Chiesi Returns To Respiratory Roots With Affibody Pact
Upfront And Milestone Payments up to $214m
Executive Summary
A busy start to the year sees the Italian firm adding to its respiratory portfolio by gaining access to the Swedish biotech’s investigational inhaled treatments.
Chiesi Farmaceutici S.p.A. is revisiting its respiratory heritage, teaming up with Sweden's Affibody AB to develop inhaled drugs in a deal that could be worth over $640m.
Under the terms of the agreement, the companies will progress up to three programs based on molecules developed using Affibody's technology platform against undisclosed targets for respiratory diseases. Chiesi will fund all discovery, development and subsequent commercialization worldwide, except in the Nordic region where Affibody has retained the option to co-promote.
The privately owned Solna-based biotech is eligible to receive upfront and various milestone payments up to $214m plus mid-single to low double-digit royalties on sales for the first program. If the agreement is expanded to three programs, Affibody could pocket $637m plus royalties.
The partners claimed that the small size of the Affibody molecules (only 6kDa) combined with their robustness allows for broad distribution and sustained exposure in the lung, as seen in preclinical models. Affibody CEO David Bejker added that the collaboration with Chiesi accelerated the firm's strategic development "and further reinforces the competitiveness of our technology which has now been validated both clinically and commercially.”
Chiesi R&D chief Thomas Eichholtz noted that the respiratory diseases area "is a strategic priority for our organization." He added that the pact with Affibody "adds an important new modality to our R&D portfolio that has particularly interesting properties for inhalation."
The Parma-headquartered firm's respiratory franchise is headed by Fostair (beclometasone/formoterol) for asthma and chronic obstructive pulmonary disease and Trimbow (beclometasone/formoterol/glycopyrronium), the first triple therapy to get European approval for COPD in 2017. Chiesi also sells Bronchitol (mannitol), an inhaled powder for cystic fibrosis.
Chiesi, which will have a new CEO in April after appointing former Baxter International chief operating officer Giuseppe Accogli, has had a busy start to 2023 on the dealmaking front. In January, the company announced its biggest ever acquisition with the $1.48bn buyout of Irish rare disease specialist Amryt Pharma plc.
That deal, which is expected to close by the end of the first half of 2023, brings in four marketed products to Chiesi's portfolio – Lojuxta/Juxtapid (lomitapide) for homozygous familial hypercholesterolemia, Myalept/Myalepta (metreleptin) for generalized lipodystrophy, Mycapssa (oral octreotide) for acromegaly and the butterfly skin therapy Filsuvez; the latter, which is made from the birch bark extract botulin and formulated in a refined sunflower oil, was approved in Europe in June after a rejection by the US Food and Drug Administration earlier in 2022. (Also see "Amryt Earns Wings For Butterfly Skin Drug In Europe" - Scrip, 25 Apr, 2022.)
Approvals
It has also been a fruitful period on the regulatory front for Chiesi. Last month, the FDA approved Lamzede (velmanase alfa) for the treatment of alpha-mannosidosis. The ultra-rare, progressive lysosomal storage disorder therapy has been available in the EU for five years. (Also see "Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon" - Pink Sheet, 20 Feb, 2023.)
Also last month, the European Medicines Agency issued a positive opinion for Elfabrio (pegunigalsidase alfa), Chiesi and Protalix BioTherapeutics, Inc.'s treatment for Fabry disease. In the US, the companies resubmitted a biologics license application for the enzyme replacement therapy after the FDA rejected the drug in 2021. The agency has since set an action date of 9 May under the Prescription Drug User Fee Act. (Also see "EMA Backs Approval For Eight New Drugs But Rejects Lagevrio For COVID-19" - Pink Sheet, 24 Feb, 2023.) (Also see "Protalix Plans US Resubmission For ERT For Fabry After Positive Phase III Trial Results" - Scrip, 4 Apr, 2022.)
As for Affibody, its most advanced asset is the interleukin-17A inhibitor izokibep. In January, its partner Acelyrin, Inc. announced positive top-line data from a Phase IIb/III trial of the drug in patients with moderate-to-severe hidradenitis suppurativa; izokibep is also in trials for a number of other autoimmune disorders, including psoriasis, psoriatic arthritis, uveitis and axial spondyloarthritis.
Affibody also has a licensing agreement with Rallybio Corp. covering the complement factor (C5) inhibitor RLYB116, which is in Phase I development for paroxysmal nocturnal hemoglobinuria and generalized myasthenia gravis. (Also see "Rallybio Looks To Deals To Grow ‘Transformative’ Rare Disease Pipeline" - Scrip, 2 Mar, 2022.)