As expected, Human Genome Sciences (HGSI) will report on progress with the commercialization of Benlysta® (belimumab) during a presentation at the 30th Annual JPMorgan Healthcare Conference in San Francisco. The drug is approved for the treatment of adult patients with active autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy.
Human Genome’s SLE drug Benlysta and Dendreon’s prostate cancer vaccine Provenge were used as examples for firms that are granted drug approval, but their sales were disappointing. As we predicted in a past article, Dendreon’s Provenge demonstrated that the reasons for not selling Provenge were reimbursement and manufacturing delays, which had nothing to do with the drug’s safety and efficacy. When the problems have been solved, Provenge’s sales began to rebound and so The firm’s stock.
Something of the same is going on now with Human Genome’s Benlysta, where the major problem - lack of physicians’ familiarity with the drug – is a temporary problem that has nothing to do with the safety and efficacy of Benlysta. When the specialists started to become familiar with the use of the drug, thousands of SLE patients began to be administered the drug according to H. Thomas Watkins, President and Chief Executive Officer of the firm who also said, “… Although we are still in the early adoption phase of our launch, our experience in the market to date reinforces our belief that Benlysta will ultimately play a major role in improving the standard of care for SLE patients.”
Mr. Watkins confirmed that the firm has seen good progress with the number of physicians initiating use. He said, “As they build their own clinical experience, more and more physicians are considering Benlysta® for appropriate SLE patients.” Mr. Watkins also expressed the firm’s belief that Benlysta® is on its way to becoming an important component of a new standard of care for SLE.
Benlysta has been approved by the European Commission on July 13, 2011, and is now available in Canada and an increasing number of European countries, including Germany, Spain, Austria, Denmark, Finland, Hungary, Norway and Sweden. HGS has built its own commercialization team to work alongside GSK in Europe, with headquarters in Switzerland and local organizations in Germany, France and Spain. Elsewhere, GSK leads local implementation, with HGS sharing costs and profits equally with GSK.
In December 2011, HGS and GSK announced that a Phase 3 trial of the subcutaneous formulation of Benlysta®, which would make it possible for patients to self-administer the drug once a week. In May 2011, GSK initiated dosing in the Benlysta® Phase 3 trial in East Asia, which will enroll approximately 630 patients in China, Japan and South Korea.
The firm’s Key goals for Benlysta in 2012:
Continue to increase sales in the U.S. and elsewhere.
Continue to work with GSK to launch Benlysta in countries around the world.
Enroll Phase 3 trial of subcutaneous formulation throughout 2012; complete enrollment in 2013.
Initiate Phase 3 trial in vasculitis.
Initiate Phase 3 trial in active lupus nephritis.
Enroll Phase 3 trial in East Asia.
To read the complete press release go to: HYPERLINK "http://www.hgsi.com/latest/human-genome-sciences-reports-progress-with-commercialization-of-benlysta-and-announces-2012-goals-at-jpmorgan-healthcare-confe.html" http://www.hgsi.com/latest/human-genome-sciences-reports-progress-with-commercialization-of-benlysta-and-announces-2012-goals-at-jpmorgan-healthcare-confe.html
Like with Dendreon’s stock, we believe Human Genome’s stock has also bottomed.
Idenix (IDIX): We follow on the news, but we keep in mind that we need to wait for further results before we get excited about all firms that have HCV drugs in their pipeline. The fact that Inhibitex will be acquired by BMS, after Pharmasset’s has been taken over must not rush our decisions before verification of data when complete data are announced.
Curis (CRIS): Good News about FDA accepting the firm’s and Genentech’s NDA application for vismodegib for the treatment of adults with advanced basal cell carcinoma for whom surgery is considered inappropriate.
We intend to buy HGSI in the next couple of days.