Shire (NASDAQ:SHPGY) has reached an agreement with U.S. regulators in the long-running saga over its low blood pressure drug, ProAmatine, that rests on the drug generating positive results in two clinical trials, or else face a withdrawal of its new drug application.
The compromise was agreed to with the U.S. Food and Drug Administration’s Center for Evaluation and Drug Research, or CEDR. In exchange for Shire agreeing to the additional clinical trials to confirm the clinical benefits of the drug, CEDR has agreed to shelve its proposal to withdraw ProAmatine.
Although the company had agreed to the additional clinical trials at the end of last year, CEDR still needed to give its blessing to the agreement. By raising the stakes in getting Shire to waive its right to a hearing should the drug fail to generate results meeting with CEDR’s approval, it would seem the regulator has secured the collateral it was looking for.
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Although the Irish pharmaceutical company, which has U.S. headquarters in the Philadelphia area, no longer manufactures the drug, it agreed to do the additional tests because it holds the new drug application for ProAmatine and did not want to risk the generic versions of the drug being pulled from the market.
The five generic versions currently on the market are manufactured by Apotex, Impax (NASDAQ:IPXL), Mylan (NASDAQ:MYL), Sandoz and Upsher-Smith.
For a brief history of the blood pressure drug, check out this link.
