Introduction: WHO reports discovery of new virus variant; AbbVie invests 60 million euros to expand manufacturing operations in Ireland; Inventiva signs collaboration worth over $300 million with China Biologic Products… BioExplorer keeps you updated on the "pharma" news and explores the value of biotechnology!
01 WHO Reports Discovery of New Virus Variant
Recently, according to a report by the San Francisco Chronicle, the latest data from the World Health Organization shows that last week, the number of new global COVID-19 cases per week stabilized at 3.2 million new cases. The weekly number of new COVID-19 deaths also decreased by 17% compared to the previous week.
WHO stated that the BA.5 variant remains the dominant variant within the Omicron lineage, accounting for 76.6% of all global COVID-19 cases, followed by the BA.4 variant at 7.5%. The organization also noted that it is currently monitoring six viral lineages, including the BA.2.75 variant. Additionally, health officials are tracking newly emerging variants such as BA.5.1+V445, BA.5.2+K444, BA.5.2.1+R346, BA.5.2.1+K444, and BE1.1.
02 AbbVie Invests 60 Million Euros to Expand Manufacturing Operations in Ireland
Recently, the Irish government announced that AbbVie will inject 60 million euros ($58.9 million) into its manufacturing base located in Carrigtwohill, a suburb of Cork City, Ireland. According to AbbVie, this 14,000-square-foot facility has been operating as a production base for tablets and capsules for oncology and virology products since 2001. This latest expansion will enable the site to also support its aesthetics business.
Construction will begin next year and be fully operational by 2025, with an additional 70 employees to be hired, although the exact scale of the expansion was not initially disclosed. The plant currently employs 150 people and has invested €177 million (US$173.8 million) in its operations since 2013.
03 Inventiva Signs Cooperation Agreement with China Biologic Products Worth Over $300 Million
Recently, Inventiva and China Biologic Products jointly announced: Inventiva has transferred the development and commercialization rights of the NASH candidate drug lanifibranor to China Biologic Products' subsidiary, Zhengda Tianqing Pharmaceutical Group (CTTQ). This includes the rights in mainland China, Hong Kong, Macao, and Taiwan.
In exchange for the licenses in these four markets, the subsidiary will make an upfront payment of $12 million to Inventiva, with an additional $5 million payable in the near future if certain undisclosed milestones are met. Most importantly, the milestone payments—clinical, regulatory, and commercial—could total up to $290 million, plus royalties.
The subsidiary will cover all trial expenses for the Asian market, but this is contingent upon whether CTTQ will join the ongoing Phase III lanifibranor study for NASH or conduct its own research. The companies noted that this decision will depend on several factors, including the perspective of Chinese regulatory authorities.
04 Zai Lab Submits New Drug for Myasthenia Gravis to FDA in Subcutaneous Injection Formulation
On September 22, Argenx announced that it had submitted a Biologics License Application (BLA) to the FDA for subcutaneous efgartigimod. In December 2021, intravenous efgartigimod was approved by the FDA for the treatment of adult patients with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) antibodies, becoming the world's first FDA-approved anti-FcRn monoclonal antibody.
gMG is an autoimmune disease that leads to loss of muscle function. Efgartigimod reduces pathogenic IgG antibodies associated with autoimmune diseases by blocking the protective receptor FcRn of immunoglobulin G (IgG). In January 2021, Zai Lab entered into a collaboration agreement with Argenx, obtaining exclusive rights to develop and commercialize efgartigimod in Greater China.
05 Maintenance Treatment HRD-Positive Ovarian Cancer Drug Approved in China
On September 22, AstraZeneca and Merck jointly announced that the NMPA has officially approved a new indication for the PARP inhibitor olaparib (Lynparza) for maintenance treatment in adult patients with homologous recombination repair deficiency (HRD)-positive advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved complete or partial response after first-line platinum-based chemotherapy combined with bevacizumab.
This approval is mainly based on the exploratory analysis of the HRD-positive subgroup in the Phase III PAOLA-1 study. The results showed that in the population of patients with HRD-positive advanced ovarian cancer, the median progression-free survival (PFS) was 46.8 months in the olaparib plus bevacizumab group, compared to only 17.6 months in the bevacizumab alone group. Additionally, treatment with olaparib plus bevacizumab reduced the risk of disease progression or death by 67% (95% CI: 0.25-0.45) in this subgroup. The five-year analysis results indicated that the olaparib plus bevacizumab group also achieved a clinically meaningful improvement in overall survival (OS).
