The immediate release analgesic drug Oxecta was co-developed by King Pharmaceuticals – acquired by drug giant Pfizer in 2010 for $3.6bn (€2.6bn) – using Acura Pharmaceuticals’ Aversion technology and was approved in the US in June 2011. However, following negotiations with Pfizer, Acura has paid $2m to terminate the technology license and reacquire the rights to the Aversion oxycodone HCL product.
The patented platform uses a combination of active and inactive pharmaceutical ingredients that induce irritation when the drug is nasally snorted, whilst the substance is converted into a viscous gel if users attempt to dissolve the tablet for an intravenous formulation.
In a conference call to shareholders to discuss the repurchase, Acura’s CEO Bob Jones said Pfizer would no longer have any involvement in either the platform or the drug going forward, although it will retain the Oxecta trademark deemed to have minimal brand importance.
“It allows for a clean breakpoint,” Jones told investors, adding the transition of the product – to be called Aversion oxycodone until a new trade name is decided upon - would be implemented immediately and take about 90 days, during which the drug will not be available on the market.
He also said Acura would begin assessing appropriate partners to help commercialize and relaunch the drug “with established commercial infrastructure to appropriately price and promote Aversion oxycodone to the healthcare providers, as well as offering distribution capabilities,” admitting “the Pfizer commercial organization never provided much support to the product, after Pfizer deprioritised its immediate-release opioid portfolio.”
However, in a statement sent to in-Pharmatechnologist.com, Pfizer said it "continues its focus on extended-release opioid analgesics with abuse-deterrent technologies," progressing two investigational stage assets - ALO-02 and Remoxy - and anticipating the return to market of Embeda which the firm voluntarily recalled in 2011 because a pre-specified stability requirement was not met during routine testing.
Same API supplier
As for manufacturing the drug, Jones said Acura would be purchasing certain raw materials from Pfizer used in the manufacture of Aversion oxycodone, and the firm expects any future partner will continue to use the same contract manufacturer as the Pharma Giant for commercial supplies of the product.
This “will avoid any additional scale-up and validation requirements to reintroduce the product,” Jones explained, adding Acura believe “this supplier has sufficient DEA quota for oxycodone raw materials to allow for a relaunch.”
According to label information on the website www.drugs.com, Oxecta’s active ingredient (oxycodone HCL) is made by Noramco, an opiate-derived API supplier with US facilities in Athens, Georgia and Wilmington, Delaware.
Acura is also developing a number of other opioid analgesics using its Aversion platform, including a hydrocodone/acetaminophen product, and though label abuse liability studies led to some challenges from the US Food and Drug Administration (FDA) last year, Jones said he believed they could be fixed.
Furthermore, he told investors Acura has been speaking to potential partners regarding the hydrocodone/acetaminophen as part of the “need to license the broader Aversion portfolio.”
He continued: “Our intent is to solicit offers from a broad array of companies, and see what those offers look like and determine whether it makes sense to move forward solely with an Oxecta, licensing deal at this point in time, or whether it makes sense to do a broader deal that includes the other Aversion opioid assets.”
Acura has also developed a pseudoephedrine drug called Nexafed using its Impede anti-abuse technology platform, which forms a thick gel when dissolved in solvents, making it hard to extract the active ingredient.