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US niche generics player Teligent intends to use its expertise in topical and injectable drugs manufacturing to push into the North American ophthalmics sector.




Leveraging its technical and manufacturing expertise in both topical and injectable generics to carve out a position in the North American ophthalmics sector is the next step in Teligent's niche generics strategy, CEO Jason Grenfell-Gardner told delegates to the 2019 Jefferies Healthcare Conference in London, UK.

Outlining Teligent’s ‘TICO’ – topicals, injectables, complex generics and ophthalmics – strategy, Grenfell-Gardner pointed out that the firm now marketed almost 40 topical formulations in the US, where significant injectables capacity was just coming online, while it was starting to add dermatology drugs to its roster of around 30 injectables in Canada.

Now, the US company is looking to employ its expertise in semi-solids, liquids and injectables to develop and market eyecare drugs.

“Ophthalmics is an interesting part of putting topical technology together with sterile injectable technology,” Grenfell-Gardner told Jefferies delegates. “If you think about the complexity of making sterile ophthalmics, obviously the environment is a critical part of that, but it is also often based on emulsion technology.”

“Using what we've learned across topical emulsions and applying that together with our knowledge of sterile manufacturing, eventually takes you into ophthalmology,” he continued. Teligent currently had three ophthalmic projects on track to be filed during 2020, he said, adding that by working with a contract development and manufacturing organization, the company was able to learn what was required to “bring ourselves into that field further down the road.”

Ranitidine Supplement To Trigger FDA Inspection
Teligent’s drive into the US injectables space is already underway. On 28 October, the company filed with the US Food and Drug Administration a prior approval supplement for its first injectable to be submitted out of its recently expanded multi-purpose site in Buena, New Jersey. The firm believes this PAS for ranitidine hydrochloride that complies with FDA impurity regulations will trigger an inspection of the Buena injectables plant within four months, potentially early in 2020.

“That will allow us then to launch our first US-manufactured injectable product,” Grenfell-Gardner stated, adding that the company had a pipeline of more injectables to file through the Buena facility.

“We started this journey into US injectables in 2014 when we acquired a portfolio of injectable abbreviated new drug applications and abbreviated new drug applications from AstraZeneca and from Valeant,” he recalled. “And we started teaching the organization how to think about the manufacturing and commercialization of those injectable drugs. For us, being able to manufacture drugs was really important.”

“Much of our competitive set in the sterile injectables space has been distracted with mergers and acquisitions, with regulatory challenges and with quality issues, which means that there hasn't been an enormous amount of new development work in the injectables space,” Grenfell-Gardner asserted. With ongoing injectables shortages in the US, Teligent was working on bringing a substantial pipeline of vial and ampoule filings to market, supported in time by plans to install a high-speed filling line capable of producing 40 million to 50 million units per year.

December Action Date For Orphan Generic
Grenfell-Gardner said the complex generics part of Teligent’s TICO strategy involved using the firm’s technical capabilities across the value chain and dosage form spectrum. As an example, he cited the firm’s generic of an undisclosed orphan drug for which the FDA had set a target action date of 23 December this year.

“This was one of those drugs where we saw some pretty significant patient impacts as a result of some egregious pricing that happened in the market a few years ago,” he elucidated. “We looked at that and said, we know how to source active pharmaceutical ingredient, we know how to do chemistry, we know how to find formulations and do bioequivalence work, so we can help be part of the solution for this problem.”

In the third quarter of 2019, Teligent – which is currently considering unsolicited offers for certain undisclosed assets as it looks to reduce its debt burden  (Also see "Teligent Weighs Sales Of Non-Core Assets" - Generics Bulletin, 3 Oct, 2019.) ­– saw its topical product sales climb by 26% to $13.3m, aided by recent launches including clobetasol, desonide and gentamicin ointments, as well as fluocinonide topical solution. The company also highlighted the positive impact from its efforts to “broaden and diversify our customer base” beyond the dominant three retail buying groups in the US.  (Also see "Teligent Targets Smaller Customers As It Seeks Sustainable Margins" - Generics Bulletin, 10 May, 2019.)

Injectable product sales were 16% lower at $4.96m amid supply disruptions in Canada. With lower contract-manufacturing revenues, group turnover edged up by 1% to $18.5m. Teligent posted a $0.29m operating profit, but higher interest expenses and foreign-currency losses almost doubled its pre-tax loss to $7.12m.

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