Watson Pharmaceuticals

Expert panel to mull broader Fentora use

Fri, 02 May 2008 06:59:55 -0400

Everyone suddenly has an opinion on Fentora. Good opinion: The Cephalon painkiller got European approval a couple of weeks ago, after two years on the market in the U.S. Another good opinion, in the imitation-is-flattery department: Watson Pharmaceuticals filed for the FDA OK on its copycat version of the oral med. In good opinion number three, analysts pooh-poohed Watson's generic challenge, saying, "Fentora is a novel invention and the patents are strong."

Then there's one not-so-sure opinion, from none other than the FDA. As the anesthetic drug advisory committee prepares to discuss broadening usage of Fentora at next week's meeting, an agency staffer raised the twin specters of drug abuse and adverse events in briefing documents. Fentora's current risk-management programs have already failed in a few instances, the documents state, leading to serious adverse events, including overdose deaths. You'll recall that the company strengthened warnings on Fentora's label to help prevent those problems, which seem to stem from prescribing the med inappropriately and from substitution errors.

Given these problems, the documents say, expanding Fentora's indication beyond breakthrough cancer pain could lead to more misuse. And it could make the med more accessible to potential abusers. Key to approval, the staffer wrote, would be an effective risk management program. Is this possible? We'll see what the advisory committee says next week.

- read the FDA briefing
- see the Euro OK piece at Motley Fool
- check out Watson's release
- read the patent coverage in the Chester Daily Local

ALSO NOTED: Smith & Nephew probes sales infractions; FDA gives nod to expanded Advair use; Eisai wins round in Aricept reimburs

Thu, 01 May 2008 06:59:50 -0400

> Smith & Nephew said "unacceptable" sales practices in a business it bought last year will cost it more than $100 million in lost sales and around $25 million in profits; the company has launched an internal investigation. Report

> FDA gave its blessing to expanded usage of GlaxoSmithKline's best-seller Advair Diskus; the drug can now be marketing to patients with chronic obstructive pulmonary disease. Advair release

> Under a new court ruling, Eisai and Pfizer will get access to an economic model used by U.K. drug regulators to decide that their Aricept drug shouldn't be used in mild cases of Alzheimer's. Report

> Testing for genetic mutations in leukemia patients could help doctors decide which treatment methods to use, a new study in the New England Journal of Medicine concludes. Report

> The Australian government has added Tykerb to its formulary for HER2-positive breast cancer. Report

> Boehringer Ingelheim boosted sales by 8.8 percent to $17 billion, posting profits of $3.25 billion; human pharmaceuticals revenue grew by 10 percent. Report

> Watson Pharmaceuticals posted $50.6 million in first-quarter profits, up from $31.6 million a year ago, despite a 7 percent drop in revenue to $626.9 million on slower oxycodone sales. Watson release

> Endo Pharmaceuticals settled a proxy battle with shareholder D.E. Shaw & Co, which owns some 13.2 million of the company's outstanding shares. Report

> Sepracor's first-quarter net income fell by 35 percent to $12.2 million on a 2 percent decline in revenues to $320.8 million. Report

> Researchers for Sweden's Independent Pharmaceutica are launching a mid-stage study of a new nicotine vaccine designed to help people give up smoking. Vaccine report

> Faced with back-to-back rejections of two would-be blockbuster drugs for cholesterol, analysts have been reading the tea leaves for what this could portend for developers. Report

> Even before its first compound hits the clinic, Concert Pharmaceuticals is having no trouble raising venture funds. The Lexington, MA-based developer has just ginned $37 million in a new venture round. Report

> Lawmakers in Florida have opted against pumping a fresh $25 million into its Innovation Incentive Fund. Report

And Finally... Between 30 percent and 50 percent of medicines for chronic illness aren't taken as directed, a WHO report shows. Report

ALSO NOTED: FDA lifts ban on Watson plant in FL; Sanofi bolstered profits but lost in drug trial;

Wed, 30 Apr 2008 06:59:50 -0400

> Watson Pharmaceuticals finally saw the FDA lift its ban on new products from a Florida manufacturing plant, allowing drugs made there to be eligible for agency approval; the facility had been under a new-product hold since 2005. Report

> Sanofi-Aventis kept sales and profits higher than analysts expected--$10.81 billion and $3.92 billion respectively--but said its experimental antidepressant saredutant failed a clinical trial. Report

> Novo Nordisk beat market estimates with a 22 percent hike in first-quarter profits to $589 million on $2.21 billion in sales. Report

> Takeda Pharmaceutical and Millennium Pharmaceuticals announced that the FTC granted an early end to the waiting period for their merger. Report

> Federal legislation calling for nationwide pharma-tracking would pre-empt the statewide pedigree systems under development in California and Florida. Report

> Canada's Nova Scotia province will cover Avastin treatment for colorectal cancer patients after a long delay over questions about the med's cost-effectiveness. Report

> AstraZeneca asked the FDA to expand the use of its Symbicort asthma drug to cover chronic obstructive pulmonary disease, or COPD. Report

> The FDA has approved Amitiza for women 18 years old and older with IBS-C. The drug is co-marketed in the U.S. by Sucampo Pharmaceuticals and Takeda Pharmaceutical Co. Report

> Compliance with schizophrenia treatment is higher when patients have lower copays and unrestricted access to their meds, according to a new study. Report

> Medco Health Solutions saw its first-quarter profits drop by 1.7 percent to $270 million on higher costs as volume continued to grow. Report

> Pfizer is providing $14.4 million to fund a research consortium involving four universities and Entelos, a company that does computer modeling for drug research work, in a drive to create a new class of diabetes drugs. Report

> Management consultant Dr. David A. Shaywitz has joined with Dr. Dennis A. Ausiello, the physician-in-chief of Massachusetts General Hospital and a director at Pfizer, to deliver a rebuttal to a small group of research scientists who have sworn off any industry-financed drug research work. Report

> An international consortium of researchers has launched a billion-dollar effort to map every way that changes in DNA contributes to the development of tumors. Report

> Mark Levin earned a reputation for a colorful personality with an incredible knack for raising cash as co-founder of Millennium Pharmaceuticals. Now Levin has sealed his reputation for raising cash with a $32 million Series A to get Constellation Pharmaceuticals up and running. Report

> With three significant development programs at work on a tamper-free alternative to the blockbuster OxyContin franchise, Purdue Pharma is bracing for an upcoming FDA panel review of its new pain therapy formulation. Report

> Unigene is racing to complete construction of new facilities in China that will house its joint venture with a Chinese pharma company. Report

And Finally ... Two new human trials of a gene therapy for inherited blindness have demonstrated that injecting replacement genes under the retinas of the blind can spur at least partial sight in some volunteers. Report

ALSO NOTED: Bayer sues Watson over Yasmin; Zimmer weeds out doc conflicts

Mon, 21 Apr 2008 06:59:50 -0400

> Open another chapter in the Bayer fight to protect Yasmin patents: Watson Pharmaceuticals filed for FDA approval for its copycat version of the birth control pill, and Bayer sued to keep the drug off the market. Release

> Device maker Zimmer is working to cut "potential or perceived conflicts of interest" in any consulting deals with docs, by banning all gifts to healthcare professionals, pulling back on sponsoring doctor presentations at conferences, and reviewing royalty deals for potential conflicts--and in some cases, suspending payments. Report

> Alabama's Supreme Court ruled that GlaxoSmithKline and Novartis will have to face claims that they inflated Medicaid drug prices--together. The drugmakers had argued for separate trials. Report

> Shire has seen its share price drop by 22 percent over the past six months as investors worry that patients aren't switching to the ADHD treatment Vyvanse, its lead drug. Report

> India's Dabur Pharma said longtime shareholders the Burman family would sell its entire 65 percent stake in the company to a unit of Germany's Fresenius. Report

> Amylin Pharmaceuticals posted a larger first-quarter loss on higher marketing costs for diabetes meds Byetta and Symlin; the company lost $68.8 million last quarter versus $49.4 million during the same period last year. Report

> QLT said that its Visudyne eye treatment marketed by Novartis posted first-quarter sales of $36.5 million, a decline of 40 percent from first quarter of last year, because of increased competition from new macular degeneration meds. Report

> BrainCells is moving its lead program into a Phase IIa trial after boosting its second venture round with a second tranche. Report

> The FDA is prepared to back a new safety standard on preclinical drugs that could--at some point--significantly reduce the time and expense of testing a new therapy. Report

> The war between Biogen Idec and Wall Street raider Carl Icahn is heating up. Report

> Wyeth and Elan have suspended dosing patients in a mid-stage study of the experimental Alzheimer's vaccine ACC-001 after seeing one of the patients in the study develop skin lesions. Report

> The U.K.'s Renovo has seen shares bounce back on the news that two more mid-stage studies have produced positive results. Report

And Finally... With a new safety threat reported almost every day, is this becoming the United States of Anxiety? Report

SPOTLIGHT: Wyeth sues Watson to quash generic

Fri, 14 Mar 2008 07:59:52 -0400

It's Watson Pharmaceuticals and Wyeth in the ring, as Watson filed for FDA approval to sell a generic version of Lybrel, a birth control pill, and Wyeth responded by suing for patent infringement. Report, Report

ALSO NOTED: Government could force doc disclosures; Barr sues Watson over Seasonique patent;

Thu, 06 Mar 2008 06:59:50 -0500

> The government is considering requiring pharma companies to disclose their doc-consulting deals as part of any settlement agreements. Report | Report

> Duramed, a Barr Pharmaceuticals subsidiary, filed a patent infringement suit against Watson Pharmaceuticals, alleging it had infringed on its patent for the contraceptive Seasonique. Release

> Teva sued the FDA for denying its exclusivity period for its version of the antipsychotic Risperdal, which goes off patent this year. Release

> Genzyme launched its phosphate-binding drug Renvela for use in dialysis patients in the U.S. Release

> Baxter may test its immune booster Gammagard against Alzheimer's after a medical claims analysis indicated the risk of developing the disease could be reduced in patients previously treated with the med. Report

> A new study showed that Novartis' cancer drug Gleevec could harm fetal development if the child was conceived during treatment. Report

> With no "firm" buyout offers coming in, PDL BioPharma has decided to axe 260 workers--on top of the 320 layoffs already announced--and take itself off the market. Report

> After concluding that its late-stage trial of MC-1 failed to hit its primary endpoint, Medicure has announced plans to slash 50 workers and full-time consultants. Report

> The FDA is sending signals that it will start to let deadlines for drug approvals go by the wayside. Report

And Finally... Surgery may effectively cure Type II diabetes, according to a new study in Diabetes Care. Report

Fosamax leads 2008 patent retreat

Wed, 06 Feb 2008 06:59:56 -0500

Fosamax is dead! Long live generic Fosamax! Reporters took the osteoporosis drug's patent expiration today as an opportunity to remind us all that $20 billion worth of drugs will go off patent this year, cutting big-time into Big Pharma's sales. Merck, for instance, expects Fosamax sales to drop to at least $1.5 billion from $3 billion in 2007, and to erode further as time goes on.

BusinessWeek kindly provides a list of products that will fall off the patent cliff in 2008, along with manufacturer, indication, 2007 revenues, and expiration date:

Fosamax, Merck, osteoporosis, $3 billion, Feb. 6
Advair, GlaxoSmithKline, asthma, $6 billion, Feb. 12
Serevent, GlaxoSmithKline, $500 million, Feb. 12
Sonata, Wyeth, insomnia, $85 million, June 6
Effexor XR, Wyeth, depression, $3.7 billion, June 13
Lamictal, GlaxoSmithKline, bipolar disorder, $2 billion, July 22
Topamax, Ortho McNeil, epilepsy and migraine, $2.5 billion, Sept. 26
Casodex, AstraZeneca, prostate cancer, $1.2 billion, Oct. 1
Trusopt, Merck, glaucoma, $700 million, Oct. 28
Zerit, Bristol-Myers Squibb, HIV, N.A., Dec. 24

One strategy that more drug makers are using--including Merck with Fosamax--is creating so-called "branded generics." They're authorized copycats licensed to a generics maker. That way, the branded drug maker gets to reap some of the generics revenues rather than ceding them all to copycat drug makers. Watson Pharmaceuticals will sell a Merck-made generic Fosamax starting today, the company announced.

- check out Watson's release on its generic Fosamax
- read the trend article in BusinessWeek
- get more Merck-related details at CNN Money

Related Articles:
Merck joins Fosamax copycats. Report
Merck expects $1.8B hit on Fosamax. Report
Blockbusters on their way to generic-land. Report

ALSO NOTED: Japan to get Roche's Tarceva next week; Barr sues two generics makers over Seasonale;

Fri, 14 Dec 2007 06:59:50 -0500

> Roche's Japanese unit Chugai Pharmaceutical is preparing to launch the lung-cancer drug Tarceva, approved in Japan in October for treatment of the non-small cell form of the disease. Report

> Barr Pharmaceuticals sued Watson Pharmaceuticals and Sandoz for infringing the patent on Seasonale, a birth control product made by Barr's Duramed unit. Report

> The FDA gave its blessing to Kuvan, a BioMarin Pharmaceutical drug designed to treat the genetic disorder phenylketonuria. Report

> Isis Pharmaceuticals promoted B. Lynne Parshall to chief operating officer; she'll also retain her position as CFO and director. Release

> Forest Laboratories announced that several companies are seeking approval to sell copycat forms of its Alzheimer's drug Namenda. Report

> GlaxoSmithKline is sinking $100 million into a neuroscience research center in China that will play a pivotal role in its ongoing drug discovery work. Report

And Finally... For protection, HIV and aggressive cancer cells cloak themselves in carbo-clothing worn by human sperm. Report

In Puerto Rico, costs send pharma packing

Mon, 19 Nov 2007 06:59:55 -0500

Poor Puerto Rico. Pharmaceuticals firms are shutting down plants in the U.S. territory, eliminating some 3,000 jobs. Reasons for the closures include Big Pharma's worldwide restructuring, Puerto Rico's expiring tax breaks and high utility bills. Already, Teva Pharmaceuticals, GlaxoSmithKline, Schering-Plough, Watson Pharmaceuticals and Bristol-Myers Squibb have either shuttered facilities or announced plans to do so.

Local lawmakers could remedy the situation by offering new industrial tax breaks to replace an IRS provision that expired last year, but they've been unable to agree on a new approach.

- read this report for more

Related Article:
GSK plant closure begins 5,000 job cuts. Report

ALSO NOTED: GSK preps for India drug launches; Watson proceeds with challenge to Bayer drug;

Wed, 07 Nov 2007 06:59:50 -0500

> GlaxoSmithKline is preparing to launch its breast cancer drug Tykerb in India by early next year, with critical care and cardio drugs to follow. Report

> The 30-month clock is now ticking on Watson Pharmaceuticals' FDA application for its version of Bayer's Yaz contraceptive; the generics maker filed for approval two days after Bayer sued to stop the copycat drug. Release

> Japanese drug makers Daiichi Sankyo and Astellas Pharma, who are vying for the No. 2 ranking in their country, posted solid sales for the first half of the year. Report

> China blacklisted 16 misleading drug ads, bringing the total number of unacceptable ads aired since March to 26,644; some 11 drug makers have had their advertising licenses revoked for false advertising. Report

> A top Army trauma surgeon has drawn fire for using a NovoNordisk hemophilia drug off-label to stanch bleeding from war wounds, but he has plenty of fans who believe he's revolutionizing soldiers' care. Report

> Pfizer researchers rolled out the data on torcetrapib--the would-be blockbuster felled by data indicating a heightened risk of death and stroke--at the annual scientific meeting of the American Heart Association. And the numbers were being carefully scrutinized by Merck and Roche, which are advancing a group of similar drugs. Report

> Momenta Pharmaceuticals took its turn at the Wall Street whipping post as investors respond to the news that the FDA has rejected its generic version of the anti-clotting drug Lovenox, which is made by Sanofi. Report

> Novartis is staring at some serious problems rolling out its diabetes drug Galvus. Report

> Neural stem cells were used to stimulate the learning and memory abilities of mice engineered to mimic the severe disabilities produced by Alzheimer's and stroke. Report

> A chemistry professor at the University of Illinois at Urbana-Champagne says that an iron-based catalyst she developed with a colleague could speed the drug development and manufacturing. Report

And Finally... A genetic modification of a single metabolism gene helped scientists create a new breed of supermouse that can run faster and longer than ever possible. Report