Some analysts have questioned whether reimbursement issues account for Dendreon’s entire problem. “Management’s reason is addressable reimbursement issues, whereas there are many reasons to believe this is, at least in part, also a permanent demand issue,” Goldman Sachs analyst Sapna Srivastava said in a note to clients, as reported by The Wall Street Journal.
In September, Dendreon withdrew its guidance calling for Provenge sales in the range of $350 million to $400 million during this year, saying only that the company expected “modest” growth during the third and fourth quarters.
Signaling potential supply problems, Dendreon terminated its 2010 contract with GlaxoSmithKline, which covered the supply of antigens intended for the manufacture of Provenge. Dendreon said in securities filings that the decision was based on “unforeseen delays and implementation difficulties.” The company also announced in September other cutbacks including the elimination of 500 jobs.
With regard to autologous manufacturing, Duffey pointed out that, “while the process of producing our vaccine might be more involved than a one-size-fits-all therapy, the indolent nature of follicular lymphoma is such that the time frames are not as limited as Dendreon’s. The logistics associated with our vaccine manufacturing allows Biovest to focus on only one manufacturing facility and operation.”
He also said that due to the nature of how BiovaxID is administered, “Biovest will have some luxury with regard to manufacturing time because it is being developed as a consolidation therapy to extend remissions that have been induced with chemotherapy, monoclonal antibodies, or both.”
While Provenge is administered in three injections, two weeks apart, for a treatment course lasting six or seven weeks versus the 30 weeks needed for 10 cycles of docetaxel, BiovaxID, if approved, will be given as a monthly subcutaneous injection after the rest period following induction therapy in months 1, 2, 3, and 4, and a fifth booster injection will be given in month 6.
“We manufacture our vaccine during the approximately six-month period while patients receive induction therapy,” Duffeey explained. “The unique nature of Dendreon’s product and process impose severe constraints on production and their therapy has to be administered quickly. That quick cycle impacts their billing and reimbursement situation.”
Should all Biovest’s development programs for BiovaxID pan out, the company anticipates a potential $1 billion market opportunity in the U.S. and Europe. Besides follicular lymphoma, the company is developing BiovaxID for mantle cell lymphoma and this October received Orphan Drug Designation for the treatment of Waldenstrom macroglobulinemia, a rare subtype of non-Hodgkin lymphoma.
There is no doubt that autologous immunotherapies are progressing through clinical trials. Their potential benefits of less toxicity, enhanced efficacy, and relatively shorter courses of administration may eclipse purely financial considerations.
Cancer vaccines may also, ultimately, lessen the cost of cancer treatment by reducing or eliminating the need for the management of side effects. All these factors should translate to commercial success, but reimbursement and physician acceptance of a new therapeutic approach also need to start trending positively.
Will Biovest’s immunotherapy for follicular lymphoma, if approved, gain acceptance more quickly than Dendreon’s vaccine for prostate cancer?