Alliance Pharmaceutical said today that the Food and Drug Administration has found its Imavist ultrasound contrast agent to be approvable. Final approval is dependent upon Alliance's submission of additional information primarily related to product labeling, according to the San Diego-based firm.
Alliance said it would reply to the FDA within the next several weeks, with information including patient subgroup analyses, a recently completed pharmacokinetic report, and an updated plan for post-approval product release testing. Imavist, co-developed with development partner Schering, can help patients with suboptimal echocardiograms by improving endocardial border delineation, according to Alliance. The firms expect to launch the product in the second quarter, pending final FDA clearance.
As Alliance nears final approval for Imavist, the vendor has formalized its distribution strategy. Berlin-based Schering has held worldwide marketing rights since September 1997, but the firms have modified the agreement. Alliance will now have exclusive marketing rights for cardiology applications in the U.S. for five years, with Schering receiving a royalty on product sales.
Schering retains marketing rights in the U.S. for other indications, and for all indications in the rest of the world, subject to Alliance's option to obtain additional indications and territories. At the end of five years, Schering would co-market the product under certain circumstances, according to the companies.
In addition, Alliance has signed a five-year, exclusive agreement with Cardinal Health, who will perform certain packaging, distribution, and sales services for Alliance under a fee-for-service arrangement. Cardinal Health will also extend a revolving line of credit (to be repaid from product revenues) to Alliance.
Alliance will manufacture Imavist and be responsible for additional clinical development to expand the agent's potential applications. The firm said it intends to pursue radiology applications, such as ultrasound imaging of the prostate and liver.
By AuntMinnie.com staff writersMarch 1, 2002
Related Reading
Alliance nets $15 million investment, December 3, 2001
Alliance completes reverse stock split, October 18, 2001
Alliance to launch prostate imaging study, October 8, 2001
Alliance wins patent interference ruling against Nycomed, September 20, 2001
Alliance closes in on Imavist clearance, August 20, 2001
Copyright © 2002 AuntMinnie.com
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&fit=crop&h=100&q=70&w=100)
![Examples of ultrasound findings and techniques. (A) Images in a 39-year-old male patient with a mass in the left thigh. The mass is heterogeneous on the B-mode US image (compared with the patient in D) and showed increased microvascularity (superb microvascular imaging [SMI]) and shear-wave elastography (SWE) values. Undifferentiated pleomorphic sarcoma was diagnosed at biopsy (with pleomorphic rhabdomyosarcoma in surgical specimen). (B) Images in an 18-year-old male patient with a mass in the left leg. The mass is hypoechoic on the B-mode image, with no other findings suggestive of malignancy. The lesion is in contact with the cortex of the tibia, which is slightly irregular. CT revealed a doubtful anteromedial tibial erosion. The microvascular study demonstrated high vascularization, suggestive of malignancy. Periosteal Ewing sarcoma was diagnosed with both histologic and immunohistochemical confirmation. (C) Images in a 69-year-old female patient with a lump growing on the outside of the left leg. Multiple SWE examinations were performed (please note the high values obtained in the measurements, whereas the color map highlights the stiffness relative to adjacent tissues). SMI showed areas of increased vascularization to target for sampling. Undifferentiated spindle cell sarcoma was diagnosed at biopsy, with residual leiomyosarcoma in the surgical specimen after neoadjuvant therapy. (D) Images in a 56-year-old female patient with a mass in the right thigh. The mass is heterogeneous at both B-mode ultrasound (similar to patient A) and MRI (coronal T2-weighted spectral attenuated inversion recovery [SPAIR]; T1-weighted pre-contrast and postcontrast imaging), which even shows uptake after the administration of paramagnetic contrast material, which is traditionally suggestive of malignancy. Low values at SMI and elastography are suggestive of benignity. Spindle cell lipoma was diagnosed at biopsy, with atypical spindle cell lipomatous tumor in the surgical specimen.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/08/images-radiol250278fig2.APCFLSvX6p.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
