Early next month, thousands of people will head to Chicago for the annual American Society of Clinical Oncology Meeting to hear pharma companies present updates and new data on their cancer drugs.
This year, perhaps more than ever, companies are feeling the pressure to make a case for the value of their therapies. Public furor over high drug prices coupled with a payer environment that is moving towards value-based pricing has only upped the ante. Increasingly in marketing, patient experience is also being factored into that value equation.
While a drug’s value is first built in the lab, a wide network of other companies throughout the drug development process can expand on that initial value. San Diego-based Halozyme has built its two-tiered business model on that kind of collaboration.
Aimed at the patient experience
Improving dosing and drug administration method can have a considerable impact on patient experience. Towards that end, Halozyme has worked with other companies to improve the administration profile of their drugs using an enzyme-based therapy called rHuPh20.
Marketed as “Enhanze,” rHuPh20 (or recombinant human hyaluronidase) works by temporarily degrading hyaluronan, a chain of natural sugars in the body, to aid in the dispersion and absorption of other injected drugs.
Big names in both oncology and immunology, such as Roche, Eli Lilly, AbbVie, and Janssen, have all partnered with Halozyme, spurring steady revenue growth for the company over the past three years.
Each company licenses the enzyme therapy from Halozyme to combine with their own drug, creating a slightly modified and, ideally, easier-to-take drug.
Using the Enhanze platform, companies can transition intravenous therapies to subcutaneous, or under-the-skin, administration and reduce the number of injections a patient needs for a given therapy. Additionally, large volumes of biologics can be delivered subcutaneously (SC) when coupled with Enhanze, thereby reducing the time need to administer a drug.
In other words, it can make the administration of a wide range of cancer therapies less taxing and invasive. “On a practical level if you’re a cancer patient and have to go to the hospital for multiple infusions, the option to get subcutaneous treatments makes life easier,” said Halozyme CEO Helen Torley.
“Companies want to use the platform to improve the patient experience, by giving them a treatment option that does not require IV injections, or requires fewer SC injections,” Torley explained.
Additionally, the pathway to approval for the slightly modified drug is relatively straightforward, predicated on showing equivalence and non-inferiority. In some cases, if the combined product has some benefit which was previously unrecognized, that can help the company seek a patent extension on their drug.
Big companies and big proteins
Swiss pharma giant Roche has had a partnership with Halozyme in place since 2006, using Enhanze to improve the profile of its drugs. A few years ago, Roche won EU approval for an SC version of its major cancer drug Herceptin (trastuzumab) as well as for its blood cancer and arthritis treatment Mabthera (rituximab).
Herceptin SC, which showed comparable efficacy in clinical trials and non-inferior plasma levels of trastuzumab, allows women to receive an SC treatment in two to five minutes, rather than the standard 30- to 90-minute IV treatment.
Roche was also able to secure a patent extension for Herceptin in the EU market because of the SC treatment option. Three years’ post-approval, almost 50,000 women per year in Europe with breast cancer are treated with Hercpetin SC.
Baxalta, on the other hand, used the platform to develop Hyqvia, an FDA-approved injection for treatment of primary immunodeficiency. With Enhanze, Baxalta designed the drug to decrease the volume of fluid used during treatment
From a marketing perspective, Baxalta emphasizes the ability to have just one visit, one time per month, for less than three hours. This is a major step up from the intramuscular injections that were the norm until the 1980’s when IV immunoglobulin (IVIG) was introduced. But IVIG has many downsides: It requires numerous dosing sessions per month, and adversely affects many patients who find the systemic effects of IV administration of immunoglobulin intolerable.
“Hyqvia requires large volumes of fluid,” said Torley. “Standard treatment requires 12 to 20 SC treatments, while the combined treatment can be completed in a single setting.”
A number of other major companies are also in early development to improve the administration profile of their drugs using Halozyme’s platform.
By offering “add-on” value to existing drugs, Halozyme may be well-positioned to take advantage of growing interest from larger pharma companies in improving patient experiences. But it also gives companies a means to shore up patent exclusivity for their drugs – a sometimes double-edged sword for patients.
Breaking down the barrier between the tumor and therapy
Halozyme is also targeting hyaluronon in its own drug development efforts. Hyaluronon accumulates around cancer cells and can act as a physical barrier to therapy. Solid tumors, including pancreatic, breast and gastric tumors, have the highest accumulation of hyaluronon—one reason that those tumors are often resistant to treatment efforts.
Halozyme’s small pipeline of cancer drugs includes a pancreatic cancer drug (PEGPH20), and two preclinical candidates.
“We focused on cancers with very small clinical survival rates and started with pancreatic cancer, which has a 6% five-year survival rate,” Torley said.
PEGPH20, a pegylated form of rHuPH20, is designed to change the tumor microenvironment by eliminating the hyaluronon barrier surrounding the tumor before delivering chemotherapy. It has shown some early promising results in mid-stage trials, leading to a higher tumor response rate when added to standard treatment regimens.
Halozyme has already begun a phase 3 trial for PEGPH20. The study includes 420 patients with advanced pancreatic cancer and is designed to evaluate the efficacy of abraxane/gemcitabine, the standard of care versus abraxane/gemcitabine in combination with PEGPH20.