By CH Unnikrishnan Pfizer Ltd, the Indian arm of US drugmaker Pfizer Inc, said on Wednesday that it has entered into a business transfer agreement (BTA) for the transfer of its manufacturing facilities located in Thane, Maharashtra, to Ahmedabad-based drug research and development company Vidhi Research and Development LLP for a total valuation of Rs 178 crore. Pfizer's Thane manufacturing plant, which was commissioned in 1960, had been making drug formulations and ingredients for both domestic and international markets till 2013. But, the production has been almost nil in these facilities since last two years as Pfizer had outsourced a substantial port of its manufacturing to third party manufacturers for some time now. Of the 212 Pfizer India workmen at the Thane plant 132 had already taken up the voluntary retirement scheme (VRS) offered by the company last year and the remaining 80 who continued to receive full wages despite plant inactivity, would also receive requisite compensation as mandated by law, Pfizer had said in an earlier statement. Upon the conclusion of the business transfer agreement, all current workmen at the Thane Plant shall be transferred to the buyer so as to facilitate manufacturing operations. Vidhi Research Development, promoted by Jayeshkumar and Talakshibhai Kotak and Pravinbhai Talkshibhai Kotak, is a new entrant in the Indian pharmaceutical research and manufacturing space. The company was registered in September 2014.
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Indian drugmaker Glenmark Pharmaceuticals is counting on strong growth in the United States, where it will launch a dozen new medicines, to offset weakness in emerging markets this year, its chief executive said. One of India's top 10 drugmakers by sales, Glenmark has seen its profit hit in recent quarters by currency volatility in Russia, Venezuela and other emerging markets, after a steep decline in oil prices and China's devaluation of the yuan. "Our US business right now is more than compensating for the hit we are taking in emerging markets," Glen Saldanha said on the sidelines of the company's annual general meeting in Mumbai. Excluding India, emerging markets account for about a quarter of Glenmark's total sales, and have been a driver of margin growth in the last few years. However, Saldanha said they will contribute only about 20 per cent to sales in the fiscal year ending in March 2016. Citing worries that the company may not be able to sustain those margins going forward, several brokerages, including JPMorgan, have downgraded Glenmark's stock in the last few months. Glenmark is one of only a few Indian drugmakers that have received a steady number of approvals by the US Food and Drug Administration to launch generic medicines this year. Many of its local peers have faced a lag in approval timelines after the FDA overhauled its review process. Weakness in Glenmark's emerging markets caused it to miss analysts' profit estimates for the quarter ended June. The company, in which Singapore's sovereign wealth fund Temasek invested $150 million in April, has said it expects to launch 10-12 drugs in the United States in 2016 and hopes to grow its US business by 18-20 per cent. Those launches will include a copy of US firm Merck & Co's blockbuster cholesterol medicine Zetia, which Glenmark expects to roll out by December 2016, Saldanha said. Glenmark was the first to file with the FDA to launch a copy of Zetia, and is entitled to a six-month exclusivity on the market. Many of its peers, including Sun Pharmaceutical Industries and Lupin have acquired companies in the United States to add scale there, but Saldanha said Glenmark won't make acquisitions for at least another two years. "Valuations are crazy," he said. "Companies are overpaying for some of these assets ... so in the near term we would rather focus on our pipeline and building our business organically." (Reuters)
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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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