Cipla expects surge in demand for respiratory drugs, inhalers in winter

 Cipla, the market leader in respiratory therapies, expects a surge in demand for respiratory drugs and inhalers during the coming months when the winter and an anticipated second Covid wave are likely to push up demand for these medicines.

The firm enjoys a massive 68.7 per cent market share in the respiratory inhalation segment in India and has started working on aligning supplies so that there is no shortage of these critical medicines.

During this time, pollution levels (especially in north India) and other environmental factors cause a surge in respiratory illnesses. Cipla aspires to become the global lungs leader and it currently ranks second in the world.

People, who are recovering from Covid-19, are also suffering from lung damage and other respiratory illnesses as an after-effect of the illness.

A recent study of 55 people recovering from Covid in China shows that even after three months of leaving the hospital, about 70 per cent of those in the study continued to have abnormal lung scans. The findings in EClinicalMedicine came from a team in Henan province of China led by Aiguo Xu of the first affiliated hospital of Zhengzhou University; Yanfeng Gao, Zhengzhou University; and Hong Luo, Guangshan People’s Hospital.

Speaking to Business Standard, Cipla global chief financial officer (CFO) Kedar Upadhye said the company’s respiratory portfolio, including inhalers and oral drugs, was significant.

“Winters, allergies during this period, pollution and post Covid complications — all these are expected to push up the demand for respiratory medications,” he said. He said the company was getting ready with its stocks and supply chain so that there is no shortage. “The demand is likely to go up and also we have a strong pipeline of respiratory launches in emerging markets that will add to our sales growth,” he said.

Cipla recently launched the third edition of their respiratory illness and inhaler use awareness campaign Berok Zindagi 3.0. The campaign is being run in local languages and people are warming up to the idea that inhalers are safe, Upadhye said.

Cipla's domestic sales have been clocking high double-digit growth in the past few months, thanks to the sales growth in its Covid-19 portfolio — remdesivir (Cipremi), tocilizumab (licensed from Roche), and also favipiravir (Ciplenza). It has supplied over 150,000 patients with these three drugs that are being used by doctors as off-label therapies to treat Covid-19.

The company’s India business grew by 17 per cent year-on-year (YoY) during the September quarter. Of this, the prescription business grew by 14 per cent. Around 95,000 patients were serviced through a 24x7 helpline that the company runs for Covid-19 drugs.

The Covid-19 portfolio is around 5 per cent of its India business now. The company recently ramped up capacities for remdesivir. Upadhye said that demand for tocilizumab is slightly muted now, while demand for remdesivir and favipiravir continue to grow.

Cipla surges 8% on completing Phase-3 study of asthma generic drug

Shares of Cipla surged 8 per cent in an otherwise weak market, to Rs 447.2 apiece, on the BSE on Friday after the pharmaceutical firm completed Phase-3 clinical end-point study for fluticasone propionate and salmeterol inhalation powder, used to treat asthma patients.

"Fluticasone propionate and salmeterol inhalation powder 100/50 mcg, 250/50 mcg and 500/50 mcg are generic versions of GSK’s Advair Diskus. The product is indicated to treat asthma in patients 4 years and older as a twice-daily prescription medicine and in long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups," it said in an exchange filing. READ HERE

The Phase-3 study was conducted over a period of 15 months, at over 100 sites in the US enrolling 1400 asthma patients, it added. According to IQVIA (IMS Health), Advair Diskus and its generic equivalents had US sales of approximately US$2.9bn for the 12-month period ending February 2020.

"Cipla will now file the product with the USFDA (another 3-4 months). Being a complex product and based on past experience with other players (Mylan, Hikma, Sandoz), it is highly likely that the approval pathway will be longer than the usual one-year cycle," analysts at Emkay Global said in a recent report. The brokerage has 'buy' rating on the stock with a target price of Rs 414.

At 11:20 am, the stock was trading 7.9 per cent higher at Rs 446.5 on the BSE. In comparison, the benchmark S&P BSE Sensex was at 27,869.82 level, down 395 points or 1.26 per cent. A total of 7.43 million shares have changed hands on the counter on the NSE and BSE till the time of writing of this report.

Pharma major Cipla gets USFDA nod for generic oral acid reflux drug

Drug major Cipla on Thursday said it has received final approval from the US health regulator for generic Esomeprazole for oral suspension used for treatment of gastroesophageal reflux disease.

The company has received final approval for its abbreviated new drug application (ANDA) for Esomeprazole for oral suspension in the strengths of 10mg, 20mg and 40mg from the United States Food and Drug Administration (USFDA), Cipla said in a statement.

Cipla is the first company to file for the 10mg strength, it added. The product is a generic version of AstraZeneca Pharmaceutical's Nexium. It is indicated for the treatment of gastroesophageal reflux disease, risk reduction of NSAID-associated gastric ulcer, among others, Cipla said.

According to IQVIA, Nexium and its generic equivalents had US sales of around $70 million for the 12 months ended November 2019, it added.

Shares of Cipla were trading at Rs389 per scrip on the BSE,up 3.27 per cent from the previous close.

USFDA issues warning letter to Cipla for Goa manufacturing facility

Drug firm Cipla Ltd on Wednesday said that the US health regulator has issued a warning letter to the company for its manufacturing facility in Goa.

"Further to our earlier communication on the Goa manufacturing facility inspection conducted from September 16-27, 2019 by the United States Food and Drug Administration (USFDA), the company has received a warning letter from USFDA," Cipla Ltd said in a regulatory filing.

The company further said that it remains committed to maintain highest standards of compliance and will work closely with the agency to comprehensively address all the observations.

Shares of Cipla were trading at Rs 418.30 a piece on BSE in the morning trade on BSE, down 1.66 per cent from its previous close.

Cipla urges govt to increase funds, ease policies for domestic pharma firms

Homegrown drug major Cipla has urged the government to increase fund allocation for the healthcare sector, improve ease of doing business and formulate policies that aid the domestic pharmaceutical industry.

Addressing shareholders in the company's Annual Report for 2018-19, Cipla Chairman Y K Hamied said basic healthcare in the country will always require urgent attention given its population and disease burden.

"India should formulate legislation on healthcare to suit the specific needs of the indigenous pharma industry as also the healthcare required in the country. An increase in the Government's public healthcare expenditure is the need of the hour," the industry veteran said.

Echoing the sentiment, Cipla Executive Vice-Chairperson Samina Vaziralli said with the government returning for a second consecutive five-year term armed with a strong mandate, expectations are high.

"As a pharma company, we look forward to support in strengthening infrastructure and ease of doing business, developing a robust regulatory framework, increasing healthcare expenditure, and balancing of pricing controls with provision of accessible and affordable healthcare," she said.

The company is also eager to explore ways to partner with the government in its ambitious healthcare schemes to ensure coverage to the maximum extent possible, Vaziralli added.

Commenting on business aspects, Cipla Managing Director and Global CEO Umang Vohra said the drug major eyes growth in various emerging markets like China.

"We have spoken about our ambitions in China as a future growth market. We are keen to take our well-established expertise in the respiratory segment to patients in China," Vohra said.

Simultaneously, the company will also explore various routes to build a portfolio of products in China in other therapeutic areas such as oncology, he added.

The company said it plans to grow private market business in Middle East, Asia Pacific and Latin America. In Brazil, it aims to focus on oncology while eyeing partnerships in the biosimilar field in its key markets.

Currently, Cipla's core markets India, South Africa and US continue to anchor its growth, Vohra said.

In India, the company said it will focus on therapeutic segments like diabetes, dermatology, cardiology and women's health. In South Africa, the company aims to scale up its over the counter (OTC) business and also continue momentum in private market.

Besides, the company said its next leg of growth in the US will be driven by opportunities in the respiratory and central nervous system (CNS) therapeutic areas, where its internal R&D driven contributions to the complex generics and specialty segment portfolios will play a key role.

The company said it will also continue driving cost efficiencies through various initiatives and drive operational efficiencies through a lean model, use of artificial intelligence and advanced analytics.

InvaGen Pharma gets USFDA approval for neuropathic pain management drug

Drug major Cipla Monday said its subsidiary InvaGen Pharmaceuticals has received final approval from the US health regulator for Pregabalin Capsules, indicated for management of neuropathic pain associated with certain illnesses.

InvaGen has received approval from the the United States Food and Drug Administration (USFDA) for the drug in the strengths of 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg, Cipla said in a regulatory filing.

Cipla said the approved product is a generic therapeutic equivalent version of Pfizer's Lyrica.

Pregabalin capsules are indicated for management of neuropathic pain associated with diabetic peripheral neuropathy, management of postherpetic neuralgia, adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older, management of fibromyalgia and management of neuropathic pain associated with spinal cord injury.

Quoting IQVIA data, Cipla said Lyrica had an estimated market size of $5.4 billion for 12 months ending March 2019.

The product is available for shipping immediately, the company added.

Shares of Cipla were trading 0.18 per cent lower at Rs 535.90 apiece on the BSE.