Ann: Phospahgenics CEO Roadshow Presentation, page-10

On p.10 of today’s presentation, some drugs with potential for TPM injectable reformulation are listed along with an indication of their relative US market opportunities.

Clopidogrel is identified as having a more sizeable market opportunity than either daptomycin or propofol, so I think it’s a fair guess that this might be one of the injectables that POH has been working on.

Here’s a brief rundown on clopidogrel.

Brand Name: Plavix

Market:  Before patent expiry in 2012, Plavix was the world’s second highest selling drug, grossing over US$9bn in sales in 2010. There are now over a dozen approved Plavix generics. To date, all approved clopidogrel products are oral dosage.

Indications: Blood thinner. Used to prevent heart attacks and strokes in persons with heart disease (recent heart attack, recent stroke, or blood circulation disease). Also used with aspirin to treat new/worsening chest pain (new heart attack, unstable angina) and to keep blood vessels open and prevent blood clots after certain procedures (such as cardiac stent).

Mechanism of Action: Works by blocking certain blood cells called platelets and prevents them from forming harmful blood clots.

Currently approved dosing regimen: Loading dose of 300mg followed by a 75 mg once daily dose.

Limitations of oral dosage form: Bioavailability through intestinal absorption is ~ 50%. Initial high dose needed to reach effective drug level in blood. Takes several hours to reach effective drug levels in blood. Bleeding.

Hindrance to injectable formulation: Inherent chemical instability and poor solubility of clopidogrel.

Potential benefits of injectable formulation: Faster onset of action, vital in life-threatening emergency settings. Suitability for patients who are unable to take oral medications. Possible benefit for the significant proportion of patients who are nonresponders to orally administered clopidogrel.

https://www.medicinenet.com/clopidogrel-oral/article.htm
https://www.health.harvard.edu/blog/wallets-rejoice-as-plavix-goes-generic-201205214727
https://www.omicsonline.org/compara...e-dose-administration-jbb.1000029.php?aid=614
https://www.jscimedcentral.com/Pharmacology/pharmacology-3-1039.pdf