West Coast Editor

On the heels of the FDA nod for Genzyme Corp.'s Campath for first-line use in chronic B-cell lymphocytic leukemia, Cephalon Inc. submitted its new drug application for the orphan drug Treanda, which targets CLL and is being developed for non-Hodgkin's lymphoma as well.

Treanda (bendamustine) is "well known outside the U.S." in its generic form, noted Jenifer Antonacci, Cephalon's senior manager of public relations. The compound proved superior in a Phase III trial by Cephalon that tested the purine analogue/alkylator hybrid against standard-of-care chlorambucil in previously untreated patients.

"We're not trying to say there are no other options out there," she told BioWorld Today, adding that Treanda is a spearhead result of an investment made a couple of years ago by Cephalon to focus in oncology, with an eye to in-license or acquire products.

If the FDA accepts the Treanda NDA, Cephalon would make a $15 million payment to former shareholders of San Diego-based Salmedix Inc., which Cephalon bought for $160 million in cash and $40 million in potential milestone payments more than two years ago. Salmedix had licensed the compound from Fujisawa Deutschland GmbH, of Munich, Germany. (See BioWorld Today, May 15, 2005.)

An ongoing study is trying Treanda in patients with indolent non-Hodgkin's lymphoma who are refractory to the monoclonal antibody rituximab (Rituxan, Genentech Inc. and Biogen Idec Inc.), and Cephalon could file an NDA in the fourth quarter of this year. Cephalon also is experimenting with a combination of Treanda and Rituxan in patients with relapsed indolent and mantle-cell NHL. Data likely will be offered at medical meetings later this year.

Cephalon's news on Treanda came one day after Genzyme, of Cambridge, Mass., and partner Bayer HealthCare Pharmaceuticals Inc., of Wayne, N.J., said the FDA gave its blessing to a supplemental biologics license application for Campath (alemtuzumab) and granted regular approval for single-agent Campath for the treatment of B-cell CLL, the most common type.

"That's where the studies with Treanda were done as well," Antonacci said, noting that Campath first won approval in 2001 for CLL. "They've been used in that space since then [for patients who have failed earlier treatments], so it's really not a new therapy." Treanda, if approved, would join Cephalon's other oncology product, Trisenox (arsenic trioxide), an injectable cleared in the U.S. for relapsed or refractory acute promyelocytic leukemia.

"Part of the reason we're making so much noise at this point, frankly, is that people don't really know Treanda," Antonacci said. "It's important for us to start having this kind of conversation."

Patient populations for CLL and NHL are "relatively small," she conceded. "We haven't set guidance for what we expect in terms of sales, so it's probably too early to start talking about that."

Bret Holley, analyst with CIBC World Markets, estimated Treanda's peak sales at around $300 million, "a meaningful contribution" to Cephalon's revenue, driven mostly by sales of approved drugs for pain and central nervous system disorders, he wrote in a research report Friday. The company's second-quarter earnings showed sales of $435.2 million, compared to $430.7 million for the second quarter of 2006, which beat the top end of Cephalon's guidance by $10 million.

CLL is a slowly progressing blood and bone marrow disease, with about 15,000 new cases diagnosed every year in the U.S., according to the National Cancer Institute. The Leukemia and Lymphoma Society estimates that 95,579 people are living with CLL, more than with any other leukemia type. Most people with CLL are at least 50.

Progress with Treanda reflects Cephalon's march forward in oncology, Antonacci said. Behind that compound is lestaurtinib, also known as CEP-701, in Phase II/III trials for a subpopulation of patients with acute myeloid leukemia. The kinase inhibitor has activity in AML-afflicted people who bear an FLT3-activating mutation at the first relapse from standard induction chemotherapy.

Frazer, Pa.-based Cephalon's stock (NASDAQ:CEPH) closed Friday at $73.25, up 64 cents.