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5:46 PM
Aug 03, 2018
 |  BioCentury  |  Finance

Functions of formulation

How Halozyme is growing its business around licensing reformulation technology

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can provide to partners.

The company has added as many new partners for its subcutaneous formulation platform in the last four years, since the first Enhanze approval, as it did in the prior six. It also has almost quadrupled the value of upfront and milestone payments compared to the total value of deals made before the first Enhanze product was approved.

One reason is that partners are finding new motivation to develop subcutaneous formulations of infused products. Halozyme’s maiden deals were primarily defensive plays by partners who hoped to stave off biosimilar competition. Now, partners also are coming to Halozyme for help differentiating products earlier in their life cycles.

Within the next five months, the number of Enhanze products in the clinic will nearly double, from five to eight. And two Enhanze products could be approved within the next few years, bringing that total to five.

With the growing number of Enhanze products advancing through the pipeline, Halozyme is projecting $1 billion in annual royalty revenues by 2027, up from $64 million in 2017. The biotech expects that royalties on its three marketed products will grow 25-30% this year.

In addition, it will have Phase III data for its first in-house candidate, PEGPH20, by next February.

Taking shape

Halozyme has been developing products based on recombinant human PH20 hyaluronidase enzyme since 1998. The enzyme was approved in 2006 as Hylenex, an adjuvant to increase absorption and dispersion of other injected drugs.

Enhanze co-formulates the enzyme with therapies traditionally given by IV. The enzyme temporarily degrades hyaluronan in the extracellular matrix to improve dispersion within the subcutaneous space. The platform thus enables products such as immunoglobulins or mAbs to be given subcutaneously.

Initial applications of the technology were aimed at producing new formulations of aging biologics, with new IP, that were more convenient for patients to use and could save the healthcare system on infusion costs (see “One-Upping Biosimilars”).

“It’s a potential added benefit, rather than just the reduced treatment burden of subcutaneous.”

Helen Torley, Halozyme

President and CEO Helen Torley told BioCentury that at the time of Halozyme’s first deals with Roche and Baxter International Inc., “people thought of the platform as a biosimilar defense play.”

That strategy rested in part on reducing infusion time, she said. “They were able to show that the reduced time it takes to deliver treatment was associated with savings to the healthcare system.”

That makes subcutaneous formulation of products traditionally given by IV more than just a convenience play.

Roche paid $20 million up front in 2006 for exclusive, worldwide rights to use Enhanze to formulate products against three targets. Roche also made an $11 million equity investment in Halozyme, and Halozyme was eligible for up to $111 million in clinical, regulatory and sales milestones, plus mid-single digit royalties.

The deal included an option to add up to 10 targets over 10...

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