CALIFON, NJ - September 14, 2011 - PediatRx Inc. (“PediatRx”) (OTCBB:
PEDX), a hospital specialty company with an initial focus on oncology supportive
care products, has entered into a U.S. co-promotion agreement with Bi-Coastal Pharmaceutical
Corp. for AQUORAL™, an FDA-cleared, prescription-only treatment for xerostomia (the
medical term for dry mouth due to a lack of saliva). Xerostomia can be a debilitating
medical condition and is estimated to impact between 35 and 40 million Americans.
It is especially prevalent in patients undergoing various treatments for cancer
and those with Sjögren’s syndrome. It is also common in the elderly and in patients
who are taking prescription medications.
“AQUORAL is an excellent addition to GRANISOL™ in our product portfolio. Both products
may offer significant benefit to patients who are suffering from the consequences
of their oncology treatments. In addition, we expect that AQUORAL will help further
establish PediatRx in the oncology supportive care arena,” said Dr. Cameron Durrant,
the founder of PediatRx. “With both AQUORAL and GRANISOL focused on a similar target
audience, this allows us to leverage our existing infrastructure, which was previously
solely supporting GRANISOL, and is congruent with our strategy of adding complementary
products."
The AQUORAL co-promotion is scheduled to begin immediately. PediatRx will provide
sales support in the United States and be compensated based on product sales.
AQUORAL is clinically tested and cleared by the FDA. The product is safe, well tolerated
and exhibits none of the side effects associated with competitive prescription products.
Selected Safety Information
AQUORAL
- AQUORAL should not be taken if there is sensitivity or allergy to corn oil, silicon dioxide, aspartame, or artificial flavorings (citrus).
- There are no known side effects when using AQUORAL.
GRANISOL
- GRANISOL is contraindicated in patients with known hypersensitivity to the drug or any of its components.
- QT prolongation has been reported with granisetron. Therefore, GRANISOL Oral Solution should be used in caution with patients with pre-existing arrhythmias or cardiac conduction disorders, as this might lead to clinical consequences. Patients with cardiac disease, on cardio-toxic chemotherapy, with concomitant electrolyte abnormalities and/or on concomitant medications that prolong the QT interval are particularly at risk.
- Safety and effectiveness in pediatric patients have not been established.
- The most common side effects observed with administration of granisetron were headache, asthenia, constipation, diarrhea, dyspepsia, and abdominal pain.
About PediatRx
PediatRx, Inc. (www.pediatrx.com) is a hospital
specialty pharmaceutical company which focuses on treatments for patients suffering
from serious conditions requiring hospitalization. PediatRx trades on the OTCBB
under the ticker symbol PEDX.
About Bi-Coastal
Bi-Coastal Pharmaceutical Corp. is a privately owned specialty pharmaceutical company
headquartered in Red Bank, New Jersey and founded in 1982.
Futher Information
PediatRx Inc.
Research & Business Development
E-mail: info@pediatrx.com
Shareholder Relations
+1 908-975-0753
E-mail: ir@pediatrx.com
PD64 (09/11)
This press release contains forward-looking statements. Forward-looking statements
are projections of events, revenues, income, future economics, research, development,
reformulation, product performance or management's plans and objectives for future
operations. In some cases you can identify forward-looking statements by the use
of terminology such as "may", "should", "anticipates", "believes", "expects", "intends",
"forecasts", "plans", "future", "strategy", or words of similar meaning. Forward-looking
statements in this press release include the Company's anticipation that AQUORAL
and Granisol may both offer significant benefit to patients who are suffering from
the consequences of their oncology treatments, the expectation that AQUORAL will
help further establish the Company in the oncology supportive care arena and the
expectation that the two products will allow the company to leverage its existing
infrastructure.
While these forward-looking statements and any assumptions upon which they are based
are made in good faith and reflect current judgment regarding the direction of the
business operations of PediatRx, actual results will almost always vary, sometimes
materially, from any estimates, predictions, projections, assumptions or other future
performance suggested in this press release. These statements are predictions and
involve known and unknown risks, uncertainties and other factors, including the
risk that PediatRx cannot execute its business plan for lack of capital or other
resources, distribution, partnering or licensing/acquisition opportunities, as well
as the risks described in the periodic disclosure documents filed on EDGAR by PediatRx,
copies of which are also available on the company’s website. Any of these risks
could cause PediatRx or its industry's actual results, levels of activity, performance
or achievements to be materially different from those expressed or implied by the
forward-looking statements in this press release. Except as required by applicable
law, including the securities laws of the United States, PediatRx does not intend
to update any of the forward-looking statements to conform these statements to actual
results.