Wockhardt to double EPO capacity ...eyes EU markets

Ananth Iyer - Mumbai

Pharma major Wockhardt Ltd is doubling erythropoetin (EPO) production by adding fresh capacities at its new biotech park in Aurangabad, a senior Wockhardt official told Express Pharma Pulse. The expansion is primarily targeted to tap regulated markets, as Wockhardt officials say existing EPO capacity is more than sufficient to cater to the domestic demands. Wockhardt is also readying a typhoid vaccine for launch in 2003-04 financial year, it is learnt.

Without being specific, a Wockhardt spokesperson confirmed saying that the company “plans to set up new capacities for all its products at the biotechnology park coming up at Aurangabad.”

Wockhardt has capacities to cater to 1.5 times the current domestic demand, company officials say. According to market research estimates, Wockhardt enjoys the number three position in the Rs 34 crore EPO market in India - the top two being J&J and Roche. This means that Wockhardt is presently utilising only a fraction of its existing EPO capacity.

Clearly, the expansion is aimed at exports. Company officials say there is great amount of interest in tapping the EU market, which, according to Wockhardt management, looks easier to make inroads compared to the regulatory firewall it will have to face to get its EPO brand approved in the lucrative US market.

Wockhardt’s game plan, say company officials, is to make inroads into the EU through UK. The company plans to leverage the marketing infrastructure and goodwill of Wallis Laboratories -- an UK-based company Wockhardt acquired in 1999 -- to do so. Company officials also say that Wockhardt plans to register its EPO version in the UK by the end of 2003-04 financial year, which, biotech analysts believe is an ambitious target considering the stiff opposition the biogeneric players face from innovator companies.

However, analysts say that traditionally, on the biogeneric approval process debate, EU regulatory authorities have been more flexible compared to their West Atlantic counterparts. Wockhardt’s hope hinges on the more liberal position taken by EU regulators on biogeneric approval process in the last couple of years. One of the major contention today on the biogeneric approvals is whether the inherent heterogeneity and complexity of macro-molecular biologic pharmaceuticals means that pharmaceutical and bio-equivalence can only ever be demonstrated through full clinical trials. Innovator companies contend that comparability-based studies are acceptable only for the drug originator as only they can truly understand a biological process and product, and only they have access to all the relevant manufacturing history. In other words, they stress that analytical specifications alone are certainly not sufficient for the effective control for the manufacture of biogenerics.

But biogeneric manufacturers say that there is little real difference in the issues of comparability and equivalence between and within companies. And they are quoting the European CPMP Guidance Notes on Comparability for Biotech Products for support. There seems to be some sort of broad consensus among prospective biogeneric manufacturers on what could be the regulatory framework for biogeneric approval process and that is it definitely cannot be through the ANDA route as is the case for generic drugs. There is an agreement that animal efficacy, human safety and pharmacokinetic studies would likely be required with some abridged human trial programs.

The European generic market (including biopharmaceuticals), according to a report by Urch Publishing, will account for 75 per cent of all prescriptions in Western Europe and the market will reach from USD 12 billion in 2002 to USD 21 billion in 2007. The key drivers of growth would be increasingly aged population, cost-containment by national governments, R&D firms opting out of generic industry, patent/exclusivity expirations, introduction of generic brands, industry expansion through new high priced innovative drugs, generic biopharmaceuticals and EU enlargement, the report says.

Having said that, biotech analysts maintain that the going would not be easy despite several factors favouring biogenerics. Privately, they point out to the events in the last couple of months, mainly the controversy involving erythropoetin, which has alarmed EU regulators. The EU reconsideration on the biogeneric approval process came to the fore in the recent EU conference. Dr Crawford Brown, CEO and co-founder of Eden Biopharm Ltd, who attended the conference, said, “It is clear that generics for biologicals will not be similar to chemical entities and that the US FDA is of the same opinion as Europe. Also, current regulations are going to change only by political intervention. Therefore, this means, biogenerics need to undergo extensive preclinical evaluation, clinical studies to GCP, chemistry packages that must be at least as good as the originator product but probably better and they would not come cheap.”

ananth_iyer@mailcity.com