FDA panel recommends Rotarix, despite pneumonia worries
WASHINGTON A panel of vaccine experts for the Food and Drug Administration has recommended the approval of Rotarix, a GlaxoSmithKline vaccine designed to help protect infants from a gastrointestinal illness caused by rotavirus, according to the Wall Street Journal. Rotavirus is the most common cause of severe diarrhea and dehydration among infants and young children.
The panel unanimously said it believed the vaccine was effective and voted 11-1 in favor of whether the vaccine was safe or not.
So far, 11 clinical studies of the vaccine, involving more than 75,000 children, hasn’t shown an increased risk of intussusception, with six cases reported among children receiving the vaccine in clinical studies compared with seven cases seen among patients receiving a placebo. Intussusception has been linked to other rotavirus drugs from Merck and Wyeth. In fact, Wyeth’s drug was pulled off the market in 1999 after being linked to the ailment, which is a rare bowel problem characterized by a twisting or obstruction of the intestine.
However, Steven Rosenthal, an FDA medical officer who presented the agency’s review of the vaccine, said there was a higher rate of pneumonia-related deaths and convulsions among vaccinated infants in one of the main studies. The overall death rate from any cause, however, was similar between infants given the vaccine and those in placebo groups. In total, there were 118 deaths among all infants in the studies, with 19 pneumonia related-deaths among those receiving the vaccine and 10 among those not receiving it.
The FDA is expected to decide whether to approve Rotarix by April 3.
Costco program delivers deep discounts to uninsured
ISSAQUAH, Wash. Costco is enrolling up to 5,000 new members per week to its Costco Member Prescription Program that gives uninsured members deep discounts on hundreds of different prescription drugs.
The program launched at pharmacies last July and is now available in every state in the U.S. where Costco does business. “It’s kind of a unique program for our members who don’t have insurance,” said Costco VP of pharmacy Vic Curtis. “We work with our manufacturers and are able to offer members a discount through savings passed on either from the manufacturer or, in Costco’s case, from within our own margins.”
To qualify for the program, people need to be current Costco members and fill out a registration form confirming they don’t insurance. To deliver the extra savings, Costco works with manufacturers to create a Preferred Drug List of branded and generic drugs that can be provided with a discount.
When filling a prescription for a program member, pharmacists check the list to see if the prescription is on it or search for a similar drug that serves the same need for less expense. “Our pharmacists have members check with their physicians to make sure a drug on the preferred list will work for them,” said Curtis.
Typical monthly savings on a 30-day supply of drugs is $15 but the savings vary. Curtis said the best example is a 30-day supply of Prevacid, which is available to program members for $101.17 at a cost savings of $49.58. On the lower end, members can save $7 on a one-month supply of Lunesta.
Curtis said Costco currently has 61,000 members in the program and hopes to enroll many more in the coming months. “Our goal is to eventually have 250,000 to 300,000 members enrolled in the program,” said Curtis.
NextGen, Warburg look to partner on cancer drugs
LONDON NextGen Bioscience and Warburg Glycomed are negotiating a deal to collaborate. Both are biotech companies focused on developing new drugs to fight various types of cancer.
Warburg Glycomed has a compound that is able to reprogram cancer cells by modulating their aerobic glucose metabolism, which affects their ability to grow. Warburg Glycomed has expressed keen interest in collaborating with NextGen in a recently signed letter of intent, and is confident that a deal can be arranged.
“These collaboration discussions with Warburg Glycomed represent progress on fulfilling our business goal to form international collaboration agreements with specialty research organizations,: Konstantinos Kardiasmenos, chief executive officer of NextGen, stated. “An alliance with Warburg Glycomed would strengthen both companies’ position to capture the phenomenal global market for therapeutic cancer agents, which is now reaching a volume of approximately $30 billion.”