BioPharma, Pharma

Pfizer acquires Amplyx Pharma in bid to shore up its antifungal drug pipeline

Amplyx Pharmaceuticals brings Pfizer a clinical-stage antifungal candidate with a novel mechanism of action. The pharmaceutical giant is trying to build its antifungal product lineup, which is currently led by a drug that has lost patent protection.

The entrance to a Pfizer office in Cambridge, Massachusetts

Pfizer joined an equity investment in clinical-stage Amplyx Pharmaceuticals last year to support the biotech’s development of a new antifungal for drug-resistant pathogens. On Wednesday, the pharmaceutical giant announced it has acquired the company outright.

No financial terms were disclosed for the deal.

The acquisition of San Diego-based Amplyx comes as the biotech evaluates its lead compound, fosmanogepix, in Phase 2 tests as a potential treatment for life-threatening fungal infections caused by a range of fungal pathogens including
Aspergillus, Candida, Fusarium, and Scedosporium.

Fosmanogepix is small molecule is designed to block Gwt1, a fungal enzyme that is important for anchoring a key protein needed to maintain the integrity of the fungal cell wall. The company says its drug does not block the human protein closest to Gwt1, and therefore can target fungal pathogens without harming healthy human cells. Pfizer said this new approach could add a new therapeutic class to the three classes of antifungals currently available.

Amplyx is evaluating both intravenous and oral formulations of its antifungal candidate. In Phase 1 tests, both formulations were well tolerated and demonstrated safety. The company added that both formulations have a low propensity for interacting with other drugs. The company says developing both IV and oral formulations may allow for patients to continue their care, transitioning from IV dosing in the hospital to a pill version after discharge.

Pfizer’s top antifungal product voriconazole, which is marketed as Vfend, accounted for $270 million in 2020 sales, a nearly 22% decline from the prior year. That drug has lost patent protection and generic versions are eating away at its market share. Vfend is part of Pfizer’s lineup of hospital-based products, which generated $7.9 billion in revenue last year.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

The equity financing that Amplyx announced last year was an extension of a $67 million Series C round from 2017. Last May, the company said that Pfizer and Adage Capital Management joined the financing, extending it to more than $90 million.

With the acquisition, Pfizer also gains other programs in the Amplyx pipeline. MAU868, an antiviral, is in early clinical development. The antifungal candidate APX2039 is preclinical.

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