Shilpa Medicare -Racing away on the Oncology API highway!


(Ayush Mittal) #304

Hi Donald,

We missed you at the AGM this time…interaction would have been even better :slight_smile: Kudos to Ankit and Anant for doing a in-depth and complete job…they continue to surprise with the level of detailing they have gone into.

On your query for revenue drivers - I feel that nothing major would happen till they get USFDA approval. I could see a lot of shift in focus of the company towards formulations going forward (which is a good thing) and getting the same will open up next set of opportunities on which they have been working. They have about 9 months to 1 year by which they should get approvals, any further delay may hamper their pipeline and plans.

Ankit has covered the specific answers above.

Regards,
Ayush


(Rajesh_R) #305

Great discussion. Learned a lot about Shilpa and have a lot more to learn.


(Ankit Gupta) #306

Shilpa filed 4 DMFs during Q3CY2015 (July - September) and now has filed 24 DMFs in the US market. For H1FY16, the company has filed 5 DMFs in total and is a sharp increase compared to 3 DMFs filed in FY15. The brief details of these 4 DMFs is give below:

  • PEMETREXED DIPOTASSIUM (gAlimta, innovator - Eli Lily): Filed on September 14, 2015. Exclusivity expiry - Oct 17, 2015 & Patent Expiry - July 24, 2016. Used for initial treatment of advanced nonsquamous non-small cell lung cancer. ANDA - Tentative approval - App (Teva subsidiary), Accord, Hospira, Glenmark (also filed for ANDA). DMF Filers - Teva, Chongquing, DRL, Sun, MSN,Emcure, Chemwerth, Reliance, Glan, Neuland. US Sales of USD 1.23 billion and worldwide sales of USD 2.79 billion (2014). It seems to be a big product.
  • ANASTROZOLE (gArimidex, innovator - AstraZeneca): Filed on September 18, 2015. Patent has expired. Used a non-steroidal aromatase-inhibiting drug approved for treatment of breast cancer after surgery, as well as for metastasis in both pre and post-menopausal women. Approved ANDAs - Accord, Apotex, Cipla, DRL, Fresenius Kabi, Mylan, Natco, Roxane, Sandoz, Santos Biotech, Sun, Teva, Zydus. Seems to be a me too product with lot of players already in the market.
  • DIMETHYL FUMARATE (gTecfidera; innovator - Biogen): Filed on September 19, 2015. Exclusivity Expiry - March 27, 2018 & Patent Expiry - April 1, 2018. Used in treatment of multiple sclerosis. DMF Filers - DMF Filers - Glenmark,Arevipharma, Yabao Pharmaceutical , Mylan, MSN, Biophore, DRL, Honour Lab, Chongqing Huapont. US Sales of USD 2.40 billion (2014). Its a blockbuster product but there are quiet a few DMF filers.
  • CLOFARABINE (gClolar; innovator - Genzyme [acquired by Sanofi]): Filed on September 25, 2015. Exclusivity expired Patent expiry - Jan 14, 2018. Used for treatment of treating relapsed or refractory acute lymphoblastic leukaemia. DMF Filers - Apicore, Olon, Scinopharm, Emcure, MSN, Biophore, Synbias. Sales of USD 80 million (ICICI Report). Seems DRL has filed ANDA has a para IV litigation was filed against it. It seems a small but limited competition product.

Out of the four DMF filing done by the company during the last quarter, two are multibillion dollar opportunities. The company seems to have developed a good pipeline for the US market. However, it all depends on execution now as and when it gets USFDA approval for its API and formulation plant.


(Dhiraj Dave) #307

any impact of Dr Reddy’s oncology facility getting warning letter from US FDA for Shilpa? Do they have any common products?

Disl: I have investment in both the companies


#308

Q2FY16 Results declared
BSE Results link

Revenue Growth 13%
EBITDA Growth 25% (Margin 21.61% vs 19.44%)
PBT Growth 31%
PAT Growth 30% (excluding exceptional item)

  • Exceptional loss of 2.42cr reported, dragging reported PAT down to 20cr

Overall looks good set of numbers, considering that we are not expecting any fireworks until US FDA approval and revenue growth thereafter.

Mr. Bhutada had already clarified after Q4FY15 results that all the ongoing initiatives will drive revenue growth by 2016 end or 2017. Until then 5-10% growth guidance was provided. They have done better than the near term guidance at least.

However, brokers have a different set of expectations.(FY16 growth: IndiaNivesh 24.5%, Karvy 23.5%)


(CommonStocks) #309

Some perspective on what goes on in an FDA inspection


(Ankit Gupta) #310

Thanks for the article. Extremely helpful. Apart from the data integrity issues, the USFDA seems to be very particular about training as well as employee hygiene.


(nabendu) #311

Cancer drugs to cost $110 Billion in 2020


(HG) #312

FDA approval possibly coming…


(Raman) #313

“The company may get US FDA nod for Raichur facility in four weeks, according to media reports.”

A media report referencing other media reports; which I am unable to locate. Would you have access to the media reports which is being referred to?


(HG) #314

Raman,

No, even I had high hopes when I read the headline but the content was lamentable. Posted it here in the hope that someone might know more.


(JKS) #315

there was a run today on the stock (8% up) and of course there were the rumors (unconfirmed) of IT raid going around in mmb…either case, I feel that such things are best clarified officially by the co and they should have either promptly said yeh or ne
PS - invested…no transactions in preceding 30 days


#316

Looks like vested interests on both sides. Pharma reacts to negative news pretty violently. Few days back Strides was taken for a ride when there was actually no new info.

Disc: No Holding


(Vishnu Ch) #317

http://twofourinsight.com/approval-novel-dosage-form-sildenafil-subject-phase-4-clinical-trial/

APPROVAL OF NOVEL DOSAGE FORM OF SILDENAFIL SUBJECT TO PHASE 4 CLINICAL TRIAL

On January 12, 2016, the Central Drugs Standard Control Organization (CDSCO) made available the minutes of the 15th Meeting of the Subject Expert Committee on Reproductive & Urology, held December 14, 2015, (15th SEC-Reproductive & Urology) at which proposals for clinical trials were reviewed. One of the Subsequent New Drug proposals reviewed by the committee involved a request for a Phase IV Clinical Trial Waiver by the Hyderabad-based Nu Therapeutics Private Limited for its Sildenafil Citrate 25 mg & 50 mg Orally Disintegrating Strips (ODS) drug product for the “treatment of erectile dysfunction”. The committee outright rejected the company’s request and noted that the manufacturing license granted on July 5, 2013 was subject to conducting a Phase IV Clinical Trial within one (1) year of receiving the approval from the Drug Controller General of India (DCGI). Accordingly, the company was given another two (2) months to file a protocol for a Phase IV Clinical Trial for this novel dosage form.

The proposal for the novel dosage form of sildenafil was originally presented to the October 30, 2012 New Drug Advisory Committee (NDAC) for Reproductive & Urology (predecessor to SEC-Reproductive & Urology), but was deferred. The proposal was subsequently reviewed by the November 2012 NDAC which recommended that the formulation should be termed as “lingually disintegrating strips”, and agreed with the proposed bioequivalence (BE) study and, based on the results of the BE study, recommended a comparative clinical trial between the disintegrating strips formulation and tablets. Subsequently, on April 13, 2013 the NDAC recommended the marketing authorization for sildenafil ODS 25mg and 50mg subject to a four hundred (400)-person Phase IV clinical trial to be conducted within one (1) year. After securing approval on July 5, 2013, the company did not submit a Phase IV clinical trial protocol within the requested time period and subsequently requested a waiver of the Phase IV Clinical Trial. The 10th SEC Reproductive & Urology Meeting on January 16, 2015, the Committee noted that it could not consider Nu Therapeutics’ proposal for a Phase IV Clinical Trial.

In addition to Nu Therapeutics, Nagpur-based Zim Laboratories Private Limited also claims to have secured DCGI approval for its Sildenafil ODS 25mg and 50mg although it is unclear when the company received such approval. Both Nu Therapeutics and Zim Labs claim to have obtained GMP status from WHO. However, according to publicly available information, neither company has filed or secured a patent for their respective sildenafil ODS formulation.

Notably, the following companies/inventors have pending patent applications in India for a fast-dissolving film formulation containing sildenafil:

Seoul Pharma Co. Ltd (#1706/MUMNP/2014) Filed August 25, 2014
Title of Invention: HIGH-CONTENT FAST-DISSOLVING FILM WITH MASKING OF BITTER TASTE COMPRISING SILDENAFIL AS ACTIVE INGREDIENT
KATAKAKI VENKATESH (#1973/CHE/2008) Filed August 14, 2008
Title of Invention: ORAL FAST-DISSOLVING FILMS FOR ERECTILE DYSFUNCTION BIOACTIVE AGENTS


(ASPN) #318

Sorry Vishnu, but failed to understand the relevance of this post on Shilpa. I am not from Pharma domain. Request you to explain, if there is any pls.


(Tolaha) #320

Nu Therapeutics is subsidiary of Shilpa Medicare Ltd.


(Vishnu Ch) #321

Nu Therapeutics is a subsidiary of Shilpa Medicare which works on Novel Drug Delivery Mechanisms for existing drugs.

They do have a patent but for a different molecule called “Ondansetron”.
https://www.lens.org/lens/patent/WO_2015_001541_A2

Intention for the above post is to highlight a lack of regulatory compliance on the part of Shilpa Medicare. It probably means nothing and simple lapse of oversight, but it is prudent to be aware and monitor.


(ASPN) #322

Ok, tks a lot Vishnu & Tolaha.


(Kunal Patel) #324

BSE announcement:

Shilpa Medicare Ltd has informed BSE that the Company have received compliance letter from USFDA for both API manufacturing sites located at Raichur, Karnataka, India (Unit-1: Deosugur Industrial Area, Deosugur, Raichur, Karnataka, India and Unit-2: Raichur Industrial Growth Centre, Chicksugur, Raichur, Karnataka, India).

Views please…


(vaibhav) #325

Just telephoned the investor relations. Got confirmation that both API plants got approval. Formulations plants’ inspection is done and approval is pending.