Hikma Pharmaceuticals has signed an agreement to acquire for $17.0m pipeline epinephrine and naloxone nasal sprays and a complementary manufacturing platform from Insys Therapeutics, which recently filed for bankruptcy. Both the epinephrine and naloxone sprays are intended for approval through the US Food and Drug Administration’s hybrid 505(b)(2) regulatory pathway.
Speaking exclusively to Generics Bulletin immediately after announcing the deal, Hikma’s CEO Siggi Olafsson described the Insys assets acquisition as “a small example that reflects the strategy that I have been talking about on mergers and acquisitions, where transformation is not our focus. If the opportunity came around [for a transformational deal], we wouldn’t hesitate, but our focus is to try to complement and supplement our pipeline and our offering with products we can compete on.”
Olafsson pointed out that the company had chosen last year to get out of many commodity generics with multiple suppliers in the US. “We have our main US generics manufacturing plant in Columbus, Ohio, and for me to compete with an Indian or Chinese manufactured product is very challenging,” he acknowledged. “But for the right technology, for complex products such as high-containment solid oral-dose oncology, nasal sprays, everything that is a little bit more complex than a tablet, I really can compete and have a steady supply to the market,” he explained.
Examples Of Shift Away From Commodity Generics
“So I look at M&A as whether I can find the assets in an inorganic way to supplement the changes I am making in R&D so I am not dragged into commodity generics,” he summarized, highlighting the two Insys 505(b)(2) candidates as prime examples of this differentiation strategy.
“It is an interesting enough concept that this could possibly be a game-changer in the market, where the reliance is currently 100% on injectable products” – Siggi Olafsson
Questioned on the potential to shift the market from epinephrine auto-injectors to the nasal spray, Olafsson stressed the need for caution on predictions, because Insys’ product was still in “fairly early development.” However, he said the spray formulation was exciting for several reasons.
“First of all,” he outlined, “the spray would have a very fast onset of action, which is needed as an emergency drug. Secondly, the pens are quite bulky, whereas these unit-dose nasal sprays are very convenient, as they are much smaller.” The spray format would also be favored by people with phobia of needles, he pointed out. While Hikma had only just got hold of the asset, he felt the market potential was clear.
“It is an interesting enough concept that this could possibly be a game-changer in the market, where the reliance is currently 100% on injectable products,” Olafsson asserted.
Naloxone Spray Differentiated From Teva’s Generic
Turning to the naloxone spray that had already been filed with the FDA, Olafsson said Insys’ 505(b0(2) candidate was differentiated from Teva’s pure generic of Narcan for which the Israeli company obtained FDA approval. However, he declined to disclose details of differentiating features for the opioid overdose treatment.
The FDA recently said it would prioritize reviews of abbreviated new drug applications for generic versions of opioid abuse drugs such as naloxone. (Also see "FDA Prioritizes Reviews Of Opioid Overdose ANDAs" - Generics Bulletin, 10 Jul, 2019.)
“There is clearly an opportunity there, the market is changing,” he told Generics Bulletin. “In the US, the market for Narcan today is growing significantly, and many US states have Narcan available in every police car and every ambulance.” Delivering an improved version to the market would clearly be attractive, he added.
While the market potential means that Hikma’s primary focus is on bringing the spray assets to market in the US, the London-listed company is also considering options further afield. “We have global rights to these assets, so we have the opportunity in the rest of the world where it makes sense,” Olafsson stated.
“These are very exciting assets. I think these reflect very clearly where we want to take the company on differentiation” – Siggi Olafsson
“These are very exciting assets,” Olafsson told investors. “I think these reflect very clearly where we want to take the company on differentiation.” Pointing out that Hikma was already the leading producer and supplier of nasal sprays in the US, he said the Insys assets would take the company into the unit-dose sector of the nasal spray market.
“If we are able to continue the development and deliver epinephrine nasal spray in unit dose to the market, what a change that would be versus EpiPen and all other epinephrine injectable doses today,” Olafsson observed. He acknowledged that the nasal epinephrine for treating anaphylactic shock was still in active development, so “there is still some way to go on that.”
FDA Fast-Track Designation For Insys’ Epinephrine
Insys said at the end of August last year that the FDA had granted a fast-track designation to the firm’s epinephrine 7mg and 8.5mg sprays as investigational treatments for anaphylaxis. “Preliminary results from this pharmacokinetic study involving 60 people with seasonal allergies demonstrated rapid drug absorption with the epinephrine nasal spray and showed that the bioavailability of the company’s novel, proprietary formulation of epinephrine delivered intranasally was similar to that of intramuscular injection with EpiPen0.3 mg,” the company stated adding that theepinephrine sprays were in Phase II clinical trials.
Nalaxone spray was “much further along”, Olafsson recognized. Insys in early July this year announced that the FDA had accepted for filing its naloxone 8mg single-unit dose spray as an emergency treatment of known or suspected opioid overdose in both adult and pediatric patients. “We believe our formulation has the potential to be a critical tool in combating opioid overdose cases. The rapid absorption and significant exposure of the formulation may be useful in opioid overdose, particularly with the rise of synthetic opioid use,” Insys’ chief scientific officer Venkat Goskonda commented at the time, noting that 47,600 of a total 70,237 drug-overdose deaths reported in the US in 2017 had involved opioids.
Hikma noted that there were no currently approved nasal forms of epinephrine in the US, but cited IQVIA data showing US sales of epinephrine auto-injectors at around $4.3bn for the 12 months ended June 2019.
Brian Hoffmann, president of the group’s US non-injectable Generics business segment, commented: “Hikma is the largest supplier of generic nasal sprays in the US and we have been looking for ways to build upon our strong manufacturing platform and expand our product portfolio. This acquisition adds unit-dose nasal spray manufacturing equipment, as well as two complex products to our pipeline. This new technology expands our existing nasal spray capabilities, creating a comprehensive platform, which we can leverage for both internal and partnership programs.”