Saturday, May 26, 2007

 

Weight loss pill Rimonabant

Businessworld

Gauri Kamath



India is getting fatter. While estimates vary, it is widely accepted that genes, diet and a sedentary lifestyle are making more Indians overweight than before. New Delhi’s Nutrition Foundation of India suggests that 29 per cent of urban India’s adult male population (roughly three out of 10) is overweight. The number for women is higher at 45 per cent.

This mirrors the global trend and is seen as one reason behind India’s dubious rise as the diabetes capital of the world. According to the World Health Organisation’s fact sheet on obesity and overweight, the likelihood of developing Type 2 diabetes and hypertension rises steeply with increasing body fatness. It points out that India and the Middle-East are set to have the highest number of diabetics by 2025.

The good news is that more Indians are now trying to lose their extra kilos, which is evidenced in the explosion of fitness clinics and brown bread vendors in the market. And if developments in the past couple of weeks are any indication, decibel levels on cutting flab will only rise in the following months.

Sales people at some of India’s leading drugmakers are fanning out across the country to promote a new weight-loss pill to doctors. The medicine, rimonabant, works on what an executive in one company calls the ‘pleasure centre’ in the brain. The result is a decreased craving for food. Torrent Pharmaceuticals in Ahmedabad claims that it has tested rimonabant on over 200 volunteers weighing 90 kg on an average in the country’s hospitals. It saw an average weight reduction of 6-8 kg in the first few weeks, it claims. Zydus Cadila Healthcare, another drug company in the same city, announced its own brand of the medicine the same day as Torrent. “We are getting news of prescriptions from all over,” claims Ashok Bhatia, senior vice-president, Zydus Cadila.

There are other weight-loss medicines in the domestic market. But companies say that rimonabant works better and has fewer of the side-effects such as diarrhoea and high blood pressure that others cause. In fact, so much store is being set by this product that it is expected to almost single-handedly drive sales for the anti-obesity pills market to over Rs 100 crore by 2010 from a relatively paltry Rs 23 crore now, according to Ruchir Modi, vice-president (marketing), Torrent. More drug companies are expected to market this pill by then.




There is a caveat. Depression is the known side-effect that the medicine could cause. Shah says he does not intend to prescribe it to patients for long periods of time until there is more long-term safety data. Plus, it is not a replacement for diet changes and exercise, warns Shah. “Patients will be thrilled when they hear of this pill, but good lifestyle is more important,” he says. The companies also say that rimonabant is most effective when used along with change in food habits and exercise.

In fact, many still believe that medicines are only a quick-fix and that lifestyle change is long-lasting. “I would never recommend medicine for weight loss,” says Veena Aggarwal, senior vice-president (R&D and technical operations), VLCC, a Gurgaon-based chain of weight loss and beauty clinics. Aggarwal’s team has 26,000 people under its care over 100 centres across India and the Middle East. Aggarwal, who hasn’t heard of rimonabant, says that many of her clients have tried other weight-loss medicines but regained their weight when taken off it. “We use a holistic approach, there has to be lifestyle modification,” she says. Chakrabarti of SaharaOne also believes that losing weight sans medicine intake is the unique selling proposition of Biggest Loser…. “This is what has made the show taste success in 22 countries,” he claims.

But while their weight-loss solutions differ, what is interesting is that both Sahara and rimonabant makers are working on the premise that the issue has mass appeal, and is not being brushed under the carpet. “Illness can put a considerable dent in your bank balance,” says Chakrabarti. The new show has cash reward prize waiting at the end. Modi of Torrent remarks that an earlier weight-loss pill called sibutramine that it marketed was popular only in “high society”. That pill cost Rs 40 a bob, and was imported. But now, Torrent is using local manufacturing for rimonabant, allowing it to be priced at Rs 8 per pill. “Treatment is now affordable, it is no longer a niche market,” says Modi.

Not surprisingly, all the noise around overweight mirrors the West. It was researchers in those markets that first found a link between obesity and diseases like diabetes, heart disease and cancer. And it is in the US that the international format of the show Biggest Loser was first aired in America in 2004 and reportedly kick-started a fitness revolution. Rimonabant, too, has been discovered by Europe’s largest drug maker Sanofi-Aventis. Indian companies are merely copying it — legally — by a different process. Sanofi-Aventis, ironically, is awaiting permission from the Indian regulator to launch the original. “We applied last year,” says a company spokesperson. There are reportedly 60 drugs under development for obesity mainly in the West, and if they ever get approved, many will no doubt reach Indian shores.

The question is whether all these efforts are good enough to avert the epidemic of obesity that India is careening towards, and safely. That, after all, is the ultimate test.

Tuesday, May 22, 2007

 

Health benefits of honey

Daily Excelsior

Som Dutt

Popularly known as ‘Food of Gods’, honey as a natural food has been mentioned in the mythical sayings in the holy Bible and Quran. In Ayurveda, honey is cited as Yogawahi, meaning synergist. Presence of cholinergic constituent resembling to acetylcholine, colloids and some antibiotics justify honey as a good medicine. With soothing and cleansing effects on skin, honey has good potential to be used in preparation of cosmetics and skin-soothing products.

In nutrition, honey is a good instant energy supplier. It acts as an energizing, a mild appetizer and digestive agent. It is a rich source of amino acids-leucine, histidine, alanine, methionine and aspartic acid.

The ancient Greeks and Egyptians had used honey for the preservation of mummies. It is also used as a good bandage since it warms up, cleans and heals wounds. Besides, it is also a remedy for several diseases and ailments for men, women, children, youth and old alike.

There are two marked segments of honey used all over the world. There are: table honey and industrial honey. Almost 60-70 per cent of total honey is consumed as table honey, while the rest for industrial purposes--bakery, confectionary and cereals mainly in USA, Japan and Italy. In most developed countries, 60 per cent of honey is consumed for industrial purpose. However in India, there is no such gradation and awareness about honey.

Total honey production has increased rapidly and consistently since 1980's to 1.27 million tonnes in 2001, up almost by 30 per cent from 1980. China, Turkey and India are main honey-producing countries in Asia. All these three countries produce 85 per cent of the total Asian honey.

Germany is biggest buyer of Indian honey, followed by USA. The USA imported Indian honey (2,000 tonnes) during 2002-2003. Total quantity of Indian honey exported was 5,961 tonnes valued at Rs 4,593 lakh. There is a great demand for Indian honey in developed countries, if proper quality as per international standards in maintained. The quality of Indian honey is very good compared to that of International Codex Standards.

Chewing of fresh honeybee comb with honey and their brood is a delicacy in several areas of northeast India. The brood is eaten after frying. The adult bees are also eaten after frying. Thus, honeybees should be managed properly so that they can produce brood. The brood can also be preserved and packed for distant markets.

Bee venom is used for arthritis and other diseases of nervous system. It has good anti-inflammatory effects. Bee venom and its injections are available in some countries. Bees defend themselves with sting and venom is injected during stinging. It is secreted by glands associated with sting apparatus. A bee can produce 0.15-0.30 mg venom.




The bee venom is collected by electro-shock collecting apparatus. Various trap designs stimulate bees by applying mild electric shock. The venom extraction trap consists of thin steel or copper wires, 6 mm apart. The wires are alternatively grounded and charged to a current of 33 volts. The bees sting the surface on which they move. This may be a glass plate or a thin plastic membrane, nylon taffeta or silicon rubber under which venom collecting plate receives it. The venom dries up rapidly on glass plate. It is scrapped off with a razor or knife. The royal jelly is produced by stimulating colonies to produce queens other than natural, i.e swarming or queen replacement instinct. It is produced at 500 gram per colony in 5-6 months. About 250-300 mg royal jelly is produced from a cell.

Its extraction should never be done outside or in sunlight. The laboratory should be clean.Its shelf-life is very limited and it is therefore stored in refrigerated conditions. The royal jelly is freeze dried, which can be stored at room temperature.

Beewax is produced by worker bees of 14-18 days old. They have 8 wax glands on the under side of their abdomen. The bees after feeding on honey and pollen-grains, hang themselves in festoons and secrete wax flakes. These pallets are chewed and masticated into pliable pieces with the addition of saliva and a variety of enzymes.

Beewax is used in metal castings and mouldings. It forms stable emulsion and increases water-holding capacity of ointments and creams. Lipsticks, cold creams, deodorants, hair creams, hair removers, mascare, rouge and eye shadows are wax-based products. Wax is also used in food processing for coating containers, insulating electric materials, colouring cloth by traditional methods, preparing superior polishes and varnishes, old art of etching and engraving, coating of drugs and pills in medicines etc. It can also be mixed with drugs. Apart from these, catholic churches require ceremonial candles made with at least of 51 per cent beewax. It is also used by beekeeping industry for preparing boundation sheets.

Pollen-grains collected by worker bees are a source of protein in the diet of bees and older brood. They are used in medicines and to treat allergies and as a food supplement for human beings and other animals. The pollen-grains find vital uses in cosmetics for rejuvenation and nourishing effect of skin. Its alcoholic and aquous extracts are used in cosmetic formulations.



Monday, May 21, 2007

 

Pharma firms diversify

TOI
Rupali Mukherjee
Unrelenting pricing pressure on generics in the US and attractive global opportunities have led domestic majors including Ranbaxy, Dr Reddy's and Glenmark to find niches such as biotechnology. While for some — Nicholas Piramal and Dishman, contract research and manufacturing services has emerged as a huge opportunity, others like Divi's Laboratories have forayed into neutraceuticals.

In February this year, Ranbaxy signed a development and marketing agreement with Zenotech Laboratories for its first biosimilar product, G-CSF (filgrastim). G-CSF is used to prevent infections from cancer chemotherapy-induced neutropenia (decrease in the number of a type of white-blood cells). Ramesh Adige, ED, Ranbaxy, says: "Biogenerics or biosimilars is an active area of interest for Ranbaxy. Our strategy to enter the segment will be through alliances or strategic investments in specialty companies that will allow us to gain access to technologies and products in this area".

Analysts say success in the biotech industry necessitates coming up with innovative products. Indian companies have identified this area and have shifted their business models to one of alliances from an erstwhile model of competition. Recently, Dr Reddy's has launched a generic version of Roche's biologic blockbuster Rituxan (rituximab), a monoclonal antibody (MAb) for the treatment of non-Hodgkin's Lymphoma. Glenmark has tied up US-based Dyax to expedite biologics research.

Utkarsh Palnitkar, industry leader (health sciences) Ernst & Young, feels "Even as the Indian industry is restructuring and advancing in key competitive niches, market trends are creating more opportunities. The country's old patent regime fostered a skilled generics industry, and many Indian firms are well positioned for the coming waves of patent expirations. Action so far has been in pharmaceuticals, but several biologic drugs are expected to go off-patent soon, including blockbusters like Epogen, Novolin, and Humulin."

"Indian biotech companies are gearing up to garner outsourced manufacturing contracts, and companies such as Biocon, Wockhardt, Panacea Biotech, and Shantha Biotech are preparing generic versions of biotech drugs," he adds. Biocon, which is focusing on biotech drugs, is reaping huge gains. Says CMD Kiran Mazumdar Shaw: "We are focused on select areas viz diabetes, cancer and cardio vascular as we believe biotech drugs have a key role to play in treating these diseases."

Sunday, May 13, 2007

 

Drug pricing issues

Businessworld

PIYA SINGH

Should the Indian government bargain down the prices of patented medicines? Indian copycat companies think it should. But patent-owning MNCs say the opposite. Since the latter have the most to lose, they are the first to raise their voice to a government committee hearing the issue.

The MNC view is that price control hampers innovation. The Organisation of Pharmaceutical Producers of India (OPPI), an MNC mouthpiece, recently knocked the Canadian model of price negotiation that has reportedly found favour with the committee. Canada has set up a board exclusively to beat down prices of patented medicines. So, medicines in Canada cost 50 per cent less than in the US, which has no price control. But, “Canada has not discovered a single new drug,” says Ajit Dangi, OPPI’s director-general. MNCs say that Americans need not bear the burden of paying for R&D. This has come through in actions like getting the US government to demand that countries such as Australia, for instance, cut these so-called subsidies on medicines as part of larger free trade agreements.



Not to be outdone, Indian drug companies are now readying their own arsenal. The first salvo is a letter that the Indian Pharmaceutical Alliance (IPA) shot off this week to the same committee. D.G. Shah, secretary-general of the indigenous lobby, points out that unlike in many other countries where governments or insurers are large payers, in India individuals account for nearly 80 per cent of money spent buying medicines. So, there is no single, large group of beneficiaries that can collectively bargain and bring prices down. “Consumers are left to fend for themselves,” Shah says. The IPA thinks this is a good enough reason for the government to intervene. Besides, other countries such as the UK, France and Germany — lucrative markets for the drugs industry — also use price negotiation in some form, IPA says. “India will be in good company,” the letter says.

Pricing tends to unite the fractious drug industry. Even now, the two sides are banding together to oppose a separate suggestion by chemicals and fertilisers minister Ram Vilas Paswan to control prices of several more on-market drugs — including copycats. But where patented medicines is the subject, they are a house divided. Indian companies also want to launch patented drugs but don’t worry about control. A 2002 policy gives pricing freedom for the first five years to any drug discovered in India. Unless MNCs do their research here, they are unlikely to benefit from this provision as much as the Indians.



Monday, May 07, 2007

 

Funding Pharma research

Businessworld
Gauri Kamath

Last Friday, Mumbai’s drug maker Lupin got Rs 10 crore from the central government to test novel medicines for psoriasis and migraine. This amount, offered as a soft loan over two years, did not impress the Street. Lupin’s shares fell slightly on the Bombay Stock Exchange that day. “It is a small sum,” says Harshad Arole, pharma analyst at ABN Amro Research. The Rs 1,606-crore Lupin spends Rs 150 crore a year on R&D. Besides, says Arole, these drugs will need to be tested in the developed world where the big bucks for novel medicines are to be made. But Rs 10 crore simply will not do. A phase three trial — the final phase where safety and efficacy is tested in hundreds of patients — in the West will cost up to $50 million-75 million (Rs 220 crore-330 crore).

But Lupin chairman Desh Bandhu Gupta wants this to be viewed in the context of Lupin’s spends on new drug research (a smaller Rs 30 crore to Rs 40 crore a year), and not the overall R&D budget. “Seen that way, it is something,” he says.
Lupin is not the only company to avail of the benefit. The department of science and technology (DST), which has loaned money to Lupin, has approval to dole out Rs 120 crore a year for pharma R&D. DST gets about 20 requests a year from all sorts of companies. In the past, India’s top drug maker Ranbaxy had also benefited from this 12-year-old programme. A DST bureaucrat says that proposals are evaluated on the basis of their scientific merit. “There is no need (for the innovator) to prove that they cannot fund it,” he says.


This begs a larger question. Does piecemeal government funding of R&D in well-off industry houses encourage innovation? According to Anil Gupta, executive chair of the DST-sponsored National Innovation Foundation that supports grassroot innovation, the impact of the government funding would be more if used to strengthen universities, which could partner with corporations. “A grant of that sum to a (university) laboratory could have served a lot more industries,” he says. Individual inventors could also benefit substantially, he adds.

Right now it appears as if nobody is happy. Industry lobbies like the Indian Pharmaceutical Alliance, of which Lupin too is a member, complain that government funding is paltry. Universities that have availed of DST funding under a different scheme say it is either insufficient or has strings attached. “We are expected to account for spending several years after the money is spent because that is how audits are done,” says a senior professor in one such university in Gujarat.

According to Gupta, Lupin will use the Indian study findings to generate interest from potential partners, who could bankroll drug development for western markets. If that happens, says ABN Amro’s Arole, it would be the “only upside” from this arrangement.


For the cooperation between Universities and Corporations in the west see:

The Bahye-Dole Act

and the for the early history of government funding of Pharma research see:
Pharmaceutical Drug Research

Saturday, May 05, 2007

 

Monoclonal antibodies

Businessworld
Gauri Kamath

Not long ago, Hyderabad start-up Zenotech Laboratories was contacted by lawyers to Swiss pharma major F. Hoffmann-La Roche. Zenotech founder Jayaram Chigurupati told a reporter it had cloned Roche’s anti-cancer drug Mabthera and could sell it for Rs 25,000 a vial, a quarter of its price. Roche warned that as the copycat was not on the market, Chigurupati’s claims were misleading and demanded the interview be pulled from its website. Chigurupati says this means Zenotech is serious competition: “I consider it a badge of honour.”

The drug, rituximab, is a monoclonal antibody (MAB), a class of biotech medicines previously sold in India by blue-chip MNCs. Now, Zenotech and others such as Bangalore’s Biocon are making inroads into this preserve. Biocon has a MAB licensed from Cuba-based CIMAB in the market. Last week, after good quarterly results, analysts such as Merrill Lynch’s Visalakshi Chandramouli upheld a ‘buy’ on Biocon. One of the reasons was a “sales build-up” for nimotuzumab, branded Biomab.

MABs (literally clones of a single parent cell) target sites in the body responsible for disease. Valuable in cancer treatment, where chemotherapy can destroy healthy cells, MABs are used for many indications. Mumbai’s Bharat Serums And Vaccines has one for tetanus.

Globally, costly MABs such as Genentech’s Avastin, at $49,000 (Rs 21.6 lakh) for a 10-month course in the US, are set to become the largest class of biotech drugs. Worth $15 billion (Rs 66,000 crore) a year, that is slated to double by 2010 to roughly match statins or cholesterol reducers — the largest drug class ever. But while statin copycats abound in India, MABs do not. They require biological expertise. Indian firms are chemistry experts. “The competencies are different,” says Sanjiv Kaul, managing director, ChrysCapital, a Delhi private equity firm investing in pharma companies. But this means competition may be limited. “There are probably 20 drugs that do not have generic versions — like MABs. They ought to be more affordable, but aren’t as there hasn’t been the capability,” says Cartikeya Reddy, vice-president (biologics), Dr. Reddy’s. The Hyderabad-based company will soon launch a copycat MAB of its own.




The jury is out on the size of this opportunity. Since 2005, any new drug sought to be patented globally after 1995 qualifies for an Indian patent. This limits what can be copied. Further, as MABs are large volume drugs (10 per cent of the world’s biotech medicines, but 75 per cent of the production capacity), they require large amounts of infrastrcuture investment. “Ramping up is expensive,” says Kaul. The big bucks lie in the West, where entry barriers are high. (See ‘Sticker Shock’, BW, 23 April 2007.)

Biocon has tried to avoid problems by tying up with the patent owner. “We want to be seen as partners in innovation,” says Subir Basak, general manager (oncotherapeutics). Indian regulators approved Biomab, the first drug from this partnership, before the West. This poses a challenge. Indian doctors prefer not to prescribe drugs that are not approved in the US or Europe, according to a Deutsche India Equities Research report. Basak says that oncologists wanted trial data on thousands of patients, like well-known global copycats, which Biocon did not have. This changed after experiencing the product, he claims.

At any time, there are 2.5 million cancer cases in India, but often drugs are too expensive. Purvish Parikh, chief (medical oncology), Mumbai’s Tata Memorial Hospital, says companies taking risk should mean more choice for patients. The ultimate proof, he says, is if “more patients are getting cured”.



Friday, May 04, 2007

 

Another global acquisition

M&C

India's leading drug-maker Wockhardt Ltd Thursday announced that it has acquired French pharmaceutical group Negma Laboratories for 265 million dollars in an all-cash deal to expand its presence in Europe.

Negma is the fourth largest integrated pharmaceutical group in France with sales of 150 million dollars.

'It (Negma) is a research-based pharmaceutical company with 172 patents. The acquisition will allow Wockhardt to extend this patented portfolio to other European markets where it enjoys a strong presence,' Wockhardt Chairman Habil Khorakiwala said.

The transaction is valued at 1.8 times the sales and 9.7 times the EBITDA (Earnings Before Interest, Taxes, Depreciation and Amortization) of the French company.

With this acquisition, Wockhardt said it would emerge as the largest Indian pharmaceutical company in Europe with more than 1,500 employees based in the continent and the European business would now account for more than 60 per cent of its total revenues.




'The acquisition would provide us the right entry vehicle to enter the French generics market valued at two billion dollars, leveraging Wockhardt's robust EU portfolio and impressive pipeline,' Khorakiwala said.

Negma is Wockhardt's fifth acquisition in Europe after Wallis, CP Pharmaceuticals both in UK, Esparma in Germany and Pinewood Laboratories in Ireland.

Growing at the rate of more than 10 per cent every year, the Indian pharmaceutical industry is keenly eyeing Europe to set up a distribution network.

Among the biggest such acquisitions, India's second-largest drug-maker, Dr Reddy's Laboratories, acquired Germany's Betapharm Group for 570 million dollars in 2006.

With the Negma acquisition, Wockhardt would now have four manufacturing facilities in Europe producing bulk drugs, injectables, tablets, capsules and creams.

'Wockhardt will now enjoy a pan-European presence, covering all the key markets of Europe - Germany, UK, Ireland and now France,' Khorakiwala added.


Add this to the earlier Global Acquisitions

Thursday, May 03, 2007

 

Interesting twist to patents case

Economic Times

Swiss pharma-major Novartis’s fight against certain provisions in the Indian patent laws — which do not allow patenting of incremental innovations — has taken an interesting turn with Norway’s minister of international development Erik Solheim asking the company to withdraw its case against India.

Novartis had filed the case following India’s rejection of its patent plea for ‘Glivec’ — a drug for fighting blood cancer. In its appeal, Novartis stated that the provisions in the Indian patent laws, which do not allow patents on incremental innovations, went against the Trips agreement and should be amended. India’s argument is that allowing patents on incremental innovations would lead to ever-greening of patents wherein companies would file for fresh patents by making superficial changes in the patented product once the life of the initial patent is over after 20 years.

In a letter to Novartis CEO Daniel Vasella, the Norwegian minister stated that India contributed in very significant ways to the overall production capacity for life saving generic drugs, with major exports to developing countries. It is important for global health that this contribution can continue, he said.




Urging Novartis to seek a solution in the current case that adequately address these concerns, the minister said the company should withdraw its case against India.
According to an official release, Mr Vasena underlined that there is a shared interest in a universal, rule-based, open, non-discriminatory and multilateral trading system, that, at the same time, can support global health security. “Building in public health safeguards in national patent laws to ensure that patents do not limit access to medicines is a right of every country. The cost of innovation cannot be borne by countries and people with the weakest economic capacity,” he said.

The minister added that international trade policies and agreements need to be placed within the context of protecting and promoting health and well-being. “Global health security is depending on each country having the capacity to safeguard public health”, the letter added.


Patents Story


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