EAST BRUNSWICK, N.J.–(BUSINESS WIRE)–Rising Pharma Holdings Inc., dba as Rising Pharmaceuticals, today announced the opening of a commercial manufacturing facility in Decatur, Illinois, to manufacture and package sterile products, including injectables and ophthalmic products in response to critical pharmaceutical supply shortages in the U.S. The site comprises a manufacturing and packaging facility spanning a combined 230,000 square feet. The move is expected to augment Rising’s existing product portfolio and offer a wider basket of products for customers.

“Rising Pharmaceuticals is proud to play a significant role supporting the healthcare system by producing more than 180 commercialized generic medicines and over 620 active SKU on the market. With one of the broadest portfolios of any U.S. generic pharmaceuticals company, we recognize that expanding manufacturing capabilities in the U.S. is mission-critical for our continued commercial success, as well as for public health in general,” said Vimal Kavuru, CEO of Rising Pharmaceuticals. “The new facility will adhere to stringent quality standards to produce generic medications that are effective and cost-efficient.”

“We look forward to creating a model of sustainable development through our partnership with the Decatur community, balancing efficient U.S. manufacturing growth while competing in the global pharmaceutical supply chain,” said Steven Coventry, Vice President of Operations and General Manager, Rising Pharmaceuticals. “Our facility is reemerging from a prior closure and has been a staple of the Decatur community since 1952. We anticipate that the new site will help create jobs, economic growth, and enhance healthcare accessibility.”

About Rising Pharmaceuticals

Rising Pharmaceuticals, a portfolio company of H.I.G. Capital, is a leading provider of generic and specialty-branded pharmaceuticals in the U.S. Rising focuses on the development, regulatory, and commercial aspects of the product life cycle while outsourcing certain manufacturing to its network of strategic CMO and CDO partners. The Company is based in New Brunswick, New Jersey, and is expanding its manufacturing footprint with a new facility in Decatur, Illinois. For more information about the Company, please visit www.risingpharma.com.

EAST BRUNSWICK N.J.–(BUSINESS WIRE)–Rising Pharma Holdings Inc., the pharmaceutical company now operating as Rising Pharmaceuticals, today announced the support of a Phase 2 clinical trial designed to determine the clinical efficacy of chloroquine phosphate (CQ) in preventing coronavirus disease 2019 (COVID-19) in healthcare workers with moderate to high risk of exposure to SARS-CoV-2, the virus that causes COVID-19. Researchers at Columbia University are conducting this critical study to assess CQ as prophylaxis against COVID-19 in healthcare workers. A 100-patient study conducted in China found that CQ was superior to control treatment in patients with COVID-19 pneumonia, with no serious adverse events reported, and preliminary in vitro data suggest that it may also block SARS-CoV-2 infection.¹

“Healthcare workers are putting their own lives on the line to protect the lives of others, and they need prophylactic agents that effectively prevent SARS-COV-2 infection and COVID-19”

“In patients with lupus, CQ can alleviate symptoms via reductions in the production of type 1 interferon, a potent inflammatory molecule. This reduction is mediated by increasing the pH of endosomes, a component of intracellular transport, which inhibits endosome maturation and transport of interferon to the cell surface for release out of the cell,” said Anca Askanase, MD, MPH, Director of the Columbia University Lupus Center, Associate Professor of Medicine, Division of Rheumatology, at Columbia University Vagelos College of Physicians & Surgeons, and the lead investigator on this investigator-initiated clinical trial. “It has been suggested that inhibiting endosome maturation may also inhibit transport and release of new SARS-CoV-2 viral particles, which would reduce viral replication. While these early findings are intriguing only a prospective clinical study, such as the one we are conducting, can provide the data needed to understand the safety and efficacy of CQ in COVID-19 prophylaxis for at-risk healthcare workers. Protecting these healthcare workers is essential for providing the health services that are essential for managing and reducing the COVID-19 pandemic.”

The randomized, double blind, placebo-controlled Phase 2 trial will enroll 350 volunteers who work in direct patient care roles at Columbia University Irving Medical Center and who have contact with patients who may have COVID-19 infection. Participants will be stratified based on exposure risk, with moderate risk defined as patient-facing work in outpatient/in-house clinic at least two days per week and high risk defined as work performed in an intensive care unit, emergency room, or procedure room that contains aerosolized particles and high risk of contamination. Subjects will also be stratified by age (younger or older than 50 years of age). Subjects will receive 500 mg of orally administered CQ daily for one week and then 500 mg weekly for the duration of COVID-19 exposure. The primary endpoint is a 67% decrease in the number of at-risk health workers with symptomatic COVID-19 between the CQ and control arms (a decrease in expected infections from 15% in the control arm to 5% in the CQ arm). The secondary endpoints are a 67% decrease in the number of at-risk healthcare workers who develop antibodies against SARS-COV-2 (a measure of infection) between the CQ and control arms, the percent of patients with adverse events Grade 3 or higher, and the percent of patients with gastrointestinal intolerance to CQ.

“Healthcare workers are putting their own lives on the line to protect the lives of others, and they need prophylactic agents that effectively prevent SARS-COV-2 infection and COVID-19,” said Sharath Koripally, Head of Regulatory Affairs and Quality Assurance at Rising Pharmaceuticals. “The hypothesis and preliminary data supporting this trial are promising. We need to move quickly to generate statistically significant data that will enhance our understanding of the potential role that CQ may play in protecting healthcare workers. Columbia University is world-renowned for its expertise in implementing well-designed clinical trials that enable improved clinical decision-making, and we are pleased to work with them on this important trial.” Since 2011, Rising Pharmaceuticals has distributed Chloroquine Phosphate Tablets in the United States under an FDA approved drug application.

References

¹ Gao J, Tian Z and Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. BioScience Trends. 2020;14(1):72-73.

About Chloroquine Phosphate, USP Tablets

Chloroquine Phosphate tablets are indicated for the: treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P. malariae, P. ovale, and P. vivax; prophylaxis of malaria in geographic areas where chloroquine resistance is not present; and treatment of existential amebiasis.

About Rising Pharma Holdings, Inc.

Rising Pharma Holdings, Inc., a privately held company, sells generic prescription products and over-the-counter pharmaceutical products under the Rising label to leading wholesalers, chain drug stores, distributors, and mass merchandisers. The company continually seeks new opportunities to develop its business through strategic partnerships with manufacturers, marketers, and distributors under the Rising label.

EAST BRUNSWICK N.J.–(BUSINESS WIRE)–Rising Pharma Holdings, Inc., operating as Rising Pharmaceuticals, today announced the donation of Hydroxychloroquine tablets in support of a Phase 2 randomized clinical trial exploring hydroxychloroquine as preventive treatment for coronavirus disease 2019 (COVID-19) in patients with cancer who are receiving radiation therapy.

“Patients may be at a higher risk for contracting COVID-19 during cancer treatment due to increased exposure”

The trial is being conducted at Memorial Sloan Kettering Cancer Center (MSK), a global leader in cancer care. The randomized, placebo-controlled Phase 2 trial will enroll patients at least 18 years of age who are undergoing radiation therapy alone or in combination with chemotherapy. Subjects will be randomized 1:1 to prophylactic hydroxychloroquine or placebo. The primary endpoint is to compare the likelihood of symptomatic COVID-19 infection between the hydroxychloroquine and placebo groups. Secondary objectives are the likelihood of severe COVID-19 between groups, and to evaluate acute toxicity associated with administration of hydroxychloroquine during radiation or chemoradiation.

“Patients may be at a higher risk for contracting COVID-19 during cancer treatment due to increased exposure,” said Dr. Nancy Y. Lee, Vice Chairman, Department of Radiation Oncology at MSK and principal investigator on the clinical trial. “There is an urgent need to identify effective risk-reduction strategies for these patients that require treatment for their cancer as we await effective therapeutic options. This trial will provide important insight into the potential role that hydroxychloroquine might play in addressing this critical need.”

Hydroxychloroquine is a medication used for the prevention and treatment of certain types of malaria, as well as rheumatoid arthritis, lupus, and porphyria cutanea tarda, and is currently being evaluated in a variety of settings for its potential ability to prevent SARS-CoV-2 infection and to treat COVID-19.

“Patients undergoing cancer directed treatment represent a vulnerable population that is at high risk for COVID-19,” said Dr. Satya Chava, Chief Executive Officer of Laurus Labs Limited. “We are pleased to be working with the expert clinical researchers at Memorial Sloan Kettering to evaluate the prophylactic potential of this drug.”

Rising Pharmaceuticals — and its partner Laurus Labs Limited in Hyderabad, India — manufacture Hydroxychloroquine Sulphate, USP Tablets under an FDA approved drug application. Rising Pharmaceuticals and Laurus Labs have agreed to donate Hydroxychloroquine tablets to support MSK’s study.

About Hydroxychloroquine Sulfate, USP Tablets

Hydroxychloroquine sulfate tablets are indicated for the following; treatment of uncomplicated malaria due to P. falciparum, P. malariae, P. ovale, and P. vivax; for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported; for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults; and for the treatment of acute and chronic rheumatoid arthritis in adults.

About Rising Pharma Holdings, Inc.

Rising Pharma Holdings, Inc., a privately held company, sells generic prescription products and over-the-counter pharmaceutical products under the Rising label to leading wholesalers, chain drug stores, distributors, and mass merchandisers. The company continually seeks new opportunities to develop its business through strategic partnerships with manufacturers, marketers, and distributors under the Rising label.

About Laurus Labs Limited

Laurus Labs Limited is a leading research driven Pharmaceutical Manufacturing Company in India. We have grown to become one of the leading manufacturers of API for Anti-Retroviral (ARV), Oncology, Cardiovascular, Anti-Diabetics, Anti-Asthma and Gastroenterology. We are thriving on growth opportunities in formulation manufacturing to service all leading markets of North America, Europe, and Low Middle-Income Countries (LMIC). We are driving growth opportunities in Contract Development and Manufacturing through our Synthesis business. Most of our manufacturing facilities are approved by major regulatory authorities USFDA, WHO-Geneva, UK-MHRA etc. Our approach remains to identify and invest ahead of time with strategic investments in State-of-the-Art R&D and Manufacturing Infrastructure enabling us to become a quality supplier of high-volume products. Corporate Identification No: L24239AP2005PLC047518