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BioShockers.com is a recently created biotech investing website that is focused on finding high-potential, low-price, and legitimate biotech/pharma companies. The great majority of stocks we will do write-ups on will be on one of three exchanges, NASDAQ, AMEX, or NYSE. Occasionally, we will... More
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  • Taking a Look at ISTA Pharmaceuticals

    ISTA Pharmaceuticals is a rapidly growing specialty pharmaceutical company and is the fourth largest branded ophthalmic pharmaceutical business in the U.S., according to data provided by IMS Health.  ISTA currently markets four products in the United States: Bepreve®(bepotastine besilate ophthalmic solution) for the treatment of itching associated with signs and symptoms of allergic conjunctivitis, Xibrom (bromfenac ophthalmic solution)® for the treatment of inflammation and pain following cataract surgery, Istalol® (timolol maleate ophthalmic solution) for the treatment of glaucoma, and Vitrase ® (hyaluronidase injection) for use as a spreading agent. ISTA also has several allergy and eye product candidates in various stages of development. ISTA Pharmaceuticals, Inc. had 2009 revenues of $111 million and is based in Irvine, California.

    ISTA Pharmaceuticals is not very well known in the investment world (they have an average 3 month daily volume of 120,000). We first noticed ISTA in 2009 – when they received approval for Bepreve. The approval of Bepreve sent the stock as high as $6, only to fall back into the $4-$5 range afterward (for a market cap of $140M-160M). So far this year, ISTA has gone as low as $2.50, and has currently rebounded to over $4.

    You’re probably wondering, “After a rebound like that (from $2.50-$4.00), what could push the price higher?”

    Answer: On October 16, 2010, the FDA will decide on ISTA’s sNDA for Xibrom - an sNDA is a label extension. Xibrom is currently approved for ocular inflammation and pain following cataract surgery, and brought in ~$90M in revenue last year (2009). In a recent investor presentation, ISTA stated that Xibrom can add up to $50M in net income over the next three years.

    We believe that ISTA, with only 33.42M shares outstanding, is undervalued and has the potential to go significantly higher into the October 16th PDUFA date. And, if the sNDA receives approval, we believe it could bring some much deserved attention to the stock.


    Disclosure: No position
    Sep 30 3:43 PM | Link | Comment!
  • Harbor BioSciences – Ship Soon to Leave the Harbor?
    Harbor BioSciences is a biotech company focused on the development of a proprietary class of adrenal steroid hormones as novel pharmaceuticals for human health. They have two lead compounds – Apoptone for the treatment of CRPC (castrate-resistant prostate cancer) and Triolex for use in type-2 diabetes, with a possible future indication in multiple autoimmune diseases.  
    Harbor has recently presented data from their lead drug candidate, Apoptone (for treatment of castrate-resistant prostate cancer), at two ASCO meetings this year (ASCO Genitourinary Cancers Symposium in March and the ASCO Annual Meeting this June). The data has looked very promising to date, which is why Harbor announced plans to move Apoptone into a Phase 2b trial after presenting initial data from their Phase 1/2a trial in March.). Also, the PCCTC (Prostate Cancer Clinical Trials Consortium) recommended an extension of the Phase 1/2a trial to include patients that have not been treated with taxane chemotherapy.
    Now on to the Apoptone data presented at the ASCO Annual Meeting on June 7, the same data that when released to the public caused a drop in the stock price of HRBR to a new 52wk low. Below is an overview of the data released:
    Changes in PSA levels were consistent with the properties of this class of agent. In most patients there is an initial increase followed by a decline and/or stabilization of the PSA levels. A decrease in PSA at any time after treatment is seen in 64% of the taxane-resistant evaluable patients with 25% greater than a 30% decline. Antitumor effects were noted in all doses studied including the lowest dose. In some individuals, there have been responses in bone scans ranging from decrease of tracer uptake to resolution of some bone lesions.
    Nothing negative was in the results, whatsoever. To further confirm this, the study investigators had many positive comments about the ongoing Phase 1/2a study, and the data so far (see ASCO PR from June 7). Take note, that there are currently no approved treatments for end-stage (hormone and chemotherapy refractory) prostate cancer and the survival time is estimated to be between 8 and 12 months.  If Apoptone succeeds in the upcoming (soon to be initiated) Phase 2b trial, and subsequent Phase 3 trials, it could possibly be the first ever FDA approved treatment for CRPC.
    Now, let’s move on to the second drug in the pipeline, Triolex. Harbor has recently reported Phase 2a results on this type-2 diabetes drug candidate. The primary endpoint in the Phase 2a trial was to determine the difference in HbA1c levels (a marker of blood glucose) in Triolex-treated patients when compared to placebo. The summarized results are below:
    While there was no significant HbA1c difference in the overall Triolex-treated patients when compared to placebo in either stage of the trial, subpopulations were found in both stages that responded to Triolex. In the second stage of the study, a retrospective analysis identified obese patients in the drug-naïve group (BMI = 31.3) that responded to treatment; a significant time-dependent decrease in HbA1c was observed with a change from baseline of -0.55% at day 84 and -1.1% at day 112 (p=0.041). Triolex reduced HbA1c at least 1.0 % in 5/9 (56 %) compared to 2/13 (15%) in the placebo group at day 112.
    As you can see, the primary endpoint of the trial wasn’t met, but there were subpopulations that responded well to Triolex (obese type-2 diabetes patients). The CEO stated that they would review the above data with potential corporate partners to determine the most favorable plan for further development of Triolex in obese type-2 diabetes.
    Harbor has said that a study to identify the Triolex target organs in obese, impaired glucose-tolerant assessment of optimal combination effects with marketed products is ongoing. The trial is designed to study Triolex effects on liver glucose output and muscle glucose uptake in response to insulin. Results from this study are expected in Q3 2010. We’re currently in Q3, so we could potentially see the results in the next few weeks/months.
    The company only has 29.5M shares outstanding, with around 14% of shares held by insiders, and the potential for huge gains down the road (future Apoptone and Triolex data, possible partner(s) for either drug, or possibly even a buyout target for a big pharmaceutical company). In my opinion, the ship is soon to leave the harbor, and in a year (or maybe just a few months), 30 cents will be looked upon as a bargain. 


    Disclosure: Long HRBR
    Jun 08 10:48 AM | Link | Comment!
  • Alexza Pharmaceuticals -- A Rare Find
    Alexza is a rare find in the biotech sector, with low outstanding shares, a revolutionary drug delivery system, and a drug (AZ-004) w/ an upcoming PDUFA date of Oct. 11, 2010.

    Alexza's drug delivery system is called the "Stacatto system". The Stacatto system is a heat package with a stainless steel substrate, onto which a thin film of unformulated drug is coated. When the patient draws a normal breath through the Staccato system, the substrate surface instantaneously heats to create a condensation aerosol. The patient inhales perfectly sized particles of pure drug down into the narrower, more vascularized tissue of the deep lung, allowing fast and more complete absorption into the bloodstream. This system has a use for potentially many different conditions.

    Alexza has a well-diversified pipeline of drugs: AZ-004 (Acute Treatment of Agitation associated with Schizophrenia or Bipolar Disorder - PDUFA date of Oct. 11, 2010), AZ-001 (Migraine Headache - end-of-phase 2 meeting w/ FDA completed), AZ-104 (Migraine Headache - phase 2b trial completed), AZ-003 (Breakthrough Pain - phase 1 study completed), AZ-002 (Acute Panic Attacks - P2a study completed, but inconclusive results), and AZ-007 (Insomnia - phase 1 trial completed w/ positive results).

    AZ-004 successfully completed both phase 3 trials (one for acute agitation in schizophrenia patients, the other for acute agitation in bipolar patients), and an NDA was filed near the end of 2009. In Feb. 2010, Alexza announced that they had formed a collaboration with Biovail to develop and commercialize AZ-004. The initial market size for AZ-004 is $300-$500M.

    As far as analyst coverage goes, JMP Securities has given a target price for ALXA of $12/shr, and multiple other analysts have initiated coverage in the past year as well.

    As you can see, Alexza is a very promising company w/ a drug going up for approval in October, along w/ possible share price appreciation in anticipation of the PDUFA date.

    As always, please read our disclaimer in our bio before investing in any stock that we alert.

    BioShockers.com is a recently created investment website, with a fully functional FDA Calendar, Daily Blog, and Research on Biotech stocks.

    Disclosure: Long ALXA
    Tags: ALXA, Biotech, Pharma
    May 12 4:43 PM | Link | Comment!
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