Innovative drug delivery platforms

In 2010, there were nearly 50,000 new cases of breast cancer alone in the UK, and the situation is only set to get worse, with the cancer incidence rate in the country predicted to rise by 45% from 2007 to 2030.

“The NHS is being asked to care for the increasing population of cancer sufferers while making £20bn in efficiency savings.”

On top of this, the NHS is being asked to care for the increasing population of cancer sufferers while making £20bn in efficiency savings. Innovation is clearly required to maintain the same level of care cancer patients currently receive, but also provide crucial time and cost savings for healthcare professionals.

Enter ENHANZE™, an innovative drug delivery platform that has recently been trialled for cancer drugs Herceptin and MabThera, among other therapies. Not only can this technology save a significant amount of time, and therefore money, for healthcare providers; it is also less invasive and painful for patients, meaning widespread use of the platform could have a transformative impact on the standard of cancer care.

We met Kurt Gustafson, chief financial officer of Halozyme, the company behind the revolutionary ENHANZE™ platform, and Julian Cole, head of medical affairs (oncology) at Roche Products, where ENHANZE™ has recently been trialled, to find out more.

Elly Earls: Halozyme’s ENHANZE drug delivery platform could eliminate the need for intravenous delivery of some drugs. Can you explain how the technology works?

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Kurt Gustafson: Halozyme’s ENHANZE technology is a proprietary delivery platform using our patented hyaluronidase enzyme (rHuPH20). This enzyme temporarily degrades hyaluronan, a structural component of the subcutaneous space that is just beneath the surface of the skin.

This temporary degradation opens channels within the tissue to allow the drugs to be dispersed over a greater surface area and be absorbed faster. Our enzyme only works locally and the tissue is reconstituted quickly.

This technology can work with many different types of drugs, including monoclonal antibodies and other large therapeutic molecules, as well as small molecules and fluids.

EE: Roche has reported a positive study of Herceptin (a HER2+ breast cancer therapy) and MabThera (a therapy for non-Hodgkin’s Lymphoma [NHL]) given by subcutaneous injection through Halozyme’s ENHANZE drug delivery platform. Why did the company opt to go through this study, rather than staying with the original IV method of drug delivery?

Julian Cole: Herceptin and MabThera are currently administered intravenously, with the initial loading dose given over 90 minutes and several hours respectively, followed by subsequent infusions given over 30 minutes for Herceptin and 146 minutes for MabThera (in an average 1.8 m2 patient, dosed per the SPC).

“Innovation is clearly required to maintain the same level of care cancer patients currently receive.”

It is clear that if we were able to demonstrate pharmacokinetic non-inferiority through the trials for both Herceptin (HannaH)[ii] and MabThera (SABRINA) – which we have been able to do – while delivering the dose more speedily, it would benefit patients as they would have to spend less time in chemotherapy suites.

With a switch from IV to subcutaneous it is expected that healthcare professional (HCP) time, patient time occupying an IV chair and medical supplies usage would also be reduced, the savings of which could be reinvested in other patient care activities, or increase the number of patients being treated at the care unit.

EE: Having carried out these two studies, what has Roche found to be the advantages of subcutaneous drug delivery over IV for Herceptin and MabThera?

JC: The advantage of subcutaneous administration over IV is time saved for both the patient and the NHS; the patient doesn’t need to spend as long in hospital receiving their treatment while the NHS will be able to reduce administration times, freeing up valuable and significant time for the healthcare professionals.

Vitally, these advantages are gained without an impact on safety or efficacy. Furthermore, subcutaneous Herceptin and MabThera will be given as a fixed dose which will negate the necessity for hospital pharmacists to spend time calculating a patient’s weight as well as reducing wastage.

EE: Could the use of this technique save costs for the healthcare industry more generally? How so?

JC: If adopted by the NHS, subcutaneous use of Herceptin and MabThera has the potential to reduce the time it takes to administer these drugs, saving valuable time for healthcare professionals.

“This technology can work with many different types of drugs, including monoclonal antibodies and large therapeutic molecules.”

Reducing administration times for Herceptin from 30 minutes with standard infusion to about five minutes with subcutaneous represents significant time and resource savings.

To put that into context, we know that there were nearly 50,000 new cases of breast cancer in the UK in 2010. Of those new cases 15%- 25% could have HER2-positive breast cancer and are therefore potentially eligible for subcutaneous injection.

KG: Moreover, Roche demonstrated in their studies with MabThera that the infusion time was reduced to five to seven minutes for subcutaneous administration using rHuPH20 versus four to six hours with IV administration. This sort of time saving could reduce healthcare costs by avoiding long infusions and freeing up the infusion chairs for more people to receive therapy.

EE: What are the other advantages of subcutaneous drug delivery over IV?

KG: Most people think of the convenience factors offered by a subcutaneous injection, but there can be other benefits as well. For example, in some cases the IV has to be administered slowly to avoid infusion reactions. By administering the drug subcutaneously, we can potentially avoid some of these infusion reactions, as the drug is absorbed into the body at a slower pace through the subcutaneous tissue.

A subcutaneous injection also does not require venous access, which can be less invasive and less painful for the patient.

EE: How soon can we expect Herceptin and MabThera to be able to be administered by subcutaneous injection to the wider patient population?

JC: Roche is waiting to receive a license indication from the European Medicines Agency (EMA) for Herceptin subcutaneous, and we would expect to have the license sometime in the first half 2013.

“A subcutaneous injection also does not require venous access, which can be less invasive and less painful for the patient.”

NICE (England and Wales) is producing an evidence summary for Herceptin subcutaneous and its publication is planned for Jan 2013. SMC (Scotland) will conduct a health technology appraisal in due course.

When it comes to MabThera, Roche is planning to submit for an updated license for MabThera with the EMA to allow all eligible NHL patients to receive MabThera via subcutaneous injection.

We anticipate this process will be concluded during the second half of 2013.

EE: Finally, what can we expect next from the ENHANZE platform?

KG: Halozyme believes that the ENHANZE technology platform can be used across a broad and diverse set of therapeutic areas.

The heart of Halozyme’s mission is to use innovative science to discover and develop new treatments and then turn these novel discoveries into commercial therapies for the patients. We are very proud of the scientific breakthroughs that have brought us to this point and we look forward to the future breakthroughs that will carry us even further.

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