PHARMA LITERATI

There is some good news for the over 72 million diabetics in India, with a cheaper version of a blockbuster drug hitting the market on December 10. The domestic pharmaceutical market is abuzz with news of over 15-20 companies launching generic versions of the widely-prescribed anti-diabetic drug Vildagliptin , with its price expected to crash by half. The potential of more affordable diabetic care comes in the wake of Swiss major Novartis-owned Vildagliptin losing patent on Monday — a development closely watched for months. Dozens of companies have readied plans to get a slice of the action in the growing Rs 14,000-crore diabetes therapy market, with the number of players expected to cross 50 soon. With the drug’s patent expiry, the price may drop to Rs 6 per tablet over the next few months, from the existing Rs 20-25 each. What makes the patent expiry significant for Indian pharma is that Vildagliptin is the first among the gliptins, a relatively new class of oral diabetes ...

Expert panel denies co permission to conduct trials on Indian patients Drug maker Cipla's plan of developing a pump-delivered inhalable form of insulin has suffered a setback with an expert committee denying it permission to conduct trials on Indian patients.The panel has said the company's preliminary data on safety and efficacy of the trial drug is insufficient. Cipla had based its application to the panel on the bioequivalence studies with Exubra , an inhalation drug and device combination that was being marked by Pfizer. Exubra was withdrawn from the market in 2007 due to slowdown in sales mainly because of issues revolving around product design. In November, the Subject Expert Committee -a group comprising experts in diverse fields of endocrinology and metabolism -met and noted: “ The firm (Cipla) has presented BABE (bioavailability bioequivalence) study data and requested for phase IV study which is not acceptable and not scientifically justified with respe...

The price of diabetes drugs have halved in the past nine months, bringing relief to around millions of diabetics in India. A new class of medicine — belonging to the gliptin family — has lowered the cost of drugs by 50% in less than a year. Of the 68 million diabetics in India, about 1.85 million are on gliptin therapy to manage their type-2 diabetes. The price came down from Rs 156 a pack in January to Rs 79 in September, thanks to aggressive pricing by domestic companies. An average daily price for other diabetes drugs stands at Rs 45 against Rs 5 to Rs 7 for teneligliptin -based drugs, launched last year. Glenmark launched teneligliptin under the brands Ziten and Zita Plus at a breakthrough price of Rs 19.90 a tablet when most gliptins were priced at around Rs 45. Today, 30 companies, including Glenmark, Mankind Pharma, Zydus, Eris Life Sciences and Intas, are making about 34 brands of drugs from the teneligliptin molecule. “ While most of the gliptins we...

Lauding the achievements of the Council of Scientific and Industrial Research (CSIR) on its platinum jubilee earlier this week, Prime Minister Narendra Modi had made a special mention of the “ BGR-34 ” ayurvedic anti-diabetic drug that it had launched with much fanfare in June. However, going by the negative reactions of several eminent scientists and a stinging editorial in a professional journal on ayurveda, Modi appears to have chosen a wrong example to highlight CSIR’s successes. They are questioning the scientific validity of the drug, launched in press conferences across the country and promoted through commercial advertisements, without any published scientific evidence or clinical trials to support the claims made. They note this raises doubts about the CSIR’s “moral, ethical and public health responsibility”. Jointly developed at CSIR’s two institutes in Lucknow — the National Botanical Research Institute (NBRI) and the Central Institute for Medicinal and Aroma...

For decades, a substitute for invasive insulin needles -tablets or insulin delivered via inhalable pumps -is seen as a holy grail but scientific endeavours have so far achieved limited success. But, good news for millions of diabetes patients may be in sight. Danish drugmaker Novo Nordisk, a dominant player in the global insulin market, is gearing up for at least two oral products that it believes could give the company a clear breakthrough lead and potentially alter the treatment paradigm. The company that reaped nearly 80% of its $16 billion sales from various insulin products last year, is hopeful for a regulatory approval for its first time oral therapies, a GLP-1 receptor agonist for type two diabetes and an insulin packed in a tablet form in about three to four years. Once commercially launched, the company said it could see a growth and a visible switch from the used needles. GLP-1 is a potent hormone that induces beta cells of the pancreas to release insulin in res...

Google and French pharmaceutical giant Sanofi has announced a new joint venture focused on diabetes care. The tie-up between the drug maker and Verily, the health subsidiary of Google's parent company Alphabet, will focus on treatments for people living with the chronic lifestyle disease. Details on what the company's products will look like - or when they will reach the market -- were scant, but they will combine the drugmaker's clinical know-how with the tech company's background in analytics and mini devices , a joint statement said. " As it will initially consist of connecting already existing products, we can expect the first innovations to arrive more quickly than if it was a pharmaceutical research programme starting from scratch ," the head of Sanofi's diabetes business, Stefan Oelrich, told AFP. The venture, called Onduo , will initially focus on type-2 diabetes, the more common form of the disease. The prevalence of type-2 diabe...

In a major breakthrough, scientists have zeroed in on key disease events triggering type 2 diabetes in obese people. Scientists at the CSIR-Indian Institute of Chemical Biology (CSIR-IICB), in collaboration with clinicians from ILS Hospitals, Kolkata , and Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata , analysed fat tissues (visceral adipose tissue or VAT) of obese people undergoing bariatric surgery. “ A lot of obese people are getting diabetes type 2 (insulin resistance diabetes). Even in rural India, obesity is increasing. We have discovered a novel mechanism in the pathway that leads to type 2 diabetes in obese people. This is perhaps the root cause of the pathway and opens up possibilities for development of new drugs based on the finding ,” immunologist Dr Dipyaman Ganguly of CSIR-IICB told IANS. Published in August in the journal Diabetes , the study builds upon existing data on the links between obesity and diabetes. “ When a per...

Parents need to be extra careful while giving antibiotics to children as new research has found that the commonly-prescribed drug can significantly increase the risk of Type 1 diabetes . In Type 1 diabetes, the immune system mistakenly destroys the islet cells in the pancreas that produce insulin. Without insulin, patients cannot properly control their levels of blood sugar (glucose), which builds up to damage nerves and blood vessels. A study conducted on mice found that antibiotics changed the mix of gut microbes in their young ones and dramatically raised their risk for Type 1 diabetes. "Our study begins to clarify the mechanisms by which antibiotic-driven changes in gut microbiomes may increase risk for Type 1 diabetes," said Martin Blaser, Professor at New York University (NYU) in the US. In the study, the team examined the effects of exposure to either continuous low-dose antibiotics or pulsed antibiotic therapy (PAT), which mimics the doses used to ...

Drug Name Luseogliflozin Structure   Drug Code TS-071 Synonym (2S,3R,4R,5S,6R)-2-[5-(4-Ethoxybenzyl)-2-methoxy-4-methylphenyl]-6-(hydroxymethyl)tetrahydro-2H-thiopyran-3,4,5-triol Molecular Formula C 23 H 30 O 6 S Innovator Taisho Toyama Pharmaceutical Novartis for marketing Condition Type-2 diabetes mellitus Mechanism of Action Sodium-glucose transporter 2 inhibitor Clinical Phase I Approval Approved in Japan in March 2014.

Drug Name Ranirestat Structure   Drug Code AS-3201 Synonym (3R)-2'-(4-bromo-2-fluorobenzyl)-1'H,2H,5H-spiro[pyrrolidine-3,4'-pyrrolo[1,2-a]pyrazine]-1',2,3',5(2'H)-tetrone Molecular Formula C 17 H 11 BrFN 3 O 4 Innovator Dainippon Sumitomo Pharma PharmaKyorin Condition Diabetic nephropathy (Orphan drug status) Mechanism of Action Aldose reductase inhibitor Clinical Phase III in USA

Drug Name (S)-Pyrrolidine-2-carboxylic acid compound with (2S,3R,4R,5S,6R)-2-(3-((2,3-dihydrobenzo[b][1,4]dioxin-6-yl)methyl)-4-ethylphenyl)-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4,5-triol (2:1) Structure   Drug Code LIK-066 Synonym - Molecular Formula C 23 H 28 O 7 .2 C 6 H 11 NO Innovator Novartis Condition Type-2 diabetes mellitus Mechanism of Action Sodium-glucose transporter 2 inhibitor Clinical Phase II in USA

Drug Name Ertugliflozin Structure Drug Code MK-8835 Synonym PF-04971729 Molecular Formula C 22 H 25 ClO 7 Innovator Merck & Pfizer Condition Type 2 Diabetes Mellitus Mechanism of Action Sodium-glucose transporter 2 inhibitor Clinical Phase III in USA