December 13, 2017

Matthias Blamont (Reuters)

Sanofi CEO Oliver Brandicourt says expect nine regulatory submissions for new drugs over the next 18 months

French pharmaceuticals group Sanofi said on Wednesday it had suffered from low uptake for a new cholesterol drug and from concerns about a dengue vaccine, but expressed confidence its pipeline of new products would support long-term growth.

The world’s sixth largest drugmaker, which is battling to contain the fallout from a safety row in the Philippines over dengue vaccine Dengvaxia, said it expected to file nine regulatory submissions in the next 18 months.

Some investors have voiced discontent with the group’s product pipeline and its failure to engage in a large acquisition since it appointed Olivier Brandicourt as chief executive in 2015.

Sanofi is under pressure to stand out in research and development as its diabetes division still has to overcome pricing constraints in the United States, the world’s largest health market, where its blockbuster insulin medication Lantus has lost its patent.

In opening remarks at a company investor day, Brandicourt said the group was “on track” to sell its European generic drugs unit in “the coming year”, a long-awaited deal which could be worth more than 2 billion euros ($2.4 billion), sources say.

“We are making good progress overall on our roadmap and I am confident that Sanofi now is much better positioned to deliver the sustained and long term growth that our shareholders are expecting from us,” he said.

The company said in November 2015 its five-year strategic plan would see six key launches likely to generate peak sales of 12 billion to 14 billion euros by 2025.

One of them, Dengvaxia, is proving disappointing after findings the vaccine could, in some cases, increase the risk of severe dengue in recipients not previously infected by the virus.

Once touted as a $1 billion-a-year blockbuster product, Dengvaxia’s initial sales last year were only 55 million euros.

Hurdles to patient access by health insurers and pharmacy benefit managers have also led to disappointing sales in Sanofi’s new cholesterol drug Praluent.

“When I turn to delivering outstanding launches I concede that our record over the past two years has been mixed,” Brandicourt said. “While we are not changing our ambition of combined peak sales, we are clearly much more reliant on our immunology franchise.”

As a key pillar of the 2020 Roadmap, the new Sanofi R&D model is based on three key strategic shifts:

• From small molecules to biologics;
• From mono-targeting to multi-targeting compounds; and
• From licensing to proprietary assets.

‘MULTI-TARGETING’

In immunology, Sanofi has been focusing on “multi-targeting” drugs that have the potential to treat more than one disease.

One example is dupilumab, which was developed with U.S partner Regeneron and for which it has secured approval in the United States and Europe for eczema. The drug is also expected to have further uses in asthma, nasal polyps, eosinophilic esophagitis and food allergies

“Phase 3 development for dupilumab is now planned in chronic obstructive pulmonary disease (COPD),” Sanofi said.

Sanofi, whose shares have underperformed major rivals, reiterated its strategy to rebuild its position in cancer and said it expected a first regulatory submission of its monoclonal antibody for relapsed refractory multiple myeloma in 2018.

The Cancer Research Institute said last week the race to develop new immunotherapy treatments for cancer had sparked an unprecedented expansion in the oncology drug pipeline, with more than 2,000 immune system-boosting agents now in development.

The result is a scramble for patients to enrol in clinical trials, duplication of effort and the likely ultimate failure of many projects, according to experts.

Editing by Richard Lough, Edmund Blair and Mark Potter

More from the presentation earlier today

Sanofi arranged to declare the pivotal data right at the beginning of its annual R&D day. For Sanofi it was an obvious opportunity to present its innovative pipeline and demonstrate that it has the R&D power and commitment needed to discover and develop new therapies — even if much of the innovation is still coming from its partners at Regeneron.

Skeptics, though, aren’t seeing anything new with today’s updates and  Sanofi's shares were down at 74.75 € (0.37%) at the closing of the presentation.