Genzyme Tolevamer Represents New Market Opportunity
This article was originally published in The Pink Sheet Daily
Executive Summary
Launch of the non-antibiotic treatment for Clostridium difficile colitis would require the biotech to build or acquire a hospital sales force.
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Genzyme is anticipating Phase III clinical trial results evaluating tolevamer for the treatment of Clostridium difficile-associated colitis in the second half of the year, the Cambridge, Mass., biotech announced during a year-end sales and earnings call Feb. 14. Pending positive results, launch is expected in 2008, providing Genzyme the opportunity to move into a new market, the company said. Tolevamer is a novel polymer therapy that could be the first non-antibiotic treatment for C. difficile colitis, a widespread infection affecting patients in hospitals and nursing homes. "We think tolevamer would be very exciting indeed if it does show positive results [in] the two Phase III trials that are currently being accrued throughout the world," CEO Henri Termeer said. "These trials were based on the very solid Phase II results," he added. "We are somewhat optimistic, but of course, we have to await these results and then if they do happen to be very positive, we will start to develop infectious and hospital-based infectious disease marketing capability." The company could look to acquire a hospital-based commercial structure or build one internally, the exec maintained. "If we needed a sales force of 5,000 people, then we would have a different situation for a company like Genzyme," Termeer said. "But we talk here about hundreds, rather than thousands, and we have a sales force in the hundreds in the orthopedic field, in the renal field and etcetera." The company has several nearer-term marketing projects planned. The firm submitted an NDA to FDA for Renvela (sevelamer carbonate), a next-generation Renagel (sevelamer hydrochloride)product for the control of serum phosphorus in patients with chronic kidney disease on dialysis in December (1 (Also see "Genzyme Will Look To Differentiate Renvela With Improved Dosing" - Pink Sheet, 21 Dec, 2006.)). Genzyme expects to launch the drug in 2008. Following approval, the company said it plans to submit an sNDA seeking marketing approval for the treatment of hyperphosphatemic patients with CKD who are not on dialysis, as well as for a powder form to be taken once daily. The firm is also anticipating results from a pivotal trial of Hylastan , a next-generation viscosupplement, which it anticipates submitting to FDA later this year for treatment of osteoarthritis pain. Hylastan is designed to be administered using a single-injection regimen. The company is also seeking to update labeling for Synvisc (hylan G-F20) to include a single-injection regimen after reporting preliminary results in December from a study showing that patients who received Synvisc through a single-injection regimen achieved a statistically significant improvement in pain from osteoarthritis of the knee over 26 weeks compared to placebo. Synvisc is currently delivered through three injections given once weekly. "We are real believers that this ... osteoarthritis program will become a very, very material part of the mix of programs that we have at the corporation," Termeer said. Genzyme reported revenues of $3.19 billion for the year, up 17 percent over 2005. The company recorded a net loss of $16.8 million for the year, compared to net income of $441.5 million, due to charges related to the acquisition of AnorMED. On a comparable non-GAAP basis, net income increased 23 percent to $742.7 million. The company outbid Millennium with a $580 million offer to acquire AnorMED, the owner of a Phase III hematopoietic stem cell transplantation candidate Mozobil (plerixafor) (2 (Also see "Genzyme Wins AnorMED As Millennium Backs Out Of Bidding War" - Pink Sheet, 18 Oct, 2006.)). -Jessica Merrill ([email protected]) |