Hundreds of patients in the U.S. are affected by myelofibrosis, or MF, each year. This rare form of cancer has a very limited number of treatment options. Keeping this in mind, a number of different biotech companies are perusing this opportunity to develop a successful treatment for this disease. Only one of them so far has been somewhat successful: oncology and respiratory drugmaker Incyte (INCY +0.51%). Let's take a look at Incyte's lead component Jakafi compared to the treatments being worked on by other companies.
Myelofibrosis, a brief introduction
MF is a type chronic leukemia that causes red blood cells to build up within the bone marrow, slowing down the production process of healthy blood cells. It often leads to an enlarged spleen and liver. Until quite recently, stem cell transplant was the only treatment for this type of cancer, and there was a significant amount of risk associated with this treatment.
Incyte launches Jakafi
The stem cell transplant was finally replaced with an alternative treatment in November 2011 when the Food and Drug Administration approved Jakafi. The drug is capable of targeting the JAK1 and JAK2 gene mutations which are considered as the root cause of myelofibrosis. Jakafi has the ability to reduce the harmful symptoms of the disease and lessen the size of enlarged spleens caused by it.
Jakafi is primarily a joint development of Incyte and Novartis. According to an agreement signed by both the companies in 2009, Novartis holds the rights to market Jakafi outside US, whereas Incyte caters the U.S. market. Incyte's revenues have escalated quite a bit from the sales of this newly developed drug .
The company's sales attributed to Jakafi were some $136 million in 2012, and the expectations in 2013 are that the sales target would be somewhere between $220 million to $230 million . This can easily be met by the company if you look at the current level of sales of the drug in the second quarter of 2013, Jakafi's net sales were as much as $54.1 million, an 82% increase compared to the second quarter of last year . The total revenues of the company have also experienced a 17.6% growth in the current year's second quarter compared to last year. This is not the end for the drug, either.
According to the company's internal sources, Jakafi is being prescribed by more than 40% of the targeted physicians. Moreover, Incyte has a bright future ahead on the basis of its strong pipeline drugs related to oncology and inflammation. Apart from Jakafi, it is working on baricitinib, which is a phase 3 component for the treatment of rheumatoid arthritis. Just like Jakafi, baricitinib also targets the JAK1/JAK2 gene and is also being tested for the treatment of psoriasis and diabetic nephropathy . Apart from that, most of the drug components in Incyte's pipeline are in phase 2, and the company has been increasing its research and development budget for the past five years. Last year, the total amount spent on R&D was $210 million. This year, the company has already spent $114 million in the first two quarters, giving visible indications that this year's R&D expense would surpass last year's. With this pace, it is expected that Incyte achieves major breakthroughs in near future.
Similar drugs in the market
Currently, pharmaceutical giant Sanofi (SNY 0.05%) is developing the compound SAR302503, which is a phase 3 JAK-2 inhibitor to treat myelofibrosis. The company has reported that its JAKARTA study to evaluate the efficiency of this compound has shown positive results in reduction of spleen volume and other related symptoms of myelofibrosis.
Sanofi is also working on determining the effects of SAR302503 on the reversal of fibrosis in the bone marrow. The study has the FDA's support for the product's application in U.S. and was also granted special protocol assessment . This is positive news for investors as it helps in regaining the revenue growth.
In the second quarter of 2013, Sanofi's total revenue went down by 6.3 % due to sales reduction . Because of this, pipeline products like SAR302503 will help Sanofi recover its former revenue figures.
Geron (GERN 1.25%) is another company that caught attention of the industry after the positive data was reported regarding its lead experimental drug Imetelstat for the treatment of MF. Initially, the drug was tested for lung and breast cancer treatment, but it failed. Because of this, the company shifted its focus to myelofibrosis.
Imelelstat works on a simple principle, stopping the heightened growth of the blood cells within the bone marrow by inhibiting an enzyme called telomerse, which provides cells the ability of limitless replication. The development phase of the drug is going quite well so far, and the market has positive expectations from it. This is why the company's shares have been on the upside for some time.
Final takeaway
Incyte certainly has first-mover advantage with Jakafi. Being the only approved drug for the treatment of MF allows it to cater to a huge demand single-handedly. It is being prescribed to a large amount of patients, meaning that revenues are going to come in huge bulks. This in turn will benefit the company and its investors.
On the other hand, Sanofi and Geron both have components in clinical trials that have shown positive results in their respective studies. With that in mind and considering the market's demand for myelefibrosis treatments, I can predict positive growth for both Sanofi and Geron in the future.
