Pharmaceutical Research News

Burke Pharmaceutical Research tests topical treatment for head lice

Head lice is the second most, infectious disease among children, next to the common cold.

A new drug for lice is coming to the market and a Hot Springs physician spear-headed the research.

The U.S. Food and Drug Administration approved the drug on Tuesday. Head lice are tiny insects that feed and live on the human scalp. They are irritating and can be embarrassing.

“You truly feel like you have bugs crawling in your hair,” says Marci Lawson.

Lawson and her three daughters tried all types of medications.

Hot Springs dermatologist Doctor Dow Stough tested the drug Natroba on Lawson’s family. The lead researcher found it eradicated the bugs and its eggs or nits.
“Eighty four percent of patients only needed a single application and they didn’t have to use a nit comb or pick out the nits,” says Dr. Stough.

Stough says lice have developed resistance to current medications and less than half of patients who use other drugs get rid of the pests.

“It didn’t require combing or require us to do our bedding or spray our house down,” says Lawson.

Natroba is easy to apply. You put it on your scalp for ten minutes. You wash it out and then you’re done.

“I think it will change the way head lice treatment is currently conducted,” says Dr. Stough.

Dr. Stough and his medical team tested it on more than one thousand patients. He says the product is safe and has very little side effects.

“A little bit of scalp irritation and scalp redness was noted in three percent,” says Dr. Stough.

Overall they found positive results. Patients like Lawson stand by it and it can now go on the market.

A doctor has to prescribe Natroba. Indiana company ParaPro invented the product and hopes to put it on the market the first half of this year.

Why Big Pharma Is the New Big Biotech

Biotechnology companies used to be distinguished by their ability to produce complex drugs requiring the culture of living organisms- drugs often based on the manipulation of DNA. Genentech and Amgen were pioneers of this field, producing recombinant human proteins and antibody therapeutics. Their success led to the development of the biotechnology industry.

Today, the biotech industry has become a catchall term encompassing nearly all recently formed drug development companies, regardless of biologics or small molecule drugs; alongside Amgen (AMGN) and Genentech stand Gilead (GILD) and Celgene (CELG), two biotech giants focused on small molecules. The same goes for developmental drug developers of all sizes.

The common theme behind companies termed “biotechs” is the expectation of innovation and above average growth compared to general pharmaceutical companies- and biotech companies delivered. Early investors in companies such as Amgen, Genentech, Gilead, and Celgene were rewarded with tremendous returns. Even during their best years, Big Pharma looked stodgy by comparison.

Big Pharma is now beset on all sides with issues including poor management, patent cliffs, a shifting regulatory environment, and late stage drug failures. Employees have been laid off in the tens of thousands, Sales and R&D have been axed as the companies struggle to rework their business plans in a bid to buy more time until the dark days are over. As a result, stock prices have stagnated.

But Big Biotech has not faired much better of late. Sales across the board for Big Biotech companies have slowed and are expected to continue slowing in the near future. PE multiples have compressed to a level that is now comparable to Big Pharma. Few have had substantial new drug approvals in years with the exception of Amgen with its bone drug, denosumab. In the last two years, an investment in the five largest biotechs would have yielded a 5% gain; an investment in the five largest pharmaceutical companies (excluding Johnson & Johnson (JNJ) due to its strong focus outside pharmaceuticals) would have gained 42%, including dividends, in the same period.

Genentech, seen as perhaps one of the most innovative biotech company — now part of Roche (RHHBY.PK) — is still innovating, but in many cases on new methods of drug lifecycle management rather than developing drugs with novel mechanism. Lifecycle management is a necessary facet of drug development, but the degree of Genentech’s attention to this is telling of its maturity.

Every Big Biotech is busy with lifecycle management. With the exception of Celgene- the youngest of the bunch- they are all fighting patent expirations, just like Big Pharma.

In recent years, Big Pharma, through a combination of internal research and acquisitions, has accumulated as much biotechnology capabilities as any biotech. What is left to differentiate Big Pharma from Big Biotech? In general, Big Pharma is bigger, with higher revenue and a larger market cap. They are also more diversified; some have diagnostics, animal care units, and generics. Also, growth rates are still higher for the large biotechs.

Still, it appears the differences are disappearing fast. Big Biotech is likely to head down a similar path of diversification. Many companies initially focusing on a single or narrow disease area have expanded across multiple areas of focus in a bid for growth. Recently, many have decided to enter the biosimilars (generics) fray. And with the advent of personalized medicine, especially in oncology, nearly all will be in the diagnostics business in one way or another.

There is, however, one more difference- Big Pharma offers outstanding dividends while their counterparts continue to hoard cash. Even as growth has slowed, there is no sign the big biotechs intend on paying dividends any time soon.

In the next few years, Big Pharma will lose tens of billions in sales due to generic competition. This is already reflected in their stock prices. Once sales hit their nadir, a new cycle of growth can begin, albeit from a smaller base. These last few years have provided unique opportunities for Pharma, and they have taken advantage.

The economic crisis has prevented all but a few biotech companies from publicly listing their stocks, making trade sales the most sought after exit strategy of biotech start-ups. Companies that would once have been prime candidates for IPOs instead stayed private or ended up in the arms of Big Pharma. Pharma has used this period to bolster their pipelines and technology, all while slimming down.

In the latest scientific conferences, some of the most interesting and newsworthy discoveries have come from Big Pharma labs or those of their collaborators: Roche’s T-DM1, Pfizer’s (PFE) ALK inhibitor, Bristol Myers Squibb’s (BMY) melanoma vaccine, ipilimumab. They are also on the forefront of combination drug clinical trials and personalized medicines.

Big Pharma is resurgent just as Big Biotech is losing steam. With a web of collaborators ranging from university labs to small biotechs to fellow pharmas, each company is focused on innovation. Perhaps it is time to remove the imaginary line separating Pharma from Biotech, after all, the two are not all that different.

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