Genzyme teased analysts during the fourth-quarter earnings call with word of a new product to follow Renagel and Renvela , while repeating the financial guidance for 2008 that was provided in top-line results more than a month ago.

Revenue increased 21 percent in the fourth quarter to $1.04 billion, up from $854.2 million in the fourth quarter of 2006.

GAAP net income jumped to $78.9 million, or $0.29 per diluted share, compared with an acquisition-related net loss - related to October's buyout of Bioenvision - of $268.2 million, or $1.02 per diluted share, in the previous period (¹ Also see "Genzyme Completes Bioenvision Takeover" - Pink Sheet, 23 October, 2007.).

Product revenues, the company noted, were detailed in an earlier release, and included a doubling of sales income from Myozyme (alglucosidase) for Pompe disease, the fastest-growing compound for lysosomal storage disorders in Cambridge, Mass.-based Genzyme's sizeable portfolio.

Oppenheimer analyst Brian Abrahams noted in a research report that sales of the sevelamer phosphate binders Renagel and Renvela turned up "essentially flat over the past year" - a situation that could be helped if Shire backs off the U.S. marketing of Fosrenol (lanthanum), cleared by FDA for end-stage renal disease in 2004 (² Also see "Shire's Fosrenol Gets FDA Nod, Will Be Available By Year-End" - Pink Sheet, 27 October, 2004.).

Shire's earnings call is slated for Feb. 21. Meanwhile, Genzyme's chairman and CEO Henri Termeer said during the conference call that the firm "will be limiting ourselves in our comments because this is a competitive area."

"Clearly, around sevelamer we are continuing to do what we can to augment our intellectual property position on that product," John Butler, president of the renal division, said, adding a next-generation compound has moved into preclinical development.

"We certainly hope today to file an IND before the end of the year and probably be in the clinic early next year," Butler stated, noting that the company has "set the bar high around improving efficacy and potency of the product," an effort "high on our radar screen."

Genzyme expects sales of Renagel and Renvela to rise as high as $700 million this year, compared to $603 million in 2007. FDA approved Renvela this fall for dialysis patients, and Genzyme plans to launch the product March 1 (³ Also see "Genzyme’s Renvela Approved For Kidney Disease Patients On Dialysis" - Pink Sheet, 22 October, 2007.).

Analyst Brian Abrahamson of CIBC World Markets predicted that label expansion into pre-dialysis patients along with price increases will help drive continued upside for the Renagel/Renvela franchise.

"We expect steady sales growth rather than a major inflection, however, given the lack of clear outcomes data, existing off-label use in pre-dialysis, and competition," he wrote.

As for Myozyme, Abrahams accurately predicted in a November note that data from the Late Onset Treatment Study (LOTS) study would suggest value in late-onset patients, as the trial did in mid-December.

Termeer said the push with Campath (alemtuzumab) for multiple sclerosis is Genzyme's largest program, and includes more manufacturing capacity in Belgium for the compound, already FDA-approved for chronic lymphocytic leukemia.

Genzyme and partner Bayer started Phase III trials with Campath in MS last year, testing the CD52 antigen binder to Serono's Rebif (interferon beta-1a) in patients with relapsing-remitting disease yet to begin treatment (⁴ Also see "Genzyme Initiates Campath Phase III Study In Multiple Sclerosis" - Pink Sheet, 26 September, 2007.).

"This program will cost us money through this period, through 2011, but will create a fantastic opportunity going beyond it," Termeer said. Genzyme targets an MS filing in 2011 or 2012.

- Randall Osborne (r.osborne@elsevier.com)

Genzyme: Next-Generation Sevelamer Bound For Clinic Next Year

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