MADRID, Jan 19 (APM) - The U.S. Food and Drug Administration’s panel on antimicrobials has rejected Grifols’ Pulmaquin, which the company acquired in 2013 and which had been expected to make $300 million sales over the next three years, financial El Economista reported on Wednesday.
“Grifols has just gone, for the first time, through one of the worst nightmares for a pharmaceutical company, as one of its drugs has been rejected after enormous amounts of money were invested in its development,” El Economista said.
The Catalonian firm acquired the drug in 2013 and had already spent € 65 million on it when the panel’s opinion was published.
The panel voted 12 to three against the approval of the drug. The Food and Drug Administration (FDA) does not automatically follow the panel’s verdict, but it takes it into consideration. A final decision by the agency is expected before January 26, El Economista noted.
Grifols acquired the licence for Pulmaquin and fellow inhaled ciprofloxacin drug Lipoquin by buying 35% of the U.S. Aradigm Corporation for $26 million. From that point, all research, development and advertising costs were Grifols’ responsibility, the financial added.
The financial quoted Igor Gonda, Aradigm’s president, as saying: “Although we are disappointed with the outcome of the vote, we are still confident about the drug’s safety and tolerability”.
In an unrelated Thursday story, financial Expansión reported that Grifols will benefit from U.S. president Donald Trump’s tax reform and the company’s revenue will increase due to strong results in the blood derivatives market.
EC to look into Andalusia’s tenders
The drug tendering system in Andalusia will be investigated by the European Commission after it was challenged by regional pharmacists’ association Afaran, daily El Mundo reported on Monday.
The association was officially informed about the investigation in a letter signed by Cecilia Wikström, chair of the committee on petitions, El Mundo reported.
Afaran argues that the tendering system is problematic and includes a number of irregularities. According to the association, patients suffer the consequences in the form of low-quality medicines and frequent supply shortages.
Tenders launched by the region have been challenged since they were first implemented, with a number of court cases and an investigation by the Spanish ombudsman. This institution came down in favour of Afaran in a 2016 report which said patients in Andalusia lack access to drugs which are available in other Spanish regions, the newspaper said. (APMHE 51468
The regional government has said roughly 12% of drugs put out to tender are affected by supply shortages, and blamed distributors and community pharmacies, the newspaper added.
Janssen’s Imbruvica approved for reimbursement
Janssen’s Imbruvica (ibrutinib) has been approved for reimbursement in Spain as a first-line treatment for chronic lymphocytic leukaemia (CLL), medical journals Gaceta Médica, Acta Sanitaria and Redacción Médica and IM Médico Hospitalario reported on Thursday. TV channel Cuatro also carried the story on its website on Thursday. Financial El Economista carries it on Friday.
Acta Sanitaria said approval of the drug is a step further into a future where these patients will not need chemotherapy.
Redacción Médica said that over 80% of patients can benefit from Imbruvica. The journal quoted Francesc Bosch, an oncologist at Vall d’Hebron University Hospital in Barcelona, as saying: “The approval is great news for patients with chronic lymphocytic leukaemia”. According to Bosch, only patients with concomitant conditions or those who are being treated with certain drugs cannot be treated with Imbruvica.
Imbruvica is administered orally once a day, thus improving patients’ quality of life, and it lacks the toxicities associated with chemotherapy, Redacción Médica added.
Presumed Agreal victims sue health ministry
Two associations representing women who were administered Sanofi/Grünenthal's Agreal (veralipride) to alleviate menopausal hot flashes have sued the Spanish ministry of health over violation of fundamental rights, dailies El Periódico and 20 Minutos reported on Thursday. Both newspapers referred to Sanofi as the manufacturer and did not mention Grünenthal.
In these kinds of cases, the institution concerned by a lawsuit must respond to the plaintiff within 20 days. After that, the case will be heard in the National High Court (Audiencia Nacional), 20 Minutos reported.
Agreal was withdrawn from the Spanish market in 2005. A report by experts from the Alcalá de Henares University said the drug’s side effects are well-documented, 20 Minutos added.
The associations claim the manufacturer knew it was dangerous to take Agreal for long periods. They have had access to clinical trials which registered a number of neurological and psychiatric side effects. These trials were provided to representatives of the associations by the European Medicines Agency (EMA), the newspaper noted.