Ethical Pharmaceuticals

Best wishes for 2007 from all of us at IPMed.

While we have been on a brief break, an important development in the campaign on access to medicines and needs-based research has been announced.

Professor Sunil Shaunak, Imperial College, and Professor Steve Brocchini, of the School of Pharmacy, University of London, have announced a new model of development and delivery, which they call "ethical pharmaceuticals." The researchers claim that by altering the molecular structure of essential expensive drugs, such as the drug for Hepatitis C, they will be able to develop and market a cheaper alternative, without infringing the original patent or involving pharmaceutical firms. Indeed, pharmaceutical companies have been relying upon such "second generation" innovation to extend the life of a profitable drug before the expiration of patent protection.

With Dr Mire Zloh of the School of Pharmacy, the researchers haved worked to improve the availability and lower costs of existing treatment for Hepatitis C. Dr Zloh has identified the interdisciplinary approach in the research as one of the key factors towards paradigmatic shifts and important developments towards the model for ethical pharmaceuticals. The Schering-Plough drug used to treat Hepatitis C is called PEG-Intron (PEGylated interferon), which means it has a polyethylene glycol (PEG) side-chain on the interferon molecule. The researchers are still using a pegylated interferon but, from the reports, have discovered a way of locating an additional side-chain (second generation pegylation) elsewhere on the molecule. This achieves a more pure modified interferon much more cheaply, effectively creating a "new medicine" that is not protected by the patent. However, the industry has suggested that such drugs will still require safety trials and may potentially result in "a huge intellectual property issue."

PolyTherics (Imperial College spin-out company) was developed to build upon the work of Shaunak and Brocchini, and has teamed with the Indian company, Shantha Biotechnics. In this way, Shaunak and Brocchini will be able to develop and market the TheraPEG without selling publicly funded research to "big pharma" to take to market. Speaking to the BBC, Professor Shaunak said, "We in academic medicine can either choose to use our ideas to make large sums of money for small numbers of people, or to look outwards to the global community and make affordable medicines."

Biologics - What's in a Name?

The World Health Organization (WHO) Expert Committee on Biological Standardization will meet at the end of this month in Geneva and will consider, among other issues, whether generic biotech drugs can carry the same clinical name or nonproprietary name as the brand-name drugs. Biotech drugs - also known as biologics or biopharmaceuticals - are some of the most expensive products on the market and form part of the arsenal against HIV/AIDS, cancer, and diabetes.

The WHO has established Guidelines on the Use of International Nonproprietary Names (INN) for Pharmaceutical Products, The WHO Programme on INN released a Review in June this year, which noted that INNs have not been assigned to blood biologicals and immunoglobulins, but have been used for some fusion proteins, gene therapy products, and transgenics. Skin substitutes are considered outside the system and vaccines are also currently not included in the system. However, the Expert Committee on Biological Standardization has made recommendations resulting in the assigning of some names.

In a recent report in The Independent, Danny Fortson describes political pressure for large-scale production of generic biotechnology drugs as a "fresh financial threat" to the pharmaceutical industry. But many commentators are concerned that this perceived "threat" is really simply an anxiety over protecting de facto monopolies in biological medicines. Such political pressure in the US comes recently from a new US Bill, aiming to improve access to lower cost drugs in the important area of pharmaceutical development.

US politicians, Representative Henry Waxman (of the Hatch-Waxman Act, establishing a system for generic drug approval in the US), and Senators Charles E Schumer and Hilary Clinton, have introduced the new bill, known as the "Access to Life-Saving Medicines Act." The aim is to establish procedures to facilitate approval of generic versions of biotech drugs. The press release notes the absence of statutory procedures for biotech drugs, leading to the potential problem of indefinite monopoly pricing, despite the expiration of patent protection.

The Bill has been strongly supported by the Generic Pharmaceutical Association (GPhA), which has stated "Introducing competition into the biopharmaceutical field would also yield tremendous cost savings for consumers ... We applaud Rep. Waxman and Senator Schumer for their true leadership."

Meanwhile, industry associations have maintained their objections, arguing that complex biopharmaceuticals cannot be copied in ways similar to traditional medicines, and so the application of traditional approval routes will not be appropriate. For instance, the VFAbio (Biotechnology within the German Association of Research-Based Pharmaceutical Companies) has urged that "such generics cannot exist."

In January 2006 the European Medicines Agency (EMEA) adopted its first positive opinion for a biosimilar, when it declared Omnitrope (Novartis) to be comparable to Genotropin (Pfizer), for which market authorisation was granted by the Commission in April (Omnitrope was later approved by the Food and Drug Administration (FDA)). In April the EU finalised its policy and legal framework for biosimilars when the EMEA adopted guidelines on the approval process for similar biological medicines.

However, the consultation on the draft guidelines attracted similar arguments, with the European Association for Bioindustries (EuropaBio) in its submission arguing that the application of the term "comparability" (from traditional manufacturing processes) to the biotech medicinal product is inappropriate. Similarly, the submission of Emerging Biopharmaceutical Enterprises (EBE) (European Biopharmaceutical Enterprises) emphasised that "Because no two cells are exactly alike, each biological medicinal product is distinct and cannot be copied exactly by a different company," while the Biotechnology Industry Organization (BIO) noted in its comments that "in important respects all protein products are unique, that each must be treated as such, and that tests performed by an innovator to demonstrate quality, safety and efficacy of its own product may not be relevant to a claimed-similar product." But Greg Perry, Director General of the European Generic Medicines Association (EGA) stated at the Biosimilars conference in London, that "The current level of biological science and recently enacted pharmaceutical legislation in Europe mean that the next generation of affordable medicines is no longer a distant dream, but rather a soon to be realised reality."

The EGA will be holding the 5th Annual Symposium on Biosimilars, "Biosimilar Medicines: Off the Starting Blocks," in London, May 2007. More details will be available early next year.