Glenmark under fire for over pricing, 'misguided' claims of Covid-19 drug

Glenmark, which markets favipiravir under brand Fabiflu for treatment of mild-to-moderate Covid-19 patients, has come under the scanner of ‘the country’s drug regulator over pricing of the drug and claims of its therapeutic efficacy.
The Drug Controller General of India (DCGI) has sent a letter to the Mumbai-based drugmaker seeking clarifications on pricing as well as claims of therapeutic efficacy.

The move was triggered by a letter Nationalist Congress Party legislator Amol Kolhe wrote addressed to the health minister.
The DCGI had given emergency use authorisation to favipiravir in the third week of June. It was an expedited approval following review by the subject expert committee (SEC) given the pandemic situation in the country.
In his letter to Glenmark, V G Somani, India’s DCGI, who heads the Central Drug Standard Control Organisation (CDSCO) has said that it received a complaint from a member of the Parliament (MP) regarding the drug favipiravir. This letter, however, did not name the MP.
Dr. Kolhe, a medical professional, had written a letter to Health Minister Harsh Vardhan on June 26, right after Fabiflu was launched. He had said that a patient has to take these tablets for 14-days (or around 122 tablets). At a price of Rs 103 per tablet, this would bring the total cost of treatment to Rs 12,500. He had urged “the government to should ensure affordability of the drug to the common people”. Later, however, Glenmark slashed the price of the drug to Rs 75 per tablet bringing down the cost of treatment to Rs 9,150.
Kolhe said six of the 12 centers for clinical trials were government medical colleges from Maharashtra, Gujarat, and Delhi. He claimed that while common people contributed to the trial as subjects, the drug is definitely unaffordable to them.
Glenmark under fire for over pricing, 'misguided' claims of Covid-19 drug
Meanwhile, Somani referred to the MP’s representation and said that while Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
Kolhe claimed in his letter that “going by the protocol summary available at CTRI website, Fabiflu was not tested as monotherapy (only Fabiflu) in any of the mild or moderate patients... It was given along with ICMR-approved standard protocol treatment in selective clinically-stable Covid-19 patients. Also, patients with 94 per cent SPO2 who are excluded from the trail.” SPO2 is a measure of the amount of oxygen-carrying hemoglobin in the blood in comparison to the amount of hemoglobin that is not carrying oxygen.
Kolhe further alleged that the data clearly showed that the claims made by Glenmark in their press conference that Fabiflu alone is effective in mild to moderate patients are “completely misguided” to all clinical practitioners and people of India.
Glenmark said it would respond to the DCGI as early as it could. Meanwhile, sources in the CDSCO claimed that the letter was sent to the company as an MP sought some clarifications. “The company will now clarify on the points raised by the MP,” a source said.
Earlier this month, Glenmark had said it had started a post-marketing surveillance study on its brand Fabiflu to monitor the efficacy and safety of the drug in 1,000 patients.
Glenmark has completed phase-III clinical studies, with favipiravir in mild-to-moderate Covid-19 patients in India. The results from the study would be out within 10 days or so, sources said. Glenmark is also conducting another phase-III clinical trial to evaluate the efficacy of two antivirals drugs favipiravir and umifenovir as a combination therapy in moderate hospitalised adult Covid patients in India. The combination study, which is called the FAITH trial, is looking to enrol 158 hospitalised patients of moderate Covid in India.

Glenmark Pharmaceuticals declines 13% in two days on profit booking

Shares of Glenmark Pharmaceuticals declined 7 per cent to Rs 459 in the intra-day trade on the BSE on Wednesday, having fallen 13 per cent in the past two trading days on profit booking.
On Monday, the stock of the drug maker had rallied 27 per cent to Rs 520 after the firm received approval for Favipiravir’s (Fabiflu), a potential Covid-19 drug, by the Drug Controller General of India (DGCI).

The approval of Favipiravir (emergency usage approval) is for mild to moderate patients. While this is a positive development for the company with short term benefits from Indian market besides additional opportunity from export markets based approvals, the recent run up is unwarranted and much ahead than fundamentals, analysts believe.
“This reaction has an irrational exuberance and will likely fizzle out in the near-term as Cipla, Strides and Natco/Laurus approval will follow soon leading to a cut-throat competition. The Remdesivir has an edge over Favipiravir in terms of efficacy and backup from FDA. Favipiravir opportunity for the company in India could only be worth Rs 40 – Rs 50 crore assuming three players market. The private medical practitioners may not opt for Favipiravir as approval lacks complete clinical trials,” Prabhudas Lilladher said in an update.
In an optimistic scenario, Favipiravir can generate revenue of Rs 50 crore with EBITDA (earnings before interest, taxes, depreciation and amortization) margin of 15 per cent and EPS contribution would be between Rs 0.19-0.22. We would wait for more clarity from GNP management during Q4FY20 earnings call, it said.
At 11:08 am, Glenmark Pharma was trading 3.5 per cent lower at Rs 468 on the BSE, as compared to 0.26 per cent rise in the S&P BSE Sensex. A combined 16.2 million equity shares have changed hands on the counter on the NSE and BSE till the time of writing of this report.

Pharma Monday blues: USFDA warnings drag down Glenmark, Aurobindo stocks

Regulatory worries dragged down major pharma stocks on Monday, with Glenmark Pharmaceuticals and Aurobindo Pharma leading the pack, falling 9.3 per cent and 19 per cent, respectively, on the bourses. While Glenmark’s Himachal Pradesh site received a warning letter from the US Food and Drug Administration (USFDA), Aurobindo’s unit VII in Telangana got seven adverse observations from the same regulator.
At close, the Glenmark stock was Rs 286.3, a 52-week low, on the BSE. Aurobindo Pharma shares fell more than 20 per cent, a five-year low, during intra-day trading. The company’s scrip closed at Rs 458.50. However, neither has an import alert and hence they can continue to export to the US.

The sites under the scanner contribute 7 per cent of Glenmark’s and 25-30 per cent of Aurobindo’s revenues from the US.
Hyderabad-headquartered Aurobindo is the fifth-largest generics player in the US and draws 46 per cent, or Rs 9,030 crore, of its revenues from there. This financial year, the revenue share of the US market is expected to cross 50 per cent.
Mumbai-based Glenmark draws around 35 per cent, or about Rs 3,200 crore, from the US and ranks among the top 20 generics players in the market. The Nifty Pharma index fell 3.35 per cent during the day. Among other drug firms, shares of Cipla (2.35 per cent), Sun Pharma (1.57 per cent), Cadila Healthcare (1.72 per cent), and Lupin (2.59 per cent) were down because regulatory developments marred sentiment.
Glenmark’s Baddi facility, which makes dermatological formulations, was inspected during April 15-20 this year and was classified as “official action indicated”, or OAI, by the USFDA. The company, however, said this facility would not be affected. “The Baddi facility is expected to contribute $30 million in sales for this financial year, which is approximately 7 per cent of US sales,” Glenmark said.
Exports from a facility stop if it is placed under an import alert. A warning letter is an escalation of Form 483, which notes adverse observations around quality and compliance. Edelweiss said while the Baddi facility was classified as OAI, there were no data integrity issues and Glenmark had cleared the latest inspection without observations.
“But the USFDA still issued a warning letter as the agency believed the problem was recurring. Glenmark is in the process of preparing a detailed response to the USFDA over the next 15 days,” the brokerage said.
chartThe company said it would work with the regulator on all corrective actions required to address the concerns in the USFDA’s letter.
Glenmark further said there were no major pending approvals from this facility in the next 12 months.
“There will be no financial impact on the organisation on account of this development,” a statement from the company said.
Glenmark has eight manufacturing facilities approved by the USFDA — five formulations facilities and three active pharmaceutical ingredients (APIs) facilities under Glenmark Life Sciences. None of these except the one in Baddi has outstanding issues with the USFDA.
As for Aurobindo, the US inspection team cited several shortfalls — ranging from an incomplete electronic trail and documenting manufacturing processes and products, to failure in cleaning equipment at appropriate intervals — in a 16-page report related to a latest inspection conducted during September 19-27 at the formulations plant located in the Polepally Industrial Park.
This facility, which has more than 130 product approvals in place, is one of the key sites for US exports. According to HDFC Securities analyst Amey Chalke, Unit VII contributes 25-30 per cent of the company's US revenues. Though Form 483 observations allow the manufacturer to respond with suitable remediation responses before any adverse import restrictions are imposed by the US drug regulator, analysts fear the process could take longer owing to the nature of the observations.
Aurobindo had seen similar compliance shortcomings with regard to three other manufacturing facilities earlier this year.
The latest Form 483 observations have raised fears of a possible disruption in US exports if Aurobindo fails to address the USFDA’s concerns in time.