Global Pharma Briefs: News from Asia, the Middle East and the United StatesBy
A roundup of developments and latest news from Israel (BiomX), India (Sanofi), and United States (Aurobindo, Novo Nordisk)
BiomX Completes Construction of Clinical Phage Mfg Facility in Israel
BiomX, a microbiome developer of natural and engineered phage therapies, has completed construction of a new clinical manufacturing facility in Ness Ziona, Israel for the company’s candidate phage products. The company says the facility could be expanded to support commercial manufacturing needs in the future.
Phage are viruses that specifically infect bacteria. BiomX develops a specific composition of phage as product candidates targeting each of its bacterial targets. Phage manufacturing requires first the manufacturing of a specific bacterial strain, that in a second stage, is used to host the growth of the phage.
The new facility has been designed to support the necessary manufacturing requirements for BiomX’s future clinical development, including the manufacturing of BX002, a drug candidate phage composition designed to target bacterial strains that potentially have a role in the onset and aggravation of inflammatory bowel disease (IBD). BiomX says clinical trials are expected to start in 2020. In its current configuration, the site can support clinical manufacturing for BiomX’s future Phase I and Phase II trials in both IBD and primary sclerosing cholangitis, a chronic liver disease, and can be expanded for Phase III and commercial stages.
Sanofi To Sell Mfg Site in Ankleshwar to Private Equity Firm Advent
The Board of Directors of Sanofi India Limited (SIL) has approved a transaction for the slump sale and transfer of its manufacturing facility at Ankleshwar, Gujarat to Zentiva and its legal entity in India, Zentiva Private Limited for a consideration of Rs. 2,617 million ($36.86 million), subject to customary working capital adjustments.
In 2018, as part of a global transaction, Zentiva, which was Sanofi’s European generics business, was sold to Advent International, a private-equity firm.
The Ankleshwar site is Sanofi India’s oldest manufacturing facility where brands such as Combiflam (ibuprofen and acetaminophen), a non-steroidal anti-inflammatory drug, Allegra (fexofenadine), an allergy medicine, and Amaryl (glimepiride), a treatment for Type II diabetes, are made. Sanofi says the production of these brands will be moved to the company’s site in Goa, India and external manufacturing sites as well. The Ankleshwar site has a chemistry and biotechnology development center and manufactures both intermediates and pharmaceutical formulations. It is a large producer of tablets, producing more than 6 billion tablets annually.
This transaction is subject to shareholders’ approval and the completion of certain conditions as defined under the business transfer agreement.
Aurobindo Recalls Simvastatin Tablets From the US for Lot Mislabeling
Aurobindo Pharma, a Hyderabad, India-headquartered pharmaceutical company, has issued a voluntary recall Class III recall of 2,352 bottles (1,000)-count of simvastatin tablets (USP 40 mg) due to incorrect lot labeling. Some bottles were labeled with lot number 05318054B instead of 05318034B.
The subject products were manufactured by Aurolife Pharma, based in Dayton, New Jersey, for Aurobindo Pharma USA.
The Class III recall was initiated on July 29, 2019 and is ongoing. The product was distributed nationwide by three major distributors who may have further distributed the product, according to the FDA.
A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Novo Nordisk Funds $27-Million Biomfg Grant to North Carolina State University
Novo Nordisk has announced it provide $27 million in funding for the Accelerated Innovation in Manufacturing Biologics (AIM-Bio) project at North Carolina State University (NC State). The new five-year project involves an international collaborative research and training program in biomanufacturing science and technology.
NC State will administer the $27 million from Novo Nordisk to the AIM-Bio program in collaboration with the Technical University of Denmark (DTU) in Copenhagen. NC State will receive $18 million to carry out its activities and the remainder will go to DTU.
The effort focuses on the next generation of biopharmaceutical manufacturing. Biotherapeutics are large-molecule drugs produced by engineered organisms, including antibodies, enzymes, insulin and blood-clotting factors, as well as ingredients for gene therapy and regenerative medicine.
NC State says AIM-Bio will establish nine new research projects focusing on technologies of critical importance to biopharmaceutical manufacturing, ranging from cell-factory engineering, to bioreactor design and optimization, to purification of biopharmaceutical products.
NC State says it and DTU will develop eight new combined lecture and hands-on short courses aimed at industry professionals, which will focusing on topics that are particularly relevant to the future of biopharmaceutical manufacturing, including biopharmaceutical process development, automation and process control, and analytical methods. Four of these courses will be co-developed and taught by faculty members and staff at both DTU and NC State and offered to students and industry professionals from both Denmark and the US.
Earlier this year (June 2019), NC State announced another Novo Nordisk Foundation-funded project to improve crop resilience by studying plant interactions with microbes. That six-year project includes three Danish universities and is funded at $30 million.
Source: North Carolina State University