PART I
ITEM 1. BUSINESS
United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to
address the unmet medical needs of patients with chronic and life-threatening conditions.
Our
key therapeutic products and product candidates are:
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- Prostacyclin Analogues. Prostacyclin analogues are stable
synthetic forms of prostacyclin, an important molecule produced by the body that has powerful effects on blood vessel health and function. Our lead product is Remodulin® (treprostinil)
Injection (Remodulin) to be administered subcutaneously or intravenously for the treatment of pulmonary arterial hypertension (PAH). The United States Food and Drug Administration (FDA) initially
approved Remodulin in 2002 for subcutaneous (under the skin) administration. Subsequently, the FDA broadened its approval of Remodulin for intravenous (in the vein) use and for the treatment of
patients who require transition from Flolan®. In addition to the United States, Remodulin is approved in many other countries, primarily for subcutaneous use. In July 2009, the FDA
approved Tyvaso® (treprostinil) Inhalation Solution (Tyvaso), an inhaled prostacyclin therapy for the treatment of PAH. We commenced commercial sales of Tyvaso in the third quarter of
2009. Our oral tablet of treprostinil diethanolamine is in the later stages of development. Our subsidiary, Lung Rx, LLC (Lung Rx), is separately developing modified release beraprost
(beraprost-MR), another type of oral prostacyclin analogue, for the treatment of PAH;
- •
- Phosphodiesterase Type 5 (PDE-5)
Inhibitor. PDE-5 inhibitors act to inhibit the degradation of cyclic guanosine monophosphate (cGMP) in cells. cGMP is
activated by nitric oxide (NO) to signal relaxation of vascular smooth muscle. Our PDE-5 inhibitor product is Adcirca® (tadalafil) tablets (Adcirca), a once-daily
oral therapy for the treatment of PAH. We acquired certain exclusive commercialization rights to Adcirca from Eli Lilly and Company (Lilly) in 2008. In May 2009, the FDA approved Adcirca for the
treatment of PAH. We commenced commercial sales of Adcirca in the third quarter of 2009;
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- Monoclonal Antibodies (MAb). MAb act by targeting
tumor-associated antigens on cancer cells to activate a patient's immune system against the cancer cells. We are developing the antibody Ch14.18 MAb for the treatment of neuroblastoma, under an
agreement with the National Cancer Institute. We are also developing another antibody, 8H9 MAb, for the treatment of metastatic brain cancer, under an agreement with Memorial Sloan-Kettering Cancer
Center; and
- •
- Glycobiology Antiviral Agents. Glycobiology antiviral
agents are a novel class of small, sugar-like molecules that have shown pre-clinical indications of efficacy against a broad range of viruses.
We
devote most of our research and development resources to developing these key products and product candidates.
We
generate revenues primarily from the sale of Remodulin, Tyvaso and Adcirca (which we refer to as our commercial products). Our sales and marketing staff supports the availability of
our commercial products in the countries in which they are approved. These efforts are supplemented by our specialty pharmaceutical distributors in the United States and our other distributors
internationally.
United
Therapeutics was incorporated in Delaware in June 1996. Our principal executive offices are located at 1040 Spring Street, Silver Spring, Maryland 20910. We also maintain
executive offices at 55 T.W. Alexander Drive, Research Triangle Park, North Carolina 27709.
Unless
the context requires otherwise or unless otherwise noted, all references in this Annual Report on Form 10-K to "United Therapeutics" and to the "company", "we",
"us" or "our" are to United Therapeutics Corporation and its subsidiaries.
Our Products
Our product portfolio includes the following as of February 15, 2011:
Product