Drug store operators soon may be seeing more prescriptions for drugs from Sanofi-Synthelabo come across the counter, as the French pharmaceutical company gains a greater share of the US. pharmaceutical market through its acquisition of Aventis--a deal worth $65 billion pending shareholder and regulatory approval.
Sanofi-Aventis, as the merged company will be called, no longer will need to partner with its larger pharmaceutical cousins in detailing a drug in the United States, as Sanofi has with Bristol-Myers Squibb in marketing its cardiovascular drug Plavix.
"By merging with Aventis, it eliminates that need [to form co-promotion partnerships], and it can, go about promoting [novel drugs] on its own, Dr. Gbola Amusa, a senior research analyst for Sanford C. Bernstein & Co., told Drug Store News.
For instance, Sanofi's Acomplia (rimonabant) is in late-stage development as a remedy for obesity and smoking cessation and could be ready for Food and Drug Administration approval as early as fourth quarter 2005.
And that's a boon for Aventis, which managed a less-than-robust developmental drug portfolio, according to analysts, before the proposed merger. The new Sanofi-Aventis has a few promising drugs to tout in the coming years.
And Sanofi plans to breathe new life into its sleep aid Ambien franchise, soon to face generic competition, with a controlled-release offering that will be filed by the second quarter of this year, according to company reports.
As for development drugs coming from Aventis, the cancer drug Genasense is on the FDA approval docket for June 8. And although Aventis is bullish on the likelihood of FDA approval, an advisory panel earlier this month suggested otherwise. "In the absence of-increased survival, the committee voted [on May 3] that the evidence presented today did not provide substantial evidence of effectiveness, as measured by response rate and progression-free survival, to outweigh the increased toxicity of administering Genasense for the treatment of patients with metastatic melanoma who have not received prior chemotherapy," Aventis stated in a press release. If Genasense is approved, it has been projected to reach $1 billion in sales.
"The [Sanofi-Aventis] combination will combine complementary research areas and make the company a much more powerful oncology and cardiovascular player," Amusa stated. With those noted exceptions, Sanofi and Aventis do not overlap in their product offerings. "Aventis emphasizes allergy, metabolism and human vaccine pharmaceuticals, and Sanofi emphasizes internal medicine and has a significantly greater presence in the central nervous system pharmaceuticals market," Amusa noted.
However, neither company is without its pharmaceutical baggage. Sanofi currently is seeking to uphold its patent rights for Plavix against Dr. Reddy's and Apotex. And Sanofi is expected to lose exclusivity for its sleep aid Ambien by mid-2006--opening $1.7 billion in worldwide sales to generic competition.
On Aventis side of the equation, Lovenox, an anticoagulant, is under patent-challenge pressure. Likewise, Aventis' blockbuster antihistamine Allegra may switch to over-the-counter status when its patent expires in 2006. Already, a pair of FDA advisory panels ruled Allegra safe for the self-medication market in 2001.
And as part of the merger deal, Sanofi has agreed to divest its Arixtra and Fraxiparine to GlaxoSmithKline for $492.4 million. The antithrombotic agent Arixtra generated $28.6 million in worldwide sales in 2003, according to Sanofi. Fraxiparine, also an antithrombotic drug, generated $380.4 million.
Of course, it may be quite some time before the new Sanofi-Aventis will be able to realize its full market potential. The new board created out of the merger calls for a fairly even split between the companies, with Sanofi enjoying a one-executive advantage. That is the chief risk facing the new enterprise," Amusa said, "whether you're looking at R&D productivity or you're looking at other operational considerations.
Analysts point to Pfizer's acquisition of Pharmacia as the model pharmaceutical merger in today's climate. Pfizer cedes very little managerial control to its new base of Pharmacia employees--a fact that analysts say hastened Pfizer's ability to incorporate Pharmacia operationally because the new company's managers were not wrangling over which cultural protocol to follow.
Nonetheless, the Sanofi-Aventis merger has been billed as a merger of equals. That being the case, it may take up to 18 months before the new management team hits full stride as the No. 3 pharmaceutical company worldwide. "The company will have a more unified vision by then," Amusa said.
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