Saving Trump Entertainment Resorts from the Trumps

Ivanka Trump and her father “The Donald” have allied with bondholders of bankrupt Trump Entertainment Resorts (TRMPQ-$0.08), to compete with a plan crafted from senior lender Beal Bank and its new partner, the legendary billionaire Carl Icahn, in salvaging the operations of the bankrupt gaming company. Her significant assets aside, given the Trump family’s dismal past performance in running casinos in Atlantic City, might the Trump Taj Mahal, Trump Plaza and Trump Marina be in better hands with just about anyone else?

Read More at BNET Media….

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.

Do Fifty CentiSeconds Justify Acorda Therapeutics' Oral MS Drug Approval by FDA?

Central to the Peripheral and CNS Drugs Advisory Committee’s review of Acorda Therapeutic’s (ACOR-$27.56) oral MS treatment Ampyra was whether the improvements seen with the drug were truly significant to patients. Wishful desires aside, MS patients and their family members would be prudent to carefully take it upon themselves to thoroughly peruse the entire contents of the 177 pages of the Fampridine SR background information and clinical trial data given to health regulators for review.

Drilling down into the data, one uncovers that the walking speed change favored the Fampridine group by just 0.88 seconds (to complete the 25-foot walk) in the first study (MS-F203) and by a scant 0.5 - second difference in the second pivotal trial (MS-F204). Are these meaningful enough improvements to justify a (likely) $10,000 price tag for one year of treatment? Read More….

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.

Why Cephalon's Nuvigil Patent-Infringement Challenges Could Backfire

The motive behind Cephalon's (CEPH-$65.00) recent patent-infringement lawsuits is clear: litigate to slow the market entrance of cheaper copycat versions while it continues to transition patients from its older narcolepsy drug Provigil (modafinil) to Nuvigil. Cephalon derived 51 percent of total sales, or almost $925 million, from its Provigil franchise in 2008.

However, the clock winding down prior to any judicial decision(s) is an overhang for Cephalon — and could rip apart the planned Provigil to Nuvigil entrenchment campaign: cheaper copycats of Provigil will flood U.S. pharmacy shelves come April 2012 — just about the time both Teva Pharmaceuticals and Mylan Labs could decide to launch “at-risk” (liable for damages if court invalidates their patent challenges) copies of Nuvigil, alongside their legal introductions of Provigil.

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.

On the Hunt for New MS Drugs: Big Pharma Eyes Acorda Therapeutics

When asked in an interview on the business channel CNBC today if its new oral treatment for MS, Ampyra, would cost between $5,000 to $10,000 a year, Acorda Therapeutics (ACOR-$28.00) CEO Cohen deferred, hinting only that the cost would be a factor of demand and the invested cost to bring the drug to market.

The company is positioned to jump out of the gate come the March launch. At September 30, the company already had a specialty sales force of 73 sales professionals in place, salivating to call on high-volume (RX) prescribers and other influential neurologists who specialize in treating patients with neuromuscular disorders.

Will deeper-pocketed pharma companies looking to broaden the breadth of their own MS drug portfolios, such as Biogen Idec or Teva Pharmaceuticals, move to make an offer for Acorda prior to the March launch of Ampyra? Continue Reading….

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 Heartburn for Procter & Gamble's Prilosec OTC

For years Procter & Gamble (PG-$60.50) has reminded customers that its Prilosec OTC remedy effectively reduced heartburn-causing acid by shutting down active acid-producing “proton pumps.” Supported by online marketing and sponsorship of popular events, from NFL and NASCAR tie-ins to Prilosec-branded cooking contests and the dice game Bunco, this proton-pump inhibitor (PPI) quickly became the best selling OTC heartburn medicine, with annual sales topping $300 million.

Given the convenience and cost-savings of shopping at the local store for GI antidotes, consumers are increasingly more willing to self-medicate. However, private-label brands have successfully muscled in on this growth in demand. To wit: sales for Prilosec OTC peaked at about $387 million back in 2006. Additionally, Prilosec has now lost market exclusivity (held since 2003) — the FDA has approved for OTC purchase two other branded PPIs. Read More….

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.

Burger King Now Serving Up Beer With Those Whoppers

Exclusively at the Whopper Bar South Beach, Burger King (BKC-$17.60) customers can “Have it Their Way” and pair premium Whopper sandwiches with an array of Anheuser-Busch and MillerCoors beer products, including Budweiser, Bud Light, Bud Light Lime and Miller Lite. “We are pleased to offer our guests the option of pairing America’s Favorite Burger with a great American beer in this ideal destination,” said Chuck Fallon, North America President…. Continue Reading at BNET Food….

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.

Innovation Key to Callaway Golf's Growth Prospects

Callaway Golf (ELY-$8.25) is the U.S. market leader (as either the No. 1 or No. 2 brand) in almost every equipment category. Management acknowledges that celebrity golfers carrying the Callaway banner — from Arnold Palmer and Gary Player to Phil Mikelson and Annika Sörenstam — help to build brand recognition. However, the company was early to recognize, too, that lots of top golfers walking the fairway with a plethora of labels also dilute the message. In contrast to Nike Golf, the company’s marketing strategy has long been built around loyalty to brand, not star.

The company’s core competitiveness has been the timely introduction of innovative and game-changing technologies, said Callaway spokesman Tim Buckman. The performance-enhancing Big Bertha driver (of then) and the shot-shaping control of its Fusion Technology fairway woods (now), illustrate how the company has strategically captured and grown its share of market.

In today’s marketplace, where consumers worldwide are more sensitive to price tags, is Callaway’s sales strategy obsolete? Continue Reading 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.

Sixty Days and Counting for Somaxon Pharma's Silenor

Somaxon Pharmaceutical’s (SOMX-$2.40), acknowledgement of a Class 1 Response for its insomnia drug Silenor indicates a receptiveness by health regulators to complete the drug review within a 60-day period. As companies — including Somaxon — do not disclose contents of complete-response letters, it is difficult to interpret the material intentions of the FDA. Nonetheless, Class 1 resubmissions typically address just small deficiencies in the application, such as labeling or a minor re-analysis of previously submitted data to the application, according to Center for Drug Evaluation and Research procedures. Read More….

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.

Afrezza: Read the FDA Label!

MannKind Corp’s (MNKD-$10.32) inhaled insulin treatment Afrezza has been unable to outrun the long shadow of doubt cast by Exubera, the inhaled insulin device voluntarily withdrawn in October 2007 by Pfizer (due to disappointing sales). The commercial failure of Exubera should not signal defeat for MannKind’s efforts to deliver insulin via the lungs, as there are significant differences between the two products, including (i) size of Afrezza delivery device is significantly smaller; (ii) dosing — Pfizer erred in marking Exubera insulin doses in milligrams instead of units; and, (iii) dearth of formulary and managed care acceptance.

If approved, it is what is put on the drug label, often referred to as the package insert, that will likely decide the success or failure for Afrezza. Read More….

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.

Abuse-Deterrent Opioids Best Medicines For What Ails King Pharmaceuticals

King Pharmaceuticals (KG-$13.00) will likely face generic intrusion for its popular muscle relaxant Skelaxin by 2012. With little visible success in the development of a longer-acting formulation, the company has already shifted promotional efforts of its 610 person sales force to pain-relief products with more promising growth prospects, such as the non-steroidal anti-inflammatory (NSAID) Flector Patch and Embeda, the first of the new abuse-deterrent opioids to reach the U.S. market (so-called because the medication incorporates physical and pharmacological barriers to obtaining the euphoric effects of opioids).

CEO Markison informed investors at the JPMorgan Health Conference that the company remained on schedule with FDA timelines for two other promising tamper-resistant pain killer drugs. Nonetheless, the road to approvable action letters is littered with potholes….

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.

Is Clock Winding Down at Somaxon Pharmaceuticals?

The fate of Somaxon Pharmaceuticals (SOMX-$1.44) and its investigational drug Silenor (doxepin) rests with the Food and Drug Administration. Management will meet with the FDA on January 20 to seek clarity as to what additional steps — if any — need be taken by the company to move forward with commercial development of its oft-delayed treatment for insomnia.

Irrespective of the outcome of this meeting, however, an analysis of the drug developer’s financial statements suggests that future prosperity actually rests in the hands of its investment bankers….and their pocket watches are ticking….

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.

Tiger Woods Still on the Green With NIKE

Tiger Woods helped to break new ground at Nike (NKE-$64.82): successfully communicating that Nike was more “than the shoes” (to paraphrase a 1991 Michael Jordan ad). Golf apparel and related accessory sales rose from some $120 million in fiscal 1996 to approximately $500 million in 2005 (which by then also included “Swoosh” brand expansion to golf balls and other equipment items).

The Tiger Woods scandal, however, reinforces a recognized danger of celebrity endorsements — in a crowded and competitive market (like golf), the sponsor will often leverage the myth of celebrity personality to try and raise product(s) profile above total brand clutter in the market.

Will Tiger’s continued relationship with Nike prove toxic to NikeGolf brands and sales?

Read More at BNET Advertising….

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.

Restful Sleep With Somaxon Pharma's Silenor?

Somaxon Pharmaceuticals (SOMX-$1.59) shares rallied about 30 percent Thursday on a surge in volume after the company's CEO said in an interview that it would continue to seek approval for its insomnia drug.

CEO Richard Pascoe told BNet.com that data collected for its sleep drug Silenor, which was contained in the company's new drug application, demonstrated sustained subjective efficacy in the adult population and that the drug effect wasn't lost over the treatment period of 30 days.

Read Interview:

An Interview With Somaxon Pharma Ceo Pascoe (Part II): Promise and Problems With Sleep Drug Silenor

An Interview With Somaxon Pharma CEO Pascoe (Part I): Efficacy and Uncertainty of Sleep Drug

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.

Shire Tweets To Boost ADHD Sales

Shire plc (SHPGY-$58.70) has been unable to capitalize on its historically dominant position in the attention deficit/hyperactivity disorder (ADHD) realm (33 percent of the branded U.S. marketing pie in 2008) and a three-year co-promotion agreement signed with GlaxoSmithKline (started in May 2009): Vyvanse (lisdexamfetamine dimesylate) sales totaled just $129 million in the third-quarter ending September 2009.

Aiming to improve the recognition and treatment of ADHD in kid and adult populations – and boost its own sales — the drug maker has unveiled a new ADHD-related support resource available through the online networking medium Twitter.

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.