India To Probe Alleged Irregularities Within Drug Regulator

The government of India announced an inquiry on the functioning of the main drug regulator, after a parliamentary report exposed dysfunction within the agency and serious irregularities in the drug approval process.

The government said in a statement that it had appointed three experts to look at the scientific basis of approving new drugs without clinical trials and recommend ways of improving the procedures of the Central Drugs Standard Control Organisation (CDSCO).The parliamentary panel accused some officials of the CDSCO of colluding with multinational and Indian drug firms to bypass normal approval procedures.

(Reuters)

Roche to sell cheaper cancer drugs in India

Just days after officials in India stripped Bayer of its exclusive rights to Nexavar, giving a local company NATCO the right to produce it at a deep discount,

Roche has stepped up with plans to slash the cost of two of its blockbuster cancer drugs.  Herceptin and MabThera will be offered in cheaper new versions from an Indian partner.

original report

Indian Patent office invokes compulsory licensing rule, Natco to sell generic version of Nexvar

Bayer has lost a landmark drug ruling in India, forcing it to grant a compulsory licence for its cancer treatment Nexavar to Natco Pharma in a move that could bring down the cost of other pricey medicines.

The Indian Patent Office issued its first ever compulsory licence to Natco, a local generic drug manufacturer, effectively ending the German drugmaker's monopoly in India on the drug for treating kidney and liver cancer. Natco has been allowed to sell the drug at a price not exceeding Rs 8,880 for a pack of 120 tablets required for a month's treatment as compared to a whopping Rs 2.80 lakh per month charged by Bayer for its patented Nexavar drug.

As per WTO agreement, a compulsory license can be invoked by a national government allowing someone else to produce a patented product or process without the consent of the patent owner. It is done for the cause of public health. The move, however, will unnerve international pharmaceutical companies. They are eyeing emerging markets like India as a major growth opportunity but remain worried about intellectual property protection in such countries.

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Wyeth Claims $960M from Sun Pharma In Protonix Case

Wyeth Pharmaceuticals Inc is seeking $960 million in damages from Sun Pharmaceutical Industries for alleged patent infringement in launching a generic version of Protonix ( Pantoprazole) in the United States., The original patent relating to Protonix, is held by Nycomed and was licensed to Wyeth, which is now owned by Pfizer. Sun launched its generic version of Protonix tablets in January 2008 after Teva Pharmaceutical Industries and its US subsidiary began selling the drug in December 2007.

Watson buys Stride's Australia Business

Watson Pharmaceuticals expanded its reach in the Asia-Pacific with a deal to buy Strides Arcolab's Australia-based generics business,( Ascent Pharmahealth) . The buyout not only gives Watson a major presence in Australia, where it becomes the fifth-largest  generic drugmaker, but it also  a  No. 1  position in Singapore.

Statin use linked to more diabetes in women: US study

Cholesterol-lowering drugs known as statins may be linked to an increased risk of diabetes in middle-aged and older women, according to a US study. A six- to seven-year study shown nearly 50 per cent more likely to be diagnosed with diabetes than those not taking statins.

Previous studies, mostly in men, have suggested a smaller 10 to 12 per cent increase in diabetes among statin users.

The conclusion still stands that overall, those people who've got existing heart disease or have had previous strokes, they still would get vast benefit from statins.

India: emerging in Specialty Chemicals

India has slowly becoming a significant player in the international chemicals market. As India's edge in speciality chemicals is more and more visible, it is not just multinationals that are ramping up their sourcing plans from India; even home-grown firms are creating new capacity, increasing productivity and going in for acquisitions. MNC’s like BASF, Clariant, Lanxess, Chemtura etc are already invested significant amount and in the process of investing additional capital to expand their business.

India is expected to drive growth in the $650 billion global speciality chemicals market. India's speciality chemicals industry is expected to grow at a CAGR of 15% - almost double the growth of the global industry. Exports of speciality chemicals from India are poised to grow from $4 billion in 2007 to $13 billion in 2013, representing a CAGR of 22%.

The largest exporter of chemicals in the world is still Europe with $955 billion The EU still accounts for 90% of total chemical exports. They are the world leaders not just in production, but also the largest exporters. The second largest is the USA with $180 billion. India exported just $24 billion which is quite insignificant at this moment.

India has improved from its export figure of $22 billion two years ago, but China had clocked chemical exports worth $88 billion. Japan had $78 billion worth of exports. Though India's growth is good as compared to the past, even fantastic, it is rather small if one compares to China.

Ranbaxy may sale Generic rights of Lipitor if the approval gets delayed

Ranbaxy may sell rights to make a generic version of Pfizer’s Lipitor, the world’s best-selling medicine, should it fail to win timely U.S. approval for the cholesterol pill, said Credit Suisse. 

A legal settlement with Pfizer gave Ranbaxy six months’ exclusivity to market generic Lipitor in the U.S.    Delays in USFDA  approval may prevent Ranbaxy from selling its copies as planned from Nov. 2011.   Lipitor is the highest-selling drug of all time, generating $10.7 billion last year. The most likely outcome will involve Ranbaxy paying a hefty fine to the FDA, which would subsequently clear the path for Lipitor approval.The company and most industry experts remain confident a resolution will be reached in time for Ranbaxy to launch on Nov. 30. 
If the Nov. 30 deadline isn’t met, Ranbaxy may postpone the release of its copycat Lipitor, said  the Credit Suisse report .  This would also delay the timeline for other generic manufacturers wanting to sell their own copies, as Ranbaxy’s 180-day exclusivity period does not start until it begins commercial marketing.   This  delay may  benefit Watson Pharmaceuticals which negotiated with Pfizer to begin selling a so-called authorized generic by Nov. 30. Alternatively, Ranbaxy may waive exclusivity in exchange for payment from a rival generic-drug maker, Credit Suisse said.

Drug R&D spending fell in 2010, and heading lower

The global drug industry cut its research spending for the first time ever in 2010 and the pace of decline looks set to quicken this year. Expenditure on discovering and developing new medicines  estimated to be  $68 billion  in 2010, down nearly 3 percent on the $70 billion spent in both 2008 and 2009, according to Thomson Reuters. 

Since 2000,  investment by drug companies   for NCE  is almost  80 percent of the industry's total R&D  spend  which has increased by more 50 percent ,  but output of  NCE has actually gone down. Last year ,  21  NCE were launched on the global market against 26 in 2009.

 Between 2008 and 2010 there were 55 terminations of projects that had already reached the final Phase III stage of clinical testing, more than double the level of 2005-07, reflecting the growing difficulty of developing new drugs that are better than existing ones.

NPPA Revised prices for Medicines

Prices of 62 drugs, mainly used for treating diabetes and tuberculosis, have been raised while the rates of 14 other medicines have been reduced  ,  prices of 21 drugs have remained unchanged after a fresh review of the pricing of key medicines by the National Pharmaceutical Pricing Authority (NPPA).

The NPPA, which considered rates for 19 drugs for the first time, reviewed prices of drugs used in treatment of diabetes, allergy, malaria, diarrhoea, asthma and hypertension along with antiseptics.

The NPPA also revised prices of four bulk drugs, following which diuretic spironolactone and salbutamol sulphate will be cheaper by 2.5 per cent and 18.87 per cent respectively.

According to it, bulk drug pyrantel pamoate (used in formulations of deworming medicines) and anti-allergic pheniramine maleate will be costlier by 8.12 per cent and 13.87 per cent respectively.

The reduction in prices of formulation drugs has been in the range of 2.47 per cent to 35.04 per cent from the prices claimed by the respective companies.

The price revision included more than 25 anti-TB drugs for which there was no significant increase while sulphadoxine plus pyrimethamine tablets will cost more due to upward revision in the import price of bulk drugs used for malaria.

Superbug

Medical tourism may not be safe in India because the ‘superbug’ possibly originated in India suggested a British  publication and further went on naming notoriously  “New Delhi metallo-blactamase (NDM-1). The growth in the flow of patients from the developed to the low cost developing world for medical treatment has consistently worried the medical fraternity in the West.  In order to slowdown the  patients flow the west came up with the story which  sponsored by  European Union,  The Wellcome Trust, and drugmaker Wyeth  who markets the superbug antibiotic Tygacil  (tigecycline) .

Such antibiotic resistant bacteria have been reported everywhere in the world, including in the UK, the US and the entire developed world for decades. The NDM-1, for instance, has even been detected in Canada, Australia, The Netherlands and Sweden.   So why India to be blamed. Similarly   genesis of MRSA is in the West . So was  West was blamed for a disease that affects the entire world.

Rather than creating controversies around the origin of the bacteria, it is better to focus on the lack of interest among pharma companies to develop superdrugs for such superbugs.

Abbot to acquire piramal healthcare

Abbott India has acquired the healthcare solutions business of Piramal Healthcare to become number one pharmaceutical company in India. The assets to be transferred include the company's manufacturing facilities at Baddi, Himachal Pradesh and rights to around 350 brands.

The deal, which is likely to be completed by September 2010, will entail an upfront payment of $2.12 billion to Piramal. An additional $400 million will be paid annually for next four years.

Going ahead, Piramal will now be left with its CRAMS, critical care business and some OTC businesses.

Two indian comapnies in the list of top 10 US generic player

In a first, two Indian drug firms, Lupin Ltd and Dr Reddy’s Ltd, have made it to the list of top 10 generic companies in the fiercely competitive US market, placed eighth and tenth, respectively, in 2009.

These companies have improved their standing in the $34-billion US generic market. Lupin and DRL have also emerged as the fastest growing among the top 10 generic players in the US market, with Lupin growing at 50% and DRL at 40% just when three big players in the top-10 club have shown negative growth. The US generic drugs market is estimated to grow at a CAGR of 8.8% during 2010-2013.

Lupin and DRL’s growth figures also outshine the average growth recorded by the top 10 generic firms at 6.5% in 2009 and the average growth of global pharma industry at just over 5.5%. While Lupin has climbed two notches up to the eighth position by improving its market share from 2.5% in 2008 to over 3.5% in 2009, DRL has broken into the hallowed league year by bettering its market share to 2.7% from 2.1%, according to the National Prescription Audit conducted by IMS in the US.

FE

Europe halts sale of Indian-sourced drug

European regulators have halted sales of several variants of clopidogrel, a drug widely used to stop blood clots, in a move that raises concerns about increased production of low-cost generic medicines from India. The European Medicines Agency said it had recalled batches of eight separate generic versions of the drug overseen by Acino Pharma, based in Germany, but with the raw ingredients made in India.


The recall will affect Acino, Sandoz, Hexal, and Ratiopharm. The action follows inspections by German regulators at the factory of Acino’s supplier Glochem Industries in Visakhapatnam in India, which concluded that it did not meet adequate “good manufacturing practice”. They however stressed that they had not identified any impurities in the clopidogrel and that its action was “precautionary”, with no consequences expected for patients. However, inspectors were not satisfied with the documentation drug manufacturers are required to maintain in order to prove that a standardised set of procedures are being followed to ensure safe and consistent production. The agency had concluded that “the processes used to manufacture the active substance … could not be trusted”. It said it “did not have sufficient confidence in the quality of the active substance, and this led to a lack of confidence in the quality of the medicines”.


FT

Ranbaxy US unit gets a violation notice

Ranbaxy Laboratories Ltd said on 24th Dec that's its wholly-owned US-based unit Ohm Laboratories Inc has received a warning letter from the US Food and Drug Administration (FDA) relating to violations of good manufacturing practices. The FDA letter, dated December 21, mentions violations at Ohm's liquid manufacturing facility in Gloversville, New York,

The FDA conducted site inspections at the plant in July and August 2009. Ohm Laboratories operates three US-based manufacturing facilities and sells generic and branded private label drugs in the United States.

Ranbaxy said the FDA inspected Ohm's other two plants earlier this year but did not observe any material deviations.Late last year, Ranbaxy had received a US ban on some of its products.

Glaxo has taken 19 % share of Aspen

GlaxoSmithKline has taken a 19 per cent stake in Africa's biggest generic drugmaker, Aspen Pharmacare, after completing a strategic collaboration with the South African group. Earlier Glaxo had originally said it would have a 16 per cent holding when the deal was announced in May.

Aspen has issued 68.5 million new shares to Glaxo in exchange for Glaxo's manufacturing plant in Bad Oldesloe, Germany, and eight specialist medicines.

Selling branded generic drugs in emerging markets is a central plank to diversify Glaxo's business away from its traditional reliance on blockbuster medicines in Western countries. In addition to the tie-up with Aspen, Glaxo also has deals with Dr Reddy's Laboratories and a number of Chinese partners.

The Biosimilars- Future of cure

The future of pharmaceutical industry now seems lies with the biotechnology as there is a growing resistance to the use chemical based drugs world over. Biopharmaceuticals thus becoming the fastest growing segment of the pharmaceutical market today. Nearly a quarter of the top 100 drugs in 2007 were biologics and 13 of them achieved blockbuster status of more than $2 bn in worldwide sales. Both generic drug manufacturers and large pharma companies are angling for a share of this emerging niche in the $75 bn global market for biosimilars. Generic drug maker, Sandoz has already taken the lead on this segment with three biosimilars approved in Europe namely Omnitrope, Binocrit and Zarzio. Teva pharmaceuticals, a leading generics producer, has plans to become a major player in biosimilars. It has one product on the European market (Tevagrastim) and has improved its capabilities in biopharmaceuticals through the recent acquisitions of Barr Pharmaceuticals and CoGenesys in the US. Teva's strategic partnership with Lonza to jointly develop, manufacture and market biosimilars confirms its resolve to enter into biosimilar market in a big way. Merck & Co has recently established Merck BioVentures and agreed to purchase a portfolio of biosimilar candidates and commercial manufacturing facilities from US-based Insmed. Indian manufacturers such as Ranbaxy, Dr. Reddy's Lab, Biocon and Wockhardt, have also plans to venture into biosimilar market by taking approvals in Europe and, ultimately, in the US.

Biosimilar products do attract a lot of interest and controversy. Because, biological drugs are complicated and expensive and used to treat complex conditions. A key point for developers of biosimilars is the issue of interchangeability. This is going to be a hard sell in the regulated markets where prescribing of chemical generics is already unpopular. The task will be more difficult for biosimilars where worries over equivalence will be greater and less easy to counter. With a regulatory framework already in place in the European Union to address the safety of biosimilars, the opportunity represented by these products has been proven and is growing there. Over 10 biosimilars have been approved in Europe, using the EU's specially adapted approval procedure. In Japan, the first biosimilar has been submitted for review recently. But, the US, the largest pharmaceutical market, is yet to open up for biosimilars as the biotech industry there is strongly opposed to the entry of biosimilar products. Introduction of biosimilars in the US market should bring down the cost of medicine substantially for critical diseases and make them available to a wider population. And that depends on the US government. If the proposed legislation before the US Congress is passed without much changes it should alter the whole look of the global biopharmaceutical industry to the advantage of millions of patients who are now denied of the benefits of advanced but expensive biologics.

Pharmabiz

Tamiflu Vs Flu, who cld be the major threat

The cure may, at times, be worse than the disease. That would now seem to be the case with tamiflu, the drug used more than any other for treating and preventing the dreaded bird flu — caused by the pathogenic H5N1 virus.

Going by the findings of a study by researchers of the Oxford-based Centre for Ecology and Hydrology, the consequences of large-scale consumption of tamiflu can be scarier than even those of a bird flu outbreak. The main fear is that the many tonnes of this drug that are in stock in various countries for combating a possible pandemic would, on consumption, play havoc with wildlife besides increasing human health hazards. Specifically, the scientists have warned that the bulk of this drug would get excreted through urine and flushed down sewers into natural water bodies and rivers, devastating aquatic bio-life. The worst hit would most likely be micro-organisms, including all manner of useful bacteria, present in these waters. This is because oseltamivir carboxylate, the active anti-viral ingredient of tamiflu that also kills bacteria, is resistant to bio-degradation and cannot be eliminated through normal sewer water treatment.

Its toxicity can, therefore, persist in water bodies for weeks, even if only treated water is released in them. As a result, fish, birds and other creatures that dwell in these tanks and rivers or feed on them could face ruin. Man, too, needs certain kinds of bacteria in the gut for the digestion of food. All these systems could go haywire if the need should arise to use tamiflu on a mass scale. As if this scenario were not alarming enough, the scientists have also pointed out that widespread consumption of this drug can create conditions in which the H5N1 virus, which normally infects only birds and some animals and does not get transmitted to humans, can mutate into forms capable of being passed on to humans.

Another likely fall-out could be the development of immunity against oseltamivir carboxylate in H5N1 virus itself, rendering tamiflu ineffective. This would further heighten the risk of a flu pandemic. And, what is worse, should this happen, mankind would find itself fighting a losing battle till an alternative vaccine targeted specifically at the new form of virus is developed, which might take months. Of course, it can be argued that these dreadful implications are hypothetical even though they emanate from a scientific study carried out on rivers in the US and UK. In any case, the possible hazards are far too serious and indeed unnerving to be disregarded.

The bird flu has not yet been eradicated and its incidence continues to be reported from the south-east Asian region. What needs to be remembered is that the flu outbreak of 1918, albeit of a different virus strain, had killed nearly 50 million people. Equally essential to bear in mind is the alarming decline in the population of vultures, which are nature’s scavengers, owing to the indiscriminate use of diclofenac, an anti-inflammatory drug, for the treatment of animals. Its residual toxicity in animal carcasses is killing the vultures who feed on them.

It is, therefore, imperative to revisit the strategies devised to cope with the bird flu menace and to look for safer drugs. An anti-influenza vaccine developed at the Bhopal-based high security laboratory of the Indian Council of Agricultural Research is believed to be a less harmful alternative to tamiflu. If that is indeed the case, enough stocks of this vaccine, as also adequate production capacity, need to be built up. Simultaneously, research needs to be initiated to evolve suitable biological and chemical treatments for sewer water to minimise its residual toxicity before the discharge is put out into natural water bodies.

Lilly seals a R&D deal with Zydus

Lilly and Zydus established a collaboration to discover and develop potential drug candidates against a novel target, with the research primarily focused on cardiovascular diseases.

Zydus’ role within this covers drug discovery, lead identification and optimisation and conducting preclinical studies and clinical trials up to Phase II human proof-of-concept. In return Lilly will provide expertise and feedback regarding toxicology, ADME (adsorption, distribution, metabolism and excretion), chemistry, biology, clinical and regulatory aspects when deemed necessary to increase the probability of success. Lilly will also supply the chemical starting points.

The deal includes the option for Lilly to license any of the resulting molecules at different stages of development, with Zydus receiving up to $300m (€226m) in milestone payments. Zydus would also receive royalties from any product that reaches commercialisation.

another wave of M & A in Pharma

So far three deals that topping $150 billion in value have been announced in the global pharma industry this year. Merck & Co. acquired Schering Plough for $41 billion and Roche announced $47 billion plans to buy an additional 44 per cent in Genentech, and earlier in January, Pfizer had announced the $68 billion purchase of Wyeth. Aimed at cutting costs and bolstering research pipelines, the mergers are reminiscent of the last round of dealmaking in the late 1990s. And at that time it had roiled some Indian subsidiaries.

In 1998, Germany’s Hoechst Marion Roussel merged with France’s Rhone Poulenc to form Aventis. In 2000, US’s Abbott acquired Knoll from Germany’s BASF. In the restructuring that followed, one Indian arm of each “combined” firm was sold. The Indian arms had little in common with their parent firm with decades-old products that had long fallen off the parent’s radar. It was clearly difficult to extrapolate synergies seen from a global merger. The Indian pharma market also figured low in Big Pharma’s priorities at that time but India has recently emerged as an important market. Every MNC knows they need an India piece. Some, such as Merck, that exited in the 1980s are back with a new focus. This time around, there may be no such sell-offs.

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