Generics Pressure Johnson & Johnson -- Motrin Anyone?

Johnson & Johnson’s Invega (paliperidone) is no Dorothy Hamill poised to skate away with the gold anytime soon. The heralded successor to the schizophrenic drug Risperdal took a tumble after flubbing the double lutz. Third-quarter U.S. revenue fell 16.4 percent to $61 million, and Invega slowly wobbled away out of the rink – but not out of sight of prying eyes: providers voicing skepticism that the drug was nothing more than an expensive “me-too” Risperdal — and health insurers restricting its usage and reimbursement (Tier-3, non-preferred status on the drug formulary plans of Kaiser and United).

Generic challenges to the marketing exclusivity of the attention deficit disorder medicine Concerta (methylphenidate), Aciphex (rabeprazole) for heartburn and acid reflux, and Levaquin (levofloxacin), an antibiotic for urinary tract infections means repleneshing a once-robust portfolio will take more effort than a missed “toe off” jump.

Read How the Venerated J&J Management Team Plans to Turn Dust into Gold at BNET Pharma….

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

MannKind Inhales -- Exhales, Awaits FDA Meeting

MannKind (MNKD-$6.58) is seeking FDA approval of Afresa for the treatment of adults with type 1 or type 2-diabetes. Afresa is a drug-device combination product, consisting of an ultra, rapid-acting insulin [an inhalation powder formulation] pre-metered into single unit dose cartridges and an inhaler. In a one-on-one interview, chief financial officer Matt Pfeffer provides an update on the status of Afresa’s assigned Prescription Drug User Fee Act (PDUFA) date of January 16, 2010 and company plans for the next-generation inhaler.

Read exclusive interview at BNET PHARMA….

Editor David J Phillips does not hold a financial interest in any stocks mentioned n this article. The 10Q Detective has a Full Disclosure Policy.

Teva Pharmaceutical Learns Legal Sword Cuts Both Ways

Teva Pharmaceutical (TEVA-$52.03) became the world’s largest generic manufacturer through an unflinching willingness to knock down the patented walls protecting the branded products owned by Big Pharma. This legal brashness has helped the company to build a portfolio of cheaper versions of such well-known drugs as the colorectal chemotherapeutic agent Eloxatin (oxaliplatin) and blockbuster drugs like Adderall XR (amphetamine salts) for narcolepsy and ADHD and Protonix (pantoprazole) for acid reflux.

In recent years the company has sought to mitigate encroaching generic competition – and resultant pressure that shorter pricing life cycles have on margins – by broadening its drug portfolio to include leading branded products. For example, Teva markets in the U.S. the self-administered, subcutaneous injectable for multiple sclerosis, Copaxone (glatiramer acetate), which now accounts for 25 percent of its total domestic sales.

Teva’s own Sword of Damocles, however, now threatens to cut short the patented life of Copaxone, as Mylan and other generic companies are petitioning the FDA to permit market access for their own cheaper, copy-cat versions of Teva’s MS drug. Ergo, Teva has initiated patent infringement lawsuit(s) against Mylan [and others]. Teva scientists argue, too, that the “seriousness of the disease” warrants a thorough review of its competitors’ products, including clinical trials assessing efficacy.

Is Teva learning the legal sword cuts both ways? Continue Reading at BNET Pharma ….

Editor David J Phillips does not hold a financial interest in any stocks mentioned n this article. The 10Q Detective has a Full Disclosure Policy.

Can BioCryst Pharma's Peramivir Boost Obama's Poll Numbers?

Does the totality of scientific evidence on Biocryst Pharma’s (BCRX-$10.00) peramivir support the intravenous administration of the drug in patients with suspected 2009 H1N1 influenza — and outweigh the known and potential risks? FDA Commissioner Margaret Hamburg opines that the answer is “yes” in her Letter of Authorization granting EUA to peramivir, despite knowing the following facts:

Dosing in pediatric patients is based on modeling of pharmacokinetic data from adult healthy volunteers and adult patients with influenza. No children (under the age of 18) have received peramivir in clinical trials… .Continue Reading at BNET PHARMA….

Editor David J Phillips does not hold a financial interest in any stocks mentioned n this article. The 10Q Detective has a Full Disclosure Policy.

Biogen Idec - Sacrificing Integrity for Profits?

On its recent earnings call, Biogen-Idec (BIIB-$42.59) management brushed aside alleged safety advantage [PML-related] to “drug holidays” for long-term Tysabri users. Specifically, when asked to comment on the proportion of patients in Biogen’s database where providers implemented drug holidays, senior researcher Al Sandrock tersely replied: “From the data we have — we are seeing very, very isolated cases of that.”

About 13,400 patients receiving monthly infusions (or approximately 29 percent of all patients taking the drug) have been on Tysabri therapy for more than two years — paying, on average, $28,500 per year for 13 infusions. It’s easy to do the math, subtract number of infusions and units sold decline.

Could physician and patient distrust lead to Tysabri (once again) losing market share to Teva Pharmaceutical’s (non-interferon) immunomodulator Copaxone?

Read More at BNET PHARMA ….

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

Continental Airlines' "Fly Right" Campaign Excludes Joey

Continental Airlines (CAL-$11.50) likes to brag that its Work Hard. Fly Right campaign reflects the philosophy of the world’s fifth largest air carrier. That – and its corporate culture –says the company, is what helped make Continental the most admired airline among FORTUNE Magazine’s 2009 list of "Most Admired Global Companies." This adulation, however, likely excludes dog lovers – given its policy of banning certain kinds of puppies from flying to their new foster homes. Just ask Joey, a four-month old pit bull…. Read More at BNET Travel.

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.

Netflix Eyes Wii Users Next

The distribution deal Netflix (NFLX-$55.32) signed with Sony is important because it not only ends the lock Microsoft had on the U.S. movie-rental service provider in the game console market — the Xbox 360 had previously been the exclusive videogame brand (the expiring agreement was recently extended to spring 2010 at Microsoft’s option) — but also because it broadens the number of TV sets already enabled to accept streaming Internet content. And, with about nine million PS3 users, Sony offers fertile ground from which Netflix can grow its own subscriber base.

Continue Reading at BNET Technology….

Editor David J Phillips does not hold a financial interest in any stocks mentioned in this article. The 10Q Detective has a Full Disclosure Policy.