Tag Archives: dreaded

Tracking MDG 6 in India – not a mean achievement to combat the dreaded disease

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At the turn of the new millennium, in 2000, 189 nations of the world under the banner of United Nations Development Program took a pledge to free people from extreme poverty and multiple deprivations.

This global pledge for humanity on eight key areas was termed as the ‘Millennium Development Goals (MDG)’, which the global community should achieve by 2015. Again in September 2010, the world reiterated its pledge to hasten progress towards achieving these goals within the same pre-scheduled time period.

Combating HIV/AIDS is the sixth of the eight MDGs that India, along with other 188 nations, is expected to achieve by 2015.

Looking Back:

Way back in late 1986, the first incidence HIV in India was diagnosed among the sex workers in Chennai. The origin of the infection was reported to be from the foreign visitors.

The National AIDS Control Organization (NACO) was constituted in the following year and by end 1987, around 135 persons were diagnosed as HIV positive and 14 were suffering from AIDS. Almost around the same time, a rapid spread of HIV was reported from within the ‘Injecting Drug Users (IDU)’ in Manipur, Mizoram and Nagaland. Incidentally, all these states have a common border with Myanmar.

According to the first joint survey conducted by UNAIDS and NACO in 2007, the number of people living with HIV in India was estimated between 2 million and 3.1 million. In 2009 this estimated number declined to 2.4 million.

As per the Government of India (March 1, 2011), there has been an overall reduction in adult HIV prevalence and HIV incidence (new infections) in the country. The estimated number of new annual HIV infections has declined by more than 50% over the last decade, from estimated 2.7 lakhs in 2000 to approximately 1.2 lakhs in 2009. Adult HIV prevalence at national level has declined from 0.41% in 2000 to 0.31% in 2009, although variations exist across the states.

Some actionable areas:

As reported by the National Aids Control Organization (NACO), ‘Injecting Drug Use (IDU)’ and sexual intercourse through homosexual route by some section of the male population have still remained the routes of transmission of HIV in different parts of India, which need to be addressed with a much greater detail.

In the North Eastern States, besides IDU, HIV prevalence among the Female Sex Workers (FSW) is increasing. This suggests a two-prong spread of the pandemic infection in the country.

Moreover, HIV prevalence within the women attending Ante Natal Clinics (ANCs) in North Indian states also needs to be addressed with utmost care.

HIV/AIDS and Drug Prices:

Pricing of HIV/AIDS drugs are globally a very sensitive issue. Currently, because of the availability of many generic drugs, intense competition between them and direct price negotiation for newer brands, there has been a declining price trend for many HIV/AIDS medicines in the developing countries, like India.

This situation has enabled about 5.25 million HIV positive persons from the developing countries to undergo treatment for the acquired infection.

In India, people living with HIV/AIDS have access to Anti-retroviral (ART) drugs, free of cost, through 292 ART Therapy centers and 550 Link ART Centers spread across the country.

As per the Ministry of Health (February 22, 2011), there is no gap between demand and supply of drugs for the HIV/AIDS patients in the country. About 3, 87,205 patients are on ART therapy through the above centers (2010).

Recently product patents for two key HIV/AIDS medicines namely, Lopinavir/Ritonavir and Atazanavir bisulphate were not granted by the Indian Patent Office giving reasons of ‘lacked inventive ingenuity’. Though, this is a patent law related legal issue, it has been hyped up as a ‘major victory for public health and access to affordable treatment’.

I hasten to add, despite this situation, all drugs used for the treatment of HIV/ AIDS are still not available at an affordable price to the poor, across the world.

Funding for HIV/AIDS treatment in India:

The Finance Minister of India in his Union Budget proposal for 2011-12 allocated a sum of Rs. 1700 Crore (around US$ 380 million ) as against an outlay of Rs.1435 Crore (around US$ 320 million) in 2010-11 for the treatment of HIV/AIDS.

Market Size of HIV/AIDS Drugs:

Current market size of HIV drugs is around Rs. 151 Crores  (around US$ 36 million) growing at 11% over the previous year. As per reported data, around 10 HIV drugs are now being marketed in India with 162 different brand names by over 30 companies including, Cipla, FDC, Torrent, Hetero, Sun Pharma, Lupin, Ranbaxy, Zydus Cadila, Natco, Alkem and GSK.

Globally Gilead, Abbott, Pfizer, GlaxoSmithKline, Merck and BMS are among the key manufacturers of HIV drugs.

The world market size for HIV Drugs is estimated to exceed US $15.5 billion by 2015. The key growth driver is still increasing disease prevalence in some countries of the world. Treatment of HIV/AIDS with cheaper Anti-retroviral (ART) drugs has transformed the treatment of this dreaded disease into a manageable proportion.

Unique initiative of UNITAIDS:

For diseases like HIV/AIDS, one school of thought leaders feel that the way forward to resolve such pricing issue is by putting in place an alternative system of ‘remuneration and reward’ to further R&D initiatives in the key areas of public health interest, globally.

Towards this direction, in 2009 UNITAID, an international institution against AIDS, TB and malaria, proposed the ‘Patent Pools’ concept. This system of ‘pool’ will hold licenses on various patented HIV/AIDS drugs, which the generic manufacturers will be allowed to produce at a much lesser price for the least developing countries of the world.

National Institute of Health (NIH) of USA has now become the first patent holder to license a HIV/AIDS drug Darunavir to the patent pool. It appears, the ‘Patent Pool’ initiative to be successful, voluntary participation of larger global pharmaceutical companies is absolutely critical, though many innovator companies may not find any significant commercial benefit within this system.

Will HIV Vaccine be the ultimate answer?

Still with so many newly infected people with HIV every day in various corners of the world, a suitable vaccine to prevent the infection would indeed be indispensable to effectively control this disease. An affordable HIV vaccine could thus be an appropriate answer to fight against HIV/AIDS across the world.

Early In March 2011, the International AIDS Vaccine Initiative (IAVI) and the Translational Health Sciences and Technology Institute (THSTI), of the Department of Biotechnology, Government of India announced together to fund an HIV vaccine design program in India. This HIV vaccine initiative is estimated to cost around Rs.50 Crore (around US$ 12 million) over a five year period.

Recent Developments:

Early this year, UNAIDS/WHO/UNDP launched a new policy brief urging countries to use IP flexibilities under the TRIPS Agreement.

The brief includes flexibilities like, compulsory licensing, parallel imports exemption of ‘Bolar Provision’ and highlights the success achieved in reducing prices in Brazil through the threat of compulsory licensing. The brief also highlights India’s 3(d) provision.

Conclusion:

In India, although the overall progress of MDG initiatives is not satisfactory just yet, ongoing intense efforts to control and treat HIV/AIDS seem to be paying good dividends.

It is interesting to note, UNAIDS ‘Outlook Report 2010’ highlights, “Up to 80% of the cost of treatment isn’t for the medication but for the systems to get it to a person and to keep him or her on it. Globally, only one third of people who need treatment are on it.” I reckon, the situation is no different in India.

By: Tapan J Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

India needs ‘Orphan Drugs Act (ODA)’ to counter growing threat of dreaded rare diseases and simultaneously boost global growth potential of the Indian Pharmaceutical Industry

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An orphan disease is a rare and uncommon disease and an ‘Orphan Drug’ is a pharmaceutical substance that has been developed to treat an orphan disease. The US FDA defines a rare disease, with a prevalence of 1 in 5,000 of the general population, whereas in the European Union (EU) defines it as a disease with a prevalence of 5 in 10,000 of the population.

Around 6-8% of the world population is manifested by such rare diseases. There are around 5000 of reported rare diseases with an ascending growth trend.

Despite such trend, high drug development cost coupled with low return on investment, do not encourage many innovator pharmaceutical companies to get engaged in R&D initiatives for such drugs. However, this perception is fast changing, as we shall see below.

US took the first step to encourage commercialization of ‘Orphan Drugs’:

Public awareness drives for ‘Orphan Diseases’ first originated in the USA with the formation of a rare disease support group representing around 200,000 patients suffering from such diseases. This awareness campaign ultimately culminated into a path breaking legislation in the US named, ‘Orphan Drugs Act’ (ODA), in 1983. The key purpose of ODA was to incentivize initiatives towards development of such drugs to treat around 25 million Americans suffering from ‘Orphan diseases’. The incentives included:

- Funding towards investigation for “Orphan Disease’ treatment
- Tax credit for Clinical Research
- Waiver of fees for New Drug Application (NDA)
- Offering more lucrative incentive than product patent (product patent requires the drug to be novel), as the orphan designation of the product by the US FDA and product approval by them are the only requirements for 7 year market exclusivity of an ‘Orphan Drug’ for the same indication.
- Market exclusivity of ‘Orphan Drugs’ become effective from the date of regulatory approval, unlike product patent, product development time remains outside this period.
- The drugs, which are not eligible for product patent, may be eligible for market exclusivity as an ‘Orphan Drug’ by the US-FDA

Thanks to this Act, currently around 230 ‘Orphan Drugs’ are available in the US for the treatment of around 11 million patients suffering from rare diseases. With the help of ‘Human Genome Project’ more orphan diseases are expected to be identified and newer drugs will be required to treat these rare ailments of human population.

1983 signaled the importance of ‘Orphan Drugs’ with the ODA in the US. A decade after in 1993, Japan took similar initiative followed by Australia in 1999. Currently, Singapore, South Korea, Canada and New Zealand are also having their country specific ODAs.

India needs ODA:

Unfortunately in India, we do not have any ODA, as of now. Such legislation could give a new fillip to the Indian Pharmaceutical and Bio-Pharmaceutical industry and at the same time usher in a new hope to thousands of patients suffering from rare diseases in India, with the availability of relatively lower cost medications to them.

The global market:

The global market of ‘Orphan Drugs’ is expected to grow to US $ 112 billion in 2014 from US $85 billion in 2009. Biotech products contribute around 70% of this turnover with relatively higher CAGR growth rate of around 7%. However, reluctance of the insurance companies to cover ‘Orphan Drugs’ due to higher price still remains a global issue.

Orphan drugs to create a paradigm shift in the Pharmaceutical Industry: says Frost & Sullivan:

“While the pharmaceutical industries have been focusing on ‘blockbuster’ small molecules (chemical drugs) for high revenue generation in the past, it is expected that in 5 years, around $90.0 billion worth of branded drugs will lose their exclusivity. The current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies and they are moving to a new business model – ‘Niche busters’, also called Orphan drugs.”

It is believed that Orphan drugs will now offer an attractive opportunity to the pharmaceutical companies than ever before to significantly absorb the impact of the ‘Patent Cliff’. Various financial incentives provided by the governments of various countries under the ODA coupled with many smaller collaborative projects towards this direction will further encourage the global pharmaceutical players to develop ‘Orphan Drugs.

Currently, EU has granted over 700 ‘Orphan Designations’ and over 60 new drugs have received favorable response for Market Authorization.

Sales potential for ‘Orphan Drugs’:

Generally ‘Orphan Drugs’ were not expected to be very high revenue earners. However, about 4 year ago in the year 2006, about 50 ‘Orphan Drugs’ were reported to had crossed a sales turnover of US $200 million. In 2006 the following ‘Orphan Drugs’ with expired market Exclusivity in the US, had assumed blockbuster status:

- Enbrel (Immunex): US $ 4.38 billion
- Rituxan (Genentech): US$ 3.97 billion
- Nupogen/Neulasta (Amgen): US $ 3.92 billion
- Epogen (Amgen): US $ 2.50 billion
- Avonex (Biogen): US $ 1.70 billion
- Betaseron (Novartis & Bayer): US $ 1.33 billion
- Intron A/ PEG-Intron (Schering): US $ 1.07 billion
- Kogenate (Bayer): US $ 1.07 billion
- Ceredase/Cerezyme (Genzyme): US $ 1.00 billion

Key growth drivers for ‘Orphan Drugs’:

In my view the following key factors will play critical role in driving the growth for ‘Orphan Drugs’:

- Market exclusivity options for a number of FDA recognized ‘Orphan Indications’ for the same drug
- Market exclusivity for seven years in the U.S. and ten years in the EU for each of the ‘Orphan Indications’
- Oncology could be a good segment to get such multiple ‘Orphan Indications’ for the same molecule

Glivec of Novartis obtained approval for around five new ‘Orphan Indications’, the key indications being Chronic Myelogenous Leukemia (CML) and Gastrointestinal Stomal Tumors. The product has already assumed a global blockbuster status with an estimated sales turnover of over US $4 billion by 2011.

Biotech companies are champions for the development of ‘Orphan Drugs’, globally:

Since long, the Biotech companies are taking initiatives for the development of ‘Orphan Drugs’. The path breaker in this respect was Genentech of the US, which developed two growth hormone molecules with names Protophin and Nutrophin, way back in 1985. Now, having realized the hidden potential of this segment more number of pharmaceutical players are entering into this arena. Thus, it is no wonder that 13 out of 19 blockbuster ‘Orphan Drugs’ were biologics in the year 2006.

Conclusion:

It is interesting to note that some of the ‘orphan diseases’ are now being diagnosed in India, as well. As India takes rapid strides in the medical science, more of such ‘Orphan Diseases’ are likely to be known in our country. Thus the moot question is how does India address this issue with pro-active measures?
Currently, India is curving out a strong niche for itself in the space of biogenerics. Pfizer-Biocon deal will vindicate this point.

Moreover, with Pharmacogenomics keep gaining ground at a faster pace, as I mentioned earlier, there will be a shift towards personalized medicines, in not too distant future, in which case the blockbuster drugs as defined today, will be effective only for a smaller number of patients. If the Government of India visualizes this scenario sooner, and comes out with appropriate ODA for the country, domestic pharmaceutical industry of India, in general and biopharmaceuticals industry of the country, in particular, will be able emerge as a force to reckon with, in this important global space, much faster than what one would currently anticipate.

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.