[Edaily Reporter Kim Jinsoo ] Alteogen Inc.(196170)’s partner, Merck (MSD), has invalidated Halozyme’s MDASE patent in a Post-Grant Review (PGR) before the U.S. Patent Trial and Appeal Board (PTAB), removing a hurdle to Alteogen Inc.’s global partnership agreements.

In particular, since Alteogen Inc.’s contracts differ in structure—being based on the partner company’s substance (ingredient) rather than Halozime’s target-based contracts—the company is expected to be able to sign agreements with more partners than Halozime in the future.

Discussions on Technology Export with 10 Global Pharmaceutical and Biotech Companies

According to Alteogen Inc. on the 14th, the company is currently in discussions with numerous global pharmaceutical and biotech

companies

regarding the export of its Hybrozyme platform technology.

An Alteogen Inc. official stated, “We have been discussing the export of ALT-B4 technology with 10 pharmaceutical and biotech companies since last year,” adding, “Even after signing contracts this year with Tesaro, a subsidiary of GlaxoSmithKline (GSK), and Biogen, two more companies have expressed interest in signing contracts, so the number of pharmaceutical and biotech companies we are in discussions with remains at 10.”

Alteogen Inc. and Halozyme possess platform technologies that convert intravenous (IV) biopharmaceuticals into subcutaneous (SC) formulations. Alteogen Inc. enables formulation conversion through ALT-B4 in its Hybrozyme platform, while Halozyme does so through rHuPH20 in its Enhance platform.

Both ALT-B4 and rHuPH20 are drug delivery technologies based on recombinant human hyaluronidase (a recombinant enzyme protein that breaks down hyaluronic acid); they locally and temporarily degrade hyaluronic acid (HA) in the extracellular matrix of the subcutaneous space, enabling the dispersion and absorption of large volumes of drug.

What is the difference between a target agreement and a substance agreement?

On the global stage, Alteogen Inc. and Halozime are reportedly the only two companies that possess formulation conversion technology using recombinant human hyaluronidase. Consequently, pharmaceutical and biotech companies worldwide are entering into agreements with Alteogen Inc. and Halozime to convert IV drugs into SC formulations.

However, there are differences in the licensing models of the two companies. First, Halozyme enters into agreements with partners targeting specific antigens and biomarkers. Under these agreements, the partner holds exclusive rights to the targeted antigens and biomarkers. Consequently, Halozyme cannot enter into additional technology licensing agreements with other pharmaceutical and biotech companies for the same target antigens.

For example, if Halozyme licenses its Enhance technology for human epidermal growth factor receptor 2 (HER2) to a partner through a contract, that partner secures exclusive rights to use the technology for converting HER2 into a subcutaneous (SC) formulation. Halozyme cannot enter into additional agreements regarding HER2-targeted drugs developed by other pharmaceutical or biotech companies.

To date, Halozyme has signed a total of 10 subcutaneous formulation modification technology export agreements through Enhance with five companies: Roche, Johnson & Johnson, Bristol-Myers Squibb (BMS), Takeda, and ArgenX. The 10 targets covered by these agreements include: △ human epidermal growth factor receptor 2 (HER2), △ epidermal growth factor receptor (EGFR), △ programmed cell death protein receptor-1 (PD-1), △ programmed cell death ligand-1 (PD-L1), △ CD-20, and △ CD-28.

Among these, Roche holds exclusive rights to use the Enhance technology for targets such as HER2, PD-L1, and CD20. In particular, since Halozime has already signed agreements for PD-L1 and PD-1—which are currently dominant in the anticancer drug field—it is difficult to secure additional agreements.

In contrast, Alteogen Inc. enters into agreements with partners based on specific compounds (ingredients) rather than targets. Partner companies can apply ALT-B4 exclusively to the compounds they own. Therefore, even if the targets are the same, as long as the compounds themselves are different, Alteogen Inc. is free to enter into technology export agreements for formulation changes with other pharmaceutical and biotech companies.

For example, under its agreement with Merck (MSD), Alteogen Inc. granted exclusive rights to use ALT-B4 for the development of a subcutaneous (SC) formulation of Keytruda, which contains the active ingredient pembrolizumab. Keytruda targets PD-1. Since Alteogen Inc. has entered into an agreement with Merck solely for the active ingredient pembrolizumab, it remains free to enter into agreements with other pharmaceutical and biotech companies regarding other PD-1-targeting active ingredients.

Conversely, it will be difficult for Alteogen Inc. to enter into technology export agreements for formulation changes regarding future generic products containing the same active ingredient as Keytruda. However, given that original product manufacturers are pursuing an “evergreening” strategy—extending their exclusivity periods through formulation and process patents by switching to subcutaneous (SC) formulations even after active ingredient patents expire—it is anticipated that applying formulation change technology to future generic drugs will hold little significance.

An Alteogen Inc. official stated, “We are currently preparing final technology export agreements with multiple global pharmaceutical and biotech companies,” adding, “The development of products utilizing ALT-B4, such as Enhertu SC, Imfinzi SC, and Relbegostomig SC, is proceeding smoothly. As full-scale sales of the Keytruda SC product begin, our financial performance is expected to improve rapidly.”