Cipla Receives USFDA Approval for Generic Voltaren® Gel (Diclofenac Sodium Topical Gel, 1%)

Press Release

Cipla Limited (“Cipla”) announced that it has received final approval on August 3, 2018, for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1% from the United States Food and Drug Administration (US FDA).

Cipla’s Diclofenac Sodium Topical Gel, 1% is AB-rated generic therapeutic equivalent to the reference listed drug (RLD), Voltaren® Gel, 1% of GlaxoSmithKline Consumer Health®. It is a non-steroidal anti-inflammatory drug
indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

According to IQVIA (IMS Health), Voltaren® Gel and its generic equivalents had US sales of approximately $353M for the 12-month period ending June 2018. The product will be available for shipping in the US in the upcoming week.

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Cipla eyes next leg of growth from global biz

In India, the company is by far the leader in the respiratory drugs segment, having a turnover of over Rs 18.93 billion.
Sohini Das

The company already enjoys a 67-68 per cent share of the respiratory drugs market in India and has potential for a 14-15 per cent growth

Cipla, a prominent name in the respiratory segment in India, is expecting its next leg of growth from the international market. Having launched products in the segment in the international market, it added $70-100 million in revenues last financial year. Cipla now aims to launch at least one product in the US (in the segment) every year from next year.

In India, Cipla already enjoys a 67-68 per cent share of the respiratory drugs market, and the company says there is potential for a 14-15 per cent growth as the market is under-penetrated. The overall respiratory market is expected to clock 12-13 per cent growth.

Cipla Chief Executive Officer (CEO) Umang Vohra said the firm was planning to work closely with diagnostic centres to boost the detection rates of respiratory illnesses.

“There are an estimated 90 million patients with respiratory illnesses in India of whom only 30 million are diagnosed. Less than 10 million actually get proper treatment,”
he said. The burden of respiratory illnesses is as big as diabetes in India.

As for the international market, Vohra said the company was already doing well in some countries where it had presence. In South Africa, Cipla grew at twice the rate of the overall respiratory market.

It launched its breath-actuated inhaler Synchrobreathe in South Africa last year. “In the emerging markets, we are clocking 10-12 per cent growth,” Vohra said. These are the lesser regulated markets such as Australia and Sri Lanka, among others.

Edelweiss Securities, in its recent report, said,
“Europe posted healthy growth in brands such as Dymista and Seroflo. The company launched Fluticasone Propionate Salmeterol (FPSM) in eight European countries.”

Respiratory franchise in the UK includes FPSM and ipratropium bromide (used for treatment for chronic obstructive pulmonary disease and asthma). Cipla launched FPSM in Australia and has also started clinical trials on the same in China.

“In two to four years, we will see good traction from the Chinese market. It is essentially a branded market and the size is huge. While it takes patience to enter the market, it does offer great potential,”
Vohra said.

“Cipla is focusing on strengthening its presence in Australia and Colombia through the respiratory portfolio and through a combination of in-house pipeline products and partnerships in China, Brazil and Indonesia,”
Edelweiss noted.

Vohra said so far as the US market was concerned, the firm had already started trials for generic Advair, the blockbuster asthma drug from GlaxoSmithKline. “Generic Advair may take around two and a half to three years to launch. Next year, we expect to launch generic Albuterol. In FY20-21 we are looking at launching a steroid-based product,” the CEO added.

Most of the respiratory products that Cipla has lined up for the international markets have a market size of around $2 billion or so, and the competition is expected from three to four players. It sees $100 million revenue from each of the key products (generic Albuterol, FPSM, and generic Advair) depending on how many other players get approval.

In India, the company is by far the leader in the segment, having a turnover of over Rs 18.93 billion (as per AIOCD AWACS). It has clocked an 11.9 per cent compound annual growth rate over five years on a high base.

Lupin and Cadila Healthcare, growing rapidly in the segment, have much smaller revenues from the segment — in the range of Rs 5.6 billion and Rs 5.5 billion, respectively.

“We expect the India base to touch around half-a-billion dollars (around Rs 36 billion) in the next five years,”
Vohra said, adding the US, India, South Africa and China would be the largest markets for Cipla in the next five years.

Respiratory illnesses have a certain stigma associated with it in India. In fact, only 30 per cent patients take inhalers in India, compared to 70 per cent globally.

Most patients here depend on oral medicines. To address this, Cipla launched its “Berok Zindagi” campaign to dispel the myths around asthma and other respiratory illnesses.

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World Post Day

Launched in 1969 by the Universal Postal Congress in Tokyo, Japan World Post Day is celebrated each year on 9 October. The purpose of World Post Day is to bring awareness to the post’s role in the everyday lives of people and businesses, as well as its contribution to global social and economic development.

This year we observed World Post Day on social media to showcase the rich collection of postage stamps and stationery in the archives.

Postcards & envelopes from the 1920s that trace the history of conflict & imperialism, notes to “Britisch Indien” and more!

Ships are carriers of people & messages. Here are letters to loved ones.

A “too late” message!

We also have correspondence sent to Bombay via Air Mail!

We are sure you are as fascinated by these items as us. We will continue to bring you more such gems from the archives, we promise!

Press Release:

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We are determined to make fearless living a habit: Cipla’s Umang Vohra

Umang Vohra Global CEO, Cipla

‘We are looking to provide end-to-end solutions in the area of disease management for Patients’

Cipla  is looking to make innovation an integral part of its business model. Can you explain what innovation entails for a pharma company?

Our innovation philosophy is all about going beyond the pill. Product innovation needs to happen and it has to be driven by the view to offer patients the best available medicine (course of treatment) coupled with a better lifestyle management regime. Moving beyond the pill, we are looking at the services that we can offer to patients and to doctors. We are actively looking to provide end-to-end solutions in the area of disease management for patients.

Can you elaborate on the issue of disease management as opposed to treatment?

Last year, we launched 80 products in the market. The reason we are able to launch so many products has to do with our deep understanding of what patients and doctors want. For example, we launched a couple of products on the diagnostics side. A few of these include machines for pulmonary tests and tabletopspirometre which is connected digitally. We have also introduced a breath actuated inhaler — a first of its kind in the industry. Innovation goals and challenges are determined by what we hear from the market. Our biggest challenge is to change the patients’ perception and change their ability to adhere and comply with their treatment. We are determined to make fearless living a habit.

The company is pushing ahead in the respiratory disease detection and cure area. How big is that market?

We live in a country where our environment does not help much; the growing pollution and dust is contributing to a rise in respiratory ailments. Look at the numbers. At present, about 90 million people are afflicted by respiratory diseases. Of this 90 million, only about 30 million people get diagnosed with respiratory ailments. To put things in perspective — 90 million is also the number of people who have diabetes. So that is the magnitude of the problem we are talking about. Unlike diabetes which is fairly well diagnosed, asthma is diagnosed only in 30 per cent of the population. What this means is that 60 per cent of people in India ignore their symptoms and their health worsens with the progression of the disease.

There is a lot of stigma associated with asthma. Is that a barrier to patients going for the right treatment. How are you tackling this challenge?

Looking at the respiratory space, we are focused on creating awareness, change attitudes into habits. And then we are moving down the entire funnel to look at diagnosis, compliance and see how people with asthma can lead more fulfiling and healthier lives.

Our experience shows the word ‘dama’ has a negative connotation to it. Our earlier pilot projects in two states — Andhra Pradesh and West Bengal — have been critical in reaching out to people and educating them about the right course of treatment for asthma, which is inhalation. When we looked at our data, we realised that affordability of treatment is not a concern, the actual issue is the stigma associated with the disease (asthma) itself and inhalation. People think inhalation therapy is expensive. Our campaign ‘BerokZindagi’ dispels this myth. In reality, an inhalation therapy today is as expensive as a course that a diabetic would take for over a month. It’s not an overly expensive therapy. Most inhalation therapy cost less than Rs 500 per month.

The company has roped in actor Priyanka Chopra for its ‘BerokZindagi’ campaign. What are the key objectives of the campaign?

Cipla has 66.3 per cent market share in inhalation therapy. But we need to do more to continue leading the category and create awareness around inhalation therapy as being the best course of treatment for dealing with asthma. India has an inverted problem with inhalation. In the rest of the world and most developed markets inhalation therapy is the most preferred treatment for asthma. About 70 to 75 per cent of asthma patients go in for inhalation. In India, it is the other way round where inhalation as a mode of treatment makes up 20-25 per cent share. Most people ask their doctors for steroids which take away the symptoms in the short run. They do not get lasting cure.

We have made Priyanka Chopra — an asthmatic herself and an achiever — the face of our campaign to deliver the message that asthma is not bad, you can have a very normal life with asthma. In fact, there are people like Chopra who are leading super normal life and have achieved a lot even with asthma.

Press Release:

To know more about #BerokZindagi, visit Breathfree

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47% of asthma patients fear social stigma more than the disease itself.” – Nikhil Chopra, EVP and head, India Business, Cipla

Abid Hussain Barlaskar , afaqs!, New Delhi

In the brand’s latest ad, Priyanka Chopra’s revelation of being an asthmatic is set to dilute the bad buzz around asthma and inhalers.

Pharmaceutical company Cipla, in its latest commercial for campaign #BerokZindagi aims at dispelling stigmas around asthma and normalising the use of inhalers in everyday life. However, roping in an in-vogue star like Priyanka Chopra and getting her to open up about her personal battles against the respiratory disorder since childhood, adds a shiny red cherry on the pie.

The inhaler is a drug delivery apparatus which is used to treat respiratory disorders like asthma. As Cipla claims, inhalers happen to be more potent than oral administration as the procedure requires smaller doses of medication delivered directly to the lungs.

Cipla's latest ad film for campaign #BerokZindagi featuring Priyanka Chopra

Cipla’s latest ad film for campaign #BerokZindagi featuring Priyanka Chopra

The latest commercial is part of the campaign launched by Cipla last year. The team at Cipla maintains that the #BerokZindagi campaign was a pilot project aimed at establishing inhalers as the most effective and safe choice to combat the respiratory illness. The campaign’s purpose was to educate the larger asthmatic audience on how to manage and control the disease. The latest ad is aimed at social stigmas – one of the key factors for limited disclosure of being asthmatic and avoiding inhaler use in public.

Cipla’s ad films from campaign #BerokZindagi from 2017

Cipla released two ads last year for #BerokZindagi, on similar lines.

And in Priyanka’s case, she learnt she was asthmatic when she was five. It was her mother, a doctor, who encouraged her to use inhalers. However, it was her relatives who were apprehensive that it would make her reliant on the medication.

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So why the ad? Aren’t inhalers prescription medicines and better demonstrated by a doctor? And, the ad speaks for all brands of inhalers in general which actually rely on the doctor for sales. How does this B2C communication benefit Cipla as a brand?

afaqs! spoke to Nikhil Chopra, executive vice president and head, India Business, Cipla, to find out more about the brand’s communication.

Nikhil Chopra

Chopra explains

There is a lack of awareness on inhalation therapy in India. It’s surrounded by social stigma. 47 per cent of patients fear the social stigma more than the disease itself. They are afraid of getting labelled, further leading to avoidance by society, peers and family. Our research also revealed prevailing myths and misconceptions that inhalers are addictive, have strong medication and are not suitable for children,

“Inhalation refers to a category of medicines and not a particular molecule or a brand. It encompasses a large number of molecules, their combinations and a large number of inhalation devices. The choice of the molecule and the inhaler is the physician’s prerogative. The campaign thus aims to normalise the use of inhalers as a category and increase patient awareness so as to better enable doctors to drive the optimum health outcomes for their patients,” he adds.

“The primary aim of our mass education drive is to promote awareness among patients to consult doctors for the most effective treatment of asthma, which is inhalation therapy. The campaign is our effort to go beyond drugs and devices and shape the respiratory health ecosystem. This thought stems from Cipla’s purpose of ‘caring for life’ and focuses on ‘patient-centricity’ that drives our innovation philosophy,” Chopra adds.

Juneston Mathana

Speaking about the brand’s brief, Juneston Mathana, creative director, Grey Group – India, who worked on the campaign, says,

“The brand’s sharply defined objective was to increase the usage of inhalers by removing the stigma associated with the disease and eliminating the myths surrounding the therapy. One of the biggest myths was related to the addiction of inhalers. With Priyanka (Chopra) on board, the communication needed to reflect her unstoppable attitude in life and use her personality to bust the ‘addiction’ myth surrounding inhalation therapy.”

With regard to the challenges of this medical communication, Mathana explains, “We had to show inhalers as the solution for asthmatics to lead a better lifestyle rather than focus on their condition. And it helped that Priyanka has been an asthmatic since childhood. Since this is a prescription-based product, not only did we have to highlight that inhalers are better and safe but encourage asthmatics to ask their doctors about their benefits.”

Expert speak:

Praful Akali, founder and MD, Medulla Communications, an agency that specialises in healthcare communication, maintains that this communication takes a real person like Priyanka, who demonstrates #BerokZindagi and gives away her secret to break myths and false perceptions.

Praful Akali

Akali says.

“I hope the brand puts media monies behind it and utilises the campaign to its full potential. It also has potential for some great PR, social and user-generated campaigns as an offshoot of the ad,”

His opinion regarding the brand’s B2C communication for a B2B category is, “Gone are the days when pharma was seen as a B2B category – it’s now clear that consumers, doctors and pharmacists, (also dieticians, gym instructors, caregivers etc. sometimes) each play a role in the decision-making process for pharma or healthcare brands. So, pharma companies are reaching out to a mix of these stakeholders to drive brand decisions”.

Akali adds his take on how Cipla would reap the benefits from the ad film, “While doctors prescribe inhalers, the challenge in the category, for Cipla, is not generating doctor prescriptions but getting patients to comply with those prescriptions. Patients believe that inhalers are addictive and users have very poor health or are weak. By using Priyanka’s story to break these misperceptions the campaign should get patients to comply with inhaler prescriptions where Cipla is by far, the market leader, thus directly benefiting Cipla’s business.”

Pravin Sutar, executive creative director, Dentsu Webchutney is of the opinion that the ad has managed to trigger the right conversation about the problem and showcases the solution in its full glory. He believes that using Priyanka Chopra and her family background as a part of the storyline is interesting, but as a creative approach, it was playing it safe.

With regard to the B2C style of communication, he says,

Pravin Sutar

“That’s a smart move, targeting the TG in this category who are surely looking for a simpler solution; contemplating between the tablets and inhalers. Brands like Cipla, an established leader, stepping in and giving their TG an assurance about a solution, will be a big relief for them. After watching this ad, anyone suffering from asthma will be aware of the message and will ask for the inhaler.”

When it comes to benefiting Cipla Sutar states, “Clearly Cipla is trying to make the awareness super-strong in this category. By having a generic dialogue rather than being specific, Cipla has managed to trigger the awareness in this category. It might help them in changing the behaviour of their TG who is stuck in that hazy dilemma. They are clearly trying to own the category. Cipla, as brand, will stick in their TG’s mind as a first option.”

Anadi Sah, lead innovation – creative and tech, Isobar, finds the film impressive and compelling. He believes that roping in a celebrity who narrates her own experience is a remarkable strategic decision that would surely benefit the brand as well as the entire category.

Anadi Sah

Sah says.

“Any category whether B2B or B2C, at the end of the day, is driven by humans who are sensitive to emotions and receptive to external stimulus. It has been a while since the Tech and IT sectors have broken this B2B vs B2C divide and shifted to a humanised approach of storytelling that has benefited them. This film initiates the approach in the Pharma and Healthcare category,”

“Being a leading pharma brand, I feel it is a thoughtful move to address a category challenge. This move benefits brands in multiple aspects. The film clearly builds awareness and recall for the brand as well as a cure for an ailment that’s always ignored or avoided. Further, I am confident that this will also generate a demand for Cipla, once there is a change in the audience’s perception through the film,” he adds.

This article originally appeared in

To know more about #BerokZindagi, visit Breathfree

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