Pharma news – 9 July 2020

Mylan gears up to sell its generic version of Remdesivir at 4,800 rupees in India:

Cipla and Hetero labs began the sale of their generic version of Remdesivir in India in June 2020. Hetero priced its generic version, Covifor at 5,400 rupees. Cipla however claimed that its generic product, Cipremi will cost less than 5,000 rupees. This was the beginning of a competitive price war and the latest one to enter this war is Mylan.

On 6 July 2020, Mylan announced the launch of its generic version of Remdesivir in India. It further added that the price of the 100 mg vial of this product would cost 4,800 rupees ($64.31). This price is around 80% lower than the price of the same drug in wealthy nations.

Gilead has already signed licensing deals with several generic drugmakers. This was done to ensure the availability of Remdesivir in 127 developing countries.

The cost of Remdesivir per patient in the rich nation is $2,340 and this was fixed by Gilead Sciences Inc last week. The company has also agreed to supply almost half of its entire supply to the United States for the upcoming three months.

Gilead has recommended six vials of Remdesivir for treating Covdi-19 patients. Mylan, however, has not broached this topic yet.

The generic version of Mylan is called Desrem. It is approved for the treatment of suspected and laboratory-confirmed severe cases of Covid-19 in the country. The company has decided to manufacture Desrem at its injectable facilities in India. It also plans to expand its production to make sure that all the 127 low- and middle-income countries gain access to Remdesivir.

India is currently the third worst-hit country across the globe. The number of cases was around 6,97,413 on 6 July 2020. The increasing number of cases has increased the demand for Remdesivir in the country. Remdesivir is administered intravenously and has reduced the hospital recovery time in clinical trials.

Lupin recalls Metformin Hydrochloride from the US market:

Lupin voluntarily recalled its diabetes treatment drug from the US market on 8 July 2020. The drug major announced that it is recalling the 500 mg and 1000 mg Metformin hydrochloride extended-release tablets from the US market.

This action was taken owing to the presence of NMDA in the diabetes drug. The company claims this as a precautionary measure and is currently on talks with the USFDA^[1] over this matter.

 Lupin Pharmaceuticals Inc., a subsidiary of the drug firm Lupin, is currently supplying this drug to the US.

The company also clarified that the metformin tablets that are supplied in India are free from this impurity. This is because the supply chain starting from manufacturing is different for India and the US. Lupin further assured that the metformin tablets sold in India comply with all the regulatory norms and are safe to use.

 

NMDA is N-nitrosodimethylamine. It is an impurity that is considered as a possible human carcinogen. NMDA is an environmental contaminant and is often found in food, meat and water.

Metformin Hydrochloride extended-release tablets is an oral drug that is frequently prescribed for Type-II diabetes. It is used as an adjunct to diet and exercise.

Abbreviation: 1. United States Food and Drug administration

Indian government takes action to ensure the availability of three Covid-19 drugs in the country:

The National Pharmaceutical Pricing Authority (NPPA) has recently written a letter to the manufacturers of three Covid-19 drugs in the country. This letter directs the manufacturers to ensure the adequate production of dexamethasone, methylprednisolone and enoxaparin in India.

Dexamethasone and methylprednisolone are corticosteroids. They produce anti-inflammatory and immunosuppressive effects when given to Covid-19 patients. Enoxaparin, also known as Heparin, is an anticoagulant. It is useful for preventing the clot formation by the virus.

This letter was sent to the managing directors and chief executive officers (CEOs) of major manufacturers like Zydus Cadila, Cipla, Sanofi, and Sun Pharma among others.

The Director-General of Health Services (DGHS) has estimated that around 33 lakhs of 6 mg dexamethasone tablets would be required for Covid-19 treatment up to 15 August 2020. It is being speculated that around 1.38 lakh vials of methylprednisolone would be required during this period. The requirement of enoxaparin 40 mg is pegged to be around 30.15 lakh vials. And the requirement of enoxaparin 60 mg strength is estimated to be around 14.07 lakh vials by 31 July 2020.

The letter directs the companies to ensure the production and maintain adequate stock of these three drugs. It has also asked the companies to immediately send in the details regarding the sale of these drugs during the fiscal year 2018-2019 and 2019-2020. The companies must also provide details about the production schedule for the next 6 months and the stocks in hand. They were also asked to reveal the details of their supplier, mention the problems in the procurement of API^[1] and the details of the orders placed by the state governments.

The top supplier for dexamethasone is Zydus Cadila that holds around 80% of the market share. Bharat Serums and Sanofi hold around 37% of the total market of enoxaparin.  Around 43.4% of the market of methylprednisolone is currently covered by Pfizer.

This letter has also been sent to the State Drug Controllers instructing them to issue further directions to these manufacturers.

Abbreviation : 1. Active Pharmaceutical Ingredients

Strides Pharma receives USFDA approval for marketing its capsules indicated for tension headache:

Strides Pharma Science has received the USFDA^[1] approval for its butalbital, acetaminophen, caffeine and codeine phosphate capsules. These capsules are used for providing symptomatic relief of tension headaches.

This product is a generic version of branded Fioricet with codeine capsules. The branded product is manufactured by Teva Pharmaceuticals Inc.

The IQVIA MAT^[2] May 2020 revealed that the US market for butalbital, acetaminophen, caffeine and codeine phosphate capsules was approximately $10 million. The 50mg, 325mg, 40 mg and 30mg strength of these capsules comprised this market.

Strides Pharma currently has 124 abbreviated new drug application (ANDA) filings with the USFDA. Among this, 87 ANDA has been approved and 37 are awaiting approval.

Abbreviation: 1. United States Food and Drug administration

• Formerly known as Quintiles and IMS Health Inc.

References:

^[1] –mylan-prices-its-generic-remdesivir- CNBC – 6 July 2020

^[2] – lupin-recalls-diabetes-treatment-drug– Economic times – 8 July 2020

^[3] – lupin-recalls-diabetes-treatment-drug– The Print – 8 July 2020

^[4] – strides-pharma-gains-on-usfda-approval– Business Standard – 9 July 2020