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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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 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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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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