Boston Scientific has announced that it has entered into a definitive agreement to acquire Augmenix, a privately-held company which has developed and commercialised the SpaceOAR system, a therapy used to reduce common and debilitating side effects that men may experience after receiving prostate cancer radiotherapy. The transaction consists of an upfront cash payment of US$500 million, and up to US$100 million for reaching sales-based milestones.
Each year, more than 1.1 million men are diagnosed with prostate cancer worldwide and approximately 400,000 men will undergo prostate radiotherapy. One of the most common complications of treatment is rectal radiation injury, due to the rectum’s proximity to the prostate and the resulting high doses of inadvertent radiation exposure. Prior to radiation therapy, the SpaceOAR hydrogel is injected to create additional space between the rectum and prostate during treatment, thereby reducing rectal radiation dose and associated side effects.
The SpaceOAR hydrogel is CE marked, cleared by the FDA, and has been used in more than 30,000 patients worldwide. As a result of commercial adoption, expanded US reimbursement and a total addressable market valued at US$750 million, product sales are estimated to reach US$50 million in 2018, and approach US$90 million in 2019.
“The acquisition furthers our category leadership strategy in urology and the SpaceOAR hydrogel is a crucial addition to our growing prostate health treatment portfolio of products that improve the quality of life and clinical outcomes for men with prostate cancer and benign prostatic hyperplasia,” says Dave Pierce, president, MedSurg, Boston Scientific. “The injection of this hydrogel during a minimally-invasive, in-office procedure can reduce the unwanted and unintended side effects of prostate radiation and provide substantial peace of mind for patients and their treating physicians.”
Clinical trials in Europe and the USA have demonstrated that the space created by the hydrogel significantly reduces the amount of radiation delivered to the rectum. Additionally, the randomised SpaceOAR hydrogel US clinical trial demonstrated that patients who received the hydrogel spacer reported significantly less rectal pain during prostate radiotherapy and had significantly less severe long-term rectal complications, including zero incidence of grade 2 rectal toxicity versus a 5.7% rate experienced by patients without the spacer.
A single injection of the SpaceOAR hydrogel is designed to maintain the space between the rectum and prostate for three months—within the duration of a standard radiation treatment schedule. The absorbable hydrogel is gradually reabsorbed by the body within six months of injection.
“We are proud of the clinical and commercial outcomes we have been able to achieve for SpaceOAR hydrogel thus far, and are excited to drive accelerated adoption leveraging Boston Scientific’s urology and pelvic health expertise,” says John Pedersen, chief executive officer, Augmenix. “The company also has the additional resources needed to further explore expansion of indication to other organs throughout the body that could benefit from space creation—such as gynaecological and pancreatic cancers.”
The transaction is expected to be immaterial to adjusted earnings per share in 2018 and 2019, accretive in 2020 and increasingly accretive thereafter. On a GAAP basis, the transaction is expected to be less accretive, or more dilutive as the case may be, due to amortization expense and acquisition-related net charges. The acquisition is projected to close early in the fourth quarter of 2018, subject to customary closing conditions.