Progenics Pharmaceuticals

Progenics, Wyeth drug fails late-stage trial

Thu, 22 May 2008 06:59:55 -0400

There's more bad news for Wyeth and Progenics Pharmaceuticals for their late-stage drug Relistor. Researchers say the drug failed to hit a primary endpoint in restoring gastrointestinal function following surgery. Just as in another late-stage trial, preliminary data revealed no significant reduction in recovery time to a first bowel movement after surgery. Relistor won approval from the FDA for treating opioid-induced constipation. The companies say they'll study the data before deciding how to proceed with their research plans.

In a separate Phase II trial involving 122 patients with chronic, non-malignant pain who were receiving opioids for pain management, "the once daily oral formulation of Relistor showed statistically significant activity as assessed by the occurrence of spontaneous bowel movements and other efficacy measures."

Earlier this week Adolor and GSK won approval for Entereg for post-operative ileus, making it the only such drug on the market.

- read the press release
- here's the AP story

FDA approves Wyeth, Progenics drug

Fri, 25 Apr 2008 06:59:57 -0400

There's a big sigh of relief coming from Wyeth and Progenics today as the FDA approved Relistor, a subcutaneous injection for opioid-induced constipation in patients with advanced illness who are receiving palliative care. Back in January the FDA added an additional three months of review time so that it could study the drug's side effects. Though European regulators gave a thumbs up to the drug on Thursday, some U.S. analysts doubted Relistor would gain FDA approval. The FDA came through though, and Progenics' stock shot up on the news. The approval triggers a $15 million milestone payment from Wyeth.

"The approval of Relistor is a transformative event for Progenics Pharmaceuticals," says Paul J. Maddon, CEO of Progenics. "This is our first U.S. product approval.

- see the release on Relistor
- read TheStreet report

ALSO NOTED: Dr. Reddy's buys small molecules biz; Labopharm appeals FDA decision; Avant touts typhoid fever data; and much more

Tue, 01 Apr 2008 07:59:50 -0400

> Dr. Reddy's has struck a deal to buy a portion of Dowharma's small molecules business in the UK. Report

> Labopharm has appealed the FDA's decision on its once-daily formulation of tramadol. Report

> Avant Immunotherapeutics says that an experimental typhoid fever vaccine--Ty800--met all primary endpoints in a mid-stage trial. Release

> Monogram Biosciences has inked a deal with Progenics Pharmaceuticals to provide resistance and tropism testing for Progenics' clinical development program of PRO 140, an investigational CCR5 monoclonal antibody being studied for HIV. Release

> VWR International has acquired the lab equipment supplier Jencons for an undisclosed sum. Report

> Here's a big strike against one strategy for protecting drug prices. A European Union advocate general said GlaxoSmithKline violated antitrust laws when it refused to fill Greek wholesalers' orders in a bid to prevent parallel importation. Report

> Did Amgen and Johnson & Johnson over-promote their anemia drugs? Congress is asking the companies for documents detailing their advertising and promotions, including a "bundling" discount Amgen allegedly offered to doctors on Neupogen and Neulasta in return for Aranesp scrips. Report

> Mylan CEO and Vice Chairman Robert Coury (photo) brought down $10.3 million during fiscal 2007, which ran only nine months because the drugmaker changed its fiscal year. Report

> The Vytorin onslaught continues, with Congressional committees circling and secret emails surfacing. Report

And Finally… The largest survey ever of American physicians' opinions on healthcare financing has found that 59 percent of doctors support government legislation to establish national health insurance while only 32 percent oppose it. Release

Four promising companies to watch

Maureen Martino — Wed, 08 Aug 2007 10:28:10 -0400

Based on strong product pipelines, positive clinical data and impressive partnerships with big drug companies, The Motley Fool profiles four small biopharm companies that could emerge as major players--and good investments.

Array BioPharma - Array BioPharma is developing small molecule drugs to treat cancer and inflammatory disease. The company has five Phase I drugs and two more in preclinical trails. It also counts Amgen, Genentech, Takeda, Eli Lilly, and AstraZeneca among the companies that fund its drug development machine, and Array has raked in a number of milestone payments over the last few years. Because of an overabundance of early-stage assets, the company says it will out-license them to other developers over the next three years, which could help the company earn some serious cash. "Even though it is burning cash and has no compounds on the market, Array clearly has the potential to become a biotech-research powerhouse with so many novel drugs in development," notes Brian Lawler of The Motley Fool.

ViroPharma - ViroPharma and Wyeth are working on a new class of hepatitis C drug that is in Phase II testing. Early-stage testing of the drug was impressive: After 14 days of doses of HCV-796 with another therapy patients had an average viral reduction close to 100 percent. And following a rough patch a few years back, ViroPharma engineered a turn-around by acquiring profitable drug Vancocin and hiking its price; Wall Street loved the move and awarded ViroPharma accordingly. In addition to the hepatitis C program, ViroPharma is developing Maribavir, an antiviral for transplant patients that was fast-tracked last year.

Alexza - Alexza is taking a different approach to drug development. Rather than creating new drugs from scratch, the company is developing inhalable versions of generic drugs for use with its Staccato System, a device that atomizes therapeutics for inhalation. The company is formulating inhalable versions Xanax (for panic attacks), fentanyl (for pain), Loxapine (for schizophrenia) and Prochlorperazine (for migraines). The company says 200 drug compounds have been identified that may work with the Staccato System. As The Motley Fool observes, Alexza's pipeline is limited only by its budget. But the has certainly caught the attention of investors: late last year Symphony Capital Partners gave Alexza $50 million for the development of two of its drugs.

Progenics Pharmaceuticals - Progenics and its development partner Wyeth are waiting on an FDA approval for a subcutaneous version of the company's methylnaltrexone compound to treat opioid-induced constipation. An oral version--which is likely to be a blockbuster--is in Phase I trials and could hit the market as early as 2009 if all goes well. Another promising candidate is the HIV drug PRO 140; the FDA fast tracked the drug early last year. PRO 140 is a monoclonal antibody in the same class of drugs as Pfizer's newly-approved Maraviroc.

- check out the Motley Fool article for more