Pharmaceuticals developer Acrux (ASX: ACR) is set to expedite commercialisation of its generic topical products in the United States via the appointment of TruPharma as their exclusive sales, marketing and distribution partner in America.
The agreement will see TruPharma take over responsibility for getting Acrux products approved by the U.S Food and Drug Administration (FDA) however most should be more straightforward than novel alternatives based on Acrux’s product suite consisting entirely of generic products.
Once approved by the FDA, TruPharma will manage the commercial manufacturing, marketing and distribution of each Acrux product for 10 years from launch.
“We are excited to enter into this agreement with TruPharma and we look forward to developing a long-lasting relationship between the two companies,” said Acrux CEO and MD, Michael Kotsanis.
“The agreement marks a significant step forward in achieving Acrux’s transition into the generics market.”
Acrux will continue to manage the pre-commercialisation activities of its products, and distribution outside of the United States but gross profits earned in the world’s most lucrative healthcare market will be shared between the two companies.
Unlike other pharmaceutical companies, Acrux’s focus on generic topical products means the company has a significantly shorter period of time towards product commercialisation. Where new drugs often can take up to 10 years to develop and commercialise, the time frame for generic products is around 4 years.
Growth in the United States has been high on Acrux’s agenda with the total American prescription pharmaceuticals valued at more than USD $460 billion. However, even Acrux’s niche market of generic topical products offers an addressable market around $20 billion.
At present, Acrux have 11 generic products in development and 3 under FDA review, of which more than half are ones with no generic alternative, and will offer significant cost savings to users once commercialised.
Having spent more than $34 million in R&D over the past four years, Acrux is aiming to launch 1-3 products before the end of 2021 and hopeful of being cash flow positive by the end of 2021.
ACR shares surged on news of the appointment of TruPharma, reaching a high of $0.185 in the first 10 minutes of trade this morning, a rise of 37% on the previous $0.135 close.
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