French Revolution - Pharmaceutical Executive


French Revolution

Pharmaceutical Executive

Stress Tests for a Pipeline

Lest anyone doubt that Viehbacher has control over his own cravings for magical molecules, in May he took the axe to Sanofi's entire portfolio of experimental drugs. Ever timely, he called it "our version of 'the stress test'"—signaling that no Sanofi compound could ever again be perceived as too big to fail.

When the results were in, 14 of the company's 65 projects had flunked: six in Phase I and four each in Phases II and III. The late-stage drugs included a novel antidepressant, a Zetia-like anticholesterol agent, and a solid-tumor cancer vaccine—projects with evident scientific merit but too risky for today's value-added market. "The bar has really been raised in terms of the regulators and payers saying your medicine has to be better than we already have," says Viehbacher, a veteran of the US healthcare wars.

Analysts applauded. Said Raymond James' Eric Le Berrigaud: "This is one step forward in the restructuring of [Sanofi's] research and development operations."

Viehbacher took another step by creating yet another newly defined position—chief of industrial development and innovation—and giving it to one of his top R&D talents. The In Vivo blog had a typically penetrating take: "That means revitalizing an industry backwater: drug delivery and reformulation. Plenty of companies have life cycle–managed plenty of drugs, but it has never before now been the face of R&D.... Should the trend catch on, we might even see drug companies split R&D in two: Novel Products R&D (largely outsourced, we'd imagine, to optionalize the spending) and Innovative Industrial R&D (think combination products, drug delivery, and single-isomer formulations)."

"First on the to-do list is probably how to expand the Plavix brand [in advance of its patent expiration]," says Bernard.

Sanofi's cardiovascular franchise, which in addition to Plavix boasts blockbuster Lovenox (enoxaparin) and Aprovel (irbesartan) and got a much-needed boost last winter when an FDA advisory panel gave a thumbs-up to Multaq (dronedarone), for atrial fibrillation. One of the few true innovations among 2009 NDAs, Multaq's six-month priority review at FDA was set to run out at the end of June. But at press time, the agency had yet to deliver a verdict. The possibility that this blockbuster-to-be will bust has further fueled downsizing rumors at Sanofi.

Out Front in Oncology

"Sanofi missed the boat in biologics," Viehbacher told the Financial Times in February. In reaction, at the annual BIO bash in Atlanta in May, Sanofi execs announced that the firm was aiming to double the 27 percent of its business that currently comes from outside R&D. Sanofi's M&A team, one of very few in pharma headed by a woman, has a goal of reviewing 75 potential deals every quarter. Among those inked this spring were a raft in oncology, indicating that Sanofi will try to restore its franchise to world-class status. Taxotere (docetaxel) is the field's leading chemo treatment—and third only to Genentech's Avastin and Herceptin in cancer sales—but its exclusivity ends next year.

"Oncology is a very lucrative field requiring very specialized skill sets. Given Sanofi's past success in major tumor types, the company should have already gained traction in the smaller tumor types," says the Arcas Group's Heybrook. "But its pipeline is nowhere near as deep and diverse as, say, Novartis'."

Two of the new partnerships merit special mention. One is with Exelixis, a San Fran biotech that has hit the jackpot with its kinase-inhibitor platform. Sanofi follows BMS and GSK as the third Big Pharma to seal a big development deal—$140 million up front for two Phase Ib/II compounds, with the possibility of $1 billion in milestones.

To shore up its position in breast and ovarian cancer, Sanofi bought BiPar Sciences, another hot Bay City biotech whose specialty is PARP inhibitors. This new class of compounds cleaves to a DNA-repairing enzyme that is overexpressed in certain tumors, making for a convenient target. Only weeks after the Sanofi purchase (worth up to $500 million in milestones), BiPar's lead candidate went on to steal the show at the annual ASCO gathering in Orlando in May.

In Phase II metastatic triple-negative breast cancer—a condition for which hormone therapy is useless—the 9.5-months survival data got raves from such independent top docs as Powel Brown, director of the Lester and Sue Smith Breast Center at Baylor College of Medicine. Calling the study "a huge bombshell," Brown said, "These PARP inhibitors are the biggest story in breast cancer." (Brown was not involved in the study.)

If Sanofi's upcoming expanded Phase II trial confirms these data, the first PARP inhibitor could be fast-tracked for FDA approval within two years.

At ASCO, Viehbacher made a point of instructing reporters that "[BiPar's] 18 people brought this product to where it is now"—and assured that, accordingly, his partnering style would be hands-off. The BiPar success is a gratifying validation of his oft-repeated preference for the small, strategic acquisition.


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