We would need to see how the vaccine succeeds (personally, would wish it succeeds). It is in trial stage; to run over the next two years involving up to 30 volunteers. At end of the day it has to be effective, safe, versatile and commercially viable. Will have to wait and see.
As Hiteshbhai says “There is a huge deluge of newsflows on almost all companies and one needs to prioritize what is important and what is not” (for now).
Till then, let’s enjoy the joker in the pack (USFDA approval). The single biggest risk factor is behind us. Cheers.
depending heavily on just one branch of medecine is always a risk for any pharma co , would prefer to be in businesses that are diversified across major verticals.immunotherapy is making steady progress in the fight against cancer but is yet to be commercialised.
Shilpa Medicare Ltd has informed BSE that the Company received GMP compliance certificate for two API sites (Unit-1: Deosugur Industrial Area, Deosugur-584170, Raichur, Karnataka, India; Unit-2: Plot nos. 33, 33A, 40 to 47, Raichur Industrial growth Centre, Wadloor Road, Chicksugur-584134, Raichur, Karnataka, India) from PMDA-Japan.
The March quarter ending DMF filing list with USFDA is out and Shilpa has filed two DMFs (including one filed in December which got recorded in this quarter’s filing) taking its total tally of DMF filed to 26 now. The details are given below:
AXITINIB (gInlyta, innovator - Pfizer): Filed on December 24, 2015. Exclusivity expiry - Jan 27, 2017 Patent expiry - June 30, 2020. gInlyta is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked or has stopped working. DMF Filers - Three including MSN Laboratories and Zhejing Jiuzou Pharmaceutical Co Ltd. In CY’15, US Sales of USD 205 million and worldwide sales of USD 430 million. Just three filers currently for DMF and moderate size molecule.
ENZALUTAMIDE (gXtandi, innovator - Astellas): Filed on March 17, 2016. Exclusivity Expiry - September 10, 2017 & Patent Expiry - May 15, 2026. Used for treatment of prostrate cancer. DMF Filers - Six including Sai Lifescience Ltd, DRL, Cadila, Mylan and MSN. US Sales of around USD 900 million and world wide sales of USD 1.50 billion. Seems to be a blockbuster products but no clarity on the date of generic launch as no Para IV filing yet.
In terms of ROE or its expansion it is not very good and negative on incremental return by way of profits. I am perplexed what could be the reason for this. Is it a red flag. Natco is far ahead in this measure.
Shilpa Medicare Ltd has informed BSE that a meeting of the Board of Directors of the Company will be held on June 27, 2016, inter alia, to consider a proposal of merger of Navya Boilogicals Private Limited with the Company.
Navya Biologicals Private Limited (“NBPL”) is a company incorporated under the Companies Act, is engaged on research and development activities in the field of biologicals. NBPL has specifically been in the development of bio-similars and product process technologies.