This Is MS Multiple Sclerosis Community: Knowledge & Support

Promising prescription: $5.5B market waiting as Pipex tests 2 drugs By Andrew Dietderich

June 25, 2007

An Ann Arbor-based company that’s moving to the American Stock Exchange today plans to tap at least two drug markets that could be worth a total of $5.5 billion annually, using drugs licensed from the University of Michigan and the University of California at Los Angeles.

Two weeks ago, Pipex Pharmaceuticals Inc. (Amex: PP) received $5 million from the National Multiple Sclerosis Society, the largest grant ever given by the organization.

Pipex has six drugs in its pipeline, but two are closest to going to market: Trimesta and Coprexa.

Trimesta is used to treat multiple sclerosis; and Coprexa is used to treat Wilson’s disease, which destroys the lungs.

Pipex was founded in Miami in 2001 by Steve Kanzer, the company’s chairman and CEO. A biotech investor, Kanzer moved Pipex to Michigan in 2004 to be nearer to the talent pool in Ann Arbor.

“Florida is working on its biotech industry. But there is so much more talent in Michigan, I decided to come here,” he said.

That’s not the only reason, though.

The compound for Coprexa is licensed from UM. Coprexa has been through two clinical trials and treats a disease called idiopathic pulmonary fibrosis — the technical name for Wilson’s disease, which kills about 128,000 people in the United States annually.

“The technology came out of the University of Michigan, so it really speaks to the kind of talent and money that is available in the Ann Arbor area,” said Tim Robinson, vice president of operations at Ann Arbor Spark, the economic development association for the Ann Arbor area.

Kanzer said there is no treatment for Wilson’s disease, and the potential market for the drug is $5 billion annually.

Pipex plans to file its application for approval for Trimesta in late 2009. The drug was discovered by a UCLA researcher who found that a specific hormone in the placenta of pregnant women with multiple sclerosis helped with remission of the disease and reduced lesions in the brain by 80 percent.

The drug, also licensed by Pipex, has completed phase II clinical trials.

Kanzer said the potential U.S. market for that drug is worth $500 million annually.

Pipex completed $13.9 million in private-equity financing in the fourth quarter and went public at the end of April.

Besides UM and UCLA, the company has agreements with McLean Hospital at Harvard University, the University of Southern California and Children’s Hospital-Boston.

Pipex recently completed a new lab in Ann Arbor. The company has 18 employees — four from Esperion Therapeutics Inc., including the co-founder and co-developer of Lipitor, Charles Bisgaier. He is Pipex president and a member of the board.

Pipex has a way to go when it comes to finances, though.

In the first three months of the year, the company reported a net loss of $2.8 million or 90 cents a share. It does research and development and didn’t have any revenue.

I was interested in this so I did a little bit of research and found that Trimesta is the estriol/Copaxone combo that is being studied by Dr. Voskhul at UCLA. There are other sites that are enrolling patients for this study. One location is Ohio State University, where I went when I was first diagnosed 5 years ago. I emailed the person who is in charge of signing up trial participants. She just emailed me back to tell me that I could not be considered for this trial because I already was on Copaxone. The criteria requires that you not be on any of the disease modifying drugs now.

But it is great to know that this study is moving along. I will be looking forward to hearing results as they become available. I know there are others on this board who also are interested in the hormone connection to MS.

If anyone does participate in this trial, would you keep us posted with how you are doing?

Lori

Pipex/Trimesta update...



Pipex Pharmaceuticals' Oral TRIMESTA Initiates Dosing in Phase II/III Clinical Trial for Multiple Sclerosis

16 Jul 2007 -- Pipex Pharmaceuticals announced today that it has initiated patient dosing of TRIMESTA (oral estriol), its proprietary therapy for multiple sclerosis, in a multi-center Phase II/III clinical trial for the treatment of women with relapsing-remitting MS

Pipex Pharmaceuticals a specialty pharmaceutical company developing innovative late-stage drug candidates for the treatment of neurologic and fibrotic diseases, announced today that it has initiated patient dosing of TRIMESTA (oral estriol), its proprietary therapy for multiple sclerosis (MS), in a multi-center Phase II/III clinical trial for the treatment of women with relapsing-remitting MS. This clinical trial has received a $5 million grant from the National Multiple Sclerosis Society (NMSS) in partnership with the National MS Society's Southern California chapter, with support from the National Institutes of Health (NIH).

Dr. Rhonda Voskuhl, professor of neurology at the University of California, Los Angeles and inventor of TRIMESTA, commented, "We are delighted to be enrolling so shortly after recently initiating the Phase II/III clinical trial."

Dr. Charles Bisgaier, Pipex's President, stated, "To our knowledge, this is the first gender-specific, oral, potentially disease-modifying agent that has entered later-stage clinical trials for the treatment of MS."

Dr. Bisgaier went onto say, "Given the convenience of an oral drug therapy, such as TRIMESTA, we have received a lot of positive patient interest in this study and hope to continue enrolling at this positive rate."

The Phase II/III clinical study is a double-blind, placebo-controlled trial that will take place at seven sites in the US and will enroll up to 150 female MS patients. Investigators will administer TRIMESTA along with COPAXONE, an FDA approved therapy for MS to women between the ages of 18-50 who have been recently diagnosed with relapsing-remitting MS.

http://www.pipelinereview.com/joomla/co ... 13215/109/

When this article came out in June, I emailed the university and asked why it was being trialled with Copaxone. This made no sense to me because it means that even if TRIMESTA works by itself, we won't know because of its trial with Copaxone.

The response I got back was that none of the patients would be put solely on TRIMESTA because the doctors didn't want patients to get worse without the Copaxone while in the study. I view this as a lot of baloney, but to each his own.

My guess is that Teva Pharmaceuticals is behind a lot of the trials money and it will benefit by being able to market their drug to more people.

TRIMESTA is being billed as an oral med, but that is no big deal if jabs are still necessary for the Copaxone.

The CRABS are jumping in bed with a lot of new drugs to make it a twosome and more profits.

gwa

If your objective is to help people with a disease (which is understood to be progressive) then how could you ethically, knowingly put a group of MS patients on a placebo. I can understand how the placebo arm of a trial is a necessity, but at the same time, if
I was setting up this trial I wouldn't be able to handle the guilt of having patients on nothing at all.

Patients are put on placebos all of the time. It is one way to find out if the drug is doing better than a sugar pill. Frequently they aren't.

My thought was that no trials are being conducted with only Trimesta, so it will be impossible to find out if it will work on its own. Thus patients will be given both Copaxone and Trimesta if the trial proves effective.

gwa

The FDA protocol for getting a drug to market demands it. Until there is another way to show results that gets approved there will always be the need for people to step up and fly naked for the length of the trial. You can't make a cake without cracking a few eggs. Being in the Tovaxin trial I can tell you that it is VERY stressful to be thinking of not being on anything. Maybe that is why there is such a proponderance of drugs that they trial on RR-MS people because they can usually go a year without treatment. If we want the good stuff, we have to be willing to go off of the marginally effective stuff for a while. My $0.02.

The fact that Copaxone is being included in this trial is no big deal - Copaxone is only marginally effective anyway (and according to the Cochrane Group - not effective at all), so if this trial shows decent results, it will be entirely because of the Estriol. That's how I choose to look at it, anyway!

Itsjustme wrote:

Some of us have tried Betaseron, then Avonex, then Copaxone and found no benefit and gave up using any CRAB years ago. I am a patient "on nothing."

My first neurologist who diagnosed me said that all the CRABs results were little better than placebo which is why the UK government is so reluctant to prescribe the stuff in the first place.

_________________
3 years antibiotics, 06/09 bilateral jug stents at C1, 05/11 ballooning of both jug valves, 07/12 stenting of renal vein, azygos & jug valve ballooning,

Interestingly the Cochran Review of interferons found in its review of all studies "If interferon-treated participants who dropped out were deemed to have progressed (worst case scenario) the significance of these effects was lost (RR 1.31, 95% CI 0.60 to 2.89, p = 0.5). "

In other words if people who dropped out of all the trials were presumed to have progressed then the studies showed no evidence of interferons slowing progression...