Global Pharma Briefs: News from AstraZeneca, Lilly, Teva, ModernaBy
A roundup of news from China (Neurophth Biotechnology), India (Biocon), and the US (Lilly, AstraZeneca, Teva Pharmaceuticals, and Moderna).
Neurophth Opens Gene-Therapy Mfg Facility
Neurophth Biotechnology, a Wuhan, China-based genomic medicines company, has opened a gene-therapy manufacturing facility in Suzhou, China.
The 8,000 square-meter gene therapy-focused production facility includes two drug-substance production suites, two filling lines, a cell banking suite, a technology transfer laboratory and a quality-control laboratory.
Neurophth is headquartered in Wuhan, China with subsidiaries in Shanghai and Suzhou, China and the US (San Diego, California),
Biocon Biologics Mfg Plant Cited with 6 Observations by FDA
The US Food and Drug Administration (FDA) has issued a Form 483 following an onsite pre-approval inspection of a manufacturing facility for insulin aspart of Biocon Sdn. Bhd, the Malaysian subsidiary of Biocon Biologics, a developer of biosimilars and part of Biocon, a Bangalore, India-based bio/pharmaceutical company.
Biocon, along with its partner, Viatris, are collaborating on a biosimilar of insulin aspart, which is a biosimilar of Novo Nordisk’s Novolog. It received approval from the European Commission earlier this year (February 2021). The companies have a collaboration for the development, manufacturing, and commercialization of select biosimilars and insulin analogs.
The FDA inspection occurred between September 13, 2021 and September 24, 2021. At the conclusion of the inspection, the agency issued a Form 483 with a total of six observations across drug substance, drug product and devices facilities.
“We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan, which will be submitted to the US FDA in the stipulated time,” Biocon Biologics said in a September 25, 2021 statement. “We do not expect the outcome of this inspection to impact our commercialization plans for insulin aspart in the US.
Source: Biocon Biologics
Lilly Issues Recall of One Lot of Glucagon Emergency Kit
Eli Lilly and Company is voluntarily recalling one lot of Glucagon Emergency Kit (glucagon for Injection, 1 mg per vial; diluent for glucagon, 1 mL syringe) to the consumer/user level due to a product complaint reporting that the vial of glucagon was in liquid form instead of the powder form.
Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus.
The firm’s investigation indicates that the liquid in this glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency. The lot was distributed nationwide to wholesalers and retailers.
Source: Eli Lilly and Company
AstraZeneca’s Alexion To Fully Acquire Caelum Biosciences
Alexion, part of AstraZeneca following AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals, a Boston-based company focused on rare diseases, has agreed to acquire all remaining equity in Caelum Biosciences, a Bordentown, New Jersey-based bio/pharmaceutical company also focused on rare diseases.
Caelum’s lead asset is CAEL-101 for treating light-chain amyloidosis, a rare disease in which misfolded amyloid proteins build up in organs throughout the body, including the heart and kidneys. CAEL-101 is in a Phase III clinical program in combination with standard-of-care therapy in AL amyloidosis. Two parallel Phase III trials in patients with Mayo stage IIIa disease and in patients with Mayo stage IIIb disease, respectively, are ongoing.
In 2019, Caelum and Alexion first entered into a collaboration whereby Alexion acquired a minority equity interest and an exclusive option to acquire the remaining equity in Caelum. Alexion is exercising this option, and upon closing the acquisition, which is expected to take place on October 5, 2021, Alexion will pay Caelum the agreed option exercise price of approximately $150 million, with the potential for additional payments of up to $350 million upon achievement of regulatory and commercial milestones.
Source: AstraZeneca and Caelum Biosciences
Teva Reaches Opioid Settlement with State of Louisiana
Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries, has settled an agreement with the attorney general of Louisiana that resolves opioid-related claims against the company.
Under the terms of the settlement, Teva will pay Louisiana $15 million over an 18-year time period and will provide an additional donation of medicines to aid in opioid addiction and recovery, valued at $3 million (wholesale acquisition cost). The agreement is contingent on confirmation from the state by November 2, 2021 that all political subdivisions will release Teva as part of the settlement.
Teva says it continues to negotiate a national settlement and remains open in parallel to pursuing opportunities with individual states. The company says it will continue to defend itself in court in states such as New York and California where it has not reached terms of a settlement agreement.
Source: Teva Pharmaceutical Industries
Moderna Investing in New Science Center
Moderna is investing in a new science center in Cambridge, Massachusetts.
The 462,000-square-foot Moderna Science Center is being built to support Moderna’s growth as the company continues to advance its pipeline of mRNA medicines. The new site will include custom spaces for research and development. The building will integrate scientific and non-scientific spaces. Construction at the location has begun, and the company expects to begin a phased move-in process in 2023.