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GlaxoSmithKline (GSK) Pharmaceutical’s application for exclusive marketing rights (EMR) for its blockbuster anti-diabetic drug Rosiglitazone and it derivative, Rosiglitazone maleate has been rejected by the Patent Controller of India (PCI). This decision has put paid to the first-ever bid by a pharmaceutical MNC to gain commercial rights on its invention in the changed patent system. The PCI has also rejected Hoffman-La Roche’s (HLR) application for EMR on anti-HIV drug, Saquinavir. The reason was the failure of GSK and HLR to meet the criteria set for granting patents under Indian patent law. It also comes as a relief to Indian companies that had launched Rosiglitazone brands in the past two years. These include brands like Torrent’s Enselin, Sun Pharma’s Rezult and Glenmark’s Rosicon. The anti-diabetic drug market in India is valued at around Rs 1,200 crore with an annual growth rate of 27 per cent. An EMR gives a company five years exclusive monopoly to market the drug in India. Original patents granted before 1995 are not eligible for EMR and the right is restricted to new drug molecules meaning that derivatives won’t qualify. Rosiglitazone is an insulin sensitiser meant for treatment of Type-2 diabetes.

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To source herbal products Ranbaxy has reportedly tied up with Cybele of Kerala for its herbal products. Under the arrangement Ranbaxy will source some herbal products form Cybele which it will market under the Ranbaxy brand. These are mainly cardiovascular and liver profile drugs.

Ranbaxy has decided to enter the lucrative herbal segment this year and has been in talks with several companies for acquisition of brands or entering into strategic tie-ups for sourcing. The company is planning to launch its herbal products along with its OTC products within the ambit of its newly created division, Ranbaxy Consumer Healthcare, by September 2002. Cybele has a wide range of products, which includes pain management, cardiovascular, and liver drugs.

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JB Chemicals and Pharmaceuticals (JBCP) has received the suitability certificate from the European Pharmacopoeia Monograph from the European Union for its active pharmaceutical ingredient (API) – Nifedipine. The company claims to be the first Asian company to get the quality certification in the European Union which has recently upgraded quality of standards. The European Directorate for Quality of Medicine (EDQM) has made the norms for its certificate of suitability more rigorous. JBCP has also applied for EP4 certification to EDQM for two other APIs – Metronidazole and Diclofenac Sodium, an anti-inflammatory painkiller. When JBCP got the certificate of suitability for its product Doclofenac Sodium a few years back, reportedly, they received a big order within a week. JBCP (sales 280 crore) has been developing drug delivery systems for various formulations and filling patents for such dosage forms in the US and EU markets.

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Indian pharmaceutical companies have been benefiting from the growing cases of constipation and gastrointestinal based illnesses caused due to urbanisation. The causes of constipation or irregular bowel habit are a hectic lifestyle, low-fibre diet, stress and eating refined foods. Besides lack of exercise and low water intake also compound the problem.

The most widely used laxative in India is Isabgol based products. They are also known as bulk producers. Beside Isabgol husks there are several value-added products flavoured products also. Zydus Cadila has launched Isbis, an Isabgol-based wafer, which is easier to eat than husk. It is estimated that the market for bulk producers is around Rs 100 crore. Besides Infar’s Naturolax is a market leader with 33 per cent market share followed by Lupin’s Softovac with a 25 per cent share.

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Ranbaxy and German major Schwarz Pharma have reportedly struck a deal by which the German firm will develop and launch Rabaxy’s new chemical entity (NCE) to treat benign prostatic hyperplasia (BPH). The NCE code named RBX 2258 is right now undergoing Phase II clinical trials. Under the agreement Ranbaxy will receive about $ 50 million as licence fee from Schwarz excluding royalty payments.

This licensing deal is the second such deal after its similar agreement with Bayer AG for licensing its NDDS drug Ciprofloxacin which is now undergoing Phase III clinical trials in the US. Under the agreement with Schwarz Ranbaxy may retain marketing rights for Indian and select foreign markets.

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Biotech is such a hot property in the US but not in India, it seems. Indian and India-focussed venture capital funds are not that keen to fund biotechnology companies in India. While investments in biotechnology was at $ 752 million in the US software attracted the highest investment at $ 1,059 million in the same country. In the US the ranking of industries are as follows: software, networking equipment, biotech and telecom in that order according to the funding accorded to them. The long pay-off period for investment may have dampened investments in biotech in India but ICICI Ventures has funded two biotech ventures, Biocon and Syngen.

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Glenmark Pharmaceutical (sales: 265 crore) will receive private equity fund finance from CDC Capital Partners to the tune of Rs 50 crore. Glenmark will make a preferential allotment of convertible debentures to CDC that will be converted to equity shares based on its after-tax profits for the year ending March 2003.

The deal was executed by Bangalore-based MAPE Advisory Group. Glenmark will utilise the money in future expansion of business. Glenmark has invested in research and development and in drug discovery for diabetes and asthma. The company will also raise funds from CDC Financial Services and South Asia Regional Fund affiliates of CDC Capital Partners. The conversion price of the debentures works out to Rs 270 to Rs 350 which is 20% more than the current market price. Glenmark’s share saw a rally on the stock exchanges as a result of this development.

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Ranbaxy Laboratories has announced the buying of Veratide, an anti-hypertensive drug brand from Proctor & Gamble Pharmaceuticals GmbH, Germany. The acquisition is believed to have cost $ 5 million. Basics GmbH, a subsidiary of Ranbaxy in Germany will market Veratide from the beginning of next month. Veratide is the second biggest brand in the calcium channel blocker plus diuretics category and is a unique combination of verapamil, hydrochlorothiazide and triamterene. The acquisition will add to Basic’s growing cardiovascular product portfolio. Basic GmbH has posted sales of $ 5.7 million in 2001.

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Dr. Morepen, a subsidiary of Morepen Laboratories has bought cold medication "Lemolate" with sales of Rs 9.6 crore from Mumbai’s Yash Pharma Laboratories for Rs 10.95 crore. Lemolate account for about 40 per cent of Yash’s sales. Lemoate will join a group of other OTC products in Dr. Morepen’s basket. This is Morepen’s second brand acquisition in 2002. Earlier the company bought "Burnol" from Reckitt Piramal and earlier in June it bought "Lifespring’ a chain of health and beauty stores in Delhi. With Lemolate Morepen will enter the cough and cold segment which is valued at Rs 800 crore.

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Pfizer has re-arranged its field force into three teams. Two will be dedicated to prescription pharmaceuticals, the third will focus on consumer healthcare and OTC products. This is further to its merger with Parke-Davis. The company went through a product prioritisation exercise with the help of international consultants. One team will meet specialists like cardiologists and surgeons with brands like Pfizer’s Minipress XL, Cardiovit and Magnamycin and Parke Davis’s Atpark. Another team will meet general practitioners about brands like Pfizer’s hepatitis B vaccine Hepashield. Both teams will promote Pfizer’s flagship B-complex drugs like Becosules and Protinex. The third team will focus on brands like Gelusil and cough syrup Benadryl.

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 060711 Indian Pharmaceutical Majors Maintain Their Lead

Growth rates of Indian and multinational pharmaceutical majors in the Jan. – May 2002 period has been 11.8 per cent. The growth is attributed to the new products introduced in the market. Products introduced in the cardiovascular, diabetics, gastro and central nervous system (CNS) disease segments are performing very well according to sources. Indian companies continue to show healthy growth rates compared to their multinational contemporaries with GlaxoSmithKline still showing negative growth.

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The American drug company Pfizer (gross sales $ 32 billion) has sued Dr. Reddy’s Laboratories for alleged infringement of patent on its $ 2.5 billion hypertension drug, Norvasc. Dr. Reddy’s had sought US FDA approval to market a slightly different version of Norvasc from the one sold by Pfizer. But Pfizer objected to this saying it will infringe the patent held by it.

The product patent on Norvasc expires in 2007 but Dr Reddy’s was planning introduction of the drug in the US around the third quarter of 2003. Norvasc is a brand of amlodipine, a hypertension and angina medication. The market has reacted adversely to the news and Dr Reddy’s shares saw a slight drop in value. If approved Dr. Reddy’s would have got three years of marketing exclusivity for the generic version of Norvasc.

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