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
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Alliance wins patent interference ruling against Nycomed, September 20, 2001
Alliance closes in on Imavist clearance, August 20, 2001
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