According to Datamonitor, market share among pharmaceutical products is shifting from oral therapeutics to injectibles due to such factors as therapeutic focus, molecule type and lifecycle stage. Drug delivery platforms have always played an important role in drug development. With this shift, Halozyme’s (HALO) technology becomes of special interest for its ability to improve the performance of injectable drugs.
The market is shifting toward injectibles due to pharmaceutical companies’ embrace of biologic medicines. This umbrella term includes recombinant proteins, antibodies, and vaccines, often treating diseases that are beyond the reach of typical small molecule drugs. Because biologics are comprised of large, complex molecules, they cannot be taken orally and instead requires direct injection.
The complexity of biologics has been a boon for the biopharmaceutical industry, allowing premium pricing and holding back generic competition. Patients have gained enormously as well from these advanced drugs. Yet the route of administration has always been a drawback. Technologies such as PEGylation were invented to increase the stability of biologic drugs, reducing the number of necessary injections.
Halozyme has a novel approach to drug delivery, focusing on converting intravenously (IV) injected drugs to more patient-friendly, subcutaneous (SC) administration. Not only will this improve patient compliance, the company believes it may enhance pharmacokinetics and boost efficacy. New formulations created with their technology also has the benefit of extending product lifecycles.
The technology is based on Pegylated recombinant human hyaluronidase enzyme, rHuPH20, which temporarily degrades hyaluronan, a ubiquitous carbohydrate polymer that is part of the extracellular matrix, skin, and cartilage. When rHuPH20 is co-injected subcutaneously with a large molecule drug, the enzyme degrades this matrix, allowing the drug to disperse under the skin. So instead of administration via a 30 minute IV, patients require only a 5 minute subcutaneous injection.
One of the most advanced products in the company’s pipeline is Herceptin SC, a subcutaneous formulation of Roche’s (OTC:RHHBY) breast cancer drug enabled by rHuPH20- Enhanze technology. It entered a Phase III non-inferiority trial of 595 patients with early stage HER2-positive breast cancer comparing Herceptin administered IV or SC. Data is expected at the end of this year. Roche is confident enough to have invested about $175 million in a manufacturing facility for a hand-held injection device.
Blockbuster Rituxan and an undisclosed target are in Phase I testing using Enhanze. Two additional targets have also been selected out of a potential total of eight.
Halozyme is also using Enhanze in its own pipeline. For its Ultrafast Insulin, a 22 patient Phase II study in Type 1 diabetes compared Humalog (fast acting insulin lispro) with Humalog coadministered with rHuPH20. Results showed coadministered with rHuPH20 was advantageous. While the total exposure remained the same, the highest serum level increased by 41% and was reached 19 minutes faster. Dropoff in exposure was significantly faster as well, mimicking a more physiological profile. The company plans on testing its technology in a Phase II study with Type 2 Diabetes patients.
Enhanze is an enabling technology with the ability to be combined with most biologics, including monoclonal antibodies, cytokines, recombinant enzymes, other proteins and peptides. It should see plenty of use as the biologics market continues to grow.
Disclosure: I am long RHHBY.PK.
Disclosure: I am long RHHBY.PK.