Merck to press for Gardasil approval for boys
WHITEHOUSE STATION, N.J. Merck is looking to get its human papillomavirus drug Gardasil approved for boys by 2009, according to The New York Times.
The drug hit the market in 2006, aimed at protecting girls and young women aged 9 to 26 from the virus, which causes cervical cancer. The vaccine is also said to protect genital warts. The primary reason to extend approval to boys would be to slow the rates of cervical cancer, because men pass the disease onto women through intercourse. By inoculating both sexes, the chances to pass on and develop the disease will decrease significantly.
Gardasil protects against four types of H.P.V. Two have been found in 70 percent of cervical cancer cases. The other two types account for 90 percent of genital warts, which affect both men and women. Immunization, which comes in the form of three, separately administered shots, gives protection for five years.
In 2007, worldwide sales of Gardasil brought in $1.5 billion.
Jury hits AstraZeneca with $215 million fine in price-inflation case
MONTGOMERY, Ala. An Alabama state court jury found AstraZeneca Pharmaceuticals at fault in inflating drug prices charged to the state’s Medicaid program, according to published reports. As a result, the company has to pay $215 million, $40 million in compensatory damages and $175 million in punitive damages.
Alabama claimed in its complaint, filed in 2005, that the companies overstated the average wholesale price of drugs, which is used to calculate Medicaid reimbursement rates to pharmacies.
AstraZeneca said the judge made numerous errors in the trial, which started Feb. 11. Those errors included barring evidence of how pharmacies manage Medicaid drug costs, according to the company.
AstraZeneca lawyer Thomas Christian told the jury in opening statements that state Medicaid officials had a complete understanding of how drug pricing worked. Once a drug was shipped to the wholesaler and then pharmacies, the company had no control over pricing, Christian said. The company plans on appealing the decision.
AstraZeneca is the first of more than 70 drugmakers sued by Alabama to go to trial. GlaxoSmithKline and Novartis Pharmaceuticals are scheduled for trial in April. Takeda Pharmaceuticals North America and Merck’s Dey unit settled pricing claims with Alabama last month for a combined $6.75 million while admitting no liability.
Prasugrel given priority review by FDA
WASHINGTON A new drug, prasugrel, manufactured by Eli Lilly and Daiichi Sankyo, has been granted a priority review by the Food and Drug Administration.
The drug is intended for the prevention of blood clots, and if approved, will be competing against Plavix, the blockbuster drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis. A study conducted in November has already shown that prasugrel was 19 percent more effect than Plavix, but resulted in a higher amount of serious bleeding.
A priority view, according to published reports, means that the FDA will decide within six months whether or not to approve the drug. An approval for a drug usually takes about 10 to 12 months.
The application for prasugrel was filed on December 26, and since the news of its priority view its shares rose up nearly 3 percent. If approved, Lilly plans its drug to be brand named Effient.