SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
-------------------------------
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): August 21, 2001
---------------
PROFESSIONAL DETAILING, INC.
-----------------------------------------------------------------
(Exact name of Registrant as specified in its charter)
DELAWARE 0-24249 22-2919486
- -------------------------------- ------------------------ ------------------
(State or other jurisdiction of (Commission File Number) (IRS Employer
incorporation) Identification No.)
10 Mountainview Road,
Upper Saddle River, NJ 07458
- ------------------------------------------------ ------------------
(Address of principal executive office) (Zip Code)
(201) 258-8450
-----------------------------------------------------------------
Registrant's telephone number, including area code:
N/A
---------------------------------------------------------------------------
(Former name or former address, if changed since last report)
Item 5. Other Events
On August 21, 2001 the Registrant issued the following press release:
"PDI REPORTS ON CEFTIN PATENT DEVELOPMENT
Preliminary injunction against Ranbaxy overturned
Upper Saddle River, New Jersey (Tuesday, August 21, 2001). Professional
Detailing, Inc. (Nasdaq:PDII) today announced that the United States Court of
Appeals for the Federal Circuit in the action captioned Glaxo Group Limited and
Glaxo Wellcome, Inc., Plaintiffs-Appellees vs. Ranbaxy Pharmaceuticals, Inc.,
Defendant-Appellant (case # 01-1151) vacated the preliminary injunction granted
by the New Jersey District Court on December 21, 2000 which enjoined Ranbaxy
from offering for sale or selling in the United States any cefurixime axetil
product. As a result, upon receipt from the FDA of approval of its Abbreviated
New Drug Application (ANDA), Ranbaxy could commence marketing of a Ceftin tablet
generic equivalent. This development does not impact Ceftin suspension which is
covered by a separate patent. Glaxo's action in the District Court seeking
damages and a permanent injunction against Ranbaxy remains pending.
Commenting on this development, Charles T. Saldarini, Chief Executive
Officer of PDI stated, "We are surprised and disappointed that the Circuit Court
overturned what we understood to be a well reasoned lower court decision. We are
evaluating our options as a result of this development which include invoking
the purchase requirement reset provisions in our agreement with Glaxo which were
incorporated to address potential generic introductions, as well as our right to
terminate the agreement upon notice. We are committed to keeping our
stockholders fully apprised with respect to this development. However, we will
require time to fully assess the financial impact of this development and will
report to you further once we complete our preliminary assessment", Saldarini
added.
The Company further announced that it would hold a conference call later
this week to discuss this development. The details of the call will be
subsequently announced.
In accordance with the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995, the Company notes that statements in this
release which look forward in time involve risks and uncertainties that
may cause actual results or achievements to materially differ from those
indicated by the forward-looking statements. These forward-looking
statements include any statements relating the introduction of any Ceftin
generic equivalents into the market place, the outcome of court
proceedings impacting Ceftin patent protection as well as any other
statements which are not solely historical. The Company's plans and
objectives are based on assumptions involving judgments with respect to
future economic, competitive and market conditions and future business
decisions, all of which are difficult or impossible to predict accurately
and many of which are beyond the control of the Company. Therefore, there
can be no assurance that the forward-looking statements will prove to be
accurate. The Company's documents filed with the SEC identify important
factors that may cause the actual results to differ materially from those
indicated by the forward-looking statements."
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PROFESSIONAL DETAILING, INC.
By: /s/ Charles T. Saldarini
------------------------------
Charles T. Saldarini
Chief Executive Officer
Date: August 21, 2001