CEO Sees FDA's Designation as Significant Validation of Medgenics' Novel Technology for Treatment of hepatitis D
(Thomson Reuters ONE) -
In near record time, Andrew L. Pearlman, Ph.D., President and Chief Executive
Officer of Medgenics (AMEX:MDGN) has helped position his relatively new publicly
traded company at a much higher level-- one that most other biotech firms
usually take far longer to reach.
Earlier this week on Tuesday, his firm raised $9.5 million via a Private
Placement and twenty-four hours later, he announced that Medgenics'
INFRADURE(TM) for the treatment of hepatitis D had received Orphan Drug
Designation from U.S. regulators at the FDA.
The significant news effectively made every protein therapy and hepatitis drug
developer (not to mention investors) looks up and take notice.
"We see this as a really significant validation of our technology by the world's
toughest regulatory agency," explains Pearlman. "This coming literally just a
month after the FDA approved our first clinical trials- which went straight to
Phase IIB- in the United States."
Asked to explain the significance of having achieved this designation for
Medgenics' proprietary tissue-based Biopump(TM) platform, Pearlman doesn't miss
a beat.
"First of all, Orphan Status is a very really significant milestone for any
company in pharma or biotechnology," Pearlman says. "Because Orphan Drug Status
means that the FDA recognizes that the treatment that you're developing is
promising and looks like it can address the need for a specific patient
population base."
Medgenics has been diligently developing the same proprietary tissue-based
Biopump(TM) platform technology for the sustained production and delivery of
therapeutic proteins using the patient's own skin biopsy for the treatment of a
range of chronic diseases including anemia, hepatitis C and hemophilia among
others. Pearlman believes this approach has multiple benefits compared with
current treatments, which include regular and costly injections of therapeutic
proteins and if he's right, his firm may have just taken one giant step toward
convincing the rest of the world he was right.
"The reason why this is so important for our Company is that this is the first
Orphan designation that we've attained for the use of our Biopump(TM) system and
the beauty of this situation for us is that with Orphan designation, often what
happens is that firms are granted an accelerated approval path by the FDA and
although that's not guaranteed, we feel we have a good chance and are certainly
hoping for that. Also, after a designation like this, the actual size of the
clinical trials one needs to conduct is usually considerably smaller than you
have to do for any of the major indications," says Pearlman.
"In Israel, we are hoping to be approved to commence the studies of our
Biopump(TM) technology in Hepatitis C. Now Hepatitis C is an enormous
indication. One hundred and eighty million people in the world have it and the
INFRADURE Biopump(TM) has a very appealing and advantageous value proposition
for the treatment of hepatitis C. It has an even more, I would say, compelling
case for treating hepatitis B and there are some 350 million patients in the
world with hepatitis B. All of these indications would use the same INFRADURE
Biopump(TM) approach. The Biopump(TM) stimulates your body's immune system to
fight the viral infection- whether its hepatitis B, C or D. The advantage of the
combined approach that we're doing in going after hepatitis D as an orphan drug
in the United States while commencing the clinical testing in hepatitis C in
Israel is that we believe that we will demonstrate safety and efficacy in both
of these indications, but that in the case of hepatitis D, there is a very
improved likelihood for a relatively rapid route to a product approval compared
to hepatitis B or hepatitis C-in which there would likely be much larger
clinical trials and a longer path toward approval."
Following a late morning confirmation about the FDA news, shares of the company
soared 25.36% to $8.65 +1.75 during regular market hours and headed higher in
early trading on Thursday. If trading has been any indication thus far, the low-
float stock may continue to appreciate in value as the market continues to
digest the significance of the news. Particularly since some of Big Pharma's
recent buyouts have targeted Drug makers developing hepatitis treatments.
Even some which have shown, arguably, less promise and innovation than
Medgenics' own novel platform-- which aims to reduce some of the terrible side
effects many patients endure with other treatments-have been acquired at huge
premiums
Pearlman is focused on making sure that his firm will continue to build its
pipeline and add value beyond its current $83.73 million market cap by executing
and continuing to share positive developments like this one with investors.
"This is now the second approval that we've gotten for our technology, for our
company and we think it will give a lot more confidence to would-be partners and
institutional investors who may have been looking for a clear sign from a
regulatory agency that we have a straight shot for an approvable product within
a reasonable time."
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: BioMedReports via Thomson Reuters ONE
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Datum: 21.06.2012 - 11:05 Uhr
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