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Novartis preps production platform for alternative to Lucentis

Dan Stanton

By Dan Stanton+

26-Jul-2017
Last updated on 26-Jul-2017 at 16:48 GMT2017-07-26T16:48:43Z

Image: iStock/stockfotocz
Image: iStock/stockfotocz

Novartis has scaled up manufacturing of wet age-related macular degeneration (AMD) monoclonal antibody RTH258 ahead of a potential regulatory submission next year.

In June, Swiss pharma firm Novartis reported its candidate RTH258 (brolucizumab), designed to treat neovascular age-related macular degeneration (nAMD, or wet AMD), met the primary and key secondary endpoints in two Phase III studies.

And last week during its Q2 results presentation head of Global Drug Development Vas Narasimhan said Novartis was set to move forward on studies in other indications – including diabetic macular edema (DME) and retinal vein occlusion (RVO) – and to finalise the manufacturing platform ahead of a potential filing in the second half of 2018.

“We have changed the scale of which we produce the drug substance which is important for the scale up and the potential for this product to enable us to have adequate supply chain, as well as appropriate COGS,” he told investors. “And so with that we expect to have to run an additional PK bridging study. But that would enable us to file in the second half of 2018.”

Spokesman Eric Althoff confirmed this was the case, telling Biopharma-Reporter the manufacturing process is being scaled up to support commercial production.

“Over the past 18 months, Novartis has continued work to scale up manufacturing processes and invested to ensure a competitive, low cost of goods formulation to maximize the long term value of RTH258.”

He said further details of the manufacturing process are confidential, but the commercial-scale process “will meet the needs of the market and development of new indications.”

If approved, the product could offer an alternative to Roche’s drug Lucentis (ranibizumab) which Novartis holds the commercial rights to outside the US, offering AMD, DME and RVO patients less regular intravitreal injections (every 12 weeks rather than every month).

“This will be the first time for us with RTH[258] in the US market a $4-5 billion wet AMD market in retina, and we are excited about what we can do,” head of Pharma Paul Hudson said on the call last week.

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