We were warned about people who post on one stock
only, have only good things to say about
a company----then disappear.
BTW here is some press hype from ADRX and an indication
how they do business, and what MDIX is up against
Notice the clever wording & little mention of the patent infringement suit. MDIX will see much the same and with no PR--
I guess the company does not believe in it as MG
stated long ago--no investor relations. So far Yeros
has failed to create a market for the stock---that is
what PR is about.
FDA Grants Final Approval Of Andrx's ANDA
For Cardizem(R) CD
FORT LAUDERDALE, Fla., July 10 /PRNewswire/ -- Andrx Corporation
(Nasdaq: ADRX - news) announced that on July 9, 1998 the United States Food
and Drug Administration (FDA) granted final marketing approval of its
Abbreviated New Drug Application (ANDA) for all four strengths of
extended-release diltiazem hydrochloride capsules bioequivalent to Cardizem(R)
CD. This is the first FDA approval of an ANDA for Cardizem(R) CD, a
hypertension and angina medication marketed by Hoechst Marion Roussel, Inc.
(HMR) that generated approximately $700 million in U.S. sales in 1997. The FDA's
approval letter states that the Andrx product ''is eligible for 180 days of market
exclusivity.''
Notably, the Andrx product employs the Company's patented PPDS(TM) drug
delivery system. PPDS(TM), one of seven Andrx patented or patent-pending drug
delivery technologies, utilizes special polymer coatings to produce a pulsed release
of medication. Andrx developed its PPDS(TM) technology to specifically deal
with the characteristics of Cardizem(R) CD. Like other Andrx technologies,
PPDS(TM) is flexible and may be modified to meet the formulation requirements
of other drug candidates the Company seeks to develop.
Because of the patent infringement litigation brought against Andrx by HMR, the
FDA's September 1997 approval of this ANDA was considered ''tentative''.
Although the Company's litigation with HMR is continuing, the FDA was
permitted to grant final marketing approval of the Company's ANDA since 30
months have lapsed since HMR received the Andrx certification of non-
infringement. In light of the previously announced stipulation between Andrx and
HMR, today's approval will trigger, among other things, the quarterly payment of
$10 million to Andrx. Under the circumstances, the Company believes that this
represents a significant step in risk management and will have a substantial
positive financial impact on Andrx.
Andrx is engaged in the formulation and commercialization of oral
controlled-release pharmaceuticals utilizing its proprietary drug delivery
technologies. In its ANDA program, the Company is developing generic versions
of selected high sales volume controlled-release brand name pharmaceuticals. In
its NDA program, the Company is developing its own brand name formulations of
certain existing drugs that it believes may be improved by the application of the
Company's drug delivery technologies. The Company also markets and distributes
pharmaceutical products manufactured by third parties.
Forward-looking statements (statements which are not historical facts) in this
release are made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. For this purpose, any statements contained in this
report that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the generality of the foregoing,
words such as ''may,'' ''will,'' ''expect,'' ''believe,'' ''anticipate,'' ''intend,''
''could,'' ''would,'' ''estimate,'' or ''continue'' or the negative other variations
thereof or comparable terminology are intended to indemnify forward-looking
statements. Investors are cautioned that all forward-looking statements involve
risks and uncertainties, including those risks and uncertainties detailed in the
Company's filings with the Securities and Exchange Commission. |
