A MUST READ

[RAY A]

I went to my oncoc office for my chemo on fri and my wife picked up a news paper and handed me this article. The few things that hit me was this drug almost didnt get this far due to lack of funding!!!! 2nd it took almost 20 years to develope. 82 billion can go to IRAQ but we cant get funding to fight cancer. This drug is a drug to be approve by the FDA NOW not two or three years from now.

CHECK OUT LINK,

http://www.philly.com/mld/inquirer/busi ... 881.htm?1c

Some people are having problems with this link so I printed the article below.

[Connie B]

HERE HERE my BROTHER!

In MHO, someone is making a LOT of $$$$$$$$$ off of sick people!! Look at all the money that goes to Breast Cancer, and yet they aren't any closer today for a cure then they were 10 + years ago. HUMMMMM! So SAD!!!!

[RAY A]

dont get me wrong. I WAS VERY EXCITED TO SEE THIS NEW CANCER TREATMENT.

[john]

Good article and I agree.

Another thing people must consider is that patients are needed for clinical

trials.

If patients don't enroll, then the drugs can not get approval.

[dave s]

Ray,

You are right to be concerned. Actually the problem is even deeper than it appears. The FDA is the controlling body over such things and rules with an iron fist. Although well intentioned, the evolution of things has produced some undesireable situations. Many major pharmaceutical companies have very close ties to the FDA and even volunteer senior personnel to "serve" in influential positions in the FDA. Conversely, FDA officials who are friendly to the major pharmaceutical companies very often get attractive job offers from those same companies. I'm not comfortable casting aspersions, but clearly there are many potential conflicts of interest in such circumstances. If you look at the P&L of the major pharmaceuticals by product line and strip away the amortization of development expense you begin to see the enormous profit of current approved cancer treatments.

The approval process required by the FDA is necessarily VERY EXPENSIVE. This means several crucial things:

1. Funding must be provided by someone. Who can make enough money from a successful result to pay off the expenses and still generate a profit?

2. Any potential treatment therapy which lacks the potential to generate huge future profits can NOT ever make it through the approval process.

3. It is possible for a desireable treatment to be suppressed by a company who purchases the protected rights to it and fears it may undermine the sale of highly profitable current product (like chemo at nearly $10,000 a treatment?).

4. If a common "unpatentable" substance could cure cancer and have no side effects, no one would/could sponsor it to the extent required to get FDA approval (hundreds of millions $?).

I know these are chilling thoughts but I'm afraid they may be valid. I'm not in a postion to prove or disprove the above but I have encountered these facts/opinions from folks who are in a postion to know.

I don't know what the answers to these potential problems are. Perhaps each of us needs to consider the possibility that traditional FDA approved treatments may not encompass the entire universe of options for us.

May we all have the wisdom to choose wisely,

Dave S

[Hebbie]

I can't seem to open the article -- it says I have to register?

[Donna G]

It brought me to a site that said I needed to register. Donna G

[RAY A]

Here is the article for those who couldnt get in to read it...

Posted on Fri, Apr. 30, 2004

Anticancer drug, created at Penn, nears approval

The drug, made by Genta, could bring tens of millions a year in royalties for the school. An FDA hearing is set for Monday.

By Karl Stark

Inquirer Staff Writer

An anticancer drug close to FDA approval has shown promising results against a broad range of cancers and could reap tens of millions a year in royalties for the University of Pennsylvania, where the compound was created more than a decade ago.

Penn officials said such a return could represent the university's biggest monetary success since it started its medical-technology transfer office in 1986.

The jury is still out on the true value of Genasense, which faces many tests. But the drug made by Genta Inc. of Berkeley Heights, N.J., seems widely effective and relatively nontoxic. Those factors mean that it will likely be tried on many forms of cancer, according to several oncologists with no ties to the drugmaker.

The U.S. Food and Drug Administration granted the drug a priority review in February for the sickest patients with melanoma, or skin cancer, a move that compels the agency to make a decision on Genasense within the next month. A hearing on the drug before an FDA advisory board is scheduled for Monday.

Genta's big pharma-marketing partner, Aventis S.A., estimates that the drug could reach $2.3 billion a year in sales.

Investors have taken note. Genta's stock, even with a decline yesterday of $1.13 to $14.43 in Nasdaq trading, is up sharply over the last month from less than $10 a share.

Genta, with 150 employees, is a tiny biotech company with one FDA-approved drug, Ganite, for cancer-related hypercalcemia, or excess calcium in the blood. The company posted revenue of $1.7 million in the first quarter and lost $12.5 million.

But Genasense could change that. Aventis has agreed to pay up to $477 million to Genta for the right to sell the drug. Genasense is a potential blockbuster, in part because it appears to disrupt the chemistry of many cancers. The company is testing the compound in more than 20 trials, from blood-borne cancers such as chronic lymphocytic leukemia to lung and prostate cancers.

Because the discoverer, John C. Reed, was a former Penn medical professor, the university was able to license the technology to Genta and has already received $1 million as the drug has reached regulatory milestones, public records show. The university stands to gain an additional $1.5 million if the FDA approves the drug.

But Penn's royalties could surge to tens of millions of dollars a year if the drug meets sales expectations, said Louis P. Berneman, managing director for Penn's Center for Technology Transfer.

"We've had some good ones. This will be the largest [return] by far," said Berneman, whose office seeks to license the university's lab advances to industry.

Berneman declined to reveal the university's exact stake. Neither would the National Institutes of Health, which also owns a piece of the discovery.

Berneman stressed that the money, while much needed, pales beside the potential advance in care.

Genasense works by making clever use of the cell's natural dying process. More than 50 billion normal cells commit orderly suicide each day in an adult. But a protein that regulates that process surges out of control in cancer cells, enabling them to live and grow dramatically. Genasense interrupts the protein's work, limiting its life-giving force and making cancer cells more vulnerable to chemotherapy and other treatments.

One downside is that Genasense is not the easiest drug to use. It breaks down easily and must be directly infused into the blood via a small, fanny-pack-size infusion pump, which patients wear on their waist.

The pump makes treatment "more complicated," said Takami Sato, a medical oncologist at Thomas Jefferson University Hospital, who oversaw the Genasense trial at that site, and has no other relationship with the company.

Patients suffered headache, congestion and fatigue similar to a mild cold, Sato said. But those side effects were far less than many cancer treatments, he noted.

Other experts were similarly upbeat. "The potential is quite large," said Mitchell Smith, director of the Lymphoma Service at Fox Chase Cancer Center, who has received no money from the company, but plans to test the drug soon with another therapy.

Genasense was created by Reed when he was an assistant professor at Penn from 1989 to 1992. His research was guided by Penn professor and legendary genetics researcher Peter C. Nowell and built on successes by the Wistar Institute lab of Carlo Croce, a prominent cancer researcher now at Jefferson.

This week, Croce called the drug "an important first step" and said its success could legitimize the technology that produced Genasense and lead to a lot of similar compounds.

Of Reed, Croce said: "I know a lot of driven people. He's probably the most driven."

Reed needed every bit of persistence on Genasense. His experience underscores how long drug development can be. A compound typically can take 15 to 20 years to travel from the research lab to the clinic, and Genasense was no exception.

Even now, with his drug poised for approval, Reed, chief executive of the Burnham Institute, a prestigious medical research center in San Diego, politely declines to declare victory. "I haven't counted my chickens yet," he said, pointing out that the FDA may yet demand more proof.

"This is a drug that almost didn't happen, because there were so many times along the way either I couldn't get research funding or the deal didn't get done or the biotech company ran out of money," Reed said.

Genasense might never have emerged from a Penn lab without the personal intervention of William N. Kelley, then dean of Penn's School of Medicine, who masterminded the university's massive research growth in the 1990s.

Reed said Genta was eager to license the drug in the early 1990s, but he could not get the attention of the university's technology transfer office, which was repeatedly losing key executives to the pharmaceutical industry.

Reed said he rushed past Kelley's assistant and barged into his office, saying, "Bill, we've got to do something. The company wants to give us a quarter of a million dollars, and they're going to walk away."

Kelley calmly replied, "I'll take care of it," Reed recalled. "And two weeks later, we had a deal."

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[Donna G]

Thanks for the info, went to the web and they are really talking about this.

http://www.genta.com/Genta/Products/pro ... sense.html

http://www.genta.com/Genta/InvestorRela ... 30408.html

Again thanks Donna G