The eternal orphan

August 28, 2008

Implemented in 1983, the basic intent of the US Orphan Drug Act (ODA) was to stimulate research, development, and approval of products that treat rare diseases. “In the US, these diseases are defined as those which affect less than 2,00,000 patients or those for which cost of development is unlikely to be covered through commercialisation. ‘Orphan drugs’ are thus used for rare diseases for which there is an unmet medical need,” says Dr Chandrashekhar Potkar, Director-Medical and Regulatory Affairs, Pfizer. Examples of these diseases include severe combined immunodeficiency syndrome, cystic fibrosis, hairy cell leukaemia etc. Malaria and tuberculosis also are orphan indications in the US. The concept of orphan drug in the US, apart from covering pharmaceutical or biological products, also covers medical devices and dietary or diet products.

“There is limited commercial opportunity for such drugs. However, research based pharma companies are able to apply their R&D expertise in partnership with government and other medical institutes for orphan indications with unmet medical needs,” Potkar adds. Government provides incentives for sponsors undertaking research on orphan indications. These incentives can take form of tax credits for clinical research expenditure, grants in aid for clinical research, design assistance for investigating orphan indications (eg. open protocols for enrolling patients) and seven year market exclusivity. But the definition of orphan drugs and diseases and the incentives attached to them may vary in different countries depending on the prevalence of diseases there and the respective population strengths.

It is the enforcement of this very Act that encouraged other countries, including European Union (EU), Australia, Japan and Singapore to follow suit. So what is stopping India from adopting a legislation similar to the Act? Potkar says that this may be due to the fact that our current legislation is focused on strengthening R&D in India.

Dr Syamala Ariyanchira, author of BCC Research‘s Global Markets for Orphan Drugs report, opines, “Considering that there are next to none pharma companies in India manufacturing or researching orphan drugs to my knowledge, there will be no incentives for them. However, in 2001, a group of pharmacologists at an Indian Drug Manufacturing Association (IDMA) conference had appealed to the Indian Government to form something akin to the Orphan Drug Act. But I have not heard of any kind of development in this context since then.”¹

¹Aashruti Kak; Express Pharma

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Mallinckrodt and Rubicon to develop PanExcea

August 21, 2008

CRO Rubicon Research and chemicals manufacturer Mallinckrodt Baker are teaming up to develop the PanExcea excipient range, which was launched by the latter firm’s parent company Covidien in July.

The current expansion of the pharmaceutical excipient sector, which a BCC Research report estimated would grow to $4.3bn (€2.8bn) by 2011, suggests that drugmakers are beginning to focus on this aspect of product development as an effective means of controlling development expenditure.¹

¹Outsourcing-Pharma.com

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Growing Role of Nanotechnology in Medical Devices

August 13, 2008

To the surprise of no one, the med-tech industry is finding that there is, still, plenty of room at the bottom, to paraphrase physicist and nanotechnology pioneer Richard Feynman. The global medical market for nanotechnology applications accounted for approximately US$1.7 billion in 2007. The vast majority of this revenue–nearly 90%–was generated by pharmaceutical applications. In the years ahead, however, nanotechnology applications in the medical device arena are forecast to surge, while its use in drug-related activities contracts. Those are some of the findings of a report titled Global Medical Markets for Nanoscale Materials and Devices.

BCC Research, which will issue the report this month, predicts that the use of nanotech-related materials, tools, and devices will attain a compound annual growth rate between 14.9% and 19.9% by 2018, potentially generating US$9.4 billion in revenue. By that time, the report predicts that pharma will account for 51% of the medical share of nanotech applications, whereas medical devices and medical research may account for as much as 20% each.¹

¹MedTech Insider; Norbert Sparrow

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Eastman launches controlled-release excipient

July 17, 2008

A new excipient could help drugmakers improve the delivery profiles of active pharmaceutical ingredients (API), according to US developer Eastman Chemical.¹

¹OutsourcingPharma.com

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DNA Vaccine Development Making Strides

July 9, 2008

While traditional antigen-based products will continue to dominate the sector, the benefits offered by DNA vaccines in terms of minimized side effect profile make any successful technology an attractive proposition.¹

¹Gareth Macdonald; In-pharmatechnologist.com

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Global Market For Pharmaceuticals Worth More Than $1 Trillion By 2013

June 30, 2008

According to a new technical market research report, GLOBAL PHARMACEUTICAL MARKETS (PHM037B) from BCC Research, the global market for pharmaceuticals was worth $693.6 billion in 2007. This is expected to increase to $737.6 billion in 2008 and reach over $1.0 trillion in 2013, a compound annual growth rate (CAGR) of 6.9%.

The market is broken down into applications of branded prescription drugs, generic prescription drugs and over-the-counter (OTC) products. Of these, branded prescription drugs have the largest share of the market. Worth an estimated $525.1 billion in 2007, this segment is expected to grow to a value of $553.2 billion in 2008 and $741.5 billion by the end of 2013, for a CAGR of 6.0%.

The second largest segment, generic prescription drugs, will experience the highest growth rate over the study period. Worth $78.5 billion in 2007 and an estimated $88.7 billion in 2008, it will reach $151.4 billion by the end of 2013, for a CAGR of 11.3%.

The OTC segment was worth over $90.0 billion in 2007. It should increase to $95.7 billion in 2008 and reach $135.1 billion in 2013, for a CAGR of 7.1%.

Though the worldwide pharmaceutical industry remains one of the most profitable and stable industries, several variables are influencing fundamental changes in its structure including increasing examples of government-imposed price reductions in pharmaceutical prices, the increasing role of generic substitutes, and enhanced outsourcing, in-licensing, contract research and manufacturing activities.

Increased health awareness amongst patients and governments, changing world demographics, declining R&D productivity, worldwide compliance of general agreements on tariffs and trade (GATT) and trade related intellectual property rights (TRIPS), along with the emergence of e-pharmaceuticals also are reshaping the dynamic pharmaceuticals industry.¹

¹BCC Research

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BASF signs up to USP certification scheme

June 23, 2008

BASF’s drug excipient manufacturing site in Geismar, Louisiana in the USA has been accredited under the US Pharmacopoeia’s (USP) voluntary certification scheme. ¹

¹Gareth Macdonald, In-pharma Technologist.com

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