BioBlast w/e 12 May 23

11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium

Korea Biomed has reported that Celltrion Healthcare has won bids to supply Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab), in Italy and Belgium to treat metastatic colorectal and breast cancer.  Celltrion says that it will supply three Italian provinces (Lombardy, Emilia Romagna, and Toscana), which make up ~40% of the market in Italy, for two to three years.  It will supply two Belgian hospital groups (Brugge Regional Hospital Group and Onze LIeve Vroiw General Hospital) for two years.

Celltrion launched Vegzelma® in the US (April 2023), and despite being “the latecomer”, Celltrion says it has achieved “significant results in key European countries since its launch, thanks to a flexible pricing strategy implemented”.

10 MAY 2023 | TR | Alvotech and Polifarma announce aflibercept agreement

Alvotech announced that an exclusive agreement with Polifarma for the commercialisation of AVT06 (aflibercept, biosimilar to Bayer/Regeneron’s Eylea®) in Turkey.  Alvotech announced the initiation of ALVOEYE clinical trials for AVT06 in July 2022 in (wet) age-related maculation degeneration (AMD).

10 MAY 2023 | EU | New Indication alert: EC approves AstraZeneca’s Ultomiris® (ravulizumab) for NMOSD

AstraZeneca announced that the European Commission has approved its Ultomiris® (ravulizumab) for an additional indication, the treatment of adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD).  According to AstraZeneca, Ultomiris® is the first and only long-acting C5 complement inhibitor treatment for the above form of NMOSD in the EU, and EU is the first region in which this new indication has been approved.

This follows the positive opinion of the CHMP in April 2023 based on results from the CHAMPION-NMOSD Phase III trial.  Ultomiris® was previously approved in the US, EU and JP for the treatment of certain myasthenia gravis, paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome to inhibit complement-mediated thrombotic microangiopathy.

09 MAY 2023 | Roche acquires worldwide rights to Zion Pharma’s ZN-A-1041 (oral HER2 TKI)

Zion Pharma announced that Roche has acquired the global rights to ZN-A-1041, an orally administered selective tyrosine kinase inhibitor targeting the Human Epidermal Growth Factor Receptor 2 (HER2).  ZN-A-1041 has the potential to treat or prevent the onset of brain metastases in patients with HER2- positive metastatic breast cancer.  Zion will receive up to US$70 million in upfront and near-term milestone payments, and will be eligible for up to US$610 million in additional payments following achievement of certain development, regulatory, and sales-based milestones events, as well as tiered royalties on sales.

The current phase I trial is being conducted across the US and China, and details will be presented at the American Society of Clinical Oncology Annual Meeting in June 2023.

09 MAY 2023 | CA | New indication alert: Health Canada approves AbbVie’s Rinvoq® (upadacitinib) for nr-axSpA

AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib, 15mg), an oral once-daily selective and reversible JAK inhibitor for the treatment of Active Non-Radiographic Axial Spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug or when use of those therapies is inadvisable.  It is the first and only JAK inhibitor approved for the full spectrum of axial spondyloarthritis.

This comes only a few weeks after the EC approved Rinvoq® for Chron’s disease in Europe.

09 MAY 2023 | Sandoz and Just-Evotec Biologics partner to develop and manufacture biosimilars

Sandoz announced that it has partnered with Just-Evotec Biologics (subsidiary of Evotec SE) to develop and manufacture multiple biosimilar medicines (with an option for expansion).  The deal will utilise Just-Evotec Biologics’ AI driven drug substance development platform and continuous manufacturing technology to expand Sandoz’s pipeline from 15 to 24 assets, and integrate development and manufacturing.  Sandoz highlighted that a mutual commitment to “use disruptive technology with lower operational costs” underpins the deal, and that development of biosimilars will ramp-up in the next 12-18 months.

This news comes only a few weeks after Sandoz signed an MOU to build a USD$400M biologics facility in Slovenia in March 2023.

09 MAY 2023 | US | New application alert: FDA accepts Roche’s sBLA for Vabysmo® (faricimab)

Roche announced that the FDA has accepted its sBLA for Vabysmo® (faricimab) to treat macular edema following retinal vein occlusion.  The sBLA is based on results from the phase III BALATON and COMINO studies which met primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.

Last year, Health Canada approved Vabysmo® for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.

09 MAY 2023 | CN | New indication alert: NMPA approves Innovent Biologics/Eli Lilly’s TYVYT® (sintilimab) for EGFR-mutated Non-squamous NSCLC

Innovent Biologics and Eli Lilly announced that the Chinese NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) in patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor therapy.  TYVYT® is globally the first approved PD-1 inhibitor for this indication.  This is the seventh NMPA-approved indication of TYVYT®.

This comes a day after Innovent Biologics announced dosing of the first participant in its phase III study of IBI311 (Anti-IGF-1R Monoclonal Antibody).

08 MAY 2023 | CN | Approval alert: NMPA approves Koselugo® (selumetinib) for plexiform neurofibromas in paediatric patients

AstraZeneca announced Koselugo® (selumetinib) has been approved in by the Chinese NMPA for the treatment of symptomatic, inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 aged three years and above.  The NMPA relied on results of the SPRINT Stratum 1 trial, published in the New England Journal of Medicine.  The study was sponsored by the National Institutes of Health’s National Cancer Institute Cancer Therapy Evaluation Program.

08 MAY 2023 | Celltrion reports US$126M profit in Q1 2023

The Korea Times has reported Celltrion has reported a Q1 2023 net profit of ₩167.1B (US$126.4 million).  Celltrion said in a regulatory filing that operating profit for Q1 rose 41.1% on-year to ₩182.4B, and revenue increased 12.4% to ₩597.5B.

In April 2023, Celltrion launched Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, in the US, and in May 2023 Celltrion won bids to supply Vegzelma in Italy and Belgium.

08 MAY 2023 | US | New Amgen Prolia® (denosumab) data

Amgen announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the US showing Prolia^® (denosumab) injection reduced fracture risk in patients versus oral alendronate, a frequently prescribed bisphosphonate treatment. Treatment with Prolia® was also associated with greater reductions in fracture risk over time.

The data were presented during an oral presentation at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), in Barcelona, May 4-7, 2023.

08 MAY 2023 | US | Innovent Biologics announces phase III commencement for IBI311 (Anti-IGF-1R Monoclonal Antibody)

Innovent Biologics announced that the first patient with thyroid eye disease (TED) has been dosed in the phase III study (RESTORE) for IBI311.  IBI311 is a recombinant anti-insulin-like growth factor-1 receptor monoclonal antibody.   The study (CTR20223393) will evaluate the efficacy of IBI311 in improving proptosis in TED subjects to support the potential new drug application of IBI311.

In June last year the Chinese NMPA approved Innovent’s TYVYT® (sintilimab injection), and Innovent’s Bevagen® (bevacizumab) was approved in Indonesia.

06 MAY 2023 | Regeneron/Sanofi’s Dupixent® (dupilumab) improves EoE

A Regeneron-sponsored study presented at Digestive Disease Week 2023 in Chicago concluded that Regeneron/Sanofi’s Dupixent® (dupilumab) improves histologic, symptomatic, and endoscopic aspects of eosinophilic esophagitis (EoE).  Dupilumab was effective regardless of whether adolescent and adult patients had a history of dilation, and improved outcomes for primary and key secondary efficacy endpoints.

Last week Health Canada issued a Notice of Compliance for Sanofi’s Dupixent® (dupilumab) for the treatment of patients over 12 with EOE.