Alteogen expects additional deals next year on its biobetter technology

Korea’s biotech firm Alteogen Inc. is in talks with three global pharmaceutical companies to sell its platform technology that allows an intravenous medicine to be injected through a subcutaneous route, said the company’s chief executive Park Soon-jae.

In a recent interview with Maeil Business Newspaper, Alteogen expects there will be several additional deals next year over the recombinant human hyaluronidase called ATL-B4. Last month Alteogen announced a surprise 1.6 trillion won ($1.34 billion) deal with an unnamed global pharmaceutical company to license out the technology that can facilitate conversion from intravenous protein therapeutics to a more convenient subcutaneous route of administration. A switch from intravenous infusion to subcutaneous one is less invasive and enables a patient to self-administer medications at home.

Hyaluronidase, an enzyme originally extracted from testicles in pigs and cattle, breaks down the protective film surrounding the egg during sperm implantation. Hyaluronidase from animals is commonly used for concomitant use to even skin surface after filler treatment or during ophthalmic surgery. Hyaluronidase found in a male sperm which is called human hyaluronidase is used primarily in the biopharmaceutical market to convert IV formulation to SC.

In order for the drug to be injected, the drug must penetrate into the blood vessel under the subcutaneous layer, Park explained. But the existing intravenous drug cannot be injected subcutaneously because of polymers in the skin blocks the penetration of the drug into the blood vessel (absorption). But when the drug mixed with ALT-B4 is injected, ALT-B4 dissolves the polymeric material in the skin and gives the drug a way to penetrate the blood vessel under the subcutaneous layer.

Alteogen Inc. chief executive Park Soon-jae

Alteogen is one of the world’s only two companies with this SC conversion technology, but Alteogen’s technology is ahead of Halozyme’s PH20 technology in terms of higher activity, lower immunogenicity and higher thermal stability, Park stressed.

Halozyme maintains an exclusive deal with a single company over a specific disorder, but Alteogen plans to provide ALT-B4 to multiple customers in a non-exclusive manner, Park said.

Alteogen founded in 2008 has a portfolio of novel drugs and pharmaceutical technology which includes next generation biobetters, biosimilars and proprietary biologics. The company now focuses on the three cutting edge areas of the biopharma industry – long-acting biobetters, proprietary antibody-drug conjugate, and antibody biosimilars with complexity. Park said Alteogen is planning to conduct a clinical trial of an SC biosimilar version of breast cancer drug Herceptin, adding it will consider whether to seek partnership for commercial development.

The proportion of SC formulations among FDA-approved antibody drugs increased from 20 percent in 2014 to 33 percent in 2018, and to close to 40 percent in the first half of this year.

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