More good news for DITI and this board is dead!
Monday June 22, 5:59 pm Eastern Time
Company Press Release
Diatide Announces P829 NDA Receives Priority Classification from FDA
Second of Two NDAs to Receive Priority Classification
LONDONDERRY, N.H.--(BW HealthWire)--June 22, 1998--Diatide, Inc.
(Nasdaq:DITI - news) announced today that the United States Food and
Drug Administration (FDA) notified the Company that Diatide's New Drug
Application (NDA) for P829 (kit for the preparation of Technetium Tc 99m
Depreotide Injection), for the imaging of malignant tumors in the lung
has been given a priority classification. P829 is the second product for
which Diatide has submitted an NDA in the last ten months and the second
to receive a priority classification.
Priority status, under the FDA's internal guidelines, is reserved for
products which would be a significant improvement in the safety or
effectiveness of the treatment, diagnosis, or prevention of a serious or
life-threatening disease compared to available therapy. Receiving
priority status means that the FDA will attempt to complete its review
of P829 within six months. Under the standard review process, which most
new drugs receive, action by the FDA would take approximately 12 months.
''A priority status for P829 confirms our belief that P829 addresses a
major unmet medical and market need for a life threatening disease,''
said Richard T. Dean, Ph.D., President and CEO of Diatide. ''Coupled
with the priority status of AcuTect, we have the potential to launch two
products over the next 12 to 15 months.''
P829 is an injectable medical imaging agent made up of two active
components: a small-molecule, synthetic peptide and a molecule of
technetium-99m. The peptide is designed to adhere to the somastatin
receptor that is present in several types of cancer while the
technetium-99m emits a gamma ray which is detectable by a gamma camera.
The Company anticipates that P829 may be used by physicians to determine
whether or not a lung mass is malignant. Currently, the primary methods
of making this determination are needle biopsy, which has an estimated
15 percent complication rate, or lung surgery. The Company believes that
P829 imaging will offer significantly less expensive, minimally
invasive, safer method to assess suspected lung cancer and may
significantly reduce the need for biopsy procedures.
Diatide is a specialty pharmaceutical company engaged in the discovery,
development and commercialization of proprietary, disease-specific
pharmaceuticals for the diagnosis and treatment of life-threatening
conditions, such as cancer, infection and cardiovascular disease.
Diatide's proprietary technologies in the areas of peptide engineering
and radiolabeling chemistry have produced a number of peptides that bind
with high affinity and specificity to molecular targets on diseased
tissue and to which a radioisotope can be attached for imaging or
therapeutic purposes. The result is a pipeline of medical-imaging agents
(Techtides(R)) and solid tumor and cardiovascular therapeutics
(Theratides(TM)).
Under the Company's partnership agreement with Nycomed, Nycomed has the
option to license and distribute Techtides in Europe, South Africa and
certain countries in the Middle East and to co-promote those products in
the United States upon obtaining marketing approval. Nycomed has
exercised this option for AcuTect and P829. Including these two product
candidates, Diatide has six products for seven indications in its
clinical pipeline. Diatide is based in New Hampshire, where it conducts
most of its research and development activities with a staff of more
than 70 full-time employees, including 15 Ph.D.s and two MDs on its
research staff.
This press release contains forward-looking statements that involve a
number of risks and uncertainties. For this purpose, any statements
contained herein that are not statements of historical fact may be
deemed to be forward-looking statements. Without limiting the foregoing,
the words ''believes,'' ''anticipates,'' ''plans,'' ''expects,''
''intends'' and similar expressions are intended to identify
forward-looking statements. Important factors that could cause actual
results to differ materially from those indicated by such
forward-looking statements are set forth under the caption ''Item 7.
Management's Discussion and Analysis of Financial Condition and Results
of Operations -- Certain Factors That May Affect Future Results''
(''Certain Factors'') in the Company's Annual Report on Form 10-K for
the year ended December 31, 1997 which is on file with the Securities
and Exchange Commission. These Certain Factors are incorporated herein
by reference. As more fully described in the Certain Factors, the
Company's potential products are all still in development.There can be
no assurance that the Company's potential products will demonstrate the
safety, efficacy and cost attributes currently expected by the Company;
there can be no assurance as to when the FDA will complete its review of
the NDA for AcuTect or P829, or as to when Nycomed will file for
European regulatory approval; there can be no assurance that the Company
will receive regulatory approvals to commence or continue clinical
trials of product candidates, or to market any products including
AcuTect and P829, or, if such approvals are received, that the Company's
products will be commercially successful, that the Company's products
will be accepted by the medical community or third-party payors, or that
technologies, patents and proposed products of other companies will not
render the Company's products obsolete or noncompetitive.
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Contact:
Diatide, Inc.
Daniel F. Harrington, 603/437-8970 |
