Roche invests in production of new Herceptin formulation
pharmafile | January 25, 2010 | News story | Manufacturing and Production, Research and Development |Â Â Herceptin, RocheÂ
Roche will spend 190 million Swiss francs ($183m) to put production capacity in place for a new self-administered formulation of its blockbuster breast cancer treatment Herceptin.
The investment will be made at the pharmaceutical company’s production sites in Kaiseraugst, Switzerland, and Mannheim, Germany, with production lines installed to make a new version that can be delivered subcutaneously.
At the moment Herceptin (trastuzumab) has to be given via a one-hour infusion that has to be administered in hospital. A subcutaneous injection means that patients could receive a shot in the doctor’s office or administer the drug themselves at home, a significant consideration given that a course of treatment can last as long as 12 months.
The subcutaneous formulation will also require just five minutes to administer, compared to 60 minutes for the current version.
Roche is hoping that the new formulation will provide a defence for its $4.8 billion Herceptin franchise against competition from other drugs which work via the same mechanism of blocking the HER2 or ErbB2 protein, notably GlaxoSmithKline’s orally-active Tykerb/Tyverb (lapatinib), which was approved for use in metastatic breast cancer in 2007.
The new product uses a delivery technology developed by Halozyme Therapeutics called Enhanze, which allows larger volumes of medicines to be injected under the skin. The delivery system works by breaking down hyaluronic acid, a constituent of connective tissue, and helps injected drugs disperse and be absorbed.
The production line at Kaiseraugst will make quantities of the new Herceptin formulation for testing in clinical trials and initial marketing, while an automated line in Mannheim will handle full-scale, commercial production.
Roche has already started a phase III trial that will compare the new formulation to intravenous Herceptin in 552 breast cancer patients who will be treated every three weeks over the course of 12 months.
At the time the trial started back in October 2009, Roche’s global head of pharma development Jean-Jacques Garaud said: “Subcutaneous Herceptin could give women more time out of hospital while dramatically reducing the risk of their cancer coming back.”
In addition, offering Herceptin treatment outside of the hospital setting could reduce costs and potentially improve the use of hospital resources.
Subcutaneous Herceptin would come in a ready-to-use administration device instead of an infusion-bag that needs to be prepared by a pharmacist.
Analysts at Datamonitor said that the new formulation could also help defend Herceptin from future competition from biosimilar versions of the antibody. However, they also pointed out that the subcutaneous formulation is not a sure-fire success, even if it passes through development successfully.
Potential obstacles include a possible reluctance by physicians to switch to the subcutaneous version as it will make it harder for them to monitor compliance, while in the US there are financial incentives for doctors to prescribe intravenous drugs.
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