Intellectual Thoughts by Sanjay Panda: 2012

AstraZeneca's Cancer drug Patent Plea Rejected in India

In a setback to AstraZeneca, the Intellectual Property Appellate Board (IPAB) has dismissed its appeal against an earlier ruling that refused it a patent on lung cancer drug Gefitinib. The Indian patents office in 2007 refused patent protection to AstraZeneca, citing lack of invention. The Intellectual Property Appellate Board (IPAB) now upheld the refusal.

In its appeal, Astra Zeneca earlier had argued the controller had erred on various aspects of patent determination and also in concluding that the comparison test did not establish increased efficacy of the drug.

Innovators  suffered a reversal in March when India granted the first ever compulsory licence to Natco Pharma to sell Bayer's cancer drug Nexavar  equiavalent. Bayer has appealed  against the order.

And early this month IPAB revoked a six-year-old Indian patent granted to Roche's hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments.

Source:  newspaper & media reports

Generic drug manufactures to pay more for registration in US

US FDA recently made amendments to introduce a generic drug user fee. According to the new law, The Generic Drugs User Fee Amendment (GDUFA) of 2012 — companies will have to pay a fee ranging between $17,435 and $51,520 an application to seek an approval. Besides, drug makers will also have to pay for inspection of their facilities by the FDA outside the US, and for supplying active pharmaceutical ingredients (APIs) for manufacturing generic drugs in the US.
According to US FDA, companies will have to pay $17,434 per generic drug application pending without tentative approval till October 1. For applications seeking generic drug approval on or after October 1, companies will have to pay $51,520, whereas for Drug Master File companies are required to pay $21,340.

OTC sale of around 92 antibiotic and anti-TB drugs will be clamped down in India soon

Resistance to antibiotics is becoming a serious threat to Indians because of popular habit to pop pills at will which is an irrational use.  A recent study by the Centre for Disease Dynamics, Economics and Policy, said there has been a six-fold increase in the number of antibiotics being popped by Indians.

In order to avoid such irrational use, DCGI has written to the Union health minister to notify a new schedule H1 in the Drugs and Cosmetics Rules. Once notified and following the clearance from the law ministry, these drugs cannot be sold without prescription. These drugs will also have to carry a prominent label in red colour with the following warning: "It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the registered medical practitioner."

This is a very welcome news as we and world, staring at a post-antibiotic era, when common infections will no longer have a cure.

Source : Media reports

Pollution-related issues are haunting few AP Pharma units

While the Visakhapatnam district administration has sought the closure of the Mylan unit along with four other units in the pharma city operated by Ramky, the Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 units around Hyderabad.

It is believed that villagers near Ramky’s Vizag pharma city have been complaining that the units there pollute air, affecting their health. In response, the district administration swung into action to verify the veracity of their allegations. According to sources, the APPCB, acting on the district administration’s request, conducted a study and confirmed air pollution. This led to immediate closure notices for five units (belonging to Mylan, Vegesna Laboratories, Actus Pharma, Vijay Organics and Acacia Life Sciences, respectively).

The Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 bulk drug units located in Hyderabad while directing their managements to stop all the industrial activities by July 23, 2012. Of the 12 bulk drug manufacturing units currently under the PCB axe, two units belong to Aurobindo Pharma while four units are of Hetero Drugs Limited.

The units involving other companies are Crix Pharmaceuticals, Covalent Laboratories, Divis Pharmaceuticals, Krishna Pharmaceuticals, Innogent Laboratories and SMS Pharma Limited.

In a press release, the board said that these units were asked to close down under the Water & Air Acts in the interest of protecting public health and environment. “After detailed discussions, the board is of the firm opinion that certain industries are violating the orders of the Supreme Court of India and the ban notification issued by the Andhra Pradesh government, among others,” the press release said.

( source:   news  papers and  press releases)

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.


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.

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.


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.