BioBlast w/e 23 Jun 23

ASLAN Pharmaceuticals announced that it entered an exclusive licence with Zenyaku Kogyo to develop and commercialise eblasakimab (a first-in-class monoclonal antibody) to treat atopic dermatitis in Japan.  ASLAN will receive an upfront payment of $12M from Zenyaku and is eligible for an extra $3M if it meets specific conditions relating to phase IIb trial data and delivery of the clinical study report.  ASLAN can potentially earn up to $29.5M in development milestones and up to $94M in commercial milestones.

Zenyaku will conduct a phase I study of eblasakimab in Japan during the first half of 2024 and will make royalty payments to ASLAN based on net sales of eblasakimab.  ASLAN retains an option to reacquire the rights to eblasakimab in Japan at any time in the future.

Samsung Bioepis has filed an IPR in the US against Alexion’s Soliris® (eculizumab) patent 10,703,809 (’809 patent) advocating that all claims of the ‘809 patent are obvious in light of the prior art (including patent applications, a granted patent, manuscripts and a journal article).

On the same day, Samsung Bioepis also filed an IPR against Janssen’s Stelara® (ustekinumab) patent no. 10,961,307 (‘307 patent), addressed here

Samsung Bioepis has filed an IPR against Janssen’s US patent no. 10,961,307 (‘307 patent) relating to Stelara® (ustekinumab).  Samsung Bioepis argues that all claims of the ‘307 patent are invalid. Claims 1-4, 6-22, and 24-34 allegedly lack novelty and are anticipated by a Janssen clinical overview summary for a phase III clinical trial of ustekinumab (NCT-236).   All claims (1-34) are allegedly obvious in light of NCT-236 combined with a journal article and the Stelara® Prescribing Information.

On the same day, Samsung Bioepis filed an IPR against Alexion’s US patent no. 10,703,809 (’809 patent) relating to Soliris® (eculizumab).

On 12 June 2023 Alvotech and Teva announced they reached a settlement and licence agreement with J&J for AVT04 (Alvotech’s biosimilar to Stelara®) providing a licensed US launch date of no later than 21 February 2025, and on 22 May 2023 Amgen settled its Stelara® patent invalidity suit with Janssen in the US with a licensed US launch date of no later than 1 January 2025.

Xbrane Biopharma announced the FDA has accepted a supplemental Biologics License Application (sBLA) for its biosimilar to Genentech’s Lucentis® (ranibizumab) to treat serious eye diseases such as wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.  The Biosimilar User Fee Amendment goal date is 21 April 2024.

Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.

On 25 April 2023, STADA and Xbrane together announced the supply of Ximluci® (ranibizumab) on the NHS in England.

LOTTE Biologics announced it has signed a memorandum of understanding with LOTTE Corporation, Incheon Metropolitan City and the Incheon Free Economic Zone to establish biologics production facilities in the area.  LOTTE Biologics plans to construct three mega plants by 2030, that can produce 360,000L of biologic therapeutics.

On 8 June 2023, Samsung Biologics and Pfizer announced a US$411M collaboration to manufacture biosimilars in Korea.

Merck announced that it has acquired Prometheus Biosciences, Inc. which is now a wholly-owned subsidiary of Merck.  Prometheus’ leading candidate product PRA-023 (now known as MK-7240), is a humanized monoclonal antibody being developed to treat immune-mediated diseases such as autoimmune disease, ulcerative colitis and Crohn’s disease.

This news comes shortly after the FDA accepted sBLA for Merck’s KEYTRUDA® (pembrolizumab) plus chemotherapy for advanced or unresectable biliary tract cancer on 8 June 2023.

Sanofi-Aventis filed one of the earliest UPC revocation cases against Amgen’s Repatha® (evolocumab) patent EP3666797 in Munich on 2 June 2023, the day after the UPC’s commencement. Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).  To date, this is the only UPC case relating to a monoclonal antibody.

On 18 May 2023, the US Supreme Court invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab).

A study published in JAMA Network Open has found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics (AbbVie’s Humira®, Amgen’s Enbrel® and J&J’s Remicade® respectively). The authors assessed 25 head-to-head trials (including 10,642 randomised participants) and found the biosimilars were associated with similar rates of adverse events, study discontinuation, and immunogenicity responses compared with reference biologics.

Only two weeks ago on 8 June 2023, the Ph III results of Samsung Bioepis’ SB15 (aflibercept biosimilar) published in JAMA Ophthalmology showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept.