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Archive for the ‘Allergan’ Category

COMING UP SOON: BDI’s Social Communications and Healthcare half-day gathering. NYC, May 11 – all details here. I will be leading a roundtable. Use discount code IMPACT for $155 registration rate.

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TODAY’S NEWS

Allergan - Rolling high-stakes legal dice re: Botox. Here and here.

Novo’s Victoza: nice results in comparison with Merck‘s Januvia. Plus, an experimental Januvia competitor gets dropped by Forest Labs.

Experimental once-a-day malaria drug looking really good – An experimental once-a-day malaria drug worked as well at treating the mosquito-borne illness as Novartis AG’s twice-daily pill Coartem, according to a study published today in the journal Lancetmore

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Serene Sunrises. 40. A visual treat.

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TODAY’S NEWS

Botox heading to an arm near you – The Food and Drug Administration said Tuesday it approved Allergan‘s botulinum-based drug Botox to treat spasms of the elbow, wrist and fingersmore

Abbott to boost pipeline with Facet buy – Abbott says the acquisition will boost its early- and mid-stage pharmaceutical pipeline. The developer has its eyes on two primary therapeutic areas–immunology and oncology. The highest-priority program is daclizumab, a Phase II biologic for multiple sclerosis that will move into Phase III trials in Q2 of 2010. Facet is already partnered with Biogen Idec on the compound. The biotech also has oncology compounds for multiple myeloma and chronic lymphocytic leukemia in early to mid-stage trialsmore

FDA panel gives (preliminary) green light to InterMune’s lung drug.

Jury verdict against Novartis for rep who claimed retaliation after taking maternity leave.

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More docs using e-Prescribing. Look for this to keep accelerating.

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Eye-catching examples of urban decay photography. More interesting than it sounds!

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TODAY’S NEWS

Spitting into the wind – Allergan sues the FDA about freedom of speech (esp. off-label discussions).  This particular legal discussion needs to happen, actually – but it takes a brass pair to be the one filing the suit!

Medical iPhone applications – list of 25 here, plus this one just released.

Genentech’s Lucentis: effective in a week in study – The optical drug Lucentis proved effective in two late-stage studies in improving the vision of patients with retinal vein occlusion as early as the seventh day of treatment, Genentech said on Sundaymore

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A doctor’s office you may just want to skip!

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Amgen gets approval for one (but not another) indication for their new bone drug – Food and Drug Administration experts unanimously voted that Amgen’s injectable drug denosumab helps prevent bone fractures in women with postmenopausal osteoporosis. But panelists said the drug should only be used by patients who face the greatest risk of fractures. In a separate 12-3 vote, the panel ruled against using the drug as a preventive measure for women with low bone density…more

Schering gets approval for new shizophrenia drug – Schering-Plough Corp. said Friday that the U.S. Food and Drug Administration has approved Saphris tablets for acute treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar disorder in adults. The pharmaceutical company said that Saphris is the first psychotropic drug to receive simultaneous initial approval for both indications…more

King‘s Embeda is approved by FDA: may help counteract pain-pill abuse – The Food and Drug Administration cleared the extended- release morphine product, Embeda, the agency said today in an e- mail. Embeda contains a chemical designed to counteract the morphine if the capsule is crushed, chewed or dissolved in alcohol to get the full dose at once. The company said, and the FDA agreed, the evidence wasn’t conclusive that the chemical truly interfered with the morphine high. More here at the WSJ Health blog.

Allergan‘s Latisse – maybe the new baldness treatment? Stay tuned!

I like to stay on top of early-on encouraging oncology advances. Many don’t pan out, of course. But this sort of result is a nice glimmer!

By the way…are you in need of a vendor/partner to help you develop specialty sales force training? Let me know and I can make a recommendation!

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Just what we need – another takeover rumor! Is GSK interested in Allergan? Or, perhaps, is Allergan interested in its own acquisitions?

Hospira cutting its workforce by 10%.

Dendreon finds a new way to endanger Provenge. This is a head-scratcher…

PLUS – Pfizer grabs its new Oncology Business Unit head from Cephalon.

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Procter and Gamble to leave pharma? Procter & Gamble Co is working with Goldman Sachs Groupto identify potential buyers for its pharmaceuticals brands or find other ways to exit the business, people close to the matter said late on Wednesday, the Financial Times reported. Plus, Allergan the latest to announce job cuts.

Green tea blocks effectiveness of popular cancer drug. Wow. Contrary to popular assumptions about the health benefits of green tea, researchers at the University of Southern California (USC) have found that the widely used supplement renders a cancer drug used to treat multiple myeloma and mantle cell lymphoma completely ineffective in treating cancer.

Novartis gets back to #1 with Managed Care Pharmacy Executives. Novartis’ rebound to No. 1 with pharmacy executives can be attributed to a big win in the area of value-added services, taking the top spot away from Pfizer. One pharmacy executive said, “Novartis has strongly responded to a previous deficiency in this area.” Pharmacy executives considered Novartis a leader in value-added services due in large part to its successful patient education materials and staff support.

PLUS – J&J and Social Media. A recap on the Eye on FDA blog. And – Pharma earning back trust – it’s a long post, but well worth the read. It ain’t just a PR problem, folks…from John Mack‘s Pharma Marketing blog.

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The Sales Force Shuffle, from Pharmaceutical Executive – The last week the pharma atmosphere was abuzz with news about sales force cuts, outsourcing, and overhauls. First, Schering-Plough announced that it had eliminated the 1,000 sales positions it said it would trim in April. This is being done as part of a new sales model called—internally—a productivity transformation program (PTP). The new model, to go into effect next month, will streamline the sales force to take a more customer-centric approach, including targeted and relevant physician calls and a relationship management–oriented business model…more

Alpharma to King: No. – In a filing with the Securities and Exchange Commission, Alpharma calls the $37-a-share offer was inadequate and continues to explore all strategic alternatives, including a possible sale to King or another party for a higher price…more

Lilly CEO to Boston: you’re scaring us away – The ink is barely dry on a new law governing how drugmakers can market to docs, but Lilly’s John Lechleiter isn’t wasting time trying to make lawmakers regret their decision. In remarks to the Associated Industries of Massachusetts Executive Forum, he claims the law will hamper innovation and force companies to reconsider expanding in Massachusetts, The Boston Business Journal reports…more

B-I goes to the shrink – The drugmaker has ended a contract with InVentiv, one of the players in the Rent-A-Rep business, which was promoting its troubled Micardis, an angiotensin receptor blocker, otherwise known as a blood pressure med…more

The needle or the drug? – Acupuncture works as well as Wyeth’s antidepressant to fight hot flashes and other menopausal symptoms caused by breast cancer treatment, and its benefits last longer without causing unwanted side effects, according to new research…more

Pfizer’s Pfuture – The big drugmaker is dramatically stepping up sales efforts in emerging markets, overhauling US business operations and slashing more costs ahead of the 2011 patent loss for cholesterol blockbuster Lipitor, the Associated Press informs us…more Plus, going after emerging markets for growth

Paxil damages sperm? – A group of 35 healthy men who were given Paxil over a five-week period had higher levels of sperm with damaged DNA, according to a report..more

Medicis to re-state numbers; stock plunges.

Tarceva linked to liver damage - Genentech Inc and OSI Pharmaceuticals have alerted doctors about cases of liver damage among patients who took the cancer drug Tarceva in a post-approval study, U.S. regulators said on Tuesday…more

Takeda goes for diabetes combo – Takeda Pharmaceutical Co said on Wednesday it had applied for approval to market in the United States the SYR-322 and the Actos diabetes drugs in a single tablet for the treatment of type 2 diabetes…more

An interesting analysis on adverse event reporting, and social media.

Is the war on cancer really winnable? A realistic and pessimistic analysis from Newsweek.

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King begins hostile takeover proceedings with Alpharma – Brain Markison, King’s ceo, is disappointed that Dean Mitchell, Alpharma’s ceo, hasn’t responded to his initial offer $1.4 billion offer, which amounted to $33 a share. So Markison raised the bid to $37, or $1.6 billion, and is going directly to shareholders…more

J&J’s Christine Poon to retire.

ImClone to BMS: maybe we’re already dating – The drugmaker calls the $60-a-share bid by Bristol-Myers Squibb ‘inadequate,’ and goes on to say in a statement this morning that famed corporate raider Carl Icahn, who chairs ImClone’s board, has had ’several conversations with the ceo of a large pharmaceutical company,’ which was not named…more And more BMS-to-ImClone here, and on the response here.

Meanwhile, BMS grounding its fleet – Bristol-Myers Squibb is preparing to shut down its aviation operation at Trenton-Mercer Airport, sell four aircraft and dismiss about 32 employees as the drugmaker and leading Mercer County employer seeks to cut costs, according to sources familiar with the company’s plans…more

Amgen violating patents?

Can Botox relieve migraines?

FDA reports rare brain infection/death with Rituxan – The agency says a woman died of the rare viral infection more than a year and a half after discontinuing the drug, which is used to treat rheumatoid arthritis and non-Hodgkin’s lymphoma, and is marketed in the US by Genentech and Biogen Idec…more

Sanofi fills top job with Viehbacher from Glaxo – Chris Viehbacher, GlaxoSmithKline Plc’s head of North American operations, is to take a top job with French drugmaker Sanofi-Aventis, a person familiar with the situation said on Tuesday…more

Januvia, 2 years in: thumbs up – Merck & Co’s diabetes drug Januvia substantially improves blood sugar levels over two years of treatment when combined with the older drug metformin and is generally well tolerated, new data on Tuesday showed…more

Experimental diabetes drug (BMS/AZ) promising – Bristol-Myers Squibb and AstraZeneca’s experimental diabetes drug Onglyza significantly improves blood sugar control when added to older medicines, researchers said on Monday…more

Fast track for cancer drug Afinitor – An experimental drug from Swiss drugmaker Novartis AG has been granted priority review in the United States as a treatment for advanced kidney cancer. Novartis said on Tuesday that RAD001 or everolimus, which it plans to sell under the brand name Afinitor, had been accepted for fast review given the medicine’s potential to help patients who fail to respond to standard therapy…more

Tysabri for cancer? - Biogen Idec and Elan Corp have launched the first clinical trial of their multiple sclerosis drug Tysabri for patients with relapsed or refractory multiple myeloma, the companies said on Friday…more

Celgene gets a fast track for lung cancer drugCelgene Corporation (NASDAQ: CELG) today announced that Amrubicin has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for the treatment of small cell lung cancer after first-line chemotherapy…more

Is Pfizer interested in Bayer?

Sample trouble: drives up costs? – Free drug samples provided by drugmakers to doctors could actually be costing uninsured patients more in the long run, according to a new retrospective study in the Southern Medical Journalmore

The Allergan-Medicis “death match” – Allergan and Medicis have been locked in a highly profitable death-match for several years, with both companies bringing out me-too versions of the others’ products, just like Coke and Pepsi…more

But will it be posted in the Post Office? The FDA 20The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed…more

Zimmer growing some spine.

GSK and Valeant on epilepsy drug tie-up.

Pfizer and Medivation to work together on Alzheimer’s/Huntington’s treatment.

Genentech and Roche acting merged: facilities closing - The fallout from Roche’s looming acquisition of Genentech has started. Roche will close a research facility in Palo Alto, Calif., where a 1,000 people work, the San Jose Mercury News reports. Back in July Roche said it would pull the plug on the lab in Stanford Research Park, but the company hedged, saying the closure would happen if the bid for Genentech were successful. Genentech has demurred so far, but most people think it’s just a matter of time before the deal happens. And now, Roche told the Mercury News it’s closing the plant, no matter what…more

No vigil for Provigil at TakedaCephalon Inc. will end its co- promotion agreement with Takeda Pharmaceutical Co. in North America for the sleep-disorder drug Provigil, because net sales dropped to less than $850 million this year…more

UCB: Yep, we’re specialty now. Translation: downsizing – If you can’t buy a biopharmaceutical company, you might as well become one. UCB Pharma last week announced that it will trim 17 percent of its work force—about 2,000 employees—in order to reestablish the company as specialty drug firm….more

Every once in a while you want to visit here – Forbes’ New Drugs to Watch page.

This is way cool – A little-used cancer drug called bryostatin can repair brain tissue if it’s administered within 24 hours after a stroke, according to U.S. researchers. Current stroke treatments must be administered within three hours and aren’t able to repair damaged brain tissue, the scientists said…more

Shire and Vyvanse for ADHD – One of the recent unheralded successes of the drug world was Shire Pharmaceuticals‘ launch of Vyvanse, a new, long-acting treatment for attention deficit and hyperactivity disorder. The fact that so little attention has been paid to Vyvanse is a shame because the take-up of this drug has been impressive — it appears to be well on its way to supplanting Adderall XR as the king of the ADHD drugs…more

I kinda think this one’s a no-win for Genentech – Negative public opinion just keeps piling on to Genentech regarding its pricing policy on Lucentis and Avastin. This weekend saw a big Associated Press story describe how the company is refusing to ask the FDA to approve Avastin for use in treating “wet age-related macular degeneration,” an eye condition that leads to blindness. Genentech is doing this, most people believe, because Avastin would be a much cheaper treatment for wet AMD than Lucentis, another Genentech drug. It costs about $60 per dose to use Avastin on the disease, and $2,000 to use Lucentis…more

Speaking of no-win – releasing Vytorin data…more

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Lessons from Heath Ledger’s tragic death: Don’t mix prescription drugs.

Merck hands over a cool $649 million to settle allegations about marketing transgressions. Also, launches authorized generic of Fosamax, which lost patent protection this month.

GSK continues slumping due to Avandia decline.

Some Q&A about that recent diabetes study that was halted due to deaths in the (intensive sugar reduction) treatment arm.

Botox and deaths. Careful out there!

A vaccine for high blood pressure? This looks pretty intriguing!

Eisai fails to get a shot at early approval for a new cancer drug.

Promising new Schering drug (vicriviroc) may help suppress HIV when used in combination with older drugs.

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From the WSJ today

Drug That Lengthens Eyelashes Sets Off Flutter

By RHONDA L. RUNDLE
November 19, 2007; Page B1

In the latest blurring of the line between cosmetics and drugs, new products that promise to make eyelashes look longer are causing a stir among physicians and regulators because they contain ingredients that are the same or similar to those in prescription drugs for an eye disease.

Doctors and patients alike have noticed that eyelash growth is a side effect of a glaucoma drug called Lumigan, sold by California drug maker Allergan Inc. That phenomenon has set off a race among cosmetics companies to create new eyelash treatments that contain either bimatoprost — the active ingredient in Lumigan — or other so-called prostaglandins found in glaucoma drugs.

[Eyelash]
Before and after using Lumigan daily for 10 weeks

The eyelash products look like mascara tubes and have a brush or tip for applying the product along the base of the lashes, and typically sell for $140 to $160 in spas and doctors’ offices. At the same time, some doctors are writing Lumigan prescriptions for their cosmetic patients, a practice allowed because a drug may be prescribed for any use once it is approved by the U.S. Food and Drug Administration for one use.

But the companies pushing into this arena are already facing two big fights: one with each other, the other with the FDA.

Allergan itself, which sells the antiwrinkle drug Botox and is making a major push into aesthetic medicine, is believed to be testing Lumigan for lash enhancement. That strategy would echo Allergan’s development of Botox for cosmetic use many years after it was launched to treat eyelid spasms and other neuromuscular problems. Earlier this month, Allergan filed a patent-infringement suit against several eyelash companies that it says use a prostaglandin in their products.

Meanwhile, the new cosmetic products are already causing regulatory concern. On Friday, federal agents sent by the FDA went to a San Jose, Calif., warehouse and seized thousands of tubes of Age Intervention Eyelash, which the FDA called an “unapproved and misbranded drug.” The agency said it hadn’t received any reports of patient injuries, but warned the product might be potentially harmful because it contains bimatoprost, the Lumigan ingredient.

Jan Marini, founder and chief executive of Jan Marini Skin Research, which introduced Age Intervention Eyelash in 2005, said it was discontinued a year ago after the FDA raised questions about it and state officials embargoed the inventory that was seized at the San Jose warehouse. This February, the company relaunched the product with a slightly different name, Age Intervention Eyelash Conditioner, and a similar active ingredient that isn’t in any prescription medication. Ms. Marini says the company isn’t aware of any safety complaints related to either the original or the new formulation.

The scramble to develop and sell eyelash products derived from the glaucoma drug shows how the line between a cosmetic and a drug isn’t always clear. Cosmetic products can use ingredients that are also used in prescription medications.

However, if a company promotes its product to change the structure or function of the body — rather than just its appearance — then it is classified as a drug and must prove its safety and efficacy in human tests. The FDA’s Web site says that a product may be considered a drug if its ingredients have a well-known therapeutic use. FDA officials have so far declined to say how its rules apply to cosmetic eyelash products that contain ingredients found in glaucoma drugs.

FDA spokesman Brad Swezey declined to say if the agency is generally investigating cosmetic eyelash products or claims. However, in its press release Friday about the seizing of the original Jan Marini product, the agency said that Age Intervention Eyelash, if used together with a prescription glaucoma drug, could increase the risk of optic-nerve damage. Used on its own, the product “may cause other adverse effects,” including swelling of the retina and inflammation in the eye “which may lead to decreased vision.” Neither the agency nor the company has received any report of adverse effects, according to Mr. Swezey and Ms. Marini.

Other companies in the eyelash business are also trying to understand the regulatory landscape. Michael Brinkenhoff, an ophthalmologist who founded Henderson, Nev.-based Athena Cosmetics Corp., the seller of a product called RevitaLash, said recently that he has talked with FDA officials and believes he is complying with government regulations. He declined to reveal the ingredients used in RevitaLash, but he says they are “of a concentration that is reduced from anything that would be in any kind of a medication,” and “I have been scrupulously careful not to make any claims outside the realm of beautification.”

Jeffrey O’Donnell, chief executive officer of PhotoMedex Inc. of Montgomeryville, Pa., said the active ingredient in the company’s MD Lash Factor is a “derivative” of a molecule used in glaucoma medications. The product was launched in September and “sales have doubled in the last month,” he said earlier this month. “Ours isn’t considered a drug and our claims are cosmetic,” he said, adding that the FDA hasn’t raised issues about the product or its marketing.

Even as the cosmetics firms search for regulatory answers, Allergan is moving to defend its turf. An Allergan spokeswoman, Caroline Van Hove, declined to discuss its drug development plans. But she added: “We’ve got intellectual property in this particular area.”

On Nov. 7, Allergan filed a patent-infringement suit in federal court in Santa Ana, Calif., against seven eyelash-product companies. Among the defendants are Jan Marini Skin Research, Athena Cosmetics and PhotoMedex. Ms. Marini called the suit “baseless” and pledged that the company would vigorously defend itself. Athena’s Dr. Brinkenhoff and PhotoMedex’s Mr. O’Donnell declined to comment on the suit.

Allergan isn’t alone in trying to learn more about Lumigan’s effect on eyelashes. Physicians at the University of California at San Francisco, who say their research isn’t funded by a pharmaceutical company, are testing Lumigan and another glaucoma drug in patients who have lost their eyelashes because of alopecia areata, an autoimmune disease that causes hair loss.

Other researchers are developing tools to measure growth of the tiny hairs. “There are scales to look at wrinkles, but no one has developed an eyelash scale,” said Leslie Baumann, director of cosmetic dermatology at the University of Miami’s Miller School of Medicine. Dr. Baumann says many more eyelash-growth products are headed to market. They are probably safe, she says, but could permanently darken the color of the iris if allowed to drip into the eye.

Lorrie Klein, a cosmetic dermatologist in Laguna Niguel, Calif., says she started prescribing Lumigan after noticing “beautiful, long lashes” on a patient using Lumigan for glaucoma. Now, Dr. Klein promotes Lumigan on her Web site as “easy to use at home with only a once daily application” for “one to three months to achieve the desired length, and then once weekly for maintenance.” She advises patients to use a disposable brush to apply the drug.

Dr. Klein says she feels comfortable prescribing Lumigan because it comes from Allergan, which sells other dermatological drugs and products. Some of her patients, she says, work for Allergan and have told her the company has recruited subjects for a clinical trial of Lumigan for cosmetic use. Dr. Klein notes that Lumigan’s safety has been validated by FDA tests. “It’s scary to me as a physician that some cosmetic companies are slipping in a prescription drug,” she said.

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