Avelient BioPharm Blog

The Pipeline Floodeth

My latest issue of the Pharmaceutical Executive recently came in the mail, its cover heralding its report on the 2007 pipeline for drug companies. The story covers 61 offerings that are being developed at the big pharmaceutical companies to treat a variety of diseases. I examined it with great interest, taking particular note of the thorough job that the magazine did in covering different medicines for different categories, and showing their stage of clinical trail and when we might expect to see them come to market.

By no means will I cover the entire list here — I am but a humble blogger, and there are far too many for me to review for the purposes of my audience. But I have covered several clinical areas in 2007 on this blog, and will try to use that as a framework for what I’ll discuss below. To get a full list and analysis on all the drugs in the pipeline for 2008 and beyond, read “The Pharm Exec Pipeline Report 2007” online at the Pharmaceutical Executive.

Alzheimer’s Disease: Prevention and Management

You may recall, back in July, I wrote a post describing my experience with Alzheimer’s disease in my own family, and about a drug called Affitope AD01 being developed by Austrian pharmaceutical company Affiris. Its purpose is to prevent the deterioration of the mind associated with Alzheimer’s disease. While it didn’t make the list of “drugs in the pipeline,” likely because it was just entering clinical trials at the time, it is a fair representation of the purpose of drugs that are in the pipeline: prevention and management.

All of the upcoming drugs in this category strive to slow the course of the disease by intervening in the ß-amyloyd pathway. This pathway releases a toxic substance that later congeals into amyloyd plaque, itself benign but indicative of the damage done. The drugs, Flurizan, Bapineuzumab, PBT2, Alzhemed and Dimebon, each approach the problem differently and are showing different levels of effectiveness in their clinical trials. Dimebon appears to be the most compelling at this time, its Phase II clinical trials exceeding hopes in Russia. The measurable difference between the effect of the drug vs. the placebo was greater at 12 months than it was at 6, a strong indicator of a disease-modifying compound.

Smoke Down

Again in July, I came across a study that linked smoking with the prevention of Parkinson’s disease. Interestingly, it didn’t have anything to do with any one particular chemical in the cigarettes, but with the act of smoking them (read more here). Well, in spite of that article and the convincing research, I didn’t become an advocate for smoking, even if it raised the question as to whether certain people should start. It didn’t slow down the development of new drugs to help wean people off smoking either, with two new drugs entering the market: TA-NIC and Dianicline.

Pfizer has had some success in this area with its drug Chantix, but as I mentioned in my last blog entry, the drug may have links to suicidal thoughts in patients. Like Pfizer’s drug, Sanofi-Aventis’ Dianicline allows nicotine to enter the brain but binding to the receptors that produce the pleasurable effects associated with it. The similar approach makes me wonder whether patients will suffer the same negative psychological effects as did the patients who took Pfizer’s Chantix during clinical trials. TA-NIC takes a more novel approach, delivered as a vaccine in the bloodstream that produces antibodies that bind to nicotine while still in the bloodstream. This in turn reduces the chemical’s entry into the brain and the positive reinforcement associated with smoking.

Obesity: The Market Gets Bigger

At several points during the year, I wrote about Sanofi-Aventis‘ drug Acomplia, a controversial weight-loss drug that had potential major side-effects, including anxiety, insomnia and depression. The first time I had written about the drug, it was being considered for approval by the FDA in the United States. Since then, an advisory panel rejected its approval here, but Sanofi-Aventis apparently hasn’t given up, according to the report.

In fact, all three compounds in clinical trials right now, Sanofi-Aventis’ Acomplia, Merck’s Taranbant and Pfizer’s CP 945598, are all cannabinoid receptor antagonists, thus they may all be subject to the same side effects that have thus far foiled Acomplia’s introduction to the market. So why continue to pursue these drugs if the precedent demonstrates that they will likely be rejected? Estimates poise the winner to have $3 billion in sales at its peak, giving big Pharmas good reason to pursue the drugs.

RSV: Close to Home

While I didn’t necessarily focus any articles on RSV (Respiratory Syncytial Virus), it is something in which I take a profound interest, because my son suffered not one, but two bouts with the disease in the 5th and 6th months of his life. In both instances, it was suspected he developed viral pneumonia as a result of the infection. I remember the nights at the hospital, and though my wife and I both were aware of how dangerous the pneumonia could be to our infant, I think we were both numbed by the entire experience. I would not wish those kinds of nights on any parents, and I would also hope to limit its effect on its other primary group, the elderly, which is why I was encouraged to see two new treatments on the way down the pipeline for this disease.

AstraZeneca’s Motavizumab, a monoclonal antibody targeted specifically for full-term infants, is quoted as being a breakthrough drug in the article because of its efficacy in clinical trials. It is currently in Phase III clinical trials and is targeted for release in 2008. Alnylam’s ALN RSV01, on the other hand, is a small interfering RNA (siRNA) compound that attacks the RSV infection at the genetic level while in the lungs, rendering it ineffective. There is no current target date for release, though it is currently being tested on adult volunteers and as a nebulized formula appropriate for hospitalized infants.

There are several other drugs in the pipeline, obviously too numerous to mention here, so I encourage you to see the full article in Pharmaceutical Executive magazine. New cholesterol drugs, improved antibiotics, new approaches and solutions for diabetes, even novel cocaine therapy are a hint of what is to come in the future. There is even a whole variety of compounds being developed to ward off and attack cancer.

Encouraging as the news is, it will be hard to get excited about any of these compounds until they are approved. Even then, given the track record of drugs in today’s market, will we need to worry about some unknown complication that was not borne out in the clinical trial data? As we move further into molecular or even genetic manipulation, how will we ascertain whether we are “fixing” ourselves by taking these drugs or just masking the problem with a complex and expensive chemical?

I certainly think there’s a lot of merit in the work that the pharmaceutical are doing to improve our lives. I will be curious to see how and when (or if) these drugs are released, and whether they truly improve the quality of life of the people they are intended to help.

I’d be curious to hear your thoughts. Please add them in the comments field below!