OTC drugs

Merck chief defines the perfect biotech buyout

Thu, 13 Dec 2007 06:59:54 -0500

Just before Biogen Idec announced it was out of the merger business, for the present, Merck's CEO was telling the Wall Street Journal that it had no interest in buying the biotech company. What it would like to buy, said CEO Richard Clark (photo), is a biotech company with about $2 billion to $5 billion in sales and a pipeline in sync with Merck's research interests. Hmm. And by the way, he added, Merck has no beef with the FDA. Even as others see the agency tightening up after the Vioxx debacle, Merck has counted seven approvals in the past two years. "It's difficult to say that the FDA has changed their approach."

- check out the report from the Wall Street Journal

ALSO: Merck recalled more than a million doses of Hib vaccine, shots given to kids under five to prevent hepatitis, pneumonia, and other infections. Report

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Zila lays of 20 in restructuring

Wed, 15 Aug 2007 06:59:54 -0400

Zila is handing out pink slips to 20 workers as it restructures its business. The small, Phoenix-based company sells oral cancer detection kits. It says the restructuring will save about $3 million a year.

- check out the release on the restructuring
- read the report on Zila from the Arizona Republic

Related Articles:
Zila sells OTC brand. Report
Zila transitions to cancer detection. Report

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

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

DEALS: J&J buys Pfizer's OTC division for $16.6B

Wed, 05 Jul 2006 20:01:32 -0400

J&J buys Pfizer's OTC division for $16.6B

DEALS
WHO	WITH	WHAT	SCOOP
Pfizer	Johnson & Johnson	$16.6B sale	Pfizer has sold its OTC division to J&J for $16.6 billion in cash.
Siemens	Bayer Healthcare	$5.3B buyout	Siemens has purchased the diagnostics division of Bayer Healthcare. The move is expected to help Bayer complete the acquisition of Schering.
Barr Pharmaceuticals	Pliva	$2.2B buyout	Barr Pharmaceuticals beat out Actavis Group when generic drug maker Pliva announced that it accepted Barr's $2.2 billion buyout offer.
Johnson & Johnson	Vertex	Collaboration deal	The companies will collaborate to develop VX-950 for hepatitis C. Vertex gains $165 million and up to $380 million in milestone payments.
Takeda	Affymax	$535M deal	Takeda will pay Affymax up to $535 million for the worldwide rights--excluding Japan--to Hematide, a therapy for anemia in cancer and kidney disease patients.
Sanofi-Aventis	Taiho	$360M deal	The deal is for most of the global rights to Taiho's S-1 cancer therapy for colorectal, head and neck cancer
Johnson & Johnson	Metabolex	Licensing deal	Johnson & Johnson is buying into Metabolex's program for diabetes and other metabolic conditions with a new collaboration pact that provides a $40 million equity stake and up to $508 million in milestones.
Mayne Pharma	SuperGen	Licensing deal	Mayne has bought North American rights to the leukemia drug Nipent and a medical surface cleaner from SuperGen for $15 million up front and up to $19 million in milestone payments.
Skyepharma	Mundipharma International Holdings	$5M licensing deal	Skyepharma bought back European rights to DepoBupivacaine for its experimental pain drug DepoBupivacaine.
Eli Lilly	Inpharmatica	Licensing deal	Eli Lilly has licensed Admensa Interactive, Inpharmatica's suite of predictive drug absorption, distribution, metabolism and excretion (ADME) models and compound prioritization tools.

Pfizer's sells OTC division to J&J for $16.6B

Sun, 25 Jun 2006 20:01:37 -0400

Clearing the way to focus more on its prescription drug business, Pfizer has agreed to sell its OTC division to Johnson & Johnson for $16.6 billion in cash. The OTC therapies include such market stalwarts as Sudafed and Visine and collectively earned $3.9 billion in revenue last year. J&J also won the OTC rights to Zyrtec when it loses patent protection. Pfizer also said it would buy back up to $17 billion in shares. Shares of Pfizer were buoyed slightly be the news.

- here's the AP report on the sale

GSK preparing $15B bid for OTC division

Thu, 01 Jun 2006 20:01:35 -0400

A bullish GlaxoSmithKline is preparing a bid of about $15 billion for Pfizer's over-the-counter drug division, according to a variety of news reports. The division includes such OTC standards as Sudafed and Listerine. Revenue in 2004 neared $4 billion.

- read the article on GSK from MarketWatch

SPOTLIGHT: Daiichi Sankyo buys OTC business

Thu, 30 Mar 2006 19:01:33 -0500

Daiichi Sankyo has inked a deal to buy the OTC unit of Astellas--Zepharma--for 20 billion yen. Report

FDA prepares to review OTC app for obesity drug

Thu, 12 Jan 2006 19:01:37 -0500

Later this month an expert panel of the FDA will take up GlaxoSmithKline's application to sell the obesity drug Xenical over-the-counter. If it gets a green light, GSK will have the first prescription obesity drug to go OTC. Analysts note, however, that the FDA can often prove hesitant about approving prescription drugs for OTC use, as Merck found out last year with its OTC application for the cholesterol-lowering Mevacor. Xenical is a 'behind-the-counter" drug in Australia and New Zealand, a special third category that the U.S. doesn't recognize. Xenical works by preventing the body from absorbing about a third of dietary fat from being absorbed by the intestine. GSK licensed the U.S. OTC rights from Roche, which had been selling the drug in the U.S. Xenical sales have faded in recent years, along with other prescription obesity drugs, over fears of possible side effects and limited results.

- read this article from USA Today for more information

GSK pushing OTC status for weight-loss drug

Mon, 24 Oct 2005 20:01:36 -0400

GlaxoSmithKline has asked the FDA to permit the weight-loss drug Xenical to go OTC. If approved, it would be the first weight-loss drug to go off of prescription. Researchers submitted new data last week that found that 36 percent of people taking Xenical lost 5 percent of their body weight, compared with 28 percent taking a placebo. The drug works by blocking the body's absorption of dietary fat.

- read this article from Newsday 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

DEALS: Novartis expands OTC operations

Wed, 20 Jul 2005 20:01:32 -0400

Novartis wins big OTC deal.

DEALS
WHO	WITH	WHAT	SCOOP
Novartis	Bristol-Myers Squibb	$660 million acquisition of US and Canadian OTC division	Novartis gains rights to a broad range of OTC drugs, including Excedrin and Comtrex.
Omnicare	excelleRx	$269 million buyout	Omnicare gains a provider of comprehensive pharmaceutical care services, primarily for hospice patients.
McKesson	D&K Healthcare Resources	$207 million buyout	McKesson adds a regional drug distributor to its operations.
Sosei	Arakis	$187.4 million buyout	The deal expands Sosei's pipeline with several compounds in development, including a $375 million global partnership with Novartis for its lead product AD 237.
Aptuit	Quintiles Transnational	$125 million business unit acquisition	The units will be reorganized by Aptuit into three global business lines: Preclinical Technologies, Pharmaceutical Sciences and Packaging & Logistics.
Roche Group	GlycArt Biotechnology	Buyout	Roche gains new technology technology for enhancing the efficacy of antibodies.
American Pacific	Aerojet Fine Chemicals	Buyout for $119 million plus liabilities	American Pacific buys an established player in the sale of active pharmaceutical ingredients.
Assay Designs	Stressgen Bioreagents	Acquisition	Stressgen develops and markets antibodies, proteins and related kits to life sciences researchers worldwide.
Hi-Tech Pharmacal	Rodlen Laboratories	$4.4 million brand buyout	Hi-Tech gains control of Zostrix OTC analgesic creams.

Novartis targets 'critical mass' in $660M OTC drug buyout

Thu, 14 Jul 2005 20:01:38 -0400

Novartis is acquiring a package of North American over-the-counter drugs -- including Excedrin, No-Doz and Comtrex -- from Bristol-Myers Squibb for $660 million. The news quickly sparked cheers from analysts, who saw the buyout as a good move for the Swiss drug giant. Novartis, already one of the largest OTC manufacturers in the world, said the move would give it greater "critical mass" in the North American market. Novartis announced on Thursday that its net profit in the first six months of the year was up 12 percent.

- read this story from Xinhuanet for more