Should Genzyme pare away at its business? That’s what a key investor is saying. Ralph Whitworth, chief of Relational Investors and Genzyme-director-in-waiting, told Bloomberg that he thinks the company’s renal business should be sold off. That way, Genzyme could focus more tightly on its treatments for genetic disease.

[ad]

Renagel and Renvela, Genzyme’s two key renal drugs, generated some $677 million in 2008 sales. Meanwhile, the genetic-disease treatments accounted for half the company’s revenue with $2.23 billion. Because of manufacturing problems–which caused shortages of Cerezyme, its treatment for Gaucher disease, and Fabrazyme, its Fabry disease drug–Q4 sales dropped by 7.7 percent year-over-year to $1.08 billion. Revenue for the full year also fell, by 2.2 percent to $4.5 billion.

Does Whitworth believe that the manufacturing problems might not have arisen if Genzyme had been single-mindedly pursuing its genetic-disease business? If so, that wasn’t his primary concern. It’s the fact that the genetic-disease drugs deliver a return on invested capital of 25.8 percent (2008). The renal drugs don’t deliver nearly so well. “We want to bring discipline to the financial side,” Whitworth told Bloomberg. “The discipline increases the likelihood that money’s well-spent.”

Last week, Genzyme made a deal with Relational to help secure its hold on management-appointed board seats. Perhaps anticipating a proxy fight with activist investor Carl Icahn, Genzyme agreed to appoint Whitworth to its board at Relational’s request–but Relational agreed not to ask until November or later, and in the meantime to support management’s board nominees. And now, Genzyme is considering tying executive pay to sales growth in certain medicines, to address Relational’s concerns about the company. Lots going on, so stay tuned.

Source: FiercePharma

Popularity: 4% [?]

The bad news is coming in clumps for biotech company Genzyme.

The company today said it has scrapped development plans for a stronger version of its Renvela kidney-failure product after a later-stage trial showed the proposed drug wasn’t more effective than Renvela. Sales of Renvela and its predecessor Renagel rose 6% in the third quarter to $181.7 million. Here’s the company’s statement and a Reuters story.

[ad]

The company has been plagued by a string of manufacturing-related problems of late. On Monday, Genzyme said the FDA wouldn’t approve its application for a drug to treat the muscle disorder Pompe disease until the Cambridge, Mass., company resolved manufacturing deficiencies at a plant in Boston.

And last week, the FDA said it had found foreign particles — read that to be fragments of stainless steel and rubber — in vials of several Genzyme products, including its top-selling Gaucher disease treatment Cerezyme. Contamination problems had also forced the company to stop manufacturing the drug for a month before it resumed production in August.

The earlier manufacturing problems resulted in shortages and have taken a financial bite out of the company. Last month, it reported worst-than-expected results for the third quarter that included an 87% profit drop.

Investors looking for some good news about the company lately might take note that billionaire activist investor Carl Icahn bought 1.45 million Genzyme shares as of Sept. 30. Here’s a WSJ story on the purchases by Icahn, who has held Genzyme shares before and sold them.

Genzyme and Isis Pharmaceuticals reported this week that an experimental drug they are developing for high-risk patients with cholesterol problems significantly lowered cholesterol in a late-stage study.

Source: The Wall Street Journal

Popularity: 4% [?]

Genzyme announced that the company obtained approval in the EU to market the tablet and powder formulations of Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD), including certain patients not on dialysis. Dan Regan, general manager of Genzyme’s renal business, stated that the marketing authorisation “is the first phosphate binder for patients not on dialysis approved through the centralised procedure in Europe.”

[ad]

In the US, Renvela’s tablet formulation is already approved for use in patients with CKD on dialysis, and Genzyme anticipates FDA approval of the powder formulation for this indication in the second half of 2009. The company has also been in discussions with the FDA regarding the treatment of hyperphosphataemic CKD patients not on dialysis, and expects the talks to continue beyond midyear.

The drugmaker is also seeking approval for Renvela in other countries and the company noted that the product was approved last week in Brazil to treat patients with CKD on dialysis.

Source: FirstWord

Popularity: 2% [?]

Genzyme initiated patent infringement litigation against Impax in a US district court over kidney disease drug Renvela (sevelamer carbonate), Impax confirmed Monday. The California-based drugmaker said the lawsuit was filed after it notified Genzyme that its application to market a generic version of the treatment had been accepted by the FDA.

[ad]

The product had sales of about $40 million in the 12-month period ended February 2009.

Source: FirstWord

Popularity: 2% [?]