February 19, 2020
Teva says the monoclonal antibody (mAb) candidate fasinumab has “big potential” and expects to see Phase III data this year.
The Israel headquartered generics firm spoke about fasinumab – the osteoarthritis pain drug – during its fourth quarter earnings call last week.
CEO Kare Schultz told analysts “In novel biologics, we have a lot of different things going on.
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“The most exciting short-term is fasinumab that we are developing together with Regeneron and where we hope to see data this year from the Phase III trials and we’re very excited about that and we we’ll see a big potential if it succeeds in clinical development.”
Fasinumab was developed using Regeneron’s VelocImmune technology. It targets nerve growth factor (NGF), a protein that plays a role in the regulation of pain signaling.
Teva partnered with Regeneron on development and potential commercialization of fasinumab in 2016.
Data published last year by Teva and Regeneron suggest the drug reduces pain and improves function in patients with hip or knee osteoarthritis (OA) who do not benefit from analgesics.
Biosimilars expansion
Teva also said its biosimilars business was a major focus in 2020.
Schultz said, “We have a strategy where we want to be leaders in generics, and we want to aim for a leading position in biopharmaceuticals. And if you look at the pipeline, you will see that we have a high number of biosimilars in development and we had one imminent launch in biosimilars.”
This was echoed by Brendan O’Grady, EVP of North America commercial operations, who said the Rituxan (rituximab) biosimilar Truxima is “going quite well.”
He also confirmed Teva plans to launch its Herceptin (trastuzumab) nbiosimilar Herzuma “in the March timeframe.”
Both Truxima and Herzuma are covered by Teva’s 2016 partnership with South Korean firm Celltrion.
According to Schultz, Teva would consider expanding the collaboration.
He told analysts “We’re certainly open to having those conversations and we have a good partnership going right now with the first two.”
Financials
Teva also spoke about its two-year restructuring effort.
The restructuring worked according to Schultz. He told analysts “we have executed the restructuring plan exactly as we laid it out 2.5 years ago. It has not been, you could say, easy on the organization.
“We’ve had to close down or divest some 23 manufacturing sites. Some of those are still in process of the final closures and we’ve had to close more than 40 offices and laboratories around the world and say goodbye to more than 13,000 employees.”
Schultz’s comments and upbeat predictions about Ajovy (fremanezumab) and Austedo (deutetrabenazine) were followed by a 9% increase in Teva’s share price.
Teva’s revenue for Q4 increased 1% to $4.5 billion largely due to contributions made by Ajovy and Austedo.
Full year revenues were $16.8 billion, down 8%. The firm attributed the decline to lower US sales and competition for Copaxone (glatiramer acetate).
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