Diatide Announces Submission by
Nycomed of European Marketing
Approval Application for NeoTect
Monday November 23, 4:03 am Eastern Time
Company Press Release
LONDONDERRY, N.H.--(BW HealthWire)--Nov. 23, 1998--Diatide, Inc. (Nasdaq: DITI - news)
announced today that Diatide's marketing partner, Nycomed Amersham plc, has submitted a Marketing
Approval Application (MAA) for Diatide's NeoTect(tm) to the European Medicines Evaluation Agency
(EMEA). The EMEA has determined the application to be valid and is proceeding with its evaluation of
NeoTect, for the scintigraphic imaging of suspected malignant tumors in the lung.
According to guidelines issued by EMEA, review and approval within 12 to 18 months are feasible. In
June, 1998 the U.S. Food and Drug Administration (FDA) notified Diatide that the Company's New
Drug Application (NDA) for NeoTect had been given a priority classification indicating the agency's
intent to complete its initial review in six months. Accordingly, the Company anticipates hearing from
the FDA about the approvability of NeoTect in mid-December.
''Nycomed and Diatide have a strong working relationship as evidenced by the joint progress we are
making in commercializing Diatide's first product, AcuTect(tm), for the scintigraphic imaging of acute
deep vein thrombosis in the legs,'' said Richard T. Dean, Ph.D., President and CEO of Diatide. ''The
timely filing of this MAA is another example of this relationship between the two companies.''
Mike Capaldi, Vice President of Strategic Marketing at Nycomed Amersham plc, said, ''NeoTect is the
second novel medical imaging agent to arise from our alliance with Diatide. Our companies are well
positioned to market this product, which we think will provide an important, noninvasive diagnostic
alternative for many patients and doctors, ultimately improving the detection of malignancies in lung
masses.''
NeoTect is an injectable medical imaging agent made up of two active components: a small-molecule,
synthetic peptide and technetium-99m, a radioisotope. The peptide is designed to adhere to the
somatostatin receptor that is present in several types of cancer, while the technetium-99m emits a
gamma ray that is detectable by widely available gamma camera systems. The Company anticipates
that NeoTect may be used by physicians to detect malignancy in the lung. 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 NeoTect imaging will offer a
significantly less expensive, minimally invasive and safer method to assess suspected lung cancer and
may significantly reduce the need for biopsy procedures. There are approximately 350,000 patients
diagnosed with lung cancer each year in Europe and the U.S.
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. Diatide has applied its proprietary technologies in the areas of peptide
engineering and radiolabeling chemistry to produce 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 development pipeline of disease-specific medical
imaging products (Techtides ), and solid tumor and cardiovascular therapeutics (Theratides ). For its
two lead products, Diatide has a marketing and sales collaboration with U.K.- headquartered Nycomed
Amersham plc, the world's leading diagnostic imaging company and one of the largest research-based
biotechnology suppliers to global markets.
Diatide is based in New Hampshire, where it conducts most of its research and development activities
with a staff of 90 full-time employees, including 15 Ph.D.s and two MDs on its research staff. More
information on the Company can be obtained from its web site, diatide.com.
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 (other than AcuTect) 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; or that results from preliminary clinical studies
will be predictive of results that will be obtained in later clinical studies; there can be no assurance as to
when the FDA or EMEA will complete its review of NeoTect (P829); and, 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 NeoTect. In addition, there can be no assurance that
AcuTect, NeoTect or the Company's other potential products will be commercially successful, or
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. |
