New Restructuring Leads to the Birth of Sanofi and Its Plan to Expand

Published: Jul 20, 2015

Restructuring Leads to Birth of Sanofi Genzyme and Its Plans to Expand
July 16, 2015
By Alex Keown, BioSpace.com Breaking News Staff

CAMBRIDGE, Mass. -- The announced reorganization of French-based Sanofi is giving a boost to one of its newest divisions, Massachusetts-based Genzyme Corporation, which will look to expand as it absorbs Sanofi’s cancer and immunology programs, the Boston Globe reported this morning.

Sanofi Genzyme, the name of the new business unit, will expand its focus to broader medical concerns under the reorganization, which takes effect Jan. 1, 2016. Genzyme’s current pipeline is aimed at treating multiple sclerosis and rarer diseases and disorders, including Gaucher and Fabry diseases.

On Wednesday Olivier Brandicourt, Sanofi’s chief executive officer, said the reorganization “is a necessary step for ensuring that Sanofi's new medicines and vaccines continue to build on our heritage of providing innovative healthcare therapies.”

The newly dubbed Sanofi Genzyme is a specialty care unit that will be led by David Meeker. The new business unit will include Sanofi's medicines in rare diseases, multiple sclerosis, oncology and immunology. Some of Genzyme’s work with renal and biosurgery products will shift to other Sanofi divisions. Some revenues from the company’s work in developing markets will also shift to other Sanofi divisions, the Globe reported.

Sanofi acquired Genzyme in 2011 for $20.1 billion. Genzyme currently employs about 4,500.

Meeker told the Boston Globe the restructuring of the company will allow for growth, but said it was “too soon to specify how much revenue and how many jobs may be added.”

Through the restructuring, Genzyme gains two investigational biologics, sarilumab and dupilumab. Sarilumab is a treatment rheumatoid arthritis and dupilumab is a treatment for itches and rashes caused by a skin ailment. Both of these biologics have the potential to be blockbuster treatments, generating more than $1 billion in sales annually.

While Genzyme will be adjusting to its newer biologics, the company will continue to focus on its present work, including olipudase alfa, an enzyme replacement therapy being investigated for the treatment of patients with nonneurological manifestations of acid sphingomyelinase deficiency (ASMD). Last month, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to the therapy. The FDA’s designation came following a five-patient Phase Ib study of olipudase alfa. The study findings showed that the dose escalation regimen was well tolerated, with all patients, with no serious side effects. The company has started enrollment of a Phase I/II pediatric study and is preparing for enrollment of a Phase II/III adult study in the second half of 2015, the company said.

This is the second FDA award in as many months for Genzyme. In April, the FDA granted Fast Track designation for the development of GZ/SAR402671, a new investigational oral substrate reduction therapy for the treatment of Fabry disease, a rare lysosomal storage disorder that results in abnormal tissue deposits of a particular fatty substance called globotriaosylceramide, throughout the body.

In March, Japan’s Ministry of Health, Labor and Welfare granted marketing approval for Cerdelga, an oral therapy for the treatment of adults with Gaucher disease type 1 in Japan. Cerdelga was approved by the U.S. Food and Drug Administration in August 2014, the European Commission in January 2015, and the Australian Therapeutics Goods Administration in February 2015.


As New Jersey Biotech Booms, Will It Overtake Other States As Prime Location?
A week after Celgene Corporation announced it is officially the mystery buyer of Merck & Co. ’s former 1 million-square-foot R&D site in Summit, N.J., it quickly became our most popular story last week.

The company announced last Wednesday that it is buying the space, ending months of speculation about what Big Pharma company might move into the neighborhood.

The Summit, N.J. site is zoned research/office. The New Jersey site would put operations closer to some of the major biotech and pharmaceutical hubs on the East Coast.

But, by far, the most tempting part of doing business in the state remains New Jersey’s operating tax credit, which allows companies to sell their net operating losses to the New Jersey Treasury. One of the state’s most recognizable biotechs, Celgene, used the program until it became profitable, which was key to it staying in the state, said local officials.

That has BioSpace is wondering if New Jersey is becoming the new face of biotech. What do you think? Can the Garden State compete with other longtime stalwarts like California or Boston?

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