A Medical Device Daily

Advanced Magnetics (Cambridge) reported that a lawsuit has been filed against it by Cytogen (Princeton, New Jersey) in Massachusetts Superior Court.

The complaint includes claims of breach of contract, breach of implied covenant of good faith and fair dealing, fraudulent misrepresentation and unjust enrichment related to a license and marketing agreement entered into in August 2000 in which Advanced Magnetics granted Cytogen certain rights to Combidex and to ferumoxytol for oncology imaging applications.

Advanced Magnetics said that the lawsuit “has no merit“ and that it will conduct a vigorous defense against the claims. It said also that the litigation will not “materially distract“ it from bringing both ferumoxytol “as an intravenous iron replacement therapeutic and Combidex as an MRI contrast agent to market.“

Both companies were hurt last year as a result of an FDA panel vote recommending against the approval of Combidex. That thumbs-down damaged shares of Advanced Magnetics by two-thirds and halved the stock of Cytogen.

The agency's Oncologic Drugs Advisory Committee cited insufficient clinical data for the product and voted 15-4 against supporting a broad indication for Combidex.

Cytogen had been drawing up plans to market the diagnostic product according to its agreement with Advanced Magnetics.

A final FDA decision on Combidex is expected this quarter.

The two companies in 2000 had made plans to merge, but they then scrapped that deal and formed the marketing, license and supply agreement for Advanced Magnetics' imaging agents instead (Medical Device Daily, Aug. 31, 2000).

Advanced Magnetics develops superparamagnetic iron oxide nanoparticles used in pharmaceutical products and imaging agents to aid in the diagnosis of cardiovascular disease and cancer.

In other legalities, the creator of allegedly false and misleading advertising for Gero Vita International's dietary supplements has settled Federal Trade Commission charges.

Chase Revel is required to post a $1 million performance bond before advertising, marketing or selling any food, drug, dietary supplement, device, or health-related service. As part of the settlement, he also will pay $27,500 for consumer redress.

In its complaint, the FTC alleged that seven corporations, A. Glenn Braswell, Revel, and three other individuals deceptively marketed five of their dietary supplements, primarily through direct mail advertising, including the Journal of Longevity, a direct mail ad that purported to be a health information magazine.

The challenged products included: Lung Support Formula, a dietary supplement that purportedly cured nearly all breathing and respiratory problems, including asthma, emphysema and smoking-related damage; Antibetic Pancreas Tonic, an herbal supplement that purportedly treated or cured both Type 1 and Type 2 diabetes; G.H.3, also known as Theraceuticals GH3 Romanian Youth Formula, marketed as an anti-aging product that could reverse and prevent Alzheimer's disease and other forms of dementia; Chitoplex, a chitosan-based weight-loss product that purportedly enabled users to lose weight without diet or exercise; and Testerex, a yohimbe product touted as effective in treating impotence and erectile dysfunction.

Revel will pay $27,500 for consumer redress. If it is found that he misrepresented his financial status, he will be responsible for the full judgment amount of $1 million.

Revel also was the subject of a 1994 stipulated order with the FTC involving the advertising and marketing of pinhole eyeglasses.

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