Global Pharma Briefs: News from Asia and EuropeBy
A roundup of developments from India (Pfizer), Malaysia (Biocon), and the UK (AstraZeneca, RedHill Biopharma).
FDA Issues Warning Letter to Pfizer for Facility in India
The US Food and Drug Administration (FDA) has issued a Warning Letter to Pfizer for cGMP violations for finished pharmaceuticals at the company’s facility in Jawaharlal Nehru Pharma City, Parawada, Visakhapatnam, Andhra Pradesh, India following an inspection of the facility from August 29 to September 6, 2019.
The agency cited the company for failing to conduct adequate investigations, including timely implementation of effective corrective action and preventive action (CAPA) plans, at the injectables manufacturing facility. The agency further cited the company for not adequately investigating failed sterility testing and deficiencies in microbiology laboratory conditions and practices. It also said the company’s quality system at the facility did adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured at the facility.
The agency is requesting that the company conduct the following: (1) a comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-limit results, out-of-specification results, and failures; (2) an assessment and remediation plan for the company’s CAPA program; (3) a complete assessment of documentation systems used throughout the company’s manufacturing and laboratory operations to determine where documentation practices are not sufficient; and (4) a comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, analyst competencies, and resources.
With respect to data integrity, the FDA is requesting the following of the company: (1) to conduct a comprehensive investigation into the extent of the inaccuracies in data records and reporting m including results of the data review for drugs distributed to the US; (2) conduct a current risk assessment of the potential effects of the observed failures on the quality of the company’s drugs; and a management strategy that includes the details of a global corrective action and preventive action plan.
Source: US Food and Drug Administration
Biocon’s Malaysia Facility Receives Inspection Report from FDA
Biocon Sdn Bhd, a subsidiary of Biocon, a Bangalore, India-based biopharmaceutical company, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the pre-approval inspection of its insulin-manufacturing facility in Malaysia, for insulin glargine. The inspection was conducted between February 10 and February 21, 2020.
The Inspection has been closed with a Voluntary Action Indicated (VAI) classification in the EIR, for the three observations issued at the conclusion of the inspection in February 2020. A VAI inspection classification indicates that, although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time, according to information from the FDA.
AstraZeneca Divests Global Rights of Movantik for $67.5 M
AstraZeneca has completed a previously communicated agreement to sublicense its global rights to Movantik (naloxegol), indicated for the treatment of opioid-induced constipation in adult patients with chronic non-cancer pain, excluding Europe, Canada and Israel, to RedHill Biopharma a specialty biopharmaceutical company, in a deal worth up to $67.5 million.
Under the agreement, AstraZeneca has received a payment of $52.5 million from RedHill. The company will also receive a further non-contingent payment of $15 million in 2021.
Movantik was licensed from Nektar Therapeutics in 2009. It was developed using Nektar’s oral small-molecule polymer conjugate technology. In 2016, AstraZeneca divested the rights in Europe to ProStrakan Group (now KKI) and the rights in Canada and Israel to Knight Therapeutics.