Sunday, May 31, 2009

India poised to be next global petri dish

The good news is that science is in vogue. According to the India Science Report, 2005, nearly one-fourth of Indians who qualified at the
graduate level had a background in science. Further, as per the National Science Survey 2004, around 3/4th of the respondents felt that science and technology was vital for education. The C in the PCM group of subjects at high school chemistry offers lot of scope in the industry today. According to career counsellors, a specialisation in chemistry opens up avenues in the areas of clinical research, environmental sciences, food technology and leather industry. After IT and ITES, India is soon poised to be the global petri dish. According to industry estimates, the market for clinical research activities is expected to touch $two billion by 2010. Spiralling R&D costs and rising overheads are forcing many global pharmaceutical majors to outsource clinical research to India. Not only that, even Indian pharmaceutical majors have moved out from reverse engineering to new drug discovery (NDD). This, in turn, provides ample career opportunities for chemists and analysts. "Clinical research organisations are on the lookout for people qualified in biochemistry," says Arun Bhat, president, ClinInvent. The starting salaries for a clinical research analyst (CRAs) is anywhere between Rs 2 lakh and Rs 3 lakh per annum.
The next in the hierarchy are senior clinical research analyst, clinical team leader, clinical study manager, project manager, and so on. According to a senior official from Orchid Chemicals and Pharmaceuticals: "An under-graduation in chemistry is not enough. Its a must to have a Phd if one aspires to be a group leader." "Chemistry offers career scope in the field of environmental sciences. With numerous chemicals polluting the environment, companies across the globe are looking at ways and means of containing such pollutants," says educational counsellor Kalavathi Amarachelvam. And, with working couples becoming the norm, the dependance on processed foods is higher than before and these contain certain natural and chemicals. This in turn offers career opportunities for young graduates.

Only the bad times are good for pharma

The one good thing about a potential global pandemic is that it puts drugmakers in an extremely favourable light. Even if the dangers of swine flu are not as dire as first thought, it is comforting to know agents like Tamiflu and Relenza exist and that governments around the world are buying them.

Pharmaceutical situations where everyone is happy are rare. Companies hitherto seen as money-grabbing and disease-mongering are suddenly acknowledged as saviours, using their expertise to protect the public from unknown and possibly fatal threats. Scientists go into over-drive, manufacturing capacity is notched up a few gears, distributors are busy, shareholders are cockahoop. The only people sidelined are those in marketing because when something is really needed it doesn't need selling.

In that scenario is a painfully simple truth: that what people want from the pharmaceutical industry is products that don't need selling. People want things that work. And what is true for vaccines against viruses the human world has never seen is true for all pharmaceuticals. People want things that make them better. They don't want to pay for them. They don't want side-effects. Ideally, they don't even want to know they are taking them. The bottom line is they don't really want to acknowledge they need them.

This widespread blindness to the fact that people do age, get sick and, heaven forbid, die, has far-reaching consequences for the industry. It puts enormous pressure on governments and insurance companies to pay truly astronomical monopoly prices to give people suffering from cancer a few weeks, perhaps months, of life. These premium prices accelerate the innovation mill to the extent there are now 861 new cancer drugs and vaccines in human trials or awaiting approval by the FDA. Whether those governments and insurance companies are able to pay for the products that are approved remains to be seen.

On another level, this quest to be fixed, whatever the cost, can be seen in nurses being employed to text overweight patients on their mobile phones to remind them to take their obesity pills. Or in the UK's NHS providing smokers with alternative means of maintaining their nicotine addiction in patches and chewing gum at prices that are set in line with tobacco and it's associated high taxes to help people stop people smoking in the first place.

Because people so much want to be made better, the distribution of healthcare resources is highly illogical. Palliative care workers and cancer surgeons would love just a fraction of the money that is poured into cancer drugs. And just about anyone would benefit from the healthcare resources spent urging people to take pills to help them lose weight (one would think they could do this for themselves), or maintain a nicotine habit that allows people to continue puffing in private and chewing in public.

Not only are they illogical but some think they are also not fair. In a recent CNN interview former US president Bill Clinton was not the first to point out that US drug prices are significantly higher than anywhere else. "At our AIDS clinic down the street here in Harlem, the taxpayers pay $10,000 a year to treat people with the big pharmaceutical companies' AIDS medicine," he said. "That medicine costs about $3,500 a year in Canada and Europe, countries with per capita incomes as high as America."

As the US grapples with how to absorb no less than 46 million uninsured Americans into state-funded programmes, different conclusions are drawn from the fact that everyone else pays lower prices than they do. Some, for example, insist it is because no-one else (except New Zealanders) can advertise direct to consumers; others think that everyone else freeloads on the back of Americans, who pay the lion's share of R&D costs. What no-one mentions is the propensity of a culture to take medicine and, with that, all the implications about how responsible people are for their individual health, how much they want to be fixed, and what they will allow (television advertising, for example) to make that fix as widely available as possible.

Cultural factors also go some way to explaining how the World Health Organisation can show Cubans and Americans expecting to live roughly the same number of healthy life-years while the former pay just over $225 a year for their healthcare and the latter more than $5,000.

Cultural or lifestyle factors are hard for healthcare systems to deal with, because, as said, people, generally speaking, just want to be made better as imperceptively as possible with products that work, that don't need advertising, that don't cost an arm and a leg and don't draw attention to the fact they are ill, fat, old, dying or any other condition they don't want to face up to and properly acknowledge. Which is why, in the normal course of events, they only view the industry positively when something like a global pandemic looms on the horizon.

Friday, May 29, 2009

Sanofi pulls out of race for Shantha; GSK in fray

NEW DELHI: British drug major GlaxoSmithKline Pharmaceuticals is in advanced talks to buy at least a 51% stake from French company Merieux Alliance
in Shantha Biotech after the other contender, Sanofi Aventis, dropped out of the race, two persons privy to the development said.

“Only a few matters relating to the valuation need to be finalised,” a senior industry executive said, asking that neither his name nor that of his company be revealed. Sanofi Aventis is understood to have come to the conclusion that the privately-held company’s product portfolio was not attractive enough for it to proceed with negotiations, one of them said. France’s Merieux Alliance bought a 60% stake in Shantha Biotech in 2006 and subsequently increased it to about 80%. GSK is interested in buying at a majority stake in Shantha Biotech and shore up its vaccine business, especially the five-in-one pentavalent variety where it has lost out to rivals such as Panacea Biotec, Novartis and Shantha Biotech, a senior industry executive said.

The pentavalent vaccine protects infants from diphtheria, whooping cough, tetanus, hepatitis-B and the Haemophilus influenzae type b bacterium which causes diseases such as pneumonia and meningitis. While the size of a potential deal is not known, the French owners are seen estimating the value of Shantha Biotech at Rs 1,000-1,200 crore. In March, ET had reported that GSK and Sanofi Aventis were in the fray to buy the company. A Merieux spokeswoman said, “Merieux Alliance has been contacted many times by different international vaccine companies. There is nothing new on this topic and Merieux Alliance has no comments to add.” A GSK India spokesman said the company did not “comment on market speculation”. The original promoter KI Varaprasad Reddy, who is also the firm’s MD, owns about a 17% stake. Mr Reddy said he was not aware of any likely deal, terming the development a “rumour”. Shantha Biotech, whose sales are estimated to be around Rs 200 crore, shot into fame in 1997 after it became the first Indian firm to develop and market a recombinant Hepatitis B vaccine. It employs over 700 people and markets a range of vaccines in India and global markets. It also provides contract research and manufacturing services and has a wholly-owned subsidiary in the US. The proposed deal demonstrates the changing business dynamics in the global drug industry which is increasingly expanding into the generics business to maintain revenues. Indian drug companies are experts in making low-cost versions of blockbuster drugs. Shantha Biotech also provides low-cost manufacturing and research hub.

Daiichi revises full-year losses to $2.2 billion

NEW DELHI: Japanese pharma major Daiichi Sankyo, which controls Indian drug maker Ranbaxy Laboratories, on Thursday revised downwards its losses to
215.59 billion yen (about $2.2 billion) for the year ended March 31, 2009, citing changes related to Japan's accounting guidelines. Earlier this month, Daiichi had reported a full-year loss of 335.8 billion yen. Daiichi in a statement said the narrowing of losses is due to accounting guidelines from Japan's National Tax Agency related to loss on valuation of stocks of subsidiaries. As a result, the losses on share valuation from its stake in Ranbaxy too came down. "The Group posted a net loss of 215.4 billion yen (compared with net income of 97.6 billion yen in the previous year) as the result of recording 351.3 billion yen in extraordinary losses due to a one-time write down of goodwill pertaining to the investment in Ranbaxy," the statement said. Daiichi noted that the firm found it difficult for a "402,420 million yen component recorded in loss on valuation of stocks of subsidiaries and affiliates under extraordinary losses in the non-consolidated financial statements of the Company to be treated as a loss for tax purposes".

Piramal Healthcare launches nutritional supplement 'Supractiv Complete'

Piramal Healthcare, one of India's largest integrated healthcare companies, has launched Supractiv Complete - a total nutritional supplement. The product is rich in many nutrients such as glutamine, zinc, vitamin B-complex, vitamins C, vitamin E, ginseng, calcium, amino acids and antioxidants.Supractiv Complete works on supporting the whole body for nutrition rather than providing only a select benefit, like energy or immunity. Supractiv Complete not only has the right ingredients but also has them in optimal quantities. Its formulation has been prepared by taking into consideration the Recommended Daily Allowance suggested by the Indian Council of Medical Research. One Supractiv Complete a day has nutrients that will provide mental agility, immunity, heart health, stamina, vitality and muscle & bone strength. The nutritional supplement market is the largest segment in the OTC market accounting for over 45 per cent of the OTC products in India. In fact this segment has witnessed a rapid rise in the last few years and is growing at a healthy growth rate of about 12 per cent.Highlighting the need for a complete nutritional supplement in India, Dr Swati Piramal, director, Piramal Healthcare, said, "Our dietary habits have changed drastically over the years, thanks increasingly to our changing lifestyles. This has rendered our everyday diet deficient in vital nutrients. Hence, there is a pronounced need for nutritional supplement in Indians. At Piramal Healthcare, we believe in reducing the burden of disease and fostering healthy lives. Propelled by our core values of Knowledge Action Care, we continuously strive to apply breakthrough innovations to provide quality products to our end customers. The idea behind launching Supractiv Complete was to empower the consumers to make an informed choice about their nutritional supplements."Supractiv Complete is available in a uniquely designed packaged jar of 30 and a convenient trial pack of 10. The clutter breaking packaging not only serves to attract the consumer but also works towards explaining the product, its attributes and the manner in which it works on the human body. Priced between Rs 60 & 180, Supractiv Complete will be available shortly at chemists' stores across India.

IPCA Lab net dips by 26% to Rs 101 cr, higher dividend at 110%

Mumbai-IPCA Laboratories has posted lower consolidated net profit of Rs 100.80 crore during the year ended March 2009 as against Rs 135.83 crore in the previous year, basically due to significant higher provision for foreign exchange loss of Rs 76.15 crore. The profit before tax and foreign exchange loss, however, went up by 48.8 per cent to Rs 226.27 crore from Rs 152.02 crore. Its consolidated net sales increased by 22.3 per cent to Rs 1285.80 crore from Rs 1051.30 crore. Its export sales increased by 27 per cent to Rs 680.39 crore from Rs 536.26 crore.With fall in net profit, it's earning per share declined to Rs 40.15 from Rs 54.31 in the last year.The board of directors has stepped up equity dividend to 110 per cent from 80 per cent in the last year. Ipca's EBDIT moved up by 44.1 per cent to Rs 265.93 crore from Rs 184.53 crore. The interest cost went up sharply by 56 per cent to Rs 31.80 crore from Rs 20.39 crore and depreciation provision increased to Rs 39.66 crore from Rs 32.51 crore. The company filed 11 ANDAs of formulations with USFDA and nine of them were approved. It commenced export of generic formulations to US. The company established subsidiary company in Mexico and China during 2008-09.

Panacea Biotec incurs consolidated net loss of Rs 67 cr

Mumbai-Panacea Biotec has suffered heavy setback during the year ended March 2009 on account of lower vaccine sales and foreign exchange loss of Rs 175.07 crore. It incurred a consolidated net loss of Rs 67.07 crore as against a net profit of Rs 128.98 crore in the previous year. The company's consolidated net sales also declined by 6.3 per cent to Rs 788.17 crore from Rs 841.34 crore. It's earning per share worked out to negative of Rs 10.06 as against positive of Rs 19.51 in the last year. In view of losses, the board of directors has not recommended any dividend on the equity share for the year 2008-09.Panacea's vaccines sales declined to Rs 562.37 crore from Rs 647.24 crore, a de-growth of 13.1 per cent and its formulations sales increased to Rs 228.73 crore from Rs 200.85 crore, a growth of 13.9 per cent. The company has opted for change in accounting policy in respect of foreign exchange fluctuation difference relating to translation of long term foreign currency monetary liabilities. This has resulted into reduction in losses during the year by Rs 85 crore. For the fourth quarter ended March 2009, its sales increased by 16.4 per cent to Rs 227.42 crore and incurred a net loss of Rs 40.17 crore as against a net profit of Rs 24.91 crore in the corresponding period of last year. Dr Rajesh Jain, joint managing director, said, "In line with our outlook in Q3, the Q4 sales turnover has increased by 16 and 28 per cent compared to corresponding quarter of previous year and Q3 of year under review, respectively. Tough times have now been left behind and the company is back on the growth path. Consolidation and optimization of product mix and increased thrust on overseas markets saw revenues growing up during the quarter by 29 per cent to Rs 227.6 crore as compared to Rs 175.9 crore in the previous year."The EBDITA margins have also improved significantly by 95 per cent to Rs 83.2 crore as compared to Rs 42.7 crore. Domestic Pharma as well as exports have gone up by 9 per cent and 27 per cent respectively over last year, while domestic vaccines have witnessed a formidable growth of 30 per cent over last year. We expect that the momentum will continue during financial year 2009-10 on a yearly basis rather than a quarter, which is typical of innovation based business models like ours."

BMS gets US FDA nod for Sprycel to treat CML in adults

New York-Bristol-Myers Squibb Company announced that the US Food and Drug Administration (FDA) has granted full approval for Sprycel (dasatinib) for the treatment of adults in all phases of chronic myeloid leukaemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec (imatinib mesylate).Sprycel, an oral tyrosine kinase inhibitor, was originally approved under the accelerated approval regulations of Subpart H for new drugs for serious or life-threatening illnesses of the Food, Drug and Cosmetic Act, based on its effectiveness on hematologic and cytogenetic response rates in CML.The full approval was based in part on results from a phase-3 randomized, open-label dose-optimization study that enrolled 670 chronic phase CML patients with resistance or intolerance to Gleevec. The primary endpoint of this study was major cytogenetic response (MCyR) (0 to 35 per cent Ph+ metaphases, which combines both complete and partial responses), in Gleevec-resistant patients. The data included a minimum of two years of follow up after the start of treatment with Sprycel 100 mg once daily, which is the recommended starting dose of Sprycel for chronic phase CML patients resistant or intolerant to Gleevec. A summary of results from the 167 patients who received Sprycel 100 mg once daily include:"Sprycel helps to fulfil a need for second-line treatments for CML patients with resistance or intolerance to Gleevec. The two-year follow-up data further support the use of SPRYCEL as an important treatment option for this patient population," said Dr Hagop Kantarjian, chairman and professor, Leukaemia Department, MD Anderson Cancer Center.The approved label also now includes a new recommended starting dosage of Sprycel (dasatinib) 140 mg once daily for accelerated, myeloid blast and lymphoid blast phase CML resistant or intolerant to prior therapy including Gleevec and Ph+ ALL resistant or intolerant to prior therapy.Safety data in the labelling encompasses results from seven clinical trials and more than 2,100 patients with CML or Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL). The most frequently reported serious adverse reactions with Sprycel included pleural effusion (11 per cent), gastrointestinal bleeding (4 per cent), febrile neutropenia (4 per cent), dyspnoea (3 per cent), pneumonia (3 per cent), pyrexia (3 per cent), diarrhoea (3 per cent), infection (2 per cent), congestive heart failure/cardiac dysfunction (2 per cent), pericardial effusion (1 per cent), and central nervous system (CNS) haemorrhage (1 per cent). The most frequently reported adverse reactions (reported in =20 per cent of patients) included myelosuppression, fluid retention events, diarrhoea, headache, dyspnoea, skin rash, fatigue, nausea and haemorrhage

United Therapeutics gets FDA nod for tadalafil tabs

Silver Spring, Maryland-United Therapeutics Corporation announced that the United States Food and Drug Administration (FDA) has approved Adcirca (tadalafil) tablets for oral administration, with a recommended dose of 40 mg, as the first once-daily phosphodiesterase type 5 (PDE5) inhibitor for the treatment of pulmonary arterial hypertension (PAH). Adcirca is indicated to improve exercise ability in WHO Group I PAH patients, which encompasses patients with multiple forms of PAH including etiologies such as idiopathic and familial PAH as well as PAH associated with scleroderma and congenital heart disease. "Thanks to the clinical development efforts led by Eli Lilly & Company, we are thrilled to make available an effective, convenient and economical therapy for PAH patients," said Martine Rothblatt, United Therapeutics' chairman and chief executive officer. "The FDA's action in approving once-a-day Adcirca is a big plus for all three P's: patients, physicians and payors." In the Phirst-1 randomized, double-blind, 16-week placebo-controlled phase-3 clinical trial of Adcirca for PAH, patients taking Adcirca 40 mg (administered as two 20 mg tablets) once daily achieved a 33 meter improvement in six-minute walk distance compared to the placebo group. In addition, Phirst-1 patients taking Adcirca 40 mg experienced less clinical worsening (defined as death, lung transplantation, atrial septostomy, hospitalization because of worsening PAH, initiation of new PAH therapy, or worsening WHO functional class) compared to the placebo group. The most common adverse events in the trial were generally transient, mild to moderate in intensity and included headache, muscle pain, flushing, nasopharyngitis, respiratory tract infection, nausea, pain in the arms, legs or back, upset stomach and nasal congestion. "Our dedicated team at United Therapeutics looks forward to working closely with the PAH community as we prepare to launch Adcirca in the United States at the beginning of August this year," said Roger Jeffs, United Therapeutics' president and chief operating officer. Adcirca is a prescription medicine used to treat PAH, a life-threatening disease that constricts the flow of blood through the pulmonary vasculature. United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer.

Alcon starts construction of its first Asian pharma facility in Singapore

Huenenberg, Switzerland-Alcon, the world's largest manufacturer of eye care products, marked the commencement of construction of its first pharmaceutical manufacturing plant in the Asian region with a groundbreaking ceremony in Singapore's Tuas Biomedical Park. The new 330,000 square foot plant is expected to be completed in 2012 and will create 150 new jobs.The new plant will primarily manufacture sight-saving pharmaceutical products for Asian markets. The location and capacity expansion will allow Alcon to more effectively and efficiently meet the eye care needs of patients and eye care professionals across Asia with treatments for glaucoma, eye infections, eye inflammation and dry eyes."With the rapid growth we are experiencing in Asia, this new Singapore plant is integral to our ability to meet the increasing demand for our products in the region," said Ed McGough, senior vice president for global manufacturing and technological operations, Alcon. "The strategically positioned Singapore location, coupled with the increased capacity of this plant, will help us supply Asia with essential eye care pharmaceuticals more efficiently, and maintain the high-quality service our customers have come to expect from Alcon."He added that Singapore was attractive due to its central position in Asia, the skilled and reliable workforce in the country and its well-developed infrastructure. The plant's location in Tuas was conceived in collaboration with and was supported by the Economic Development Board of Singapore."Alcon's decision to site its first Asia-Pacific manufacturing plant here in Singapore is a strong vote of confidence for Singapore and our attractiveness to businesses. EDB has also played a pivotal role in helping Alcon start up this plant today. Singapore remains committed to providing a conducive and supportive environment that facilitates biomedical companies' expansion here," said Gan Kim Yong, minister for Manpower.Alcon Singapore operations were established in 1992. Currently the company employs 40 staff focused on serving the needs of the Singapore eye care community, as well as providing centralized human resources support, marketing and health economics capabilities for the Asian region.Alcon is the world's leading eye care company, with sales of approximately $6.3 billion in 2008.

Thursday, May 28, 2009

Indian healthcare market to grow despite slowdown: McKinsey

WASHINGTON: Notwithstanding the current global economic crisis, India's pharmaceutical industry and its health care market are expected to grow

rapidly in the next few years, a global management consulting firm has said. Driven by strong local demand, Indian health care market is expected to continue growing close to previously projected rates of 10 to 12 per cent, McKinsey said in its report 'New Opportunities for US-India Biopharma and Healthcare Collaboration'. Released recently at the US India Biopharma and Healthcare Summit, the high growth of the Indian health care sector is primarily driven because of domestic reasons. Eminent corporate leaders from the US attended the day long summit organised by the USA Indian Chamber of Commerce in Boston. With average household consumption expected to increase by more than seven percent per annum, the annual healthcare expenditure is projected to grow at 10 percent and also the number of insured is likely to jump from 100 million to 220 million. Further hospital beds are expected to double from 1.5 per thousand to 2.9 per thousand and the diagnostic laboratories to grow by 20 to 25 percent. There will be an addition of 300,000 to 400,000 doctors and another 250,000 to 300,000 nurses.

Gujarat-based pharma firms in pink of health

AHMEDABAD: In the time of economic slowdown when major companies are facing pressure on their balancesheets, Gujarat-based pharmaceutical firm have

registered a healthy growth and seen substantial rise in net profit in the financial year 2008-09. Top drugmakers like Torrent Pharma, Zydus Cadila and Dishman Pharma have seen growth in domestic as well as international sales, and rise in profits. "Despite recession in Western markets, pharma companies here have seen jump in their exports, which is a positive sign," said Sunil Parekh, a pharma industry expert who is also advisor to some firms in the state. Zydus Cadila has posted registered a net profit of Rs 303 crore, up 18 per cent year-on-year. The company has clocked a total income of Rs 2,948 crore, up 26 per cent from Rs 2,333 crore in the corresponding period last year on a consolidated basis. Torrent Pharma's profit has gone up by 36 per cent and sales by 21 per cent, from Rs 1,336 crore to Rs 1,617 crore, in the last fiscal during which the economic downturn started. In its exports segment, Torrent has witnessed 38 per cent growth and its sales outside India stood higher at Rs 823 crore. In the case of Zydus, the topline growth was driven by 50 per cent rise in formulation exports, 34 per cent in API (active pharmaceutical ingredients) exports and 27 per cent in consumer business. The growth in formulations exports was buoyed by 55 per cent increase in sales in the US market, 32 per cent in Brazil and 81 per cent rise in exports to the other emerging markets, according to a company release. Dishman Pharma is another company to put up an impressive show. It has seen a 21 per cent jump in consolidated net profit, which stood at Rs 146.74 crore in 2008-09 as compared to Rs 121.52 crore in the previous year.

Ranbaxy misses May deadline to supply raw materials to Astrazeneca

NEW DELHI: Ranbaxy Laboratories’ scrip shot up 20.7% on Monday, a day after former owner and CEO Malvinder Singh stepped down, despite missing the

deadline of May 2009 to start supplying raw materials to British drugmaker Astrazeneca. The supplies to Astrazeneca which could have potentially brought revenues of $40 million this year (May-December 2009) has been delayed by 2-3 months, a top company executive said. Atul Sobti, who tookover as the Ranbaxy CEO & MD from Mr Singh on Sunday said Astrazeneca had already reviewed and approved the company’s drugs. Meanwhile, the Ranbaxy scrip rose 20.7% to end the day at 266.70 at the Bombay Stock Exchange (BSE) on the anticipation that Daiichi Sankyo, which owns 64% in the company, may increase its stake. Says CLSA's research analyst Hemant Bakhru, “There are expectations that Daiichi Sankyo might acquire more stake in Ranbaxy, at some point of time.” The surge translates into a gain of Rs 1,900 crore for Ranbaxy in a single day. There are also expectations that the direct involvement of the Japa-nese parent in day to day operations would be able to resolve the on-going problems with the US drug regulator sooner. In an analysts call on Monday, Mr Sobti said the company has met the US Food and Drug Administration (FDA) officials three times since January this year and expects to have another meeting next month. The company’s new chairman Tsutomu Une said Daiichi Sankyo has laid the foundation to monetise gains from its acquisition of Ranbaxy. Daiichi Sankyo and Ranbaxy have also formed a team for drug re-search and emerging markets businesses. On Sunday, in a swift move, Malvinder Singh stepped down as the chief of Ranbaxy, ending his ties with the company which his family owned for almost 50 years. Two other board members of Ranbaxy who were nominees of Mr Singh also resigned giving Daiichi Sankyo a complete control in the seven-member board. Adds Angel Broking pharma analyst Sarabjit Kour,”Normally in top management rejigs stocks react negatively due to uncertainty in the company. But in the case of Ranbaxy, Daiichi Sankyo already had a controlling stake and expectations are that they would expedite the FDA matter, though this is not in their hands and it will take time.” Daiichi Sankyo’s complete control of Ranbaxy would also allow the Japanese company to take proactive actions to mitigate the forex loss.

Investors at risk as US FDA gets tough with drug cos

MUMBAI: The recent warning letters issued by the US Food and Drug Administration (FDA), to manufacturing units of Indian pharmaceutical companies,

have significantly raised investors risk. With the FDA getting more stringent with its quality inspections and upcoming approvals for companies put on hold, investors are the ones who could lose out in the long-run, said analysts. "Companies need to put things in place. Once the US FDA issues inspectional observations or '483' concerns and if it goes to the next level of warning letters, it will take a couple of quarters for things to get sorted out," said Abhishek Singhal, an analyst with Macquarie. The reason for this delay is because the concerns that the FDA raised will have to be addressed and until that is done it will withhold approval for new products from those facilities. "The FDA will have to come and inspect the facility again and only once they are satisfied will approvals be granted. This will take time," he added. Lupin, Cipla, Ranbaxy and Caraco Pharma, the US subsidiary of Sun Pharmaceuticals, have received '483' notices from the US FDA in the recent past. Lupin was issued a warning letter for its Cephalosporin facility at Mandideep, when the plant was inspected in November 2008. The FDA had initially raised 15 inspectional observations. The recent escalation into a warning letter raises concerns since a Cephalosporin product and a line extension of highly successful branded product, Suprax, are pending approvals from this site. HDFC Securities VP (institutional research) Ranjit Kapadia said: "Warning letters pull down the stock price and delays in approvals could have 5-10% impact on the company’s performance. Products, which were to hit the market in 2009, will be especially impacted. But the seriousness depends on the company and the importance of the facility." Ranbaxy, for example, has seen its stock price fall sharply since news broke of the warning letters and charges of falsified data and test results in approved and pending drug applications from its Ponta Sahib facility. The FDA invoked its 'application integrity policy' against Ponta Sahib facility. While it is assessing the validity of the data and information in all of Ranbaxy's applications with respect to Ponta Sahib site, it has stopped review of any new or pending drug approval applications that contain data generated by the facility. Analysts do not expect the issues to be resolved within the year and this could affect potential sales of Ranbaxy in 2010. Cipla also received '483' notices at its Bangalore facility in April, which could reduce the comfort level of its partners, since it follows a partnership-based model. In November, Sun Pharma's US subsidiary, Caraco Pharma, received a warning letter for its manufacturing facility and the FDA is withholding approval of pending new drug applications from that facility. "Increased regulatory risk would be an overhang in the near term and reflect on the sector’s valuations until the issues are resolved," said Mr Singhal.

FDA-approved inspectors plan short-notice audit of trials

NEW DELHI: Drug Controller General of India (DCGI) is planning random audit of clinical trial sites across the country on a regular basis by this

June and will suspend any human experiment if the research organisation is found violating the guidelines. The move comes in the wake of successful audits over the last few months that enabled the drug regulator to efficiently monitor the human trials, a health ministry official said. Under the scheme, a team of drug inspectors will walk into clinical trial centres at short notice and audit the internal processes and the clinical trials data. “The audit programmes that we had run in last few months have been very successful. The team of US Food and Drug Authority (USFDA) that trained our drug inspectors through workshops for conducting audit are also very satisfied with the process. Now, we plan to do such audits on a regular basis in each zone—North, South, East and West,” DCGI Dr Surinder Singh said. The USFDA had trained 24 officials from the health ministry to conduct such audits. These people then trained state drug inspectors. The trained state drug inspectors will now do regular audits in each zone and hence keep a tab on human experiments going on across the country. While the first phase of the training was funded by the USFDA itself, the second phase of training state drug inspectors was funded by the World Health Organisation, an official said. According to Dr Singh, the audits will be conducted at a short notice and if required, we may suspend the clinical trials as well. The drug regulator had earlier suspended clinical trial for a vaccine by US drug maker Wyeth, following the death of an infant. The DCGI had also ordered a first ever audit of the trial sites. While recently the DCGI decided to allow the company to go ahead with the trial, the drug regulator removed the ban only from 11 hospitals out of 12 where the trials were being carried out. “The ban continues to be there on the trials at Bangalore’s St. John’s Hospital,” the official said. The idea is to keep a check on unethical experiments on human beings as well as to improve the tarnished image of the country in regulating human experiments. It is believed that Indians are treated like guinea pigs in clinical trials due to lack of expertise and adequate infrastructure to conduct trials. Experts also say that very few pathology laboratories in India follow good laboratory practices and the data generated by several pathology labs are often fake. According to estimates of ministry of health and family welfare, clinical research market in India is more than $389 million and is expected to be around $ 1 billion by 2010.

Ranbaxy acquires dermatological firm

MUMBAI: Ranbaxy Laboratories Ltd said late on Thursday it has acquired trademarks, product dossiers and marketing rights from Ochoa Laboratories Ltd
for its entire range of dermatological and lifestyle products. Ranbaxy already has a presence in the dermatology market including steroids with products such as Zole-F, Suncros, Efflora, Fucidin and Teczine, it said in a statement. It did not provide any financial details.

Dr Reddy's announces reorganisation of its drug discovery biz

Hyderabad: Drug firm Dr Reddy's Lab (DRL) on Thursday said it will hive off its drug discovery business to a wholly-owned subsidiary, Aurigene, and

will close the Atlanta Research facility in the US. From July 1, 2009 onwards, all the resources used for drug discovery business including employees, facility and infrastructure will be transferred to Bangalore-based Aurigene, DRL said in a statement. "Aurigene, a wholly-owned subsidiary of Dr Reddy's Lab will now operate out of two sites Bangalore and Hyderabad," the company said. Besides this, Dr Reddy's would also create a new group to focus on proprietary products development, which will be responsible for building branded research and development portfolio in collaboration with various partners and service providers. All the existing intellectual property rights will be owned and managed by the new unit, the company said. As a part of the reorganisation, the company will close its Atlanta-based research facility in US, it added.

Indoco to supply Rs 50-cr worth diabetic tablets in Germany

MUMBAI: Phara firm Indoco today said it would supply Rs 50-crore worth Metformin, anti-diabetic, tablets per annum to Germany for two years towards

the AOK tender. AOK, Allgemeine Ortskrankenkassen, is Germany's biggest health insurance company, rendering services in medical care for over 10 decades. "Metformin is one of the top selling products in Germany, in terms of volume. This order marks a milestone achievement in Indoco's endeavour to propel the international business to higher altitude," Indoco Remedies's Chairman and Managing Director, Suresh G Kare said in a release. Indoco commenced supplies of finished formulation to Germany in 2005. The company has a turn over of USD 100-million and employs 3,000 people in 35 countries.

Pfizer ties up with Claris for injectables

AHMEDABAD: World No 1 pharma company Pfizer on Wednesday announced a marketing tie-up with Rs 800-crore Ahmedabad-based Claris Lifesciences, that

specialises in injectables. The pact will give the Indian company wider access for 15 of its products in the highly regulated markets of North America, Europe and Australia. Pfizer will commercialise the products which have gone off-patent in the western markets under its own brand name, thereby giving itself an edge with a wider portfolio of generic drugs.

The pharma MNC's latest tie-up, that comes close on the heels of a similar tie up with another Indian company Aurobindo Pharma, is in tune with its two-year old strategy to enter into partnerships with generic firms. As per its pact with Aurobindo, the MNC will market 60 drugs of the Indian company in 70 countries. Talking to ET Pfizer's senior vice-president Kelvin Cooper said "The worth of company's off-patent drugs is close to $11 billon and if we do nothing about it, the revenues will continue to decline." with the global generic business set to rise from $230 billion to $500 billion by 2012, it is a planned strategy to tap this segment, Mr Cooper said. Pfizer, he said, is open to more such tie-ups in the generics space. Claris managing director Arjun Handa, who saw the partnership through,said Pfizer's marketing muscle would ensure wider reach for his products. On his company's IPO plans, he said, the company eventually plans to go public, but was awaiting for the right time.

The partnership is part of the big pharma's shift to generics markets, he added. Pfizer, whose global annual sales of generic products is around $10 billion, said it evaluated 20-30 companies before finalising the agreement with Claris. While the financial terms of the deal were not disclosed, the MNC will get marketing rights for 15 injectable products covering a broad range of therapeutic products in areas like anti-infectives and pain.

Dept of Pharmaceuticals calls brainstorming session on R&D on May 26

Mumbai: The Department of Pharmaceuticals (DoP) has called a government-industry meeting on May 26 to discuss the issues pertaining to research and development (R&D) in pharma sector. All major industry associations, with the exception of OPPI, have been invited for the meeting.
The meeting, which will be a brainstorming session, will discuss on R&D capabilities in private and public sectors, the issues pertaining to human resources in R&D, elaborative research and public-private partnership in R&D, etc. Apart from industry associations like IDMA, BDMA, SPIC, FOPE, CIPI and IPA, NIPER has also been invited for the meeting.
The brainstorming session will be held at India International Centre (IIC) in Delhi. The government has specified that only issue related to research and development (R&D) in pharma sector will be discussed in the meeting.
The meeting holds significance as it coincides with the formation of new government at the Centre. The Union health ministry will be under a new minister in a day or two and the department wanted to prepare a document related to the issues pertaining to R&D in pharma sector. Sources said that since the Union Budget is yet to be presented by the new government, the DoP wanted to be in readiness to press for the industry's demands related to R&D sector. In fact, the industry was looking for several benefits in the Union budget last year presented by P Chidambaram to encourage R&D in the pharma sector, but was disappointed as no major benefits were announced in the last budget.

Malvinder Singh steps down as chairman, CEO & MD of Ranbaxy

Mumbai: Malvinder Mohan Singh has stepped down from the positions of chairman, CEO and managing director of Ranbaxy with immediate effect. Atul Sobti, currently Ranbaxy's COO, has been appointed as CEO and managing director. Dr Tsutomu Une, non-executive director of Ranbaxy, has been elected as chairman of the board.
Commenting on these changes, Takashi Shoda, a director of Ranbaxy and the CEO of Daiichi Sankyo, which owns 63.92 per cent of Ranbaxy's outstanding shares, said "We very much appreciate the efforts of the Singh family, which grew Ranbaxy from a small, local Indian company to the large multi-national company it has become today. We especially acknowledge the contributions of Singh. His strategic vision and passion for the pharmaceutical industry will be missed in Ranbaxy's operations. We wish him continued success as he pursues his many other business interests. Shoda also said "I am pleased that Sobti has been appointed as CEO and managing director, providing continuity at the senior management level."
"It was a difficult decision to separate from Ranbaxy," said Singh, "but it was the right time for me to do so. I leave with complete confidence that the initial transition phase that followed Daiichi Sankyo's acquisition of majority shareholding interest in Ranbaxy has been completed successfully; and that the company's excellent team of management colleagues are well-positioned to take full advantage of the company's growth opportunities."
Sobti has held the role of chief operating officer at Ranbaxy since January 2007 and has been a senior executive at the company from October 2005.
Dr Une is currently a non-executive director of Ranbaxy, a post he has held since December 2008, and is senior executive officer and member of the board of Daiichi Sankyo.

Drug export quality certificate to be issued only by DGCI

New Delhi: The Drug Controller General of India (DGCI) has decided to withdraw the powers given to State-level regulators to issue export quality licence, technically called Certificate of Pharmaceutical Products (CoPP). The move is to centralise pharmaceutical sector regulating.
Speaking to this reporter, Dr Surinder Singh, DGCI, said, “The power to issue CoPP was given to the State regulators earlier outside the Concurrent List. Therefore, now we are going to take it back to bring uniformity in regulations. We will notify this in over the next month or so.”
CoPP is internationally recognised by national drug regulatory authorities for establishing the status of medicinal products under a national drug product licensing system. The certificate is specific to a product and the country of import. The DGCI gives the certificate for a product for two years.
“Pharmaceutical exporters have been experiencing problems in international markets on account of delays in getting government approvals. By centralising the activity, the DGCI can keep a tab on the time line and ensure that exporters get the certificate without any delay,” said Mr Singh.
However, drug-makers in non-metro areas may find it tedious to get the certificate as they will have to travel to the DGCI headquarters instead of applying to the local authorities. To address such concerns, the DGCI is IT-enabling its systems, which will allow manufacturers to apply and receive approvals online. There is also a proposal to increase the duration of the certificates to five years so that manufacturers need not approach the regulator for renewal every two years

Indian pharma players to benefit from generic drugs in US

MUMBAI: Increased use of generic drugs helped the US healthcare system save billions of dollars over the last decade. A recent report by the Generic Pharmaceutical Association in the US (GPhA) says that generic drugs saved the healthcare system more than $734 billion in the last decade, a trend that could be good news for Indian pharma players with a strong presence in the US.
"In 1984, it was predicted that the Hatch-Waxman Act would save the US $1 billion in the first decade. Now, generic medicines save more than that every three days," GPhA president and CEO Kathleen Jaeger told ET in an emailed response. "These savings are truly remarkable and demonstrate the real value of generic medicines for consumers and the entire health care system."
According to GPhA's analysis, high growth rates were driven by factors such as increase in the overall percentage of generic utilisation (from 61% in 2006 to 69% by 2008) and loss of patent protection by several brand-name blockbusters such as Pravachol, Ambien, Fosamax, Zoloft and Zocor.
This is good news for Indian pharma players like Lupin, Sun Pharma and Ranbaxy, who have a major presence in the US. According to IMS' annual ‘Global Pharmaceutical and Therapy Forecast’, the US pharmaceuticals market will be worth about $300 billion in 2009. Exports have become an important growth driver for this industry in recent years with more than 50% revenues coming from overseas markets, particularly the US. According to Indusview Advisors, in February 2009 alone, large and mid-sized Indian companies secured approvals for 15 abbreviated new drug applications (ANDAs).
Lupin MD Kamal Sharma said: "The change in policy coupled with numerous drugs going off patent in the next few years is a huge opportunity for Indian industry to address between 2009-2013. Though there is stiff competition from the likes of Teva, Mylan and Sandoz , we expect to grow this market through additional product launches. The US has always been a major focus area for us and we expect to maintain our growth momentum."
Industry analysts also estimate that brand products with approximately $90 billion in annual sales globally will lose market protection between 2009 and 2012, including mega-sellers as Lipitor, Plavix, Singulair and Viagra, increasing the opportunity for Indian companies. "With increased spending year on healthcare year on year, governments are pushing for generic substitution to reduce healthcare costs. The generic companies, such as Ranbaxy, have played a significant role to support such government programs and the potential is still huge," an industry expert said.
However, Big Pharma companies like Pfizer are also looking at this lucrative segment and intend to push more branded generic products, providing increased competition to Indian companies. Bill Kennally, Pfizer's regional president of established products in the US told ET: "While the overall US market is expected to show modest growth, Pfizer will stay competitive in the generic sector by launching 39 off-patent products which are licensed from Aurobindo Pharma."
Pfizer plans on introducing generic products in various categories; its generic subsidiary Greenstone, is exploring opportunities to expand the US generic presence through acquisitions or partnerships.
Teva, one of the largest generic players in the US, declined to comment when contacted.
The GPhA report also says that increased savings would result from increasing funding for the USFDA, creating a workable pathway for biogenerics and expanding utilisation of generics. "Greater savings can be achieved by encouraging greater use of FDA-approved generic medicines in publicly-funded prescription drug benefit plans such as Medicaid, Medicare and other federal and state programmes. Based on the current generic utilisation rate and the average costs per brand and generic prescriptions, a 3% increase in generic use nationally would generate approximately $9 billion in added savings annually. In addition, an increase in the Medicaid generic drug utilisation rate of just 3% would result in an additional $1.4 billion in savings each year," Ms Jaeger said. With a change in policy towards generics by the Obama administration, GPhA feels that even with flat or modest growth over the next couple of years, the generic industry could provide as much as $1 trillion in cumulative savings by the end of this decade.

Cancer drugs may come under NPPA lens

MUMBAI: Cancer drugs may soon come under the purview of India’s drug price regulator, as they have become too expensive for the common man to afford, according to Drug Controller General of India (DCGI) Surinder Singh.
The move could hurt the margins of multinational companies, such as Sanofi-Aventis, Pfizer, Roche, GlaxoSmithKline and Eli Lilly, who enjoy a near monopoly in the category, also populated by Indian drug-makers Dr Reddy’s, Natco and Dabur.
Mr Singh told this reporter on Tuesday that he has recommended that cancer drugs be brought under the National Pharmaceutical Pricing Authority (NPPA). “As the DCGI, I have outlined the technical inputs and rationale behind the suggestion for the inclusion of new drugs. Cancer drugs, in particular, should be included, since they are expensive and beyond the means of the common man,” he said.
A final decision on this will have to be taken by the department of pharmaceuticals. According to a pharma analyst, oncology is still a small segment for Indian firms, but they have a number of products in the pipeline over the next two to three years.
“It (the price regime) would be a negative for MNC companies, as the return on investment will take longer,” said the analyst, who asked not to be named.
This may lead firms to launch their oncology drugs in other emerging markets instead of India. Cancer, the second-largest non-communicable disease, accounts for 3.6% of the total deaths in India. According to a study published in the Indian Journal of Cancer, more cases were projected in the 45-55 and 65-70 age groups for women and men, respectively.
Oral and lung cancer in males and cervix and breast cancer in women account for over half of all cancer deaths in India. The Indian breast cancer drug market alone is expected to double from $35 million in 2007 to $64 million by 2012.

Karnataka drugs control dept issues over 3000 show cause notices, suspends 1,000 licenses

Bangalore: Karnataka drugs control department has issued a total of 3,768 show cause notices, suspended 1,398 licenses and cancelled 921 licenses of both manufacturers and the pharmacy outlets during the period ending March 31, 2008-09.
During the year a total of 88 prosecution cases were filed in the court. In addition, there were 69 cases disposed and 50 convictions carried out. Around 178 complaints received from the public are being investigated.
In the government drug testing lab, a total of 3,311 samples were analyzed of which 240 were declared not-of-standard quality and investigations are being carried out.
Drugs like diclofenac sodium tablets manufactured by Ankur Drugs and Pharma and MoxMac-500 capsules produced by Everest Formulations also at Salon district in Himachal Pradesh were found to be not-of-standard quality.
Saffron Biotech P Ltd which is located at the HSIDC in Haryana was engaged in the production of Ranitidine Hydrochloride and was found to be of not-of-standard quality and its sales were banned in Karnataka. Another company, Pharmadeep Remedies in Hyderabad which produces cetirizine dihydrochloride syrup was intimated that its product did not approve the required quality standards.
According to Dr BR Jagashetty, Karnataka Drugs Controller, the regular investigations have helped to seize the not-of-standard quality drugs. The presence of a full-fledged lab has now led to ensure constant monitoring of the drug quality. "We have warned the pharmacy outlets and the medical care centres in the state not to sell or use the drug if they had stocks," Dr Jagashetty said.
Among the offences brought to the notice of the Special Court for Economic Offences, Bangalore, the proprietor of Re-Life Clinic was convicted for stocking Schedule H drugs and fined Rs 6,000. Family Medicals in Bangalore was found to stock drugs without license and failing to disclose the source of the medicines. Panchvati Chemists and Druggists was found to sell expiry dated drugs and convicted for the offences under the Drugs & Cosmetics Act. A pharmacy outlet Sri Vinayaka Medical Hall was found to sell Scheduled drugs without the presence of a qualified pharmacist.
In addition, the Additional CJM Court at Mysore also convicted the proprietors of Olcare Laboratories at GIDC Estate at Wadhwan City for manufacture of not-of-standard quality drugs.
"The constant checks will only help to maintain the quality standards in the State. We have found that companies in Karnataka have been adhering to the required quality standards. But units located outside the state especially the excise free zones in the north have found to produce poor quality drugs. The need of the hour is surprise inspections which will help to clamp down the violators of the Drugs & Cosmetics Act," informed Dr Jagashetty.

Dept of Pharma to organise international meet on pharma industry in Mumbai in Nov

New Delhi: The Department of Pharmaceuticals, in association with FICCI and other pharma organisations, is organising an international conference on pharmaceuticals in Mumbai on November 30, ahead of the proposed CHI happening from next day, to showcase strength of Indian companies.
A meeting, called by Pharma secretary Ashok Kumar recently, decided to organise the event in a bid to lure the big traders from the developed countries and thereby giving a fillip to the exports from the country by showcasing the strengths of the domestic industry. The meeting was attended by joint secretary Arun Jha, deputy secretary Paresh Johri, representatives from organisations like SPIC, IDMA, BDMA and OPPI, experts from UNIDO, Pharmexcil and CPhI organisers to chalk out the detailed plan for the event.
The event will showcase the strength of Indian companies for meeting global requirement of quality medicines as a vision of 2020. This year event will be novel drugs and drug discovery. The government could consider luring visitors from Vietnam, Korea, CIS countries, South Africa etc. Members who want to suggest the name of prominent members can forward the same to us and all efforts will be made to call those prominent persons at the cost of government, it was decided.
Pharma associations suggested that conference should also involve segments like medical devices, pharma machinery and excipients industry. Besides, there was also suggestion to extend 50 per cent concession to the small and medium pharma units to take part in the exhibition.
"Focus will be on inviting big traders mostly from Europe who get the major share of WHO tenders to come to India as guests along with the consumer organizations of developing countries and the regulatory authorities of focus countries to come to India to see our commitment to quality drugs at affordable prices by arranging visits to SME sector units all over the country. This is essential to remove the stigma of spurious drugs being originated from India," an official said.
The conference, in general, will emphasise India as a destination of quality generic medicines at affordable prices for all range of customers besides demonstrating the capabilities of the country in the field.

CDSCO port office in Bangalore to be ready by month end: DCGI

Bangalore: The Drugs Controller General of India (DCGI) has now formally granted permission for the setting up of a port office or export facilitation centre at the Bengaluru International Airport. In this connection, the State drugs control department and the DCGI met here to chalk out an action plan to kick off the operations by the month end. The setting-up of the port office will have a positive cascading effect including bringing down cost overheads and prevent inordinate delays for pharma manufacturers here. It also viewed to provide the much-needed boost to several green field initiatives.
The new port office has appointed Manivanan as assistant drugs controller to over see the operations. The State requires a dedicated port office as the increasing number of companies focusing on international sales.
Right now we have assigned a room for the port office. The long pending port office will streamline the logistics and save time for the pharma exporters in the State. Karnataka exports both bulk and formulations. So long Karnataka pharma sector had to dispatch all its consignments to Chennai and furnish the details of the products. Now the dedicated port office here will prevent any further delays. It was also proving to be cumbersome for the companies to transport drugs to Chennai stated Dr Surinder Singh, DCGI.
The demand for a port office was mandated by the Karnataka Drugs Pharmaceutical Manufacturers Association (KDPMA).
It has been mandatory to have an independent office in Bangalore which accounts for over Rs 2000 crore of earnings. The State's total pharma earnings is estimated at Rs 3850 crore ending March 31, 2009 of which exports account for 8 per cent. The leading exporters are Biocon, Micro Labs, Bal Pharma, Medriech, RL Fine Chem, Strides Arcolab to name a few.
Current area for the port office is 150 sq. ft. and will be expanded based on the volumes. Once the facility is commissioned, we will look at expansion based on the requirement. Efforts are also made to have two drug inspectors at the port office here, stated Dr. Singh.
According to Dr BR Jagashetty, Karnataka drugs controller, the department is a big relief. Going forward, the companies and the port office is a turning point in the pharma exports for the State. It will demonstrate the faster turnaround and efficiency of the exporters.
The port office was a long overdue. There will be both increased exports and investments of new units, stated: Anjan K Roy, president, KDPMA and MD, RL Fine Chem.
Currently CDSCO port office for exports of pharmaceuticals is located at Chennai and the manufacturers were finding it difficult to coordinate. Now the port office will give a fillip to our activities, stated, Kaushik Desai, CEO & director, Global Pharmatech.
In addition, Karnataka is also setting up a sub-zonal office of the CDSCO located within the State drugs control department which is expected to be operational by July.

Friday, May 1, 2009

World closer to swine flu pandemic

MEXICO CITY: A new virus has killed up to 149 people in Mexico and the World Health Organization moved closer on Monday to declaring it the first flu pandemic in 40 years as more people were infected in the United States and Europe

The WHO raised its pandemic alert level for the swine flu virus to phase 4, indicating a significantly increased risk of a pandemic, a global outbreak of a serious disease.
The last such outbreak, a "Hong Kong" flu pandemic in 1968, killed about 1 million people.
Although the new flu strain has so far killed people only in Mexico, there were more than 40 confirmed cases in the United States, including 20 at a New York City school where eight cases were already identified.
In Mexico City, fearful Christians paraded a centuries-old statue of Jesus, believed to protect against disease, through the streets for the first time in more than a century.
The swine flu is not caught from eating pig meat products, but several countries imposed import bans on pork from the United States. Stocks in companies such as airlines were also hit as investors worried about the impact on travel.
Spain became the first country in Europe to confirm a case of swine flu when a man who returned from a trip to Mexico last week was found to have the virus.
Texas health authorities confirmed a third case of swine flu at a school near the Mexican border and California said it now had 11 confirmed cases.
The US State Department and the European Union urged citizens to avoid non-essential travel Mexico and other areas affected by swine flu.
Mexico relies on tourism as its third biggest source of foreign currency and millions of Americans travel there every year.
Mexican Health Minister Jose Angel Cordova said the outbreak was now suspected of having killed 149 people and warned the number of cases would keep rising.
Thirty-three million Mexican schoolchildren will be off school until the middle of next week as authorities seek to contain the outbreak. Schools in the sprawling capital had already been closed but the government ordered classes canceled across the country until May 6.
Most of the those who died were between 20 and 50 years of age, an ominous sign because a hallmark of past pandemics has been the high rate of fatalities among healthy young adults.
Worldwide, seasonal flu kills between 250,000 and 500,000 people in an average year but the new strain worries experts because it spreads rapidly between humans and there is vaccine for it.
Spain became the first country in Europe to confirm a case of swine flu when a man who returned from a trip to Mexico last week was found to have the virus.
Texas health authorities confirmed a third case of swine flu at a school near the Mexican border and California said it now had 11 confirmed cases.
The US State Department and the European Union urged citizens to avoid non-essential travel Mexico and other areas affected by swine flu.
Mexico relies on tourism as its third biggest source of foreign currency and millions of Americans travel there every year.
Mexican Health Minister Jose Angel Cordova said the outbreak was now suspected of having killed 149 people and warned the number of cases would keep rising.

Thirty-three million Mexican schoolchildren will be off school until the middle of next week as authorities seek to contain the outbreak. Schools in the sprawling capital had already been closed but the government ordered classes canceled across the country until May 6.
Most of the those who died were between 20 and 50 years of age, an ominous sign because a hallmark of past pandemics has been the high rate of fatalities among healthy young adults.

Worldwide, seasonal flu kills between 250,000 and 500,000 people in an average year but the new strain worries experts because it spreads rapidly between humans and there is vaccine for it. 

Healthcare to get a shot with 'auto-disable' syringes

MUMBAI: The country’s healthcare delivery system is set to get a safety shot, with a government mandate on the use of auto-disable syringes (AD) coming into effect in end-April. A legislation signed late last year requires all central government hospitals under CGHS to use only auto-disable (AD) syringes to avoid the spread of disease. 

AD syringes are designed for a single use, with a lock that prevents reuse and eliminates unauthorised packaging or even resale. In a study conducted in 2005 by the Union government and Indian Clinical Epidemiology Network, 62% of injections were found to be unsafe because of the reuse of syringes.

Marc Koska, CEO and founder of SafePoint Trust, a UK-based charity organisation that advocates the use AD syringes, especially in developing countries, said, “It costs 10% more to make a conventional syringe into an AD syringe. The price in the market is not too different either. A conventional syringe costs Rs 2, while an auto-disable syringe costs Rs 2.50.”

However, despite the deadline being just a few days away, Mr Koska said only five states have placed orders for AD syringes so far: Maharashtra, Karnataka, Andhra Pradesh, Uttar Pradesh and Gujarat.

The sting — for the government as well as manufacturers — is in the heavy costs. Industry observers say only one manufacturer in the country makes AD syringes. Moreover, in government tenders, conventional 2 ml syringes sell for 90 paise while ADs sell for Rs 1.5.

JM Narsing Rao, managing director of Sangam Healthcare Products told ET, “The design for AD syringes is patented and we will have to pay a lot to buy the rights to the patent. From a manufacturing standpoint it is only the addition of another mould to the process. The rest of the machinery remains the same.” None of the developed countries have mandated the use of AD syringes, he said, adding his company would shift to AD syringes if mandated.

However, Mr Koska clarified that patent holders are willing to share their designs for free or at a nominal cost. “It's true that none of the developed countries have mandated the use of AD syringes. They count on the system to work well and not reuse syringes. In developing countries, however, where the risk of disease prevalence is much higher, many countries have found it to their advantage to shift to AD syringes,” he said.

Narendra Jain, secretary of the All India Syringe and Needle Manufacturing Association (AISNMA) said the capacity for manufacturing conventional syringes in India is at around 1,000 million units per month, whereas the capacity for AD syringes is almost nil, incurring huge foreign exchange expenses on imports.

“It will almost be a monopoly of one or two companies in India, which is unfair to all other manufacturers. On the contrary, it will also attract the MRTP (Monopoly of Restricted Trade Practice) Act,” he added.

The change-over from manufacturing conventional to AD syringes will involve considerable investment for every unit, which in turn will be an additional burden for the country, without the added benefit of an increase in production capacity, he said.

According to AISNMA, the syringe market in India is currently worth Rs 2,000 crore and is growing at 10%.

Per capita consumption in India, he said, was low, with a person takes 7-8 shots per year on an average. In rural areas, reuse of conventional syringes is common.

In the US, it is at an average of 28 syringes per person per year. "If the government can control the reuse of conventional disposable syringes, this figure can see a four-fold increase," Mr Jain said, adding, the law has been misinterpreted.

"It is only for immunisation programmes, but has been misread as being for all types of syringes. The government should clarify that they do not plan to ban conventional syringes." 

Pharma industry insulated from eco downturn says Biocon Chief

BANGALORE: The pharmaceutical industry in the country is insulated from the global economic slowdown, Biocon Chairman and Managing Director Kiran Mazumdar-Shaw on Tuesday said. 

"The pharma industry in general was not impacted and instead was insulated from the economic downturn," Mazumdar- Shaw told reporters here.
"We in
India can infact leverage the global approach to reduce cost of healthcare. India is already a popular health destination because of cost effectiveness," she said.
 "(US) President (Barack) Obama's call for bio-generics and affordable healthcare heralds a new era for Biotherapeutics. Our pipeline of bio-generic monoclonal antibodies and insulins supported by strong manufacturing base, provides us with a unique opportunity to build partnerships with key players in this segment", she said

Pfizer may buy RFCL's veterinary co for Rs 250 cr

BANGALORE | MUMBAI: GlobaL pharma giant Pfizer has emerged as the frontrunner to acquire RFCL’s animal health unit, Vetnex, in a deal estimated around Rs 250 crore, people familiar with the situation said. This follows the ICICI Venture-controlled RFCL’s move to divest its animal health business earlier this year. 
Pfizer is in advanced talks with RFCL — and possibly close to a deal — to acquire the unit, leaving other potential bidders out of the race. ET first reported on the RFCL (formerly Ranbaxy Fine Chemicals Ltd ) decision to sell the unit in March this year.
When contacted, an ICICI Venture official refused to comment on individual portfolio companies or deals. A Pfizer spokesperson said the company does not comment on market speculation or rumours regarding acquisitions. 

Pfizer has been exploring opportunities to bolster its animal health business, estimated below Rs 100 crore. 

Sanofi Aventis and Virbac — the others who reportedly evinced an interest in the RFCL unit — have also been on the prowl to grow their veterinary healthcare operations in the country. Virbac had acquired GSK India’s animal healthcare division in 2006. RFCL’s animal health unit Vetnex is believed to have annualised turnover in the region of Rs 120 crore. Sectoral analysts said that veterinary business with indigenous molecules attracted 1.5-2x valuations in M&A discussions. 

Vetnex, which has a presence in poultry, livestock and companion pet-healthcare verticals, acquired the Chennai-based Alved Pharma & Foods last year in a bid to scale up the business. Vetnex is believed to be the third-largest player in the Rs 1,400-crore domestic animal health market, which is growing annually at 10%. Scaling up business, both in terms of market penetration and size, remains a challenge for the segment. 

MNC firms, including Vetoquinol, are in the fray to buy Wockhardt’s animal health business. On April 25, Wockhardt informed the stock exchanges that its board of directors approved the sale/transfer/disposal of the animal healthcare business





Local drug cos may chip in to treat swine flu

NEW DELHI: The swine flu outbreak, classified by the World Health Organisation as a “public health emergency of international concern”, may see


Indian drug makers pitching in with the generic version of the antiviral Tamiflu as the world looks for quick, affordable options to counter the infection.

“We have already received proposals from people on behalf of countries in Latin America, Mexico and Israel. We have the capability to supply 1.5 million dosages of the drug within 4-6 weeks,” said Amar Lulla, joint MD, Cipla.

Cipla and other Indian pharma majors can now legally manufacture generic versions of Tamiflu after the patent office in Delhi last month rejected a patent application by Swiss company Roche, which markets the antiviral in India. With this, Indian companies can export the generic versions to countries where Tamiflu is not patented.

Even in countries where Roche holds the patent, the government concerned can issue compulsory licensing, which essentially means waiving the patent to allow generic players to supply drugs in public interest.

The swine flu outbreak that was first reported from Mexico has so far claimed over 100 lives and has now spread to Canada, parts of Europe, and at least five states in the US, where it has already been declared a public health emergency.

Swine flu, or swine influenza, is a form of the virus that normally infects pigs. There are many forms of flu, and the different varieties have the ability to exchange genes with one another. The form of flu that originated in Mexico is a genetic mixture of viruses that have been seen in pigs, birds and people.

In 2006, when the bird flu outbreak took place, Cipla and Ranbaxy had supplied the antiviral to some Asian countries after the respective governments intervened to buy the generic version.

"The Indian government already has a stockpile of Tamiflu which it procured during the bird flu outbreak, and one million more will be procured," said to Dr VN Katoch, Director General, Indian Council for Medical Research (ICMR).

The joint secretary in the health ministry Debasis Panda said that a generic drug in the market definitely makes a difference in terms of affordability and availability. However, since the judgment against Roche has come only recently, it remains to be seen how much time they would take to translate it in terms of availability.

Mr Lulla said he is yet to hear from either the WHO or the health ministry, but his company is ready for any eventuality. Cipla's stocks at the Bombay Stock Exchange (BSE) gained Rs 4.35 or 1.82% on expectations that the Mumbai-based company may get a huge order for the drug.

Cipla sells the drug at Rs 1,000 ($20) for 10 days (a typical course is five days), which is much cheaper than the patented ones. The shares of Biota Holdings, which markets GSK's antiflu drug Relenza, jumped 82% on Monday on the Sydney Stock Exchange.

Tamiflu (Oseltamivir Phosphate) is a drug developed by American company Gilead, and Roche has the marketing license for the drug in India. At present, Hy-derabad-based Hetero has an agreement with Roche to develop and market generic Tamiflu.



Roche to tap tissue diagnostic biz here

KOLKATA: Roche Diagnostics India, a wholly-owned arm of Swiss pharma and diagnostics major F Hoffmann-La Roche, plans to expand its India footprint by foraying into the tissue diagnostic segment. It plans to roll out tissue diagnostic systems, which will help in faster and easier diagnosis of cancer and infectious diseases. 

This will be in conjunction with substantial investment on clinical research for generating India-specific data for both, new product development, and marketing existing products. Roche plans to consolidate its Indian operations over the next 3-4 years and emerge as one of India’s top healthcare diagnostic equipment companies.

Talking to ET, Roche Diagnostics India CMD Bhuwnesh Agrawal said the tissue diagnostic products would enable doctors and pathologists to undertake analysis of tissue samples.

“We got this portfolio by virtue of Roche’s global acquisition of US’ Ventana Medical Systems. It will help us to expand our presence in India,” he said. Globally, the diagnostic division has a revenue of around $9 billion and accounts for nearly 20% of Roche’s overall turnover.

Roche is one of the world’s leading players in the in-vitro diagnostic devices segment — products used to test blood, other body fluids and tissues.

Roche Diagnostics India is also planning to focus on rolling out products which are targeted around the main disease burden of India. “For instance, we are looking at rural and child healthcare in a major way. This includes products to diagnose and prevent cases of maternal mortality, sepsis, TB, renal function and cardio-vascular diseases,” said Mr Agrawal.

In line with this, the company on Monday announced the launch of a new diagnosis device for heart failure — NT-proBNP. Roche feels this product will help doctors to diagnose the risk of developing heart disease and its management in a cost-effective manner. The test is likely to cost around Rs 1,000 to Rs 1,200 for patients in India.

Roche also plans to undertake clinical research in a major way in India. “We have recently undertaken a study of 15,000 subjects on blood transfusion systems in Delhi. Such studies will generate clinical data that will help us to devise product standards since the genetic make-up, weight and height of Indian people are quite different. Such clinical research will provide medical value to pathologists and doctors here,” said Mr Agrawal.


Yash Birla to take ayurvedic wellness biz abroad

MUMBAI: The Yash Birla group is considering an overseas foray for its ayurvedic health and wellness centres, but this would be done only after consolidation of its domestic operations, a top group official said. 

"It (overseas foray) is something that we will definitely undertake. And it would be much bigger than what we do in the domestic space," Yash Birla Group Chairman Yash Birla told PTI here.

The group runs its ayurvedic business in a joint venture with Kerala Vaidyashala, having recently bought a majority stake in the Kerala-based entity. It has plans to invest Rs 50 crore and set up 200 ayurvedic wellness centres pan-India over the next five years.

The market potential for take-home ayurvedic products is estimated to be in the range of Rs 2,500-crore

The group's ayurvedic business is still in the evolving stage and "we need to stabilise it here in the domestic market before venturing abroad," Birla said.

The Rs 3,000-crore Yash Birla Group is a conglomerate of over 20 diversified companies operating across sectors such as auto and engineering, wellness and lifestyle, education and IT, textiles and chemicals, power and electrical.

The company as such did not have a ready business plan for an overseas foray presently but it would endevour to tap the international market, Birla said.

The ayurvedic therapy chain offers treatment for lifestyle and chronic health disorders which conventional medicines may not be able to treat effectively.

The group would be launching its ayurvedic medicines business next month, he said.

"We are launching some 65 Ayurvedic medicines next month and after that we will come up with cosmetics, which is a separate venture," he said.

The group also plans to launch a more modern contemporary body-shop type of products in the next two months, which will be available in the retail market, he ssaid


Glenmark gets first nod for Zetia generic

MUMBAI: Glenmark Pharmaceuticals has got tentative approval from the USFDA for the generic version of Schering Plough and MSP Singapore Company LLC's hypercholesterolemia treatment Zetia (ezetimibe). 

The company's US subsidiary Glenmark Generics, said this is the first tentative approval granted by the FDA for a generic version of the drug. Glenmark said it has first-to-file status on Ezetimibe tablets, giving it a potential of 180-days of marketing exclusivity.

Glenmark would have the earliest opportunity among any competitors to gain market share from the branded product Zetia which achieved sales of $1.5 billion in 2008. Product launch is dependent upon receipt of final approval of its Abbreviated New Drug Application, or ANDA from the US FDA and resolution of litigation currently pending in the US district court of New Jersey, the company said in a release.

Glenmark filed an ANDA with the USFDA seeking regulatory approval to market a generic version of Ezetimibe on October 25, 2006. Glenmark's ANDA included a Paragraph IV certification with respect to patents listed by Schering The company will also be vertically integrated by manufacturing the active pharmaceutical ingredient for its Ezetimibe tablets.

Glenmark's current portfolio consists of around 40 generic products authorized for distribution in the US market. The company currently has over 40 ANDAs filed with the USFDA pending approval.



Ranbaxy to trim European operation

NEW DELHI: Leading Indian drug maker Ranbaxy Laboratories, which on Friday posted a $153 mn first-quarter loss and forecast for a annual loss, plans to trim its European operations, its chairman said. 

Malvinder Singh told analysts in a conference call his company would cut back on chasing higher volumes and focus on profits from the European markets, where prices have fallen sharply on the back of tough competition and the firm has "barely managed" to breakeven in the past three years.

"We did decide that in Europe we would rather be happier with a more bottom line approach rather than going for volumes ... therefore, we've started pulling back, especially in the UK, recently even in Germany," he said late on Friday.

"And in France, in 2009 we'll give it a good shot, because that's one area, which we still believe that has some promise."

Ranbaxy, in which Japan's Daiichi Sankyo <4568.t> owns a controlling stake, said revenue from the European market fell 14 percent in the March quarter from a year earlier.

The company has been facing trouble in the United States. The Food and Drug Administration (FDA) said in February Ranbaxy had sold misbranded or adulterated drugs in the United States, having earlier banned imports of more than 30 generic drugs.

"We are maintaining a close and regular dialogue with FDA and corrective actions are underway. Our internal team along with regulatory consultants and legal experts continue to work intently towards addressing and resolving all issues that are currently open," Singh said.