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NEWS SNIPPETS   Dr. Reddy's to Set up Facility for Opium-Based Drugs Dr. Reddy's Laboratories Ltd. Is setting up an exclusive manufacturing facility for opium-based drugs with an investment of over Rs. 40 crore. Dr. Reddy's, one of few companies in India which has licence for manufacturing opium-based drugs (like morphine), is of the opinion that the segment can yield significant revenue over a period of time. Growing through collaboration - Dr. Reddy's proposed joint venture with the UK based Johnson Matthey, the world's largest producer of opium-based drugs, is also expected to be operational over the next one year.   Advinus to Collaborate with Genzyme and Medicines for Malaria Venture Advinus Therapeutics, a Bangalore based company promoted by the Tata group, has announced a new collaboration with Genzyme and Medicines for Malaria Venture (MMV). The Collaboration seeks to develop new, improved treatments for specific patient groups most at risk for malaria, particularly pregnant women and infants. Genzyme is a leading biotechnology firm while MMV is a not-for-a-profit virtual R & D organization. The ongoing MMV/Genzyme partnership also includes The Broad Institute of MIT and Harvard. The collaboration will focus on identify new molecules effective at fighting malaria, from early-stage screening to the first steps of preclinical assessment. One important aim is to develop therapies to address the danger of emerging drug resistance that current antimalarial treatments face.   Aurobindo Gets Approval for Marketing Alendronate Tablets in US Aurobindo Pharma has received US-FDA approval to manufacture and market alendronate sodium tablets, used in the treatment of bone diseases, in that country. “The company has received final approval from the US-FDA to manufacture and market Alendronat Sodium tablets in variants of 10 mg, 35 mg and 70 mg, Aurobindo Pharma said in a note. Alendronate sodium tablets, used in the treatment of osteoporosis, are generic equivalent to Merck & Co's 'Fosamax' tablets of variants in 10 mg, 35 mg and 70 mg.   US -FDA Approves Zydus Cadila's Drug Zydus Cadila has received approval from United States Federal Drug Administration (US-FDA) to market its bromocriptine mesylate capsules 5 mg in the United States. The drug falls in women healthcare segment and is also used in adjunct therapy in CNS segment. The market for bromocriptine mesylate is around US$11.7-mn in the US. The company has so far received 40 approval from US-FDA and total number of filings for approval with US-FDA is 79, since 2003-04.   Orchid Gets Approvals to Market Two Antibiotic Drugs in EU Orchid Chemical & Pharmaceuticals Ltd. has received approval to market its Piperacillin and Tazobactam (antibiotic drugs) injections in European Union nations. Orchid has filed a marketing authorization (seeking approvals for marketing) with the UK Medicines and Healthcare products Regulatory Agency (MHRA) earlier. “This is an important milestone in our regulated generics plan. Through this approval we are expanding into a new range of premium penicillin injectables and also foraying into the EU generics market. We are launching this product through our exclusive marketing alliance with Hospira for the EU market and given the limited competition envisaged in this product we are confident of a robust market share and revenue stream,” Orchid's Managing Director Mr. K. Raghavendra Rao said.   Anu's Labs to Focus on Supplying Intermediates for Off-Patent Drugs Hyderabad-based Anu's Laboratories will focus on making intermediates for off-patent drugs using its strengths in research and development (R & D). The company which has 5-6 products in the market, wants to push its R & D efforts to get into new products, according to Mr. K. Hari Babu, the company's Managing Director. Anu's Laboratories manufactures basic, advanced intermediates and fine chemicals and suppliers them to various drugs manufactures. Key intermediates like 2, 4 dichloro 5-fluoro acetophenone (DCFA) (used in antibiotics like ciprofloxacin); Chlorohexanone (cardiovascular medicine) and methyl-4-(4-chloro-1-oxo butane) are produced.   Piramal Gets Approval for Clinical Trials of Two Cancer Drugs Piramal Life Sciences has received the approval from the Drugs Controller General of India to take forward its clinical trial on two of its molecules in India. “We have received notifications to carry on the next phase of clinical trials on our cancer molecules. One is for phase 2 and the other for Phase 1,” informed Piramal Life Sciences' Chariman Mr. Ajay Piramal at the company's AGM held recently. The company has a pipeline of 15 candidates, including five in clinical trials. The company is targeting to launch its first drug in 2011. Commenting on the company's future outlook, Mr. Piramal told shareholders not to expect income for the next two years. “Do not expect revenues before 2011, but returns shall be tremendous on commercialization of the molecules into drugs,” he said.   Strides receives US-FDA Approval for Two Drugs Strides Arcolab has received US regulatory approval for its two new drugs used for normalizing blood circulation. The company has received Abbreviated New Drug Application (ANDA) approval for two drugs - dexamethasone injection and dexamethasone sodium phosphate - from the US FDA. The products are licensed to Akornstrides, a joint venture between Nasdaq-listed Akorn Inc and Strides Arcolab. 'Akorn-Strides partnership has now received 11 ANDA approvals of the 18 filed till date and commercialization in case of some of these products has already commenced in third quarter of 2008,” informed Strides Arcolab CEO (International Operations), Mr. Ravi Seth. The two drugs would be used to treat fluid retention and swelling in the brain, normalize blood circulation due to surgical or accidental trauma and also in the treatment of inflammatory disorders like asthma and arthritis. AIDS relief programmers.   Israeli SC Delays Sun's Offer for Taro Acquisition The Israeli Supreme Court has issued a temporary injunction blocking Sun Pharmaceutical Industries' bid to take over Taro Pharmaceutical Industries. As per the Israeli SC, the order will remain in force until the court rules on Taro's motion to overturn an August 26 ruling by a lower court the would have allowed Sun Pharmaceutical, to proceed with the take over. The apex court will hear the appeal before December 15. Sun Pharma had recently issued a note informing that the Telaaviv Court has ruled in its favour and no special tender offer was necessary to take over the Israeli drug-maker.   Strides Arcolab Completes 50.1% Acquisition of Genepharm Bangalore: Strides Arcolab has completed the acquisition of a controlling 50.1% stake in listed Australian pharma company Genepharm Australasia Ltd. The Melbourne based company is to be renamed Ascent Pharmahealth Ltd. Post-deal, Strides put its Australasia operations at US$90-mn (around Rs. 360 crore). The transaction announced in February this year gives Strides a significant presence in the highly regulated Australian market and makes it the fourth largest generics company there. Strides said that by September this year, it may raise its stake in Ascent to 55%, including the assets of a fully owned Strides subsidiary in Singapore, DHA (Drug Houses of Australia). Ascent, the five year old generics and cosmoceuticals major ranks as Australia's No. 2 listed generics player. In the cashless transaction, Strides has to cede its South East Asian operations excluding China and Japan for the stake; these accounted for revenues of around Rs. 114 crore (A$ 32.5 mn) for the year ended June 2008. the activities included manufacturing and OTC distribution in Singapore, Malaysia, Thailand, Vietnam, Hong Kong and Australia. DHA now becomes Ascent's Asian launch pad.   NPPA Urged to Clear Price Change Application in 30 Days The Department of Pharmaceuticals has asked the National Pharmaceutical Pricing Authority (NPPA) to clear price revision application received from drug companies within a period of 30 days, instead of the current norm of 60 days. The decision to quicken the process comes in the wake of problems faced by the industry due to rising prices of bulk drugs imported from China. China is the largest supplier of raw material for bulk drugs to India and controls over 70% of the Rs. 15,000-crore annual market for imported bulk drugs. While the Chinese Government had closed down many of its drug manufacturing units due to environmental norms around the Olympics, prices of drugs and gone up exponentially. During the past months, the industry had threatened to stop production of some essential medicines as it was commercially unviable for them due to the steep rise in various input costs. It is learnt that the Government had rejected the industry's demand for any suo moto increase in prices of drugs. Instead, the Government is understood to have asked the industry to file individual application for price revision to NPPA with documentary evidence of increase in input costs. The Government is now planning to take measures to revive bulk drug units which have either closed or stopped manufacturing bulk drugs due to short supply of raw material from China. Around 50 bulk drug manufacturing units have reportedly closed, while others have cut down production of loss-making drugs.   Pharma Dept Wants Drug Controller's Office Under Its Ambit New Delhi: The newly-formed department of pharmaceuticals wants to take Drug Controller General of India (DCGI) under its control. The DCGI, which looks after the safety and efficacy issues of drugs and also gives marketing approvals to companies for their medicines, presently functions under the health ministry. It is learnt that the government may bring office of DCGI under the purview of the new department. The pharma department feels the transfer will ensure that companies getting marketing approvals for medicines will automatically qualify for seeking price approval as well. While the DCGI is the authority granting approval for new brands, it is learnt that drug makers often do not apply for price approvals while launching their drugs in the market. Pricing violations come to light only when the National Pharmaceutical Pricing Authority (NPPA) finds out that price approvals have not been obtained. Pharmaceutical companies also often change the composition of a drug under price control and easily get an approval with a new brand name till NPPA finds out. Several pharma companies have used the strategy to manage drug under price control, and the Monopolies & Restrictive Trade Practices Commission has initiated investigation into several such instances.   Indian Lab Equipment Market Benefiting from Pharma Industry Growth The growth in the pharmaceuticals industry that has been witnessing rampant outsourcing of clinical trials and drug discovery research to the country has influenced strong growth in the Indian laboratory analytical instruments market, reveals a new report from US-based consultancy firm, Frost & Sullivan. In addition to this, increasing emphasis on environmental conservation and the burgeoning biotechnology sector are expected to help the Indian market for laboratory analytical instruments to register double-digit growth rate compared to the modest 3-4% growth rate in other countries. The report pegs the earning of the laboratory analytical instruments market at over Rs. 7.89 bn. in 2007 and estimates this to reach Rs. 8.07 bn in 2011. The increasing trend toward contract research and contract manufacturing, which has resulted in significant outsourcing of research and manufacturing in the pharma industry, is seen as influencing growth in the laboratory analytical instruments market in India,” commented Frost & Sullivan's Program Manager, Ms. Deepa Doraiswamy.   CII - Interlink Study Analyses Growth Drivers for Domestic Pharma Industry The Confederation of Indian Industry (CII) and Interlink, a business and management consulting firm in the pharmaceutical and healthcare industry, have developed an 'income-con-sumption' model to forecast growth of pharmaceutical industry by 2015 in a white paper entitled 'CII-Interlink paper on growth agenda of pharmaceutical industry in India. According to the study, the growth of pharmaceutical industry in India would be facilitated by factors like increasing health consciousness, affordability due to rising incomes of expanding middle class and health insurance facilities. Rural markets were also identified as a substantial growth driver for the pharmaceutical industry. The developments would also make the pharmaceutical industry more focused on meeting the challenges of innovations and pricing pressures, the study pointed out. Interlink has quantified market growth of six specific growth drivers. These include middle class population, health insurance facilities unpenetrated markets, marketing efficiencies, generics and brand development   Pharma Retailers to Set UP Shops in Villages New Delhi: To tap the opportunity in semi-urban and rural India, pharma retail companies such as Guardian Lifecare, Apollo Pharmacy and Medplus, among others, are introducing no frills versions of their urban outlets with new branding. Guardian Lifecare has launched five outlets under the new 'Aushadhi brand', Apollo has opened Aadhaar Pharmacy in a tie-up with Godrej Agrovet and Medicine Shoppe has launched Sehat in Mumbai suburbs. Guardian's first Aushadhi outlet opened in Khairthal, which is midway between Delhi and Jaipur. An Aushadi outlet measures 150-200 sq ft and stocks generic drugs and affordable medical kits, baby care products, and bandages for cattle. “Aushadi's contribution is less than 2% of our total revenue but we expect this to grow in the near future. We plan to open 50 stores by 2010,” added Mr. Garg. According to Harish Bijoor, CEO of Harish Bijoor Consults, a branding and business strategy-consulting firm, rural and sem-urban organized pharma retail has huge potential in India. For this, companies need to pay attention to rural consumer behaviour and focus on localized branding strategies. Apollo Pharmacy has tied up with Godrej Agrover for its rural pharmacy foray. Its first store opened in Mamcher near Pune last year and now there are 15 Apollo Aadhaar Pharmacy outlets dotting the countryside. Apollo Pharmacy COO PB Ramamoorthy said while the investement per outlet is Rs. 8 lakh, revenues could be as high as Rs. 3-4 lakh every month: “Our aim is to reach every nook and corner of India, and provide the right drugs to the right patients at the right time.”   Excellence Award for Avesthagen CMD Dr. Villoo Morawala-Patell, founder and CMD of biotech company Avesthagen Ltd., has been conferred the 'Astitva Award' for excellence in science and technology 2008. The award was presented by the Zee - Archana Astitva Awards in Mumbai recently. The 'Astitva Award' recognizes and honours dynamic Indian women achievers who have made significant contributions in various fields to society. Dr. Patell was chosen for her commitment to the development of biotechnology in India and contribution to scientific research.
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