Global Briefs Gilead, Pfizer, GlaxoSmithKline & More

A roundup of news from Gilead Sciences, Pfizer, GlaxoSmithKline, and Hikma.

FDA Puts Clinical Hold on Gilead Drug Combo
The US Food and Drug Administration (FDA) has placed a partial clinical hold on Gilead Sciences’ studies evaluating the combination of magrolimab plus azacitidine due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions (SUSARs) between study arms. 

Gilead acquired magrolimab, a monoclonal antibody for treating several cancers, including myelodysplastic syndrome, acute myeloid leukemia, and diffuse large B-cell lymphoma, as part of its $4.9-billion acquisition of Forty Seven Inc., a Menlo Park, California-based immuno-oncology company.

The partial clinical hold is being implemented by Gilead across all ongoing magrolimab and azacitidine combination studies globally as additional data is gathered and analyzed to address the concerns raised by the FDA.

Source: Gilead Sciences

Gilead Reports Actions to Stop Counterfeit HIV Drugs
Working with law enforcement, Gilead Sciences has taken action to stop the distribution of counterfeit and tampered Gilead HIV medications within the US supply chain, which involved 85,247 bottles of purported Gilead drugs.

As part of an ongoing investigation and litigation, in coordination with the US Marshals and local law enforcement, Gilead has executed seizures at 17 locations in nine states and seized thousands of bottles of Gilead-labeled medication with counterfeit supply-chain documentation, including bottles labeled as the HIV medicines, Biktarvy (bictegravir 50-mg, emtricitabine 200-mg, and tenofovir alafenamide 25-mg) tablets and Descovy (emtricitabine 200-mg and tenofovir alafenamide 25-mg) tablets.

The investigation revealed that pharmaceutical distributors, not authorized by the company to sell its medicines, were selling drugs to pharmacies that they sourced from various “fly-by-night” (as characterized by Gilead) entities. Gilead reported the counterfeit medications in circulation to federal law-enforcement authorities, including the US Food and Drug Administration, as well as dispensing pharmacies and consumers, and took direct legal action to stop distribution of the counterfeit drugs. The US District Court for the Eastern District of New York has ordered all defendants involved in this litigation who are responsible for distributing the counterfeits to stop selling Gilead-branded medication.

Evidence showed that the distributor defendants sold 85,247 bottles of purported Gilead drug product to pharmacies over the past two-years (as reported on January 19, 2022) using counterfeit supply-chain documentation to conceal their illicit origin. All seized products included counterfeit drug supply-chain documentation, and many had additional counterfeit elements such as patient leaflets and/or caps. The company also received a limited number of reports of bottles labeled as Gilead medication that did not contain the HIV treatment or prevention medication listed on the label.

Source: Gilead Sciences

FDA Issues CRL for Pfizer’s Pediatric Growth Hormone Treatment
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for Pfizer’s/OPKA Health’s biologics license application somatrogon, a long-acting recombinant human growth hormone for treating growth hormone deficiency (GHD) in pediatric patients.

Pfizer says it is evaluating the FDA’s comments and will work with the agency to determine next steps.

In 2014, Pfizer and OPKO Health, a Miami, Florida-based bio/pharmaceutical company, entered into a global agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program, and Pfizer is responsible for registering and commercializing the product for GHD.

Source: Pfizer

GSK Appoints Chief Scientific Officer Designate
GlaxoSmithKline (GSK) has appointed Tony Wood, Senior Vice President, Medicinal Science & Technology, as Chief Scientific Officer (CSO) designate. Mr. Wood will assume full accountability for R&D from Dr. Hal Barron, CSO and President, R&D, on August 1, 2022, after which Dr. Barron will remain on GSK’s Board and become a Non-Executive Director, with additional responsibilities to support R&D.

Mr. Wood joined GSK from Pfizer in 2017 as Senior Vice President, Medicinal Science and Technology and is responsible for all science and technology platforms supporting the discovery, clinical development, and delivery of new medicines across GSK. He will assume full accountability for R&D across GSK’s portfolio and pipeline from August 2022.

Source: GlaxoSmithKline

Hikma To Acquire Sterile Injectables from Teligent
Hikma Pharmaceuticals, a pharmaceutical company and supplier of generic injectable medicines, has agreed to acquire the Canadian sterile-injectable assets of Teligent, a Buena, New Jersey-based topical and injectable pharmaceutical company, for $45.75 million.

The acquisition marks Hikma’s expansion into Canada and includes a portfolio of 25 sterile-injectable products, three in-licensed ophthalmic products, and a pipeline of seven additional products, four of which are approved by Health Canada, the regulatory body of Canada. The transaction is expected to be completed before the end of the first quarter of 2022.

In October 2021, Teligent filed for voluntary protection under Chapter 11 of the US Bankruptcy Code. As part of this process, Teligent initiated a sale of its core assets, following which Hikma has agreed to acquire Teligent’s Canadian assets. 

Separately, Hikma launched a new outsourced sterile compounding business, Hikma 503B, focused on providing ready-to-administer injectable medications in the US.

Hikma 503B will operate principally out of a 65,000-square-foot purpose-built facility in Dayton, New Jersey, which was acquired by Hikma in 2020. Hikma 503B is registering for state licenses across the US and expects to be operating nationwide by the end of 2022.

Source: Hikma and Hikma