A Medical Device Daily
Acusphere (Tewksbury, Massachusetts) reported a $1 million payment by Cephalon (Frazer, Pennsylvania), the cancellation of Cephalon's $15 million senior secured convertible note and the amendment of its March and November 2008 license agreements with Cephalon for the oncology applications of Acusphere's Hydrophobic Drug Delivery System (HDDS) technology and AI-525, an intravenous formulation of celecoxib.
Under the amended terms of the license agreements, Cephalon is no longer obligated to make a $15 million milestone payment or any royalty payments upon approval of AI-525 and Cephalon will assume primary responsibility for patent prosecution of licensed technology.
As a result of this transaction, Cephalon's pledge and security agreement, and registration rights agreement have also been terminated and Cephalon no longer has a security interest in any of Acusphere's assets.
Also as a result of this transaction, Cephalon no longer has any rights related to equity ownership in Acusphere nor any product rights to Imagify (perflubutane polymer microspheres) for injectable suspension, Acusphere's lead product candidate.
Acusphere now has global rights to Imagify, a perfusion stress echo imaging agent for detecting coronary artery disease, the leading cause of death in the U.S. Imagify is being developed to offer a low cost, radiation free alternative to the 7 million nuclear stress imaging procedures performed each year in the U.S.
The company is seeking a partner for the continued development of Imagify. Previously, the company reported that it received in February a complete response from the FDA to its New Drug Application for Imagify. FDA's response stated that additional clinical work demonstrating Imagify's performance relative to non-contrast ultrasound would be required before approval for marketing in the U.S.
The amount of time and funding required to complete the additional clinical work will depend on the design of the clinical program, which will be developed collaboratively with the potential partner and FDA. The cardiovascular and renal drugs advisory committee of the FDA rendered a lopsided vote of 16-1 against approvability for Imagify this past December (Medical Device Daily, Dec. 12, 2008)
After the $1 million payment from Cephalon, Accusphere said it has about $2.8 million in unaudited cash which it expects will fund operations to 4Q09 based on the current operating plan.
In other dealmaking news, Varian Medical Systems (Palo Alto, California) reported that it has acquired the assets of IKOEmed and IKOEtech (both Houston), privately-owned suppliers of software used in the planning of radiotherapy and radiosurgery treatments.
The acquisition enables Varian to offer hospitals and clinics an additional software tool to automate and accelerate the most time-consuming portion of the treatment planning process, the company said.
Varian is paying about $2.2 million plus an additional amount based on achievement of specified milestones to acquire the IKOE assets.
The software is designed to achieve greater than 50% reduction in the contouring portion of the radiotherapy treatment planning process, which typically takes anywhere from 30 minutes to 4 hours. It automates the contouring process by matching patient images with pre-contoured images from an expert database created by renowned radiation oncologists. This eliminates the need for clinicians to manually outline between 10 and 20 organs in each of anywhere from 100 to 200 images of a patient's disease site.
"This is another important step in our ongoing initiative to make cancer treatments better, faster, easier, and more cost-effective," said Tim Guertin, president/CEO of Varian. "This new tool should save a lot of time in planning for complex cases, particularly in cancers of the head and neck and lymph systems."
The IKOE software, which has FDA 510(k) clearance, complements Varian's existing segmentation tools currently used to automate planning for prostate, breast, and lung treatments, the company said.
Varian will sell the software initially in the U.S. as a standalone product that will work with most radiotherapy treatment planning software products in the industry. The company plans to integrate it with its Eclipse treatment planning software for radiotherapy, radiosurgery, and brachytherapy.
Four IKOE employees and consultants are being offered jobs with Varian to support the product at Varian facilities in the U.S.