Biogenerics: Future perfect

They are called biogenerics, and much like their counterparts in the pharmaceutical domain, they are simply biologics (biotech products; human insulin, for instance, is one) that go off patent. Estimates suggest that the size of this market could be around $12 billion (around Rs 55,200 crore) by 2010, although some executives at India's biotech majors believe this number is conservative (they prefer the $20-billion, around Rs 92,000-crore, estimate). Given their expertise in areas such as recombinant technology, fermentation and mammalian cell technology, Indian firms such as Biocon and Wockhardt are well placed to benefit from this boom. As are other firms such as Bharat Biotech, Shantha Biotechnics, Panacea Biotech and Dr. Reddy's. Indian firms, says Biocon CEO Kiran Mazumdar-Shaw, need "to focus on documentation, characterisation and validation to make products acceptable to regulatory authorities". And much like Indian pharma companies, they had better learn to navigate the global legal circuit.

-E. Kumar Sharma

BEST PRACTICES
Crude Collection

As is the case in another fast-growth industry (think: credit cards), India's telecom operators are discovering a flip side to accelerated growth: bad debts. And taking a leaf from the approach of credit card companies, the telcos have outsourced their collection woes. "The collection agencies are common to telecom operators and credit card companies," says an executive at one telco. "In fact, one parameter employed while choosing an agency is the existing customer profile." Here is how the process works: collectors are paid between 2.5 per cent and 7 per cent of the default amount, depending on the age of the debt (the older the debt, the greater the cut). And, as the marketing head of one cellular company admits, everyone is aware that the collectors use a graded system of threats. A Delhi-based subscriber of Tata Indicom got up close and personal with what must be one extremity of this gradient when a collector threatened to molest his wife. His complaint to the company evoked a contrite apology (although the same company chose not to respond to this correspondent's queries), but fact is, as a spokesperson for a rival telco says, "We are not accountable as per the law in any case (that may arise from such threats)." Now, that's total outsourcing!

-Priyanka Sangani

MEASURE
Monsoon Math

» Number of meterological sub-divisions in India: 36

» Number of divisions that registered deficient rainfall (between 20 and 59 per cent lower than average): 13

» Number of divisions that registered scanty rainfall (over 60 per cent lower than average): 0

» Number of divisions that registered excessive rains (over 20 per cent higher than average): 0

» Number of divisions that registered normal rainfall (between 20 per cent lower and 20 per cent higher than average): 23

OUR TAKE: Not so bad after all
Figures are for the period between June 1 and September 29, 2004

Trials By Fire
Indian pharma is making steady progress in R&D, but don't expect that magic pill any time soon.

Gienmark Pharma's CEO Glenn Saldanha: Shedding inhibitions

First the good news: some of India's finest pharma firms are getting a move on in their quest to discover a new drug, or a new chemical entity (NCE). Right from the industry's pioneer in research, Dr. Reddy's Laboratories, to a relatively new kid on the R&D block, Glenmark Pharma, domestic drug firms have done well to move molecules out of pre-clinical trial phases into the clinical phases.

So, it shouldn't be too long before an India drug major rakes in billions of dollars with a new blockbuster, right? Not quite. The global failure rate is a little over 40 per cent at the pre-clinical stage, rising up to 50 per cent during Phase I, going up further to 70 per cent in Phase II and reducing somewhat to 47 per cent by Phase III. Point to note of course is the 70 per cent failure rate in the second phase, which a few Indian drug firms have squeezed into, and most have yet to reach.

That high rate of failure makes for an even grimmer picture when you bring in decreasing R&D productivity-investments in R&D across industry have shot up eight times to $80 billion (Rs 3,68,000 crore) since 1991-yet the pipeline is as full (or as empty) as it was 14 years ago. Indian pharma in that light appears to be making enviable progress with the paltry millions it spends every year on drug research. Still, Indian firms have little choice but to out-licence development work to their multinational counterparts, who are better-versed with regulatory processes, clinical trials and registration procedures (across nations). The latest such agreement is Glenmark's with Forest Labs of the United States, which will develop the Indian company's oral pde4 inhibitor molecule and commercialise it in North America. Glenmark hopes to earn milestone payments of $190 million (Rs 874 crore) via this deal. Plum deal? Don't forget those failure rates, which are even higher for pde4 inhibitors, Merck's suspension of development in Phase II last year being just one recent setback. Failure, though, will always be a constant companion in drug research, and for Indian pharma there's no turning back in its quest for the magic pill.

-Brian Carvalho, with Supriya Shrinate and E. Kumar Sharma

THE GREAT INDIAN R&D GAMBIT

Ranbaxy: 8-10 NCEs in pipeline. Molecule for benign prostrate hyperplasia
licensed out to Schwarz of Germany for Phase II trials in Europe. Received upfront payment of $6 million (Rs 27.6 crore), another $4 million (Rs 18.4 crore) milestone payment in June 2004

Dr. Reddy's: Three compounds in clinical development, four at pre-clinical stage. Phase II trials completed on insulin sensitiser licensed to Novo Nordisk. Phase II trials on cancer molecule on in India. Phase I trials for dyslipidemania on in Canada

Wockhardt: Two anti-infective chemical entities in Phase I clinical trials

Biocon: Commenced Phase II trials on antibody for treatment of head and neck cancers

Sun Pharma: One molecule currently in Phase I trials in Europe, two novel drug discovery systems (NDDS) will enter trials by year-end; will possibly seek partner after Phase II

Glenmark: Oral PDE4 inhibitor molecule will enter Phase I clinical trials in the UK. Agreement with Forest Labs of the US for development of this molecule (and commercialisation in North America). Hopeful of payments worth $190 million (Rs 874 crore) totally

Lupin: In September filed investigational new drug application (INDA) with Drug Controller General, India (DCGI), for psoriasis. Recently filed INDA for treatment of TB with DCGI after extensive pre-clinical studies

Nicholas Piramal: Focus on cancer, diabetes, inflammation and anti-infectives. Lead molecule in oncology on track to enter Phase I trials by year-end