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Shilpa Medicare -Racing away on the Oncology API highway!

Refer foot notes of the results:

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Astellas’s OSI Pharmaceuticals unit and Roche’s Genentech have reached an agreement with Shilpa to drop a case in which the companies had accused Shilpa’s proposed copy of a lung-cancer treatment of infringing a patent for Tarceva.

  • No mention of a settlement in a proposed joint consent order of dismissal, filed Tuesday in federal court in Wilmington, Delaware.
  • OSI owns the patent and Genentech is a co-exclusive licensee, according to complaint
  • For Roche, Tarceva had U.S. sales of 233 million Swiss francs ($233.4 million) in 2018, 0.4% of revenue, according to data compiled by Bloomberg; for Astellas, Tarceva had global sales of 29.7 billion Japanese yen ($268.4 million) in the 12 months ended March 31, 2018, 2.3% of revenue
  • CASE: OSI Pharmaceuticals LLC v. Shilpa Medicare Ltd., 18-cv-1096, U.S. District Court, Delaware (Wilmington)
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US FDA approval received for its ANDA, Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial.
Gemcitabine for Injection USP is a generic equivalent of reference listed drug (RLD), GEMZAR used in the treatment of ovarian cancer, breast cancer, non-small cell lung cancer & pancreatic cancer as recommended in the label approved by FDA.’

According to IQVIA MAT 12/2018, the US market for Gemcitabine for Injection USP, 200 mg/vial and 1 g/vial is approximately US$ 11.7 Million.

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Shilpa medicare gets FDA approval (tentative) for Bortezomib (Treatment marketed by Takeda as Velcade)

U.S. court upholds Takeda patent on cancer drug Velcade

Jan Wolfe

3 MIN READ

(Reuters) - A U.S. appeals court ruled on Monday that a patent on Takeda Pharmaceutical Co Ltd’s cancer treatment Velcade is valid, pushing back the date when generic drug makers including Teva Pharmaceutical Industries Ltd and Mylan NV will be allowed to launch lower-cost versions of the drug in the United States.

The U.S. Court of Appeals for the Federal Circuit rejected arguments by a dozen generic drug companies that the Velcade patent was obvious and should not have been granted. The ruling, which reversed a lower court, will allow Takeda to sell Velcade exclusively until the patent expires in 2022.

The generic companies had moved to invalidate the patents after Takeda sued them for patent infringement.

Amy Atwood, a spokesman for Takeda, said the company was pleased with the decision.

Velcade is used to treat multiple myeloma, a type of blood cancer. The drug had $1.13 billion in U.S. sales last year.

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@Rajesh1975, I don’t track Shilpa Medicare actively currently. Having said that, I do feel it could be an interesting story after couple quarters.

Here I am assuming (and I could be wrong) that revenue contribution from “3a 7b Dihdyroxy” (i.e. CRAMS agreement with ICE Italy) will taper off to approaching zero in quarters to come. Thus will create a low base to grow from. Tough to replace “3a 7b Dihdyroxy” revenue quickly thus some challenges in short-term.

Interesting insights about Shilpa in annual letter by Vallum Capital -

The Raichur based oncology API & Formulation Company is progressing well with more than 25 Oncology/Non-Oncology filings for the regulated markets. It is also in the process of building a strong pipeline for the Rest of the World market. It has an enviable standalone infrastructure for Oncology : 9 Oncology Blocks – the Largest in Asia. The company has taken a lead in filing for products under the 505(b)(2) route, which is a capital intensive process and requires tremendous R&D capabilities. Considering the potential complexity and risk, payoffs in a 505(b)(2) molecule are manifold in comparison to a traditional ANDA filing. We must highlight to you about the progress at a jewel of the company, the biologics division, which is working on multiple promising projects. Its lead product candidate includes NavAlbumin, a recombinant human Albumin. It has developed a novel method for efficient purification of human serum Albumin. Currently, commercial production of human serum Albumin is primarily based on collected human plasma, which is limited in supply, but has high clinical demand. Globally, Albumedix, a global biologics leader spun off from Novozymes has progressed in this area. It is in the process of setting up a world class biologics manufacturing unit at Hubli, Karnataka. The company has invested about 32% of Pre-R&D EBDITA over the last 4 years, amounting to an investment of ~400cr, on regulatory filings, exhibit batches for R&D and building a commercial pipeline, without any commensurate earnings yet. This percentage is the second highest in India among noticeable Pharma Companies, the first being Lupin. As the strategy matures this year, the earnings of the company will see non-linear rise over the next few years.

Source: http://www.vallum.in/wp-content/uploads/2019/04/VallumDiscovery-Stakeholders-March2019.pdf

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Thanks Sandeep. Nice digging. Actually company is non communicative but mysterious. We find many things from here and there suddenly without any proper communication. That is why Valuepickr is the best collaborative platform. Keep updating whatever you find.

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Slew of positive news

  • Receives USFDA EIR for R&D unit at Modavalasa
  • USFDA approval for Busulfan injection
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US FDA approval for its ANDA, Zoledronic Acid Injection

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And another one… US FDA approval for Docetaxel Injection

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Thanks, @akbarkhan for posting these notices.

Given such small TAMs and that Shilpa will be the n’th player in these drugs, I wonder why Shilpa is even trying to get into these micro markets. More importantly, could the monetary and technical resources needed to shoot these rabbits been better employed to shoot an elephant? I am sure Shlipa is taking all the right decisions, but why don’t they be more communicative!?

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These were probably submitted 2/3 years back -due to delays in EIR for Jadcherla , these ANDA approvals were delayed as well & are now coming through.I am reasonably confident that they may not pursue such small opportunities. Again lets look at it from a positive side - after a long time , slew of approvals are coming through for Shilpa.

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Stagnant results. Rise in CWIP.


For dissection by experts.
Any scuttlebutt experiences?

See attached director’s report in 2017-18 AR.


On page 15 and 16 there is a mention about Biologics and Derma-patches.
Experts may decode for general benefit. Is this adding value to post 606 by @spatel.