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news.Shares in Penwest Pharmaceuticals fell by 16% following news that the company will not be developing its angina treatment. The decision was made after the FDA rejected the company's application to market the product as a new drug.
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The FDA issued a non-approvable letter to Penwest in response to the company’s application to market PW2101 as a treatment of hypertension and angina. The reasons behind the regulator’s decision include the variability across individual response to the drug.
Penwest defended its decision not to continue the development of the beta blocker citing restraints such as time and resources.
Robert Hennessey, president and CEO of Penwest, said: “We are very disappointed by the FDA’s decision. We have concluded that given these circumstances it is not in the best interests of our company and our shareholders to continue with the additional activities we believe would be required for this product.”
Mr Hennessey added: “We are continuing the development of the other product opportunities in our portfolio and are pleased with the progress we are making in developing compounds targeted at diseases of the central nervous system.”