Thursday, May 22, 2008

 

Cancer drug market

The global market for anti-cancer drugs is expected to touch $48 billion this year, fuelled by higher drug spending in emerging economies including India. Pharmaceutical spending in countries such as India, Mexico and Turkey will grow by 12% over the next 15 years, compared with single-digit growth for more developed nations, estimates research consultancy IMS.


"With the incidence of cancer cases rising in India, companies have realized the potential that this segment has to offer. Approximately 30 companies operate in oncology segment like Biocon, Ranbaxy, Cipla, Dr Reddys, Sun Pharma, Nicholas Piramal, AstraZeneca are already here with a slew of drugs" says Sujay Shetty associate director (life sciences), PricewaterhouseCoopers India.

To get a toe-hold in the growing market, Ranbaxy has entered into a partnership with Zenotech for oncology products. In US, Ranbaxy-Zenotech has successfully filed seven generic injectable ANDAs (abbreviated new drug applications) for products with combined market share of over $2 billion (at innovator prices). In India, Zenotech has introduced a speciality oncology product for treatment of renal cell carcinoma (kidney cancer).

Biocons BIOMAb EGFR —the first humanized monoclonal antibody, is currently approved in India for use in management of head and neck tumors (new cancer drug).


A phase II trial for adult glioma cancers is currently underway. Another trial in non-small cell lung cancer is expected to initiate shortly at several key cancer centers. More trials expanding the application of BIOMAb EGFR to other solid tumors are being planned for roll out in near future, he adds.

Friday, May 16, 2008

 

Ranbaxy drug-discovery with Merck

Even as Ranbaxy Laboratories fights the Battle for Lipitor with Pfizer, it has tied up with another global pharma giant Merck for joint drug discovery.


Merck is also working with another Indian drugmaker Nicholas Piramal to jointly develop cancer treatments (Pharma Acquisitions). Ranbaxy continues its old partnership with another global pharma giant GlaxoSmithKline in drug development (Ranbaxy GSK to develop respiratory drug)

Pharmaceutical Business

Ranbaxy Laboratories and Merck & Co have signed a strategic product development agreement providing for a drug discovery and clinical development collaboration for new products, in the anti-infective field.

Ranbaxy and Merck will work together to develop clinically validated antibacterial and anti-fungal drug candidates. Ranbaxy will carry-out drug discovery and clinical development through Phase IIa clinical trials, with Merck conducting development and commercialization of drug candidates thereafter. The agreement provides that the collaboration will begin in 2008 with an initial term of five years and can be extended mutually thereafter by the parties.


Under the terms of the agreement, Ranbaxy will be paid an undisclosed upfront sum, with the potential to receive payments totaling more than $100 million associated with the achievement of various research, development and regulatory approval milestones for each target included in the collaboration. Ranbaxy is also eligible to receive significant royalties on worldwide net sales of any products commercialized under the agreement.

Malvinder Mohan Singh, CEO and managing director of Ranbaxy, said: "This collaboration with Merck positions Ranbaxy to extend its capability set and move up the value chain for drug discovery and development."

Tuesday, May 13, 2008

 

Heparin and China

Heparin

Deerfield, Illinois-based Baxter Healthcare spent $730,000 lobbying the US government on health care issues in the first quarter of 2008. Baxter markets the blood thinning drug heparin which is used by kidney patients to prevent clotting during dialysis.


Baxter was forced to recall its heparin vials due to contamination that has been linked to 81 deaths and hundreds of allergic reactions. The Food and Drug Administration (FDA) has said it suspects the problems stem from a contaminant found in raw heparin imported from China. But Chinese officials say it is too early to tell who is at fault and have accused the U.S. of blocking its attempts to investigate the problems.

U.S. Health and Human Services secretary Mike Leavitt said he was optimistic that American and Chinese officials could soon resolve a dispute over the FDA's investigation into the cause of deaths and reactions linked to heparin. He added that Heparin is now safe because of tighter testing and controls, but warned that future shipments would face closer scrutiny.

"We have put in place processes that we believe can ensure the safety of the heparin supply within the United States," Leavitt told The Associated Press in an interview in Shanghai. The US now plans to set up FDA offices in China to help improve product safety following allegations that many of Beijing's exports — from toys to fish — are shoddy or dangerous.

FDA finds it difficult to inspect foreign manufacturing facilities as their number has risen rapidly in recent times. There are at least 4,000 foreign manufacturers that export active drug ingredients to the US. In the past five years, only 12.5 per cent of FDA inspections were in foreign countries. Normally the FDA regards regulating and approving new drugs as more important than inspecting foreign manufacturing facilities.


Implications for India:
Indian firms may shrug this off as China’s problem, but during hearings, India does get mentioned in the same breath as China. The problem of contamination is higher in biologics such as heparin, and Chinese companies make far more biologics than India. However, this situation may not last for long. Says Mukund Chorghade, a pharma consultant near Boston who specialises in collaborations with Indian companies, "A large number of pharma and biotech companies are now interested in manufacturing biologicals out of India." India now has the largest number of FDA certified facilities outside the US. But that may not save Indian companies from close US scrutiny.

Tuesday, May 06, 2008

 

New pharma policy

Businessworld

Noemie Bisserbe

A fresh policy is in the offing, two ministries are drooling over their shares in its implementation, and the industry concerned is already up in arms. India’s new pharma policy, to be finalised by the Department of Chemicals & Petrochemicals — part of the Ministry of Chemicals & Fertilizers — after over a year of debate, is a controversy in the making. The new policy, aimed at improving access to essential medicines, will determine the number of drugs whose price will be controlled by the government, regulate trade margins and set the framework for price negotiation for patented drugs. It will also introduce new Acts to compound all drug-related offences.



While the Department of Chemicals & Petrochemicals defends the need for a stricter pricing regime, the pharma industry has vehemently opposed the draft pharma policy, which calls for increasing the number of bulk drugs under price control from 74 to 354.

"Instead of controlling drug prices, the government should itself manufacture and make drugs available to those who can’t afford them," says Amar Lulla, CEO of Mumbai-based Cipla. "It has the facilities and we would be happy to share the technology with it. We could also supply these drugs directly to the government."

To that, advocates of price control reply that Indian pharma companies can already set off 1.5 times the money spent on research. "The list of essential medicines was framed by the health ministry, we are only implementing it," says a top government official close to the discussions, who did not wished to be named.


A new pharmaceuticals department, too, will come under the Ministry of Chemicals & Fertilizers. It will bring together functions that deal with various aspects of the pharmaceutical industry. The Ministry Of Environment & Forests covers areas of clinical trials on animals, while the Ministry of Science & Technology allots funds for research projects. The Department of Commerce and the Department of Industrial Policy & Promotion (under the Ministry of Commerce & Industry), handle World Trade Organization-related issues and negotiations at the World Intellectual Property Organization, respectively. According to people in the know, the National Pharmaceutical Pricing Authority will also come under the new department.

Thursday, May 01, 2008

 

Battle for Lipitor

TOI

India's Ranbaxy Laboratories has received a boost in its patent litigation with Pfizer over cholesterol lowering drug Lipitor (atorvastatin), with the US Patent and Trademark Office rejecting the world's biggest pharma firm's request for reissue of patent.

The issuance of another preliminary rejection by the USPTO would allow Ranbaxy to advance the launch of its generic version of atorvastatin in the US market by 15 months to March 2010 with a 180-day exclusive marketing rights. When contacted a Ranbaxy oficial told TOI: "The judgment speaks for itself."

Lipitor is the world's largest selling drug and last year it clocked over $12 billion sales and the two companies are engaged in patent infringement battles in various geographies, including United Kingdom and other countries in Europe.


While Pfizer officials could not be immediately contacted, reports in the United States media quoting that the company spokesperson said it would continue to pursue for reissue.

Originally, the Lipitor patent is scheduled to expire in June 2011.

It was, however, invalidated in 2006 by a federal appeal's court after Ranbaxy challenged the patent (see Pfizer vs Ranbaxy).

Ranbaxy has targetted the US market for its generic drugs, when in the next few years, the originals (with a market value of $70 billion) are due to go off-patent (see Ranbaxy in the US market). But it may have more such tough battles to fight in US courts.

UPDATE (June 18 2008): OUT OF COURT SETTLEMENT

Ranbaxy announced on Wednesday that it will be able to sell the generic version of Lipitor in November 2011, a delay of 20 months without any upfront payment from Pfizer. This means that revenues from the sale of Lipitor genrics will only be garnered in 2012.....this is for the $8 billion US pharma market. In Canada Ranbaxy can sell its generic from this calendar year. In addition to the US and Canada, the Indian drug maker will also have the licence to sell Atorvastatin in six more countries - Belgium, Netherlands, Germany, Sweden, Italy and Australia - on different dates. In return Pfizer will provide Atorvastatin technology to Ranbaxy.


An industry source said Ranbaxy opted for the settlement route as it wanted to cut down on litigation costs, which would have quadrupled when the case moved to higher courts. Also, Daiichi Sankyo, which bought the Ranbaxy promoter’s 35% stake, would not have been keen on a pursuing a legal fight with Pfizer. (see also Generics firms need to diversify).

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