Shilpa Medicare -Racing away on the Oncology API highway!


(MONK88888) #612

The site is now up and running. If you look under products -we can see Azacitidine (from image one can make out that its Shilpa medicare product). Otherwise a very sketchy website to start with


(naishadh) #613

Where is this ? Can you please paste a source link here?


(MONK88888) #614

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210291


(MONK88888) #615

A query to boarders here
Maia loss on half yearly basis is close to 23cr (for just 34.79% stake in the associate. What are they into -from filings and R&D perspective-that this loss has been incurred. I have written to CEO for clarification. Would help if any boarder has information


(MONK88888) #616

Little bit that I could garner on Maia

https://www.biospace.com/article/releases/maia-pharmaceuticals-announces-the-tentative-approval-by-the-fda-of-its-nda-for-sincalide-for-injection/ (its an old article)

I sent a mail to Bikram Malik , seeking update on its dispute with Bracco


(Dhairya) #617

Thank you @MONK88888 for the continuous work on Shilpa. I just feel that management should throw more clarity on the various subsidiaries and the kind of work each of them are doing and how much further investments required in each before they become self sustainable. Not able to get any such information at present.


(MONK88888) #618

You are welcome. Little bit that I have been able to garner Dimethyl Fumarate , it cannot be launched till 2021 (please do your own investigation). Now Lupin also has got the tentative approval. The positive is that Shilpa is able to manage complex molecules
Discl: Invested


(Karanops) #619

The product is already launched in india by MSN. Cipla will be in market very soon through MSN. Also newgen has launched in india. All brands are manufactured by MSN it’s own technology (non infringing). DRL will soon launch the product they are discussing with both MSN and optimus.

Since the product is launched in India I dont see any issue as such. This is different from Ticagrelor where DRL is on blackfoot and sales are suspended at the moment.


(Rajesh) #620

In spite of delay in launch date, I am very hopeful of Dimethyl Fumarate sanction. Many drugs came for Psoriasis like one from Roche and it amassed 1 BD market for itself. Copaxone went generic, still having great market. Dimethyl Fumarate market is increasing every year in spite of other drugs in market, presently 3.8 BD. I remember NATCO increased in 2014 to 2016, 5 times in hope of copaxone approval which came after 3 years. 2021 is not too far. Market is not considering this FTF opportunity. Shilpa has many other opportunities too. Once sales in US starts flowing in, perception will change and Psoriasis drug approval will be seen differently. I am hopeful here and dont consider disruption in Dimethyl Fumarate business. Company is non communicative to shareholders but big investors are still holding, no dilution. They are in board too so they dont need separate communication. Very less free float, Robust pipe line of complex molecules. Technically also, it looks, stock has formed bottom, there is too much demand below 380. More patience is required here.
Disclaimer - Invested and increased stake recently.


(MONK88888) #621

Dear Karan: Launch in India is irrelevant . We are talking about US launch and that is delayed till 2021 . Infact a couple of hedge fund managers tried squashing Tecfidera but lost against Biogen. Same happened to Forward (as you can read from web) & as of now 2021 is the projected launch date. Agreed with Rajesh on market potential for Tecfidera down the line.
Karan also keep market action in mind-If it was a 3.5 billion USD market & Shilpa was FTF -this stock should have skyrocketed -clearly supporting my initial take. I am not being negative considering that all my savings are in Shilpa -just asking new investors to get more visibility before taking exposure to Shilpa (end of the day that’s what this forum is intended for). Infact a case docket on Forward seems to indicate that Biogen holds fort till 2028

Request members to correct me , if my line of thinking is wrong


(MONK88888) #622


A good read on what the Dimethyl approval entails


(Rajesh) #623

Can you sum up the this approval in short. There are many patents for same drug, I can not get idea when it will launch. One is expiring in 2028 which is challenged.by Shilpa.


(Ranga Kiran) #624

(MONK88888) #625

First date before they receive the final approval is Oct 2019. Also they have filed a case & if Shilpa loses then its Feb 2028. So in all they should win the Biogen case for launch at least by Dec 2019 (giving some time from OCt 2019 to USFDA final approval to proceed)-hope that helps


(MONK88888) #626

However we are now seeing a slew of approvals from USFDA-a big positive for all Pharma & we can hope that Shilpa should see a substantial number getting approved.


(Harshit Goel) #627

Shilpa gets approval for Imatinib Mesylate Tablets, 100 mg and 400 mg from USFDA. According to IQVIA MAT Q2 2018 data, the US market for Imatinib Mesylate Tablets, 100 mg and 400 mg is approximately US$ 885 Million.

Regards
Harshit


(Rajesh) #628

Sandeep,
Are you still tracking Shilpa ? If yes, is it possible to update this list. I know this is big job, in fact, even analysts have abandoned this company. I am ready to help with my clerical skills.


(Divyanshu Taneja) #629

Please explain what you have written ,why many analysts have abandoned this company?


(Rajesh) #630

I mean brokerages not forum members.