A roundup of developments from Malaysia (Biocon), Saudi Arabia (Grifols), UK (AstraZeneca), and the US (Merck & Co., Taro Pharmaceuticals).

Malaysia

Biocon Receives FDA Form 483 for Insulin Mfg Plant in Malaysia

The US Food and Drug Administration (FDA) has issued a Form 483 with three observations following a pre-approval inspection conducted between February 10 to February 21, 2020 of Biocon’s insulin-manufacturing facility in Malaysia for the manufacture of insulin glargine.

Biocon says the observations are procedural in nature and that it plans to respond to the FDA with a corrective and preventive action plan to address the observations. The agency has set a target action date for Biocon’s insulin glargine application for June 2020, and the company says the outcome of the inspection will not impact the commercialization plans of insulin glargine in the US.

Source: Biocon

Saudi Arabia

Grifols, Public Investment Fund of Saudi Arabia To Build Plasma Collection Centers

Grifols, a healthcare company specializing in plasma medicines, transfusion diagnosis and pharmaceuticals for hospital use, has agreed to a non-binding term sheet with the Public Investment Fund of Saudi Arabia (PIF) to boost the self-supply of plasma medicines in the region. The agreed term sheet is non-binding, and Grifols and PIF plan to execute definitive agreements thereafter. Following definitive agreements being signed, the project would be executed through a joint venture, which will be owned jointly by Grifols and PIF.

The financing needs of the project will be determined by the parties depending on the specific needs of each phase of the project. Part of the recognized value that Grifols would contribute to the joint venture includes its experience in the industry, as well as the intellectual property it holds. Grifols would provide engineering services and support for the quality assurance of infrastructure and processes.

Under the agreement, the companies would develop collection centers, production facilities, including a fractionation facility and a purification facility. Until the infrastructures are operational, Grifols will guarantee the supply of plasma-derived products to Saudi Arabia, through supply, manufacturing and distribution agreements to be entered into.

Source: Grifols

UK

AstraZeneca Divests Global Rights for Movantik Medicine to RedHill Biopharma

AstraZeneca has agreed to sublicense its global rights to Movantik (naloxegol), excluding Europe, Canada and Israel, to RedHill Biopharma (RedHill), a specialty biopharmaceutical company. Movantik is a peripherally acting mu-opioid receptor antagonist (PAMORA) indicated for the treatment of opioid-induced constipation (OIC).

Under the deal, RedHill will make an upfront payment of $52.5 million to AstraZeneca on closing and a further non-contingent payment of $15 million in 2021. In 2019, Movantik generated sales of $96 million in the US.

The divestment is expected to be completed in the first quarter of 2020, subject to customary closing conditions and regulatory clearances.

Under the agreement, AstraZeneca will continue to manufacture and supply Movantik to RedHill during a transition period. In 2015, AstraZeneca entered into a co-commercialization agreement with Daiichi Sankyo for Movantik in the US, which will be transferred to RedHill.

Source: AstraZeneca

US

Merck &Co. Receives FDA Complete Response Letter for New Dosing for Keytruda

Merck & Co. has received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding Merck’s supplemental biologics license applications (sBLA) seeking to update the dosing frequency for Merck’s Keytruda (pembrolizumab), an anti-programmed death (PD)-1 antibody for treating cancer, to include a 400-mg dose infused over 30 minutes every-six-weeks option in multiple indications. 

The European Commission approved the 400-mg, every-six-weeks dosing for Keytruda monotherapy indications on March 28, 2019. Merck is reviewing the letter and says it will discuss the next steps with the FDA.

Source: Merck & Co.

Taro Pharmaceuticals Issues Voluntary Recall of Seizure Medication

Taro Pharmaceuticals is voluntarily recalling two lots of phenytoin oral suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin oral suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures. The reason for the recall is that product from these two lots of phenytoin oral suspension may not re-suspend when shaken, as instructed for administration, which could result in under or overdosing. This recall is being conducted with the knowledge of the FDA.

The population at risk is primarily infants and young children. In those patients, there is a reasonable probability that inaccurate dosing might result in a serious adverse effect such as intoxication or breakthrough seizures requiring medical intervention. To date (February 20, 2020), Taro has not received any adverse event reports related to this recall.

The two lots being recalled were distributed to wholesale distributors, long-term care providers, a repackager, and mail order customers in the US market between May 3 and July 5, 2019. One lot was distributed to wholesale distributors, long-term care providers, and mail order customers in the US market between July 1 and August 21, 2019. These customers may have further distributed these lots to retail pharmacies for prescription dispensing to patients who were prescribed the drug.

Taro is notifying its distributors and retail customers by phone, e-mail, and letters and is arranging for return of any containers or quantities of the drug.

Source: Taro Pharmaceuticals