contraceptive

Organon, Schering end male contraceptive deal

Mon, 18 Sep 2006 20:01:36 -0400

Akzo Nobel's NV arm Organon and Schering have announced that they will discontinue their collaboration on the development of a male hormonal contraceptive. In a press release, Organon and Schering noted that while their work together was constructive, they "came to the conclusion that the administration route investigated in the trial, which combined an annual implant with three-monthly injections, would unlikely result in a product that would be acceptable for widespread everyday use." Their collaboration began in 2002 and the companies said that they'll part ways when a current Phase II trial is completed.

- check out the press release for more on the break-up

Barr takes cautious approach in marketing Plan B

Thu, 24 Aug 2006 20:01:36 -0400

An FDA approval of any kind is often the trigger to a massive advertising blitz, but ad experts say that Barr Pharmaceuticals is likely to stay focused on a discreet, tailored campaign while talking directly with healthcare professionals. Barr notes that the agreement with the FDA also limits sales of the contraceptive to pharmacies and clinics, so a major branding campaign hardly makes sense.

- read the article on Plan B from The Wall Street Journal (sub. req.)

ALSO: Despite the brouhaha over the OTC approval, most analysts say that Plan B will barely register on the radar of drug industry sales. Article

FDA clears Plan B, ending FDA confirmation fight

Wed, 23 Aug 2006 20:01:38 -0400

After three years of regulatory limbo, Barr Laboratories has won the right to market the Plan B contraceptive without a prescription. Women over 18 will be required to show proof of their age to buy the drug while under age girls will still need a prescription. Plan B has been a favorite cause on both sides of the political divide. Opponents say that OTC access of what it calls an "abortion pill" would encourage promiscuity and further spread sexually transmitted diseases while backers have insisted that the FDA had to approve the drug before they would allow Bush's nominee to run the agency gain official title to his office. In the end, the shift happened swiftly as Andrew von Eschenbach signaled a desire to deal with the controversy and move on. Resolving the impasse over Plan B is likely to swiftly lead to a Senate confirmation of his nomination.

- check out the article on Plan B from The Washington Post

Editor's Corner

Sun, 20 Aug 2006 20:01:40 -0400

On Friday Barr Laboratories resubmitted its application to make Plan B available without a prescription. Given the FDA's sudden willingness to work out a marketing plan for the contraceptive, Barr has a good shot at finally obtaining an approval that should have come through in 2004. More importantly, it's a chance for the FDA to demonstrate that science and not ideology dictates how it reviews a therapeutic. Given the Bush administration's clear preference for ideology, the FDA may have more difficulties ahead. But for now, there's reason for hope. - John Carroll

FDA clears way for Plan B to go OTC

Tue, 08 Aug 2006 20:01:39 -0400

After a lengthy wait, the FDA and Barr Pharmaceuticals have come up with an agreement that clears the way for the over-the-counter sale of the contraceptive Plan B. Under the agreement, Barr will sell Plan B OTC to women over the age of 18 while women under that age will be required to have a prescription. The agency has been sitting on this decision for more than two years, leading several U.S. senators to vow to indefinitely hold up Dr. Andrew von Eschenbach's appointment to head the FDA until the impasse over Plan B was resolved. Conservative groups had fiercely opposed any agreement to allow Plan B to go OTC, calling it an abortion drug. Abortion rights groups, meanwhile, say Plan B would actually reduce the number of abortions in the U.S. The agreement marks a significant turning point for the FDA. With a plan now for Plan B, the FDA is likely to get Dr. von Eschenbach's appointment completed and the FDA can move on to other business.

- read the article on Plan B from The New York Times

FDA indicates it may allow Plan B to go OTC

Mon, 31 Jul 2006 20:01:39 -0400

In what could mark a major breakthrough in the impasse over Plan B, the FDA has indicated that it may move ahead and make the controversial contraceptive available over-the-counter for women 18 and older. In a letter to Barr Pharmaceuticals, the agency asked what steps could be taken to ensure that underage girls don't obtain it and that a final decision was being sought in a matter of weeks. The morning-after pill has proved to be a major stumbling block at the FDA. A number of Democrats in Congress vowed to hold up the confirmation of acting FDA Commissioner Andrew C. von Eschenbach until the agency pushed ahead and allowed Plan B to go OTC, as recommended two years ago by an agency advisory board. The FDA has been severely criticized both internally and externally for allowing politics to trump science in its decision-making process. Religious conservatives, meanwhile, vowed to keep up the fight, maintaining that Plan B could only promote promiscuity among teens.

- here's the article on Plan B from the Los Angeles Times

Poll finds problems at the FDA

Thu, 20 Jul 2006 20:01:38 -0400

A study released by the Union of Concerned Scientists has found that about 15 percent of FDA staffers polled say they've been "asked to… inappropriately exclude or alter technical information or conclusions in an FDA scientific document." In addition, 39 percent of respondents stated that the FDA wasn't "acting effectively to protect public health." The questionnaire was sent to almost 6,000 FDA workers and 997 responded.

The survey underscores critics concerns that the science isn't the only factor that informs the FDA's decisions. The agency has taken heat for the Vioxx debacle, and a head women's health official resigned in protest to the way politics interfered with science in the FDA's handling of Plan B, a controversial morning-after contraceptive. A spokeswoman for the FDA dismissed the poll, saying it was unscientific and asked leading questions.

- check out this San Francisco Chronicle article

Wyeth to conduct more research on DVS-233

Wed, 12 Jul 2006 20:01:39 -0400

Wyeth says it will hold off on an expected launch of the experimental depression drug DVS-233 until next year as it conducts more trials to "further define the profile" of the therapy. Patients in recent trials had complained of nausea, so Wyeth wants to see how volunteers respond to lower doses of the drug, which was derived from Effexor XR. Analysts say that DVS-233 is one of the more important drugs in Wyeth's pipeline. In addition, Wyeth announced that it expects to release its low-dose contraceptive Lybrel next year, provided it can satisfy the FDA's concerns about its manufacturing operation in Puerto Rico.

- here's the AP report on Wyeth

Duramed gets FDA OK on Seasonique

Thu, 25 May 2006 20:01:36 -0400

Duramed Pharmaceuticals has received FDA approval for Seasonique, an extended cycle contraceptive that should hit the markets in July. Seasonique's low-dose estrogen pills--which limit menstrual cycles to four times a year--replace a series of placebos in the monthly cycle that researchers say will help limit bloating and hormonal fluctuations.

- read the report from the Kaiser Network

Democrats vow to block FDA nominee

Tue, 28 Mar 2006 19:01:35 -0500

Two Democratic senators--Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY)--said they met with newly nominated FDA chief Dr. Andrew von Eschenbach on Tuesday but failed to gain a timeline on a decision for Plan B. Both senators said they would continue to work to block his nomination until some decision was forthcoming on the controversial contraceptive.

- here's the article from ABC News

Von Eschenbach nomination faces challenges

Wed, 15 Mar 2006 19:01:38 -0500

President Bush nominated Andrew von Eschenbach to the permanent post of FDA commissioner, but the nomination is in trouble from the get-go, with senate leaders vowing to hold the nomination hostage to a firm decision from the agency on making the controversial Plan B contraceptive available over the counter. Scientists at the FDA have been clear that the contraceptive is safe and effective, but top regulators have pushed Plan B into regulatory limbo. Conservatives see Plan B as a tacit encouragement to promiscuity, which some internal and external critics say shouldn't be an issue at all.

Plan B was a major snag for Lester Crawford, who left abruptly after only a brief period following his controversial nomination process. But with both sides vowing to hold on and fight to the bitter end, it's likely to be some time before von Eschenbach prevails. That is likely to continue the prolonged sense of uncertainty that has plagued the FDA during the bulk of President Bush's administration.

- read this Los Angeles Times report

ALSO NOTED: Warner Chilcott contraceptive approved; Inspire inks deal with Boehringer;and much more...

Mon, 20 Feb 2006 19:00:50 -0500

> The FDA approved Warner Chilcott's 24-day contraceptive Loestrin(R) 24 Fe. This is the first 24-day contraceptive to hit the U.S. market. Warner Chilcott focuses on dermatology and women's health. "This FDA approval is a significant step forward for Warner Chilcott as we continue to sharpen our therapeutic focus on women's health and expand our product portfolio in this area," said Roger Boissonneault, CEO. Report

> Inspire Pharmaceuticals has inked a licensing deal with Boehringer Ingelheim to develop a new therapy for rhinitis. Report

> Shares of Merck were on the rise this morning as investors bid up the stock after the company won its first federal trial regarding Vioxx. Report

> Iceland's deCODE Genetics has reported the successful conclusion of a Phase I trial of DG041 for peripheral artery disease. Release

> Corgentech announced that pivotal Phase 3 trial results from the second of two Phase 3 trials. The results demonstrated that children undergoing medical procedures requiring venipunctures and intravenous line placements treated with ALGRX3268 experienced significantly superior pain relief in just one to three minutes versus those receiving placebo. Release

> Memory Pharmaceuticals of Montvale, NJ released positive Phase I cognitive data for MEM 3454. Release

> Germany's Schwarz Pharma has received EMEA approval to market its Neupro Parkinson's disease treatment in 25 EU countries. Report

> Cerimon Pharmaceuticals of South San Francisco has licensed the worldwide rights to Novartis Pharma's Simulect for inflammatory bowel disease. Release

> Neurochem's safety review board has given its fourth recommendation to continue a late-stage trial of Alzhemed for Alzheimer's. Report

> Following discussions with the FDA, Synthetic Blood International says it will start a Phase II sickle cell anemia trial in the second quarter. Release

And Finally… Researchers are trying to determine if stem cells could hold the key to curing cancer. Article

Schering contraceptive earns approvable letter

Tue, 24 Jan 2006 19:01:37 -0500

The FDA has issued an approvable letter for Schering's contraceptive Yaz for women with PMDD, or premenstrual dysphoric disorder. Schering said that the FDA's letter noted that the agency needed to review newly submitted data but was not asking for any new clinical trials.

- read this AFX report for more

ALSO: The FDA also approved a generic version of Plavix, an anti-clotting drug made by Sanofi-Aventis and Bristol-Myers Squibb. Report

Government regulators stumble, may yet find a successful strategy

Thu, 22 Dec 2005 19:01:37 -0500

Lester Crawford was no sooner in as the new head of the FDA than he was out, with no clear, satisfactory explanation of what had spurred the sudden exit. As the new interim commissioner, Dr. Andrew von Eschenbach, took over, he outlined the agency's responsibility to adapt and handle the emergence of personalized medicines. Meanwhile, the agency's top women's health official, Dr. Susan Wood, resigned in protest to the evident way that politics trumped science in the FDA's handling of Plan B, a controversial morning-after contraceptive.

This has been a turbulent year for the FDA. Drug developers devoutly hope that the FDA will spend 2006 demonstrating its commitment to science rather than to social conservatives, and a more clearly defined path to evaluating the safety of a drug is being warmly received. More is being done to clarify the type of data that regulators will find persuasive without adding greatly to the already considerable expense of proving a new drug's effectiveness. It's a tricky path to navigate. This is one story that will definitely continue into the New Year.

FDA issues warning for Ortho Evra patch

Thu, 10 Nov 2005 19:01:39 -0500

On Thursday the FDA issued a warning that the popular Ortho Evra birth control patch puts women at higher risk of blood clots and other serious side effects. Though Ortho McNeil's patch and the Ortho-Cyclen pill have similar levels of estrogen, women absorb about 60 percent more hormone on the patch because it is delivered directly into the bloodstream, rather than being digested first. The FDA's warning is a result of an Associated Press report that found women on the patch were three times more likely to die and suffer blood clots than women taking an oral formulation of the contraceptive. The AP report also claimed that in 2004 about a dozen women died and many more suffered strokes after using the patch. Ortho McNeil is a subsidiary of Johnson & Johnson.

- read this report from the AP

Report: Crawford wouldn't cooperate in Plan B investigation

Thu, 13 Oct 2005 20:01:36 -0400

A draft copy of a General Accounting Office report on the FDA's handling of the decision on the morning-after contraceptive Plan B indicates that former FDA commissioner Lester Crawford refused to answer any of its questions in the probe, according to The Washington Post. Plan B's advocates say the report makes clear that political considerations dictated the FDA's announcement that it would delay any final decision on the drug, leaving it in limbo. Conservatives had fiercely opposed the drug, which was endorsed by an expert panel at the FDA, saying that it would encourage teen promiscuity.

- read this article from The Washington Post for more

Chutes & Ladders: FDA consultant resigns over Plan B

Thu, 06 Oct 2005 20:01:35 -0400

An FDA expert consultant has handed in his resignation in protest of the agency's handling of Plan B. Dr. Frank Davidoff said that the FDA's decision to indefinitely delay OTC access to the contraceptive put politics ahead of science. His departure follows the resignation of Susan Wood, the FDA's top women's health official, who also left in protest.

- read this AP article for more

Editor's Corner

Thu, 01 Sep 2005 20:01:40 -0400

Dr. Susan Wood's decision to resign as the FDA's top official for women's health should be a warning sign to the entire drug development industry. As she noted, FDA Commissioner Dr. Lester Crawford's decision to indefinitely delay any decision on pushing the morning-after contraceptive to OTC is purely the result of abortion politics, and partisanship should have no role to play in the world of pharmaceutical approvals. The great irony here, as she notes, is that Plan B will help women avoid unwanted pregnancies and reduce the number of abortions in this country. In the future, of course, it will grow increasingly easy to introduce pure partisanship in drug decisions, and it will get easier to ignore the opinions of its expert panels. And that should frighten us all.

On another note, FierceBiotech will not publish Monday, September 5, in observance of Labor Day here in the US. We'll be back on Tuesday, September 6. Enjoy your long weekend! - John Carroll

Theramex gains €10M in licensing deal

Mon, 30 May 2005 20:01:35 -0400

Merck affiliate Laboratoire Theramex will pocket a €10 million licensing payment from Organon for the marketing rights to its new contraceptive EMM 310066, which has demonstrated efficacy in a Phase II trial. Theramex retains marketing rights in certain companies and also stands to garner milestones and royalties.

- read this story from AFX for more on the deal