SEC Company Response from Pathogenics, Inc. (CIK 0001320731) — Aug 29, 2005
Pathogenics, Inc. (CIK 0001320731)
Date: Aug. 29, 2005 · CIK: 0001320731 · Accession: 0001332277-05-000064
AI Filing Summary & Sentiment
File numbers found in text: 333-123431
Referenced dates: July 25, 2005
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DAVID M. LOEV, ATTORNEY AT LAW
2777 ALLEN PARKWAY, SUITE 1000
HOUSTON, TX 77019
TELEPHONE (713) 524-4110
FACSIMILE (713) 524-4122
August 29, 2005
Ms. Mary K. Fraser, Esq.
Division of Corporate Finance
United States Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549
RE: Pathogenics, Inc.
Form SB-2 Registration Statement
File No. 333-123431
Dear Ms. Fraser:
We have enclosed three red-lined copies of the amended registration statement
for your review. In response to your letter dated July 25, 2005, Pathogenics,
Inc. (the "Company") has the following responses:
Comments applicable to the entire filing
---------------------------------------------
1. We have revised the wording of the Registration Statement to address
the use of capitalization, the excessive use of parenthetical phrases,
improper use of acronyms, excessively long sentences, legalistic and over
complex explanations, highly technical business terminology and have
attempted to limit our use of defined terms.
2. We have revised the prospectus as you have requested and eliminated
the following technical terms from the forefront and the body of the
prospectus:
Active Halogen Compounds
Main long-lived oxidant produced by human granulocytes and
monocytes
Cytotoxicity
Endogenous
Endogenous Antiseptic
Endothelial Cells
Formulation Development Program
Genotoxicity Screening
Innate Immunity
Novel Endogenous anti-infective
Oxidizing Mechanism of Action
Rhinosinusitis
<PAGE>
We have also followed your suggestion to explain the following
remaining technical terms the first time they appear in the Registration
Statement and have eliminated the glossary from the Registration Statement
altogether:
Crural Ulcer
Amino Acid
Derivatives
Otitis Externa ("Swimmers ear")
Clinical Trials
Conjunctivitis ("Pink eye")
3. We have revised the information presented on the cover page of the
prospectus to include only the information specified by Item 501(a) of
Regulation S-B.
4. We have removed the information from our cover page regarding
responsibility for misstatements, and included only the information
specified by Item 501(a) of Regulation S-B.
Prospectus Summary
-------------------
5. We have either sent you the supporting documentation listed below
(marked as necessary to show the location of each fact or statistic we are
relying on for the claims made in the prospectus) for the factual and
statistical claims we have made in the Prospectus or deleted those claims
entirely. We have also deleted these citations in the prospectus.
Claim #1: In pre-clinical studies conducted by the researchers,
N-chlorotaurine demonstrated the ability to kill bacteria, viruses,
parasitic intestinal worms, and destroy or inhibit the growth of fungi.
(Description of Business - N-chlorotaurine)
Support for Claim #1:
(a) Nagl, M and Gottardi, W. In vitro experiments on the
bactericidal action of N-chlorotaurine. Hyg.Med. 17:431-439,
1992.
(b) Nagl, M and Gottardi, W. Enhancement of the bacterial
efficacy of N chlorotaurine by inflammation samples and selected
N-H compound. Hyg.Med. 21:597-605, 1996.
(c) Nagl, M, Larcher, C and Gottardi, W. Activity of
N-chlorotaurine against Herepes simplex and Adenoviruses.
Antiviral. Res. 38(1): 25-30, 1998).
<PAGE>
Claim #2: Additional pre-clinical studies conducted by the researchers
showed that when N-chlorotaurine was applied in the presence of human nasal
mucus, its ability to destroy microorganisms was increased. (Description of
Business - N-chlorotaurine)
Support for Claim #2:
Nagl M, Lass-Floerl C, Neher A, Gunkel AR, Gottardi W. Enhanced
fungicidal activity of N-chlorotaurine in nasal secretion. J
Antimicrob Chemother 2001; 47: 871-4.
Claims #3 - #6: The clinical trials conducted by the researchers to
date have proved N-chlorotaurine's tolerability on the skin and mucous
membranes and have demonstrated initial signs of efficacy in:
(a) outer ear infections,
(b) Infected leg ulcers,
(c) eye infections, and
(d) inflammation of the sinuses caused by infections.
(Description of Business - N-chlorotaurine)
Support for Claims #3 - #6:
(a) outer ear infections, Laryngoscope, "Acute Otitis Externa:
Efficacy and Tolerability of N-chlorotaurine, a Novel Endogenous
Antiseptic Agent," 2004; 114: 850-4
(b) Infected leg ulcers, Br J Dermatol, "Tolerability and
efficacy of N-chlorotaurine compared to chloramine T for
treatment of chronic leg ulcers with purulent coating," 2003;
149: 590-7)
(c) eye infections, Ophthalmologica, "Tolerance of
N-chlorotaurine, a newantimicrobial agent, in infectious
conjunctivitis - a phase II pilot study," 2000, 214: 111-4)
(d) inflammation of the sinuses caused by infections of
bacterial, fungal and viral origin, Auris Nasus Larynx,
"Tolerability of N-chlorotaurine in Chronic Rhinosinusitis
Applied via Yamik Catheter," (Submitted) 2005.
Claim #7: This field is considered the third largest in terms of
annual sales, surpassed only by drugs for treating central nervous system
disorders and cardiovascular disease. (Description of Business -
N-chlorotaurine - Potential Market for N-chlorotaurine)
Support for Claim #7: Nature Biotechnology, Vol. 21:1256, Nov
2003.
<PAGE>
Claim #8: Anti-infectives are the third largest segment of the
pharmaceutical industry, with annual sales totaling $45 billion.
(Description of Business - N-chlorotaurine - Potential Market for
N-chlorotaurine)
Support for Claim #8: Roehr, Bob. Anti-infective Drug Development
in Decline. 43rd ICAAC. Presented Sept. 15, 2003, as reviewed by Gary
D. Vogin, MD for Medscape Medical News.
Claim #9: Of the $45 billion in the anti-infectives markets, 62% is
for antibacterials, 12% is for HIV, 6% is for other viral infections, 7% is
for antifungals, and 13% is for vaccines and immunology. The 4-year
compounded growth rate for anti-infectives is strong at 10%. The best
markets for anti-infectives are the United States (48%), Europe (22%), and
Japan (13%). (Description of Business - N-chlorotaurine- Potential Market
for N-chlorotaurine)
Support for Claim #9: Bartlett, Bob G. 43rd ICAAC. Presented
Sept. 15, 2003.
Claim #10: Broad-spectrum, multi-indication anti-infective drugs
generally have potential annual sales of $1 billion within three years of
market introduction. (Description of Business - N-chlorotaurine- Potential
Market for N-chlorotaurine)
Support for Claim #10: "Superbugs & Superdrugs: A Strategic Guide
to the Global Antimicrobials Industry, Industries and Therapies," SMi
Publishing Ltd. 2000, at page 130, "Superbugs".
Claim #11 : Treatment of sinus and ear infections are the most common
reason for outpatient antibiotic prescriptions (Description of Business -
N-chlorotaurine - Potential Market for N-chlorotaurine)
Support for Claim #11: Consumer Reports, "Super-germ alert,"
January 2001, 60-61.
Claim #12: conjunctivitis (eye infections commonly referred to as
"pink eye") is considered the most common reason for non-traumatic eye
complaints. (Description of Business - N-chlorotaurine- Potential Market
for N-chlorotaurine)
Support for Claim #12: American Family Physician, "Should We
Prescribe Antibiotics for Acute Conjunctivitis," Vol. 66, No. 9,
November 1, 2002.
<PAGE>
Claim #13: The Impact of N-chlorotaurine on the Candida virus.
(Description of Business - N-chlorotaurine - Research and Development of
N-chlorotaurine)
Support for Claim #13: Antimicrob Agents Chemother, "Impact of
N-chlorotaurine on viability and production of secreted aspartyl
proteinases of Candida spp." 2002; 46: 1996-9.
Claim #14: Explanation of the chemical properties of N-chlorotaurine
and how it is a key compound in the human defense system to infections.
(Description of Business - N-chlorotaurine - Research and Development of
N-chlorotaurine)
Support for Claim #14: Arch Pharm (Weinheim), "Chemical
properties of N-chlorotaurine sodium, a key compound in the human
defence system," 2002; 335: 411-21.
Claim #15: Comparison of N-chlorotaurine with another treatment -
chloramine T - for the treatment of infected leg ulcers. (Description of
Business - N-chlorotaurine- Research and Development of N-chlorotaurine)
Support for Claim #15: Br J Dermatol, "Tolerability and efficacy
of N-chlorotaurine compared to chloramine T for treatment of chronic
leg ulcers with purulent coating," 2003; 149: 590-7.
Claim #16: Study of influence of N-chlorotaurine on nasal mucous.
(Description of Business - N-chlorotaurine- Research and Development of
N-chlorotaurine)
Support for Claim #16: Am J Rhinol, "In vitro study on the
influence of N-chlorotaurine on the ciliary beat frequency of nasal
mucosa," 2003; 17: 149-52.
Claim #17: Application of N-chlorotaurine to sinusitis complicated by
immune suppression. (Description of Business - N-chlorotaurine- Research
and Development of N-chlorotaurine)
Support for Claim #17: ORL J Otorhinolaryngol Relat Spec,
"Refractory rhinosinusitis complicating immunosuppression: application
of N-chlorotaurine, a novel endogenous antiseptic agent," 2003; 65:
303-5.
Claim #18: Down-regulatory effect of N-chlorotaurine. (Description of
Business - N-chlorotaurine- Research and Development of N-chlorotaurine)
Support for Claim #18: Immunol Lett, "Down-regulatory effect of
N-chlorotaurine on tryptophan degradation and neopterin production in
human PBMC," 2004; 93: 143-9.
<PAGE>
Claim #19: Tolerability of N-chlorotaurine shown in the middle ear of
a guinea pig. (Description of Business - N-chlorotaurine- Research and
Development of N-chlorotaurine)
Support for Claim #19: Ann Otol Rhinol Laryngol, "Tolerability of
N-chlorotaurine in the guinea pig middle ear - a pilot study using an
improved application system," 2004; 113: 76-81.
Claim #20: Efficacy and tolerability of N-chlorotaurine in treating
Otitis Externa ("swimmers ear"). (Description of Business -
N-chlorotaurine- Research and Development of N-chlorotaurine)
Support for Claim #20: Laryngoscope, "Acute Otitis Externa:
Efficacy and Tolerability of N- Chlorotaurine, a Novel Endogenous
Antiseptic Agent," 2004; 114: 850-4.
Claim #21: Non-motor symptoms, such as dementia occurs in at least 50%
of the patients; depression is also very common. (Description of Business -
Choloroquine Diphosphate).
Support for Claim #21: "The Columbia Electronic Encyclopedia,
Sixth Edition," Copyright 2003, Columbia University Press. Licensed
from Columbia University Press. All rights reserved.
Claim #22: The Parkinson's Disease market will undergo a relatively
consistant growth pattern over the next several years, growing from $1.9
billion in 2001 to over $2.4 billion in 2007. (Description of Business -
Choloroquine Diphosphate - Potential Market for Chloroquine).
Support for Claim #22: Marketresearch.com: The CNS Outlook to
2007.
6. We have revised the summary section of the Prospectus to include the
general nature of the studies completed on both N-chlorotaurine and
Chloroquine Diphosphate as you requested and that section now states:
"All of the research and development which has been completed on
N-chlorotaurine has been completed by the researchers in Austria. The
researchers have completed studies on the impact of N-chlorotaurine on
the Candida virus; studies on the chemical properties of
N-chlorotaurine and how it is a key compound in the human defense
system to infections; research on N-chlorotaurine for the treatment of
infected leg ulcers; a study of the influence of N-chlorotaurine on
nasal mucous; the application of N-chlorotaurine to combat sinus
infections complicated by immune suppression; the tolerability of
N-chlorotaurine in the middle ear of a guinea pig; and efficacy and
tolerability of N-chlorotaurine in treating swimmers ear.
<PAGE>
All of the research and development on Chloroquine Diphosphate
has been conducted by Alpha Research Group, LLC. Alpha Research Group,
LLC has conducted a ten (10) patient clinical study using less than
one half of the conventional malarial treatment dose of commercially
available Chloroquine Diphosphate in a time-released formula with a
brain targeting agent. Data from this study showed that Alpha Research
Group, LLC's novel Chloroquine Diphosphate formulation alleviated both
Parkinson's Disease motor symptoms in patients diagnosed with
Parkinson's Disease, as well as the manifestation of involuntary jerky
motions in patients and was generally well tolerated even after
several months of continual use."
7. We understand that our previous comment letter was not confidential
and we have revised our disclosures regarding the status of the studies we
have conducted as described in question 6, above.
8. We have revised the Summary of the prospectus as you have requested,
and have eliminated references to "Phase 2b" or "Phase 2a" "pilot studies"
throughout the Prospectus so as not to be related to the official
characterizations used by the FDA. Additionally, the adjective "pilot" in
reference to clinical studies has been replaced throughout the prospectus
with the adjective "small-scale."
9. We have revised the last paragraph on page 5 of the prospectus as you
have requested, and stated that "To date, neither product candidate has
completed the pre-clinical d