Roche to pay $12.9 million in Accutane suit
ATLANTIC CITY, N.J. An eight-member jury in Atlantic City, N.J. found that Roche’s acne medication Accutane caused severe irritable bowel syndrome in three Florida residents who had used it as teenagers. In some cases, the illnesses continued after they had stopped using the drug.
Ending a five-week trial in the New Jersey State Superior Court, the jury ordered the Swiss drug maker to pay the plaintiffs $12.9 million in compensatory damages.
The plaintiffs—Kelly Mace, 25, Pensacola, Jordan Speisman, 27, Gainesville, and Lance Sager, 28, Fort Lauderdale—were prescribed the drug for treating acne as teenagers. All three developed severe forms of IBD, including ulcerative colitis and Crohn’s disease. Mace and Sager will have to rely on medications to manage their disease, while Speisman will require surgical removal of his colon. All three face increased risk of colon cancer.
Punitive damages were not sought, but Speisman will receive $8.64 million; Sager will receive $2.6 million; and Mace will receive $1.6 million.
“After years of denials, Roche will at last be forced to accept responsibility for its actions and the horrible illness its drug has burdened me with,” Speisman said in a statement. “While I am pleased with the jury’s verdict, it’s too bad that Roche can’t give me my life back.”
FDA, SciClone meet agreement on distribution of melanoma treatment
NEW YORK The Food and Drug Administration has reached an agreement with a drug maker on the design of a phase 3 trial of a skin cancer drug.
SciClone Pharmaceuticals announced Monday that it had reached the agreement with the agency concerning the drug thymalfasin, which it sees as a potential treatment for stage 4 melanoma.
“Patients suffering from stage 4 melanoma have very few treatment options available,” SciClone chief medical officer Israel Rios said in a statement. “Based on the positive data from an earlier phase 2 trial, thymalfasin could provide new treatment modalities for this high unmet medical need.”
The drug, if approved, will be sold under the brand name Zadaxin. The full name of its active ingredient is thymosin alpha 1.
Teva releases generic version of AstraZeneca’s Pulmicort
NORTH WALES, Pa. The world’s largest maker of generic drugs has introduced a generic version of AstraZeneca’s Pulmicort Respules.
Teva announced Wednesday that it had launched budesonide inhalation suspension, a treatment for asthma, in 0.25-mg-per-2-milliliters and 0.5-mg-per-2-milliliter strengths.