European approval

Wyeth bails on European Pristiq app

Tracy Staton — Thu, 16 Oct 2008 10:15:43 -0400

Wyeth just can't catch a break on Pristiq. The company withdrew its European application for the antidepressant, known as Ellefore in that market, because drug watchdogs there aren't convinced it works well enough to warrant approval.

Cleared for marketing as an antidepressant in the U.S., Pristiq is based on the active ingredient in Wyeth's now-off-patent blockbuster Effexor. Some doctors and researchers question whether the drug is much different from--or better than--other antidepressants already on the market.

As you know, Wyeth hasn't been much more successful at getting Pristiq the nod as a treatment for menopausal symptoms. It withdrew its European application for that indication in March, and last July it received the dreaded "approvable" letter from the FDA.

Now, the company is trying to figure out what to do in Europe. Wyeth really wants to get Pristiq/Ellefore onto the Euro-market, but it's not sure of the best strategy. One option could be seeking approval from individual countries one by one, rather than the EU as a whole. Analysts expect European approval to take at least two more years.

- here's Wyeth's release
- read the WSJ story

Rumor Mill: Pfizer eyeing MediGene

Wed, 14 May 2008 06:59:54 -0400

Rumors are swirling that Pfizer is looking to take over the German biotech MediGene. Shares of the smaller company leapt more than 12 percent today as reports of a possible deal hit the newswires. Neither company would comment on whether they've held talks, as reports suggest.

MediGene specializes in cancer, autoimmune disease, and skin disease; its two marketed products are the prostate cancer treatment Eligard and a genital warts med Veregen. European approval for a skin drug, Oracea, is pending. In the pipeline: A pancreatic cancer drug, Endotag.

- see the story in Forbes
- check out the brief at Thomson Merger News

ALSO NOTED: Apotex assails Canadian goodwill drug program; Amgen CEO: "I felt real economic pain";

Fri, 09 May 2008 06:59:50 -0400

> After winning a bid to produce and ship generic AIDS drugs to Rwanda, Apotex says it won't participate in the goodwill program again unless the Canadian government simplifies the process. Report

> What do you do when your biggest therapeutic earners are swooning, your stock price is down and analysts have turned scornful? Look for that silver lining. That was Amgen's CEO Kevin Sharer's approach yesterday when he was confronted by an angry horde of shareholders at the company's annual meeting. Report

> FDA chided Shire for distributing Fosrenol promotional materials that fail to include information on the drug's indication and risks. Report

> India's FDA got FDA approval for its glaucoma treatment. Report

> Quintiles Transnational said it had agreed to buy Eidetics, a decision-analytics and market research firm, as a bid to expand its pharmaceuticals consulting business. Report

> FDA gave its blessing to the atypical antipsychotic Abilify as an add-on treatment for bipolar disorder, Bristol-Myers Squibb and partner Otsuka Pharmaceutical announced. Release

> Astellas Pharma won European approval for Mycamine, its antifungal drug. Release

> Germany's Gruenenthal announced it would add $76 million to its trust fund set up in the 1970s to compensate thalidomide victims. Report

Earnings News

> Weak U.S. sales depressed Barr Pharmaceuticals' first-quarter profits as the company faced surprise competition on a new generic of Fosamax, Merck's osteoporosis drug. Contraceptive sales also fell short. Report | Report

> Japan's Takeda posted a 5.9 percent hike in profits for its year ended March 31, but said its purchase of Millennium Pharmaceuticals will put a damper on the new fiscal year's earnings. Report

> Hungarian drugmakers Richter Gedeon announced a 41.7 percent increase in first-quarter profits to $62.25 million, but it cut its sales forecasts for the U.S. and Hungarian markets. Report

> Warner Chilcott posted net income of $33.7 million on a 5.1 percent increase in revenues to $229.5 million. Release

> Weak sales of its allergy drug Elestat depressed Inspire Pharmaceuticals' first-quarter results, leading to a $25.9 million loss that disappointed Wall Street. Report

Biotech News

> Backed by a positive review from FDA staffers, an expert panel at the agency has recommended the agency approve Eisai's fospropofol disodium, a sedative designed for use in a number of procedures. Eisai report

> Eli Lilly has won FDA approval of Strattera, a therapy designed to treat ADHD. Lilly says this is the first regulatory win for a non-stimulant ADHD drug in a market dominated by two stimulants--Adderall (Shire) and Ritalin (Novartis). Report

> The life sciences equipment maker Millipore is looking extra green today. The company announced plans to reduce its carbon footprint by 20 percent. Millipore report

And Finally... The Financial Times delves into the push to develop new therapeutics from traditional Chinese and Indian remedies. Report

ALSO NOTED: FDA interviews for Singulair psych effects; Wal-Mart offers 90-day scrips for $10;

Mon, 05 May 2008 06:59:50 -0400

> The FDA is collecting personal stories of suicide and other unusual side effects from Merck's allergy med Singulair as part of a nine-month review of the drug's safety; parents of one teen are lobbying for a "black box" warning of mood changes and suicidal thoughts. Report

> Wal-Mart said it's rolling out a new phase of its generic-drugs program, promising to fill many 90-day scrips for $10 and offering several women's meds--including the cancer drug Tamoxifen--for $9 a month or $24 for a 90-day supply. Report

> New Zealand's government drug-buying agency has started a court-ordered study on whether it should fund 12-month courses of the breast cancer drug Herceptin, rather than the nine-week course it now pays for. Report

> GlaxoSmithKline inked a deal to sell Japan-based Astellas Pharma's injectable anti-fungal Micafungin in India. Report

> A slowdown in pharma has braked sales of Applied Biosystems' mass spectrometers, depressing overall quarterly revenue growth to 4.3 percent. Report

> Boehringer Ingelheim got European approval for use of its Aptivus drug in HIV-positive patients resistant to commonly prescribed meds. Report

> Employees at a former Merck plant in Karachi, Pakistan, are balking at the loss of their stock options after the plant was sold to Organon BioSciences. Report

> Pfizer is still hunting for buyers for two factories in Cork, Ireland, some 15 months after putting those facilities on the market. Report

> Alpharma posted a tenfold rise in first-quarter profits, to $163.1 million, on a leap in revenues from its Flector pain patch. Report

> Novartis' painkiller Voveran has overtaken Pfizer's Corex cough syrup as the fastest-selling drug in India. Report

> In an effort to bring expenses in line with revenues, Valeant is cutting 130 workers in the U.S. and Mexico. Report

> Discovery Labs has been dealt another blow in its quest to gain approval for Surfaxin, a treatment for premature infant respiratory distress syndrome. Report

> Roche has exercised its option to further develop and commercialize Memory Pharmaceuticals' drug candidate, MEM 3454, for various neurological and psychiatric disorders. Report

> Critical Therapeutics is merging with Cornerstone BioPharma Holdings, a specialty pharmaceutical company that develops treatments for respiratory disorders. Report

And Finally... Another windfall from the Neurontin marketing settlement: Consumers Union has nabbed a $4.4 million grant to distribute free, unbiased prescription drug info. Report

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: Pharma plant explosions in India, Ireland; Sanofi inks $192M avian flu vaccine deal;

Mon, 28 Apr 2008 06:59:50 -0400

> At least one worker was killed and others seriously injured in two separate pharmaceutical-plant explosions, one at Sirius India Ltd. in Hyderabad, India, and the other at Cordon PharmaChem in Little Island, Ireland. Report | Report

> Sanofi Pasteur announced a $192.5 million contract to provide 38.5 million doses of avian influenza vaccine to the U.S. government. Report

> Australia's drug watchdogs have received a petition to change the Roche antiviral Tamiflu to an over-the-counter drug so that patients can get it quickly enough to be effective. Report

> India's Lupin launched its urinary tract infection treatment Suprax in the U.S. Report

> Bayer got European approval to market its Zevalin lymphoma treatment as an add-on to first-line chemo; previously the drug was only approved as a second-line treatment. Report

> Apotex is suing the FDA for 156 more days of exclusivity on generic Plavix; the company launched its copycat version at risk in 2006, but was stopped by a preliminary injunction 23 days later. Report

> Glenmark Pharma posted fourth-quarter profits of 2.19 billion rupees, triple the same period a year ago. Report

> There's a big sigh of relief coming from Wyeth and Progenics as the FDA approved Relistor, a subcutaneous injection for opioid-induced constipation in patients with advanced illness who are receiving palliative care. Report

> Solvay has made a $278.2 million (€177.6 million) takeover bid for Belgium's Innogenetics. Report

> Another day, another big biotech deal. This time it's Japan's Astellas Pharma, which is paying $760 million for access to CoMentis's Alzheimer's drug. Report

> Which Massachusetts-based biotechs are ripe for buyouts. Report

And Finally... Would patients be better off if doctors stopped accepting insurance? Report

SPOTLIGHT: Boehringer beats Bayer drug to market

Thu, 27 Mar 2008 07:59:52 -0400

Boehringer Ingelheim won European approval for its new blood thinner Pradaxa to prevent clotting in patients after orthopedic surgery. The OK lets Pradaxa beat to market its supposed future rival, Bayer's yet-to-be-approved Xarelto (rivaroxaban). Report

ALSO NOTED: GSK faces Tyverb setback over safety; Boehringer warns of inhaler's stroke risk;

Wed, 19 Mar 2008 07:59:50 -0400

> GlaxoSmithKline's cancer med Tyverb--sold in the U.S. as Tykerb--faces a reassessment for European approval on news that a small number of patients have suffered liver side effects. Release

> Boehringer Ingelheim warned regulators that patients using its respiratory inhaler Spiriva Handihaler face a greater risk of stroke. Boehringer jointly markets the treatment with Pfizer for use in chronic obstructive lung disease and emphysema. Report

> Takeda Pharmaceutical is reportedly close to a deal to buy out Abbott Laboratories' interest in their joint venture, TAP Pharmaceutical Products. Report

> Big Pharma's collective stampede from the inhaled insulin field is claiming the jobs of 150 people who work at Alkermes. Report

> Kosan Biosciences is laying off more than a third of its 91 workers as the developer concentrates its resources around its lead cancer therapies in a restructuring that has also shuffled its newly appointed president into the CEO's post. Report

> Switzerland's Basilea took its turn on the public markets' whipping post, shedding 27 percent of share value after announcing that its antibiotic ceftobiprole had failed to quickly win over FDA regulators. Report

> The argument over the FDA's role in regulating cancer therapies often comes down to one man: Dr. Richard Pazdur, a veteran oncologist and chief of the agency's oncology office. Report

> A team of scientists led by British Nobel laureate Sir Aaron Klug has advanced a new approach to gene therapy. Report

> What do you get when you mix 20 drug developers active in the diabetes field with a room full of geneticists? Hopefully, a new generation of therapies that pinpoint subsets of the disease. Report

And Finally... Scientists are heralding a breakthrough on blindness therapies. Report

ALSO NOTED: FDA announces generic Risperdal, then retracts; Botox maker probed for off-label marketing

Wed, 05 Mar 2008 06:59:50 -0500

> The FDA announced that it had approved Ranbaxy's version of the Johnson & Johnson antipsychotic Risperdal--only the Indian firm hadn't applied. The agency quickly issued a retraction; Risperdal isn't scheduled to go off-patent till June. Report

> Botox maker Allergan may be in hot water for promoting the injection as a headache remedy, an off-label use; the Department of Justice is investigating. Report | Report

> Sanofi-Aventis got European approval to sell a 300 mg "loading dose" of its blood-thinner Plavix. Report

> A Nigerian court granted bail to a former Pfizer exec jailed in connection with a lawsuit over a meningitis drug trial in that country. Report

> Drug developers with questionable data beware. The FDA is taking no prisoners, and handing out no approvals, for developers suffering from data integrity issues. Report

> Cambridge, Massachusetts has been home to many of the world's most innovating drug developers--and now it's home to a start-up in the biotech fold that is pioneering a pricey new service to map the entire genetic code of individuals. Report

> When is a cancer therapy good enough? The Boston Globe examines answers to that question following the recent controversy over the FDA's decisions in the field. Report

> Leaders in the nanotech field have been beating a path to Congress, asking lawmakers to significantly boost federal support of research into molecular-level advances. Report

> Hormones produced by the heart could play a remarkable role in controlling and perhaps even curing cancer. Report

> Forget those studies of long-lived Italian shepherds and Greek fishermen. It's not fresh air or exercise or a simple whole-foods diet that causes certain people to live past 100, a new study shows. Instead, it's a set of genetic mutations thought to interfere with normal cell growth and thus slow aging. Report

And Finally... Several of the world's top biomedical research institutes--including a couple run by biopharma giants--have made this year's list of the best places for postdocs to work. Report

EU blesses Avastin for broader use

Mon, 28 Jan 2008 06:59:54 -0500

Here Avastin, there Avastin, everywhere there's Avastin. Roche got European approval to use the cancer therapy with any type of chemo for patients with advanced colorectal cancer.

Designed to inhibit tumor growth by choking off their blood supply, Avastin was first approved in the U.S. in 2004 for colorectal cancer, and since has been OK'd for use in other forms of the disease; in Europe, the med is sold for kidney, lung, and breast cancer in addition to bowel cancer. But unfortunately for Roche, the FDA appears set to reject the drug for use in breast cancer next month, after an advisory panel gave the indication a thumbs-down.

Meanwhile, Bayer got the OK from Japanese regulators to sell its cancer drug Nexavar as treatment for advanced kidney cancer. Bayer partners with Onyx Pharmaceuticals on the drug.

- see the release from Roche
- read this MarketWatch report
- check out this Bayer-Nexavar piece

Related Articles:
Avastin re-submitted to FDA. Report
MAbs are hottest segment of biotech industry. Report
FDA approves Avastin for lung cancer. Report

Avastin wins new regulatory approval

Fri, 24 Aug 2007 06:59:58 -0400

Watch a blockbuster cancer drug become a behemoth: Roche has won European regulatory approval for treatment of advanced non-small cell lung cancer with Avastin. The approval came on the strength of trials that showed "improved survival benefits beyond one year in NSCLC patients," the company said. It's the first new treatment for NSCLC in more than 10 years that's demonstrated an ability to extend patients' lives.

This is Avastin's third indication for cancer treatment in Europe. Previously the drug has been used to treat metastatic colorectal cancer and breast cancer there; in the U.S. it's also approved for NSCLC. Roche is exploring its use in pancreatic and ovarian cancers, among others. Already this year, Avastin sales have topped $1.5 billion, 40 percent higher than last year's first-half figures.

- see this announcement on the approval
- check out the AP report

Related Articles:
Patients balk at Avastin's $100,000 price tag. Report
Avastin encounters rare failure for pancreatic cancer. Report
FDA approves Avastin for lung cancer. Report