Side Effects, Efficacy and Social Media Will Be the Big Factors
The recent Global Business Intelligence Research report on anti-inflammatory drugs puts their global market in 2010 at $57.8 billion. According to the report, "The main factor that is driving the big pharmaceutical companies towards the inflammatory therapeutics market is the large patient base. Respiratory diseases and arthritis continue to be some of the most common diseases and are among the leading causes behind major chronic disabilities in the workforce." The report also provides "an in-depth analysis of the top seven inflammatory therapeutic indications, which are respiratory diseases, arthritis, multiple sclerosis, psoriasis, spondyloarthropathies, inflammatory bowel disease and gout." It's no wonder the report forecasts the global market to reach $86 billion by 2017.
Today's Anti-Inflammatory Drugs
After studying four of the most popular prescription anti-inflammatory drugs, Humira, Remicade, Enbrel and Celebrex, I was surprised to find they all had numerous harmful side effects that could occur as a result of using their products, each of these being clearly stated on the company web sites and their product packaging. And during the fast-talking warnings that are rattled off under images of happy, smiling people during the direct-to-consumer marketing of prescription drugs. Even popular over-the-counter painkillers are known to have harmful side effects from prolonged and excessive use.
Do a Google search for any of the drug names above followed by the word "attorneys" and you'll see another indication of the severe side effects. Your search returns a long list of law firms specializing in class action suits with massive settlements.
On social media sites people are talking about the drugs, but I found very little praise or mention of relief, just a great deal of concern regarding the harmful side effects. The blogosphere seems no different, with many posts on the terrible side effects but very few about how effective the drugs are for their conditions.
A Closer Look At The Big Four
Following is a comparison of the most popular anti-inflammatory drugs that account for over $12 billion in sales in the past 12 months. Here's how Celebrex, Remicade, Enbrel, and Humira match up on side effects, efficacy and sales.
Celebrex, by Pfizer (PFE) is a pill and a class of non-steroidal anti-inflammatory drugs known as COX-2 enzyme inhibitors. It is approved to treat the signs and symptoms of osteoarthritis and rheumatoid arthritis, and for the management of acute pain in adults.
- Cardiovascular warning: All prescription NSAIDs, like CELEBREX, ibuprofen, naproxen, and meloxicam have the same cardiovascular warning. They may all increase the chance of heart attack or stroke that can lead to death. This chance increases if you have heart disease or risk factors for it, such as high blood pressure or when NSAIDs are taken for long periods.
- CELEBREX should not be used right before or after certain heart surgeries.
- Stomach and intestine risk: All prescription NSAIDs have the same warning for serious stomach and intestine problems: They may cause ulcers and bleeding, which can occur without warning and may cause death.
- Serious skin and allergic reactions can occur with CELEBREX. Do not take it if you've had an asthma attack, hives, or other allergies to aspirin, other NSAIDs, or certain drugs called sulfonamides. Get help right away if you've had swelling of the face or throat or have trouble breathing.
Testimonials on the use of Celebrex are very discouraging. The most frequent comments site minimal effect and that it is very hard on the stomach.
Sales are reported at $1.7 billion for the past 12 months, despite continued controversy about its efficacy and risks. The success of Celebrex is proof positive of the power of great direct-to-consumer marketing.
Enbrel. Humira & Remicade - Block That Protein!
Enbrel by Amgen (AMGN) and Pfizer, Humira by Abbott Labs (ABT) and Remicade by Johnson & Johnson (JNJ) are injected biologics used to treat long-term inflammatory diseases including moderate to severe rheumatoid arthritis, plaque psoriasis, psoriatic arthritis juvenile idiopathic arthritis, and ankylosing spondylitis. These biologics are TNF-alpha blockers that bind to protein and help block the process of inflammation. Because TNF-alpha blockers affect the immune system, they can lower the ability to fight infections and may cause other serious side effects.
Serious side effects of these TNF-alpha blockers are summed up nicely by the Enbrel site:
- Risk of infection. ENBREL can lower the ability of your immune system to fight infections. Some people have serious infections while taking ENBREL. These infections include tuberculosis (TB), and infections caused by viruses, fungi or bacteria that spread throughout their body. Some people have died from these infections.
- Risk of cancer.
- There have been cases of unusual cancers in children and teenage patients who started using TNF-blocking agents at less than 18 years of age.
- For children, teenagers, and adults taking TNF-blocker medicines, including ENBREL, the chances of getting lymphoma or other cancers may increase.
- People with rheumatoid arthritis or psoriasis, especially those with very active disease, may be more likely to get lymphoma.
- Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use ENBREL.
- Nervous system problems. Rarely, people who use TNF blocker medicines have developed nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes.
- Blood problems. Low blood counts have been seen with other TNF blocker medicines. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding very easily, or looking pale.
- Heart failure including new heart failure or worsening of heart failure you already have. New or worse heart failure can happen in people who use TNF blocker medicines, like ENBREL.
- Psoriasis. Some people using ENBREL developed new psoriasis or worsening of psoriasis they already had. Allergic reactions. Allergic reactions can happen to people who use TNF blocker medicines.
- Autoimmune reactions, including: Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun.
- Autoimmune hepatitis. Liver problems can happen in people who use TNF blocker medicines, including ENBREL. These problems can lead to liver failure and death.
Testimonials for Enbrel are mostly positive. For Humira they are generally favorable and that it actually works better than Enbrel. Remicade reviews are mixed, but one thing in common for them all is the concern about shot after shot after shot and over side effects.
Sales of Enbrel, Humira and Remicade reached $3.6 billion, $3.7 billion and $3.5 billion respectively for the last 12 months. Along with Celebrex, these four drugs account for 20% of the global anti-inflammatory market. With treatments that are extremely expensive, have mixed reports on efficacy and all with serious risk including cancer and death.
The Obvious Question
If all these drugs have such negative side effects and don't work that well, why are their sales so high? The answer is very simple. Constant pain will drive anyone to a point of desperation and they will try anything to get help. Combine that pain and desperation with aggressive marketing and you have the formula for very big sales.
This leads to the next big question. What do you think would happen if there were an anti-inflammatory that really worked well and had no side effects? With today's powerful social media, it wouldn't take long for patients in severe pain to find out and race to their doctor's office for a prescription.
With new science developing every day, is there such a drug now?
Is Ampion a Breakthrough Anti-Inflammatory?
After spending weeks of research on drug pipelines for a previous article, I did find one anti-inflammatory drug that appears to be profoundly more effective than any other. And unlike the others, Ampion from Ampio Pharmaceuticals (AMPE) also appears to be very safe.
Reported results from a recent Phase II trial seem nothing short of miraculous. According to Yvonne Lungershausen, the Senior Director of Clinical Services who oversaw the phase II trial at CPR Pharma in Australia, "In terms of safety issues, there were none". "There were no adverse events and I would even say that Ampion had an exceptional safety profile".
A press release from Ampio states, "There were no significant adverse events and no minor adverse events that were more common in the Ampion™ group compared to the placebo group indicating the treatment is well tolerated."
Celebrex, Enbrel, Humira and Remicade have all been around since the late 90's to the early 2000's and they are based on science dating back to the 80's. According to Dr. David Bar-Or, the drugs inventor, Ampion is based on "new science." He says it works by using a naturally occurring substance in our bodies to trigger a shutdown of certain immune responses which alleviate inflammation and associated pain.
Ampion is also a component of Human Serum Albumin that has been administered to millions of patients over the past 40 years with an excellent safety record.
Of course critical phase III trials are forthcoming, and though the initial results are promising, time will tell whether Ampion's safety profile will hold strong.
With a drug not yet approved by the FDA, user reviews and testimonials are harder to find. But for some, seeing is believing and this Channel 9 News video shows a man who was in so much pain that he was scheduling to have knee replacement surgery. Desperate, he enrolled in a clinical trial for Ampion and within one hour after his injection, the results he reports are amazing. And, after six months, the injection was still working; he cancelled his appointment for knee replacement surgery.
According to a CPR Pharma Services press release: "The result of the trials - conducted in 104 patients with osteoarthritis of the knee - showed significant reduction in pain in those that received a single injection of the drug. The treatment also appears to have no side effects, which can be a problem with another current treatment for osteoarthritis - steroids - which can only be used a few times and can have significant side effects."
Dr. Lungershausen reports in the press release that "even while the study was still blinded it became clear that some of the patients had significant decrease in their pain levels."
Lungershausen also says that "Patients were followed up in 30 days and then again at day 84 with pain questions and CT scans and the data just kept getting better and better".
This brings us back to our big question: If Ampion is much more effective at alleviating pain and with no adverse side effects, what is its sales potential?
Currently, Ampion is entering pivotal phase III clinical trials as a direct injection to treat knee osteoarthritis and soon afterwards for other joints like hips, shoulders, elbows, etc. Dr. David Bar-Or says that Ampion could be offered in a pill form if that form of delivery proves successful for specific indications in additional clinical trials. If all continues to go well, Ampion could be cleared for sale by the FDA in late 2013 and available by prescription shortly thereafter.
Ampio's worldwide patent position is extremely strong for Ampion, being issued composition of matter, multitude of uses, and manufacturing patents not expiring before 2021.
With today's powerful social media, Ampion could very easily go viral and dominate anti-inflammatory sales regardless of other companies marketing attempts.
A recent 48-page analyst report on Ampio researched and written by Raghuram Selvarju, Ph.D. at Aegis Capital details the risks and their reasoning for initiating coverage with a "buy" rating and an $11.00 price target.
There is risk investing in all of the companies in this article, but there is even greater risk investing in a small company like Ampio Pharmaceuticals. The company may fail in future trials, it may not have adequate capital to complete all of its trials, and another unknown drug that is better may make its presence known.
Disclosure: I am long AMPE.