HONG KONG – South Korean company Alteogen Inc. signed a nonexclusive global license agreement with a top 10 global pharmaceutical company for its recombinant human hyaluronidase enzyme, ALT-B4, in exchange for an up-front payment of $13 million. It is also eligible to receive additional payments of up to $1.37 billion tied to the achievement of development, regulatory approval and sales milestones.

While the undisclosed big pharma will secure the global rights to develop and commercialize multiple products in combination with the Hybrozyme technology, Alteogen will be responsible for the clinical and commercial supply of ALT-B4 materials.

ALT-B4 is developed using the company’s Hybrozyme technology, a hyaluronidase-derived technology that enables large volume subcutaneous (SC) administration of drugs that are typically administered as I.V. injections by temporarily hydrolyzing hyaluronan in the extracellular matrix.

The technology is reportedly under negotiations for out-licensing to other multinational pharmaceutical companies, according to Korea’s local media. However, the Daejeon-based company declined to disclose any details for now.

“We cannot comment on any future deals,” Arun Swaminathan, chief business officer and senior vice president at Alteogen, told BioWorld Asia. “We do believe our technology has applicability to many potential partners and we will pursue appropriate partnerships that make strategic sense to both parties.”

“We are not able to comment on which company we have licensed ALT-B4 out. It is a strategic decision that will be made in alignment with our partner company,” he added.

Nevertheless, the deal provides validation to the company’s technology that could bode well for future negotiations.

“The license deal of ALT-B4 has more premium than general new drug license deals as it theoretically has a high possibility of clinical success, which is applied to pipeline value calculation, and a low discounting rate of time value,” Kevin Jin, analyst at Korea Investment and Securities, told BioWorld Asia. “As the deal was nonexclusive and proved the quality of the technology, there may be more opportunities for Alteogen’s future license deals.

“Also, more deals may take place as Alteogen is known to be negotiating additional technology transfers with some global companies,” Jin added.

One of the global key players in developing hyaluronidase enzyme is Halozyme Therapeutics Inc., a U.S. biotech based in San Diego. In 2006, Halozyme and Roche Holdings AG entered a licensing agreement for the Enhanze technology. Under the agreement, Halozyme granted Roche exclusive, global rights for the application of Halozyme’s recombinant human hyaluronidase PH20 enzyme rHuPH20. Other global pharmaceutical companies such as Janssen Pharmaceutica NV, Bristol-Myers Squibb Co., Eli Lilly and Co. and Alexion Pharmaceuticals Inc. have also introduced Enhanze technology to the development of their therapies in SC formulations.

“Like Halozyme, Alteogen is expected to transfer its hyaluronidase technology to other biotech companies and receive royalties as the SC formulations are commercialized. Its future partnership deals will go smoothly once the company proves a stable production capability,” Jin said.

Alteogen is focused on developing long-acting biopharmaceuticals, proprietary antibody-drug conjugates (ADCs), and antibody biosimilars with complexity. Since its foundation in 2008, the company has developed Nexp Fusion technology, a next-generation long-acting technology, Nexmab ADC technology, and novel human hyaluronidase PH20 based on the Hybrozyme technology. PH20 is widely used to improve the absorption of drug biologics delivered via subcutaneous injection.

According to the company, the human PH20 proteins not only possess the economic value due to higher productivity in Chinese hamster ovary (CHO) cells but they also have demonstrated enhanced protein function resulting from better physicochemical properties compared with wild-type PH20. Thus, the company said its PH20 products use less protein for clinical applications and have a longer shelf-life.

In its own pipeline, the company has ALT-P1 as its most advanced candidate. A long-acting human growth hormone currently in phase II trials, ALT-P1 was licensed out to Sao Paulo, Brazil-based Cristália Produtos Químicos Farmacêuticos Ltd. in July for joint development and commercialization. Under the agreement, Cristália would invest about ₩50 billion (US$42.4 million) to conduct phase II and III trials in Brazil. The up-front payment was $2 million.

Alteogen’s ALT-L2, a Herceptin (trastuzumab, Roche Holdings AG) biosimilar, has completed global phase II testing and the company is preparing for the phase III trials. An SC formulation of trastuzumab with an ALT-B4 enzyme is also being developed. Additionally, the Korean biotech is working on ALT-L9, an Eylea (aflibercept, Regeneron Pharmaceuticals Inc.) biosimilar; ALT-Q2, a long-acting factor Vlla; ALT-P7, a breast/gastric cancer ADC; and ALT-Q5, an ovarian cancer ADC.

Alteogen’s (KRX: 196170) stock price closed at ₩66,300 with a rise of 2.31% Tuesday.

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