Global Pharma Briefs: News from Asia, Europe, and the USBy
A roundup of developments from China (Seneca Biopharma), India (Biocon), Japan (Astellas), Switzerland (Novartis), and the US (Amneal and Merck KGaA).
Seneca Biopharma Completes Stem-Cell Mfg Facility in China
Seneca Biopharma, a Rockville, Maryland-based clinical-stage biopharmaceutical company, has completed a new stem-cell manufacturing facility in Suzhou, China. The facility will be used to manufacture NSI-566, the company’s stem-cell therapy, for clinical trials within China. The trials include a non-GCP compliant Phase II trial currently underway for the treatment of chronic ischemic stroke, which occurs when an artery that supplies blood to the brain is blocked by a blood clot or plaque.
Source: Seneca Biopharma
Biocon Receives EIR for India Manufacturing Facilities
Biocon Biologics India, a subsidiary of Biocon, a Bangalore, India-based biopharmaceutical company, has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the pre-approval inspection (PAI) at two of its biologics manufacturing facilities in Bangalore, Karnataka, India. The inspection was conducted between September 10 and September 19, 2019.
The receipt of the EIR indicates a successful closure of the inspection. Biocon Biologics responded to the eight observations from the PAI inspection in October 2019.
Subsequent to the inspection, Biocon Biologics received approvals for the two products trastuzumab, a biosimilar to Roche’s Herceptin, a drug for treating breast, stomach, and esophageal cancer, and pegfilgrastim, a biosimilar to Amgen’s Neulasta, which is used to help reduce the chance of infection due to a low white blood cell count in people with certain types of cancer.
Biocon says the formal closure of the FDA inspection will enable the company to file marketing authorization applications for biosimilar products in several global markets.
In a separate development, Biocon received an EIR from the FDA for the post-approval and GMP inspection of its small-molecule active pharmaceutical ingredient manufacturing facility in Bangalore, Karnataka, India based on an inspection conducted between February 20 and February 26, 2020. The EIR has been closed with a Voluntary Action Indicated (VAI) classification, which means objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action. At the conclusion of the inspection, the FDA had issued a Form 483, with two observations, which Biocon says are procedural in nature and are being addressed.
Source: Biocon (biologics manufacturing facility) and Biocon (small-molecules manufacturing facility)
Daiichi To Remove Contaminated Soil Storage Facility at Japan Plant
Daiichi Sankyo announced it will remove a contaminated soil-storage facility located on the site of its former Sankyo Yasugawa plant in Yasu, Yasu-shi, Shiga, Japan.
The plant began operations in 1939, manufacturing agricultural chemicals. After production ceased in 2003, it has been managed as a vacant site. In 1993, it was confirmed that mercury, which was one of the agrochemical raw materials, was distributed in the former plant site in excess of environmental standards. Daiichi Sankyo established a underground storage facility in line with government directives and has managed the contaminated soil appropriately.
Although the company says that there have been no reports of leakages or adverse effects on health, in accordance with the wishes of local residents, Daiichi Sankyo says it has decided to remove the underground storage facility. Through consultation with the relevant stakeholders, Daiichi Sankyo says it will take every effort to prevent any impact on the surrounding environment during the removal process.
Daiichi Sankyo says it allocated a provision for environmental measures of approximately JYP 8.2 billion ($76 million) as related expenses in the fourth quarter of fiscal 2019, which will be used to cover the cost of removal work.
Source: Daiichi Sankyo
Novartis Acquires Amblyotech to Pursue Digital Therapy
Novartis has completed the acquisition of Amblyotech, a US-based software start-up, and will, in collaboration with Ubisoft, a video-game developer, and McGill University in Montreal, pursue the development of the acquired digital technology for the treatment of amblyopia, which is decreased eyesight due to abnormal visual development.
Amblyotech uses active gaming and passive video technology with 3-D glasses to train the eyes to work together to view an image in full. The company reports that its software employs a visual presentation, called dichoptic display, where each eye is presented with different images using a proprietary algorithm. In early clinical studies, Amblyotech’s software demonstrated improvements in vision in both children and adults with faster onset compared to standard of care treatments, according to information from the company.
With the transaction closing, Novartis says it plans to work in partnership with video game developer, Ubisoft, to develop the Amblyotech software as a medical device, create a series of engaging games for the device, and conduct a proof-of-concept study, planned for later in 2020.
Astellas Acquires Nanna Therapeutics for $15 M
Astellas has acquired Nanna Therapeutics, a Cambridge, UK-based company focusing on mitochondria-related diseases, for £12 million ($15 million) through its subsidiary in the UK, Astellas Pharma Europe, and has purchased all of the issued share capital of Nanna through execution of a share-purchase agreement.
Nanna’s proprietary screening platform with new DNA-encoded chemical libraries (DELs) adds to Astellas’ early-stage drug-development capabilities. Nanna’s capabilities enable the creation and testing of diverse chemical libraries to enable phenotype-based screening that is not feasible with conventional DELs, according to the companies. Nanna says it can also be applied to various assay systems, including cell-based assays using patient-derived cells, which potentially enables screens that are tailored to a specific disease biology.
Consideration for the acquisition, £12 million ($15 million), was paid upon closing of the acquisition, and Nanna became a wholly owned subsidiary of Astellas. In addition to this payment, Nanna’s shareholders are eligible to receive potential future development milestone payments of up to £57.5 million ($72 million).
Source: Nanna Therapeutics
Amneal Pharmaceuticals Issues Voluntary Recall of Ulcer Medication
Amneal Pharmaceuticals, a Bridgewater, New Jersey-based generic-drug manufacturer, reported on April 15, 2020 that is voluntarily recalling three lots of nizatidine oral solution, 15 mg/mL (75 mg/5mL), packaged in 480-mL bottles to the consumer level. Nizatidine oral solution, 15 mg/mL is indicated for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD). Nizatidine oral solution is being recalled due to potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the US Food and Drug Administration.
NDMA is classified as a probable human carcinogen based and is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables.
Amneal says it has not received any reports of adverse events that have been confirmed to be directly related to this recall. The affected nizatidine oral solution lots were distributed by Gemini Laboratories, a wholly owned subsidiary of Amneal Pharmaceuticals based in Bridgewater, New Jersey, to wholesalers who further distributed to retail pharmacies and consumers nationwide in the US.
Source: Amneal Pharmaceuticals and US Food and Drug Administration
Merck KGaA, Awarded US Patent for CRISPR Gene-Editing Technology
The US Patent and Trademark Office has granted Merck KGaA’s patent for CRISPR-chrom technology, which is the fusion of chromatin modulating peptides to CRISPR proteins, which is used to clear chromatin out of the way to increase access to the genome.
Because genomic DNA in mammalian cells is wrapped tightly in protein complexes called chromatin, the genomic DNA is often inaccessible to CRISPR. CRISPR-chrom technology works by fusing chromatin modulating peptides to a CRISPR protein, Cas9 (i.e., CRISPR’s DNA scissors), allowing for more efficient gene editing, according to information from the company.
Merck KGaA received its first US patent in February 2019 for its proxy-CRISPR technology. The company has out-licensed its CRISPR patent portfolio and continues to license its entire CRISPR patent portfolio for all fields of use. The company is pursuing CRISPR patent out-licensing partners for therapeutics, agriculture and research.
Source: Merck KGaA