Aagami has received a new assignment from their publicly listed Japanese client, to help them out-license Topical Lidocaine Patch (Patented) for the US market.
In the previous assignment, Aagami had brought 5 serious parties who were in term sheet level discussions for the US market. Then the assignment was paused until NDA was resubmitted to the FDA.
Highlights of the opportunity for commercial Biopharma in the US:
1. NDA submitted to the US FDA. Approval expected before September 2025.
2. Lidocaine 10% Topical Patch (Patented).
3. Indication: the treatment of PHN (postherpetic neuralgia)
4. The Non-aqueous lidocaine 10% patch (200mg lidocaine) is developed with Client’s proprietary drug formulation technology, ILTS® (Ionic Liquid Transdermal Technology).
5. The comparative pivotal PK study in the US confirmed the bioequivalence between the product (lidocaine patch 10%, containing 200mg lidocaine) and Lidoderm® (containing 700mg lidocaine).
6. Size: 10 cm x 14 cm. Thickness 0.66 mm
7. Weight (adhesive area) 2.0 gm. Lidocaine strength 200 mg
8. ZTLido captured a good market despite having no TE rating and with generics available in the market. Our client’s product has advantages over current products like ZTLido and also would do well.
9. Lydolyte also has a similar regulatory pathway as ZTlido.
Client is not a commercial company, but a R&D focused publicly listed company head quartered in Japan. Hence would like to out-license the product to be launched by a Commercial company in the US.
Aagami are thrilled to get this assignment again and are confident to bring success to its client who has given Aagami 4 assignments so far for various assets in their pipeline.