Ambrose Healthcare and Smartway Pharmaceuticals have signed an agreement for the provision of international Early Access Programs for Ambrose products.

About Ambrose Healthcare 

Ambrose Healthcare is a specialist pharmaceutical company with ambitious plans to address unmet medical needs in rare disease. The company will provide treatments for use in hospitals or specialist care environments.

The US National Institutes of Health (NIH) lists more than 7,000 rare diseases1, affecting around 400 million people worldwide2 a $195bn market (2022) growing at 8.5% pa4.. However, the US FDA reports that only 600 drugs have been approved in rare disease, as of 20203.

Ambrose is developing a portfolio of commercial and clinical-stage therapeutic assets through acquisition, licensing and collaborations with manufacturers and biotechs.

We are delighted to work with Smartway. They have built an impressive team with the necessary regulatory and other experience and expertise to help specialist companies like Ambrose develop global, early or expanded access programs. We will lock into their global regulatory expertise and global distribution coverage. The most important thing for us was to find a partner who wanted to work with us to develop the programs and add capability to our team. Smartway have shown that this is what they do and how they work.

Toby Wilson Waterworth, Chair of Ambrose 

This latest deal extends Ambrose Healthcare’s collaborative approach, which is establishing an international network of expertise from asset acquisition, product launch, to revenue generation and sales. 

How will Smartway contribute  

Over the last 20 years, we have gained the experience and expertise it takes to strategically advise, design, initiate and manage global or regional programs with biotechs and pharma to empower patient access to medicines.

As part of our specialist offering, we provide end-to-end solutions to manage complex EAPs, whatever the size and scale. We partner with pharma and biotechs who trust us as a leader in the provision of expanded access, early access, compassionate use and named patient programs across 98 countries.

Under our agreement, we will be the exclusive supplier of end-to-end EAP services to Ambrose. This will include all regulatory design and submission and global compliant distribution of Ambrose Healthcare therapeutics under international early access, compassionate use, and named patient supply provisions.  

Ambrose is embarking on an ambitious journey to develop important medicines for rare conditions and we are pleased to help them in their quest. It’s exciting for us to find an experienced and commercially-focused company that shares our patient centred mission to “transform lives by empowering access to medicines globally”.

 Josh Cocklin, Chief Executive of Smartway

Our partnership with Ambrose will further strengthen our work towards our mission to ensure no patient goes untreated, regardless of the rarity of their illness. We are thrilled to start our collaboration and look forward to maintaining our work in helping patients access the medicine they need. 

If you need help with Early Access Programs, don't hesitate to contact our experts by emailing [email protected]. 

For more information on how we design, implement and manage EAPs worldwide, please visit our EAP page.  

Smartway EAP

References:

  1. 1. U.S. National Institutes of Health (rarediseases.info.nih.gov/about)
  2. 2. CamRARE – Cambridge Rare Disease Network (www.camraredisease.org/)
  3. 3. National Organization for Rare Disorders (rarediseases.org/new-study-investigates-the-number-of-available-orphan-products-generics-and-biosimilars/
  4. 4. GMI Insights (www.gminsights.com/industry-analysis/rare-disease-treatment-market)  ​