By Mark Terry


As part of its fourth-quarter earnings report, Paris-based Sanofi released a pipeline update, showing it plans to halt several mid-stage drug programs.

Sanofi is ending a mid-stage program for isatuximab for acute lymphoblastic leukemia, and SAR428926, an anti-LAMP1 ADC for solid tumors. With no explanation, the company is ending its next-generation version of Lemtrada, GLD52 (GZ402668) for relapsing multiple sclerosis, and SAR100842, an LPA1 receptor antagonist for systemic sclerosis.

In addition, after a Phase II trial for SAR156597 for idiopathic pulmonary fibrosis was finished, they ended the program. SAR156597 is an IL-4/IL-13 antibody. It also shuttered a late-stage program for a vaccine for Clostridium difficile.

John Carroll, with Endpoints News, writes, “The fresh roster of setbacks underscores the issues that Sanofi has had to confront in trying to focus more on its in-house pipeline. Most of its most promising development programs have come from partnerships with Regeneron and Alnylam.”

Those include 2018 readouts on its cholesterol drug Praluent, as well as cemiplimab and dupilumab, all three in a partnership with Regeneron. The fourth big readout expected this year is for isatuximab in relapsed refractory multiple myeloma (RRMM).

Dupixent, for eczema, has done well in the U.S., but the company indicated sales are sluggish in Europe. The drug brought in about $145.6 million in the fourth quarter worldwide, very close to Leerink analyst Seamus Fernandez’s projections of $146.9 million. In Europe, Dupixent sales were $1.23 million, way below the $8 million projected by Kennen MacKay, an analyst with RBC.

In a note to clients, MacKay wrote, “We view the U.S. result as indicative of continued solid uptake with Dupixent’s 40%-plus quarter-over-year growth continuing to impress. In contrast, we anticipate that the European ramp could take additional time.”

The company also announced that it was laying off 130 people at its manufacturing site at Allston Landing in Boston.

The company reported total fourth-quarter revenues of $10.72 billion, dropping 2 percent on a constant-currency basis compared to the same period in 2016. Earnings per share (EPS) dropped 8.8 percent at a constant exchange rate, to $1.31. Operational expenses were 9 percent over Fernandez’s projections.

For 2018, Sanofi has provided guidance of EPS growth of 2 to 5 percent at constant exchange rates, including the contributions from its recent acquisitions of Bioverativ and Ablynx.

On January 22, it announced it had acquired Waltham, Massachusetts-based Bioverativ for about $11.6 billion. In January 2017, Bioverativ spun off from Cambridge, Mass.-based Biogen’s hemophilia unit. Bioverative has two drugs on the market, Eloctate for Hemophilia A and Alprolix for Hemophilia B.

A week later, on January 29, Sanofi acquired Ghent, Belgium-based Ablynx for $4.8 billion. Ablynx focuses on Nanobodies, a novel class of proprietary next-generation biologics. It has a pipeline of more than 45 proprietary and partnered drug candidates in hematology, inflammation, immuno-oncology and respiratory diseases. Eight of their compounds are currently in clinical trials.

For the last year, Sanofi has been making plans to sell off its European generic drug business, Zentiva. Reported by Reuters, potential buyers have been narrowed down to two pharma companies, three private equity funds, and a consortium of buyers. The two industry companies are Brazil-based EMS and India-based Torrent Pharma. The consortium is made up of Blackstone and Nordic Capital. The three other private equity funds are Carlyle, BC Partners and Advent.

Reportedly, the companies all made bids in January, and Sanofi expects to winnow it down to a single buyer by the end of the first quarter. Zentiva is valued at about $2.49 billion.



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