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  • The Risks and Rewards of Javelin Pharmaceuticals, Inc.

    Shares of the Javelin Pharmaceuticals Inc (AMEX: JAV) plunged 30% to close at $1.26 after the company announced that Therabel Pharma UK Limited ("Therabel"), a subsidiary of Therabel Pharma N.V. and Javelin's licensee of commercial rights to Dyloject™ (diclofenac sodium) in the European Union recently informed Javelin and publicly announced that it is withdrawing all batches of Dyloject (diclofenac 75mg/2ml) from the UK market with a Drug Alert Class 2 Medicines Recall.

    As per UK’s Medicines and Healthcare products Regulatory Agency, these batches may be contaminated with small amounts of white particles. The particles are not readily visible and work is ongoing to determine the nature, size and risk posed by this contamination. In order to minimize risk to patients, all remaining stock is being recalled. A review of pharmacovigilance information, carried out by the marketing authorization holder, does not appear to indicate any detected safety concerns and these batches have been in use since 2008.

    Last month Javelin announced that Hospira, Inc. (NYSE: HSP) and Javelin Pharmaceuticals, Inc. have entered into a definitive merger agreement providing for the acquisition of Javelin by Hospira for $2.20 per share in cash, or approximately $145 million. Upon the news the share price of Javelin rallied from $1.34 to close to the tender offer price (from Hospira) of $2.20. However, on May 19th 2010 the stock price took a beating after Hospira, Inc. announced the extension of the tender offer to purchase all outstanding shares of the common stock of Javelin Pharmaceuticals referencing to some unsatisfied conditions. The offer, which was scheduled to expire at 12:00 midnight, New York City time, on May 18, 2010 (the end of the day on May 18, 2010) has been extended until 12:00 midnight, New York City time, on June 2, 2010. Javelin Pharmaceuticals disagreed with the statement by HSP and believes the latter is using a DYLOJECT supply chain issue in the UK as the basis for extending the tender offer. However after the expiration of the offer on June 2nd 2010, if all conditions of the tender offer have been met, Hospira intends to acquire all of the remaining outstanding shares of Javelin common stock by means of a merger under Delaware law for the price of $2.20/share.

    DYLOJECT is marketed in the UK and a NDA is currently pending in US with a PDUFA action goal date of 10/3/2010 under a standard, 10-month review. Last month, JAV terminated an all-stock merger agreement with Myriad Pharma (NASDAQ:MYRX) in favor of the higher all-cash bid from Hospira. If approved, Dyloject will be the first IV non-steroidal anti-inflammatory drug (NSAID) marketed in the U.S. as a single agent for the management of acute moderate-to-severe pain in adults since ketorolac in 1990. The active ingredient in Dyloject is diclofenac sodium, a widely prescribed oral NSAID.

    Given the stock price already plunged to the pre-merger agreement levels and trading close to 52 week lows and the tender offer still in place as of current (Note that Hospira extended the offer to June 2nd 2010 even after knowing that there are DYLOJECT supply chain issues in the UK), this clearly could be an excellent speculative play which may pay off 74% premium on the current share price within less than 10 days if the merger deal with Hospira closes without any further issues.



    By Venkat Nukala and Philip Runfeld




    Disclosure: Mr. Nukala has long position in JAV.
    Tags: JAV, HSP, MYRX, Biotech
    May 24 6:36 PM | Link | Comment!
  • Nutra Pharma's Cobroxin Drug is Finally Showing Reward - Conference Scheduled
    Nutra Pharma's (OTC: NPHC) hard work on its Cobroxin drug is finally paying big reward dividends now that its R&D is completed, and its sales began in October of 2009.  Cobroxin is the first non-prescription drug approved by the FDA to treat stage 2 (severe) chronic pain.  It is a non-addictive cobra venom derivative that has received positive initial feedback, and its sales are increasing rapidly.  Current company headlines constantly portray more and more marketing campaigns with Winne Dixie, CVS and Hannaford Supermarkets being the more recent stores carrying the non-narcotic over-the-counter drug.  CVS is the United States’ largest pharmacy in terms of square feet retail space and number of stores at about 7000. Walgreens is currently slated to begin carrying it beginning sometime around May 1st
     
    Cobroxin’s 4Q 2009 sales totaled $583,955 for the fourth quarter ending December 31, 2009 with limited marketing.  Sales will be increasing as more and more stores carry the product whose demand should continue to increase.

    Cobroxin is available as an oral spray to treat migraine headaches, neck aches, shoulder pain, cramps, lower back pain, and neuralgia.  It is also available topically as a gel for treating joint pain due to repetitive stress and arthritis.  Consider the possibilities in terms of sales of this product if it treats with great efficacy any one of these ailments!  For example, according to the CDC website http://www.cdc.gov/arthritis/data_statistics/faqs/case_definition.htm#4, the number of doctor-diagnosed arthritis cases in the United States exceeded 46 million patients as determined by data collected in 2003-2005.  If Cobroxin’s efficacy is sufficient to help a large portion of these people with a safe, non-narcotic, non-addictive drug, then its market will unfortunately only increase as the aging population of the United States increases.  Additionally, the FDA has been reviewing the dangers of acetaminophen pertaining to its liver toxicity, and this may very well come into play as Cobroxin is marketed and efficacy to the general population is documented.

    On Tuesday, April 27th at 1:00 PM EST, Nutra Pharma will be hosting an analyst and media conference discussing Cobroxin's marketing and distribution as well as speaking about its other products.  I am excited about the possibilities of the product and this meeting.  Anything from good news to something big (an agreement to be marketed by Wal-Mart would be huge, for example) could really get the attention of shareholders and potential shareholders. 

    In my opinion, this is certainly a company to have on your watch list for current and future growth as well as for the potential for partnerships that Nutra Pharma is always pursuing.  The conference can be accessed via the company's website via the following link: http://www.nutrapharma.com/newsroom/display.php?newsid=154
    As always, please do your own due diligence with this company and understand the risks associated with small biotech companies.  Technical analysis of Nutra Pharma from October 2009 to current yields a nice converging triangle with current stock price of 0.38 being just above support with the current catalyst of this Tuesday’s meeting and any other announcements possibly coming soon.

    By Stephen Ramey and Philip Runfeld



    Disclosure: Stephen Ramey has a position in NPHC.OB
    Tags: Biotech, NPHC.OB
    Apr 26 1:06 AM | Link | 1 Comment
  • DCTH Shares are up on positive Phase 3 results and APPY is up as well

    Today on Market Summary Updates:

    DCTH:
    Shares of Delcath Systems, Inc. (NASDAQ:DCTH), traded on a huge volume and were up 30% in the pre-market to close the day at $12.93(19% up), after the company announced that its Phase III National Cancer Institute (NYSE:NCI)-led multi-center clinical trial has successfully met the study's primary endpoint of extended hepatic progression-free survival in patients suffering from melanoma metastases in the liver.

    TapeBeat profiled DCTH on Monday, 29 March 2010 (Read Here) and expected positive results with a bullish view on the stock when the price was in the $6 range.  The stock price today exceeded our expectations.

     

    APPY: Shares of AspenBio Pharma (NASDAQ:APPY) have been trading at a higher than normal volume and the stock closed at $3.30(17% up) ahead of its data analysis for AppyScore(A Blood based diagnostic test for Appendicitis). The study completed patient enrollment on 03/23/2010 and expects the data analysis in 6-8 weeks(May 4-18).

    Tags: DCTH, APPY
    Apr 23 12:01 AM | Link | Comment!
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