July 21, 2014
Taiwan Discovery
PharmaEssentia (6446.OT):
Engineering the
Next-generation Interferon
Improved interferon may offer dosing and side
effect benefits: PharmaEssentia’s lead candidate is
P1101 (pegylated proline interferon α-2b), a purer and
longer-acting (biweekly) version of the previous-
generation Pegasys and Pegintron. Its improvements
aim to significantly lower flu-like and neuro side effects.
P1101 is in Phase 3 trial for polycythemia vera (PV):
PV is a rare disease marked by high red blood cell
content. PharmaEssentia expects partner AOP to
complete the European trial by 4Q14. By leveraging the
European data, PharmaEssentia expects the US FDA to
have an accelerated evaluation. In 2012, the FDA
granted P1101 the orphan drug designation. PV is
designated a rare disease in the US – i.e., prevalence of
<200,000. The IND was submitted in 2Q14.
More indications to come: PharmaEssentia has a full
clinical program to develop P1101. It is conducting three
other trials (all Phase 2) in the US/EU for three other rare
blood illnesses: chronic myeloid leukemia, essential
thrombocythemia, and primary myelofibrosis. It is also
conducting late-stage trials in Asia Pacific for hepatitis B
and C, two highly prevalent conditions in the region.
Currently on the Emerging Board: PharmaEssentia
went on Taiwan’s Emerging Board in March 2014. In
local parlance, it is a “pre-IPO” company. It is seeking a
listing on the GreTai board in 2Q15. It is one of the most
actively traded biotech stocks on the Emerging Board,
together with Taimed, OBI, and Panion. Key investors
include the CEO Dr. Lin and the National Development
Fund.
All manufacturing in-house: The company has a plant
in Taichung that is GMP-certified by Taiwan’s FDA. It is
capable of commercial scale manufacturing. The US
FDA is scheduled to inspect the plant in 2015.
Stock Data
Rating NOT COVERED
Ticker (Reuters) 6446.OT
Price (July 18, 2014) NT$173.95
Market Cap (July 18, 2014) US$1.09bn
Outstanding Shares (mn) 187.5
Company Description
PharmaEssentia is a drug company with a PEGylation technology
platform. Its strategy is to improve formulations for existing drugs.
Primary markets are the US and EU. The company was founded by a
group of Taiwanese-American executives and scientists. It has 103
employees, of which 35 hold PhDs and 2 are medical doctors.
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M O RG A N S T A N LEY RESE A R CH
A S I A /PA C IF I C
Morgan Stanley Asia Limited+ Bin Li
Bin.Li@morganstanley.com
+852 2239 7596
Laurence Tam
Laurence.Tam@morganstanley.com
+852 2239 1753
MORGAN STANLEY RESEARCH
July 21, 2014
Taiwan Discovery
Disease Markets Overview
Here we provide an overview of the more advanced indications
(Phase II and III trials) for P1101.
Polycythemia Vera (PV): This condition is marked by an
abnormally high concentration of red blood cells, as measured
by hematocrit level (>55%). The main cause is overproduction
in the bone marrow. Patients present with headaches and
vertigo, enlarged spleen and/or liver, and redness in the face
and li
