Approvable letter

ALSO NOTED: Valeant to halve its workforce; Pharma testing mobile marketing waters;

Fri, 02 May 2008 06:59:50 -0400

> Valeant Pharmaceuticals said it will cut 130 jobs in the U.S. in Mexico, on top of the 1,250 positions set to go when the company sells off its European subsidiaries. Valeant report

> As text-messaging grows in the U.S., more pharma companies are dipping their toes into mobile marketing via the brief communications, according to a report from PharmaVoice. Report

> Australian drug companies are joining the chorus of firms asking their governments to cut corporate taxes or suffer a pharma exodus. Report

> Glenmark Pharmaceuticals expects to launch five drugs each quarter of 2008, plus file 25 apps for new generic drugs, chairman Glenn Saldanha said. Report

> Discovery Laboratories got an "approvable" letter from the FDA on its Surfaxin med for prevention of respiratory distress in premature babies. Release

> China Pharma Holdings reported a 62 percent spike in revenue to $11.7 million; profits grew even more, by 76.5 percent to $4.2 million. Release

> A major shareholder in Enzon Pharmaceuticals is calling for the resignation of several board members for approving the "runaway" compensation of CEO Jeffrey Buchalter. Report

> Penwest Pharmaceutical lost 41 cents per share, or $10.3 million, in the first quarter as revenue dropped to $739,000. Report

> The transatlantic EUSA Pharma has spun off its monoclonal antibody research operation along with a development program for leukemia as it narrows its focus to late-stage drug development and marketing. EUSA report

> Sepracor has struck a licensing deal with Arrow International Limited for the intellectual property rights related to stable sterile steroid suspension formulations and other applicable nebule technology for the use in developing ciclesonide, a corticosteroid. Sepracor report

> Nucryst Pharmaceuticals has shaken up its management and shelved one of its development programs. Nucryst report

Special Report... CEO Pay: Who makes what in Big Biotech? Report

And Finally... Some 23 percent of Americans admitted lending their prescription meds to someone else, and 27 percent confessed to borrowing them. Report

ALSO NOTED: Merck's Cordaptive fails to get U.S. approval; Medtronic sub faces FDA-imposed outage;

Tue, 29 Apr 2008 06:59:50 -0400

> In a blow to Merck's 2008 plans, the cholesterol candidate Cordaptive failed to get the FDA's OK; in a "not approvable letter," the agency asked for more data. Release

> The FDA has imposed new requirements on Medtronic's Physio-Control subsidiary after finding new manufacturing problems affecting its external defibrillators; the company faces an extended outage as it fixes the problems. Report

> Five officials from a Chinese pharma were sentenced to prison time for selling a tainted antibiotic that killed 13 people in 2006. Report

> Britain's consumer watchdog has asked GlaxoSmithKline--along with a host of big brand-name companies--for pricing information as part of a price-fixing probe. Report

> As more drug marketing migrates online, pharma companies are struggling to determine their ROI on Internet promos. Report

> The Clinton Foundation and international drug-purchasing consortium Unitaid have struck deals for deeper discounts on more than 40 generic AIDS meds. Report

> The Indian government is mulling plans to cap retail drug margins and penalize drug makers that give pharmacists higher-than-allowed mark-ups. Report

> Pfizer plans to launch its stop-smoking drug Champix in Japan on May 8. Release

> Merck's Indian subsidiary launched its diabetes treatment Januvia in the subcontinent at a price comparable to other diabetes drugs. Report

> Teva got the FDA nod for its generic version of GlaxoSmithKline's Flolan, an IV drug for hypertension. Report'

> In what may signal a major shift in FDA standards, Isis and Genzyme say that they expect to add another year to the development timeline for a closely watched cholesterol therapy in order to produce data demonstrating a reduced risk of heart attacks and related diseases rather than just an ability to lower levels of cholesterol. Report

> Economic development officials in Baltimore are fretting that they're one step behind the pace being set in Montgomery County, where low-cost lab space along with offers of small loans and grants have been luring away emerging drug developers. Report

> Shares of Medarex slipped seven percent this morning as investors digested Friday's announcement that its application for a new cancer drug will be delayed into 2009. Medarex report

And Finally... Feeling thick-headed? Train your brain to be more intelligent. Report

ALSO NOTED: Appeals court votes for FDA approval shield; Suicides rose as depression treatment fell;

Wed, 09 Apr 2008 06:59:50 -0400

> A federal appeals court backed the drug industry's arguments that it should be insulated from lawsuits over FDA-approved products, ruling 2-1 that antidepressant makers GlaxoSmithKline and Pfizer could not be held liable for the suicides of two patients using SSRIs. Report

> A new study shows rising suicide rates among children and teens in Canada, two years after drug regulators there warned of the safety risks of antidepressant use in children; the climbing suicide rate coincided with a 10 percent drop in the rate of doctor visits for depression treatment among children. Report

> Galderma Pharma has wrapped up its $420 million tender offer for fellow dermatology drug company CollaGenex Pharmaceuticals. Report

> Louisiana's new attorney general withdrew a multimillion-dollar antitrust lawsuit filed against Amgen by his predecessor. Report

> The healthcare and IT company McKesson has agreed to pay $190 million for McQueary Brothers Drug Co., a pharma and beauty products distributor based in Springfield, Mo. Report

> Novartis' plans to erect three wind turbines on its Grimsby, England, campus have drawn fire from environmentalists worried that the huge windmills might disturb birds. Report

> India's Dabur Pharma has agreed to supply Thailand with a copycat form of Sanofi-Aventis' Taxotere, which the Thai government is importing under a patent-busting compulsory license. Report

> Estrogen-only hormone replacement therapy has been linked to a benign breast-lump disease that's often a precursor to cancer. Report

> There's a shakeup under way at Inotek. The Beverly, MA-based developer says it is closing several international sites and a pilot manufacturing facility in Israel as it focuses all of its efforts on its two main programs and two preclinical programs. Report

> Endo Pharmaceuticals says a close reading of a non-approvable letter from the FDA for Frova prompted officials to pull their request to gain approval for the short-term relief of menstrual migraine. Report

> Scientists at Memorial Sloan-Kettering Cancer Center in New York City have identified the molecular process by which breast cancer cells spread to other tissue during metastasis. Report

And Finally... Russia has improbably emerged as a world leader in new cancer vaccines. The country's regulatory body approved the use of Antigenics' new kidney cancer vaccine, Oncophage--a world first. Report

FDA nixes long-acting Zyprexa

Thu, 28 Feb 2008 06:59:58 -0500

Who at the FDA really cares what those advisory committees think? The FDA has nixed Eli Lilly's plans for a long-acting formulation of its antipsychotic Zyprexa, once again ignoring an advisory committee vote. Eli Lilly's troubles with the drug appear to be related to a small number of cases of "profound sedation" among patients taking the injected drug. When the committee voted, those cases had been restricted to a few hours of profound sedation after injection. But since then, another case was reported when the sedation affect occurred three to five hours after injection. And that's what the agency cited in the non-approvable letter.

For its part, Lilly suggests the adverse effects may have been triggered by physicians who injected the drug into the patient's blood stream, rather than muscle. But the agency is demanding more data before it hands out an approval.

The bad news came as Eli Lilly was preparing for its first civil case on Zyprexa from a patient suing over the side effects of the drug, which include weight gain and diabetes. Analysts say the verdict could affect Lilly's reported negotiations for a big settlement over the drug with states and the federal government.

- see this release
- read the report in the Wall Street Journal
- check out the AP article

Related Articles:
Zyprexa shot gets panel's OK. Report
Lilly strengthens Zyprexa warnings. Report
Lilly accused of promoting off-label Zyprexa use. Report
NYT accuses Lilly of hiding safety problems. Report
Zyprexa--Top 10 Warnings and Recalls. Report

FDA shoots down Mevacor OTC

Mon, 28 Jan 2008 06:59:56 -0500

It's official: Merck's off-patent statin drug Mevacor can't go over-the-counter. About a month after an advisory panel said "nay" to the idea, the FDA sent Merck a not approvable letter. It's the third time the agency has denied Merck's request to sell Mevacor without a prescription.

This time, there was an added wrinkle: GlaxoSmithKline had inked a deal with Merck for the over-the-counter rights to Mevacor in the U.S. So Merck was asking the FDA for an OK on GSK's behalf. The panel's chief concern: that even Merck's own patient survey showed some who shouldn't be taking statins would choose to do so.

Merck's OTC group is now "evaluating the conditions outlined in the agency's response" to see where to tack next. The FDA asked for a revised label--and, most importantly, for additional data. We'll see what Merck can pull out of its hat.

- see the release
- read the report from CNN Money
- here's a PharmaTimes article

Related Articles:
FDA panel: No can do on Mevacor OTC. Report
FDA unsure consumers can self-Mevacor. Report
Merck faces fierce debate on OTC statin. Report
GSK buys OTC rights to Merck statin. Report
Switching to generic statins not so healthy. Report

Sun copycat to cut $500M off Wyeth sales

Thu, 20 Dec 2007 06:59:58 -0500

Wyeth shouldn't be facing generic competition for Effexor XR until 2010. It already fought that battle in court, prevailing over patent challenges in 2005. But Sun Pharmaceuticals figured out how to put the drug in pill, rather than capsule, form--and because the active ingredient goes off patent in June, Sun will likely be able to launch its copycat med. Analysts expected Sun's drug to shave off 10 to 15 percent of Effexor XR sales. That's a $500 million-plus hit to Wyeth's top line.

Meanwhile, Wyeth has other problems, too. Generics firms are taking aim at Protonix, its blockbuster heartburn drug. Bifeprunox, its experimental antipsychotic, got a "not approvable" letter from the FDA in August. The agency in July asked for another one-year study before it will approve Pristiq, an antidepressant Wyeth wants to market for menopausal symptom relief.

And now Wyeth must deal with Sun's Effexor-like pill. The Indian generics maker will have a tough job marketing the new drug, because it's not an exact copy and so can't be automatically substituted for Effexor XR; docs will have to write prescriptions specifically for the Sun product. But that sales challenge isn't likely to help Wyeth execs sleep better at night.

- read the AP report

ALSO: Take a look at Wyeth's pipeline. Report

Related Articles:
Wyeth gets OK to use Effexor XR for panic disorder. Report
Wyeth names Poussot CEO. Report
Wyeth stumbles badly trying to develop new drugs. Report
Wyeth stock down after several setbacks. Report

Indevus gets approvable letter

Fri, 17 Aug 2007 06:59:55 -0400

Indevus got a preliminary FDA nod on Valstar, its bladder cancer therapy. The drug had been taken off the market in 2002 because of "impurities" in the original formula; since then, the company has revamped its process. In May, Indevus submitted a chemistry, manufacturing, and controls supplement to the agency.

The FDA's new approvable letter blesses the chemistry portion of the app and asks for more info about manufacturing. Company officials say they'll answer within two months, and that they expect to re-introduce VALSTAR late this year or early next.

- check out the release

Related Articles:
Indevus in $120M deal to acquire Valera. Report
Indevus halts research on pagoclone for PE. Report