Manufacturing roundup: GenBioPro looks to counter Mississippi trigger law; Pisgah Labs to invest $55M in NC expansion  

28 Jul 2022
endpts.com
Generic DrugImmunotherapy
As the issues from the Roe V. Wade decision continue to cascade in various circles, including the biotech world , one manufacturer is looking to push back against state law. According to a report from Bloomberg BNN, mifepristone manufacturer GenBioPro is looking to challenge a Mississippi anti-abortion law set into motion by the US Supreme Court’s reversal of Roe v. Wade, stating that the move is keeping its product off the shelves. While Mississippi’s trigger law committed to banning most abortions, it includes abortions relying on pills approved by the FDA such as mifepristone. GenBioPro is now amending its complaint it filed in 2020 in Mississippi to the state to address the trigger law. The case is attempting to push back Mississippi’s mifepristone restrictions, which were in effect before the Roe V. Wade decision, counters FDA regulations over the pill. The company is arguing that FDA dispensing and prescribing regulations for the pill preempt state requirements, including having a licensed physician prescribe the drug in person. Pisgah Laboratories a pharmaceutical manufacturer and subsidiary of India-based Ipca labs, will invest $55 million to expand its manufacturing product line and add 57 new jobs in eastern North Carolina. According to the North Carolina governor’s office, the site originally started producing x-ray film dye and agrochemicals. The company received FDA approval to manufacture APIs in 2002 before exclusively developing pharmaceuticals in 2005. Pisgah manufactures the active ingredients for pain medicines and the treatment of disorders and diseases, such as Alzheimer’s and fibromyalgia. The expansion will also add sterile injectables, liquid filling operations and a quality control laboratory, warehousing and microbiological laboratories. “Our parent company, Ipca Laboratories Limited, is making a large investment in Pisgah’s future. Carving a space in the highly competitive pharmaceutical market is not an easy task, but we welcome the challenge and intend to see many years of company growth, job creation and education opportunities for Pisgah Labs and western North Carolina,” said site manager Dani Bailey. The site also received a performance-based grant of $50,000 from the One North Carolina Fund, which provides financial assistance to local governments to help attract economic investment and create jobs. Companies receive no money upfront and must meet job creation and capital investment targets to qualify for payment. Sun Pharma and Glenmark, two manufacturers of generic drugs, issued a recall over manufacturing issues. According to a report from Fierce Pharma, On June 21, Sun Pharma initiated a voluntary recall of 50,680 vials of testosterone cypionate injection because of “water leakage” at a plant in Gujarat, India. Glenmark recalled over 98,307 packs of mometasone furoate topical solution, a lotion that treats skin conditions such as eczema, psoriasis, allergies and rash. Glenmark started the recall on June 16. The issue for Glenmark was over defective packaging at its plant in Himachal Pradesh, India. Precision NanoSystems (PNI) and Replicate Bioscience are looking to enter into a licensing agreement to accelerate the creation, scale-up and delivery of self-replicating RNA (srRNA) therapies. The agreement will see PNI provide lipid nanoparticle solutions for scale-up and manufacturing of up to 15 Replicate srRNA therapeutics. The terms include aggregated milestone fees, royalties, and sublicensing for income sharing, but the company remained mum on the wider details. “I’m confident in PNI’s delivery technology and our working relationship. With this agreement, Replicate aims to significantly expand our portfolio of srRNA therapeutics beyond our lead candidates slated to enter human trials next year,” said Andy Geall, chief development officer of Replicate. The deal will also allow Replicate to explore more drug candidates in areas beyond the company’s lead programs, which address endocrine therapy resistance in breast cancers, immunotherapy resistance in solid tumors and possibly future pandemics.
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