Global Pharma Briefs: News from Viatris, Janssen, and CureVacBy
A roundup of news from Canada (Bausch Health Companies), Germany (CureVac, Janssen, BioMed X) and the US (Viatris, Biocon).
Bausch Health Completes $740-M Sale of Amoun Pharmaceuticals
Bausch Health Companies, formerly Valeant Pharmaceuticals, has completed the sale of all of its equity interests in Amoun Pharmaceutical, an Egypt-based pharmaceutical company, to ADQ, an Abu-Dhabi-based holding company, for a total gross consideration of approximately $740 million. The sale was first announced in April 2021.
Separately, Bausch plans to pursue an initial public offering (IPO) of its Solta Medical business, a provider in medical aesthetics with skin rejuvenation and body contouring services. Solta had 2020 revenues of $253 million. The timing of the anticipated IPO is anticipated to occur in the fourth quarter of 2021 or first half of 2022, subject to market conditions.
Source: Bausch Health Companies (ADQ) and Bausch Health Companies (IPO)
CureVac Appoints New COO, Head of Manufacturing
CureVac, a Tubingen, Germany-based clinical-stage biopharmaceutical company developing messenger ribonucleic acid (mRNA) therapeutics and vaccines, has appointed Dr. Malte Greune as Chief Operating Officer (COO), effective July 1, 2021. He will lead, among others, CureVac’s clinical and commercial manufacturing activities.
Dr. Greune joins CureVac from Sanofi-Aventis Deutschland, where he held various management positions for almost 10 years. As General Manager and Vice President Cartridges, Devices & Insulin Technology Group, he was responsible for several manufacturing sites in Frankfurt, Germany. Prior to his position as Head of Diabetes, Oncology and Devices at Sanofi, he worked as Senior Vice President of Animal Health Manufacturing for the Merck Manufacturing Division, where he led an international network of 28 sites.
CureVac also announced that Dr. Florian von der Mülbe, co-founder and Chief Production Officer, will now focus his production expertise exclusively on the expansion and accelerated development of The RNA Printer, CureVac’s solution for mobile and automated manufacturing of RNA vaccines and therapeutics. To drive this project forward, which requires building its own operational infrastructure, Dr. von der Mülbe will resign from the Management Board of CureVac. Dr. Greune will assume Dr. von der Mülbe’s position on the Management Board.
Janssen, BioMed X Start New Research Projects
BioMed X, a Heidelberg, Germany-based independent research institute, has started two new research programs in autoimmune diseases and drug delivery with Janssen Research & Development, one of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The new research group, Protective Tissue Factors in Autoimmune Diseases, is led by Mojca Frank Bertoncelj, MD, PhD, who is joining BioMed X from the University Hospital Zurich in Switzerland. Her research group will develop new approaches to combat chronic inflammatory diseases with a goal to identify protective factors in the tissue microenvironment of patients with auto-inflammatory diseases.
The second research group, Translocation of Complex Macromolecules Across the Intestinal Epithelial Barrier, is led by Kyungbo Kim, PhD, and aims to discover transport mechanisms in the human intestinal tract that could be used for oral delivery of various macromolar therapeutic modalities. Dr. Kim is joining BioMed X from the University of Kentucky in Lexington, Kentucky.
Source: BioMed X
FDA Approves First Interchangeable Biosimilar Insulin Product
The US Food and Drug Administration (FDA) has approved Semglee (insulin glargine-yfgn), a biosimilar interchangeable product by Viatris and Biocon Biologics of Sanofi’s Lantus (insulin glargine), a long-acting insulin to treat Type 1 and Type 2 diabetes. Biocon Biologics is a biosimilars company and a subsidiary of Biocon, a Bangalore, India-based pharmaceutical company. Viatris is the company formed from the merger of Mylan and Pfizer’s Upjohn, Pfizer’s generic and established medicines business.
Semglee is the first interchangeable biosimilar product approved in the US for the treatment of diabetes. An interchangeable biosimilar product may be substituted for the reference product without the intervention of the prescriber. The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution,” much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state, according to information from the FDA.
Viatris says Semglee will be introduced before the end of the year (2021). The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway.
Viatris’ and Biocon Biologic’s insulin glargine has received regulatory approval in more than 60 countries globally. It is the third product from the Viatris–Biocon Biologics biosimilars collaboration that has been approved by the FDA.
Source: US Food and Drug Administration, Viatris, and Biocon