Biotech Values

[DewDiligence]

Stricter Rules on ‘Similares’ Lure Pharma to Brazil

[Brazil is perhaps the “purest” pharmaceutical market among any of the world’s major countries in the sense that almost all drugs are paid for by users rather than government or other third parties. The expanding middle class has created a robust market for branded generics, which has been the impetus for recent deals by such companies as SNY and PFE (#msg-36917487, #msg-55730816).

The main thrust of this article — that Brazil is phasing out the use of low-quality generic drugs that are paradoxically called “similares” — was noted in #msg-48743492.]

http://www.ft.com/cms/s/0/b16ac1e0-edfe-11df-8616-00144feab49a.html

›By Andrew Jack
November 14 2010 23:31

Three decades after they quit Brazil, western pharmaceutical companies are rushing back to expand and make acquisitions, just as domestic groups begin to consolidate and spread abroad.

In the 1980s, many multinationals left, driven out by high inflation, tough price controls, and weak intellectual property rules [not to mention a military dictatorship].

They signed distribution deals with local companies, but also saw market share taken by “similares” – drugs containing ingredients similar to original products but often without rigorous testing to demonstrate they are identical in composition and effect.

Now the environment has changed. Since the mid 1990s, patent rules and regulatory requirements for generic drugs have become stricter.

A tougher attitude by Anvisa, the national drug regulator, has imposed “bioequivalence” measures; while new auditing requirements are reducing the discretionary ability of pharmacies to sell prescription drugs or substitutes over the counter.

Such measures are likely further to reduce the scope for similares by 2013, as a clearer distinction between patented and generic products – already familiar in the west – emerges.

The changes are luring western companies back, just as growth in their established more developed markets is slowing and they see the need to expand geographically to maintain momentum.

While sales are coming largely without any reimbursement from state or private health insurance, the rapid growth in the middle class – and the increasing number of pharmacies to meet demand – is stoking expansion that has turned the country into the eighth-largest drug market in the world by sales.

With the authorities keen to encourage domestic production, Novo Nordisk was an early mover with its purchase in 2001 of Biobrás, a large insulin production plant outside São Paulo.

A more eye-catching recent buying spree began last year when Sanofi-Aventis of France acquired Medley [#msg-36917487], boosting its portfolio of over-the-counter and branded products to complement its own innovative and “mature” offerings.

Last month, Pfizer of the US bought 40 per cent of Teuto, another generics business [#msg-55730816]; and other US, European and Japanese companies are studying the market closely.

Some have so far held back from acquisitions, but are investing internally: AstraZeneca, for example, is gearing up for the launch of a series of products combining its own drugs with others that are already off-patent.

Meanwhile, national groups have not been dormant. Aché, a family-owned group and one of Brazil’s largest branded generics producers, has made smaller domestic acquisitions, and was considering buying Medley.

It has also begun forging alliances across Latin America, while its rival Eurofarma earlier this year bought Laboratorios Gautier in Uruguay, as the groups seek economies of scale in manufacturing and sales across the region.

Even Farmaguinhos, the state-owned drug company, has been co-operating with Mozambique.

Domestic research and development still remains in its infancy, although government research units such as the Butantan Institute in São Paulo and Oswaldo Cruz in Rio de Janeiro are involved in international scientific collaborations and technology transfer.

The question is whether their commercial peers will be able to take up the slack before they are acquired by western groups keen to return to Brazil.

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SIDEBAR: List of best-selling drugs gives picture of nation’s health worries

Brazil’s list of top-selling drugs reveals much about national preferences and the state of the healthcare sector alike.

Two “lifestyle” drugs – Viagra and Cialis for erectile dysfunction – are among the leading 10 products sold, outstripping their popularity in many other countries, according to data from IMS, the healthcare consultancy.

The more familiar high-ranking presence of Lipitor and Crestor to lower cholesterol and Diovan to reduce blood pressure highlight how far infectious diseases have been displaced as a heavy healthcare burden. Their place has been taken by chronic “lifestyle” conditions – only too familiar in western countries – that affect the wealthier but ageing population.

Other patented drugs that would typically be among the top-sellers in many countries are absent. That reflects restricted access in Brazil to more costly innovative therapies, because few drugs are reimbursed by the state or even private insurers. Most are bought “out-of-pocket” by patients.

The best-selling product on the IMS list is Dorflex, an over-the-counter muscle relaxant and painkiller; Neosaldina, a similar product, and paracetamol, are also among the top 10.

The first two both contain metamizole, which is not used in other countries, including the US, where it was banned long ago because of a rare side effect called agranulocytosis – where the body does not make enough white blood cells.

Sanofi-Aventis, which makes Dorflex, stresses that Latin American regulators have reviewed the drug and considered the benefits outweigh the risks.

Not that the IMS numbers are perfect. Like those in other emerging markets, the data cannot always pick up the nuances of a fragmented system that includes substantial over-the-counter sales of drugs which are officially available on prescription only.‹