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Time of India
6 days ago
- Health
- Time of India
Lab-grown rabies antibodies show promise as cheaper, safer alternative
Mumbai: India's public hospitals and dispensaries may soon have a safer, more affordable option for preventing rabies after a suspected rabid dog bite: one already in use in private clinics since 2017 and by BMC since 2019. A post-marketing clinical trial involving more than 4,000 participants, conducted and funded by a pharmaceutical company and recently published in The Lancet, could now pave the way for its large-scale public use. For decades, the life-saving protocol has been the same across public or private health set ups: wash the wound, inject a dose of rabies immunoglobulin if the bite is severe, and follow with multiple doses of anti-rabies vaccine. The possible shift lies in the kind of immunoglobulin used. The relatively new lab-made candidate could replace the animal and human derived versions in use since the 1970s. An immunoglobulin is a concentrated solution of antibodies, injected directly into and around the bite, that offers immediate but short-term protection against the virus, effectively buying time until the vaccine takes full effect. The earliest ones in use have been derived either from rabies-vaccinated horses (Equine Rabies Immunoglobulin - ERIG) or human donated plasma (Human Rabies Immunoglobulin - HRIG). by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like No annual fees for life UnionBank Credit Card Apply Now Undo In 2016, Serum Institute of India (SII) received permission to make immunoglobulin which has monoclonal (lab-made,RmAb) antibodies. You Can Also Check: Mumbai AQI | Weather in Mumbai | Bank Holidays in Mumbai | Public Holidays in Mumbai | Gold Rates Today in Mumbai | Silver Rates Today in Mumbai "Most private facilities at least in Mumbai have phased out the use of the horse-derived one. While it has been proven safe at large, there are risks associated; it can cause mild allergic reactions or in rare cases a serious adverse event," said Dr Trupti Gilada, city-based infectious disease specialist. The private facilities have moved on to either the human derived or lab-made ones. "Both, human derived one and the lab-made one have high efficacy. The former has risk of infection transmission, though rare. The ones made in labs are safer and more easily available due to ease of largescale production," said Dr Mandar Kubal, another infectious disease specialist. A survey by ICMR published in July on the availability of anti-rabies vaccine and rabies immunoglobulin in health facilities found that, of the 534 facilities surveyed across 15 states and 60 districts -- 467 in the public sector -- 78% still used horse derived immunoglobulin. But even that was out of stock for most apart from a small 20.3% of those surveyed. While BMC uses the lab-made alternative, it is no stranger to shortages; at the moment it is short of rabies vaccine shots. A senior doctor from one of the four BMC-run medical college hospitals, said, "Mumbai has a heavy burden of dog bite cases and early on BMC decided to move on from animal derived ones due to risks associated. We either use generic human derived immunoglobulin or largely lab-made alternatives." But this lab-made alternative is still to make its way into the National Guidelines for Rabies Prophylaxis. The ICMR survey states, "RmAb presents as a promising alternative to both HRIG and ERIG. Compared to ERIG, RmAb offers the potential scope for large-scale production with standardised quality, elimination of animal use in the manufacturing, and reduced risk of adverse events. "It is cheaper compared to HRIG. Studies have shown that RmAbs are safe for human use, but... [there is] need for larger clinical trials and post-marketing surveillance to assess the safety and efficacy of RmAbs in the Indian setting." The Serum Institute–funded post marketing trial of its lab-made product compared with horse-derived immunoglobulin found to be equally effective in preventing rabies, with slightly higher average antibody levels on day 14. It was linked to fewer mild adverse events (11 vs. 17), and no serious reactions related to RmAb were reported, compared with one serious reaction related to ERIG. "Anti-rabies vaccines and immunoglobulins are severely in shortage across the country. Monoclonal antibodies is the answer [due to scalability] and it needs to be included in the national guidelines," said one of the authors of the ICMR survey. Stay updated with the latest local news from your city on Times of India (TOI). Check upcoming bank holidays , public holidays , and current gold rates and silver prices in your area.
Time of India
6 days ago
- Health
- Time of India
Lab-grown rabies antibodies show promise as safe alternative
MUMBAI: India's public hospitals and dispensaries may soon have a safer, more affordable option for preventing rabies after a suspected rabid dog bite: one already in use in private clinics since 2017 and by BMC since 2019. Tired of too many ads? go ad free now A post-marketing clinical trial involving more than 4,000 participants, conducted and funded by a pharmaceutical company and recently published in The Lancet, could now pave the way for its large-scale public use. For decades, the life-saving protocol has been the same across public or private health set ups: wash the wound, inject a dose of rabies immunoglobulin if the bite is severe, and follow with multiple doses of anti-rabies vaccine. The possible shift lies in the kind of immunoglobulin used. The relatively new lab-made candidate could replace the animal and human derived versions in use since the 1970s. An immunoglobulin is a concentrated solution of antibodies, injected directly into and around the bite, that offers immediate but short-term protection against the virus, effectively buying time until the vaccine takes full effect. The earliest ones in use were derived either from rabies-vaccinated horses (Equine Rabies Immunoglobulin - ERIG) or human donated plasma (Human Rabies Immunoglobulin - HRIG). In 2016, (SII) received permission to make immunoglobulin which has monoclonal (lab-made,RmAb) antibodies. "Most private facilities at least in Mumbai have phased out the use of the horse-derived one. While it has been proven safe at large, there are risks associated; it can cause mild allergic reactions or in rare cases a serious adverse event," said Dr Trupti Gilada, city-based infectious disease specialist. The private facilities have moved on to either the human derived or lab-made ones. "Both, human derived one and the lab-made one have high efficacy. Tired of too many ads? go ad free now The former has risk of infection transmission, though rare. The ones made in labs are safer and more easily available due to ease of largescale production," said Dr Mandar Kubal, another infectious disease specialist. A survey by ICMR published in July on the availability of anti-rabies vaccine and rabies immunoglobulin in health facilities found that, of the 534 facilities surveyed across 15 states and 60 districts -- 467 in the public sector -- 78% still used horse derived immunoglobulin. But even that was out of stock for most apart from a small 20.3% of those surveyed. While BMC uses the lab-made alternative, it is no stranger to shortages; at the moment it is short of rabies vaccine shots. A doctor from one of the four BMC-run medical college hospitals, said, "Mumbai has a heavy burden of dog bite cases and early on BMC decided to move on from animal derived ones due to risks associated. We either use generic human derived immunoglobulin or largely lab-made alternatives." But this lab-made alternative is still to make its way into National Guidelines for Rabies Prophylaxis. The ICMR survey states, "RmAb presents as a promising alternative to both HRIG and ERIG. Compared to ERIG, RmAb offers the potential scope for large-scale production with standardised quality, elimination of animal use in the manufacturing, & reduced risk of adverse events. "It is cheaper compared to HRIG. Studies have shown that RmAbs are safe for human use, but... [there is] a need for larger clinical trials and post-marketing surveillance to assess the safety and efficacy of RmAbs in the Indian setting." The Serum Institute-funded post marketing trial of its lab-made product compared with horse-derived immunoglobulin found to be equally effective in preventing rabies, with slightly higher average antibody levels on day 14.
Associated Press
28-02-2025
- Business
- Associated Press
How Kamada (NASDAQ: KMDA) Is Transforming Its Strategic Focus Into Commercial Growth
NEWMEDIAWIRE) - Although advancements in the broader healthcare ecosystem have delivered countless life-saving solutions, there remain significant unmet medical needs. As an enterprise engaged in the development, manufacturing and commercialization of specialty plasma-derived therapeutics, Kamada Ltd (NASDAQ: KMDA), plays an important role in helping address rare and severe medical conditions. Although the broader category of plasma biologics commands a well-established legacy, modern applications of plasma-derived therapies have dramatically elevated the discipline. While the global plasma protein therapeutics market reached a valuation of $28.2 billion in 2022, Kamada is hoping to fill the gaps in the industry and is focused on the development of therapeutics for which there are limited solutions offered by other companies, if any. As Kamada knows, a pivotal reason why plasma protein and immunoglobulin therapeutics are crucial in the broader healthcare landscape is that they often represent the only treatment option available for rare, chronic and life-threatening conditions. Some examples of these disorders are: Post-exposure complications: Products such as human rabies immunoglobulin (HRIG), which is one of Kamada's leading products, help prevent deadly infections. Organ transplants and immune modulation: Kamada has spearheaded efforts to provide immunoglobulin products that prevent complications resulting from cytomegalovirus (CMV) infections, a leading cause of organ rejection in transplant patients, and hepatitis B virus (HBV) recurrence following liver transplantation. Alpha-1 antitrypsin deficiency (AATD): Another specialty for Kamada, plasma-derived AAT therapy slows down lung damage tied to a deficiency of the alpha-1 antitrypsin protein through augmentation therapy which is currently the only specific therapy for lung disease caused by AATD. As an expert in the field of specialty plasma therapies, Kamada reports achieving success thanks to its diverse commercial portfolio, advanced pipeline and vertical integration. So far, the U.S. Food and Drug Administration (FDA) has approved six of the company's plasma-derived therapeutics, which target rare and underserved conditions such as rabies, AATD and infectious diseases after solid organ transplantation, such as CMV and HBV. Moreover, Kamada is advancing a phase 3 pivotal trial for its inhaled alpha-1 antitrypsin (AAT) therapy. AATD is a genetic disorder that results in a deficiency of the alpha-1 antitrypsin protein, which can lead to lung damage and chronic obstructive pulmonary disease (COPD). A fundamental advantage of inhaled AAT therapy is that it is non-invasive, allowing patients to self-administer easily at home. This protocol eliminates the need for intravenous infusions. Combined with the lower dosage of medicine (thus potentially improving COGS) and improved quality of life for patients, Kamada has hopes that pending regulatory approval, this proposed investigational solution will revolutionize the way AATD specialists and patients treat this chronic disease. Management is targeting the global market for AATD-related lung disease, predicted by a 2024 Cantor Fitzgerald report to reach $2 billion by 2029. Kamada's Commercial Growth Kamada developed itself as a vertically integrated company through the establishment of a plasma-collection subsidiary, and commercial infrastructure in the U.S. and additional countries. By controlling key aspects of its value chain, Kamada says it has been able to streamline processes that are often fragmented in traditional biopharma models. Similar to Israeli-based pharmaceutical company, Teva Pharmaceutical Industries Ltd., Kamada says it is committed to using its strategic focus, operational excellence and vertical integration as a springboard to commercial growth. Today, Kamada is evolving past its portfolio of drugs to expand into commercial operations. For example, the company is focused on developing its own plasma collection capabilities, which reduces some of the dependency on third-party suppliers and which it hopes will allow it to be a supplier for industry peers. As it stands, Kamada Plasma is one of a limited number of specialty plasma collection firms in the United States. According to the company, it is working to leverage its strong cash position to identify and secure future business developments and M&A opportunities, especially in the U.S. market. The company is also looking into exploring manufacturing agreements to produce plasma-derived solutions for other companies, which it believes would create additional revenue. During recent years, Kamada has consistently delivered growth in its financial results, supported by both its existing portfolio and ongoing strategic initiatives. For 2024, the company recently reaffirmed its guidance of revenues of $158 million to $162 million, with adjusted EBITDA in the range of $32 million to $35 million. The company is expecting to reach $178 to $182 million in revenue and $38 to $42 million of adjusted EBITDA in 2025. If this is accomplished, it would represent a year-over-year increase of 13% in revenue and 19% in adjusted EBITDA based on a mid-point of 2024 annual guidance. 'We enter 2025 from a position of significant strength and are pleased with the progress made over the past year. We look forward to achieving our value-generating objectives for 2025 driven by our four strategic growth pillars, comprising of organic commercial growth, the execution of business development and M&A transactions, our plasma collection operations, and the further advancement of our pivotal phase 3 Inhaled AAT program,' shared Amir London, Kamada's chief executive officer. 'We expect continued double-digit profitable growth in 2025, driven by our diverse commercial portfolio marketed in over 30 countries.' By focusing on areas of unmet medical needs, expanding its geographic footprint and distribution network while maintaining operational excellence, Kamada aims to ensure it remains a key player in a growing industry. With a proven track record and a commitment to innovation and excellence, the company seems poised to capitalize on emerging opportunities, delivering solutions for patients around the world. Featured photo courtesy of Kamada This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Cautionary Note Regarding Forward-Looking Statements This post includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including (among others) statements regarding: 1) prospects of regulatory approval for our AATD treatment which our management targets as a $2 billion global market, 2) Kamada's focus on developing its own plasma collection capabilities to reduce third-party dependency and become a supplier of plasma-derived solutions for other companies to create additional revenues, 3) Kamada's intent to leverage its strong cash position to identify and secure future business developments and M&A opportunities, especially in the US market, 4) Kamada's 2024 guidance of the $158-$162 million in revenues and $32-$35 in ETIBDA, 5) Kamada's 2025 guidance of $178 – $182 Million in revenue and $38 -$42 million of adjusted EBITDA and if this is accomplished it would represent, a year-over-year increase of 13% in revenue and 19% in adjusted EBITDA based on a mid-point of 2024 annual guidance, and 6) Kamada's expectations to continue double-digit profitable growth in 2025. Forward-looking statements are based on Kamada's current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, conflicts in the Middle East and the impact of such conflicts, continued demand for Kamada's products, financial conditions of the Company's customers, suppliers and service providers, Kamada's ability to leverage new business opportunities and integrate the new product portfolio into its current product portfolio, Kamada's ability to reap the benefits of the acquisition and expansion of plasma collection centers, Kamada's ability to continue enrollment of the pivotal Phase 3 InnovAATe clinical trial, unexpected results of clinical studies, Kamada's ability to manage operating expenses, additional competition in the markets that Kamada competes, regulatory delays, and other risks detailed in Kamada's filings with the U.S. Securities and Exchange Commission (the 'SEC') and available at the SEC's website at . The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
