A pricing war? Cipla pips Hetero, fixes remdesivir under Rs 5,000

The pricing war for antiviral drug remdesivir has begun in the domestic pharmaceutical market. Two Indian drug majors — Cipla and Hetero Healthcare — have come out with the final pricing of their products.
Hetero has priced the injectable drug at Rs 5,400 per 100 mg vial. Cipla said it would price its generic version of Gilead Sciences’ antiviral drug for use in Covid-19 patients at less than Rs 5,000 per vial. Each patient will need six vials for the course of treatment.
Commenting on the drug’s pricing, a spokesperson for Cipla said, “In line with our overall philosophy of driving access and affordability, the drug will be priced at less than Rs 5,000 per vial for 100 mg injection — among the lowest pricing for remdesivir globally.” Cipla will be selling it under the brand Cipremi. Hetero’s brand is Covifor. Sources revealed that Cipla may price the drug around Rs 4,000 per dose.
More drugmakers, including Jubilant Pharma, Mylan, Cadila Healthcare, and Dr Reddy’s Laboratories, are in line to launch this drug soon. The prices may see further erosion then.
ALSO READ: India coronavirus dispatch: How close are we to a Covid-19 vaccine?
A senior government official said it is in wait-and-watch mode and has not decided to take any suo motu action on the pricing of the drug. Cipla had signed an agreement to contract the manufacture of remdesivir with BDR Pharmaceuticals International recently. BDR had transferred the formulation technology and other methods of development to Sovereign Pharma.
Hetero and Cipla received approval from the country’s drug regulator to launch the drug this weekend. Hetero said it is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which will be immediately despatched to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and parts of Maharashtra.
chart
The other lot will be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneswar, Ranchi, Vijayawada, Cochin, Trivandrum, and Goa within a week’s time to meet emergency requirements.
M Srinivasa Reddy, MD, Hetero Healthcare, said: “Through Covifor, we hope to reduce the treatment time of a patient in a hospital, thereby reducing the increasing pressure on the medical infrastructure, overburdened currently due to accelerating Covid-19 infection rates. We are working closely with the government and the medical community to make Covifor quickly accessible to both public and private health care settings across the country.”


Hetero had earlier told Business Standard it is diverting some of its export stocks to the Indian market to meet local demand. Hetero has even started a toll-free helpline to support doctors and hospitals interested in procuring the drug.
The drug is available in a 100-mg injectable vial. It needs to be administered intravenously in a hospital (critical care setting) under supervision of a registered medical practitioner.

ALSO READ: Chinese firm launches phase-3 trial of Covid-19 vaccine in UAE: Report
Meanwhile, Glenmark is also working towards making favipiravir available soon across the country. The company has already made it available in Delhi, Haryana, and Himachal — these are areas near the site of manufacturing in Baddi.
Within a week, the drug will be available across the country.
Sources claim Cipla’s price would lower by 30 per cent, compared to Glenmark’s. The company did not verify this.
A source close to the development said while mild patients are to be given favipiravir, if someone does not show symptoms of fever, clinicians may choose not to do so. Each tablet costs Rs 103 and Glenmark is selling it as a pack of 34 tablets. “Around 1,000-2000 patients per day would be prescribed favipiravir,” added a source.
Some companies have geared up to launch the drug and more brands will hit the market in a month’s time, bringing prices down.
Sources claim Cipla’s price would lower by 30 per cent, compared to Glenmark's. The company did not verify this.

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.

Cipla rebounds 13% from 52-week low on heavy volumes

Shares of Cipla gained 5 per cent to Rs 442, thus bouncing back 13 per cent from its early morning low on the BSE on Friday as, according to analysts, the USFDA's inspection of Goa facility found no repeat or data integrity (DI) observations, so there is no chance of import alerts at the plant.
The stock of the pharmaceutical company hit a 52-week low of Rs 390 in the intra-day trade. The trading volumes on the counter jumped seven-fold with a combined 16.6 million shares, representing 2 per cent of the total equity of Cipla, changing hands on the NSE and BSE till 02:50 pm.

The United States Food and Drug Administration (USFDA) conducted a cGMP (current good manufacturing practices) inspection at the company’s Goa manufacturing facility from September 16-27, 2019. The inspection ended with 12 observations, none of which were related to data integrity, Cipla said in a regulatory filing on September 28.
Cipla's US business contributes 22 per cent of total sales. Goa unit is an important facility for Cipla (injectable plant; around 20-25 per cent of US sales; one source products contributes 2.5 per cent of total sales).
Analysts at Reliance Securities expect there will be limited financial impact (sales of around US$40-50 million) due to lack of new approvals from the facility. Most of the new filings are from Indore facility. Further, the company can do site transfers for large products (Cipla has multiple USFDA approved plants), it added.
The brokerage firm said it has shown Form 483 to few regulatory experts, and as per them, some of the observations are of serious in nature. The observations are very detailed ones and USFDA inspectors have raised questions on cleaning validations, batch failures, quality of drugs, design of the equipments, aseptic processing areas, size and construction of the building, prevention of microbial contamination of the drugs and material specifications.
Hence, resolution of this plant would be time-consuming and it would take at least 8-10 months unlike Cipla’s historical track record of resolving USFDA issues within 2-3 months. There are good chances of getting Official Action Indicated (OAI) status for the facility; however, it may be avoided by providing robust Corrective & Preventive Action (CAPA) by the company. Additionally, all the observations are related to plant-specific and hence, we are not expecting Global CAPA, the brokerage firm said in a company update.
In the past three months, Cipla has underperformed the market by falling 22 per cent, as compared to a 2 per cent decline in the S&P BSE Sensex till Thursday.