Glenmark On Course For Xolair Biosimilar Deal, US Capital Raise For Innovation
Executive Summary
Glenmark appears close to sewing up a deal for its biosimilar version of Novartis/Genentech's Xolair amid the firm's ongoing focus on partnering out some key assets. It also expects to kick off plans to raise capital in the US for its innovation business in Q4 of fiscal 2019-20.
Glenmark Pharmaceuticals Ltd., which aims to seal at least one partnership for its innovative or specialty assets in fiscal 2019-20, appears to have made significant headway towards one such potential deal, for its proposed biosimilar version to Novartis AG and Genentech Inc.'s Xolair (omalizumab).
Glenmark had last year announced encouraging Phase 1 results suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between GBR310 (its proposed biosimilar) and the reference product. The Indian firm has now indicated that the potential partner is expected to invest and run Phase III studies and commercialize the drug. (Also see "Glenmark Readying Xolair Biosimilar Challenge" - Generics Bulletin, 27 Apr, 2017.)
“We are very close to bringing a partner on board,” Glenn Saldanha, chair and managing director of Glenmark said on the firm’s first-quarter earnings call 14 August, adding that the company hopes to retain “some rights for some of the markets” where it has a presence, and that it would be “like a royalty-based” deal.
Saldanha declined to provide details on potential trial or launch timelines in view of the complexities involved in the biosimilars space.
“You've got the 'patent dance', you've got all kinds of other attributes one has to look at and not just the filing and the filing dates and stuff like that. The good news on Xolair is we are the first biosimilar that we know of in the clinics - completed Phase I and ready to start Phase III. So we are ahead in the game,” the executive said in response to an investor’s query.
Competitors like Celltrion Inc. have recently outlined plans for development of biosimilar omalizumab and aim to finish a Phase III trial by 2022. Others like Sorrento Therapeutics Inc. and partner Mabtech Ltd. had previously completed a combined Phase II and III clinical study in China for STI-004, a biosimilar antibody to Xolair, though an updated position on this could not immediately be ascertained. (Also see "Sorrento Taps China’s Mabtech For Biosimilars Deal" - Scrip, 6 Aug, 2015.)
Fountain Biopharma Inc. and Longrui Pharmaceutical in Shenzhen are also known to be developing biosimilar omalizumab, while the Dutch/Australian biotechnology company BiosanaPharma recently received permission from the Australian Bellberry Human Research Ethics Committee HREC to start a Phase I trial of their biosimilar.
Other Partnering Discussions
Partnering discussions are also underway at Glenmark for other specialty assets such as Ryaltris nasal spray (olopatadine HCl and mometasone furoate monohydrate) for treatment of seasonal allergic rhinitis, for which the firm already has alliances in Australia, New Zealand, South Korea and China. (Also see "Glenmark Ponders Partners For Omalizumab And Ryaltris Spray" - Generics Bulletin, 11 Jun, 2019.)
Glenmark recently received a Complete Response Letter from the US FDA for Ryaltris, which it hopes to resolve in the next six to nine months by working closely with the agency. The Indian firm said that it is in the process of roping in a partner to commercialize Ryaltris in the US and close to concluding a partnership deal for EU markets as well.
But in general, Glenmark’s commentary on the specialty segment in the US was cautious. The management referred to the challenging environment there and the need for a much deeper pipeline of products “which have significant value creation” to get reimbursed and to get “real value” out of the US market, because of the changing dynamics there in terms of the reimbursement environment, patient co-pay and rebates.
Innovation Spin Out, Capital Raise
For the Indian firm's innovation assets, some key data readouts are expected next year, though the company expects to focus in the short term on the new spin-out innovation entity and a potential capital raise, before “going out and aggressively looking for partners on the innovation side.”
“But as we speak, we also have partnering discussions ongoing. So we don't know how it will play at the end of the day,” chair Saldanha added.
Glenmark had earlier this year outlined plans to spin out its innovation business, which includes a basket of promising early to advanced new chemical entities and new biological entities, into a new company based in the US. (Also see "Glenmark Spins Out Innovation With New US Base" - Scrip, 14 Feb, 2019.)
The new company will be a wholly-owned subsidiary of Glenmark and is expected to initiate the process to raise capital in the US starting Q4 FY 2019-20, to fund the development of its pipeline and future growth plans.
The name of the new company is expected to be announced by mid-October 2019, at which time its strategic blueprint will also be outlined. The innovation entity has instituted an independent board of directors to govern its functioning. (Also see "Glenmark’s Coup: Gilead’s Riva Now CEO Of Spin-Out Innovation Firm" - Scrip, 6 Mar, 2019.)
Currently, Glenmark’s innovation pipeline comprises six assets in various stages of development, in the areas of immunology, oncology and pain management. Five of these assets are in clinical development including GBR 830 (an OX40 antagonist) and GRC 27864 (an mPGES-1 inhibitor), which are currently in Phase IIb studies. The sixth one, an oncology molecule, is in preclinical development.
Remogliflozin Traction In India
On the home market, Glenmark’s novel sodium glucose co-transporter-2 (SGLT2) inhibitor, remogliflozin etabonate, has made strong gains. The company said that the response from KOLs had been “extremely positive” and maintained that the product was one of the successful launches for its India business. Sales for remogliflozin are already tracking around INR20m ($281,000) per month less than two months from launch, as per IQVIA June 2019 data.
“I think going forward this could be a really big product,” Saldanha predicted.
Glenmark recently struck a co-marketing alliance with peer Torrent Pharmaceuticals Ltd. for the product and said it hopes to close one more such deal in Q2. Line extensions for remogliflozin are also expected to be launched. (Also see "Glenmark Readies Push For SGLT2i With Torrent Deal, More In Store" - Scrip, 11 Jul, 2019.)
Revenues Up 7%
Glenmark’s India business grew by 13% to INR7.52bn ($108.2m) in the first quarter ended 30 June, while overall consolidated revenues were INR23.22bn (+7%). The US business stood at INR7.30bn (+4%) and consolidated net profit was INR1.09bn.
The company also aims to divest non-core global assets in fiscal 2019-20. Saldanha explained that these are essentially assets which are "not in the areas of dermatology, respiratory, and some of the firm’s core therapeutic areas."
“These fall outside of that in various geographies, where we really don't have a pipeline to support these portfolios. And we think they are not going to add a lot to us,” Saldanha explained.
This article first appeared in our sister publication Scrip.