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Bengaluru: Biocon Limited, an innovation-led global
biopharmaceutical company, has announced the signing of an exclusive licensing and
supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the
commercialization of its vertically integrated drug product, Semaglutide (gOzempic), which is
used to improve glycemic control in adults with type-2 diabetes.

Under the terms of this agreement, Biocon will undertake the development, manufacturing
and supply of the drug product, and Biomm will be responsible for obtaining regulatory
approval and commercialization in the Brazilian market.

Biomm is Brazil’s biotechnology company focuses on developing, manufacturing and
commercializing complex biotech and biosimilar drug products at their state-of-the-art
production facility in Nova Lima.

Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd, said, “Our
partnership with Biomm marks another important step forward in our strategy to expand our
global footprint beyond the U.S. and Europe for Peptides. This is also in line with our growth
strategy of bringing to market a portfolio of complex, GLP-1 drug-device combination
products. We are confident that our collaboration with Biomm will provide patients in Brazil,
who are living with diabetes, much needed access to advanced, high quality treatment options
to help them manage the disease better.”

Heraldo Marchezini, Chief Executive Officer, Biomm, commented: “Brazil is the fifth country
in the world with the highest incidence of diabetes, having 16.8 million adults in the age group
of 20 to 79 years with the disease, and an estimated 21.5 million cases by 2030, according to
the Diabetes Atlas of the International Diabetes Federation (IDF). We have, therefore,
prioritized strategic partnerships to expand the population’s access to advanced treatments
for this disease and enhance the quality of life for people”.

The total addressable market opportunity of Semaglutide in Brazil is approximately US $580
million as per the IQVIA MAT Q4 2023.

Read also: Biocon gets MHRA UK nod for weight management injection Liraglutide

The findings of a recent clinical trial determined that obese patients who undergo laparoscopic sleeve gastrectomy experience significantly lower levels of acute postoperative pain (APP) when subjected to deeper levels of anesthesia. The findings of this study were published in the recent edition of Obesity Surgery journal offers new insights into pain management protocols that could improve the recovery outcomes.

This prospective, double-blinded randomized clinical trial included 90 patients and segregated them into two groups based on the depth of anesthesia administered during surgery. One group received what is termed as light anesthesia (Bispectral Index of 50, BIS 50), while the other was subjected to deeper anesthesia (BIS 35). Close monitoring of the pain levels was performed with the visual analogue scale (VAS) at various intervals post-surgery, specifically at 0, 12, 24, 48 and 72 hours. Along with pain levels, this study evaluated the use of analgesics, incidence of postoperative nausea and vomiting (PONV) and overall patient recovery quality through the Quality of Recovery-15 (QoR-15) score.

The results from this trial indicated that patients in the BIS 35 (deep anesthesia) group reported lower pain scores at the initial 24 hours post-operation when compared to their counterparts in the BIS 50 group. Also, these patients also expressed a reduced need for pain relief medication during their recovery period. Assessments carried out on the third day post-surgery showed elevated patient satisfaction in the group that received deeper anesthesia.

These findings suggest that the depth of anesthesia plays a pivotal role in managing APP and contributes towards reducing the consumption of analgesics and enhancing the patient satisfaction. The reduction in pain experienced by the deep anesthesia group could significantly impact recovery trajectories which potentially leads to quicker discharges from the hospital and better overall recovery experiences.

The implications of this study are majorly important for the surgical management of obesity, which is linked to increased sensitivity to pain. Thereby, optimizing anesthesia protocols during surgeries like the laparoscopic sleeve gastrectomy could become a critical element of surgical strategies. This research opens new avenues for patient care and also sets the stage for further studies and trials to explore how anesthetic depth can be leveraged to improve surgical recovery across the different types of operations.

Reference:

Zhang, X., Chen, X.-Y., Gao, R.-J., Huang, Y., Mao, S.-M., & Feng, J.-Y. (2024). The Effect of Depth of Anesthesia on Postoperative Pain in Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Trial. In Obesity Surgery. Springer Science and Business Media LLC. https://doi.org/10.1007/s11695-024-07207-3

Researchers have shown that dangerous cysts, which form over time in polycystic kidney disease (PKD), can be prevented by a single normal copy of a defective gene. This means the potential exists that scientists could one day tailor a gene therapy to treat the disease. They also discovered that a type of drug, known as a glycoside, can sidestep the effects of the defective gene in PKD. The discoveries could set the stage for new therapeutic approaches to treating PKD, which affects millions worldwide. The study, partially funded by the National Institutes of Health (NIH), is published in Cell Stem Cell.

Scientists used gene editing and 3-D human cell models known as organoids to study the genetics of PKD, which is a life-threatening, inherited kidney disorder in which a gene defect causes microscopic tubes in the kidneys to expand like water balloons, forming cysts over decades. The cysts can crowd out healthy tissue, leading to kidney function problems and kidney failure. Most people with PKD are born with one healthy gene copy and one defective gene copy in their cells.

“Human PKD has been so difficult to study because cysts take years and decades to form,” said senior study author Benjamin Freedman, Ph.D., at the University of Washington, Seattle. “This new platform finally gives us a model to study the genetics of the disease and hopefully start to provide answers to the millions affected by this disease.”

To better understand the genetic reasons cysts form in PKD, Freedman and his colleagues sought to determine if 3-D human mini-kidney organoids with one normal gene copy and one defective copy would form cysts. They grew organoids, which can mimic features of an organ’s structure and function, from induced pluripotent stem cells, which can become any kind of cell in the body.

To generate organoids containing clinically relevant mutations, the researchers used a gene editing technique called base editing to create mutations in certain locations on the PKD1 and PKD2 genes in human stem cells. They focused on four types of mutations in these genes that are known to cause PKD by disrupting the production of polycystin protein. Disruptions in two types of the protein – polycystin-1 and polycystin-2 – are associated with the most severe forms of PKD.

They then compared cells with two gene copy mutations in organoids to cells with only one gene copy mutation. In some cases, they also used gene editing to correct mutations in one of the two gene copies to see how this affected cyst formation. They found organoids with two defective gene copies always produced cysts and those that carried one good gene copy and one bad copy did not form cysts.

“We didn’t know if having a gene mutation in only one gene copy is enough to cause PKD, or if a second factor, such as another mutation or acute kidney injury was necessary,” Freedman said. “It’s unclear what such a trigger would look like, and until now, we haven’t had a good experimental model for human PKD.”

According to Freedman, the cells with one healthy gene copy make only half the normal amount of polycystin-1 or polycystin-2, but that was sufficient to prevent cysts from developing. He added that the results suggest the need for a second trigger and that preventing that second hit might be able to prevent the disease.

The organoid models also provided the first opportunity to study the effectiveness of a class of drugs known as eukaryotic ribosomal selective glycoside on PKD cyst formation.

“These compounds will only work on single base pair mutations, which are commonly seen in PKD patients,” explained Freedman. “They wouldn’t be expected to work on any mouse models and didn’t work in our previous organoid models of PKD. We needed to create that type of mutation in an experimental model to test the drugs.”

Freedman’s team found that the drugs could restore the ability of genes to make polycystin, increasing the levels of polycystin-1 to 50% and preventing cysts from forming. Even after cysts had formed, adding the drugs slowed their growth.

Freedman suggested that a next step would be to test existing glycoside drugs in patients. Researchers also could explore the use of gene therapy as a treatment for PKD.

Reference:

 Courtney E. Vishy, Chardai Thomas, Thomas Vincent, Daniel K. Crawford, Matthew M. Goddeeris, Benjamin S. Freedman, Genetics of cystogenesis in base-edited human organoids reveal therapeutic strategies for polycystic kidney disease, Cell Stem Cell, DOI:https://doi.org/10.1016/j.stem.2024.03.005.