Rovi suffered a blow yesterday with his new schizophrenia drug, Doria. The American FDA delayed the validation of the factory where the drug will be produced for a period of about six months.
This delay complicates participation in the drug market during 2022, ultimately causing the loss of almost a year to enter a market valued at 9.5 billion euros in the United States. Estimates now suggest that the approval of the drug on the other side of the Atlantic will not arrive until the third quarter of 2022, whereas before the first quarter was handled.
The good news for the Spanish company is that the reported delay is not due, in principle, more than a bureaucratic issue caused by the coronavirus crisis. Namely, the FDA has only postponed its trip to inspect the factory until pandemic conditions improve. “The delay in the inspection of manufacturing facilities is due to movement restrictions due to Covid-19, so the FDA has pending to set the date for the inspection,” says Rovi.
However, Rovi has yet to complete the questionnaire sent by the agency for the inspection to take place. The company submitted the application for Doria’s marketing authorization to the FDA on November 24, 2020. On September 24, 2021, Rovi received a letter from the agency with outstanding questions about the drug’s dossier.
This is the second negative news the company receives of its great therapeutic promise. In March, the company had to request a time-out to redefine the clinical trial with which it intended to obtain authorization. Technicians from the European Medicines Agency asked Rovi to compare its medicine with the reference treatment on the continent, instead of with that of the United States. It will be on November 16 when the Spanish pharmaceutical company will have to provide the data requested by Europe. In the Old Continent, the market is valued at 5,800 million euros.
Bullish turn in the stock market
At the beginning of the session, Rovi shares lost more than 2% in the stock market after the announcement of the news. However, it gradually recovered to the point of ending the day with an increase of more than 1.5%. So far this year it has already scored almost 55%, reaching historical highs in August at 68 euros per share.
According to Banco Sabadell’s calculations, this drug justifies 11% of the company’s target price. “Although this delay is negative, in the absence of knowing the date of the inspection, we do not expect a delay of more than six months, taking into account the favorable evolution of the pandemic and the relaxation of restrictions, and we value positively that the delay has nothing to do with it. with no question of draft but a formal procedure such as the inspection of the facilities “, they explain. The analysts who have reviewed their recommendation today have ratified their buying advice, which reaches 92% of the total valuations.
Maximum sales after five years
The delay that Doria accumulates in the regulatory agencies will also have its impact in reaching the peak of sales. Rovi explained to this medium that they would arrive in 2027 because it was thought that during the next year the drug would be on sale. “We hope to launch it in 2022. We are tremendously excited because we believe that our product offers advantages to the doctor and the patient and, therefore, we think we can play a relevant role. Possibly the typical sales will not arrive until 2027,” said Javier López-Belmonte.