Biosimilars
Today, we have created a rich pipeline of novel and biosimilar assets aimed at addressing local as well as global unmet medical needs associated with both chronic and acute conditions. We have a rich pipeline of biosimilar molecule studies.
Aqlivia has one of the global research collaborators, focusing on multiple biosimilar studies, spanning recombinant human Insulin (rh-Insulin), insulin analogs, monoclonal antibodies and other biologics for diabetes, oncology and immunology. We have built multiple methods & research platforms with capacities to support global Pharma Alliances.
Insulins & Analogs
The portfolio comprises Recombinant Human Insulin (rh-Insulin), Insulin Glargine, Insulin Aspart and Insulin Lispro along with delivery devices. Our future research on biosimilar studies has also been extending in Australia, Russia, Mexico, South Korea, Malaysia and over 25 other countries.
Monoclonal Antibodies & Other Recombinant Proteins
Our vision, to make difference by enhancing affordable access to cutting-edge biologic therapies for Cancer patients. Aqlivia in process of launching a high quality, world-class biosimilar research projects and Drugs for patients of various types of cancer in India, targeting on metastatic colorectal cancer (mCRC) and several other types of lung, kidney, cervical, ovarian and brain cancers in India.
We are also working on regulatory approvals for conducting studies on biosimilars in Brazil and Turkey, two of the Top 4 emerging markets globally for this key breast cancer drug.
Prepared to Make a Difference Globally
Allowing research to expand and afford and hence expand access of new advanced treatments to their patient populations. Our conviction that our success would enable us to make a very significant change in managing both chronic and acute conditions continues to push us forward.
Partnering to Win
To take our research to a global patient pool, we partnered with major global research groups for the co-development of a high-value portfolio of biosimilars for oncology and autoimmune indications in 2019. This partnership, structured as a sharing of risks and rewards, leveraged the complementary strengths of each partner and was a forerunner of many global research partnerships including those involving many innovator companies.
With one of the longest-standing partnerships in the global biosimilars space, Aqlivia and Australian-Southern Eastern Bio have achieved a leadership position in the nascent industry. By leveraging mutual strengths we have successfully building most diverse products targeting cancer.
We have also agreed to extend the partnership to include two new assets, which target opportunities that are expected to open up in the middle of next decade.
After successfully collaborating with Southern Eastern Bio, try partnering with other divisions & global players in biosimilars & Onco Drugs. This collaboration is targeted at developing a next-generation biosimilars portfolio which help patients worldwide gain access to a range of high quality, affordable immunology and oncology biologics. Aqlivia and Sandoz will strategically leverage their combined strengths to address the next wave of the global biosimilars opportunities.
At the same time, we continue to work independent of these partnerships towards augmenting our portfolio with more biosimilar candidates under development.
Novel Research Projects
As practitioners of frontier science, we have built a pipeline of research projects that can address unmet needs in diseases such as diabetes, cancer and autoimmune conditions. Our novel assets under development represent an interesting combination of early and advanced stage programs. Our foray into novel biologics predates our entry into the biosimilars segment.
These include an oral insulin molecule; monoclonal antibodies against novel targets like CD6, against established targets like CD20 and EGFR; a pipeline of bispecific fusion antibodies that exploit the recent understanding of the role of checkpoint inhibitors; and a siRNA-based molecule.
We have generated encouraging and exciting data, garnering a great deal of licensing and partnering interest. The endorsement of our approach is evidenced by the financial and scientific participation of credible organizations like UTS (Australia) in the development of drugs for people with Type 1 diabetes. Such partnering, combined with a prudent stage gate approach to development, help mitigate our financial exposure in these high risk but high reward initiatives.
Insulin
Insulin exerts effect on glucose metabolism by binding to Insulin receptors throughout the body. Upon binding, Insulin promotes the cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose. Based on the time-action profile of Insulin, Aqlivia has developed two kinds of insulin:
1. Short acting – Insulin Regular – Used to control post-meal surge in glucose level
2. Intermediate/Longer acting- Insulin NPH- Used to control fasting glucose levels.
Insulin therapy involves patients taking these two types of Insulin one or many times during the day depending on the type and stage of diabetes. To enhance the convenience of therapy, we have combined the above types of Insulin, e.g. Insulin 30/70 containing 30% regular insulin and 70%, Insulin NPH and Insulin 50/50 containing 50% regular Insulin and 50% Insulin NPH.
Indications:
– Type 1 diabetes mellitus
– Type 2 diabetes mellitus uncontrolled on maximal combination therapy with oral agents
– Gestational diabetes
– Hyperglycemic emergencies such as diabetic ketoacidosis and hyperosmolar Non-ketotic coma
– Total pancreatectomy patients
– Acute or chronic hyperglycemia provoked by:
– Infection or trauma
– Chronic medical illnesses
– Major surgery – Other types of secondary diabetes.
Aqlivia is the competitive research collaborator working on Recombinant Human Insulin in proprietary technology & DNA recombinant technology.
Insulin Glargine
Insulin Glargine is long-acting biosynthetic human insulin analog. This analog results from elongation of the C-terminal end of insulin B chain by 2 positively charged amino acid residues, as well as a substitution of an amino acid residue at a certain point. These modifications lead to a shift in the isoelectric point, rendering the insulin analogue less soluble at physiological pH levels. Therefore the insulin analogue retains its glucose lowering property for 24 hours without a pronounced plasma peak with just one injection. Due to this nature, the insulin analogue is preferred for maintaining the basal insulin level throughout the day.
Insulin Glargine is manufactured from recombinant DNA technology using the yeast, Pichia Pastoris. The mode of action is the same as that of Insulin. Insulin analogue binds to receptors and promotes cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose.
Indications:
– Type 1 diabetes mellitus
– Type 2 diabetes mellitus
Insulin Lispro
Insulin Lispro is a short-acting human insulin analogue obtained by altering the normal form of insulin. Switching the amino acids at 2 positions on the insulin B chain prevents the analogue from self aggregating in solution and therefore is more rapidly absorbed than human regular insulin. The onset of action is 10-20 minutes with peak of 1-3 hours and lasts 3-5 hours. It is taken 5-10 minutes before a meal to stabilize post meal glucose levels. Due to its rapid onset of action, it affords a more flexible treatment regime with a lower risk of developing hypoglycemia. And hence, short acting analogues are fast becoming the preferred mode of insulin control.
Insulin Lispro is manufactured from recombinant DNA technology using the yeast, Pichia Pastoris. The mode of action is the same as that of Insulin. Insulin analogue binds to receptors and promotes cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose.
Indications:
– Type 1 diabetes mellitus
– Type 2 diabetes mellitus
Insulin Aspart
Insulin Aspart is a short-acting human insulin analog obtained by altering the normal form of insulin. Substituting the amino acid at a certain position by a more negatively charged amino acid on the insulin chain, prevents the analog from self aggregating in solution and therefore is more rapidly absorbed than human regular insulin. The onset of action is 10-20 minutes with peak of 1-3 hours and lasts 3-5 hours. It is taken 5-10 minutes before a meal to stabilize post meal glucose levels. Due to its rapid onset of action, it affords a more flexible treatment regime with a lower risk of developing hypoglycemia. And hence, short acting analogues are fast becoming the preferred mode of insulin control.
Insulin Aspart is manufactured from recombinant DNA technology using the yeast, Pichia Pastoris. The mode of action is the same as that of Insulin. Insulin analogue binds to receptors and promotes cellular uptake of glucose into fat and skeletal muscle and inhibits hepatic glucose output, thus lowering the blood glucose.
Indications:
– Type 1 diabetes mellitus
– Type 2 diabetes mellitus
