By CH Unnikrsihnan Drug maker and researcher Glenmark Pharmaceuticals Ltd's new biological drug candidate Bi-Specific Antibody - GBR 1302 is entering Phase I trials after successfully completing its pre-clinical studies. The phase 1 trial of the new drug candidate, which has demonstrated superiority over current antibody therapies against most HER2 positive cancers, including breast cancer, is an important milestone in the research and development process and is crucial for Glenmark as its business model typically is to license out such successful molecules for premium valuation. Glenmark will be doing the Phase 1 trials of the new cancer drug in Germany. The phase 1 trial application for this antibody has been submitted to German regulatory authorities, said Glenmark Pharmaceuticals SA, a wholly owned subsidiary of Glenmark Pharma. GBR 1302 has the potential to be used in the treatment a broad array of cancers including breast cancer ·and could constitute an innovative treatment for HER2 positive cancers if confirmed in clinical trials. It is also potentially superior to the currently available monoclonal antibody treatments. Glenmark expects to obtain approval for the initiation of clinical studies with GBR1302 during this financial year. The material for the trial candidate was manufactured in Glenmark's production unit in Switzerland. HER2, also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, is the target of the multibillion dollar antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine and is implicated in breast cancer, ovarian, gastric, and certain uterine cancers.Commenting on this milestone, Glenmark's chief scientific officer and president (Biologics), Glenmark Pharmaceuticals Michael Buschle said that the company has high expectations for GBR 1302. "During the preclinical characterization of the bi-specific antibody we have discovered that GBR 1302 does not only kill trastuzumab resistant cancer cells, but also very efficiently kills cancer cells with a weak expression of HER2 against which all current HER2 targeting antibodies are not effective," he said. GBR 1302's mode of action is different from current HER2 targeting antibodies. It redirects cytotoxic T cells through its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells. HER2 positive or Herceptin (trastuzumab) resistant metastatic breast cancers and breast cancers with intermediate expression of HER2 also apply to other HER2 overexpressing cancers including; ovarian, certain uterine cancers, pancreatic cancers and bladder cancer. So the drug, if successfully developed, can also be useful treating other types of cancers. Glenmark's novel biologics entity pipeline with the addition of GBR 1302 has now four monoclonal antibodies with three of them undergoing active clinical development. First, GBR 500, a monoclonal antibody representing a first-in-class opportunity indicated for the treatment of multiple sclerosis (MS) and other autoimmune diseases. GBR 500 has been licensed to Sanofi and is in Phase 2 clinical trials in the US. The second monoclonal antibody, GBR 900 targets the TrkA receptor for chronic pain and is currently in clinical Phase 1. This project is developed under license from Lay Line Genomics SpA., an Italian based Company. Monoclonal antibodies specific for TrkA represent a first-in-class opportunity for the treatment of chronic pain, which has a high level of unmet need. The third antibody is GBR 830, a best in class OX40 antagonist for autoimmune diseases which recently entered Phase I clinical development.
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US-based hCentive Inc, a health insurance exchange solution company, has announced ambitious investment and hiring plans for its R&D centre in India.hCentive has R&D centres in the US and India (Noida) and employs over 750 people with about 600 based in the India R&D centre. It has planned to invest Rs 750 crore in India over the next five years at its R&D centre and expects to ramp up its India team by about 25% over the next twelve months. The announcement comes on the heels of Prime Minister Narendra Modi’s ambitious ‘Skill India Mission’, which aims to professionally train 40 crore Indians by 2022.hCentive provides cloud-based / Software-As-A-Service (SaaS) solutions to US government agencies, carriers, and brokers to offer health insurance and benefits to consumers and businesses. The company has witnessed rapid growth since its inception in 2009, making the Inc. 500 list of fastest growing private companies in America for the past two consecutive years.VJ Bala, Senior Vice President and Head of Marketing at hCentive said, “As our research and development hub, our India office will see continued investment for hiring and scaling the infrastructure and facilities to support our aggressive growth plans. We are committed to hiring top talent with competitive compensation and benefits in the IT industry.”(BW Online Bureau)
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Sun Pharmaceutical Industries Ltd, India's top drugmaker by sales, said on Saturday (19 September) it had agreed to sell two divisions marketing central nervous system drugs to Strides Arcolab Ltd for Rs 165 crore ($25 million). Sun Pharma, which last year bought domestic peer Ranbaxy Laboratories Ltd, in July said it may sell low-margin businesses it deemed do not hold long-term value. Under the latest deal, Strides Arcolab will take over Ranbaxy's Solus and Solus Care divisions, Sun Pharma said in a statement. As per IMS July 2015 MAT report, all the products of these two divisions together accounted for approximately Rs 92 crore in sales. “The agreement with Strides is part of our strategy to firmly consolidate our CNS business in India. We firmly believe that the potential of Solus and Solus Care divisions can be greatly enhanced with the focus that Strides will put in growing them. The divestment will help these divisions, its customers and the team,” said Abhay Gandhi, chief executive officer — India Business, Sun Pharma. “The acquisition of Solus and Solus Care divisions is of strategic significance to the growth of our branded business in India. The rich product portfolio and capable teams of these two divisions will help us establish a strong footing in the fast growing CNS market of India,” said Subroto Banerjee, president – Brands, India of Strides Arcolab. In May, Strides Arcolab had acquired Australian generics business of Aspen Pharmacare Holdings Ltd for Australian $380 million. Strides Arcolab had also acquired 74% stake in the domestic business of Bafna Pharmaceuticals Ltd for Rs48 crore in July last year. The deal includes Bafna’s flagship haemoglobin tablet Raricap, which fetched Rs20 crore sales in fiscal year 2014. Bafna’s domestic business was valued at Rs65 crore for the deal. In September 2014, Strides had agreed to buy rival Shasun Pharmaceuticals Ltd in an all-stock transaction valued at about Rs 1,200 crore. Sun Pharma had completed the $3.2 billion acquisition of Ranbaxy Laboratories in March to create the world’s fifth-biggest generic pharmaceutical company by revenue. The closure of the deal, announced on 6 April last year, created an entity with almost Rs30,000 crore in combined annual revenue and Rs2.5 trillion in market value.
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Overnight showers in the national capital and prediction of more rains has triggered an alarm among health officials, with experts warning on Saturday that the dengue situation might worsen. According to experts, the aedes aegypti mosquito, which transmits the dengue virus to humans, breeds in clean water and the showers might lead to water accumulation on rooftops, and other spots. "When intermittent rains take place, common diseases which pose risk to people are dengue, malaria and chikungunia. At a time when hospitals are already grappling with shortage of beds with more patients approaching them for treatment for dengue, it might be an alarming situation," a senior doctor at the All India Institute of Medical Sciences (AIIMS) said. Another doctor at RML Hospital shared his concern, calling upon the civic bodies to be more efficient in ensuring that water doesn't collect at places. "This is really a matter of concern as already hospitals are flooded with patients and health centres are groaning with shortages of beds, people have to be sensitised too. Also the Municipal Corporation of Delhi (MCD) should check mosquito breeding at the sensitive places," he said. "Civic bodies will have to intensify checking of mosquito breeding grounds as puddles near houses and office buildings are major risks," he added. According to MCD officials, they have been regularly sending people from door-to-door for the mosquito breeding checks. "If there is any collection of water anywhere, we will step up our measures there. The residents should also take precautions," they said. Charan Singh, Nodal Officer said, "To tackle this issue door-to-door awareness campaign and active volunteer participation is necessary and there is need to take on board NGOs too for the purpose. The approach has to be wholesome to tackle the menace". Four more persons succumbed to dengue in the capital on Friday, taking the death toll to 20, prompting the Delhi government to approve nearly 800 additional beds in 48 private hospitals. Facing criticism for failing to control the situation, Chief Minister Arvind Kejriwal had reached out to the Opposition parties seeking their suggestions to deal with the crisis. On Wednesday, the Delhi government had directed private hospitals to increase their bed capacity by 10-20 per cent as soon as possible to treat dengue patients. The Aam Aadmi Party has also decided to set up "fever clinics" across Delhi to offer free treatment to the patients. Incompetent Civic BodiesThe ruling party accused the BJP-ruled civic bodies of "total failure" in containing spread of the vector-borne disease. Currently, the total bed capacity of city hospitals is around 50,000 which include 10,000 beds in Delhi government- run hospitals and 20,000 in private hospitals. The hospitals run by municipal corporations and Centre have a capacity of 10,000 beds each. People are demanding that fumigation should be stepped up by civic bodies. A section of residents living in south Delhi, from where a number of dengue death cases have been reported, are complaining that "not enough" is being done by MCD to combat the health menace. "Well, the MCD hardly sends anyone to fumigate the area. And, this year, with even so many cases, they are taking things lightly," said 80-year-old J.C. Bakshi, who lives in Lajpat Nagar. Rohan Desai, a resident of Kalkaji in south Delhi, also criticised the municipal corporations. "Some of these dengue deaths were preventable. There was fumigation in my area last week, but this week I haven't seen it happening. And, even if it has been done, MCD needs to step up its efforts. What they are doing is not enough," he said. (Agencies)
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Visible from neighbouring France and Germany, a new 41-storey skyscraper that drugs company Roche opened near the river Rhine on Friday reaches 178 meters into the sky, easily the tallest building in Switzerland. The 550-million Swiss franc ($575 million) tower shows that the company retains its loyalty to the city of Basel where it was founded in 1896. It also sends a lofty message to cross-town rival Novartis and other drugmakers that Roche, the world's biggest cancer drug company, is determined to retain its leadership of the $100 billion-a-year oncology market, despite mounting competition. "This new building can be seen as a defiant reaction to the arrival of others moving into a space Roche has dominated for the last 15 years," said Michael Nawrath, an analyst at Zuercher Kantonalbank. Roche said its decision to erect "Building 1," as the tower is prosaically called, is motivated by a dearth of space at its existing Basel campus, rather than a desire to cast a shadow on Novartis. Novartis became a more powerful rival in the treatment of cancer this year after concluding a deal to buy GlaxoSmithKline's oncology business for $16 billion. "We regard Building 1 as a clear commitment to Switzerland and to Basel," said Roche CEO Severin Schwan of a structure conceived by the architecture firm, Herzog and de Meuron, that came up with the "Bird's Nest" stadium for the 2008 Beijing Olympics. Building 1 will house about 2,000 workers. Schwan, an Austrian who will retain his office in Roche's three-story headquarters down the street, already has an even taller building, at 205 meters, in the works, due to be occupied around 2021. Previously, Switzerland's tallest building was Zurich's Prime Tower, at 126 meters. Roche's new skyscraper comes at a time when other rivals including Bristol-Myers Squibb and Merck & Co are developing promising new therapies to harness the human body's immune system to attack cancer. That's turf that Roche, with its pharmaceuticals and diagnostics businesses, has laid claim to since it helped bring the monoclonal antibodies Rituxan and Herceptin to the market in the late 1990s. While Roche has been touting trial results of its investigational immunotherapy atezolizumab in shrinking tumours in bladder cancer and certain lung cancers, Merck and Bristol-Myers have similar drugs on the market. AstraZeneca , Pfizer and other drugmakers are also pursuing their own compounds. Novartis wants a share of immuno-oncology, too. "These agents allow your own body to work as a defence against the cancer," Novartis Chief Executive Joe Jimenez said in an interview on Friday on CNBC. "This is what's so exciting about it." Meanwhile, Novartis' Jimenez has building plans of his own. The company has enlisted star architect Frank Gehry, designer of the Guggenheim Museum Bilbao in Spain, among others, as part of its multi-billion-dollar reshaping of its Basel campus. Novartis is aiming for the clouds, too: three high-rises, each around 120 meters, are being planned for completion over the next few years, according to a local newspaper. (Reuters)
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Intas Pharmaceuticals Ltd could get approval this year to launch a version of Amgen Inc's white blood cell boosting Neulasta drug in the United States, chief financial officer Jayesh Shah said. That would make it the first Indian drugmaker to secure a green light to sell a biosimilar in the United States, the world's biggest healthcare market. Until recently, the regulatory pathway for such medicines was unclear and the first biosimilar was approved there only in March. "We're expecting the approval any time now," Shah said. The launch of the copy of Amgen's blockbuster drug, developed with Canada's Apotex Inc, could fuel sales growth of between 20 and 25 percent over the next three years for Intas, Shah told Reuters in an interview. Intas, among India's top 15 drugmakers by sales, is one of a handful of firms in India's $15 billion pharmaceuticals industry that are developing biosimilars. These are cheaper imitations of biological drugs that are much more difficult to develop than regular copycat medicines and command a much higher price. For generic drugmakers that have the manufacturing capabilities to develop them, biosimilars present a lucrative opportunity. The global market for such medicines is expected to reach $14 billion by 2020, as a number of top-selling biological medicines lose patent protection. In India, Dr Reddy's Laboratories Ltd and Biocon Ltd are in the race. Neulasta, chemically called pegfilgrastim, is Amgen's second-biggest selling drug, and brought in sales of $4.6 billion in 2014. Intas has a profit-sharing arrangement in place with Apotex, but the CFO declined to disclose details. Intas, which has been selling biosimilars in India and several other emerging markets since 2004, is now starting to focus on the United States and Europe. It launched its first biosimilar in Europe in February, and is in the process of identifying other molecules for both regions, Shah said. In 2016, the company plans to launch 50 new products in its largest market, India, Shah said. Unlisted Intas notched up more than $780 million in sales in the year to March and has twice considered a market debut. It sold a 10 percent stake to Singapore state investor Temasek in November last year, putting IPO plans on the backburner. "We don't feel the need to consider a listing for the next one to two years at least," Shah said. "When we are thinking of it, we will explore all options, including an overseas listing." (Reuters)
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CH Unnikrishnan India's healthcare industry, which is estimated to grow by at least 16 per cent from $73.92 billion in 2011 to $280 billion in 2020, will see its workforce demand doubling to 7.4 million in the next 6 to 7 years, according to a report released by Federation of Indian Chambers of Commerce and Industry (Ficci) in collaboration with consultancy firm KPMG. The healthcare report titled -- Healthcare: The Neglected GDP Driver -- also says the medical travel market to triple to $10.6 billion in 2019 from $2.8 billion in 2014, with a 30 per cent increase a year. “The aim of this report was to highlight that investment in healthcare propels overall economic growth and is more than just social expenditure in India. Improvements in the health of citizens contributes to overall economic prosperity of the nation, says Nilaya Varma, partner and head, Government and Healthcare, at KPMG in India. According to Varma, healthcare is one of the largest employers in India at present. "The sector has attracted billions of dollars from private ventures, foreign investors and inflow of equity capital through numerous deals in the past year. Additionally, medical tourism is growing well and is contributing significantly to the overall growth in the sector,” he added. The FICCI-KPMG report also highlights how a robust healthcare system drives the growth of the country's gross domestic production (GDP) in the presence of adequate investments and an encouraging environment by not only acting as a productivity and employment generator, but also as a magnet to attract foreign exchange earnings and provide opportunities for innovation and entrepreneurship. With Indian healthcare workforce expected to double to 7.4 million in 2022 from 3.6 million in 2013 and the sector’s revenue expected to grow by a robust 16 per cent annual growth to 280 billion in 2020 from $73.92 billion in 2011, Indian healthcare sector has already established itself to be an important contributor to nation’s GDP. Another important finding of the report is that increasing investments, growing innovation and entrepreneurship are expected to enhance the size of the healthcare market, thereby increasing the contribution of the healthcare sector to India’s GDP. India has received an aggregate of $377.3 billion in foreign direct investment (FDI) from April 2000 to May 2015. Hospitals and diagnostics centres received FDI of $3.1 billion, or about 1.21 per cent of the FDI inflow. The share of healthcare FDI has almost doubled since 2011, highlighting the growing interest of foreign players in the sector.
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The acquisition is part of Sun Pharma's plan to set up a branded ophthalmic business in the US, reports CH Unnikrishnan Sun Pharmaceutical Industries Ltd said on Wednesday (16 September) that it has signed a merger deal with US-based ophthalmic drug development company InSite Vision Inc for a total equity valuation of $48 million (Rs 319 crore). The loss-making InSite Vision currently focuses on developing new specialty ophthalmic products. This acquisition is part of Sun Pharma's plan to set up a branded ophthalmic business in the US. As part of this, Sun Pharma had also recently licensed an eye drop brand Xelpros. Under the terms of the agreement and plan of merger, an indirect wholly owned subsidiary of Sun Pharma will commence a tender offer for all of the issued and outstanding common stock of InSite Vision at a price of $0.35 per share in cash. According to Sun Pharma, it has valued the shares at a 30 per cent premium. "This potential acquisition is a part of our overall objective of transitioning to a specialty company. Besides Dermatology, we have identified Ophthalmics as one of the key segments for establishing our branded presence in the US," said Kal Sundaram, CEO of Sun Pharma’s North American business. The transaction value of $48 million on fully diluted basis plus related debt and other transaction costs are on the assumption that all shares of InSite Vision are tendered in the tender offer. The deal has been approved by the Boards of Sun Pharma subsidiary and InSite Vision. InSite Vision has at present developed two drug delivery platforms--DuraSite and DuraSite2, which are capable of extending the duration of drug retention, thus resulting in lower dosing frequency, and potentially enhanced efficacy. Based on this technology, InSite Vision has developed a pipeline of late-stage clinical candidates, and has recently filed a new drug application (NDA) with the US drug regulator for its product titled as BromSite for the treatment of inflammation and prevention of pain associated with cataract surgery. It also plans to file another NDA in 2017 for DexaSite for the treatment of non-bacterial blepharitis, a common ocular condition for which there is no approved product currently available. InSite's two other products AzaSite Plus and ISV-101 are currently in Phase-3 clinical development for the treatment of eye infections and in Phase 1/2 clinical development for dry-eye disease and inflammation respectively. The US drug developer has also commercialized its two products AzaSite and Besivance approved for the treatment of bacterial eye infections. For the 6-month period ended June 30, 2015, InSite Vision recorded revenues of $3.8 million, with an operational loss of $6.4 million and a net loss of $7.5 million. The acquisition/merger is subject to InSite Vision’s stockholders tendering at least a majority of their shares or, alternatively, its stockholders representing a majority of the outstanding shares voting to approve the transaction as required by applicable law, in addition to other customary closing conditions. The acquisition is expected to close in the fourth quarter of 2015, Sun Pharma said. Sun Pharma shares traded 2.09 per cent up at Rs 884.30 per unit on BSE in the morning trade on Wednesday, while the benchmark index- Sensex rose 0.71 per cent to 258887.53 points. unni@businessorld.in
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When looking to develop employable skills and in gaining meaningful employment, persons with disability in India face many challenges. Persons with disability continue to face many difficulties in the labour market, even when India has ratified the United Nations Convention on the Rights of People with disability (UNCRPD). UN defines Persons with Disabilities (PwDs) as all persons who have long-term physical, mental, intellectual or sensory impairments, which in interaction with various attitudinal and environmental barriers hinder their full and effective participation in society on an equal basis with others. Disability is not purely a result of impairment - it is aggravated by attitudinal and physical barriers present in society.According to a census of India, 2011, there are 26.8 million Persons with Disability (PwDs) in India. About 13.4 million PwDs are in the employable age of 15-59 years; this is a large number when one considers the pressing need for skilled labour in India. PwDs face numerous barriers at every stage of life. They are often looked at as a liability to their families and society, rather than as productive and contributing members of it. Even the ones who cross multiple barriers and try getting a job face numerous challenges in finding a job that suits their abilities. All women and men with disabilities want to and can be productive members of our society.Presently, catering to the needs of all PwDs looks like a distant dream, since we as a country face issues such as a lack of institutions that can provide appropriate and adequate training to these people, poor infrastructure, ineffective training models and a general lack of jobs suited to their skills, interests and abilities. Even though some organizations are working towards training them and facilitating their employability, there are impediments to these initiatives like the lack of proper wages, an ill-equipped and inaccessible work-place environment, and discrimination at the workplace along with greater issues such as the absence of substantial, data based information regarding the various job opportunities that could be made available to them. In order to integrate PwDs into the community and society in a manner that harnesses their maximum potential, it is imperative to change the very paradigms of skill training in terms of improving the pedagogy, introducing multi-dimensional technology that enables e-content solutions and improving the capacities of Institutions/NGOs offering skill training to PwDs.The Copyright Act of 2012 stated that companies that had a turnover of more than 5 crores per annum must provide 2% of their funds for CSR initiatives. Promotion of opportunities for PwDs should also be made a mandatory part of this protocol. According to Shri Rajiv Pratap Rudy, Minister of State (IC) for Skill Development & Entrepreneurship, "Skill Development is one of the highest priorities of the Prime Minister of India as only around 2% of the workforce in India is skilled". As appreciation and encouragement, the government also gives various incentives to corporate houses that employ a certain percent of persons with disabilities. To promote employment opportunities in the private sector for persons with disabilities, their help could also be taken in developing course content providing vital information in a variety of formats that challenges the biased attitudes and mistaken assumptions about the potentialities of such people.There is a great need to expand these interventions to rural areas as well, as a part of appropriate program models. This would indeed be a major contribution to "Skill India" initiative of Hon'ble Prime Minister.The author, Sweta Rawat, is chairperson at The Hans Foundation
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By C.H. Unnikrishnan India's second largest drugmaker Dr Reddy's Laboratories Ltd, which is planning an array of product and technology collaborations with foreign counterparts as part of its recent business re-modelling, has signed at least a couple of new marketing and distribution deals in the last one week. The latest in the series is a product commercialisation agreement with Australian drug developer Hatchtech for an anti-lice technology. It had also collaborated with US pharma company PanTheryx Inc for an anti-infectious diarrhoea product four days ago. Dr Reddy's said on Monday (14 September) that it has signed an exclusive agreement with Hatchtech to commercialise a new haircare drug developed by the latter. The agreement on the new product, an innovative prescription anti-head lice drug branded as Xeglyze Lotion, is applicable for the territories of the US, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela. As part of the agreement, Dr Reddy's will pay Hatchtech an upfront amount of up to $50 million based on pre-commercialization milestones and an undisclosed amount based on post-commercialization milestones, linked to achievement of annual net sales targets. Hatchtech will be filing its new drug application for Xeglyze with the US Food and Drug Administration (FDA) on Monday for marketing approval in that market. If approved, the product will be marketed in the US by Dr Reddy's Lab's wholly-owned subsidiary Promius Pharma. In September 2014, Hatchtech had announced positive results from its two important Phase 3 clinical studies evaluating Xeglyze Lotion as a potential treatment for head lice infestation. The studies involved 704 people, across 14 clinical trial sites in the US and resulted in an 81.5 per cent success rate. The company said that this Lotion, a topical formulation containing abametapir, an inhibitor of metalloproteases, has demonstrated both ovicidal and lousicidal activity and offers the potential for a more effective treatment using only a single application. The active drug substance was developed in collaboration with Dr Reddy's custom or contract pharmaceutical services (CPS) business unit. PanTheryx DealOn September 10, Dr Reddy's signed a multi-country supply and licensing agreement with Colorado-based medical nutrition company PanTheryx Inc to market and distribute the latter's breakthrough nutritional intervention product DiaResQ. An innovative treatment for infectious diarrhea, DiaResQ will be sold by Dr Reddy's Lab in India and Nepal. It may also extend the marketing to Russia, Myanmar, Vietnam, Ukraine, Sri Lanka, Kazakhstan, Belarus, Jamaica, and select Latin American markets. Dr Reddy's will market the product in India and Nepal under the brand name Reliqua. DiaResQ helps promote intestinal repair and boost natural immune defense, resulting in the restoration of normal digestive function. The product was recently recognized in Reimagining Global Health, a medical conference, as one of the 30 leading healthcare innovations with great promise to transform global health by 2030. PanTheryx president and chief executive Mark A. Braman had said at this announcement that since Dr Reddy's Lab is a recognized leader in the gastrointestinal market, this agreement covers some of the largest and most promising markets throughout the world for PanTheryx and its products. With DiaResQ, Dr Reddy's Lab is adding an important product to its existing gastrointestinal portfolio. "This innovative product will address a significant unmet need in the area of diarrhoea, and our agreement with PanTheryx is another step towards ensuring good health can be delivered to those who need it," said Dr Reddy's co-chairman and CEO G.V. Prasad last week. unni@businessworld.com
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