Isis Pharmaceuticals Inc. has received $7 million from Drug Royalty USA, Inc. (DRC) as partial payment for a portion of Isis' royalty rights in Macugen. In December 2004, Isis sold a portion of its royalty rights in Macugen to DRC in exchange for $24 million to be paid over three years.
"Licensing our patents to Eyetech and then accelerating a portion of the value anticipated from our royalties on Macugen, demonstrate how we are capitalising on the value of our extensive patent estate. Patents on our RNA-based inventions have generated over $75 million, providing additional resources for the continued development of our exciting antisense drugs. We look forward to continuing to benefit from the commercial success of Macugen," said B. Lynne Parshall, executive vice president and chief financial officer of Isis Pharmaceuticals
In 2001, Isis licensed specific patents to Eyetech Pharmaceuticals Inc. necessary for the development, manufacturing and commercialization of Macugen. The Eyetech license provides for royalties on sales of Macugen and milestone payments upon the approval of Macugen for new therapeutic indications. In 2004, Isis sold a portion of its Macugen royalty rights to DRC in exchange for $24 million, to be paid over three years. Under Isis' agreement with DRC, through 2009, DRC will receive all royalties on the first $500 million of annual sales of Macugen. Isis will receive 50 percent of royalties on annual sales between $500 million and up to $1 billion, and 90 percent of royalties on annual sales in excess of $1 billion. After 2009, Isis will receive 100 percent of royalties on annual sales of Macugen.
Macugen is indicated in the United States and Brazil for the treatment of neovascular age-related macular degeneration (neovascular AMD) and in Canada for the treatment of subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration. In September 2005, the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), issued a positive opinion recommending approval of Macugen for the treatment of neovascular AMD in Europe. Macugen applications have also been filed in twelve additional countries, claims a company release.
Isis has an extensive intellectual property estate of more than 1,500 issued patents that it owns or exclusively licenses covering RNA-based drug discovery and development. Isis' patent estate covers fundamental oligonucleotide chemistries; antisense drug discovery (multiple mechanisms); antisense therapeutics; manufacturing; formulations, and delivery of oligonucleotide therapeutics, as well as Ibis' RNA technology for the identification of infectious organisms.
Age-related macular degeneration (AMD) is a chronic, progressive disease of the macula that results in the loss of central vision. According to the Macula Vision Research Foundation, as many as 15 million people in the United States suffer from some form of AMD, with more than 1.6 million experiencing the active blood vessel growth and blood vessel leakage associated with neovascular AMD or wet AMD. In addition, AMD Alliance International reports that approximately 500,000 new cases of neovascular AMD arise each year world- wide, including approximately 200,000 new cases of neovascular AMD each year in North America.