Gliclazide

A former Par Pharma site in Irvine, CA, will now have a new tenant. BioDuro-Sundia will acquire a 40,000-square-foot oral solid dose manufacturing site in Irvine, the company announced Monday. The site will allow the company to scale up and cater to companies that need larger-scale production, Kent Payne, the president of development and manufacturing, said in a press release. The new site should be operational by the start of 2022. It will be able to produce 1 billion tablets and capsules a year, the company said. “BioDuro-Sundia is a pioneer in enhancing bioavailability, with 25 years of experience applying stabilized amorphous solid dispersion technology to poorly soluble drug product candidates,” he said. “Our clients have requested our support to provide commercial scale manufacturing to save time and maximize success, and it is a pleasure to take this next step with them.” BioDuro-Sundia is a CDMO with 2,000 employees in 10 sites across the country, including China and the US. The company specializes in small- and large-molecule discovery, IND submission support and the scaling of batches. It bills itself as a one-stop shop for its clients. The site is located at 72 Fairbanks in Irvine and was previously used by Par Pharmaceuticals. They acquired the site from Anchen Pharmaceuticals back in 2011, when they acquired the company. In 2020, BioDuro invested in a 150,000-square-foot R&D site in Wuxi City, China, and says that the integrated system can help save time and produce a better quality drug. In April, the company invested in adding a cGMP manufacturing site at the facility. That location handles oral dosage tablets and capsules. That added to its already-existing site in San Diego. Among the drugs manufactured by the company is Gliclazide, a sustained release tablet to treat diabetes from Tianjin Jun’an Bio. The drug is often used with metformin tablets, acarbose tablets or pioglitazone.

BEIJING, Oct. 19 /PRNewswire-Asia-FirstCall/ -- Lotus Pharmaceuticals, Inc. (OTC Bulletin Board: LTUS) ("Lotus" or the "Company"), a fast-growing, profitable developer, manufacturer and seller of medicine and drugs in the People's Republic of China ("PRC"), announced today that its wholly owned subsidiary, En Ze Jia Shi Pharmaceuticals, has been issued a patent by the State Intellectual Property Office of the People's Republic of China for controlled-release oral gliclazide. The patent covers the composition and preparation methods for the drug through 2030. Gliclazide is commonly used to control mild to moderate adult-onset Type 2 diabetes. The drug belongs to the second generation of sulfonylureas, a class of anti-diabetic drugs that stimulate the pancreas to release more insulin. Lotus' novel controlled-release gliclazide tablet is formulated using osmotic pump technology, which encases the drug in a semi-permeable framework for a gradual, sustained release. The drug release is designed to be minimally affected by pH, gastric acid and food intake. In preclinical studies, the tablets demonstrated a similar rate of drug release in both in vitro and in vivo models. According to the Company's proprietary market research, the worldwide diabetic population is expected to reach 239 million people by 2010. China currently has about 40 million diabetic patients, with an additional 1.5 to 2 million patients diagnosed each year. China's diabetes drug market is estimated at RMB 7 billion (US $1.1 billion) annually and is expected to surpass RMB 10 billion (US $1.5 billion) in four years. Gliclazide accounts for approximately 28%, or RMB 1.25 billion (US $188.1 million), of the sulfonylurea market in China. Chairman and Chief Executive Officer Mr. Zhongyi Liu stated, "We believe our controlled-release gliclazide tablet will have a meaningful impact on the clinical treatment of diabetes. The drug release rate of conventional oral gliclazide is uncontrolled, which can lead to unpleasant side effects due to quick drug release. Our controlled-release formulation has the potential to provide a more stable and sustained drug delivery compared to conventional gliclazide, resulting in fewer side effects, greater efficacy and an improved safety profile. In addition, the controlled-release tablet could potentially reduce dosing frequency. This is a significant benefit for diabetic patients, who generally require long-term daily medication." Mr. Liu continued, "We expect to start clinical trials in 2012 after receiving authorization from the State Food and Drug Administration, with regulatory approval expected in 2014. Our market research indicates that the global gliclazide market will reach RMB 1.5 billion, or approximately $225.7 million, by that time. We aim to capture nearly one-tenth of this market, achieving peak sales of approximately $15 million per year. We expect a gross margin of about 60 percent and a net profit of about 30 percent for this product. The demand and market potential are significant, and given our 20-year patent protection, we expect to enjoy market exclusivity for controlled-release gliclazide through at least 2030." About Lotus Pharmaceuticals, Inc. Lotus Pharmaceuticals, Inc. is a fast-growing, profitable developer and producer of drugs and a licensed national seller of pharmaceutical items in the People's Republic of China (PRC). Lotus operates its business through its two controlled entities: Liang Fang Pharmaceutical, Ltd. and En Ze Jia Shi Pharmaceutical, Ltd. Lotus' current drug development is focused on the treatment of cerebro-cardiovascular diseases, asthma and diabetes. Liang Fang sells drugs directly and indirectly through its national sales channels to hospitals, clinics and drugs stores in 30 provinces of the PRC. Information Regarding Forward-Looking Statements Except for historical information contained herein, the statements in this press release are forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause our actual results in future periods to differ materially from forecasted results. These risks and uncertainties include, among other things, product demand, market competition, and risks inherent in our operations. These and other risks are described in our filings with the U.S. Securities and Exchange Commission.For more information, please contact: At the Company:Xing Shen, Ph.D.VP of Corporate Development Lotus Pharmaceuticals, Inc.Phone: +1-415-690-7688Email: shen@lotuspharma.comWeb: Investor Relations:Dave Gentry RedChip Companies, Inc. Phone: 1-800-733-2447, Ext. 104Email: info@redchip.com Jing Zhang, ChinaRedChip Beijing Representative OfficePhone: +86-10-8591-0635Web: SOURCE Lotus Pharmaceuticals, Inc.