Susan Haigney

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Dr. Reddy’s Laboratories, a pharmaceutical company located in Hyderabad, India, announced on March 27, 2024 that it has entered into a partnership with Sanofi Healthcare India Private Limited to exclusively distribute Sanofi’s vaccine brands in India, including its pediatric and adult brands Hexaxim, Pentaxim, Tetraxim, Menactra, FluQuadri, Adacel, and Avaxim 80U. Sanofi retains ownership and will manufacture and import the vaccines into India.

“Vaccine confidence has reached its highest in India in the last few years. Yet, there is much to be done for the rest of the country’s large unvaccinated cohort. To fulfill our long-term commitment to India and expand our geographic reach, we’re pleased to partner with Dr. Reddy’s Laboratories (Dr. Reddy’s) for exclusive distribution and promotion. We’re confident this partnership will further bolster our promise of saving millions of lives against vaccines preventable diseases with improved vaccination coverage,” said Preeti Futnani, general manager India for Vaccines, Sanofi, in a press release.

“We are happy to have the opportunity to leverage our strengths in promotion and distribution to considerably expand engagement with healthcare professionals and help widen access of Sanofi’s well-established and trusted vaccine brands in India,” said M.V. Ramana, chief executive officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s, in the press release. “We continue our efforts to become the partner of choice in bringing novel, innovative and trusted drugs to patients in India through strategic collaborations. The portfolio now gives Dr. Reddy’s a strong presence in the vaccine segment, propelling us to the second position among vaccines players in India. Through each product and partnership, our aim is to serve over 1.5 billion patients by 2030.”

In addition to the Sanofi partnership, on March 22, 2024, Dr. Reddy’s announced it has entered into a licensing agreement with United States biopharmaceutical company, Pharmazz, for the commercialization of the company’s first-in-class innovative drug, Centhaquine, in India. Centhaquine is a resuscitative agent that treats hypovolemic shock. Dr. Reddy’s will have exclusive rights to market and distribute the drug, under the brand name Lyfaquin, in India. Pharmazz will receive upfront payments and royalties (1).

“The partnership with Pharmazz and launch of this first-in-class drug marks the latest in our effort to enter into strategic collaborations to bring novel molecules to India to meet genuine unmet patient needs,” said Ramana in a press release. “The clinical studies for Lyfaquin have demonstrated significantly better and promising outcomes, making it as a potential add-on drug in the management of hypovolemic shock and enhancing the current standard of care for its treatment in India.”

Anil Gulati, inventor, CEO, and chairman of the Board of Directors of Pharmazz, said in the release, “India's emergence as a hub for developing and introducing innovative medicines is a remarkable achievement. It reflects the country's growing capabilities in research and development within the pharmaceutical sector. It is a large step for Pharmazz to partner with Dr. Reddy's, a leading global pharmaceutical company from India. For patients with hypovolemic shock, I believe Dr. Reddy's is the best partner for Pharmazz to market Centhaquine, an innovative, first-in-class novel resuscitative agent, in India."

Dr. Reddy's and Pharmazz, Inc. Enter into Licensing Agreement to Market First-in-Class Centhaquine (Lyfaquin®) for Hypovolemic Shock in India. 

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Dr. Reddy’s has gained exclusive rights to promote and distribute Sanofi’s vaccines in India.

Dr. Reddy’s Partners with Sanofi Healthcare India to Distribute Vaccines

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Endo International announced on March 12, 2024 that one of its operating companies, Par Pharmaceutical, is voluntarily recalling one lot of Treprostinil Injection 20 mg/20 mL (1 mg/mL) because of the potential presence of silicone particulates in the particle solution (1).

Treprostinil Injection is a prostacyclin vasodilator used to treatpulmonary arterial hypertension. It is formulated for subcutaneous or intravenous infusion. According to the company, administration of an injectable product containing particulate matter may cause irritation or swelling. More seriously, if the particulates reach the blood vessels, they can travel to organs and block blood vessels, which can cause a stroke or death.

The recalled product was distributed in 20-mL multidose vials as sterile solutions in water for injection. Vials are individually packaged in cartons under NDC #42023-206-01. The impacted lot, 57014, was distributed nationwide to wholesalers and hospitals from June 16, 2022 through Oct. 17, 2022 and has an expiration date of 04/2024.

Written notification about the recall has been sent to wholesale accounts and hospitals that received the affected lot. The company stated in a press release that, “Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately. If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.”

The company states that it has not received any reports of adverse events related to the recall as of the date of the press release. Adverse reactions may be reported to FDA via it’s MedWatch Adverse Event Reporting program.

There are regulatory guidelines in place to mitigate the problem of particulates. According to the FDA guidance document, 

Inspection of Injectable Products for Visible Particulates

 patient safety can be impacted by visible particles in injectable products (2). The guidance states that companies should develop and implement a “holistic, risk-based approach” to controlling these particulates and preventing contamination. The guidance document states, “The clinical manifestations of adverse events caused by particulate contamination vary and may depend on the route of administration (e.g., intravascular, intravisceral, intramuscular), patient population, and nature or class of the particulates themselves (e.g., physical size or shape, quantity, chemical reactivity to certain cells or tissues, immunogenicity, infectivity, carcinogenicity). Particulates in intravascular or intravisceral injections generally can cause more adverse events than those in subcutaneous or intramuscular injections.”

Risk assessments should be conducted during product development, according to the FDA guidance document, and any visible particulates that may pose a risk should be identified. “Manufacturers should also consider the potential sources of particulates, appropriate analytical methods to monitor them, and mitigation strategies to prevent their presence in the final product,” the guidance document states.

Visual inspection of the product should be part of a program to ensure products are free of contaminates, according to the agency. “During injectable product development, manufacturers should establish procedures for inspecting the product, statistical sampling plan(s), acceptance/rejection criteria, and procedures for evaluating inspection results. Inspection procedures carried over from another site or another product may not always be suitable for a new product,” the agency states in the guidance document.

FDA. Par Pharmaceutical Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates in the Product Solution. Press Release. March 12, 2024.

Draft Guidance for Industry,Inspection of Injectable Products for Visible Particulates

The company is recalling one lot of the product because of the potential presence of silicone particulates.

Par Pharmaceutical Recalls Treprostinil Injection 20 mg/20 mL (1 mg/mL)

on March 12, 2024 regarding the development of treatments for early Alzheimer’s disease (AD). The purpose of the guidance document is to assist sponsors who are in the clinical phases of development of drugs for treating the stages of sporadic Alzheimer’s disease that occur before dementia becomes overt. FDA refers to these stages in the document as “early AD” but stresses that the disease occurs on a “continuum and patients in the last stage of early AD (i.e., late Stage 3) and patients with AD in the earliest stages of overt dementia (i.e., early Stage 4) may not differ significantly in clinical presentation.” The agency expects the document to create discussions between the Office of Neuroscience in the Center for Drug Evaluation and Research, the Office of Therapeutic Products in the Center for Biologics Evaluation and Research, sponsors, the scientific community, and the public, where appropriate. The draft guidance is a revision of the February 2018 guidance and is open for comments until June 10, 2024.

According to the guidance document, in the past, enrollment in clinical trials for AD treatments were based on clinical criteria that defined the later stages of AD. Because of this, the study subjects “exhibited both the cognitive changes typical of clinically evident AD and the degree of functional impairment associated with overt dementia,” according to the FDA guidance document. Approved treatments were, therefore, based on that context.

FDA states in the document that there has been an effort to use biomarkers that reflect underlying AD pathophysiological changes and to include study subjects with early AD. “These efforts are particularly important because there may be an opportunity to intervene very early in the disease process of AD, given the slowly progressive course of AD and the development of characteristic pathophysiological changes that greatly precede the development of clinically evident findings,” the document states. “Delaying or, preferably, halting or reversing the pathophysiological process that will lead to the initial clinical deficits of AD is the ultimate goal of presymptomatic or very early symptomatic intervention, and treatment directed at this goal must begin before there are overt clinical symptoms. This opportunity carries with it the need to understand ways to assess treatment benefit in these earlier stages of disease.”

The document details diagnostic criterial and clinical staging of AD for the selection of endpoints for the disease stages and enrollment in clinical trials. The document does not cover clinical trials designed to focus on patients with AD that have developed overt dementia or any of the autosomal dominant forms of AD. It also does not apply to treatment of other forms of dementia.

Treatment options for AD have been a focus for industry. In September 2023, 

Roche entered into an agreement with Ionis Pharmaceuticals 

for early stage programs for a RNA-targeting investigational therapeutic for treating AD (1). Roche gained exclusive worldwide rights and is responsible for clinical development, manufacturing, and commercialization of the candidate worldwide. The agreement built upon a 10-year-long partnership between the companies, which started in 2013. In 2018, the companies entered another collaboration to develop an Ionis therapeutic candidate for immunoglobulin A nephropathy and geographic atrophy treatment.

"We are excited to expand our partnership with Roche … ," said Brett P. Monia, CEO, Ionis, in a company press release, at the time (1). "With this new collaboration, we are joining forces to accelerate the discovery and development of novel therapies for people living with Alzheimer's disease and Huntington's disease globally. Collaborating on these two programs enables Ionis to advance our wholly owned programs, including those in neurology, aligned with our strategic priorities."

"Our lasting partnership with Ionis … is a great example of two collaborators mutually benefiting from their relationship by complementing and learning from each other," said James Sabry, global head of Roche Pharma partnering, in the press release (1). "By expanding our alliance, we bring together the companies' combined knowledge of the science in Alzheimer's disease and Huntington's disease with Roche's proven capabilities in the development and commercialization of innovative treatments in neuroscience."

1. Ionis Pharmaceuticals. Ionis Enters Agreement with Roche for Two Novel RNA-targeted Programs for Alzheimer’s Disease and Huntington’s Disease. Press Release. Sept. 27, 2023.

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

FDA Gives Guidance on Developing Treatments for Early Alzheimer’s

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API manufacturer, Noramco, announced on March 14, 2024 that it has launched the Noramco Group, which includes subsidiaries Purisys, Noramco, and the recently acquired Halo Pharma, to create a supply-chain solution in North America for both clinical and commercial APIs and drug products.

Drug shortages can often be a fallout of supply-chain problems and quality control issues. The reliability of foreign supplies and limited domestic manufacturing of APIs and drug products, has spurred Noramco to enhance supply chain performance and increase domestic North American production by forming the Noramco Group. The new group consists of Wilmington, DE-based Noramco, which supplies commercial APIs globally; Purisys, which offers clinical API development and manufacturing services out of Athens, Georgia; and Halo Pharma, a contract development and manufacturing organization (CDMO) with operations in Whippany, NJ, and Montreal, Quebec. Noramco expects to reduce complexity in industry processes, minimize costs, and improve regulatory compliance by aligning the three companies into one group. Additionally, by combining into one group, Noramco will be able to protect intellectual property with a known domestic source, especially important for companies with new chemical entities.

Lee Karras, CEO of the Noramco Group, emphasized the importance of this alignment in the current market. "The COVID-19 pandemic exposed critical vulnerabilities in our drug supply chain. Government responses, while well-intentioned, proved to be somewhat superficial, leaving the threat of future disruptions unaddressed,” Karras stated in a company press release. “The formation of the Noramco Group is our proactive solution to some of these challenges. We are uniquely positioned to provide our customers with a complete, North American-based supply chain solution. By leveraging our advanced manufacturing capabilities, stringent quality control and compliance measures, and timely delivery, we aim to mitigate the risks associated with drug shortages and ensure a stable and reliable supply of vital APIs and drug products. We are committed to supporting patients by ensuring the supply of critical, lifesaving drugs.” 

Noramco manufactures more than 350 products sold in over 30 countries for indications such as ADHD, pain management, and abuse treatment and prevention. The company’s APIs are used by brand and generic-drug small to mid-scale companies.

CDMO, Purisys, offers a 17,000-square-foot manufacturing facility and innovation center and can support the development of custom APIs for a wide range of clinical and commercial applications. The company’s capabilities include controlled substance APIs and a catalog of more than 250 commercial reference standards.

announced the acquisition of Cambrex Drug Product Business Unit

, which was previously known as Halo Pharmaceuticals, in November 2023. The acquisition gave Noramco drug product formulation development, clinical and commercial drug product manufacturing, and packaging services to add to their portfolio.

“This acquisition allows Noramco to provide our customers with more sourcing options beyond APIs. With these additional capabilities, Noramco/Purisys customers can develop drug product formulations for their APIs for both clinical and commercial purposes,” Karras said at the time of the acquisition (1). “Having previously operated the Halo Pharmaceuticals business, I have a direct appreciation of the capabilities of both sites and look forward to working with existing and future customers while welcoming the almost 400 new employees to the Noramco group of companies.”

Noramco Group will be highlighting its services at 

1. Noramco. Noramco Announces the Acquisition of the Cambrex Drug Product Business Unit. Press Release. Nov. 2, 2023.

Noramco Group will be an integrated North American-based API and supply chain services provider.

Noramco Aligns with Purisys and Halo Pharma to Create Noramco Group

LGM Pharma, a contract development and manufacturing organization (CDMO), announced on March 13, 2024 that it is investing more than $2 million in its analytical testing services and expanding offerings by 50%. The company is also adding suppository manufacturing capabilities and expanding its facility in Rosenburg, Texas. These enhancements will offer the company’s customers streamlined, comprehensive manufacturing.

The addition of suppository drug delivery systems to its Rosenburg facility comes as the delivery system gains traction in the industry. According to the company, “Suppository drug delivery systems enable more direct and efficient drug absorption for precise drug release kinetics, including for high medication concentrations and extended drug release times. They provide an excellent solution for patients with difficulty swallowing pills or those experiencing nausea, as well as for chronic conditions and women’s health.”

Ian Gibson, executive vice president of operations at LGM Pharma, stated in a company press release, “As patient needs become increasingly diversified, the pharmaceutical industry needs CDMO partners that can provide specialized capabilities. Our expertise in suppository formulation development and manufacturing, including the most advanced delivery systems, represents another example of our dedication to providing strategic solutions to our industry partners.”

The CDMO’s analytical testing services include method development, validation services, and stability testing. The company’s Irvine, Calif., facility offers chromatography and spectroscopy instrumentation. In addition, the company provides API sourcing and procurement, formulation development, and raw material and finished product testing and packaging.

“Offering standalone analytical testing expands our agility and capacity to serve as a strategic resource for our pharmaceutical partners, providing them with flexibility to meet the precise needs of their expanding product portfolios,” said Prasad Raje, CEO at LGM Pharma, in the release. “With our continuum of robust and tailored support services, we enable pharmaceutical companies to get to market faster and achieve sustainable success in today’s complex market.”

“We take a rigorous, multi-disciplinary approach to address our customers’ most complex analytical needs,” said Shailesh Vengurlekar, senior vice-president of Quality and Regulatory Affairs at LGM Pharma, in the press release. "Our team consists of more than 60 quality and analytical specialists who have decades of experience in all aspects of analytical testing, method development, and validation.”

LGM Pharma will be showcasing its ATS and CDMO services at 2024 DCAT Week, March 18–21, in New York City.

The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.

LGM Pharma Expands Analytical Services

Bormioli Pharma, an international manufacturer of pharmaceutical packaging and medical devices based in Milan, Italy, announced on March 12, 2024 that the company’s North American sales for 2023 saw an increase of 47%. The company points to evolving infrastructure and expanded capacity in the North American market as the root of the increase.

The company expanded its focus in the United States by creating a commercial branch in the country four years ago. An FDA-approved warehouse and dedicated product offerings have been established that are compatible with regional standards. This enabled the company’s US customers to streamline purchasing processes and reduce supply chain complexity, according to Bormioli.

In a press release, Bormioli points to the significant growth in the pharmaceutical glass vials market as a part of its success, with the US market as a major contributor. The company signed a contract with a US-based allergen immunotherapy company for the supply of vertically integrated packaging kits that include aluminum seals, rubber stoppers, Type I molded glass vials, and Type I tubular glass expansion 33 vials.

The company has also committed to sustainable pharma packaging and increased use of sustainable raw materials in 2023 to 45%. It aims to achieve 50% of sustainable raw materials in its pharmaceutical packaging products by 2025. The company conducted analyses of its sustainable packaging and partnered with a clean technology company to use 100% recycled resin for developing a novel pharmaceutical packaging bottle.

“As we grow our presence in North America and expand our capabilities to meet regional standards, we are committed to the partnerships that enable us to broaden our reach,” said Johann Depperschmidt, Bormioli Pharma’s head of Sales, Americas, in a press release. “To best serve our North American customers, we've adapted our manufacturing processes to produce Type I Glass expansion 33 vials in our European facilities, ensuring robust production and backup. We have an on-site, dedicated US sales team and a local warehouse, and we look forward to expanding these resources further in 2024. Additionally, we are collaborating with a US-based sterilization company to prepare ready-to-use packaging kits—a partnership we believe is a significant step forward in ensuring that quality healthcare becomes a more accessible reality for people everywhere.”

“Our momentous growth in the North American market embodies our dedication to meeting and exceeding the evolving needs of this dynamic market,” the company’s CEO, Andrea Lodetti, said in the release. “We are not just expanding our footprint but also enhancing our efficiency and adaptability. This growth aligns perfectly with our mission to provide innovative and sustainable pharmaceutical packaging solutions, and we are proud to say that our growth is not only robust but also responsible.”

Bormioli Pharma offers glass and plastic bottles, plastic and aluminum closures, and accessories in more than 100 countries and nine plants in Europe. The company will be showcasing its products and services at DCAT Week 2024 in New York City, March 18–21, 2024.

The European company has seen its business increase by 47% in North America.