December 2018 gone and no news on TEVA's Zolpimist MAA - expected in December 2018 - as announced on 6 December 2017 - reaffirmed as approval expected late 2018 in announcement 21 June 2018.
SUDA’s licensee in Latin America, Teva Pharmaceuticals, anticipates first approval in late 2018, which will trigger a milestone payment to SUDA and then royalties on sales.
Also announced on 21 June 2018
In China, SUDA’s licensee, Eddingpharm, anticipates submitting a Clinical Trial Application in the next few months.
This has required substantial work by the teams at both Eddingpharm and SUDA. Eddingpharm is required to conduct a small pharmacokinetic study to demonstrate that ZolpiMist is bioequivalent to the Chinese branded tablet.
With the successful completion of this study, Eddingpharm will be in a position to submit its New Drug Application to the Chinese FDA.
SUDA is on track to file a Marketing Authorisation Application (MAA) for ZolpiMist with the Australian Therapeutic Goods Administration in Q4 CY2018.
The Company is firstly required to conduct an in-vitro dissolution study to show that the US-branded reference drug, Ambien, is the same as the Australian brand, Stilnox
SUDA is scheduling a meeting with the World Health Organisation (WHO) to discuss the addition of ArTiMist to the WHO’s Guidelines for the treatment of children with severe malaria.
The decision to meet with the WHO prior to the anticipated regulatory approval of ArTiMist by the TGA was stimulated by SUDA’s discussions with a prospective acquirer/licensee of the product.
As part of the negotiation, the pharmaceutical company is seeking to know whether any further data is required by the WHO prior to adopting ArTiMist into the Guidelines.
ArTiMist artemether sublingual spray (malaria) The Australian Therapeutic Goods Administration (TGA) is continuing its review of SUDA’s MAA.
In the last few weeks, the TGA approved the clinical section of the dossier.
SUDA is finalising its responses to some other items that have been raised by the TGA and anticipates approval of ArTiMist before the end of CY2018.
SUD Price at posting:
0.6¢ Sentiment: None Disclosure: Held
