LTP enters deal with Aptar Pharma to develop Spontan nasal spray

• LTR Pharma and Aptar Pharma have entered into a co-development agreement for Spontan
• The primary goal is commercialisation of Spontan in the USA and other key global markets
• The agreement will encompass joint development and expertise

Special Report: LTR Pharma and Aptar Pharma have entered into a co-development agreement to commercialise Spontan nasal spray for global markets and expand its reach.

LTR Pharma (ASX:LTP) is focused on improving men’s health, physically and mentally, through the commercialisation of an innovative nasal spray treatment for erectile dysfunction (ED), a pressing health issue for millions of men that can negatively impact self-esteem and relationships.

LTP’s lead product Spontan is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor. The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less, at a lower dose than traditional PDE5 oral tablets.

The drug development and biopharmaceutical company recently welcomed the news that a second medical practitioner had been authorised to prescribe Spontan under the Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS).

That move represents another significant step in LTP’s strategy to introduce Spontan to the market through a carefully managed approach.

Co-development agreement with Aptar Pharma

Now, LTP has entered a co-development agreement with Aptar Pharma to commercialise Spontan in the USA as well as other key markets around the world with a long-term alliance for ongoing innovation for healthcare solutions.

Aptar Pharma has supported numerous market authorisation holders in obtaining their combination drug-device product approvals incorporating Aptar’s nasal delivery systems from regulatory agencies such as the US Food and Drug Administration (FDA).

The agreement will encompass joint development and expertise, combining LTR Pharma’s pharmaceutical development capabilities with Aptar Pharma’s expertise in nasal spray technology – including Aptar’s VP7 model nasal spray components.

LTP says the application for Spontan nasal spray will be filed in the US via the FDA’s 505(b)(2) regulatory pathway, which governs a change in route of administration of an already approved drug, here Levitra® (Vardenafil) tablets.

De-risks FDA application process

“We are delighted to enter into a co-development agreement with Aptar Pharma – a respected and experienced partner in our imminent goal to obtain regulatory approval for Spontan and to expand its global market reach and impact,” LTP chairman Lee Rodne says.

“As part of this, we will gain access to Aptar’s expertise in the VP7 nasal spray system and related specialised services to support our FDA application process.

“This vastly de-risks the FDA application process and elevates the profile of LTR Pharma as a long-term partner of a global market innovator, which we anticipate may create opportunities for other products with alternative indications in future.”

This article was developed in collaboration with LTR Pharma, a Stockhead advertiser at the time of publishing.  

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.