A Pune-based biotechnology company Indus Biotech Pvt. Ltd claims it can help the government in its fight against the H1N1 virus—by providing a new antiviral, which is derived from a plant in the human food chain and hence is very low on toxicity, a burden that most synthetic drugs come with.
The claim comes even as governments around the world are continuing to hunt for more weapons in their arsenal to fight the influenza virus, which, historically, is known to surface in mutated forms.
While Indus has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for the compound’s action against HIV, subsequent research at one of the laboratories it works with at the National Taiwan University Hospital in Taipei showed that the compound is very effective against another virus—H1N1.
The company now proposes to develop this drug for influenza and H1N1, both as a drug as well as a prophylactic since it shows promise in preventing the infection.
The Indus team will present the data, which was reviewed by Mint, to the Union health ministry next week and seek an approval road map as India, unlike the US, doesn’t have guidelines for botanical drugs—drugs that are made from plant extracts. “Our science is impeccable and we are open to scrutiny from any agency,” says Sunil Bhaskaran, managing director of Indus.
The start-up has worked for 12 years on developing a new class of drugs for chronic life style, autoimmune and degenerative diseases, and a new drug for infectious diseases could well be a way to cash in on the current flu scare. That isn’t the case, says Bhaskaran: “This is sheer coincidence and serendipity as we don’t work on infectious diseases.”
While testing a compound on asthma, and studying the link between inflammation and autoimmune diseases, Indus came across an interesting mechanism that triggers inflammation. “We were curious and tested our compound on HIV virus two years ago in a high safety lab in Taipei and we found it confirmed our hypothesis,” says Bhaskaran. The influenza virus came next; the H1N1 test followed. Indus claims its compound is effective in Tamiflu-sensitive (strain 676) as well as Tamiflu-resistant (strain 6706) swine flu.
After completing its patent filing on 11 August, Indus submitted its H1N1 data to the health ministries of Cambodia and the Philippines, which are currently evaluating it for placing supply orders. Experts say H1N1, like other influenza viruses, mutates fast, so attacking it with just one drug—as is the case today—is not a good strategy. “Combination therapy, as is seen in HIV, is always advisable in fights against virus. That’s why you see that countries that use flu shots for the seasonal virus, develop it every year, depending on the virulent strain,” says Sunit Kumar Singh, a scientist at the Centre for Cellular and Molecular Biology in Hyderabad, who works on infectious diseases and immunobiology.
Founded in 1997 with a small round of angel fund of $600,000 (Rs2.9 crore today), Indus got a monetary infusion when the private equity (PE) arm of Kotak Mahindra Bank Ltd invested about $6 million in it in late 2007. The cornerstone of this biotech firm is a proprietary technology that allows it to isolate new molecules from plant extracts, and keep them in stable conditions as such molecules tend to degrade or change composition once outside the plant body.
One of the challenges before the drug discovery companies that do bioprospecting is their inability to produce a standardized product, says Rajan R. Srinivasan, executive director of Indus. In the absence of such a process, called chemistry and manufacturing control by FDA, plant-derived products remain in the nutritional category and never reach the prescription drug level.
Perhaps, because of this, since June 2004 when FDA first released its botanical drug guidelines, the drug regulator has only approved one—a green tea extract-based medicine for topical application in vaginal warts, says Srinivasan. His team was pleasantly surprised when FDA assigned them a pre-IND number, which is usually given after the final approval.
Indus has a calculated strategy: the starting point, always, is food chain raw materials with well-known medicinal value, so that toxicity risk is minimal. It conducts proof of concept studies in humans at a very early stage, even though they are not mandatory in standard IND application. “By design, we have orphan positioning for most drug candidates with respect to the US FDA, which allows for shorter approval time with smaller studies,” says Srinivasan. An orphan drug, according to FDA, is one that addresses a disease affecting less than 200,000 people in the US and hence, isn’t of interest to most pharmaceutical firms.
Indus has been exporting finished formulations as prescription herbal medicines through pharmaceutical marketing partners in West Asia and South-East Asian countries.
Nitin Deshmukh, head of PE at Kotak Mahindra, calls it “the most promising botanical drug company out of India”.
“That’s why we are filing INDs in the US and we’ll take these molecules to their logical conclusion in the US market,” he added.
