lagging. The shot uses the same base as the chicken pox vaccine, and Merck had had some trouble ginning up enough of that ingredient. Plus, the CDC recently recommended two chicken-pox shots for kids rather than just one.

Merck says the delays could continue for "the coming months." Providers who've ordered doses first were told they'd arrive in 12-15 weeks, but now the word is, "We're not sure," said one pharmacist.

- read the story in the Wichita Eagle

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

GSK gets bad press in U.S., Argentina

Christe Bruderlin-Nelson — Wed, 24 Sep 2008 04:31:20 -0400

Families in Argentina are saying GlaxoSmithKline tricked them into participating in an experimental vaccine trial by telling them their children were receiving medical treatment, according to an ABC News exposé. One Argentine woman says the misleading information led to her infant's death. The study involves more than 13,000 children living in Argentina and has been set up to test GSK's pediatric pneumonia vaccine's efficacy. The experimental vaccine is called Synflorix, which is comparable to the Prevnar vaccine.

An increasing number of drug studies are happening in emerging markets in an attempt to cut costs. Some say the rationale also includes the fact that many patients in these poorer countries are not on any conflicting medications. Critics allege companies are conducting trials countries where there are fewer regulations to protect patients and few resources to enforce the regulations that are in place. To date, at least 12 babies have died in the GSK trial in Argentina over the last year.

- read the ABC News story
- here's the Pharmalot blog entry

Novartis buys Protez, invests in vaccines

Christe Bruderlin-Nelson — Wed, 04 Jun 2008 07:27:49 -0400

Novartis is purchasing U.S.-based antibiotics developer Protez Pharmaceuticals for a base price of $100 million, but has promised up to $300 million in additional payments if Protez's new broad-spectrum antibiotic is a success. The antibiotic, PZ-601, is in Phase II development and aims to treat multi-drug resistant bugs such as methicillin-resistant staphylococcus aureus (MRSA), which cause over 100,000 deaths in the U.S. and Europe annually.

The company has also been placing greater strategic emphasis on vaccine development, announcing today that it will start an anti-ulcer vaccine trial before year-end. The vaccine, which is in Phase I trials, will attempt to prevent recipients from acquiring Helicobacter pylori, a bug responsible for stomach ulcers. Novartis also has a candidate vaccine for Group B Streptococcus in Phase I trials and another for Group A Streptococcus slated to enter Phase I trials in 2010, along with a pneumococcal vaccine. Vaccines against meningococcal infections are in late stage development as well.

- see Novartis' release
- read the report from Forbes
- see what MarketWatch has to say

GSK nabs EU approval for pandemic shot

Tracy Staton — Mon, 19 May 2008 10:42:52 -0400

Put GlaxoSmithKline at the head of the list of vaccine-makers able to profit from a potential flu pandemic. The company just got EU go-ahead to market its H5N1 vaccine, Prepandrix, becoming the first pharma to get a Euro-license for a pre-pandemic vaccine. Prepandrix gives some protection against several currently circulating strains of avian flu. If a pandemic broke out, it would be administered to health workers and others most at risk as a sort of stop-gap measure, while drugmakers worked to develop another vaccine precisely targeted to the pandemic strain.

Countries such as Switzerland and Finland had already placed orders for the shots, anticipating approval, while others are in talks with GSK. As in the case of Roche's Tamiflu antiviral med--and to a lesser extent GSK's antiflu Relenza--countries are looking to stockpile Prepandrix to prep for the possibility of an H5N1 outbreak. Sanofi-Aventis, Novartis, and Baxter all are developing pandemic vaccines, too, but GSK obviously will have the first-to-market advantage.

- see the story in the Wall Street Journal
- check out the coverage in The Times

Novartis injects $816.5M in vaccine plant

Fri, 07 Sep 2007 06:59:56 -0400

Novartis is pledging to sink €600 million ($816.5 million) into new and expanded facilities in Italy, a local newspaper reports. The company would upgrade its vaccine research center in Siena to the tune of €100 million. Novartis also would plunk down €500 million for an Italian production facility that would turn out its meningitis vaccine.

Adding credence to the story is the fact that Novartis chairman Daniel Vasella met Thursday with Italian Prime Minister Romano Prodi. "We're ready to proceed with new investments in Italy," Vasella said after the meeting. Whether they're of the magnitude reported we'll have to wait for Novartis to say.

- read the report from Interactive Investor

Related Articles:
EU: Tips for a successful biotech sector. Report
Novartis to build $600M flu plant in NC. Report
Novartis wins $220M flu vaccine contract. Report
Vaccine "renaissance" attracts huge new venture investments. Report