AstraZeneca India got approval from DCGI to import and market Dapagliflozin in adults for the treatment of heart failure with reduced ejection fraction.
Dapagliflozin was marketed under the brand name Forxiga was originally used as oral antihyperglycemic agent for Diabetes Mellitus.
US FDA has approved the use of Forxiga in heart failure patients based on phase III DAPA-HF trial ,which showed statistically significant and clinically meaningful reduction of cardiovascular death or hospitalisation for heart failure (HF), compared to placebo.
https://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-approved-in-the-us-for-the-treatment-of-heart-failure-in-patients-with-heart-failure-with-reduced-ejection-fraction.html
Important point to note is how quickly AstraZeneca India is introducing the patented branded products in India. For the above indication Forxiga was approved in the US in oct 2019.
Forxiga seems to lose patency starting Oct 2020. Based on the below letter Teva has got tentative approval for a generic version. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211541Orig1s000TAltr.pdf
There seems to be different patent nos with expiration dates.I am not sure about how it will apply to the Indian scenario(?same as global) or patency gets extension for different clinical indications?
@NauticalTwilight can you please help me to understand with below questions:
- Does the US FDA patent expiration date is universal to all countries or is there any specific country wise variation ,anything specific to India?
- Do the companies gets new patent on drug if they get approval for new clinical indication for the same drug?
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Initial positive outcome from phase 1/2 study of vaccine trial which AstraZeneca and OXford university are conducting
https://www.astrazeneca.com/media-centre/press-releases/2020/covid-19-vaccine-azd1222-showed-robust-immune-responses-in-all-participants-in-phase-i-ii-trial.html
It may be too early to conclude anything on success of vaccine. Hope the ongoing phase 3 trial shows positive data and helps mankind to fight ongoing covid pandemic.
(AstraZeneca has manufacturing partnership with Serum institute of India to produce one billion doses of vaccine. Not to expect any financial implication on AstraZeneca India)
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Covishield : Phase 1-2 trials is a pass - Phase 3 trial is in progress UK has already started trials.
Price : Under 1000
2020 Manufacturing 300 -400 million doses
2021 Manufacturing 1 Billion doses
Few million doses are already made.
As per our deal with AstraZeneca, they will be making one billion doses over the next one year for India and other low- and middle income countries (GAVI countries). The vaccine will be procured and distributed by the respective governments and organisations like GAVI
Oxford Vaccine Human Trials Should Start In A Month And Half In India, Says Adar Poonawalla
Disc : No holding
@spartan : I don’t understand whats the relation between Serum Institute and Aztra Zeneca : The news are totally confusing as both talk in mere peers of both the companies are making drug. - Please assist me in understanding
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Astrazeneca is actually the one who is developing and will market the vaccine. What they have done is that they have outsourced the manufacturing to Serum Institute. So the entire relation between Astrazeneca and Serum is that of contract manufacturing, given the fact that Serum has large capacities for manufacturing vaccines.
Also, everyone should take note that Astrazeneca India will have no role to play here. They don’t have vaccine manufacturing capabilities. Also, distribution would most likely be through government agencies only.
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Hi Nithin,
Completely agree with what Ankush has written.
At this point no relation between AstraZenaca India and vaccine. No disclosures were made by regarding this and even annual report which got published recently doesn’t mention anything.
AstraZeneca ( Global) and Oxford university developing vaccine where AstraZeneca (Global ) is involved in manufacturing, distribution etc. Global company has entered into agreement with serum institute of India to manufacture vaccine. As of now nothing to do with AstraZeneca India.
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Some notes from FY20 AGM-
- For imported products, Indian entity basically acts as a distribution agent.
- Some products are imported directly and some products are packaged in India.
- The pricing of products between the Parent and Indian company depends on variety of factors like end market price of product, transfer pricing arrangements etc (Not very clear answer)
- In case of exclusive distribution rights (Sunpharma and Abbott), company earns profits in the form of margins which are in-built into the final goods sold to such exclusive distribution licensee.
- Company does not pay any royalty to the Astrazeneca Group. The royalty expense in other expenses is on account of one in-licensed product which is distributed by Astrazeneca India on account of some other company.
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