Replies to post #3714 on Biotech Values

[DewDiligence]

Antares PR re LibiGel:

[A companion PR was issued yesterday by BPA, Antares’ licensee and the company responsible for developing LibiGel (see following post). Although Antares (AIS) will get a royalty on potential LibiGel sales, the royalty rate is probably in the low single digits, so it may not amount to a lot for AIS. On the other hand, LibiGel could be quite a large moneymaker for BPA.

The market-size info in the final paragraph requires some clarification because there are two kinds of male/female sexual dysfunction: 1. erectile dysfunction (ED) / female sexual arousal disorder (FSAD); and 2. hypoactive sexual desire disorder (HSDD), which is a fancy name for low libido. ED/FSAD is considered a *vascular* condition caused by insufficient blood flow to the genitals. For example, Viagra, Levitra, and Cialis increase blood flow but do not alter levels of sex hormones and do not increase libido. HSDD is considered a *hormonal* (or possibly psychiatric) condition. Products such a P&G’s Intrinsa and BPA’s LibiGel normalize testosterone levels but do not directly improve blood flow to the genitals. The important point is that 1. and 2. are considered distinct indications by the FDA. (This was the subject of considerable discussion on the NSTK message board today.)]

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Antares Pharma's (OTCBB: ANTR / Amex: AIS as of September 23, 2004) North American Licensee BioSante Pharmaceuticals, Inc. Announces Positive Results of Phase II Study of LibiGel(TM), Topical Testosterone Gel

Antares Pharma Says Study Shows LibiGel(TM) Significantly Increases Sexual Activity in Surgically Menopausal Women Suffering From Female Sexual Dysfunction (FSD)

EXTON, Pa., Sept. 22 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (OTC Bulletin Board: ANTR - News; Amex: AIS effective September 23, 2004), an evolving specialty pharmaceutical company with headquarters in Exton, Pennsylvania, announced today that its topical testosterone gel North American licensee, BioSante Pharmaceuticals, Inc. (Amex: BPA - News) reported that its placebo-controlled Phase II study showed treatment with LibiGel(TM) significantly increased satisfying sexual events in surgically menopausal women suffering from female sexual dysfunction (FSD).

Today's announcement follows yesterday's decision by the Food and Drug Administration to grant Procter & Gamble fast track status for its formulation of Intrinsa(TM), an investigational female testosterone patch, based upon data for its two Phase III trials.

LibiGel(TM) utilizes Antares Pharma's propriety advanced transdermal delivery (ATD(TM)) gel technology designed to allow delivery of hormones and other products across the skin. The LibiGel(TM) study was a double-blind placebo controlled study in 46 surgically menopausal women. The effective dose of LibiGel(TM) produced testosterone blood levels within the normal physiological range for pre-menopausal women and the safety profile was similar to that of the placebo product.

By incorporating Antares Pharma's ATD(TM) gel technology, LibiGel(TM) is quickly absorbed through the skin after application on the arms, shoulders or abdomen, evenly delivering testosterone to the bloodstream in a non-invasive and painless manner. Although generally characterized as a male hormone, testosterone is also present in women, and its deficiency has been found to decrease libido (sex drive). Additional information on the study will be presented at the October 30, 2004 Annual Meeting of Sexual Health in Women in Atlanta. Phase III studies are expected to start in early 2005.

Antares Pharma will receive milestone payments at certain stages of development and royalties from end sales of LibiGel(TM) in North America [probably small –see above]. Additionally, Antares Pharma has rights to the clinical data generated for further licensing of testosterone for the treatment of FSD in other territories, including Europe and Japan.

Jack E. Stover, President and CEO of Antares Pharma, stated, "Credible estimates of the U.S. market for female sexual dysfunction range between $1 billion and $4 billion. [But it’s actually two drug markets as described in the preface to this post.] We think the market potential in Europe could be as large as the U.S. market, and we also believe the Japanese market will prove to be significant. We are very encouraged by the positive results of BioSante's clinical study." Mr. Stover added, "Recently, Proctor & Gamble was given fast track status by the FDA for Intrinsa(TM), its transdermal patch containing testosterone for FSD. We believe that this further validates the importance of this unmet medical need. We further believe that gel technology may prove more attractive to patients than transdermal patches."

A study published in the Journal of American Medical Association reported that 43 percent of American women (about 40 million) experience some degree of impaired sexual function. Among the more than 1,400 women surveyed, 32 percent lacked interest in sex [HSDD] and 26 percent could not experience orgasm [FSAD]. The majority of women with FSD [i.e. either HSDD or FSAD] are postmenopausal, experiencing FSD due to hormonal changes following menopause, whether natural or surgical.
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[DewDiligence]

Antares gets patent on “fast melt” technology:

[Antares has not exactly had an enterprising start on the Amex exchange, as the stock price is down by almost a third since trading on the Amex began two weeks ago. The stock is still up sharply from its summer low, however, perhaps based on the visibility from the successful phase-2 LibiGel data from Antares’ licensee, BioSante.

BTW: Antares is the company whose CEO was squirming during an online interview with CBSMW’s Bambi Francisco, who happened to be wearing a very short skirt (#msg-4115660).]

http://biz.yahoo.com/prnews/041014/phth044_1.html

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Antares Pharma Receives European Patent For Easy Tec(TM) Fast-Melt Technology

EXTON, Pa., Oct. 14 /PRNewswire-FirstCall/ -- Antares Pharma, Inc. (Amex: AIS - News), an evolving specialty pharmaceutical company with headquarters in Exton, Pennsylvania, announced today that it has received notification from the European Patent Office that an additional patent for its Easy Tec(TM) fast-melt tablet technology has been granted. The patent issue date was September 22, 2004, as European Patent Number 0974365. Antares Pharma believes that this patent further strengthens the company's intellectual property portfolio for this technology, particularly because it follows the issue of a U.S. patent in February 2004.

Commenting on the patent, Dario Carrara, Ph.D., Managing Director for Antares Pharma's European operations, where the technology was developed, said, "Oral fast-melt tablet technology has proven very popular with patients, and the current market for such products has reached approximately $1.5 billion per year. Additionally, it is one of the fastest growing sectors of the drug delivery market with industry experts projecting a 20% annual growth rate for the next several years. Fast-melt technology allows oral drugs to be taken without water in a form that disperses in less than 30 seconds. This is beneficial for children and the elderly who often have difficulty swallowing solid dosage forms." Dr. Carrara added, "While there are other fast-melt technologies available, Easy Tec(TM) distinguishes itself in its simplicity of manufacturing, which we believe will provide differentiated advantages to Antares Pharma."

Jack E. Stover, President and CEO of Antares Pharma, said, "As part of our focus as an emerging specialty pharmaceutical company, we intend to develop several important generic products using our Easy Tec(TM) technology. We believe that many of these will have short development pathways and will potentially be approvable based on a short clinical study showing that the drug absorption profile is the same as a currently marketed conventional product. Additionally, we will continue to offer Easy Tec(TM) to pharmaceutical company partners for specific applications as part of our corporate partnering program."
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