Therapy Areas: AIDS & HIV
ViiV Healthcare, Halozyme Enter Collaboration, License Agreement for Enhanze Drug Delivery Technology to Enable Development of "Ultra Long-Acting" Medicines for HIV
23 June 2021 - - UK-based ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc, with US-based Pfizer Inc. and China-based Shionogi Ltd. as shareholders, and Halozyme Therapeutics, Inc. (NASDAQ: HALO) have entered a global collaboration and license agreement that gives exclusive access to Halozyme's Enhanze drug delivery technology, recombinant human hyaluronidase PH20 enzyme (rHuPH20), for specific targets used in the treatment and prevention of HIV, ViiV Healthcare said.

Under the terms of the agreement, ViiV Healthcare will make an upfront payment of USD 40m to Halozyme for the exclusive license to four HIV small and large molecule targets and is obligated to make potential future payments of up to USD 175m in development and commercial milestones per target, subject to achievement of specified development and commercial milestones, including certain specified sales milestones.

Halozyme will also be entitled to receive mid-single digit royalties on sales of commercialised medicines using the technology.

The PH20 enzyme breaks down a substance called hyaluronan that is found in the body's subcutaneous space (under the skin) that acts as a barrier to the flow of fluid.

By breaking down HA locally at the injection site and temporarily removing that barrier, large amounts of fluid can be injected into the subcutaneous space and dispersed.

This facilitates the rapid delivery of large volume fluids by subcutaneous injection, potentially reducing the treatment burden of injectable drugs and providing optimised treatment options to patients.

The HA is restored under the skin via normal processes within 24-48 hours.

Halozyme's technology provides ViiV Healthcare with more opportunities to develop ultra-long acting medicines (dosing intervals of three months or longer) with its long-acting portfolio and pipeline products.

Plans are underway to initiate the first experiments with the technology by the end of 2021 for investigational, long-acting cabotegravir for prevention of HIV, which is currently administered every two months.

The license gives ViiV exclusive use of Halozyme's proprietary rHuPH20 technology for four, specific HIV medicine targets that will expand opportunities for development of nearly all of ViiV's pipeline assets.

These assets are integrase inhibitors, reverse transcriptase inhibitors limited to nucleoside reverse transcriptase inhibitors and nucleoside reverse transcriptase translocation inhibitors (NRTTIs), capsid inhibitors and broadly neutralising monoclonal antibodies (bNAbs), that bind to the gp120 CD4 binding site.

Halozyme has licensed its technology to 11 pharmaceutical and biotechnology companies, for potential use in oncology, autoimmune disease, rare disease and infectious disease with products currently approved in oncology and immune deficiency indications.

In addition, Halozyme currently has a Cooperative Research and Development Agreement with the National Institute of Allergy and Infectious Diseases' Vaccine Research Center in the US, which includes a bNAb, N6LS, that ViiV Healthcare licensed from the National Institutes of Health in 2019.

Halozyme is a biopharmaceutical company. As the innovators of the Enhanze technology, which can reduce hours-long treatments to a matter of minutes, Halozyme's commercially validated solution has touched more than 500,000 patient lives via five commercialized products across more than 100 global markets.

Halozyme and its partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe.

Halozyme's proprietary enzyme rHuPH20 forms the basis of the Enhanze technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients.

ViiV Healthcare is a specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE: PFE). Shionogi joined in October 2012.

The company's aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.