Cipla Receives Final Approval for Generic Sustiva® (Efavirenz Tablets 600mg)

Press Release

Cipla Limited, today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Efavirenz Tablets 600mg from the United States Food and Drug Administration (US FDA).
Cipla’s Efavirenz Tablets 600mg is AB-rated generic therapeutic equivalent version of Bristol-Myers Squibb Pharma Company’s, Sustiva®. It is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults and in pediatric patients at least 3 months old and weighing at least 3.5 kg.

According to IQVIA (IMS Health), Sustiva® and its generic equivalents had US sales of approximately $105M for the 12-month period ending April 2018.

The product is available for shipping immediately.

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CFO Perspectives: In Conversation With Kedar Upadhye

1. Indian healthcare is one of the fastest growing sectors, with an increase in the size of middle-class households coupled with the improvement in medical infrastructure and increasing penetration of health insurance in the country. What are the opportunities you foresee for the industry?
The Pharmaceutical industry has grown rapidly over the last decade and has been instrumental in driving generics penetration globally. Over the last 15 years, Indian companies have done well in the generic business and India remains an attractive destination for generic R&D and manufacturing of pharmaceuticals owing to its strong capabilities across the value chain.

While pharmaceutical industry has been impacted by several challenges like patents issues, significant price erosion, increasing competition and increased regulatory scrutiny in global markets. However, we believe that Indian pharma industry owing to its strong fundamentals, can overcome these challenges and can turn to the trajectory of strong growth.

As an organization, we have a positive outlook on domestic markets. The profile of diseases is changing in India from communicable diseases like malaria, diarrhoea to lifestyle diseases like heart diseases, diabetes and metabolic disorder problems. There are lot of opportunities for pharma companies in this newer space where the growth will be promising and margins will be better. But affordability would still remain as the key theme for India market. The pharma companies need to be cognizant of the cost and would need to focus on cost optimization to grow margins.

2. What would be your key drivers for growth in the next three years?
Our key drivers for growth in the next three years would be:

  • Expanding domestic markets and specialty products: Our company has been focusing on expanding its reach and recall in respiratory diseases. The company engages directly with patients, addresses social stigma and environmental concerns to expand the brand footprint in respiratory diseases. As part of our growth plan, we plan to increase our investments in this high margin segment. Efforts are aligned on improving profitability driven by greater share of high margin SKUs and country rationalization.
  • Focus on US markets: The Company has started to focus on the US markets to grow revenues and improve overall margins. The Company has launched multiple new products and has a cumulative annualized sales run-rate of about $400M. In the coming quarters, the company will continue to build on these launches and introduce new products with a focus on differentiated products.
  • Exploring the alternative channels: Our Company has started to partner with the innovative companies like MEDRx for various categories under specialty products in US. In addition, for domestic market, we are also collaborating with companies like Novartis and Roche to build a product portfolio and at the same time leverage existing opportunities available in the market.

3. The company has increasingly been making investments in the US markets—will this be a refocus on strategy from domestic to international business? Do you expect an improvement in margins as a result of effective execution of your US strategy?
There is no shift of focus from domestic to international markets. Instead of a shift in focus, the investments in US markets are part of our overall global strategy.

Cipla is utilizing selective licensing opportunities for driving sales, in addition to its own pipeline, while our domestic and other key markets, such as Africa continue to grow at a healthy pace. Given our small scale in the US market currently, US is offering the biggest opportunity for us, despite pricing pressures and regulatory compliance. In the longer run, our efforts on specialty products like respiratory, CNS (neurology) and oncology drugs should also yield good results. Currently, our pipeline is strong and evolving and would remain in focus. In terms of margins, domestic market India and South Africa are at peak margins whereas the US markets have not yet started generating margins post R&D and manufacturing costs. Unlocking value in US markets will help improve our margins. We are careful in evaluating our investments, markets and portfolio to drive efficiency and reduce complexity. We are looking at all these investments with a clear focus on high margin, high return expectations.

4. Given the volatility and uncertainty (especially w.r.t, the US policies) how would you, as a CFO, balance growth expectations and margins?

Business is always run in an uncertain environment which stems sometime from external environment and other times from internal environment. As a modern day CFO, there are three key things I focus on to support growth of our businesses:

  • Always have a clear governance agenda: Governance principles serve as our safeguards against the uncertainty in the environment. The CFO, besides acting as a strategic partner to the CEO, plays a vital role in presenting the public face of the company to investors, regulators and policy makers. The CFO plays the lead role in keeping the stakeholders well informed about the company. He should ensure that the company maintains an open and transparent communication with its stakeholders in order to build and enhance confidence.
  • Reinventing the Finance function: While the changes are inevitable with the emerging trends in businesses, as a CFO, I feel it is equally or more important for the finance function to be radical. Not just the access to information but speed of information along with the analytics would be key for the business to make the right decisions at the right time. Reinventing the finance function from a support function to a business partnering function would be the key.
  • Partnering for growth: As a CFO, I feel it is important to own growth. CFOs are becoming increasingly involved in business strategy, and need to fully understand company’s operations. It is critical for a CFO to work with business to deliver growth and improve our margins. CFOs should help business to use leveraging data and provide insights to make more knowledgeable business decisions and increase the bottom line.

This article originally appeared in Deloitte Newsletter.

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Cipla Receives Final USFDA Approval for Generic Depo-Testosterone® (Testosterone Cypionate for Injection 100mg/ml and 200mg/ml)

Press Release

Cipla Limited, today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Testosterone Cypionate Injection 100mg/ml and 200mg/ml from the United States Food and Drug Administration (US FDA).

Cipla’s Testosterone Cypionate Injection 100mg/ml and 200mg/ml is AO-rated generic therapeutic equivalent version of Pharmacia and Upjohn’s Depo-Testosterone®. It is indicated for replacement therapy in males in conditions associated with symptoms of deficiency or absence of endogenous testosterone.

According to IQVIA (IMS Health), Depo-Testosterone® and its generic equivalents had US sales of approximately $191M for the 12-month period ending April 2018.

The product is available for shipping immediately.

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Cipla Receives Final Approval for Generic Isuprel® (Isoproterenol Hydrochloride Injection USP, 0.2mg/mL)

Press Release

Cipla Limited (“Cipla”), today announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Isoproterenol Hydrochloride Injection USP, 0.2mg/mL, single-use sterile Ampoule from the United States Food and Drug Administration (US FDA).

  • Cipla’s Isoproterenol Hydrochloride Injection USP, 0.2mg/mL, ampoule is AP-rated generic therapeutic equivalent version of Hospira Inc’s Isuprel® Injection, 0.2mg/ml and is indicated for the treatment of…
  • Mild or transient episodes of heart. block that do not require electric shock or pacemaker therapy.
    Serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation).
  • Use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available.
    Bronchospasm occurring during anesthesia.
  • As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock.

According to IQVIA (IMS Health), Isuprel Injection and its generic equivalents had US sales of approximately $148M for the 12-month period ending April 2018.

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Cipla Opens Up To Crowd Sourcing Innovation

Cipla has outlined its intent to incubate disruptive ideas in the healthcare space, along the lines of similar initiatives to accelerate innovation from US/European big pharma. It hopes that this “culture” will expand in India.

Cipla Expects to back disruptive ideas in the healthcare space
Cipla Ltd. has initiated efforts to back open innovation/crowd sourcing models in the healthcare space, breaking new ground as an Indian company entering a domain that has primarily seen the active engagement of big US and European pharma groups.

The Indian firm has introduced “Innoventia”, through which it expects to crowd source and incubate“disruptive” ideas across the healthcare spectrum ranging from pharma, diagnostics, devices, digital and services, to “any other way to help in taking Cipla’s purpose of ‘Caring for Life’ forward.”

Disruptive ideas under the Innoventia innovation challenge that make the cut stand a chance to be partnered by Cipla; the Mumbai-headquartered company indicated that it could also invest in and incubate a unique idea with $15m especially allocated for this purpose.

“Investment size may vary from a “few crores of rupees (1cr=10m) to $15m,” a statement from Innoventia said. Innoventia expects to back ideas at any stage – ideation, proof of concept or in early revenue stage; the idea should, however, have “growth potential” over the next three-five years.

Incubating The Next Set Of Start-Ups
Cipla told Scrip that it hopes some of these new ventures will help take the healthcare sector to the “next level” as it undergoes major transformation.

“Across the world, large pharma invests in new ideas and we want to bring the same culture in India. As a large and responsible corporate citizen, Cipla feels it is its responsibility to incubate the next set of start-ups in healthcare,” Cipla explained.

Cipla’s Innoventia initiative, claimed to be the first such effort by an Indian pharma company launched globally, but with a special focus on Indian start-ups, is interesting in the backdrop of the general trend of domestic pharmaceutical firms and venture capitals seemingly more willing to “shop abroad” rather than to back home-grown innovation. Several Indian entrepreneurs including Sun Pharmaceutical Industries Ltd. founder Dilip Shanghvi and Biocon Ltd. chair Kiran Mazumdar-Shaw are, however, known to have made investments in their personal capacity to back promising young firms.

Innoventia also comes at an interesting juncture as front-line Indian companies transition from pure generic plays to embrace complex/specialty products; some are also developing new drugs. Acquiring late-stage opportunities and targeting areas that have unmet needs or provide clinical advantage are expected to be part of strategic efforts to supplement internal pipelines, top industry executives have previously indicated. It will be interesting to see if more Indian firms open up to similar incubation ideas.

Navroz Mahudawala, managing director of Candle Partners, a boutique investment banking firm, believes that Cipla being a larger firm with a “slightly wider corporate initiatives gamut” is more of an exception and it’s unlikely many other Indian firms would follow suit.
“Majority of the large and mid-sized companies today are completely embroiled in sorting out the domestic pricing and US FDA issues currently. There is a lot of senior management bandwidth which seems to be dedicated on day-to-day operational issues rather than strategic initiatives for most large Indian companies,” Mahudawala told Scrip.

As Flexible As Possible
While the details around Innoventia are not immediately clear Cipla underscored that it would be flexible with a partnership and investment model, should a start-up want to continue to be “perceived as independent rather than an arm of a large pharma company.”

On comparisons with similar large initiatives in the space such as Johnson & Johnson’s JLABS and Bayer AG’s Grants4Targets, Cipla said: “We believe our focus across the entire healthcare spectrum is wider than more specific pharma focus. We also believe our support – across funding, incubation, commercial agreements, mentorship – is vaster than many other events.”

JLABS, which provides resident emerging firms with a capital efficient and resource-rich environment, is built around a “no-strings attached” model. Beyond infrastructure, JLABS resident firms can also access to Johnson & Johnson Innovation’s broader network, which includes R&D and therapeutic area expertise, deal-making teams and venture capital arm JJDC.  Cipla also appears to be flexible in how intellectual property issues could be dealt with. On whether Cipla will generally have the first right of refusal to ideas incubated under Innoventia and also joint ownership around the intellectual property, the company said that Innoventia would be “as flexible as possible”, keeping the “inclinations” of the start-ups in mind.

“Our learning has been that the best start-ups would want that freedom to choose and we are prepared for that.” JLABS companies typically retain complete intellectual property and equity in their companies and can do deals – or not – with J&J or its competitors.

This article originally appeared on Scrip.

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