Update on #SyngeneInternational ππ§¬
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#Syngene announced a 10 year agreement with Zoetis to manufacture the biological entity for Librela(bedinvetmab). It is the first monoclonal antibody for the treatment of osteoarthritis in dogs
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#Syngene announced a 10 year agreement with Zoetis to manufacture the biological entity for Librela(bedinvetmab). It is the first monoclonal antibody for the treatment of osteoarthritis in dogs
1. About the drug
Currently, the product is only approved for sale in Europe but management has indicated that US approval is expected by the end of 2022. Zoetis launched the product in the second quarter of 2021 in Europe.
Currently, the product is only approved for sale in Europe but management has indicated that US approval is expected by the end of 2022. Zoetis launched the product in the second quarter of 2021 in Europe.
Sales for the product were $15 million in both Q3 and Q4 of 2021 and $20 million in Q1 of 2022. Zoetis management has said that the product will be a blockbuster by the end of 2022 bringing in $100 million from the EU alone. (Blockbuster product in animal health is products with
more than $100 million in revenues)
The management has said that the total opportunity size for Librela is about $400 million.
The management has said that the total opportunity size for Librela is about $400 million.
2. What does it mean for Syngene?
Syngene has stated that the deal could potentially be worth $500 million to them over the next 10 years. They have said that this deal brings opportunities to collaborate on other drugs as well.
Syngene has stated that the deal could potentially be worth $500 million to them over the next 10 years. They have said that this deal brings opportunities to collaborate on other drugs as well.
The drug substance is currently manufactured by Zoetis in the US and the final drug product is manufactured by them in Belgium for sale in the EU.
Syngene was involved with the development of Librela and has now become the supplier for commercial batches.
Syngene was involved with the development of Librela and has now become the supplier for commercial batches.
This means that post inspection, they will have an EU-GMP approved biologics facility.
We currently do not know if the deal extends to manufacturing for the US market as well. If it does, that could trigger a USFDA inspection for their biologics facility as well.
We currently do not know if the deal extends to manufacturing for the US market as well. If it does, that could trigger a USFDA inspection for their biologics facility as well.
3. Critical Mass
Syngene has been working with biologics for over a decade and has world class capabilities. They have multiple biologic drugs in the pipeline which could be commercialized over the next few years.
Once Syngene has a regulatory approved biologics facility, they
Syngene has been working with biologics for over a decade and has world class capabilities. They have multiple biologic drugs in the pipeline which could be commercialized over the next few years.
Once Syngene has a regulatory approved biologics facility, they
could receive orders for commercial products that they were not involved in the development as well. USFDA or EU -GMP approved facilities are not different for human and animal drugs.
They could also receive a contract for manufacturing the drug substance for Solensia - Zoetisβ
They could also receive a contract for manufacturing the drug substance for Solensia - Zoetisβ
other monoclonal antibody for osteoarthritis in cats.
Solensia is a much smaller product than Librela with sales of $2 million in Q3 of 2021 and $3 million in Q4 2021 and Q1 2022 in the EU region. Management has said that the total opportunity size for
Solensia is a much smaller product than Librela with sales of $2 million in Q3 of 2021 and $3 million in Q4 2021 and Q1 2022 in the EU region. Management has said that the total opportunity size for
Solensia is $200 million.
The point is, Syngene could see many more biologic products commercialized over the next few years and this could be a turning point in their journey of being an integrated CRAMS player.
The point is, Syngene could see many more biologic products commercialized over the next few years and this could be a turning point in their journey of being an integrated CRAMS player.
4. Expansion
Syngene already spent ~βΉ60 Cr in expanding their biologics capacity in FY22. They have guided that they will be spending about $50 million (~βΉ375 Cr) in FY23 for expanding their biologics facility which will come online in FY24.
Syngene already spent ~βΉ60 Cr in expanding their biologics capacity in FY22. They have guided that they will be spending about $50 million (~βΉ375 Cr) in FY23 for expanding their biologics facility which will come online in FY24.
This shows that the company is seeing increasing traction for outsourced biologics manufacturing.
This is in line with the global trend where the global giants are also investing big into biologics capacity. Samsung Biologics is investing ~$2 billion into their
This is in line with the global trend where the global giants are also investing big into biologics capacity. Samsung Biologics is investing ~$2 billion into their
Plant 4 and Lonza invested most of their ~$1.3 billion capex for 2021 into expanding biologics capacities.
Check the model portfolio to learn more about #Syngene and #SuvenPharma
Link : valueeducator.com/advisory/
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Link : valueeducator.com/advisory/
Like and retweet for max reach !
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