Global Briefs: Roche, GSK, Ispen & MoreBy
A roundup of news from Roche, GlaxoSmithKline’s Viiv Healthcare, Ispen, Coherus BioSciences, and Marengo Therapeutics. Highlights below.
FDA OKs Biosimilar of Roche’s Blockbuster Eye-Care Drug Lucentis
The US Food and Drug Administration (FDA) has approved a biosimilar product interchangeable with Roche’s Lucentis (ranibizumab), an eye-care drug, to Coherus BioSciences, a Redwood City, California-based bio/pharmaceutical company. Roche’s Lucentis had 2021 sales of CHF 1.35 billion ($1.41 billion).
Coherus BioSciences partnered for the biosimilar with Polpharma Biologics Group, an Amsterdam, the Netherlands-based biosimilars company, Formycon, a Munich, Germany-based biosimilars company, and Bioeq, a Zug, Switzerland-based biosimilars company. The biosimilar was developed by Bioeq, a joint venture between Formycon and Polpharma Biologics. In 2019, Coherus BioSciences entered into a license agreement for the exclusive commercialization of the drug under the brand name Cimerli in the US.
The biosimilar was approved for all five FDA-approved Lucentis indications: neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
The commercial launch of Cimerli in both 0.3-mg and 0.5-mg doses by Coherus in the US is planned for early October (October 2022).
GSK’s Viiv Healthcare in Pact for HIV Drug
ViiV Healthcare, a specialist HIV company majority-owned by GlaxoSmithKline (GSK) with Pfizer and Shionogi holding minority stakes, and the Medicines Patent Pool, a United Nations-backed public health organization, have signed a new voluntary licensing agreement for patents relating to ViiV’s cabotegravir to enable access in least developed, low-income, lower middle-income, and Sub-Saharan African countries.
The agreement specifically involves cabotegravir long-acting (LA) for HIV pre-exposure prophylaxis (PrEP), a long-acting injectable that is approved in the US to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents.
Under the agreement, selected generic manufacturers will have the opportunity to develop, manufacture, and supply generic versions of cabotegravir LA for PrEP in 90 countries, subject to required regulatory approvals being obtained.
Source: Viiv Healthcare
Ipsen, Marengo in $1.6-Bn Immuno-Oncology Deal
Ipsen, a Paris-based bio/pharmaceutical company, and Marengo Therapeutics, a Cambridge, Massachusetts-based bio/pharmaceutical company, have formed a partnership to advance two of Marengo’s preclinical immuno-oncology drug candidates, in a deal worth up to $1.6 billion ($45 million upfront and up to $1.592 billion in milestone payments).
Margengo has a proprietary T cell activation platform, Selective T Cell Activation Repertoire (STAR), which encompasses of understanding of T cell function and receptor signaling for developing advanced therapies for cancer.
Ipsen will make an upfront payment of $45 million, together with potential payments up to a total of $1.592 billion if all milestones are met in addition to tiered sales royalty payments.
Under the agreement, Marengo will lead the preclinical development efforts and will expense related costs until the submission of an investigational new drug application to the US Food and Drug Administration. Ipsen will assume responsibilities for clinical development and commercialization.