Eli Lilly partners with Halozyme to develop subcutaneous injectables

A depiction of the now-open subcutaneous space following injection of Haloyzme's Enhanze enzyme--Courtesy of Halozyme

Big Pharma is lining up to partner with Halozyme ($HALO) by deploying its Enhanze drug delivery platform, which enables subcutaneous injections of drugs that might otherwise require infusion. Add Eli Lilly to a list that includes AbbVie, Roche ($RHHBY), Baxalta ($BXLT), Pfizer and Johnson & Johnson's ($JNJ) Janssen.

Lilly ($LLY) will pay Halozyme $25 million and milestone payments of up to $160 million for each of up to 5 collaboration targets. Halozyme will earn royalties in the mid-single digits if any of the candidates achieve commercialization.

"We are pleased to collaborate with innovators like Halozyme as we develop our pipeline assets and optimize them for the clinic," said Divakar Ramakrishnan, Lilly's vice president of delivery and device R&D, in a statement. "Halozyme's Enhanze technology will provide a platform for our scientists to optimize delivery of Lilly medicines through subcutaneous injection."

The Enhanze enzyme (dubbed rHuPH20) enables subcutaneous delivery by degrading hyaluronan, a component of the subcutaneous space located just under the skin. Halozyme says on its website that Enhanze facilitates the passage of molecules as large as 200 nanometers through the subcutaneous space. And the degradation is temporary because hyaluronan reestablishes itself after several days.

In addition, Halozyme touts the benefits of converting an intravenous drug to a subcutaneous one, saying doing so can reduce costs, improve efficacy and extend a product's life cycle.

The drug delivery specialist offers its Enhanze enzyme as a standalone product dubbed Hylenex. It's the only FDA-approved human hyaluronidase, or an enzyme that helps the body absorb subcutaneously injected medicine. The enzyme is injected prior to subcutaneous administration of another drug or fluid, with a goal of improving its absorption. Hylenex is also used during subcutaneous urography to improve resorption of radiopaque agents.

Via partnerships, Halozyme hopes to integrate the Enhanze enzyme with other medications, meaning it wouldn't necessarily be sold separately. Subcutaneous formulations of Roche's breast cancer medicine Herceptin and Mabthera for non-Hodgkin lymphoma are approved in the EU, and Baxalta's subcutaneous HyQvia for primary immunodeficiency was FDA-approved in 2014.

In November, the first subject in a Phase I study of Pfizer's ($PFE) subcutaneous sickle cell anemia candidate was dosed, triggering a $1 million milestone payment to Halozyme. Halozyme outlicensed Enhanze to Pfizer in 2012, for use in up to 6 Pfizer biologic candidates on an exclusive or nonexclusive basis in return for an upfront payment of $8 million, milestone payments and royalties on the sale of commercialized products.

AbbVie ($ABBV) entered the fray in June, paying Halozyme $23 million upfront and up to $130 million in milestones on each of up to 9 programs.

FierceBiotech reports that Halozyme is developing the investigational candidate PEGPH20 on its own. Since suffering from safety concerns last year that put a temporary halt on development, the candidate is progressing in clinical trials for pancreatic, gastric, lung and breast cancer.

- here's FierceBiotech's take
- read the release

Special Report: FierceDrugDelivery's 10 biggest partnerships in drug delivery - Johnson & Johnson - Halozyme

Editor's Note: This article has been corrected to include information about commercialized drugs using Enhanze.

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