3 pharma firms get USFDA nod for blockbuster cholesterol drug

Sun Pharma, Aurobindo and Glenmark to manufacture & market high-value generic

In what could boost their fortunes significantly, three Indian companies — Sun Pharma, Aurobindo Pharma and Glenmark Pharma — have received approval from the United States Food and Drug Administration (USFDA) to manufacture and market generic versions of a blockbuster cholesterol drug, Crestor, in the American market.

According to IMS Health, a global information and technology services company, this drug has had annual sales of $6.8 billion in the US itself.

Crestor, under the patent of AstraZeneca, is the brand name of rosuvastatin calcium tablets. It works by controlling bad cholesterol, which can build up in the arteries and obstruct the flow of blood to the heart, brain and other parts of the body. Therefore, it is known to prevent heart disease and strokes in patients with high cholesterol.

On the BSE, the Sun Pharma shares rose 1.89 per cent — from ~782.20 apiece to ~797 — on Wednesday. The shares of Aurobindo Pharma and Glenmark Pharma, too, rose 5.09 per cent and 2.39 per cent, respectively.

Observing the patent period for this drug was expiring, the three companies had filed an Abbreviated New Drug Application (Anda) for this drug with USFDA this year. Abbreviated new drug applications are ‘abbreviated’, as they do not require the applicant pharmaceutical company to conduct clinical trials and require less information than a ‘new’ drug application.

The three companies received the USFDA approval on Wednesday to manufacture and market generic versions of the drug in four variants — 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base).

The drug is not without its major side effects. In May this year, the USFDA published the adverse reactions of a major study conducted on patients taking Crestor.

However, states have now demanded that the budgetary allocation be made to them directly so that they can procure the equipment themselves. According to a senior official in the MP state government, there was a price escalation of 20 per cent in the central procurement over the state’s own prices. “We have only asked the Centre to revisit the process as the price received is higher,” he said requesting anonymity.

UP state officials said that the standardisation process designed by the Centre did not match the specification of the state and, hence, it would continue with the ongoing procedure.

Central procurement was the idea of Piyush Goyal, minister of state for coal, power, mines and renewable energy. The tender was to be on the lines of mass procurement of light-emitting diodes (LEDs) and lowering of prices, as reported by Business Standard in February. This is the first National Democratic Alliance scheme, which has faced resistance from states.

Earlier, many other schemes, such as the coal block auction and Ujwal Discom Assurance Yojana (UDAY), had seen active participation by states. The mass procurement programme for LED had also witnessed states taking active steps.

According to officials in the Union ministry of power, prices have come down significantly just by bringing out the tender. “We cannot force states to follow a certain model. But, this tender has benchmarked the prices lower than the prevailing rates,” said the official in the know of matter.

The government decided to standardise price and specifications for last-mile equipment in the power distribution sector in December 2105. Two committees – ‘A’ led by Rural Electrification Corporation and ‘B’ under Power Grid Corporation of India - were formed for designing standards and executing the bidding, respectively.

The bidding was held last month for four equipment cables, conductors, power transformers and distribution transformers. The Centre had issued tenders for 40 per cent of the aggregate demand of the country for these equipment. Officials refused to disclose the price and quantity of the tender, as it would stand cancelled now.

The procurement was done through the ‘reverse bidding’ mode, on the basis of national aggregate demand. Vendors were also selected, said a Rural Electrification Corporation official, but since they will all lose the tender, the names have not been disclosed.

The government was expecting that aggregation of demand would bring down the prices of equipment, leading to considerable savings to the state.

With four big states showing red flag to the ambitious programme, it would hit the government’s power reforms plan. “One of the parallel motives of the scheme was to put an end to the arbitrary procurement of electrical equipment, which is rampant in most states and design a singular tendering process,” said a senior central government official, who did not wish to be named.

The UDAY reform plan, apart from clearing the books of financially-stressed power distribution companies (discoms), also emphasises on operational efficiency and reduction in aggregate technical and commercial losses of each state to 15 per cent from the current level by 2018-19. It also aims to improve last-mile power transmission and distribution, reducing the difference between average revenue realisation and the average cost of procurement to zero by 2018-19. Along with it, the new tariff policy for electricity mandates the use of smart meters above 200 units of consumption.

State-owned power discoms, which sign up for UDAY, will have their future borrowing linked to efficiency parameters. The UDAY agreement envisages reforms to percolate till the last lineman. It said the most commonly reported adverse reactions (incidence greater than two per cent) in the ‘Crestor-controlled clinical trial database of 5,394 patients’ were headache, myalgia (muscle pain), abdominal pain, asthenia (tiredness, loss of energy) and nausea.

In 2012, the USFDA had said that the serious side effects of this drug might be liver problems. “Your health care professional should do blood tests to check your liver before you start taking Crestor and if you have symptoms of liver problems while you take Crestor. Call your doctor right away if you have symptoms of liver problems like feeling unusually tired or weak,” said the FDA. It said the additional side effects reported with Crestor are memory loss and confusion.

Aurobindo Pharma stated: “This is the 112th Anda — including 19 tentative approvals — to be approved out of Unit III formulation facility in Hyderabad, India for manufacturing oral non-antibiotic products. Aurobindo now has a total of 274 Anda approvals (234 final approvals, including 13 from Aurolife Pharma and 40 tentative approvals) from USFDA.”

Glenmark Pharma’s current portfolio consists of 115 products authorised for distribution in the US marketplace and 61 Anda’s pending approval with the USFDA. “In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio,” said a company spokesperson.