EPIX Pharmaceuticals

C&L: PDL BioPharma's L. Patrick Gage resigns

Wed, 04 Jun 2008 06:59:52 -0400

PDL BioPharma director and interim Chief Executive L. Patrick Gage resigned due to differences among the board about prioritizing company goals.

Histogenics has named F. Ken Andrews president and CEO. Andrews is a former vice president of marketing and sales of the tissue repair division of Genzyme.

Epix Pharmaceuticals announced the resignation of Dr. Andrew Uprichard from his position as president and head of research and development.

Alexza Pharmaceuticals announced that Jeffrey S. Williams has rejoined the company in a part-time position as president, Alexza Singapore, a wholly owned subsidiary of Alexza.

Biogen Idec has promoted Hans Peter Hasler to chief operating officer. He had been executive vice president, global neurology.

Etrials Worldwide said James W. Clark, Jr. has resigned his position as secretary, treasurer and chief financial officer.

Genmab AS said it has appointed David Eatwell as new chief financial officer of the group.

Amazon Biotech announced that Dr. Michael Silver has been appointed as the company's new scientific director.

ImClone Systems has appointed Bernhard Ehmer, M.D. as senior vice president and managing director, international operations.

Adolor Corporation has promoted Lee Techner, DPM to vice president, medical affairs and medical director.

MAP Pharmaceuticals has appointed Marco F. Rosa to the newly created position of vice president of human resources.

Stem Cell Therapeutics Corp. has appointed Thomas Franck as vice president of commercial planning.

BioChemics has named Dr. R. Rox Anderson, professor at Harvard Medical School, as a member of the company's Scientific Advisory Board.

DermTech announced that Herbert A. Fritsche, Ph.D., has joined DermTech's Scientific Advisory Board.

Avantogen Ltd welcomed Professor Ian Frazer to the Scientific Advisory Board of Hawaii Biotech Inc.

Provectus Pharmaceuticals has announced that Kelly M. McMasters MD, PhD, has agreed to serve as a member of the corporate board of directors. Additionally, Dr. McMasters will head the scientific advisory board.

TOPIGEN Pharmaceuticals has named Jeremy Curnock Cook, MA, to its board of directors.

Trius Therapeutics announced the appointment of Paul Truex to its board of directors.

NanoBio announced the appointment of David M. Stout to its board of directors.

Enzon Pharmaceuticals announced that Dr. Jack Geltosky has been appointed to the company's board of directors

SPOTLIGHT: Epix wins $7.5M milestone

Mon, 05 May 2008 06:59:53 -0400

Epix Pharmaceuticals says it's due a $7.5 million milestone payment from GSK now that it's launched a Phase IIb trial of a new therapy for Alzheimer's. Researchers say the therapy could one day be part of a drug 'cocktail' used to treat the memory-wasting illness. Epix release

Emerging Drug Developer: Epix Pharmaceuticals

John Carroll — Mon, 14 Apr 2008 08:45:53 -0400

Epix follows a new course in developing CF program

For most investors, the sweet spot in any biotech play is right around proof-of-concept data on a new therapy for a disease that afflicts a large population of patients. That’s the point when a big pharma company can size up the commercial opportunities along with late-stage development costs and step in and make an offer to partner up.

It’s also the reason why emerging drug developers like Epix focus on diseases like Alzheimer’s and obesity, where current therapies often don’t work very well and the unmet medical need and market potential is greatest.

But two years ago the Cystic Fibrosis Foundation made Kauffman an offer that made him disregard the traditional business model and move into a disease category that otherwise wouldn’t have made much economic sense. The foundation put up $12 million to fund a program at Epix that put the biotech’s technology to work exploring a new therapy for cystic fibrosis. Rather than look for a market payoff, the foundation’s primary objective is to advance the research far enough along that the commercial opportunity comes within reach -- and the biotech can advance on its own to commercial development.

Last week, after Epix hit its fourth milestone in that development pact, the foundation came back and added a very big carrot in the form of an additional $37 million in fresh research funds.

“This funding goes through Phase IIa, early stage clinical proof-of-concept,” says Epix CEO Michael Kauffman, M.D., Ph.D. “If we see an effect in the clinic by then, I would stand by this. We would be very excited about this mechanism.” The foundation, he adds, “wants to see this disease treated. They want to take it to a point of top priority. There’s a different late-stage focus for the foundations and nonprofits.”

Epix’s success in the field comes from its expertise in developing computer models of the 3-D structures of drug targets – in this case the cystic fibrosis transmembrane conductance regulator, or CFTR. The most common mutation of the CFTR gene is the Delta F508 mutation, which is responsible for key symptoms of CF in about 70 percent of the patients who suffer from the disease. The body eliminates the abnormal protein made from the mutated gene, and the reduced levels of CFTR protein spur the creation of a sticky mucous material that causes lung infections and disrupts digestion in people who suffer from the disease.

“What happens is that the Delta F508 protein is made just fine,” says Kauffman. But the correct 3-dimensional folding process that normally follows goes awry. The body in turn detects the misfolded CFTR proteins and discards them as it normally does to protect the body from abnormal proteins. “The problem is that less than five percent of the Delta F508 ever makes it to the surface, so people with CF have a level of CFTR maybe 20- to 50-fold lower than normal, which is why you get the disease. The little bit that gets to the surface also doesn’t function as well as the normal protein.”

Any new therapy doesn’t have to be 100 percent effective, he adds. Even a 20 percent to 25 percent increase in CFTR would probably trigger a considerable improvement in patients.

Understanding the structure of CFTR gives Epix an inside track in developing a therapy that can make the protein work properly, eliminating those symptoms.

“We create our own computer-derived model we think is right,” says Kauffman. “Essentially, we’re trying to replace X-ray crystallography.”

To illustrate what he’s talking about, Kauffman frequently uses an analogy of examining a lock – the drug target -- to come up with a key – the drug. “If you know the structure inside the lock, it’s far easier to make a key.” That’s a far different approach than high-throughput screening technology, where you try a few hundred thousand keys to see which ones best fit the lock.

Epix developed the technology around G protein-coupled (GPCR) receptors that play a role in some ‘big’ diseases like Alzheimer’s. And the company has developed partnerships with the likes of GlaxoSmithKline and Amgen to advance new therapies into mid-stage clinical development.

The Cystic Fibrosis Foundation “came to us and said, Can you modify your technology so you can come up with a 3D structure of what this ion channel protein looks like and use this structure to come up with new drugs to treat cystic fibrosis?” recalls Kauffman. “Ion channels have a different structure than GPCRs, but both traverse the cell membrane, which makes them very difficult to crystallize. But they do have certain properties in common.”

Over the past 10 years, the Foundation has pumped $300 million into research programs.

And it isn’t hard to find other examples of non-profits stepping in to help fund early-stage research work. The Boston Globe recently concluded that the disease foundations provided $75 million to drug developers last year, up from only $7 million in 2000.

Aside from the CF program, Epix has a number of irons in the fire as it pursues a total of five clinical development programs.

Kauffman just killed off a mid-stage development program in depression after failing to come up with the kind of compelling data needed to justify continued clinical work. That program is up on the auction block. And while Kauffman points to its added potential in pain and memory loss on top of depression, he also is realistic about its potential following a mid-stage trial failure.

But Kauffman believes the company can easily overshadow that setback with a new review of its crucial Vasovist Phase III program, an imaging agent already approved in 33 countries but long stymied at the FDA. Essentially, says Kauffman, the FDA handed the company a “non-decision” in an approvable letter. It took some time, but Epix got the clarification it needed to provide specific data to the FDA and Kauffman says its amended NDA for the FDA could come mid-year with a decision by the agency at the end of this year.

Epix already has a profit-sharing deal on Vasovist. But Kauffman says the company “will likely monetize the asset. We won’t wait for a profit share to pay off; near term cash is more important.”

Funds from non-profit groups flow to biotech R&D

Mon, 07 Apr 2008 06:59:57 -0400

Epix Pharmaceuticals said this morning that its development pact with the Cystic Fibrosis Foundation has mushroomed into a $50 million deal, adding $37.7 million to the $12 million already provided by the Foundation for new drug research. Epix will have to hit a series of goals for the money. And as a story in the Boston Globe makes clear, Boston-area biotech companies have been able to garner ever larger sums of cash to advance new therapies. Other examples include $25 million in research cash provided by the Juvenile Diabetes Research Foundation, $8.5 million from the Muscular Dystrophy Foundation and $6 million from the Multiple Myeloma Research Foundation.

"It's becoming a significant method of funding," Robert Coughlin, president of the Massachusetts Biotechnology Council, tells the Globe.

"By utilizing our proprietary in silico technology to model the CFTR ion channel, we were able to quickly discover novel CFTR modulators that are fueling our structure-based optimization approach," says Epix CEO Michael G. Kauffman.

- check out the press release
- read the article in the Boston Globe

Related Articles:
Epix shares dive after mid-stage depression failure. Report
Epix shares soar on Alzheimer's trial data. Report
Epix touts data on pulmonary hypertension drug. Report
Epix shares soar on $1.2B pact with GSK. Report
Epix anxiety drug fails in late-stage trial. Report

Epix shares dive after mid-stage depression failure

Thu, 20 Mar 2008 07:59:58 -0400

Epix Pharmaceuticals has pulled the plug on its depression drug, saying that a mid-stage trial of PRX-00023 failed to demonstrate sufficient efficacy for major depression. Investors bailed on the news, sending its shares down by about a third.

"While PRX-00023 continued to show a highly desirable safety and tolerability profile, we are disappointed in the overall results observed in our recently completed Phase IIb trial in major depressive disorder," stated Michael G. Kauffman, M.D., Ph.D., chief executive officer of EPIX. "In light of these results, we have made the strategic decision to discontinue further development of this product candidate."

Next up: A right-heart catheter study for PRX-08066 in patients suffering from pulmonary hypertension from chronic obstructive pulmonary disease. Kauffman also tried to assuage the market by highlighting a slate of ongoing partnerships with leading developers like Amgen and Glaxo as well as its late-stage work on Vasovist.

- check out the press release for more

Related Articles:
Epix shares soar on Alzheimer's trial data. Report
Epix touts data on pulmonary hypertension drug. Report
Epix shares soar on $1.2B pact with GSK. Report
Epix anxiety drug fails in late-stage trial. Report

Epix shares soar on Alzheimer's trial data

Tue, 18 Dec 2007 06:59:55 -0500

Shares of Epix Pharmaceuticals soared 53 percent this morning on the news that its experimental Alzheimer's therapy proved efficacious, safe and well tolerated in a mid-stage trial. There was mixed improvement in patients depending on dosage, but researchers for the company say the results merit a larger mid-stage trial of the drug. Patients taking the 150 mg dose of PRX-03140 demonstrated a significant improvement in memory and cognitive ability, while patients taking a placebo recorded deteriorating results.

"While we recognize that this is a two-week study on a relatively small population of patients, these statistically significant results, as well as the anecdotal reports we have received from study investigators and patients' families since the trial concluded, support our belief that PRX-03140 has the potential to improve memory and cognition," said Epix CEO Dr. Michael G. Kauffman.

- check out the release
- read the AP report on the trial results

Related Articles:
Epix touts data on pulmonary hypertension drug. Report
Epix shares soar on $1.2B pact with GSK. Report
Epix anxiety drug fails in late-stage trial. Report
Epix to buy Predix in $90M merger. Report