By David Wallace 13 Jul 2020
Increased uptake for generics and biosimilars must become Belgium’s “new normal” in the wake of the coronavirus crisis, local off-patent...
Hikma’s launch of propofol 20ml, 50ml and 100ml vials in the US to help address COVID-19 shortages forms part of the firm’s wider strategy to react quickly to demand spikes related to the coronavirus pandemic, as set out by CEO Siggi Olafsson in an exclusive interview with Generics Bulletin.
Announcing this week the launch of the three presentations of propofol injectable emulsion – following US Food and Drug Administration approval of the firm’s supplemental abbreviated new drug application – Hikma noted that the product was currently on the FDA’s shortages list “following a surge in demand due to the increase in hospitalized, ventilated patients resulting from the COVID-19 pandemic.”
The firm is “launching with available, limited quantities of its 20ml and 100ml vials, with 50ml vials to follow shortly thereafter.” Hikma says it is working to scale up manufacturing, insisting that it will “continue releasing product as soon as it is available.”
“The launch of propofol is the latest example of Hikma’s ongoing, company-wide commitment to delivering essential medicines to our customers and their patients during this critical time,” said Hikma’s injectables president Riad Mishlawi. “We have focused our strong US and global manufacturing capabilities on producing medicines that are in highest demand due to the outbreak of COVID-19 including anesthetics, pain medicines, sedatives, neuromuscular blocking agents, anti-infectives and other support medications.”
“We are grateful to the FDA for their timely approval of our application for propofol injection,” Mishlawi said, “and look forward to delivering this needed medicine to hospitals and patients.”
The launch is the latest in a string of recent injectables launches for Hikma that has also included generic versions of opioid analgesic Buprenex (buprenorphine) 0.3mg/ml and antihypertensive Cardene (nicardipine) 0.9% in 200ml bags to accompany an existing 10ml vial presentation.
Despite rising demand for much of its portfolio as a result of the COVID-19 pandemic, Olafsson told Generics Bulletin that Hikma was managing to keep on top of the needs of its customers through close collaboration and communication that gave the firm the ability to react quickly to market developments, as well as maintaining production output and navigating supply-chain obstacles.
“There has been increased demand in our business all around the world, and especially in the US,” Olafsson commented. In Hikma’s injectables business “we have seen a significantly increased demand overall,” he said, “and I think we have been coping well,” with the firm recently offering a positive trading update amid “challenging market conditions.” (Also see "Hikma Sharpens Focus On COVID-19 Demand" - Generics Bulletin, 30 Apr, 2020.)
“The challenge that every company in our industry has is to maintain the supply chain, to be able to have enough inventory of active ingredients and other things to be able to react to the demand,” Olafsson said. “We have always kept a fair amount of inventory of raw material, both active pharmaceutical ingredients and excipients, [and] we have monitored the situation and we haven’t seen any issues,” he observed. This included Olafsson personally receiving “an update every week on every molecule that we have.”
Health and safety of the firm’s employees was also a key consideration, Olafsson highlighted, pointing to Hikma’s strong track record in employee attendance at its factories. “You have up and running plants that are able to deliver the products,” he said. And “in terms of the manufacturing in the plants I think our employees have done an outstanding job.”
“All our plants are at 90% attendance rates and our employees are doing the best they can to attend and deliver,” he said, with output from the production facilities currently higher than average.
As an example of how quickly the firm had bounced back from the obstacles that accompanied the COVID-19 pandemic, he noted that at the firm’s plant in Milan, Italy, “the first week after the curfew the attendance rate went down to about 70%. But straight away in the second week the attendance went up to 90% again.”
“In terms of demand,” he revealed, “the customers – which are group purchasing organizations and hospitals, mainly – are sharing a lot more data with us. They are trying to help us reschedule our manufacturing runs to be able to react to their requests, so we are getting a lot better understanding of where we need to react.”
“That has been helpful,” he highlighted. It had “brought the customers closer to the manufacturer” – with communication “on a daily basis sometimes with our customers” – as well as allowing Hikma to hear “directly from the hospitals.”
Hikma’s manufacturing base also allowed it to respond quickly to demand spikes in the US, Olafsson observed. “By having one of our injectables plants in the US, in Cherry Hill [New Jersey], we have had a little bit more flexibility about manufacturing there to be able to react much more quickly to the changing demand,” he noted. “And we also have a big plant in Portgual which has been constantly exporting to the US at the same time.” (Also see "Portuguese Plant Opens Up Prospects For Hikma To Expand In Europe" - Generics Bulletin, 29 Aug, 2019.)
Hikma’s broad portfolio had also been a benefit, Olafsson emphasized. “In intensive care units today, of the 13 drugs that are most used for patients on ventilators, Hikma today offers 11,” he pointed out.
The firm had also not witnessed a significant drop associated with the lower rate of elective surgery amid the pandemic, he suggested. “Many of the drugs being used in the ICUs today – sedatives, strong pain medications, neuromuscular blockers – are the same drugs being used for elective surgery,” he observed, “so we haven’t seen a big change in the portfolio offering. And the same is true around the world.”
“The challenge for a company today is to try and understand where the demand is, where the demand is going, and how we can best support the customers,” Olafsson summarized. And from Hikma’s point of view, the firm had seen “no build-up of inventory, no hospitals trying to build inventory, because what we have been able to do with our customers is to tell them exactly what our inventory is, and when our manufacturing schedule is.”
Moreover, he observed, “if you look at the FDA website on shortages, the shortages haven’t really increased in terms of numbers of molecules over the pandemic period. There might be short-term shortages for a day or two, but overall I don’t think the overall shortage situation in the US has got worse.” The US authorities had “done a very good job working with the companies to try and have product available where the need is the most,” he suggested.
On the small-molecule generics side, Olafsson said, Hikma had also seen a pick-up in demand, driven partly by an increase in 90-day prescriptions over 30-day prescriptions. “But I see that as only temporary.”
“We have seen an increase in antibiotics and the use of steroids,” he noted, in the same way as would be seen for a traditional flu season. “That will continue over the year,” he anticipated, “and that will be an increased demand.” But regarding medicines for chronic conditions “that is just a small increase in the first quarter that will equal out over the course of the year.”
“In terms of extra inventory on the generics side,” he noted, “I think that in the beginning our customers wanted to build extra inventory – but how we handled it was more or less as we did on the injectables side, to be very transparent on our inventory status. There is no need to buy extra at times like this, so I think we have managed the extra inventory to a minimum on the generics side.”
Moving on to Hikma’s Middle East and North Africa branded segment and the impact of COVID-19 on the firm’s promotional activities, Olafsson acknowledged that “it has been a learning experience.”
“We have 2,000 people in MENA in sales and sales support,” he highlighted, and “we have been solely doing promotion digitally since this started, for six or seven weeks now. And it has been going extremely well.”
Online promotional events were “getting really good attendance rates,” he said, suggesting that “we have better access to doctors contacting them digitally.”
“We are all new to this and we are learning our way,” he conceded. And looking to the medium-term future, he predicted that “we will still have feet on the ground going forward. But the experience we have now will help us to understand what is the ideal mix between digital promotion and in-person promotion of drugs.”
Talking specifically about Hikma’s biosimilars business in the MENA region – on which the firm is partnering with Celltrion on a number of molecules – Olafsson said “it’s been doing well.”
On Remsima (infliximab), “we now have approval in eight markets and we are getting two more approvals in two markets this year,” he revealed. “Even in the pandemic we are seeing a steady use of the product.”
“We are also getting a lot of safety information from Celltrion, and that is what doctors are focusing on,” he said. “And then this year we will start the launch of trastuzumab and rituximab.” These next products were “slowly coming through in terms of approvals,” he said, acknowledging that “the regulatory process in the MENA region can take some time. We are just getting the first ones at the moment, so we will have a little contribution from these products this year and then [that will be] growing going forward.”
“We have a good partner in Celltrion,” he insisted. “We have access to the safety information that they get globally. And the education programs we have in place and the relationships we have with doctors are showing that there is a lot of use of Remsima today.”
“I think doctors have to understand biosimilars and get comfortable with them,” Olafsson concluded, “and then when we bring the next biosimilar product to the market there will be a quicker pickup.”
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