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Local pharma companies to challenge MNCs in pneumonia vaccine space

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The duopoly of pneumonia vaccines in India is in for some shake-up soon, as homegrown players like Aurobindo Pharma, Cadila Healthcare (Zydus Cadila), and Serum Institute are readying their vaccine candidates. The Indian market is at present dominated by GlaxoSmithKline Pharma and Pfizer.


India has the highest burden globally for pneumonia-related child deaths. In 2016, the number of pneumonia deaths among children under five was 158,176 in India, according to the Pneumonia and Diarrhoea Progress Report released in 2018-end by International Vaccine Access Centre (IVAC) at the Johns Hopkins Bloomberg School of Public Health. Over two-thirds of the global burden of pneumonia and diarrhoea mortality occurs in just 15 countries and nearly half a million pneumonia and diarrhea deaths still occurred in two countries — India and Nigeria.



Lupin co-markets a pneumonia vaccine with another multinational player MSD.


The lion’s share of the market, however, lies with GSK and Pfizer — shows data from market research firm AIOCD AWACS.


GSK’s Synflorix has a 56.74 per cent share of the Rs 458 crore market while Pfizer’s Prevnar 13 has 27.3 per cent share and Prevnar 7 has a 12.85 per cent share.


“By all means, this is a duopoly between the MNCs who dominate around 97 per cent of the market. Entry of new players will definitely challenge the market shares; however, this will take time. Initially, the new entrants are likely to target the government-tendered market to gain the volumes,” said a Mumbai-based analyst.


Hyderabad-based US focussed drug maker Aurobindo Pharma is all set to complete the phase one clinical trials for the pneumococcal conjugate vaccine (PCV) that will protect against 15 types of bacteria causing pneumonia.


Pfizer’s Prevnar13 protects against 13 types of bacteria-causing pneumonia and Prevnar7 protects against seven types, while GSK’s Synflorix provides protection against 10 types of bacteria.


Aurobindo aims to finish the phase-two trials this year and submit results to the Drug Controller General of India (DCGI) by mid 2020 and sources indicate it aims to participate in the government’s tender process to procure the vaccine in 2021.


Cadila Healthcare’s PCV is also in phase II of development, informed a source.


The Serum Institute of India is collaborating with a non-profit healthcare agency PATH for the development of a 10-valent PCV, focusing on the serotypes prevalent in 70.4 per cent of the affected population (Asia, Africa, Latin America, India).


“At present, the Indian government is procuring PCV from Pfizer that imports it. Gavi, the Vaccine Alliance provides support to India’s immunisation programme. However, this is till 2021. After that, the government will have to procure it with its own funds and is thus looking for cheaper variants of the same vaccine. Entry of Indian players opens up the market,” said a person in the know.


Aurobindo will try to supply to Gavi markets, but for that it would need three years of track record in the domestic immunisation programme. The addressable market size for the vaccine globally is estimated to be over $6.2 billion and Aurobindo plans to start filings from 2021 onwards.


Prevnar 13 was introduced in India’s public immunisation programme in 2017 and is aimed to protect over 20 mn children in the first phase. Himachal Pradesh, Bihar, Uttar Pradesh, Rajasthan and Madhya Pradesh were the first set of states to sign up. Prevnar13 also enjoys a patent in India.


“Each dose of PCV 13 requires two and a half years to manufacture with 400 different raw materials, 580 manufacturing steps and 678 quality tests. We are pleased that after a thorough examination by competent authorities, including a study of all pre grant oppositions, the validity of the Prevenar 13 patent has been recognized by the Indian Patent Office,” the Pfizer spokepserson said adding that the company welcomes innovation in the PCV space by all stakeholders as it will help address continuing public health needs and protect more children against this disease.


Speaking about the entry of new players in the scene that is expected to lower prices, a Pfizer India spokesperson said, “Launched in India in 2006, Pfizer’s pneumococcal conjugate vaccine has been administered over 8 million times to help protect over 2.5 million child lives in the country. Even though in the past decade, the vaccine was upgraded to include 13 serotypes that cover 78.4 per cent of serotypes of pneumococcal disease found in India, the price of PCV 13 has been kept the same as what it was for PCV7 in 2006 – a decade old price.”


graphic


Aurobindo has partnered with Tergene Biotech, a company where it has picked up a significant stake, to develop a potent vaccine candidate for pneumonia. Tergene has developed the product and Aurobindo is funding the clinical trials, production and marketing costs. “The company does not have a presence in the domestic market and thus it is natural for it to aim for the government tender process,” said an industry source.


GSK, on the other hand, does not participate in the Indian government tender. It operates in the private market here.


The national immunisation programme offers a volume game, about 25 mn birth cohorts as opposed to one million birth cohorts in the private market.


“As more states add the PCV to their immunisation list, the private market is expected to shrink further,” said an industry source. Data also ratifies the same. AIOCD AWACS data showed that from a moving annual turnover (MAT) value of Rs 485 crore in March 2018, the PCV market had shrunk to Rs 458 crore in March 2019.


Pfizer’s Prevnar13 has clocked a decent 5-year CAGR of around 44 per cent, while its Prevnar7 has clocked an eight 8 per cent CAGR. In comparison, GSK’s Synflorix has clocked a 14 per cent value CAGR.



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Final approvals for Adani coal mine to be decided within 3 weeks: Australia

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The process to obtain final approvals for Indian energy gaint Adani’s Carmichael coal mine in Australia will be settled within three weeks, the leader of the country’s Queensland state said on Friday as she sought to expedite the controversy-hit project.


If given the green light, Adani could begin breaking ground at its Carmichael mine site within weeks, after more than eight years of planning.



Adani group entered Australia in 2010 with the purchase of the greenfield Carmichael coal mine in the Galilee Basin in central Queensland, and the Abbot Point port near Bowen in the north. The massive coal mine in Queensland state has been a controversial topic, with the project expected to produce 2.3 billion tonnes of low-quality coal.


In addition to its impact on climate change, environmentalists have argued the mine could do serious damage to Great Barrier Reef World Heritage Area. Another major concern about the environmental impacts of the proposed mine has been that it would wipe out the most important habitat of the threatened black-throated finch.


Queensland’s Premier Annastacia Palaszczuk announced that the two last final approvals involving groundwater and endangered black-throat finch will be settled within the next three weeks.



According to media reports, Palaszczuk said the black-throated finch plan decision is due by the May 31, the groundwater management plan decision is due by the June 13th this year.


“I know initially people thought this was months, and what I’m announcing today is it’s in a matter of weeks,” she said in Cairns.


“Everybody needs to have these issues resolved. That’s the timeframe the Coordinator General has set,” she added.


Earlier this week, Palascczuk ordered the state’s Coordinator-General to bring Adani and the state environmental authority together for discussions stating that she was ‘fed up’ with the ongoing delays.


While the post the final approval, the mining giant could start the work on the mine within weeks the coal exports could take up to two years.


“Now it’s really a case for the independent regulator to work through their internal processes and then they can make a determination and then we will be in a position to then start construction,” ABC news quoted Chief Executive of Adani Australia Lucas Dow as saying.



“We’re not expecting any significant surprises. Our construction activity will start as almost immediately as we’ve got these approvals,” he said.


Dow said over the past 18 months the company had so far produced 11 versions of its groundwater plan and seven for the black-throated finch.


The groundwater management plan has failed to meet key environmental requirements, including identifying the source of protected desert springs.


Last month, the Federal Government granted its final environmental approvals for the project days before the election was called.


While construction at the mine could begin with approvals, Adani’s proposed railway line plan is yet to be finalised.


Dow said the state’s Coordinator-General would also be publishing dates for other key activities, including the deadline of completion for the rail line’s deed of access and required sublease.


“That will also give us certainty and will also give the folks of central Queensland certainty of our project being able to proceed and deliver those jobs,” he said.



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EY working on govt’s Air India disinvestment, to issue EoI soon

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The government has put top consultancy firm EY to work for divesting its stake in flag carrier Air India and “quickly” issue expression of interest (EoI).


“EY continues to be the transaction advisor for the sale of Air India. We have been directed to close the accounts for FY19 and provide updated data for EoI to take the disinvestment process forward,” said a senior Air India official.



“Until the transaction gets completed EY is our advisor. They will be paid their fees after disinvestment process is complete. The instruction now is immediately start the process for EoI. Of course, approval of the Union Cabinet will be required for it,” he added.


The development comes close on the heels of Prime Minister’s Office (PMO) directing the Aviation Ministry to speed up the process of strategic disinvestment of Air India and three of its subsidiaries.


In a letter to Air India Chairman Ashwani Lohani, Civil Aviation Secretary Pradeep Singh Kharola had advised to finalise the financials of Air India and its subsidiaries by end of June, 2019.


“Also, the accounts for FY19 would form the basis of bidding. Therefore, it is necessary that they are prepared with utmost caution so as to reflect the correct financial status,” Kharola had written in the letter which has been reviewed by IANS.


The Aviation Secretary directed the airline to get contingent liabilities and account receivables verified thoroughly besides a physical verification of the inventories. A list of pending litigations is also required to be drawn up.


The government had last year initiated the process to sell majority 74 per cent stake in the national carrier but the plan proved a damp squib with no private investor turning up for the offer.


In view of rising fuel price and weak investment environment, the government had put the process on hold maintaining that it would be taken up after Lok Sabha elections 2019.



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Grasim Industries plans to invest additional Rs 6,400 crore to add capacity

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Aditya Birla Group’s Grasim Industries plans to invest an additional Rs 6,400 crore in expanding its capacity as its existing plants are unable to meet growing demand from the local customers.


Dilip Gaur, managing director of Grasim, said the investment would be made in the speciality fiber business, which would increase its capacity by about 40 per cent in the next two years as the company.



“We have invested Rs 7,000 crore in the last 10 years and will invest a similar amount in the next two years as demand is fast picking up. We have to divert our exports consignments to the domestic market to cater to the demand,” he said.


The additional capacity will be commissioned at Vilayat plant in Gujarat in two years. Grasim also holds stakes in Ultratech and Aditya Birla Financial Services.


ALSO READ: I-T dept slaps Rs 5,872-crore tax demand notice on Grasim Industries



Sushil Agarwal, Grasim’s outgoing chief financial officer, said as Grasim mirrors the trend in the economy, they are expecting the government’s thrust on the infrastructure sector will help it to boost demand for cement and financial services business in the coming quarters.


“With the government planning to invest heavily in building infrastructure, it would boost all our business.”


“The government’s thrust on infrastructure development like construction of cement concrete roads, metro rail networks, airports, irrigation projects and increase in the pace of execution under the low cost housing program supported strong volume off-take of cement,” the company said in a statement. “All of these are expected to result in sustained demand growth for cement going forward. This augurs well for the industry,” it said.



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