Halozyme Therapeutics [NASDAQ: HALO]
Revolutionizing Drug Delivery for a Better Future

For many cancer patients, a visit to the clinic has traditionally meant hours tethered to an IV line, waiting as life-saving medications slowly drip into their veins.

But what if, through technology, this can be changed?

Imagine patients receive their treatments and leave within minutes to reclaim their day to spend more time with their loved ones, pursue personal interests or simply rest and recover in the comfort of home.

Making this possible is Halozyme Therapeutics’ ENHANZE drug delivery technology. Based on its proprietary rHuPH20 enzyme, which transforms the way medications are administered by enabling rapid, highvolume delivery through a simple injection under the skin.

For decades, traditional intravenous (IV) infusions have been the norm for administering critical treatments because they allow precise control over dosage and ensure that medications are delivered directly into the bloodstream. But this process is far from patient friendly. Hours spent in infusion centers can take an emotional toll, disrupt daily life and expose patients to the risk of complications.

ENHANZE is a game-changer, converting these lengthy IV infusions into quick subcutaneous (SC) injections that take as little as five minutes. This dramatically improves the patient experience, bringing greater comfort, freedom and a sense of normalcy throughout their treatment journey.

Halozyme’s technology marks a pivotal shift in healthcare, offering a faster, more convenient and potentially safer alternative to traditional drug delivery methods.

But ENHANZE’s impact goes beyond convenience. The rHuPH20 enzyme ensures that patients receive their full dose of medication quickly and effectively, optimizing the therapeutic process. This advancement holds tremendous potential for treating not only cancer but also neurodegenerative and infectious diseases, where efficient drug delivery can significantly affect outcomes.

Halozyme’s technology marks a pivotal shift in healthcare, offering a faster, more convenient and potentially safer alternative to traditional drug delivery methods. For example, clinical studies have shown that patients can save up to three hours per treatment session compared to IV infusions, significantly enhancing their quality of life. It’s not just about innovation—it’s about redefining what’s possible for patients and opening new frontiers in treating a wide range of diseases.

Treatment Made Easier, The ENHANZE Solution

ENHANZE offers several advantages beyond patient comfort. By converting IV therapies to SC administration, it simplifies treatment regimens and reduces the burden on patients.

This technology also unlocks new possibilities for SC drug delivery, enabling the administration of large volumes of medication in a single injection. For instance, with ENHANZE, patients requiring immunoglobulin (IgG) therapy can receive up to 1200 mL in a single SC infusion, potentially extending the dosing interval to once every three or four weeks.

Studies have shown a remarkable 3- to 5-fold reduction in infusion-related reactions when medications like daratumumab, IgG, and pertuzumab/trastuzumab are administered subcutaneously with ENHANZE.

And it’s not just about the clinical benefits—patients overwhelmingly prefer SC administration with ENHANZE. In clinical trials, most patients receiving treatments of these medications favored the subcutaneous approach over traditional IV infusions.

This technology also offers the unique advantage of combining two therapies into a single injection, further simplifying treatment regimens and enhancing patient compliance. Additionally, it can increase the bioavailability of certain drugs. On average, a 10 percent higher bioavailability is observed for antibodies co-administered subcutaneously with ENHANZE compared to SC administration alone. This means patients receive more of the active drug, potentially leading to improved treatment outcomes.

Elevate Your Drug Development with ENHANZE

Backed by over 20 years of experience, Halozyme provides a robust framework for success in drug development. It offers comprehensive support to its partners, streamlining the path to market. This includes expertise in key areas like chemistry, manufacturing and controls (CMC), regulatory affairs and clinical development.

The ENHANZE development timeline is designed for efficiency and collaboration. It begins with a project initiation phase, during which compatibility assessments and stability studies are conducted. Halozyme provides crucial support in pharmacokinetic and pharmacodynamic (PK/PD) modeling, which informs clinical trial design and optimizes dosing strategies.

In Phase 1, partners can leverage ENHANZE Drug Product (EDP) for a simplified “mix-and-deliver” approach, eliminating the need for immediate co-formulation. This approach allows for early assessment without the need for immediate co-formulation, simplifying the process. Halozyme also provides comprehensive resources, including pharmacy manuals and administration instructions, to support clinical sites. In parallel, co-formulation development is initiated to prepare for later-stage trials.

The approach for Phases 2 and 3 is tailored to the specific program. New programs typically follow a traditional clinical development path. However, for late-stage or commercial programs, an abbreviated Phase 3 trial focused on PK noninferiority may be sufficient. This flexibility can significantly expedite the development process.

Halozyme’s support extends to regulatory submissions as well. With established Module 3 CMC documents, pre-approved dossiers and relevant regulatory filings, Halozyme facilitates a smoother regulatory process. Dedicated subject matter experts are available to address any regulatory inquiries and provide guidance based on extensive experience with global health authorities.

Even after approval, Halozyme continues to provide ongoing support, including annual updates to the rHuPH20 Investigator’s Brochure and routine immunogenicity screening. This commitment to long-term partnership ensures the continued success and safety of ENHANZE-enabled therapies.

The Halozyme Difference, Values-Driven Teamwork

Beyond its technological prowess and streamlined development framework, Halozyme’s success is deeply rooted in its core values. These values serve as guiding principles, uniting the team and driving their relentless pursuit of improving patient experiences and outcomes.

At Halozyme, the team is paramount. They foster a culture of collaboration, mutual respect and open communication. Every team member’s opinion is valued, and contributions are recognized and rewarded. This emphasis on teamwork creates a supportive and empowering environment where everyone works together towards common goals.

Central to Halozyme’s values is its focus on patients. It is committed to developing safe and effective therapies that not only treat diseases but also enhance the patient experience. This patient-centric approach drives it to collaborate closely with partners, ensuring that products are designed with the patient’s well-being and comfort in mind.

Integrity and ethical conduct are at the heart of everything Halozyme does. It upholds the highest standards in its work and relationships, taking pride in the quality of the products and the contributions to society. This commitment to doing the right thing underscores the company’s dedication to responsible development and the advancement of human welfare.

Empowerment and accountability are key values that drive Halozyme’s success. Every team member is encouraged to make informed decisions, set priorities and meet goals. It embraces flexibility and adaptability, working together to overcome challenges and fulfill commitments to patients, partners and shareholders.

Finally, innovation is woven into the fabric of Halozyme’s culture. The company constantly seeks creative solutions, improves processes, and strives for efficiency without compromising quality. This spirit of innovation fuels its ongoing quest to transform healthcare and make a lasting impact on patients’ lives.

Leading the Way to a Better Future

Halozyme Therapeutics is more than just a biotechnology company; it’s a pioneer in the field of drug delivery, driven by a passion for innovation and a commitment to improving patients’ lives. With its groundbreaking ENHANZE technology, Halozyme is transforming how we approach treatment, making it faster, more convenient and more effective for people worldwide.

By fostering a culture of collaboration, integrity and scientific excellence, Halozyme has built a strong foundation for continued success. Its dedication to patient-centric values and pursuit of innovation position it as a leader in the healthcare industry.

As it continues to push the boundaries of drug delivery, Halozyme Therapeutics is shaping a brighter future for patients and paving the way for a new era of healthcare.