FDA issues Form 483 to Intas after finding docs destroyed by staff; Eisai-Biogen’s Leqembi bags fast-track nod

By PharmaCompass

2023-01-12

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In Phispers this week, we bring you news about regulatory action on three Indian firms – Intas, Piramal and Sun Pharma. While the US Food and Drug Administration (FDA) issued a Form 483 with 11 observations to Intas after finding documents destroyed by its employees at its facility in Ahmedabad, India, it issued a warning letter to Sun Pharma’s Halol plant, which is already on import alert, for multiple good manufacturing practices (GMP) violations. And Piramal Pharma’s US facility got hit by FDA’s Form 483 with six observations.

After the Aduhelm imbroglio, Eisai and Biogen have received a shot in the arm as their second Alzheimer’s drug – Leqembi (lecanemab) – received an accelerated approval from the FDA last week. The agency has also granted a priority review to Pfizer’s 20-valent pneumococcal shot – Prevnar 20 – in children aged six weeks to 17 years.

Several deals were announced at the ongoing annual JP Morgan Healthcare Conference. AstraZeneca is buying US-based drug developer CinCor Pharma for up to US$ 1.8 billion. Italy’s privately-held Chiesi Farmaceutici will acquire Ireland-based rare diseases drugmaker Amryt Pharma for up to US$ 1.48 billion. Ipsen has picked up Albireo for US$ 952 million in cash. And BioNTech is buying out its artificial intelligence partner InstaDeep for up to US$ 682 million.

FDA finds docs destroyed by Intas employees at India facility, issues Form 483

The FDA has issued a Form 483 with 11 observations to Intas Pharma’s drug manufacturing facility in Ahmedabad (Gujarat, India). A team of three FDA drug regulators had conducted an inspection of the manufacturing facility from November 22 to December 2 last year. The 36-page report issued by the FDA has alleged that employees at the facility had destroyed documents related to manufacturing practices by tearing them into pieces and disposing of them inside the quality control lab and scrap areas.

Eisai-Biogen’s second Alzheimer’s drug gets FDA’s accelerated approval

Even though the controversy surrounding Biogen and Eisai’s Alzheimer's drug Aduhelm is yet to die down, the partners have notched up another victory. The duo has received FDA’s accelerated approval for their second Alzheimer's drug – Leqembi (lecanemab) – to treat patients who are in the earliest stages of the neurodegenerative disease.

The approval came days after the New England Journal of Medicine reported a third potential treatment-related death linked to Leqembi. Eisai has priced Leqembi at US$ 26,500 annually – less than half the price at which Aduhelm was launched. However, as of today, the drug’s reach is limited to patients who can pay out of pocket.

Eisai has already applied for a full FDA approval of the drug. It has also filed for a marketing authorization of the drug in Europe.

AstraZeneca buys CinCor for up to US$ 1.8 bn in bid to expand cardio-renal portfolio

AstraZeneca is buying US-based drug developer CinCor Pharma for up to US$ 1.8 billion with the aim to expand its portfolio of heart and kidney drugs. The deal was announced on the first day of JP Morgan’s 41st annual Healthcare Conference (JPM23) being held in San Francisco. AstraZeneca will pay US$ 1.3 billion upfront. It will pay an additional US$ 500 million if CinCor’s lead product – baxdrostat – hits regulatory milestones. The drug, being developed as a treatment for high blood pressure and chronic kidney disease, had failed a mid-stage clinical trial in November last year. Despite the failure, Astra hopes to combine baxdrostat with its blockbuster drug Farxiga as a treatment for cardio-renal diseases.

Chiesi Farmaceutici to buy Amryt for up to US$ 1.48 billion

Italy’s privately-held Chiesi Farmaceutici said it will acquire Ireland-based rare diseases drugmaker Amryt Pharma in a deal valued at up to US$ 1.48 billion. Chiesi will pay US$ 1.25 billion in cash, along with contingent value rights worth up to US$ 225 million if Amryt’s skin disease drug – Filsuvez – hits certain milestones. The drug is already approved in Europe for an inherited skin disease known as epidermolysis bullosa.

Ipsen buys Albireo: French biopharma Ipsen has picked up Boston-based Albireo for US$ 952 million in cash. Ipsen will get access to Albireo’s liver disease drug, Bylvay, which is already approved in the US and UK.

BioNTech acquires InstaDeep: Announcing its largest-ever takeover, BioNTech said it is buying out its UK-based artificial intelligence partner InstaDeep for up to £562 million (US$ 682 million) to speed up its biotech research and manufacturing capabilities.

AbbVie ties up with Immunome, Anima: AbbVie has inked two collaborations. It has tied up with Immunome to discover multiple novel oncology targets in a deal worth up to US$ 2.8 billion. And, it has signed a potential US$ 582 million collaboration with Anima Biotech to discover and develop messenger RNA modulators for three oncology and immunology targets.

Moderna signs US$ 1.2 billion deal with CytomX: Moderna has signed a potential US$ 1.2 billion biobucks deal with cancer-focused drug developer CytomX Therapeutics to work on messenger RNA-based therapies for a wide range of diseases.

Amgen inks US$ 2 billion deal with Synaffix: Amgen has inked a licensing agreement worth up to US$ 2 billion with Amsterdam-headquartered Synaffix to work on next-generation antibody-drug conjugates. Synaffix CEO Peter van de Sande has indicated cancer to be the target area for the collaboration.

Pfizer’s 20-valent pneumococcal shot gets FDA’s priority review in children

The FDA has accepted Pfizer’s application for priority review of Prevnar 20 (its 20-valent pneumococcal vaccine) for use in children aged six weeks to 17 years. This means that the vaccine can be approved for use as soon as April, four months ahead of schedule. Prevnar 20 had gained FDA’s approval for use in adults in June 2021.

Piramal Pharma’s US facility hit by FDA’s Form 483 with six observations

The FDA has issued a Form 483 with six observations to Indian drugmaker Piramal Pharma’s Lexington facility in Kentucky, USA. The agency had conducted a pre-approval inspection and GMP inspection of the facility from December 27, 2022, to January 10. The drugmaker said the observations were classified under voluntary action indicated and do not relate to data integrity. It plans to submit a detailed response within the stipulated timelines.

Sun Pharma’s Halol facility on import alert gets hit by FDA’s warning letter

The FDA has issued a warning letter to Sun Pharma’s drug manufacturing facility located at Halol (Gujarat, India) for multiple violations of GMPs. The FDA had conducted an inspection of the facility between April 26 and May 9, 2022. It had issued a Form 483 with 10 observations to the facility following the inspection. In December, the FDA had placed the facility on import alert.

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