A recent study published in the Journal of the American Medical Association (JAMA) showed that patients who received the anticoagulant fondaparinux (Arixtra®) and had experienced a certain type of heart attack had a lower risk of major bleeding events and death, both in the hospital and after six months, compared to patients who received low-molecular-weight heparin (LMWH).
The authors analyzed data from a Swedish registry, which included 40,616 patients who had experienced an NSTEMI (non-ST-segment elevation myocardial infarction). A certain pattern on an electrocardiogram following the heart attack was observed, and 14,791 patients (36.4 percent) received fondaparinux, while 25,825 (63.6 percent) received LMWH.
Fondaparinux, an injectable blood thinner that fights clots in the legs (deep vein thrombosis – DVT) and lungs (pulmonary embolism – PE), is a synthetic pentasaccharide, which is difficult to manufacture on a commercial scale.
Arixtra belonged to GSK as recently as 2013, when it was sold off to the South African company Aspen Global Incorporated. Due to Aspen’s lack of a sales representative in the US, they were forced to enter into a $300 million agreement with Mylan for the US market, through which Mylan would pay Aspen $225 million upon completion of the transaction, and an additional $75 million would be held in escrow until certain conditions were met. Apotex had previously been given the rights to sell the authorized generic of Arixtra, the rights of which would eventually transfer to Mylan, which was scheduled to occur by the end of 2014.
Arixtra and the authorized generic of Arixtra had US sales of approximately $18.8 million and $95.3 million, respectively, for the 12 months ending on June 30, 2014, according to IMS Health.
Currently, the only approved product on the US market, other than Mylan’s, is that of Dr. Reddy’s, which was approved in 2011. Dr. Reddy’s entered into a partnership with the Australian company Alchemia, who claims to have been granted patents over novel synthetic pathways that prevent others from using Alchemia’s proprietary process to manufacture fondaparinux until at least 2022.
The regulatory filing review on PharmaCompass shows two suppliers of the key intermediates who have submitted USDMFs, along with multiple API DMF fillings indicating increased availability of the drug substance. This should overcome a major barrier to entry into the Fondaparinux business.
What makes us believers in Fondaparinux? Here are some facts:
- $150 million – This is the size of the market in the United States alone.
- There are only 2 approved US marketing authorization holders (Mylan and Dr. Reddy’s).
- There are alternative API supply sources emerging other than Aspen (through Sanofi’s Sisteron site and Alchemia).
- Blood thinners are a booming opportunity. Pfizer’s Eliquis, Bayer’s Xarelto, and Boehringer Ingelheim’s Pradaxa are all expected to achieve sales of more than $1 billion each.
- There has been limited development activity in India as demonstrated by the trade data.
- The high development costs will keep this market niche in the long run.
- The recently published study data is extremely positive and will increase sales.
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Image Credit : Opportunity Center by Jason Tester Guerrillia Futures is licensed under CC BY 2.0
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