Eli Lilly's Wrong Road With Livalo

Eli Lilly (LLY-$35.01) chairman and chief executive office John Lechleiter stated that the drug maker’s deal to co-promote Japan-based Kowa Pharmaceuticals’ new lipid-modifying med Livalo would permit Lilly to expand its “product offerings in the cardiovascular therapeutic area and more efficiently utilize [its] existing cardiovascular sales force.” Corporate-speak, no doubt, to signal that its representatives need something to do. Although still in the early phases of launch in the U.S., worldwide sales for Effient (prasugrel), used to prevent clots in patients undergoing artery-opening stent procedures, were just $22.6 million in the third quarter of 2009.

Continue Reading 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.

Ford Motor to Ask Santa For More Common Stock

The VEBA-UAW deal eerily resembles other debt reduction initiatives undertaken by Ford Motor Company (F-$10.00) — improving liquidity and rinsing its balance sheet clean of debt, in part, by issuing new stock and swapping debt for stock. For example, during the first-half 2009 the company exchanged $4.3 billion in convertible debt for 467.9 million shares of common stock.

In the last seven quarters, common stock outstanding rose by some 65 percent to 3.24 billion, which does not include almost 933.6 million in additional shares reserved for issuance under executive bonus plans, VEBA contributions, and debentures/notes with convertible options; yet, in the same period of time stockholder equity plummeted from $5.63 billion to negative $7.3 billion, as the company burned through piles of cash and quarterly losses to survive the dark days of the Great Recession. Read More at BNET AUTO….

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.

Tamiflu Infected With the Truth -- How Debilitating to Health of Roche and Gilead Sciences?

Gilead Sciences ($43.20) receives a blended royalty on sales of Tamiflu (oseltamivir), marketed by Roche Holdings. Leveraging global concerns over avian and swine flu, Roche has skillfully raised awareness of the purported need to treat the complications associated with seasonal flu in otherwise healthy adults. The Swiss drug maker’s demonstrated success in challenging the conventional wisdom that “rest and aspirin” be the preferred treatment option for seasonal flu is found in sales of Tamiflu, up 362 percent to $1.93 billion in the first nine months of 2009.

Allegations have surfaced, however, that Roche has misled governments and physicians alike on the actual effectiveness of Tamiflu in preventing complications, such as hospitalization from pneumonia or death, in otherwise healthy people afflicted with the seasonal flu…. 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.

How Much For Life? Allos Therapeutics Says $30,000 - Per Month

The cost of Folotyn (pralatrexate injection) runs about $120,000 a year, a price tag that few drugs for incurable, rare cancers can match. With the runaway cost of healthcare under intense debate, critics contend that Allos Therapeutics' (ALTH-$5.99) drug for for relapsing or refractory peripheral T-cell lymphoma is excessive — especially since clinical benefit, such as improvement in progression-free survival or prolonging life, has not been demonstrated. In the pivotal PROPEL trial that led to FDA approval, duration of response was, on average, 9.4 months and the mean overall survival time was 14.7 months.

Will insurers push back on the cost of Folotyn treatment? Continue Reading 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.

Abbott Labs Looks to TriLipix and Certriad for Future Success'

The success behind Abbott Laboratories’ (ABT-$53.78) patent-expiry settlement with Teva Pharmaceutical is that it buys the drug maker more time to switch patients from its blockbuster drug TriCor to the brand sequel TriLipix.

Efforts to broaden the commercial appeal of Abbott’s lipid franchise, which also includes Niaspan (extended-release niacin) and Simcor (simvastatin/niacin extended release), hinges on a fixed-dose combination of TriLipix and Crestor, to be called Certriad.

What are the competitive threats coming down the pipeline? Continue Reading 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.

GameStop's Gamer Hell

In fiscal 2008, GameStop (GME-$21.35) generated approximately 40 percent of its sales and 56 percent of its operating profit during the all-important fourth-quarter holiday selling season. Christmas is also critical to the company’s cash flow. For the first half of fiscal 2009, GameStop bled $261 million. Nonetheless, the nation’s largest video game retailer expects to generate free cash flow in the range of $400 million to $425 million this fiscal year — fueled by holiday sales.

Last week Wal-Mart declared “Game On,” announcing 15-20% savings on 25 top video game titles, including bestsellers Rock Band: Beatles (Wii) and Left 4 Dead 2 (Xbox 360). Could GameStop find coal in its Christmas stocking this year? Read more at BNET Retail….

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.

Valero 'Fills 'Er Up With Ethanol Profits

Valero (VLO-$16.36) is looking to improve margins by shifting its crude diet away from heavy sours to lighter “sweet” (lower sulfur content) grades of oil. Prior to the shuttering of doors at the 200,000 barrel-per-day heavy crude facility in Delaware City, Valero had idled about 20 percent of its total capacity of 2.8 million barrels of oil a day — with another 24 percent of refinery utilization down for maintenance.

Cost cutting will not be enough to shore up weak fundamentals. Though refineries coming online in China and Brazil are expected to serve domestic markets, capacity expansions in the Middle East and India are expected to cater to export markets, dampening any hoped for recovery in near-term refinery margins at Valero. Read More at BNET ENERGY….

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.

More on Novartis' Promising MS Drug Fingolimod

Novartis’ (NVS-$55.78) fingolimod, first in a new class of immunomodulatory drugs called S1P-receptor modulators, reduces circulating levels of white blood cells (by bottling them up in lymph nodes). Though effective in relapsing forms of MS, treatment with fingolimod – like all disease-modifying agents – is not without risk Skin cancer being Novartis’ alleged alabatross. The FDA will likely weigh the drugs promising efficacy, however, against this adverse event by requiring Novartis to develop a RiskMap protocol.

Can fingolimod cross the finish line before German drug maker Merck KgaA’s cladribine tablet and be the first oral MS treatment to market?

Continue Reading 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.

Second Life for Pfizer's HIV Drug Selzentry

Pfizer’s (PFE-$18.85) anti-HIV drug Selzentry is now approved for combination use with other antiretroviral agents for treatment-naïve patients infected with CCR5-tropic HIV-1. Granted accelerated approval by the FDA in August 2007 for treatment-experienced patients infected with the R5 HIV-1 strain, industry pundits forecasted sales of more than $500 million by 2012. Uptake of Selzentry by HIV specialists has been less than expected — a marketing disaster — with Pfizer reporting paltry sales of just $46 million in 2008.

Will expanded labeling lead to usage beyond salvage therapy for this entry inhibitor? 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.

Jacked up Dreams at Incyte

In the newly inked commercial deal with Novartis, drug designer Incyte (INCY-$8.39) retained exclusive rights for the development and potential commercialization of INCB18424 in the US. With more than 100,000 patients suffering from MF or related disorders, on the surface this looks like a sound commercial strategy. Think again — although the company had about $361 million in cash available as of November 5, no revenue stream currently exists to fund in-house development.

With an accumulated deficit of $1.3 billion sitting on its balance sheet, Incyte knows first hand the financial risks that coincide with navigating a small molecule compound from proof-in-principle and clinical trials to FDA approval and commercial viability.

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.

Patterson-UTI Expands Rigging Activity in Shale Basins

The drilling slowdown has eroded Patterson-UTI Energy’s (PTEN-$15.25) U.S. land rig market share, which is down some 50 percent in the last 24 months to about 7.5 percent. Competitor Helmerich & Payne has been able to snag market share and maintain a relatively higher utilization due to stronger drilling demand — and longer duration of term contracts — for their higher horse-power rigs specially adapted for shale play operations.

With about 350 marketable rigs, Patterson-UTI is the second largest onshore driller in North America. The contractor has deployed six of its new-build Apex to shale and unconventional resource plays …. “Recovery but No Recovery” – continue reading at BNET Energy….

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.

Novartis Breathes Life Into Blood Pressure Franchise

Novartis AG (NVS-$55.85) loses patent protection for its $4.4 billion blood pressure medicine Diovan (valsartan) in the major countries of the European Union in 2011 and the following September here in the U.S. Expect generic challengers to strangle Exforge’s (valsartan-amlodipine) lease-on-life, too. Does anyone know CPR? The drugmaker is reaching into its life-cycle playbook to introduce several new fixed-dose combinations before much of its anti-hypertensive franchise experiences near-fatal wheezing episodes.

The two brands comprised almost 23 percent of global pharmaceutical sales for the nine-months ended September 30.

To find out if the novel renin-inhibitor Tekturna can resuscitate Novartis' BP franchise, click through to 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.

Johnson & Johnson Itches for Successful Stelara Launch

Stelara (ustekinumab), the Johnson & Johnson (JNJ-$62.76) drug approved for the treatment of moderate-to-severe plaque psoriasis in adult patients, could be a blockbuster drug. This first-in-class interleukin (IL) inhibitor offers the appeal of fewer injections than the established biologics for psoriasis, the tumor necrosis factor-alpha inhibitors.

Commercial success of Stelara, however, could hinge on acceptance by dermatologists. Which TNF-alpha inhibitor has the most to lose if Stelara changes prescribing habits—Humira or Enbrel? To find out, continue reading 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.

Should Genzyme Hire Beer Girls Instead?

Genzyme (GENZ-$49.63) has already spent more than $1 billion in the last two years to build new and bigger bioreactors — notably in the U.S., Ireland, and Belgium. Eventual plans call for total perfusion bioreactor capacity to climb from 20,000 Liters to 32,000 Liters by 2012. The global brewer of enzyme replacement therapies for rare genetic diseases disclosed this week that the FDA was delaying final approval of the company’s application to market Lumizyme (alglucosidase alfa) for the treatment of Pompe disease.

Can Genzyme finally redress its quality control problems at Allston Landing and keep unwanted particles out of its enzyme stews? Find out 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.

ITT Educational Services' Healthy Assets Hide Growing Loan Defaults

Do not be mislead by ITT Educational Services (ESI-$93.00) impressive balance sheet or 27 percent gains in new student enrollments for the third quarter, as the trail of money starts and ends back at ITT itself. Federal loan programs are falling short, so the for-profit educator is dipping into its own coffers to help students cover this widening tuition gap. Up to 65 percent of its students need private lending, and analysts estimate that $100 million to $120 million in loans and scholarship assistance will need to come from ITT’s internal lending program.

With a likely deliquency rate of 40 – 50 percent from internally generated loans, how much bad debt expense will likely fall to ITT’s bottom line? Read more 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.

Biogen Idec's Social Media Successes

In the battle for market share and sales, Biogen Idec (BIIB-$46.75) has successfully conveyed the Tysabri message to providers and potential customers alike through popular social media websites ranging from YouTube to Facebook. Despite the increasing amount of PML cases that have been diagnosed since Tysabri was re-introduced to the U.S. market in July 2006, neurologists’ confidence in the drug remains strong – with 63 percent of providers agreeing to a survey statement: “Tysabri’s benefits outweigh the risk it poses to MS patients.”

Notwithstanding the drug’s known efficacy, would it not be interesting to find out (a) to what extent do busy physicians rely on the Internet for drug education and updates? And, (b) how much of this information originates from company-sponsored sources?

To read more about Biogen’s web-enabled social media strategies, click though to 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.

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.