LTR Pharma Ltd (ASX: LTP) shares are on fire on Tuesday afternoon.
At the time of writing, the ASX small cap share is up 37% to a record high of $1.32.
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Why is this ASX small cap rocketing?
Investors have been fighting to get hold of the pharmaceutical company's shares this morning following the release of a promising announcement.
According to the release, the company has entered into a co-development agreement for its Sponton product for global markets.
The agreement has been secured with Aptar Pharma (NYSE: ATR), which is a global leader in drug delivery systems, services, and active material science solutions.
The ASX small cap notes that Aptar Pharma has supported numerous market authorisation holders in obtaining their combination drug-device product approvals incorporating Aptar's nasal delivery systems. This includes from regulatory agencies such as the U.S. Food and Drug Administration (FDA).
What is the agreement?
LTR Pharma advised that the agreement will encompass joint development and expertise, combining its pharmaceutical development capabilities with Aptar Pharma's expertise in nasal spray technology.
The application for Spontan Nasal Spray will be filed in the US via the FDA's expedited regulatory pathway, which governs a change in route of administration of an already approved drug. In this case it is Levitra (Vardenafil) tablets.
LTR Pharma recently completed its clinical trial to compare the pharmacokinetics, safety, and tolerability of Vardenafil following administration of Spontan nasal spray and Levitra tablets in healthy male adults.
The trial showed that Spontan achieved a rapid absorption and faster onset of action compared to oral PDE5 inhibitors and delivered a similar amount of drug at half the dose of the oral PDE5 tablet. Following the success of this clinical trial, medical providers have started prescribing Spontan in Australia under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).
Commenting on the agreement, the ASX small cap's chair, Lee Rodne, said:
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.
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.
