Corrections or additions?
This article by Barbara Fox was prepared for the October 2, 2002 edition of U.S. 1 Newspaper. All rights reserved.
Palatin’s Approach: Dysfunction Drugs
Palatin Technologies, a development-stage biopharmaceutical
company in Cranbury, joins NexMed in trying to develop therapies for
both women and men, but whereas NexMed is working on a topically applied
cream or liquid, Palatin uses a nasal spray that stimulates receptors
in the central nervous system rather than acting directly on the vascular
"Our pharmaceutical therapeutic, PT-141, is a nasally administered
peptide, which we believe is activated through the hypothalamus, and
we believe it signals sexual arousal," says Stephen T. Wills,
Palatin’s CFO. "We anticipate the program for males could be approved
in mid 2006, and for females up to a year later."
Palatin has doubled its size in two years. Several months ago the
company consolidated office space at the Carnegie Center with laboratories
in Edison by moving from a total of 16,000 square feet to 28,000 feet
at Cedar Brook Corporate Center. Its 46 employees are working on a
variety of therapies (including a product for infection imaging and
an overall technology to design compounds). The facility can hold
up to 75 people, and Palatin is hiring chemists, biologists, analytical
scientists, quality control specialists, and product developers. In
August it concluded an offering of 2.6 million shares that brought
in $4.2 million.
In the first part of Phase II trials for the treatment of erectile
dysfunction (ED), 24 patients with a mild-to-moderate condition were
able use PT-141 to achieve sufficient rigidity (greater than 60 percent)
to begin sexual intercourse in about 30 minutes. When compared to
a placebo, the PT-141 tripled the duration of erectile activity.
For patients with a more severe form of ED (those who had no response
to visual sex stimulation), the drug increased the erectile activity
by a factor of 12. Phase 2B trials of PT-141 for the treatment of
ED in an at-home setting are expected to start this fall.
"We have had such robust results that we have actually started
a trial with severe dysfunction, people who are not responsive to
Viagra, and are halfway through these trials," says Wills.
How does this drug work? "PT-141 contains a synthetic analog of
a melanocyte-stimulating hormone. Hormones that stimulate melanocyte
also stimulate another receptor that is associated with sexual arousal,"
says Shubh Sharma, chief technical officer. His researchers have determined
that this receptor subtype is specifically involved in controlling
Approximately 30 minutes before intercourse, the patient takes a single
nasal dose of PT-141. Current oral ED therapies require 1-plus hours.
"In addition, the nasal formulation of PT-141 is as convenient
as oral treatments, and more patient friendly than invasive treatments
for ED, such as injections and trans-urethral pellets," says Wills.
Palatin has just announced good news from the Phase 1 clinical trial
of its drug for women. Thirty-two premenopausal women volunteers viewed
sexually stimulating photos and used a nasal spray, either the Palatin
drug or a placebo. For those who used the Palatin spray, genital blood
flow increased. Preclinical animal studies had showed that administering
PT-141 resulted in dramatic increases in female rodents’ solicitations
of their male partners.
"Given that PT-141 acts on the areas of the brain responsible
for sexual arousal, as opposed to the peripheral vasculature, this
observation of increased genital blood flow is especially encouraging,"
says Raymond Rosen, professor of psychiatry and medicine at University
of Medicine and Dentistry New Jersey. "The results of this initial
Phase 1 trial demonstrate that PT-141 can facilitate the initial stages
of physiological sexual arousal in normal women."
Early next year Palatin will begin clinical studies to evaluate PT-141
in women with arousal disorders. The market could be big: According
to an article published in the Journal of the American Medical Association,
nearly FSD affects more than 30 million women in the U.S.
— Barbara Fox
Drive, Cedar Brook Corporate Center, Cranbury 08512. Carl Spana, CEO.
609-495-2200; fax, 609-495-2201. Www.palatin.com
109 Morgan Lane, Plainsboro 08536-9636. Lance Bronnenkant, vice
president. 609-897-0809; fax, 609-897-9636. Home page: www.barrlabs.com
Enhance Pharmaceuticals, which works on innovative products for women’s
health, such as intrauterine and intravaginal devices, has been bought
by Barr Laboratories and has changed its name and website address.
Barr Labs, a genetic drug maker, paid $46 million in June and acquired
at least five products. One of the vaginal ring technologies is for
urinary incontinence, and Phase III trials are scheduled for next
year. Another product could administer anesthesia.
Barr offers generic contraceptives and hormone replacement therapies
and has submitted new drug applications for therapies that would reduce
the number of pills that must be taken.
Ed Cohen founded Barr Laboratories in 1970 and the company is headquartered
in Pomona, New York (near the New Jersey border). It has grown to
be the sixth largest independent generic firm with $1.2 billion in
revenue this year and just over 1,000 employees.
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