Cipla Receives Final Approval for a Generic Version of Gilead’s Viread®

Press Release

Cipla Ltd, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Tenofovir Disoproxil Fumarate Tablets, 300mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Gilead Sciences’ Viread® Tablets, 300mg.

Cipla’s Tenofovir Disoproxil Fumarate Tablets, 300mg, are AB-rated generic equivalents of Gilead Sciences’ Viread® Tablets, 300mg, and are indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults and paediatric patients 12 years of age and older. Cipla is excited to add this important antiretroviral product to its growing portfolio of ARVs in the U.S.

The product will be available for commercial shipment in the U.S. immediately. Viread® Tablets,
300mg, had U.S. sales of approximately $725M for the 12-month period ending November 2017,
as reported by IMS Health.

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Cipla Q3 FY18 Results Reflect Continuously Improving Quality Of Earnings Backed By Strong Momentum Across Key Regions

Press Release

Cipla Limited (BSE: 500087, NSE: CIPLA) today announced its unaudited consolidated financial results for the quarter ended December 31, 2017. The Company reported quarterly revenues of Rs 3,914 crores, a growth of 7% on a year-on-year basis, with EBITDA at 20.9%, growing 21% on a year-on-year basis. EBITDA margins have been improving continuously driven by cost optimization across all spend lines despite R&D getting stepped up to 7.6% of sales during the quarter. When adjusted for the one-offs during the quarter, the Profit After Tax rose by ~25% on a year-on-year basis. The Company reported healthy growth across businesses in India, South Africa, API, Europe and Sub-Saharan Africa markets.

“This has been one of our better quarters. Key performance metrics look healthy and are inline
with the internal targets we set for ourselves. We are stepping up our investments in R&D
which has resulted in approvals for differentiated products in the US”
– Umang Vohra
MD and Global CEO, Cipla Ltd

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Programme On Nutritious Food Organised By Cipla

Samala Hema, Seethaphalmandi Corporator attended the programme about nutritious food organised by Cipla industries at Jyothi Model High School, here on Wednesday. As a part of the programme, experts from the health industry held a session to explain parents’ about child health and immunity.

The corporator too encouraged children and the parents to adopt a hygienic and healthy lifestyle to protect young lives. Later, the corporator along with officials of the GHMC and senior TRS leaders comprising Laxman Rao, ward member of the constituency interacted with the residents of Beedal Basthi as a part of the Basthi Baata programme to know their problems.

This article originally appeared in The Hans India.

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India’s Cancer Cases Far Lower Than Those In The West, Yet Death Rate Higher

India’s cancer graphs tell two distinct stories. The first holds out hope as India’s cancer incidence is far lower than developed nations such as Denmark and the US. If cancer strikes over 300 out of every 100,000 population in Denmark, the corresponding number in India hovers around 80. But the second Indian cancer story is worrisome: cancer manages to get the upper hand in almost 70% of cases in India. A study in the medical journal, The Lancet, in 2014 indicated only 30% of India’s cancer patients survive for over five years.

So while India has lower cancer rates than many other countries, it has a high death rate. Check the World Health Organisation’s Globocan 2012 report’s analysis for breast cancer: only 1 out every 5 or 6 women newly diagnosed with breast cancer died in the US, but corresponding figures in India stood at 1out of every 2 patients.

Experts said early detection could go a long way in reducing the high death rate caused due to illiteracy, fear and taboos. “In India, almost 50% of all cancers are seen in late stages. This is the reason our death rate is higher than western countries,” said senior medical oncologist Shona Nag.

Maximum cancer patients succumb to lung, head and neck and breast cancers. “We lose almost 80% of all patients detected with lung cancer. The death rate due to breast cancer world over is 20%, but we lose over 50% of our breast cancer patients,” Nag said.

Almost 80% of cervical cancer patients are diagnosed in stage 3-4 in India, but the West has almost eradicated this cancer due to regular pap smear tests. Given India’s population, it is impossible to scan everybody. “Self-breast exams and clinical exams involving community workers or ancillary health professionals are hence crucial,” she added.

Lack of awareness is the main cause for late detection. “In the western world, the culture is openness and they are more aware. Though we have facilities, we cannot reach out to such a huge population. Almost all cancers are detected at late stage in India mainly because of lack of awareness and social stigma,” said medical oncologist Anantbhushan Ranade.

Cancer surgeon Anupama Mane said, “We have women with 10cm lumps who come to us late because the lump didn’t hurt or cause pain so they did not think a check was needed.” Moreover, men don’t discuss women’s health. “So a blood stain or excessive bleeding is dismissed and not taken up as cause for worry,” Mane said. Early detection is key to reduce mortality. “It is important to diagnose cancer early because then you have a chance at curing it. The spread and extent of it make it harder to control,” said oncosurgeon Snita Sinukumar. Lack of a dedicated health care system is one of the big reasons for higher deaths. “Just like Aadhar, we need to make it compulsory to invest in one’s own healthcare,” Sinukumar added.

This article originally appeared on The Times of India

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Budget 2018: Pharma Companies Want A Push On Research, Innovation

The government needs to seriously re-think the ways to promote research and innovation in the country, especially within the Indian pharmaceutical industry. This seems to be coming across as a clear message from the various stakeholders in the Indian pharmaceutical industry.

Perhaps, some of it has to do with the mood within the industry driven by the changing market dynamics in the two most important markets – the US and India, and the fact that most recent budgets have been largely disappointing for the sector.

Many companies, with some leading players, are already coping with challenges around price erosion in generics, erosion of base business resulting from new competition and buyer consolidation in their biggest global market, the US. They clearly see the writing on the wall: Moving up the value chain in terms of developing niche, hard to replicate products, is the only way out and are gearing up for that, with some already moving ahead in this journey.

This is one reason why most that Business Today spoke to were unanimous in picking research and innovation as the top item on the list of priorities for the sector. But then, given that research spending in the pharmaceutical industry is a risky proposition, especially in areas of drug discovery and innovation, fiscal incentives could provide the necessary fillip.

For instance, it is very likely that even after spending 10 years investing in research, the product may finally not get a regulatory approval. “If you want to promote innovation then incentivize investments into research and innovation. This could be done either by government offering a matching grant to a private enterprise or by extending a tax credit,” says D G Shah, secretary-general at the Indian Pharmaceutical Alliance, that has leading Indian pharma companies as its members.

He feels the tax credit could be spread over a period of two to three years also. This backed by some procedural simplifications, say around ease in filing of patents, could go a long way in encouraging research, he feels hoping the Union Budget would address this issue.

In fact, Kiran Mazumdar-Shaw, chairperson and managing director, Biocon, goes a step further and says, if India needs to move the needle with respect to its goals around Making in India and carving out a niche for itself globally, it needs to support research and innovation.

“India needs to spend at 2 to 3 percent of GDP on science and research as against the 0.69 percent at present,” she says.
According to a recent report by the department of science and technology, India’s gross expenditure on R&D as a percentage of GDP for the last couple of years has been at around 0.69 percent.

But then, if funds are an issue, her suggestion: perhaps the government could look at deploying collections made from the R&D cess. There are enough media reports on the over Rs 7,000 crore that have have been collected by way of R&D cess.

This is crucial, she feels and points to a recent report by the European Commission which says that if you increase R&D investment by 10 percent in public research institutions, it grows the GDP by 1 percent. This coupled with a focus on meritocracy could go a long way in the Indian context, she feels.

Kiran Mazumdar-Shaw and others in the pharma industry, while not in favour of the government move towards gradually doing away with the weighted deduction on R&D for the private sector, want its scope expanded to all areas connected with R&D.

This is despite the government’s roadmap that seems to favour a move towards a system where there is a reduced corporate tax rate with all the deductions eliminated, apparently to make it all simple.

“The budget should ensure that the weighted deduction on R&D is brought back (from 150 percent) to 200 percent and its scope expanded to cover various nuances of R&D such as in-house intangible asset development, expenditure on R&D facility, clinical trials by CROs (contract research organisations),” says Kedar Upadhye, Global Chief Financial Officer at Cipla, a global major pharma player with significant presence in the Indian market.

That apart, there is also an expectation that perhaps the budget would look at clearing some of the issues around GST payment, especially in cases where medicines cannot be sold, either on account of being damaged or for crossing their expiry date.

This article originally appeared in Business Today

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