Introgen Hints at Suit against Benda/SiBiono

by Richard Daverman, PhD
ChinaBio Today



IP for Cancer Gene Therapy at Issue

A Washington Post article, published today, looked at US cancer patients who are traveling to China to receive Gendicine, the gene therapy for cancer that is produced by Shenzhen SiBiono GeneTech in China, a company that is majority owned by Benda Pharma (BPMA) (see story).

Although the interviewed patients are happy with their treatments - which they must pay for themselves - they are angry that the same medications are not available in the US. The costs run about $20,000 for a two-month period of treatment, and not being FDA-approved, this money must be paid out-of-pocket.

As an example, the Washington Post looked at the example of Houston businessman, Richard Weissenborn, who suffers from squamous cell cancer of the head and neck. He maintains that he has already outlived the norm for a person with his diagnosis, claiming that he “would be dead already,” if it weren’t for Gendicine.

But the article structured the story around the argument that the treatments are yet another example of China ignoring the legitimate intellectual property rights of Western enterprises. In this case, according to the article, the aggrieved company is Introgen (INGN) of Austin, Texas, which has been working for 15 years to bring a similar drug to market.

According to the Washington Post, Introgen holds 258 patents worldwide, 4 of them in China, which cover the intellectual property of its gene therapy drug, Advexin, and the Post alleges that SiBiono GeneTech has infringed these patents.

Further, the article charges that Gendicine was approved in a hurry-up process that could not have fully assessed the dangers or advantages of Gendicine.

Peng Zhaohui, founder of SiBiono GeneTech, responded that he developed Gendicine from published materials and that it does not violate any patents. The only similarity between Gendicine and Advexin, in his words, is that they both target the p53 gene. The p53 gene is supposed to induce cell death when cells begin over-multiplying. In many cancers, p53 gets turned off, and tumors result.

Gene therapy is an attempt to replace defective genes with healthy ones. It was once considered the wave of the future for drug development, but the first gene therapy trials caused horrible side-effects. A patient in the US died and three patients in France were diagnosed with a leukemia-like disease, all cases that seemingly resulted from the drug. Those side-effects cast a pall over the entire field, and drug companies began looking at other models to attack cancer.

So far, Introgen has not filed any patent infringement suits against SiBiono, but the CEO of Introgen, David Nance, refused to describe any of its patents, because he might muddy up the case if the company chooses to do so at a later date.

Introgen, meanwhile, recently announced positive Phase II results for Advexin, though they were not overwhelming. The drug was given to 112 patients with recurrent head and neck cancers. In the patients who responded with a 50% or greater reduction in the size of their tumors, the median survival shot up to 41 months, against a normally expected six months (caution: this was not a double-blind test and the Advexin results are compared to a historical norm). But the patients who had this response constituted only 6% of the population.

In all, 41% of the patients experienced at least a 10% reduction in their tumor size, though more than half of these were in the lowest group, which was a reduction between 10% and 24%. Even these, however, had an improved median survival of 10 months.

So far, SiBiono Genetech has administered its drug to more than 5,000 people. Both Nance and Peng say that their respective drugs are helpful, but they are not the magic bullet long sought to fight cancer.

Still, both drugs could find a profitable niche if they can extend survival. An IP case, however, over a drug is a notoriously difficult call. Probably Introgen won’t start the contentious process until it knows what it has.



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ChinaBio Today is a regular contributor to BioHealth Investor
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