Novartis intends to launch Zelnorm without a co-promotion partner following an internal review of the company's strategic options, CEO Daniel Vasella said.

"Our thoughts are clearly that we want to launch the product alone," Vasella told investors attending Novartis' Nov. 7 meeting in Basel, Switzerland to release fourth quarter results.

Novartis reopened the bidding for co-promotion rights to Zelnorm (tegaserod) after Bristol-Myers Squibb backed out of an agreement to market the irritable bowel syndrome therapy (¹ [A#00630340018], p. 26).

Bristol and Novartis ended the co-marketing deal two months after FDA deemed Zelnorm "not approvable," citing an unfavorable risk-benefit ratio and concerns with gall bladder surgery incidence (² [A#00630260003], p. 7).

Recent approval delays for some Novartis products have freed up resources that otherwise would have been spread across multiple launches, Vasella noted.

"When we had the assumption that we would launch Xolair and Zelnorm and everything at the same time, it was a crunch in resourcing, training the sales force and everything," he said. Now that the launches are more spread out, "if we can, we go alone." Novartis/ Genentech's asthma antibody Xolair , submitted in June 2000, is awaiting additional data that the companies plan to submit in the fourth quarter.

Vasella provided an update on Novartis' negotiations with FDA over Zelnorm. "We have a fact-based and constructive dialogue. There's no time clock running for FDA, so it's very open."

Novartis foresees Zelnorm approvals in 2004 for treatment of IBS, functional dyspepsia and chronic constipation, with GERD to follow in 2006. At the time of the "not approvable" letter, Novartis predicted the first approval would not come before 2003.

When asked if FDA's Drug Safety & Risk Management Subcommittee's April 23 review of GlaxoSmithKline's IBS agent Lotronex (alosetron) could have positive implications for Zelnorm, Vasella said: "We have a date of 2004 in our list. Everything else would be a positive surprise for us."

While Novartis has decided to market Zelnorm on its own, the company is still looking for a partner for its COX-2 inhibitor COX-189.

"This is a highly competitive market, competing against companies like Pfizer and Merck, so this is a compound we would consider for partnering, provided that the deal terms are attractive to us," Pharma CEO Thomas Ebeling said.

Vasella stressed, however, that the company is not afraid of competition. "We don't fear either one," he said, noting that the angiotensin II inhibitor Diovan has overtaken Merck's Cozaar and its ACE inhibitor/calcium channel blocker combo Lotrel is gaining share against Pfizer's Norvasc .

Novartis' long-term safety study for COX-189 could provide an advantage over Pharmacia/Pfizer's Celebrex and Merck's Vioxx . The 18,000-patient TARGET trial is powered to assess both gastrointestinal and cardiovascular outcomes (³ Also see "Novartis COX-189 TARGET Study Will Assess CV Safety Of COX-2 Inhibitor" - Pink Sheet, 12 November, 2001., p. 32).

GlaxoSmithKline is one logical candidate for a co-promotion in the COX-2 category; its COX-2 candidate is in Phase I. Johnson & Johnson could also look to fill a hole in its pipeline after a COX-2 licensing deal with Japan Tobacco ended in December 2000. Bristol, which has a COX-2 inhibitor in Phase IIb, appears to be an unlikely candidate.

Novartis remains interested in mergers, but is in no hurry to close a deal. "We are growing dynamically, so there is no urgency to go and acquire or merge," Vasella said. "But the market is consolidating, so you cannot just stay aside and be inactive."

"One needs to be acquisition-ready...but not hasty," he added. "We'll act if we see a good opportunity, but we won't just act in order to act." Vasella noted that he and Ebeling "have some targets," and some ideas have been submitted by Oncology President David Epstein.

Ebeling pointed to recent deals to illustrate Novartis' partnering capabilities: an osteoporosis R&D deal with Celgene; a deal with Novo Nordisk for the type 2 diabetes agent NN622; and the acquisition of U.S. rights to Aventis' estradiol/norethindrone patch CombiPatch . "We are always invited to the final round," he said.

Novartis COX-189 Is Co-Promotion Candidate; Zelnorm Will Not Have Partner

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