SangStat will set up a "transplantrx.com" website designed to increase enrollment in The Transplant Pharmacy, the company's mail-order pharmacy and patient disease management program.

"We will be having an Internet site transplantrx.com which will be online at the end of October to enroll additional patients," Jean-Jacques Beinaime announced at the Warburg Dillon Read Global Life Sciences Conference Sept. 28.

With new centers being added every month, the current mail-order pharmacy program has over 1,300 patients and the company expects enrollment to near 1,500 by the end of the year.

The Transplant Pharmacy provides pharmacy consultants, refill reminders and on-call pharmacy services. The website will allow patients to refill prescriptions online.

SangStat is awaiting FDA approval of its generic cyclosporine capsule. Abbott has also filed for approval for a capsule formulation of cyclosporine.

SangStat and Abbott have agreed to co-promote whichever capsule form is approved first. The companies assume that, since Abbott filed first, it will receive approval before SangStat.

The companies have already implemented a co-promotion agreement for SangCya, a generic oral solution of Novartis' Neoral (¹ Also see "SangStat/Abbott SangCya Co-Promotion Provides Entry To Managed Care" - Pink Sheet, 17 May, 1999.).

SangStat said the cyclosporine capsule should be approved and launched by the first quarter next year.

"With the combination of SangStat and Abbott...we believe we can gain a double digit market share of the U.S. cyclosporine market [in] early 2000," Beinaime said.

SangStat can currently compete in only 4% of the cyclosporine market, because capsules comprise 96% of the market, Beinaime noted.

The agreement does not apply outside of the U.S. SangStat filed for approval of its cyclosporine capsule, in the U.K. March 31 and expects to launch the drug by year-end or early in 2000.

The combined SangStat/Abbott sales force is the largest transplant sales force in the U.S., the company claimed, with each firm contributing 20 reps.

Novartis has filed a lawsuit challenging the oral solution approval, but the first hearings are not expected until October 2000. Novartis also filed a patent infringement suit, and SangStat has filed a countersuit claiming antitrust violations (² Also see "FDA Elimination Of Neoral "Microemulsion" Designation Disputed By Novartis" - Pink Sheet, 15 February, 1999.).

Discussions are still underway as to how much of FDA's administrative record will be made available to Novartis.

SangStat highlighted the growth of Thymoglobulin (antithymocyte rabbit immunoglobulin) for treatment of acute renal rejection episodes and the potential to take market share from Novartis' Atgam (antithymocyte globulin horse).

"After only four months of launch in the U.S., [Thymoglobulin] became number two," Bienaime said, "and I think it will be number one in the U.S....this month."

Bienaime claimed the company can grow Thymoglobulin "beyond what Atgam achieved at its peak of about $45 mil. in the U.S."

The company plans to seek new Thymoglobulin indications for the prevention and treatment of graft vs. host disease, conditioning of bone marrow and stem cells, and the treatment of aplastic anemia and myelodysplastic syndrome. The company is "starting to implement" trials in bone marrow transplantation and stem cell transplantation.

SangStat said it has had requests from the bone marrow and hematology treatment communities for information on the use of Thymoglobulin for oncology.

The company said the Washington Legal Foundation v. Henney case aids its strategy for Thymoglobulin oncologic use. The ruling, which allows companies to disseminate reprints on off-label uses without having to file a supplemental application, is under appeal (³ Also see "WLF Appeal Could Receive Hearing By Spring 2000 Under FDA Expedited Plan" - Pink Sheet, 20 September, 1999.).

SangStat Will Launch Website To Boost Transplant Pharmacy Enrollment

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