| FDA Investigates Deaths in Connection With Recalled J&J Medicines: Biotech's Latest Mishaps The Burrill Report submits: The U.S. Food and Drug Administration is investigating reports of complications with dozens of recalled children's medications made by Johnson & Johnson (JNJ), including 30 deaths, but so far no direct link has been found, according to a Congressional staff report, Reuters reported. “At this time, FDA is not aware of any child being harmed by taking one of the recalled products,” according to the report. “FDA is still investigating some of these adverse events to determine if the events were related to a child taking one of the recalled medicines.” A Congressional hearing May 27 looked into manufacturing problems at a J&J facility that led to contamination of Children’s Tylenol and other drugs. Stem Cell Therapeutics said its therapy for patients with acute ischemic stroke failed in a mid-stage clinical trial. While NTx-265 was well tolerated, there was no statistical difference in the changes observed in patients receiving its treatment and those given a placebo. “The profile and magnitude of the placebo response is extremely surprising and merits further examination” says Alan Moore, CEO and President of Stem Cell Therapeutics. “We are currently conducting a validation review process of the full trial.” NTx-265 is a sequential administration of human chorionic gandotropin followed by erythropoietin. GTx (GTXI) said top lines results from a late-stage trial of toremifene 20 mg, a selective estrogen receptor modulator, for the prevention of prostate cancer in men with high grade prostatic intraepithelial neoplasia failed to demonstrate a statistically significant difference compared to a placebo. The incidence of prostate cancer was lower in men receiving toremifene and showed a 10.2 percent relative risk reduction at three years. In the study, there were no clinically significant differences in the adverse event safety profile between men treated with toremifene 20 mg and men receiving placebo. InterMune (ITMN) will cut about 60 employees or 40 percent of its workforce following its failure to win U.S. Food and Drug Administration approval for its idiopathic pulmonary fibrosis drug pirfenidone. The cut are being made mostly in the commercial and discovery research areas, the company said in a regulatory filing. When completed, the company expects to have about 85 employees. The cuts are expected to save about $12 million a year. The FDA wants an additional clinical trial to support the efficacy of pirfenidone in IPF patients. Teva Pharmaceutical Industries (TEVA) said it will stop producing the sedative propofol, Reuters reported. The decision following an FDA warning letter in December over lapses at the company’s plant in Irvine, California. The U.S. Food and Drug Administration warned of a possible increased risk of fractures of the hip, wrist, and spine in people with high doses or long-term use of a class of medications called proton pump inhibitors. The product labeling will be changed to describe this possible increased risk. Proton pump inhibitors, available by prescription and over-the-counter, work by reducing the amount of acid in the stomach. Prescription proton pump inhibitors include esomeprazole (Nexium), dexlansoprazole (Dexilant), omeprazole (Prilosec, Zegerid), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). Prescription proton pump inhibitors are used to treat conditions such as gastroesophageal reflux disease or GERD, stomach and small intestine ulcers, and inflammation of the esophagus. Over-the-counter versions, used for the treatment of frequent heartburn, include omeprazole (Prilosec OTC, Zegerid OTC) and lansoprazole (Prevacid 24HR). The U.S. Food and Drug Administration warned about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli. The FDA has approved a revised label for the prescription drug Xenical. The agency is working with the manufacturer of Alli on label revisions to reflect this rare occurrence. Both Xenical and Alli are medications that contain the same active ingredient, orlistat. Xenical, available only by prescription, contains 120 milligrams of orlistat. Alli, sold over-the-counter without a prescription, contains 60 mg of orlistat. An estimated 40 million people worldwide have taken either Xenical or Alli. Though rare, the agency has identified 13 cases of severe liver injury, 12 of which were reports from outside the United States.Complete Story » seekingalpha.com |
The Market Is Wrong About Vanda Joseph Krueger submits: After a surprise FDA approval for Fanapt (iloperidone) for second-line schizophrenia therapy in May 2009, Vanda Pharmaceuticals (VNDA) stock rose nearly 800% and has traded in the $12-$15 range since then until mid-April of this year. This approval was a surprise because Vanda had initially received a non-approvable letter after completing two massive clinical trials involving 4,000 patients. After the approval, investors were justifiably bullish on VNDA, as Vanda found a marketing partner in Novartis (NVS), who secured exclusive US and Canadian rights to sell Fanapt. Interestingly, Vanda had bought the rights to iloperidone from Novartis several years earlier and managed to successfully bring it to FDA approval. Novartis as a partner made sense: Development of iloperidone was presumably to replace their blockbuster drug clozapine, which has gone generic. Under the terms of the agreement, Novartis made an upfront payment of $200 million and VNDA will be eligible for additional payments totaling up to $265 million for certain milestones as well as royalties from the U.S and Canadian sales of Fanapt (Titan Pharmaceuticals (TTNP.OB) will also receive some royalties from Vanda Fanapt sales). The fact that Novartis paid $200 million upfront (plus royalties) to Vanda to market their own once-discarded drug is a complete turnaround. Novartis’ CEO Joe Jimenez commented on their about-face for Fanapt, saying here, "We have to look very hard before we give up on a compound." However, if VNDA stock price is any reflection, the fairy tale appears to be over. Currently, VNDA is trading below $7, a far cry from its peak of $15. The slide of VNDA share price seemed have begun with a poor review given in The Manual of Clinical Psychopharmacology, the standard drug reference guide used by psychiatrists. The Manual cited disadvantages of Fanapt: Fanapt has been shown to cause irregular heart rhythms and low blood pressure, and patients are required to start at low doses, gradually building up to the maximum dose. In addition, Fanapt provided no advantage over other medications in diminishing the side effect of weight gain. However, Fanapt is not alone in having these side effects; several “atypical” medications (atypical refers to the absence of side effects like tremors and rigidity seen with first generation antipsychotic medications) for treating schizophrenia have these side effects. Yet, as time passed, criticisms of Fanapt’s stiff competition also surfaced: Fanapt is the seventh atypical antipsychotic on the market in the U.S. There are many branded as well as two generics available, some with derivatives like extended release formulations and injections. Critics claim that Fanapt will not be able to capture significant sales with so much market saturation, especially in the face of generics. But investors are not really considering the hard data: Despite the fact that there are so many atypical antipsychotics on the market, the market for these drugs is more than $20 billion (according to IMS Health). The leading drugs are Eli Lilly’s (NYSE: LLY) Zyprexa and AstraZeneca’s (NYSE: AZN) Seroquel, each which generate worldwide sales of about $5 billion per year. Pfizer’s (PFE) Geodon sales are about $1 billion per year; and Bristol-Myers Squibb (BMY)’s Abilify sales are about $2 billion per year. The remaining $7 billion is sales are from the generic drugs risperidone and clozapine and other traditional psychotic drugs. Factoring in the generics, branded drugs are capturing $13 billion of the market, which is thriving even in the face of generics. The reason the non-generic competitors are doing so well is due to the nature of the therapy: Psychiatry is an empirical, clinical science; experience, trial and error, and responsiveness to patients' progress are what determine the course of therapy. Unlike high cholesterol or high blood pressure, where a straightforward test and well accepted course of therapy are mandated, psychiatry itself depends on a patient-specific exploration of options which is constantly altered and refined throughout the therapy to try and obtain the optimal result. A patient doesn’t walk in to a doctor and say “I have schizophrenia” and the doctor says “Fine, here is clozipan” and the two part ways and live happily ever after. Diagnosing and treating schizophrenia is a lengthy process for which the psychiatrist relies on a variety of treatment options, determining which is best through trial and error. This trial and error is the reason why so many different antipsychotics are needed. Even within the atypical psychotics, there are three different types of classes of drug, and each drug in the class has a unique mechanism of action. Although all the “atypical” drugs bind serotonin as well as dopamine receptors, some bind one over the other better and may also have activity towards serotonin receptors. In essence, each different drug affects each of these receptors differently. Drugs like clozapine are more potent against the serotonin than the dopamine receptors; drugs like risperidone are more potent against the dopamine than the serotonin receptors; and drugs like aripiprazole (Abilify) actually activate the dopamine receptors and block the serotonin receptors. Complete Story » seekingalpha.com |
Lilly Asks Court To Block Generic Strattera Lilly asked a federal judge to temporarily block the U.S. launch of generic versions of its drug Strattera while the company appeals last week's ruling striking down the drug's patent. online.wsj.com |
Quest Diagnostics Marks Seventh Year on Dow Jones Sustainability Index [PR Newswire] - Quest Diagnostics Incorporated , the world's leading provider of diagnostic testing, information and services, today announced that it has again been selected to be part of the Dow Jones Sustainability World Indexes and North America Indexes . us.rd.yahoo.com |
Arena Investors Still Look for Silver Lining Pharmalot submits: The intense bickering leading up to the FDA decision to reject - for now - Arena Pharmaceuticals' (ARNA) Lorqess diet pill has some angry investors looking for the proverbial silver lining. For instance, in discussing the complete response letter issued by the agency late last week, investors have noted on blogs and message boards that the drugmaker will soon report preliminary data from a clinical trial in obese diabetics and that an independent third-party will be retained to review tumor data in rats.For weeks, some investors have been railing that the FDA conducted a biased, or at least flawed review, after agency staffers released a report prior to an advisory committee meeting last month that focused on tumors in rats. To press their point, an online petition was begun. Since then, the FDA has confessed that having a toxicologist on the panel would have been helpful, but continues to believe the Arena pill has “marginal efficacy” (back story).Complete Story » seekingalpha.com |