Another Block buster bites the dust

Yet another milestone on pharma's journey away from the mega blockbuster era: Plavix (the world's second-best-selling medicine) goes off patent. And unlike Pfizer BMS plans to back off Plavix marketing immediately. Thanks to the monopoly Plavix enjoyed, USD 9 Billion on its peak and it brought in $6.6 billion in net U.S. sales last year and the drug has generated an estimated $42.8 billion for the company during its 15 years on the market.

FDA said it gave seven companies permission to sell generic Plavix or clopidogrel in the standard 75-milligram dose. According to the FDA, 75-milligram generic Plavix can now be sold by Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals.

The larger dose of 300 mg will be sold by Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan and Teva.

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)

Indian Rupee sliding.....

Rupee is under serious pressure.  Dropped from Rs 44 for a dollar in August 2011 to almost 55 in early May 2012 especially the rate of fall , after a pulling back above the Rs 49 mark during Jan-March 2012. The slide perhaps contributed to S& P decision to downgrade India’s outlook and current balance of payment situation. The Current account deficit likely to hit more than 4% of GDP and a worsening trade gap complicating the situation further. The trade gap likely to widen further as one of the biggest forex earner, the IT industry seems to be loosing its shine.

With a high external debt repayment in next several months and possible portfolio outflow, seems we are moving to a crisis situation as far as value of INR is concerned.

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.

BW,BS

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.

FDI in Indian retail

Decision to allow 51 per cent FDI in multi-brand retail and 100 per cent in single-brand retail should easily count as one of the boldest economic reform measures initiated by the government. At this moment all the poltical parties are opposing the idea in the pretext of that this move would destroy domestic small retail businesses and result in more job losses. They think fears of wiping out small retail shops and kirana ( mom and pop)stores.  But comfort should come from the many conditions that have been attached to the entry of foreign capital into the sector. Retail multinational, keen on entering India with a 51 per cent equity, will be required to procure at least a third of their raw materials from small Indian companies, allocate a minimum of 50 per cent of their investments to create backend infrastructure and operate only in towns or cities with population of more than one million. These are tough conditions and should be able to address fears of job losses with the advent of big retail multinationals.

On the positive side, the entry of big retail should result in a marked improvement in the efficiency of the retail chain. Large multinational retail firms will bring not only their capital but also more advanced technologies and processes that will bring down transaction costs and improve the retail delivery system. It is also expected that the presence of big retail chains and competition will have an impact on inflation. 

The share of organised retail in the total retail business in the country, estimated at around Rs 25 lakh crore, is still very low, at only seven per cent. China’s share of only the top 100 retail groups in its total retail business is over 11 per cent. Clearly, India has much to catch up on, and the decision to allow FDI in the retail sector should help start the process.

BS

Roche R&D chief affirms $10B peak potential for HDL drug

Who says the mega-blockbuster is dead? Certainly not , as per, Roche research chief Jean-Jacques Garaud, who believes that despite the troubled history of CETP inhibitors.Roche’s HDL drug “dalcetrapib” has the potential to earn upwards of $10 billion a year. And Garaud shrugged off the prospects of Merck's rival HDL drug "anacetrapib", which has done even better in the clinic at boosting levels of "good" cholesterol.

Even though their (anacetrapib's) HDL elevation is higher, that might not be the best marker for potential activity,. "What is important is how much cholesterol we pull from the blood. We think ours is better than any other drug , he said.

But even more importantly than the positive data on HDL levels, Roche's investigators recently were able to reassure observers that in mid-stage studies the drug appeared safe, with no spike in blood pressure.

Merck, of course, may not be ready to take a back seat to dalcetrapib. In a Phase II trial their drug was linked to a whopping 138% rise in good cholesterol and a 40% drop in LDL levels.  That's a much better result than the 31% boost in HDL levels seen in a mid-stage study for dalcetrapib. Vontobel  estimated potential sales of $5 billion a year whereas. UBS projected peak sales at $6.8 billion.

Reuters

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.

India looses one rank in world competitiveness

India slipped one rank, to 32nd position in overall competitiveness among 59 nations, according to the ‘World Competitiveness Rankings’

The recovery of financial markets pushed the US and Hong Kong to first two  places, followed by last year’s topper, Singapore, which fell to third spot. In 2010, the US and Hong Kong ranked second and third, respectively.  Sweden jumped to fourth, from sixth and Germany came sixth

China,  slipped one rank, to 19th and Japan went up one rank to 26th slot .  Though India’s ranking is below the midway mark, it still did better than Indonesia (37) Philippines (41), Brazil (44) and Russia (49).