PHARMA LITERATI

Co to pay $40 m to Auven Therapeutics upfront; deal to help pharma major bolster its specialty ophthalmic drugs pipeline India's largest drug maker Sun Pharma announced it agreed to acquire Ocular Technologies from Auven Therapeutics , a private equity firm focused on accelerated development of breakthrough drugs. Sun will pay Auven $40 million upfront, contingent development milestones and sales milestones, in addition to royalties on sales of Seciera, a drug used for the treatment of dry eye disease . Sun is aiming to steadily bolster its specialty ophthalmic drugs pipeline for the global markets, particularly in the US. Its existing pipeline drugs for eye care related diseases in the US include BromSite, DexaSite and Xelpros. “ This potential acquisition signifies continued momentum in enhancing our global branded specialty portfolio ,” said Dilip Shanghvi, managing director, Sun Pharma. Seciera is presently in phase three confirmatory clinical trials

Hyderabad-based Dr Reddy's Laboratories Ltd on Wednesday said that it had entered into a strategic collaboration with Gland Pharma , a globally recognized developer and manufacturer of sterile dosage forms, to market and distribute a diverse portfolio of eight injectable Abbreviated New Drug Applications (ANDAs) in the US market. The portfolio is a mix of filed ANDAs pending approval by the US Food and Drug Administration (USFDA) and ANDAs that will be filed imminently, and comprised of generic injectables administered in hospitals and clinics in the US. The combined sale of branded and generic versions of the products in the US is nearly $1 billion for the most recent 12 months ending August 2016, according to IMS Health. " Dr Reddy's Laboratories has a strong track record in developing, marketing and distributing generic injectables in the US. Our strengths, combined with Gland's track record of manufacturing and operational excellence, will help bring aff

Ireland-based Perrigo Co. Plc is looking for a buyer for its active pharmaceutical ingredients (API) plant at Ambernath in Maharashtra as part of its efforts to reduce mounting debt, three people close to the development said. The Ambernath plant, which has a capacity to produce 600,000 tonnes of API per annum, is Perrigo’s only manufacturing unit in India. The US Food and Drug Administration-approved plant’s enterprise value is estimated to be around Rs200 crore, according to one of the people who spoke on condition of anonymity. The plant has been on the block for the last seven to eight months and number of domestic firms are in talks with the management but no deal has been sealed yet, the person added. Perrigo acquired 85% in the plant from Vedants Drug & Fine Chemicals Pvt. Ltd for $11.5 million in cash in August 2009. It bought the remaining 15% for $7.2 million in cash in 2014. “Valuations and limited interest in the industry to expand API capacities cou

A 15-year plan is laid out by the government to eliminate the vector borne epidemic malaria beginning from 2016 to 2030, according to Dr. Amit Sharma, head and structural computation biology, International Genetic Engineering and Biotechnology (IGEB). He is also winner of the Infosys Prize 2015 for Life Science. The country is a critical channel to be monitored for malaria spread. This is because, currently, malaria is prevalent in India, Sub Saharan Africa, South East Asia, China and parts of Middle East. Another reason is that Chloroquine resistance in South East Asia is migrating to India. There is also resistance to the best discovered drug Artemisinin reported in Mynamar which is 20 km from the Indian border. There is a need to exercise caution, since malaria has defeated many drugs in the past, he added. The total elimination of malaria in India is a reasonably achievable goal. The control of this disease is not just with drugs, but public awareness, economic develo

Apex pharma exports body Pharmaceuticals Export Promotion Council of India (Pharmexcil) is in talks with the Union government to secure manufacturing of top 100 drugs, many of which are are being imported from China. Apex pharma exports body Pharmaceuticals Export Promotion Council of India ( Pharmexcil ) is in talks with the Union government to secure manufacturing of top 100 drugs, many of which are are being imported from China. " We have requested the government to take steps to facilitate manufacturing of top 100 products that are being imported from China. Currently, we import over $3 billion worthof pharma products from China ," Pharmexcil chairman and Aurobindo Pharma director M Madan Mohan Reddy said. He said a major challenge in securing manufacturing of these drugs in India is that Chinese manufacturers operate on a larger scale, which makes them more viable. Speaking about other challenges, he said that the Indian pharma industry is reeling under a

With possible far-reaching consequences for the pharmaceutical industry in India, a report from a European agency campaigning for the environment has blamed manufactures in Hyderabad for growing antibiotic resistance in the world. Titled ‘ Superbugs in the Supply Chain’ , the report by London-based Changing Markets Foundation aims to show how effluents from pharma majors, including Aurobindo, Hetero and Mylan based in Hyderabad, besides drug-producing units from other parts of the country, are polluting the environment with drugs that in turn are driving drug resistance at a global scale. The report claims findings of antibiotic-resistant bacteria in effluent samples tested at 14 sites in and around Hyderabad in addition to sample testing in New Delhi, Chennai and Vishakhapatnam. According to the report, sample testing outside one of Aurobindo’s production units in Polepally, about 80 km from Hyderabad, showed 70 percent of E.coli bacterial colonies in the samples were resi

Banking on patent expiry of several drugs in near future, Indian pharma majors anticipate a growth of about 15 per cent in exports this year. Setbacks Pharmexcil, the pharma exports body representing the industry, said here on Tuesday that there were setbacks to growth in pharma industries like shortage of skilled manpower and attrition but growth could be expected given the expiry of patents on drugs. “ Several companies have filed dossiers for seeking approvals for exporting drugs the patents of which will expire ,” said Madan Mohan Reddy, Chairman of Pharmexcil. Mr. Reddy and other representatives of other pharma companies said problems like the currency crisis in Venezuela would be dealt with and would not impact the industry severely. Speaking on imports from China, industry representatives said Chinese companies mostly supplied intermediaries and active ingredients for drugs but efforts were being made to ramp up such production capabilities in India. They also t

Around half of all India's pharma companies face losing market share in the US because they are unlikely to meet medicine traceability mandates, claims an industry expert. Arjun Guha Thakurta of Life Science Consulting tells Indian trade journal Pharmabiz that with the deadline for implementation of second phase of US Drug Supply Chain Security Act (DSCSA) just over a year away, drugmakers are struggling to meet the level 3 (site level software and hardware) and level 4 (business logistics systems) requirements. If that level of non-compliance is evident by the next deadline in November 2017, it will raise a question mark over India's ability to serve the US market - or the ability of the US authorities to enforce compliance without risking drug shortages. As it stands, North America is the destination for more than a quarter of India's pharma exports. Thakurta says that meeting the 2017 serialization requirements will require Indian drugmakers to implement &

A Pharmabiz study of R&D spending by 25 research based Indian pharmaceutical companies reveals that their research expenditure during 2015-16 went up by 24 per cent as compared to the previous year. These 25 companies spent a total amount of Rs 11,710 crore for R&D during 2015-16 as compared to Rs 9,439 crore in the previous year. And on an average these companies are spending more than 7 per cent of their net sales on R&D. In fact the average R&D spending of these companies stood at 7.8 per cent in 2015-16 as against 7.1 in the previous year. Among the 25 companies, - Sun Pharma, the largest Indian pharmaceutical company, spent the highest amount of Rs.2,303 crore on research during the year. - Dr Reddy’s Lab spent Rs.1,790 crore. - Lupin’s R&D expenditure stands at Rs.1,732 crore which is almost 55 per cent more than what the company spent in the previous year. - Cipla’s R&D spend increased by 22.7 per cent to Rs 1,035 crore during 2015-16 from

Indian firms have stepped up investments in research and development to enhance their product pipeline, especially in the specialty drugs and complex generics space. The lucrative US drug market has become challenging for Indian companies because of regulatory issues, product pricing pressure and limited number of high-value drug approvals. Sluggish performance in the US and unfavourable currency movements in emerging markets are expected to weigh on the earnings of local drug makers in the September quarter. Analysts expect overall sales growth of 7-10% during the quarter, but profits are likely to be under pressure as higher spending on research and development and on remedial measures at manufacturing plants facing compliance issues has squeezed margins. Indian firms have stepped up investments in research and development to enhance their product pipeline, especially in the specialty drugs and complex generics space. The manufacturing facilities of various com

The price of diabetes drugs have halved in the past nine months, bringing relief to around millions of diabetics in India. A new class of medicine — belonging to the gliptin family — has lowered the cost of drugs by 50% in less than a year. Of the 68 million diabetics in India, about 1.85 million are on gliptin therapy to manage their type-2 diabetes. The price came down from Rs 156 a pack in January to Rs 79 in September, thanks to aggressive pricing by domestic companies. An average daily price for other diabetes drugs stands at Rs 45 against Rs 5 to Rs 7 for teneligliptin -based drugs, launched last year. Glenmark launched teneligliptin under the brands Ziten and Zita Plus at a breakthrough price of Rs 19.90 a tablet when most gliptins were priced at around Rs 45. Today, 30 companies, including Glenmark, Mankind Pharma, Zydus, Eris Life Sciences and Intas, are making about 34 brands of drugs from the teneligliptin molecule. “ While most of the gliptins we

Supreme Court dismissed appeals filed by pharma companies, including Cipla and Dr. Reddy’s, against a notification issued under the Drugs (Prices Control) Order, 1995 The Supreme Court on Friday upheld a 1995 central government notification fixing the retail price of a drug formulation without first deciding the sale price of a bulk drug used in its manufacture. In doing so, a bench comprising justices Madan B. Lokur and R.K. Agarwal dismissed appeals filed by pharma companies, including Cipla Ltd and Dr. Reddy’s Laboratories Ltd, against a notification issued under the Drugs (Prices Control) Order, 1995. “ The notifications (issued since 1999) are valid and not issued mechanically or without any application of mind ,” the court said in its order. At least six pharma firms had moved various high courts which had stayed the notifications. The apex court transferred these cases to itself in 2005. The pharma companies had alleged that the notifications that capped retai

The government will soon be announcing a marketing code for pharmaceutical companies to curb unethical practices, which will benefit the industry, a senior ministry official said. " The code will be mandatory, and will be for the growth and development of industry ", Sudhansh Pant joint secretary department of pharmaceuticals said at the annual general meeting of Organisation of Pharmaceutical Producers of India (OPPI) on Friday. Concerned with unethical marketing practices and illegal promotions, the government had last year announced its intentions to announce a code which will be mandatory on the industry. At present, the code is voluntary, with certain companies having indulged in unethical practices like offering freebies, gifts, and exotic trips to doctors and healthcare professionals. Pant also said that a dedicated venture capital fund with a corpus of Rs 500 crore will be floated to encourage innovation in the industry. Speaking at the AGM later,

Aurobindo, Orchid Chem & Asiatic sites harbouring superbugs due to poor disposal of pharmaceutical waste, alleges an environment lobby group Three Indian drug companies have been accused of causing drug resistant bacteria due to their polluting manufacturing practices, according to a report by Changing Markets, an environment lobby group. The investigation revealed that out of 34 sites tested across India and China, 16 were found to be harbouring bacteria resistant to antibiotics. The manufacturing sites of Hyderabad-based Aurobindo Pharma, Chennai's Orchid Chemicals and New Delhi-based Asiatic Drugs and Pharmaceuticals were found to be harbouring drug-resistant bacteria due to poor disposal of their pharmaceutical waste. The report found resistance to three major classes of antibiotics - cephalosporins, carbapenams and fluroquinolones - in four manufacturing sites. At eight of the sites under investigation, resistance to cephalosporins and floroquinolon

German co merges pharma, consumer health businesses here to build scale  German drug maker Merck has merged its pharmaceuticals and consumer health businesses as part of a major makeover, unique to India, aimed at building scale and ramping up local businesses with a hybrid model . Merck's ambition is to push its established primary care and vitamins and mineral supplements businesses, alongside new launches from its market-leading fertility and oncology divisions . Its strategy of uniting the two businesses locally runs counter to some global drug makers that have separated the two businesses. The German drug maker, also known to be the oldest pharmaceutical company in the world and clocked 17% growth on the 12-month MAT from Sept 2015 to Sept2016, is ranked the second fastest growing multinational drug firm after Janssen in India. “We have brought together the portfolios of what we used to call primary care, mainly vitamins and mineral supplements with the po