'General Buzz'
 Merck Makes an Endeavor for a New Approach to Treat Insomnia |
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Merck is to file a new drug application with the U.S. Food and Drug Administration following successful Phase III clinical trial results.
The Whitehouse Station, New Jersey pharmaceutical company’s drug, Suvorexant, generated positive results in clinical trials that sought to prove the efficacy of the drug.
“Suvorexant selectively targets an important pathway involved in helping to promote sleep and, if approved, will be a new, first-in-class treatment for patients with insomnia,” according to a statement from the company.
Although there are several insomnia drugs on the market already, Merck’s drug takes a different approach. Instead of depressing the central nervous system, which can lead to excessive drowsiness the next morning, it focuses onorexin receptors in the brain. Orexin receptors were found to be linked to a genetic mutation found to cause narcolepsy in dogs as well as humans.
Last year, the U.S. Food and Drug Administration approved Transcept Pharmaceuticals‘ drug Intermezzo, the first drug approved for treating the version of insomnia typified by people waking up in the middle of the night and not being able to get back to sleep, a statement from the FDA said. Intermezzo is a lower dose version of zolpidem tartrate, approveby US regulators in 1992 as Ambien.
The National Center for Sleep Disorders Research at the National Institutes of Health said 30 percent to 40 percent of Americans say they suffer at least some of the symptoms of insomnia.
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| Serum Institute of India Ltd to Sell Off Overseas Buys |
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Serum Institute, the over Rs. 1,000 crore privately held vaccine maker, has learned its lesson after picking up minority stakes in vacccine and pharma companies in India and abroad. It will stick to its core business, vaccines and immuno-biologicals, to emerge as a major global player in these businesses, a senior company official said.
"We have learned that we should stick with what we know best, vaccine making. We will soon offload our stakes in Lipoxen Plc of the UK and Akorn Inc of the US since the objectives (in the stake acquisition) were not achieved. We will be happy to get our costs since we invested Rs. 100 crore in each of the two companies," a senior official said.
Lipoxen is a bio-pharma company while Akorn is a maker of sterile speciality pharmaceuticals.
In India, Serum Institute of India Ltd holds stakes in Orchid Chemicals and Pharmaceuticals which it bought as a white knight investor and currently holds a 10.1% stake in it. An official explained, "It was a diversification for our group since we are not in that business. At one time, we thought we could even hike our stake but right now, we see it as a long term holding."
Serum Institute is now considered the fifth largest vaccine maker by volume globally, making 900 million doses annually. It plans to add capacity in the next couple of years for another 200 million doses, taking the total to 1.1 billion doses.
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| Himalaya Drug Co Plans to Spread out Global Operations |
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Himalaya Drug Company, the maker of blockbuster liver care drug, Liv 52, plans to set up manufacturing plants in Indonesia and Russia to expand its global operations.
The Himalaya Drug Pharmaceutical Division Chief Executive Officer said that the company has also decided not to float an IPO as it does not want to be “answerable to quarterly pressures.”
He has also ruled out any fund raising plans for the company in the short term.
The company said Russia was the biggest pharma market outside India for the company. A senior official also said that the pharma division is also setting up new categories such as ENT, lifestyle diseases and baby care, which will expand the total number of categories to 13 from eight currently.
The company is betting on rural initiative to drive its next phase of growth. Its 100-member team of medical representatives covers about 4,500 villages currently and the team will be expanded to about 500 in a phased manner.
Currently, about one-fifth of its total sales come out of rural initiative. The company has also invested in a hospital division which carries out projects to make medical doctors aware of its various initiatives and brands.
Himalaya is also working on drugs for women's health, GI, derma as well as oncology. Liv 52 HB, its latest drug for treating hepatitis infection, took nearly 15 years to develop and now is one of its fastest growing products in its portfolio.
The Rs 1,200-crore Himalaya Drug Company has 66 brands and 91 SKUs as part of its portfolio. Its blockbuster drug, Liv 52 launched 57 years ago is growing at an average of 27 per cent every year..
According to the ORG figures, Himalaya's pharma division has a turnover of about Rs 400 crore.
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