AstraZeneca Signs Alteogen Deal Worth Up to $1.35B for Subcutaneous Cancer Drugs Despite Patent Drama
AstraZeneca, a leading British pharmaceutical company, has entered into two significant agreements with Alteogen, amounting to a potential total of $1.35 billion, aimed at developing subcutaneous formulations of various oncology products. This partnership comes into play amid a complex patent dispute involving Halozyme, the developer of rival hyaluronidase enzymes, which poses potential risks to AstraZeneca’s advancement of these cancer drugs.
Details of the Agreements
In a recent announcement on Monday, AstraZeneca declared that it has acquired exclusive rights to utilize Alteogen’s hyaluronidase protein, ALT-B4, for the creation and commercialization of subcutaneous versions of “several oncology assets.” The deals, as disclosed in Alteogen’s filings with the Korea Exchange, comprise two separate agreements. The first agreement entails an upfront payment of $25 million accompanied by potential milestone payments reaching up to $725 million. The second deal includes an upfront payment of $20 million, with potential milestones totaling $580 million. However, AstraZeneca has chosen to withhold information regarding the specific oncology assets involved and the finer financial details.
Patent Disputes and Risks
The move to collaborate with Alteogen occurs despite a burgeoning patent dispute concerning ALT-B4. Halozyme has indicated it may take legal action against Merck & Co. over its subcutaneous formulation of Keytruda, a prominent cancer drug that leverages Alteogen’s technology. Halozyme contends that the use of ALT-B4 in commercial applications would infringe upon its modified hyaluronidase (Mdase) patent portfolio. Merck is aiming for an upcoming product launch of the new Keytruda formulation in the United States, pending approval from the FDA.
Halozyme has reportedly reached out to Merck to negotiate a potential licensing agreement but has signaled readiness to initiate legal action to prevent the sale of subcutaneous Keytruda if necessary. In response to inquiries about a similar patent dispute affecting AstraZeneca’s collaboration with Alteogen, a spokesperson for AstraZeneca refrained from commenting on third-party patent matters, expressing enthusiasm for the partnership with Alteogen.
Other Collaborations and Market Context
In addition to AstraZeneca, Alteogen has collaborated with Daiichi Sankyo to create a subcutaneous version of the Japanese pharmaceutical’s antibody-drug conjugate Enhertu, which is also under a partnership with AstraZeneca. While Daiichi declined to comment on how the ongoing Merck case might influence its agreements with Alteogen, Halozyme CEO Helen Torley emphasized the company’s intent to establish licensing agreements for any firm utilizing their intellectual property for subcutaneous drug delivery.
Intellectual Property Landscape
In light of the mounting questions surrounding Merck’s patent strategies, Alteogen has highlighted its confidence in ALT-B4’s patent validity, asserting that it has undergone rigorous analysis by the company and its licensing partners via multiple patent law firms. Although patent protection for ALT-B4 extends until 2040, Halozyme’s Mdase patents are set to remain in effect until 2034 in the U.S. This situation presents a notable contrast to Halozyme’s Enhanze technology approach, which supplies partners with a particular hyaluronidase protein, while Mdase encompasses a wider patent group.
Expert Insights and Predictions
Industry analyst Umer Raffat from Evercore ISI has speculated that Merck and Halozyme may eventually settle the dispute, given the complexity of patent claims involved. He believes that the U.S. Patent and Trademark Office may not grant Merck’s requests due to the lack of novelty in the language of Halozyme’s patents. Raffat also pointed out potential vulnerabilities in Halozyme’s broad patent claims following a recent Supreme Court ruling that invalidated broader claims made by Amgen against Sanofi, suggesting that similar parameters could apply to Halozyme’s patent landscape.
This ongoing situation highlights the intricate interplay of innovation, patent protection, and its implications for pharmaceutical collaborations. As AstraZeneca forges ahead with Alteogen, the outcome of these patent disputes will be critical not only for Merck and Halozyme but also for other stakeholders in the biopharmaceutical landscape.
