Sep 21, 2005|
Pharma: New drug wonders!
Until January 2005, since India had recognized process patents, it resulted in domestic pharma companies becoming an expert in 'reverse engineering' of products. However, a major development took place in the Indian pharmaceutical market, when the product patent law was introduced with effect from January 1, 2005. This means that domestic majors will have to focus on new drug discovery research in the long term if they want to benchmark themselves against the global pharma majors. In this article, we take a look at what Indian companies are doing on the drug discovery front.
On the discovery of a molecule, the US FDA grants a patent for the molecule for a period of 20 years. New drug discovery involves various steps, which starts with the building up of a new molecule. This is followed by synthesis of the molecule and the conduct of pre-clinical testing (laboratory and animal). After this, the molecule enters the clinical trials stage, which comprises of 3 phases - I, II and III. In Phase I, studies are conducted on around 20 to 80 healthy volunteers to determine safety and dosage. In Phase II and III, a larger patient population is enrolled for the purpose of determining efficacy and side effects and also to monitor the adverse reactions of long-term use. After successful conduct of these trials, a pharma company applies for US FDA approval followed by additional post-marketing testing.
| What does new drug discovery involve?
This entire process takes around 10 to 12 years of the patented life of the molecule. Which means that the remaining 8 to 10 years of the patented drug is called the 'commercial life' of the drug. Investment in launching a new product could be anywhere between US$ 400 m to US$ 800 m.
In the global pharmaceutical market, pharma behemoths such as Pfizer, GlaxoSmithKline, Sanofi-aventis etc. have been the pioneers in new product launches, which has resulted in them being labeled as 'innovators'. It must be noted that patented products enjoy a significant premium in terms of pricing, which more than makes up for the costs involved in drug discovery. Blockbuster drugs for instance generate revenues to the tune of US$ 1 bn annually. This translates into US$ 10 bn for the 10 years of its commercial life during which it enjoys a patent, compared to around US$ 800 m that is incurred on research!
As far as the top 10 products in the global pharmaceutical market are concerned, Pfizer, the largest pharma company in the world, leads the pack with 2 blockbuster drugs 'Lipitor' (US$ 12 bn in revenues in CY04) and 'Norvasc' (US$ 4.8 bn in revenues in CY04) under its belt. Other products in the top 10 include Merck's 'Zocor' (US$ 5.9 bn in revenues in CY04), Sanofi-aventis' 'Plavix' (US$ 5 bn in revenues in CY04), Eli Lilly's 'Zyprexa' (US$ 4.8 bn in revenues in CY04) amongst others.
Domestic pharma majors such as Ranbaxy and Dr.Reddy's have been the forerunners as far as drug discovery research in India is concerned. Currently, Dr.Reddy' has 5 molecules undergoing Phase I and Phase II clinical trials. These are in the areas of oncology (anti-cancer) and metabolic disorders. Ranbaxy meanwhile has 2 molecules in Phase II clinical trials - its bronchial asthma molecule RBx 7796 and its Urology-BPH molecule RBx 2258.
Wockhardt has also identified new drug discovery as one of its growth drivers going forward. The company currently has 5 molecules in the pipeline in the anti-infectives segment, including its molecule WCK 771 undergoing Phase II clinical trials. Nicholas Piramal's anti-cancer molecule recently entered Phase I clinical trials. All these initiatives could translate into potential revenue generators in the long term.
Despite the initiatives taken by the domestic pharma industry on the drug discovery front, it is early days yet. A new patented drug from a domestic pharma company's stable will probably not see the light of day for the next 4 to 5 years or so. Also, a domestic pharma company may not have the resources to conduct the clinical trials all the way through, keeping in mind the cost involved. This means that they will have to rely on out-licensing the molecule to a global pharma major. However, despite hiccups, domestic companies have to be acknowledged for taking major strides in the area of new drug discovery. Though not in the medium term, efforts by these companies could turn into global opportunities in the long term.
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