MannKind: 5 Potential Technosphere Applications
Oct. 18, 2014 8:38 AM ET | 3 comments | About: MannKind Corporation (MNKD)
Disclosure: The author is long MNKD. (More...)
Summary
•MannKind's Technosphere technology allows drugs to be taken through an inhaler instead of through an injection.
•There are many injected treatments that could eventually be replaced by inhaled versions due to this technology.
•This article will list some 5 possible currently injected treatments that could be challenged by inhaled treatments due to the Technosphere technology.
•Request Article #1, suggested by User 14219752.
Shout-out and Introduction
This article was suggested by User 14219752. Although he said I should do 10 applications, I decided 10 would be too many, but thank you for the suggestion nonetheless. If you want to request an article on a certain topic (any topic), you can message me directly or comment on this article with a short description of your idea.
I thought this article would complement my last article about Technosphere nicely. In that article, I talked about Technosphere and a couple of possible applications that the technology could have in the future, but I only included 2 applications based on experiments already done by MannKind (NASDAQ:MNKD), the owner of the Technosphere technology. In this article, I will look at 5 currently injected treatments that could possibly be replaced in the future by an inhaled version, whether MNKD produces the alternative inhaled therapy itself or whether the company licenses out Technosphere to another company to utilize. If you're curious to know more about Technosphere, you can read my previous article by clicking here, though I will also provide a brief explanation of the technology in the following section.
Background
MNKD's Technosphere technology allows for medication to be taken by inhaler instead of through an injection. Drugs that would normally have to be administered subcutaneously can be delivered into the bloodstream through the lungs, eliminating the need for patients to poke holes in their skin to take medication. The technology is the first of its kind to gain FDA approval for one of its applications, MNKD's inhaled insulin drug Afrezza. This shows the efficacy of Technosphere and leads to the question, "what other applications does the technology have?" In this article, I will explore five injected therapies on the market now that could one day be challenged by inhaled versions of the therapies created through the use of Technosphere technology.
In short, the 5 drugs I will mention on this list were all chosen because they are injected either through a syringe, an injection pen or through an IV. Because Technosphere can lead to new drugs that would make taking medication more convenient and more comfortable for the patient, Technosphere's biggest opportunities in the marketplace is its potential to upset the status quo with inhaled therapies as an alternative to injected therapies. The way the list is ordered is by how much revenue the injected drug generated because that shows the market potential on which Technosphere could capitalize by challenging the injected treatment with an inhaled version.
When researching which injected treatments to mention on this list, I took 3 things into account: whether the drug was injected, the market size of the drug and whether there were any competitors in the space that would make an inhaled version of the drug impractical. I tried to find the injected treatments with the most sizable markets because this indicates a lack of good, non-invasive alternative treatments where Technosphere could succeed. Some drugs I chose because the markets they address are so large that an inhaled treatment could be successful even if oral treatments are already competing in the market. Of course, this list is not perfect so if you think you know some better applications than the ones I mentioned on the list (or the ones I mentioned after the list), then be sure to let me know in the comments.
#1: Humira (Adalimumab)
Humira is made by the pharmaceuticals giant AbbVie (NYSE:ABBV) and is approved for the treatment of, among other diseases, rheumatoid arthritis. The drug was made to inhibit production of TNF, or tumor necrosis factor, because TNF can cause severe inflammation and can impair the mobility of limbs and joints. Sales of Humira for full-year 2013 totaled a whopping $5.2 billion in the U.S. alone, a sales increase of nearly 18% year-over-year. The drug is taken by injection either by syringe or by injection pen usually weekly or biweekly in a new injection site every time.
Pfizer (NYSE:PFE) has developed an oral form of the drug called Xeljanz, but a combination of sluggish sales and rejection by European regulatory authorities who questioned the drugs benefit-risk profile have taken a lot of the air out of the potential for the drug. Xeljanz causes side effects that Humira does not cause, so even the fact that it's taken orally does not convince many to use it. The opportunity is still open for a non-injected therapy to come in and steal market share from Humira, which is expected to see peak annual sales of $11.2 billion in 2016. Additionally, the rheumatoid arthritis market is expected to grow to $18.2 billion in 2023.
Technosphere could be used to create an inhaled TNF inhibitor treatment that could compete with Humira for the sizable market that AbbVie's drug now dominates. The process would be simple: create a formulation with Technosphere particles and monoclonal antibodies that bind to and inhibit the TNF protein, and get FDA approval. Now I mean simple in theory, because actually making the formulation and getting passed regulatory hurdles is anything but simple. But the potential is there, and MNKD could benefit greatly from either creating this inhaled TNF inhibitor treatment itself or by licensing out Technosphere to another company that wants to try and develop the treatment.
#2 Neulasta (Pegfilgrastim)
Neulasta is a drug that patients take while undergoing chemotherapy, and the injection is taken once every chemotherapy cycle, which varies depending on the type of cancer and the patient. Specifically, Neulasta stimulates the bone marrow to produce more white blood cells to help fight off infection because chemotherapy leaves the immune system weak and vulnerable. The drug is produced by Amgen (NASDAQ:AMGN) and achieved sales of $3.5 billion for full-year 2013. Though sales growth has been slightly decreasing, Neulasta is the 9th best selling drug in the world.
There are currently no non-injectable alternatives to Neulasta, leaving the market wide open to an inhaled treatment to gain some market share. The same argument I made for Humira can be made here: there is a large market opportunity, a need for a non-injected treatment and a company with the technology to create an alternative treatment. This all translates into a great opportunity for a Technosphere drug.
#3 Copaxone (Glatiramer acetate)
Copaxone was developed by Teva Pharmaceutical (NYSE:TEVA) to treat multiple sclerosis (MS), an inflammatory disease that affects the nerve cells. The drug is thought to reduce the progression of the disease, which causes disability by affecting nerves in the spinal cord and elsewhere.
For full-year 2013, the drug generated sales of $4.3 billion, only a 1% increase year-over-year. Now, I don't know if you caught this, but sales of Copaxone are higher than #2 on this list, Neulasta. This is because Teva's best-selling drug is struggling with a lot of competition from both oral versions of the drug and generics, and Copaxone sales are expected to tumble 56% by 2016. However, the market opportunity for MS drugs is so large (the global MS market is projected to be $18.3 billion by 2018) that an inhaled MS treatment could carve out a good amount of market share.
#4 Rituxan (Rituximab)
Rituxan is a monoclonal antibody treatment that binds to the CD20 protein presented on B cells and kills the cells. The drug is used to treat diseases where B cells are either proliferating rapidly or becoming dysfunctional, such as lymphomas, leukemias and autoimmune diseases.
Rituxan is produced by Roche (OTCQX:RHHBY) and generated sales of $3.2 billion in the U.S. with a growth rate of 6% year-over-year. Rituxan is administered intravenously by a healthcare provider and dosage depends on the patient and the disease. Like most blockbuster drugs, many companies are out to create a generic copy of Rituxan, but so far none have been able to get past regulatory agencies.
An inhaled version of Rituxan could be a big hit, as the intravenous treatment now requires an appointment and a healthcare professional to administer the drug. A monoclonal antibody treatment or some other formulation taken through an inhaler to accomplish what Rituxan accomplishes could be a much more convenient alternative to what is now the only treatment on the market for this area.
#5 Lantus (Insulin glargine)
Now, don't jump to any conclusions yet. I am aware that Sanofi (NYSE:SNY) and MNKD have a partnership agreement, but I'll explain why this makes sense.
Lantus is produced by French pharmaceuticals company Sanofi, which currently has a partnership with MNKD to market and sell Afrezza, MNKD's inhaled insulin drug. Like Afrezza, Lantus also provides patients with insulin, but Afrezza is a rapid-acting (prandial) insulin treatment generally taken before meals and Lantus is a long-acting (basal) insulin injection that steadily releases insulin into the bloodstream throughout the day. Type 1 diabetes patients require both a prandial and basal insulin treatment, so the two drugs do not compete.
For full-year 2013, Lantus sales were $2.5 billion in the U.S., a 14% increase year-over-year. However, Lantus' patent expires in February 2015 and sales numbers will probably take a hit when generic versions of the drug are put on the market. So far, Sanofi has been fortunate. Novo Nordisk's (NYSE:NVO) Lantus competitor Tresiba was rejected by the FDA and so probably won't even have a chance of coming to market until late 2015 or later, and Eli Lilly's (NYSE:LLY) Lantus knockoff was approved by the FDA, but won't be brought to market until at least 2016 because SNY claimed patent infringement.
Sanofi has a higher concentration version of Lantus coming to market soon, which would reduce the dosage from two injections daily to one injection daily, but this will not be enough to retain market share when NVO and LLY enter the market. Sanofi needs something better than a higher concentration injectable treatment. Sanofi needs Technosphere.
Either through the acquisition of MNKD or by licensing Technosphere, Sanofi needs to create an inhaled basal insulin therapy to retain its current share of the diabetes market. I believe that Sanofi is thinking the same thing and, pending the results of Afrezza, Sanofi will then try to develop a basal insulin therapy that utilizes Technosphere and delivers long acting insulin to a patient via the lungs. This would put Sanofi a huge step ahead of NVO and LLY, and would help Sanofi combat the competition NVO and LLY are mounting against its domination of the diabetes market. Because of this, Sanofi's partnership with MNKD could become closer in the next year or so, depending on how Afrezza performs in the marketplace.
(For those of you who didn't read my previous article, I keep mentioning Afrezza because it is the only application of Technosphere technology, and so its success or failure could mean the success or failure of Technosphere. Afrezza could succeed and financially validate the technology or fail and financially invalidate the technology).
Some Thoughts
With the technology modern societies have at their disposal, it's only a matter of time before injected treatments are phased out and more patient-friendly alternatives take their place. With Technosphere, we might be witnessing the beginning of a new era of drug administration. The 5 injected therapies mentioned in this list are some of the best-selling drugs in the world, and soon they will be taken by inhaler or orally. In terms of being non-invasive, oral and inhaled therapies are both on equal ground, but oral drugs cannot compete with inhaled drugs in terms of how quickly the drug takes effect. With pills, the medication has to travel to the digestive system and be digested before the medication can take effect, but with inhaled treatments, the effects are felt very soon after inhalation.
The 5 drugs on this list are just a few examples of ways in which Technosphere can be applied either by MNKD or by another company licensing the technology. The actual range of applications is limitless. I didn't include this application on the list, but MNKD has a U.S. patent on delivering migraine medication through a pulmonary delivery system, which could potentially yield great reward, as the migraine drug market in the U.S., U.K., Japan and other developed countries is expected to reach a combined $5.8 billion by 2021. There are other inhaled migraine treatments in development, but there is still market share open for the taking for inhaled migraine medication.
Conclusion
In this article, we saw 5 currently injected treatments that could one day be challenged or replaced by inhaled alternatives, perhaps created with the use of Technosphere technology. While there is still a long way to go before any of these alternate treatments materialize, the potential for MNKD to develop the therapies or for other companies licensing Technosphere to do so is present. Injected treatments will soon become obsolete and MNKD has the technology that may speed up the already rapid shift from injected to non-invasive treatments.
