ViroPharma says modified bioequivalence standards could have significant health ramifications

By Jennifer Lanning Drey

Eugene, Ore., July 13 - ViroPharma Inc. believes there could be significant public health ramifications to the Food and Drug Administration's decision to modify the bioequivalence standards for generic copies of Vancocin capsules, according to Michel de Rosen, chief executive officer of the company.

Those ramifications could include an unacceptable risk of increases in the number of deaths associated with clostridium difficile-associated disease (CDAD) and enterocolitis caused by Staphyloccus aureus, de Rosen said Thursday during a company conference call.

Vancocin is used to treat both diseases.

In May, the company submitted a supplement to its petition for stay of action regarding the FDA's Office of Generic Drugs' new bioequivalence requirements for abbreviated new drug applications that seek to copy Vancocin capsules.

"We do strongly believe that there is an obligation to assure that generic drugs are truly bioequivalent to the innovative products and this is absolutely essential for a drug such as Vancocin that is used to treat severe life-threatening diseases," he said.

ViroPharma also believes the changed requirements could lead to decreased effectiveness in the treatment of CDAD and enterocolitis caused by Staphyloccus aureus, said Colin Broom, chief scientific officer for ViroPharma.

In addition, the company said that without human studies, it is impossible to assess whether enhanced absorption into the blood stream might occur with a generic product.

Subtle alterations could significantly enhance absorption into the blood stream, causing potential toxicities, Broom said.

"Evaluation in humans is the only way to determine whether a generic version of Vancocin would have similar absorption characteristics and therefore a similar safety profile of Vancocin," Broom said.

ViroPharma also believes that in the case of Vancocin, the Office of Generic Drugs' proposal does not meet its own stated criteria, which says drugs requesting a biopharmaceutics classification system waiver must be rapidly dissolving, highly soluble an highly permeable, he said.

"The proposal from OCG simply is not applicable to Vancocin," said Broom.

Located in Exton, Pa., ViroPharma develops and commercializes products to treat viral diseases including cytomegalovirus and hepatitis C.

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