Starpharma's DEP® remdesivir versus Gilead's Veklury (Remdesivir)

Sources for these comments have come from internet, announcements, and analysts


Remdesivir has broad-spectrum antiviral activity. Current formulations of remdesivir are required to be administered intravenously due to the drug’s low solubility, with each infusion taking up to two hours and requiring daily administration for either 5 or 10 days.

Intravenous Infusion

Some medications must be given by an intravenous (IV) injection or infusion. This means they're sent directly into your vein using a needle or tube. In fact, the term “intravenous” means “into the vein.” With IV administration, a thin plastic tube called an IV catheter is inserted into your vein





Gilead’s remdesevir has low water solubility, requires excipient {Excipients are inert pharmaceutical ingredients that are used in product formulations. Excipients may perform a variety of functional roles in the pharmaceutical product. In the vast majority of cases, excipients have limited (if any) pharmacological activity, unlike the API [Active Pharmaceutical Ingredients are the active ingredients in medications, carried by the excipient to make it soluble and be given as IV infusion} An excipient called Captisol is used in Gilead’s remdesivir formulation as a solubilizing agent due to the limited aqueous solubility of remdesivir. This excipient is renally cleared and can accumulate in patients with decreased renal function so the drug is not recommended to be administered in patients with eGFR of less than 30ml. It also requires daily administration for at least 5 days.









https://btbcku.com/wp-content/uploa...ing-find-a-cure-for-the-coronavirus-1.mp4?_=1


In contrast, Starpharma’s DEP^® remdesivir is a highly water-soluble nanoparticle formulation of remdesivir with controlled release properties, which would potentially allow for less frequent dosing and use in a non-hospital setting, such as aged-care. The solubility of DEP^® remdesivir is 100‑fold higher than standard remdesivir. The benefit of DEP^® remdesivir’s enhanced aqueous solubility is that it would enable subcutaneous injection rather than intravenous infusion, allowing for outpatient treatment and reducing the burden on hospitals.

Subcutaneous Injections

A subcutaneous injection is administered as a bolus (the administration of a discrete amount of medication, drug, or other compound within a specific time, generally within 1 - 30 minutes, in order to raise its concentration in blood to an effective level) into the subcutis, the layer of skin directly below the dermis and epidermis, collectively referred to as the cutis.

Subcutaneous injections are highly effective in administering medications such as insulin, morphine, diacetylmorphine and goserelin. Subcutaneous (as opposed to intravenous) injection of recreational drugs is referred to as "skin popping." Subcutaneous administration may be abbreviated as SC, SQ, sub-cu, sub-Q, SubQ, or subcut. Subcut is the preferred abbreviation for patient safety. Subcutaneous tissue has few blood vessels and so drugs injected here are for slow, sustained rates of absorption.



SUBCUTANEOUS INJECTION SITES





Comments by Jackie Fairley

“Given the limited treatment options available for COVID-19 patients, Starpharma has been actively reviewing development programs globally, and evaluating where Starpharma’s proprietary DEP® technology has potential to improve delivery, expand use or reduce frequency of dosing”.

“The ability to deliver remdesivir via a long-acting, subcutaneous injection has the potential to expand its application outside hospitals, into settings like aged care, and also facilitate its use in countries with less developed healthcare systems. It would also improve patient convenience and reduce the burden on the healthcare system. We’re pleased to be able to utilise the DEP® platform to improve the delivery of this important antiviral medicine”.

“The development of DEP® remdesivir is Starpharma’s 2nd program addressing COVID-19, and potentially future pandemics. This is separate to the development of its SPL7013 antiviral nasal spray for COVID-19, which was detailed in a market update last week”

Advantage of using DEP® remdesivir
A subcutaneous formulation would be desirable in settings such as aged care, nursing homes and for less developed countries which typically have less developed healthcare systems and shortage of resources such as hospital beds to cope with the COVID-19 pandemic. It can also be given to COVID-19 patients who do not require hospitalization, to speed up their recovery.







Advantage of Starpharma's DEP® remdesivir over Gilead's Veklury (Remdesivir)

• Can be injected subcutaneously and not infused intravenously
• Does not need to be used in hospital settings
• Can be administered in aged care, nursing homes
• Can be freely available in less developed countries which have less developed healthcare systems and shortage of resources such as hospital beds to cope with COVID-19 pandemic
• Can be administered to COVID-19 patients who do not require hospitalisation

Gilead's Veklury (Remdesivir) is still patent protected in most jurisdictions. For progression of DEP® remdesivir, Starpharmat would need to partner with Gilead. One must assume Starpharma is currently in discussions with Gilead. Clinical trials would need to be conducted.

While in early stages of development, the development path for DEP-remdesivir is likely to be accelerated under Emergency use Authorisation pathways in US and elsewhere for COVID-19 therapies. Clinical data would be required in humans (potentially healthy volunteers and non-hospitalised COVID-19 patients) to assess whether pharmacokinetics, safety, tolerability and plasma drug levels of the drug is comparable to Gileads IV remdesivir formulation

Could you imagine if Gilead say to Starpharma......

"look we do not want you as partners.....we want to buy the your formulation outright

Here is an offer you cannot refuse US$500 million

What do you say"



Look forward to some more market sensitive announcements
I am sure everyone shares my current excitement and enthusiasm for Starpharma