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Recent Developments, Views & Opinions in Pharma:

Most deals in 2015 are with companies focussing on a specialised portfolio. Cipla-Serum; Famycare-Mylan & Valeant-Salix...Read on...2015 - Deals in Nice Areas

An Old but interesting article on the Japanese Generics Market

2014 - Year Review
A quick recap of the key events that shaped 2013: GDUFA fees, Obamacare, Pay-for-delay and the key M&As that were closed.

Its a big victory for Korea's Hanmi as the "strontium" salt of Nexium gets approved and declared non-infringing. The difference with this approval of a new NDA is that Hanmi sought approval by citing the 505(b)(2) pathway for approval & Hanmi's version is non "AB" and not directly equivalent to the original innovator drug. The approval of esompeprazole strontium as an NDA product which differs only in the "salt" is quite a significant & a noteworthy development.
The below article provides clarifications & insights on approvals via the 505(b)(2) pathways and its advantages.

The Veterinary Drugs segment is fast emerging as a high growth potential area within Pharma and with few established   players. The Vet Pharma Industry not only has Big Pharma, but also several 
companies fully focussed on this space like Virbac. As per the article (link to the source article given), the burgeoning companion animal business (pets 'health) that generated about $8 billion in global sales last year. Another $14 billion in revenue came from medicines and vaccines for the global food animal market.  The research firm Global Industry Analysts predicted the world animal medication market will top $43 billion by 2018

No wonder we see activities back home in India, where Shasun is forming a JV with Sequent to develop Vet API & Formulations.

See Related Articles:

The Emergence of the Era of Biosimilars: The current Generics boom is expected to last uptil 2015 and one could question the growth opportunities for pharma companies beyond 2015. The next big opportunity for pharma, post the generics era seems to be with biosimilars. We may be nearing the end of the big blockbuster molecules from chemical synthesis and moving more & more towards biologics.

SuperGenerics is the new buzzword today and a number of companies are looking to develop products that have improved properties by way of efficacy, safety, stability etc. SuperGenerics are attractive today as it offers better commercial returns in the generic space where pricing & competition are quite severe. Infact companies, including Big Pharma are employing 'fusion' strategies from both Generics & Innovative products. We have had articles in the past which have talked about Big Pharma looking at revenues & growth from combining generics & innovative products, but this article also seems to falsify the myth that generics does not offer enough returns in comparison to innovative products. A very interesting article to read from Contract Pharma:
 Read This Interesting Article from Contract Pharma: Supergenerics & The Future of Pharma

K. Anji Reddy was not only the founder of Dr. Reddy's, but in many ways pioneered the development & the globalisation of Indian Pharma. During the 1980s, the Govt. owned Indian Pharmaceuticals & Drugs Limited (IDPL) where Dr. Reddy previously was employed was at that time the only organisation which that was well-equipped with personnel & labs that could do R&D in chemistry & pharmaceuticals. IDPL and Standard Organics (one of the 1st private companies established by Dr Anji Reddy) were one of the very first Indian Pharma companies that laid the foundation in the development of this industry in India, & is considered to be the 'mother' of all pharma companies in India.

In fact, Hyderabad as a pharma-hub developed only because of Dr. Anji Reddy's initial work with IDPL & SOL and his entrepreneurial capabilities. And also most pharma companies today in Hyderabad & the South India, would most-likely have some common origins or links to the erstwhile SOL or IDPL. In many ways therefore, I believe, the Indian pharma industry owes a lot to Dr. Anji Reddy, a pioneering entrepreneur, who has not only built a global company, but has developed an entire industry in India that is now globally recognised to be the third largest supplier of pharmaceuticals by volume in the world today.

We salute Dr. Reddy and will certainly miss him.

A possible deal of about ₹ 10K crores ($ 1.8 Billion) for Strides' Agila is an un-imaginably enormous amount for this injectables unit and highlights the growing importance of the injectables market. Solid Oral dosages are now passe, and pharma is slowly looking at areas with lesser competition, greater returns and with technological & regulatory barriers like derma & injectables.
The Agila valuations have only opened our eyes, but we have already seen a number of deals of-late in this space - Hospira/Orchid; Claris/Otsuka and now Agila. Point to note is even in India there are very limited players in injectables with regulatory approvals & ready dossiers, which explains the valuations that Agila seems to get.

            Contract Manufacturing Magazine, pegs the injectables market to grow at a whopping 42% and to $17 Billion by 2020.

Glenmark is probably India's most successful Pharma companies, in terms of innovative NCE research. Their recent announcement of a discovery of a monoclonal antibody for immune disorders speaks a lot about their capabilities in NCE research. Earlier they also signed a deal with Sanofi Aventis worth $613 Million for India's first biologic molecule. At a stage when most Indian companies target Generics to grow, Glenmark thinks differently and seems to succeed in their unique approach.

Interesting Articles & Reports on the Pharma Industry:
  • Generic Drugs & its Regulatory Processes - PDF File / PPS File
  • An Introduction to the API Drug Master File - PDF File / PPS File