PropThink: Pozen Presents Impressive Phase 3 Data At ACG
(Thomson Reuters ONE) -
By Jason Napodano, CFA
On October 22, 2012, Pozen (NASDAQ:POZN) presented a full analysis of the
integrated results of its two Phase 3 studies comparing PA-325/40 (EC-ASA 325 mg
+ IR omeprazole 40 mg) to enteric-coated aspirin (EC-ASA) 325 mg in patients
requiring aspirin (ASA) for secondary cardiovascular prophylaxis who were at
risk for ASA-associated gastric ulceration. In the two Phase 3 trials, subjects
were randomized to either PA-325/40 or EC-ASA 325 mg, taken once daily in the
morning on an empty stomach, approximately 1 hour before breakfast. At baseline,
subjects were required to be H. pylori stool-antigen negative and have no
endoscopic ulcers. Subsequent endoscopies were performed at months 1, 3, and 6.
Both trials were run under a special protocol assessment (SPA) with the U.S.
Food and Drug Administration (FDA).
The primary endpoint of the study was cumulative proportion of subjects with
endoscopically-confirmed gastric ulceration (defined as a mucosal break of at
least 3 mm in diameter with depth) at any time throughout 6 months. Results
below show an impressive separation for PA-325/40 vs. EC-ASA:
The data equate to an impressive 63% reduction in gastric ulcers. We expected
the ASA cohort to offer a gastric ulcer rate around 10% and PA-325/40 to be low-
single digits. These results are consistent with our expectations and show the
powerful efficacy of Pozen's drug. When duodenal ulcers were included in the
analysis, the reduction increased to 71%. Data on new or worsening erosive
esophagitis showed an astonishing 87% reduction in favor of Pozen's PA-325/40
versus EC-ASA 325 mg. Discontinuation rates and treatment success at six months
also showed strong statistical significance in favor of Pozen's PA-325/40 versus
EC-ASA 325 mg. At six months, the observed incidence of discontinuations due to
pre-specified upper-gastrointestinal events was significantly lower with PA-
325/40 vs. EC-ASA 325 mg, 1.5% vs. 8.2%, (p<0.001). Treatment success at six
months was 95.2% for PA-325/40 vs. 83.2% for EC-ASA 325 mg, a 14% improvement in
outcome based on intent to treat (p<0.001).
Secondary analysis also show statistically significant reductions in the
presence of heartburn as reported on a standardized questionnaire at months
1, 3, and 6. A post-hoc esophageal mucosal assessment showed a meaningful and
statistically significant reduction in new esophageal erythema (2.7% vs. 7.6%,
p<0.001) and new esophageal erythema or new or worsening erosive esophagitis
(4.8% vs. 22.5%, p<0.001). Treatment-emergent adverse events, including GERD,
esophagitis, erosive esophagitis, or reflex esophagitis, was 6.1% for PA-325/40
versus 23.9% for EC-ASA 325 mg (p<0.001).
The data above was presented in poster form (Poster 608: "PA32540 [Enteric-
coated Aspirin 325 mg + Immediate-release Omeprazole 40 mg] Is Associated with
Significantly Fewer Gastric Ulcers and Significantly Less Endoscopic Erosive
Esophagitis than Enteric-coated Aspirin [EC-ASA] Alone: Results of Two Phase 3
Studies.") at the American College of Gastroenterology (ACG) meeting on October
22, 2012 in Las Vegas, NV. Pozen received two awards for its poster. The first
award was the ACG Auxiliary Award for $1,000 to the primary authors of the two
best papers presented at ACG2012. The $1,000 is hardly anything to get excited
about, but over 1,600 posters were presented at ACG this year. The fact that
Pozen's poster was considered one of the two best posters certainly says
something about the quality of the data and the excitement it generated from the
attendees.The second award was the prestigious Presidential Poster Award.
According to the ACG's website: "The ACG Educational Affairs Committee will
identify the most highly ranked abstracts selected for the poster sessions in
each category and acknowledge their achievement with the ACG Presidential Poster
Award. These recipients will receive a special commendation on their poster in
the Poster Hall, a certificate of achievement, and recognition in the meeting
program book." All posters are eligible for this award. Similar to the Auxiliary
Award, the fact that Pozen's poster of the phase 3 data was selected to win the
Presidential Poster Award certainly validates the quality of the data and the
efficacy of the drug. We think this type of data and recognition by the ACG
could help drive meaningful market share for PA-325/40 post-approval.
Quick Background
Pozen's PA-325/40 is a combination pill containing enteric-coated aspirin 325 mg
surrounded by a pH-sensitive film, surrounded by an immediate-release omeprazole
40 mg.
Pozen designed the drug for patients requiring daily aspirin for secondary
cardiovascular prophylaxis who are at risk for aspirin-associated gastric
ulceration. Low-dose aspirin (ASA) is recommended for the secondary prevention
of cardiovascular (source) and cerebrovascular (source) events. However, daily
aspirin therapy is associated with adverse gastrointestinal events, including
gastric ulceration and bleeding, as well as dyspepsia and GERD-like symptoms
(source) which may limit patient compliance and continued use (source). Proton-
pump inhibitors, like omeprazole, are recommended to reduce the risk of upper
gastrointestinal injury in patients at risk for potentially harmful events
associated with chronic daily aspirin use (source), including dyspepsia and GERD
(source).
The Phase 3 trial above was designed to evaluate whether PA-325/40 is associated
with fewer gastric ulcers and fewer upper gastrointestinal (UGI) symptoms
compared with EC-ASA 325 mg alone. A full presentation of the data can be
found here.
We expect Pozen to be in position to file the new drug application (NDA) for PA-
325/40 during the first half of 2013. We still believe that Pozen will be able
to secure a U.S. commercialization partner for the drug in the near future. An
upfront payment for PA could be in the area of $15 to $20 million, along with
over $150 million in back-end milestones and royalties on sales. A deal that
includes countries outside the U.S. presents upside (perhaps a doubling) to
these figures. As a point of reference, the Vimovo transaction with
AstraZeneca (NYSE:AZN) provided $40 million upfront, $45 million in approval
milestones, and $290 million in sales milestones plus roughly 10% royalties on
sales. Pulling in a deal of this magnitude has the potential to double the
stock.
Read this report in its original form by clicking here.
About PropThink
PropThink is an intelligence service that delivers long and short trading ideas
to investors in the healthcare and life sciences sectors. Our focus is on
identifying and analyzing technically-complicated companies and equities that
are grossly over or under-valued. We offer daily market coverage, weekly feature
stories, and a newsletter to investors who subscribe on PropThink.com. To learn
more, follow us on Twitter or visit us at http://www.propthink.com.
Disclaimer:
You should assume that as of the publication date of any report or letter,
PropThink, LLC and persons or entities with whom it has relation ships
(collectively referred to as "PropThink") has a position in all stocks (and/or
options of the stock) covered herein that is consistent with the position set
forth in our research report. Following publication of any report or
letter, PropThink intends to continue transacting in the securities covered
herein, and we may be long, short, or neutral at any time hereafter regardless
of our initial recommendation. To the best of our knowledge and belief, all
information contained herein is accurate and reliable, and has been obtained
from public sources we believe to be accurate and reliable, and not from company
insiders or persons who have a relationship with company insiders. PropThink was
not compensated to publish this article. Our full disclaimer is available
at http://www.propthink.com/disclaimer.
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: PropThink via Thomson Reuters ONE
[HUG#1651642]
Unternehmensinformation / Kurzprofil:
Datum: 23.10.2012 - 17:25 Uhr
Sprache: Deutsch
News-ID 195429
Anzahl Zeichen: 9250
contact information:
Town:
New York
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 155 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"PropThink: Pozen Presents Impressive Phase 3 Data At ACG"
steht unter der journalistisch-redaktionellen Verantwortung von
PropThink (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
