Staff Writer

SAN FRANCISCO – Before there even was a J.P. Morgan Healthcare conference – and this is the 29th – there was Amgen Inc., founded in 1980, and Genzyme Corp., founded in 1981. When two of the corporate godfathers of biotech present on the same morning, people take notice; it's the industry's version of Arnold Palmer and Gary Player hitting honorary tee shots at the Master's.

Henri Termeer, Genzyme's CEO since 1985, had the most news to share. But Kevin Sharer, who's been Amgen's CEO since 2000, chipped in with some interesting thoughts on his company's possible entry into the biosimilars market.

Termeer told attendees that according to preliminary, unaudited revenue figures, the company had a record quarter, with $1 . 15 billion, up 23 percent from $938 million in the fourth quarter of 2009. Annual revenue for 2010 was $4.1 billion, up from $4 billion in 2009 – but lower than anticipated because of continuing manufacturing hiccups and shipping delays. Genzyme expects 2011 revenue of approximately $5 billion compared with previous guidance of $5.1 billion.

The company said it will provide full results and guidance on Feb. 16.

Increasing inventories of Cerezyme (imiglucerase for injection) and Fabrazyme (agalsidase beta), and the U.S. launch of Lumizyme (alglucosidase alfa) drove the fourth quarter growth, he said, adding that revenue and earnings have returned to levels they were at in the first half of 2009 before a virus was discovered in two of six bioreactors at its Allston Landing manufacturing facility, forcing a six-month shutdown of Cerezyme and Fabrazyme. Problems at Allston eventually prompted the FDA to step in with a costly consent decree. (See BioWorld Today, June 17, 2009, and March 25, 2010.)

Termeer said Genzyme is expanding its biologics and manufacturing capacity with a new manufacturing facility in Framingham, Mass., expected to start process validation runs this month. He said that when the new plant is approved, the company will have three plants up and running and will be "beyond supply limitations."

As for the pipeline, he said three product approvals are expected by the end of 2013 for alemtuzumab for multiple sclerosis, mipomersen for familial hypercholesterolemia and eliglustat tartrate for Type 1 Gaucher's disease.

He also told them that the company plans to divest its cell therapy and regenerative medicine business, which includes product lines Carticel (autologous cultured chondrocytes), and MACI (Matrix-induced Autologous Chondrocyte Implant) for cartilage regeneration, and Epicel (cultured epidermal autographs) for severe burns, during the first half of 2011. "We want to focus on high-priority areas," he said.

In December, Genzyme sold its genetic testing business to Laboratory Corp. of America for $925 million and expects to complete a $265 million sale of its diagnostics business to Sekisui Chemical Co. this quarter.

Rumors have abounded on Genzyme, which is the target of an $18.5 billion hostile bid from Sanofi-Aventis SA, but the biotech's leader wouldn't say anything about ongoing discussions or terms of a negotiated transaction with Sanofi-Aventis.

"This is not the place," he explained.

Deutsche Bank Equity analyst Robyn Karnauskas said that her firm "continues to believe Genzyme will be acquired by Sanofi."

Analyst Joshua Schimmer of Leerink Swann Research said that "we had hoped the process would have been closed by now, but alas it continues to drag on. Hopefully the two companies can come to terms . . . and this drawn-out process can come to an end."

Earlier, Amgen's Sharer welcomed attendees to a breakout session, saying that "This is when the year feels to me like it really begins."

Asked later if it is unthinkable that Amgen might enter the biosimilar market, Sharer – who described himself as "a plain-spoken guy without nuance" – answered simply "No."

He went on to explain that Amgen is one of the first targets for biosimilars, but added that he didn't think the company could ignore the opportunities of biosimilars either.

"The question is: How do we do that? We should participate in an intelligent way without disturbing the core business. . . . It is something we have to get good at."

Karnauskas noted that Amgen "has significant manufacturing capacity, which could potentially be used for biosimilar operations."

Sharer said that he is happy with the firm's 2010 results, which will be reported in full on Jan 24. He said the company expects to grow revenue in 2011, with newly approved osteoporosis drug Prolia (denosumab) "well positioned for 2011" and Xgeva (denosumab) for skeletal-related events in patients with bone metastases from solid tumors expected to be "a meaningful contributor in 2011."

Amgen's 2010 profit will be higher than was previously forecasted and earnings will be "somewhat above the middle" of its forecasted range of $5.05 to $5.25 per share for the big biotech.

"Our EPS growth estimate in 2011 is driven exclusively by share repurchase, which we expect to continue at an aggressive pace," Schimmer said. "Growth could also be driven by accretive M&A, which we do not model."