Med Ad News - June 2015

he U.S. biotechnology arena is undergoing a re-cord-breaking M&A cycle for the industry. After generating M&A activity valued at $235 billion during 2014, the U.S. biotech sector produced more than $100 billion in deals during first-quarter 2015. Industry analysts note that most M&A cycles last between three to five years. With 2014 being the first year in the newest cycle, the biotech industry is anticipated to continue wheeling and dealing at record levels, with some analysts firms projecting a growth rate of about 20 percent for the next two years.

Since the last time this annual report was published by Med Ad News two years ago, 14 of the top 100 revenue-generating biotech entities from that listing have been acquired, including former top 20 members Elan Corp. (purchased by Perrigo Co.) and Cubist Pharmaceuticals Inc. (bought by Merck & Co.)

Another former top 100 company acquired since 2013 was InterMune Inc.

by the world’s largest biotechnology company, Roche. The Swiss pharma giant spent about $8.3 billion on the August 2014 acquisition despite the

California biotech firm’s leading drug prospect having not yet produced any revenue at that point in time. But three months later, InterMune’s Esbriet ( pir-fenidone) was FDA-approved for treating idiopathic pulmonary fibrosis. Patients with IPF gradually lose the ability to breath as fibers fill up their lungs.

Another biotech acquisition by Roche during the past year was that of Trophos in January 2015 for up to EUR 470 million. A privately held biotech company based in Marseille, France, Trophos’ proprietary screening platform generated olesoxime (product code TRO19622), which is being developed for spinal muscular atrophy.

SMA is a rare and debilitating genetic
neuromuscular disease most commonly
diagnosed in children. Pivotal Phase II
results with olesoxime in SMA demon-
strated a beneficial effect on the main-
tenance of neuromuscular function in
individuals with Type II and non-ambu-
latory Type III SMA, as well as a reduc-
tion in medical complications associ-
ated with the disease.

The investigational medicine olesoxime is designed to protect the health of motor nerve cells. Olesoxime has been granted Orphan Medicinal Product designation for treating SMA by the European Medicines Agency and Orphan Drug Designation by FDA.

Roche announced in December 2014 a deal to acquire Dutalys GmbH, a privately held biotech company with headquarters in Vienna, Austria. Dutalys is dedicated to the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMab technology. The bi-specific antibodies developed with this platform are designed to provide novel, best-in-class molecules for several therapeutic fields. This transaction further highlights Roche’s leadership in developing therapeutic antibodies.

A conventional bi-specific monoclonal antibody is a biotechnologically engineered artificial protein consisting of fragments of two different monoclonal antibodies and consequently can bind to two different antigens. The DutaMab technology platform varies by allowing for the development of fully human bi-specific antibodies where each arm of the antibody demonstrates high affinity and simultaneous binding against both targets, excellent stability, and good manufacturing properties. This process enables the treatment of disease mechanisms that could not be addressed with conventional bi-specific antibodies.

Another private company acquisition by Roche during 2014 was that of Santaris Pharma in August. The Copenhagen, Denmark-based biopharmaceutical company pioneered its proprietary Locked Nucleic Acid (LNA) platform that has contributed to an emerging era of RNA-targeting therapeutics. This new class of medicines has the potential to address hard-to-treat diseases in various therapeutic fields.

Santaris’ LNA platform and drug discovery engine unites the company’s proprietary LNA chemistry with its highly specialized and targeted drug discovery capabilities to rapidly deliver drug candidates against mRNA and microRNA. As a result, scientists are able to develop drug candidates for diseases that are difficult, or impossible, to target with contemporary drug platforms including antibodies and small molecules. The LNA platform is designed to overcome the limitations of earlier antisense and siRNA technologies, in particular via a unique combination of small size, high binding affinity and metabolic stability that enables this new class of drug