The gout drug candidate BioCryst (NASDAQ:BCRX) is developing now has the green light to advance into phase 3 clinical trials, but some of the best news CEO Jon Stonehouse heard recently came from business deals that did not even involve the company.
AstraZeneca (NYSE:AZN) announced it would acquire Ardea BioSciences for $1.26 billion; Takeda Pharmaceutical (TYO:4502) reached an agreement to buy URL Pharma for $800 million up front. Gout treatments were centerpieces for both deals. Stonehouse said that the acquisitions validate the commercial opportunity for gout products and show that large pharmas are willing to put up the dollars to add these products to their drug portfolios — important because the Durham, North Carolina company is seeking a partner to take its gout candidate BCX4208 into late-stage clinical development and commercialization.
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While the AstraZeneca and Takeda acquisitions likely remove those large pharmas from partnership contention, Stonehouse said the deals also shrink the market for other late-stage gout candidates and make the BioCryst compound more attractive and more valuable.
“Good phase 3 assets are not always available,” he said on a conference call to discuss first-quarter financial results. “We think we have the best and only remaining phase 3-ready, high-quality asset left in the gout space.”
BCX4208 is a compound that BioCryst developed to be administered in addition to the currently used gout treatment allopurinol, a drug that reduces the uric acid production that contributes to the inflammation and joint pain experienced by patients who have gout. Gout affects an estimated 8.3 million patients in the United States, according to a 2011 study published in the journal Arthritis & Rheumatism. But allopurinol does not work for all of these patients. BioCryst developed BCX4208 as an adjunct therapy to make allopurinol work for millions of patients who don’t respond to allopurinol alone.
BioCryst has more than BCX4208 riding on the partnership discussions. The company expects that revenue in the form of milestone payments and royalties will help fund the company’s efforts to commercialize other drugs on its own, such as BCX4161, a preclinical compound being studied as a treatment for hereditary angiodema, a rare disease that causes swelling in the face and airways. BioCryst plans to start human studies on the orphan drug candidate by the end of the year.
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BioCryst last month completed a BCX4208 end of phase 2 meeting with the U.S. Food and Drug Administration, which gave the company guidance for the phase 3 program. Stonehouse said the company expects to “conclude the partnering process in 2012,” which will then allow the phase 3 program to start.
[Photo from stock.xchng user Eastop]
