Hetero, Cipla's Remdesivirs Hit India Market, 'Surplus' Envisaged By August
Prices Well Below $100/vial
Executive Summary
Gilead licensees Hetero and Cipla introduce remdesivir, the antiviral seen as a potential treatment for COVID-19, in India. Pricing plans will be closely watched and supplies in the country are expected to stabilize soon, possibly turning to a surplus situation in several months.
There has been a flurry of activity around investigational COVID-19 treatments in India over the past weekend.
While Glenmark Pharmaceuticals Ltd. became the first Indian firm to get the go-ahead for its version of the oral antiviral favipiravir, news of much-anticipated regulatory clearances for local licensees of Gilead Sciences Inc.’s remdesivir, the injectable antiviral in the global spotlight, also trickled in soon after. (Also see "Flutter Over Debut Of Glenmark's Favipiravir For COVID-19 In India" - Scrip, 22 Jun, 2020.)
Hetero Drugs Ltd. and Cipla Ltd. on 21 June both separately announced the launch of their generic remdesivir versions in India for the treatment of COVID-19. Gilead has sealed non-exclusive, voluntary licensing agreements with five generic firms in India and Pakistan, including Hetero and Cipla, to manufacture remdesivir for distribution in 127 countries. (Also see "Gilead Licensing Deal Expands Remdesivir Access, Capacity" - Scrip, 13 May, 2020.)) Earlier this month Gilead expanded its list of licensees for remdesivir to include Dr. Reddy's Laboratories Ltd., Syngene International Ltd. and Cadila Healthcare Ltd., among others.
Hetero said that its version, to be marketed as Covifor, had been approved by the Drugs Controller General of India for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children hospitalized with severe symptoms of the disease. Peer Cipla specified that the approval for restricted emergency use for its remdesivir product, to be marketed as Cipremi, was part of an accelerated approval process in view of the “urgent and unmet” medical need.
“As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients,” the Mumbai-based firm said.
Pricing Plan
Covifor will be available in 100mg vials and is expected to be priced at around INR5,000-6,000 ($65.70-$78.90) per vial, while Cipla told Scrip that Cipremi will be priced at “less than INR5,000 vial for injection 100mg – amongst the lowest pricing for remdesivir globally.”
The price line of Gilead's Indian licensees appears to be in a similar range to thus far non-licensed peers from neighboring Bangladesh. Beximco Pharma, the Bangladesh firm which launched what it maintains is the world’s first generic version of remdesivir, previously indicated to Scrip that it had priced its product at $55-65 per vial for "initial orders." It has also been approached by "many countries" for the supply of the product and has received “few firm purchase orders" for supply and expects to commence exports soon.
While Gilead’s licensing terms allow licensees to set their own prices for the generic product they produce, it will be interesting to see how the Indian price range is viewed in the overall context of global pricing expectations for Gilead’s own product Veklury (remdesivir) amid the pandemic and stretched national budgets.
Gilead is yet to unveil its access and pricing model for Veklury; the company earlier donated 940,000 vials to the US, adequate to treat an estimated 120,512 patients. (Also see "COVID-19 Shifts ICER Pricing Targets, Creating New Hurdles For Drug Developers" - Pink Sheet, 4 May, 2020.)
On 22 June, an open letter from Daniel O’Day, Gilead’s chairman and CEO, noted that the company had donated its entire existing supplies of remdesivir through June and expects to have more than two million treatment courses manufactured by the end of the year, plus “many millions more” by 2021.
Veklury was recently approved in India for the treatment of suspected or laboratory confirmed coronavirus disease in adults and children hospitalized with severe disease. (Also see "Coronavirus Update: India Approves Remdesivir, Ex-Biogen Employee Charged" - Scrip, 3 Jun, 2020.)
Gilead noted at the time that there is currently limited global supply of remdesivir but that it anticipates new quantities to start to become available in July, with supply continuing to increase through the end of this year and into next year. (Also see "Coronavirus Notebook: Remdesivir Supply Dwindles; US FDA Signs Another RWE Deal; Corning Gets BARDA Contract For Glass Vials" - Pink Sheet, 9 Jun, 2020.)
Control Over Supply Chain
Meanwhile, Hetero emphasized that it is fully backward-integrated in production, making both the active pharmaceutical ingredient (API) at its site in Vishakapatnam in India and formulating the product at its Hyderabad facility, and is prepared to ensure “enough stocks” to cater to present needs.
Dr Vamsi Krishna Bandi, managing director, Hetero Group of companies, explained that it is the API which is the key bottleneck for manufacturers.“Since we are doing it indigenously, it is fully under our control,” Bandi said, adding that the company probably could offer the product to other licensing holders “if at all the time comes.”
The executive also expects to have “reasonable” control over the entire supply chain come July and does not foresee a "supply risk", at least for India, thereafter.
“By August we may all [including other licensees] even be surplus and probably be able to support other countries,” Bandi added.
For now though, the priority is to ensure that the antiviral will be available in all key Indian cities and for government requirements.
“Because of logistics reasons, we will take seven to 10 days to get the product there. By the end of this month, in some quantities all the key metros will have the drug,” Bandi added.
Partnered Approach
Significantly, Cipla has outlined its intent to deploy a partnered approach to expand access to remdesivir.
“As part of its efforts to enable speedy and equitable access to this treatment and in anticipation of demand, Cipla expects to commercialize remdesivir through its own facilities and partnered sites," the firm said. Cipremi will be supplied through both government and open market channels to ensure "equitable distribution."
Indian company BDR Pharma is among the partners, Cipla confirmed to Scrip, though it’s not clear whether BDR will also have its own remdesivir brand on the market.
Cipla had roped in BDR to contract manufacture the drug, seemingly along the lines of a sub-licensee. While the license granted to Cipla to manufacture remdesivir did not specifically permit a sublicense to BDR (or any other firm), Gilead at the time clarified to Scrip that, subject to certain conditions including prior written notice, Cipla and its other licensing partners for remdesivir could engage manufacturing subcontractors anywhere in the world.
The US firm said it hoped this "will enable their ramp-up for the production of remdesivir for the developing world.” (Also see "Remdesivir India Sub-Licensing: Gilead Indicates Conditional Position For Subcontracting" - Scrip, 2 Jun, 2020.)
The arrival of the first Indian versions of the drug is also likely to dull enthusiasm around potential supplies from Bangladeshi firms. The western Indian state of Maharashtra, which has emerged as a hotbed of coronavirus infections, had earlier created a flutter when its Minister of Public Health and Family Welfare suggested the state could consider procuring remdesivir from a Bangladesh company, though it was said to have backed down.