Antibe Therapeutics Receives Approval to Initiate Part Two of Phase 2B Dose-Ranging, Efficacy Study for ATB-346

TORONTO–(BUSINESS WIRE)–Antibe Therapeutics Inc. (“Antibe”) (TSXV:ATE, OTCQB:ATBPF), a leader in
developing safer therapeutics for pain and inflammation, is pleased to
announce that it has received approval from Health Canada to initiate
the second part of its Phase 2B dose-ranging, efficacy study for its
lead drug, ATB-346. The primary objective of the study is to evaluate
the efficacy of ATB-346 in reducing osteoarthritis (“OA”) pain over a
14-day treatment period. The study will involve a total of 360 patients
with OA of the knee, who will be randomized to placebo or one of three
doses of ATB-346 administered once daily: 150 mg, 200 mg or 250 mg.

Antibe’s CEO, Dan Legault, commented, “This is an exciting time for
Antibe as a significant number of patients will be receiving ATB-346 for
the first time to assess efficacy in a controlled setting. A positive
outcome in this Phase 2B study will validate the effectiveness of
ATB-346 in reducing pain, and will be a breakthrough for patients and
physicians. Furthermore, it will unlock significant value for Antibe as
we advance global partnering discussions and deepen our understanding of
the ideal development path for ATB-346 and our other pipeline drug

The study will be conducted by Veristat, Inc. (“Veristat”) in
approximately 35 clinical sites across Canada and is expected to
commence enrollment shortly. Antibe will update the timing for the trial
completion as Veristat informs us of enrollment progress during the
coming months.

About ATB-346
ATB-346 is a hydrogen sulfide-releasing
derivative of naproxen. Nonsteroidal anti-inflammatory drugs (“NSAIDs”)
are the most commonly used therapy for osteoarthritis, but their use is
associated with a high incidence of gastrointestinal ulceration and
bleeding. NSAIDs are also widely used in conditions such as rheumatoid
arthritis, ankylosing spondylitis, gout, and general pain reduction,
with a similarly high rate of gastrointestinal ulceration and bleeding.
It is well-accepted that patients with these conditions would benefit
greatly from an effective, non-addictive, GI-sparing
anti-inflammatory/analgesic agent such as ATB-346.

About Antibe Therapeutics Inc.
Antibe develops safer
medicines for pain and inflammation. Antibe’s technology involves
linking a hydrogen sulfide-releasing molecule to an existing drug to
produce a patented, improved medicine. Antibe’s lead drug ATB-346
targets the global need for a safer, non-addictive drug for chronic pain
and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets
the urgent global need for a non-addictive analgesic for treating severe
acute pain, while ATB-340 is a GI-safe derivative of aspirin.

Antibe’s subsidiary, Citagenix Inc. (“Citagenix”), is a leader in the
sales and marketing of tissue regenerative products servicing the
orthopedic and dental marketplaces. Since its inception in 1997,
Citagenix has become an important source of knowledge and experience for
bone regeneration in the Canadian medical device industry. Citagenix is
active in 15 countries, operating in Canada through its direct sales
teams, and internationally via a network of distributor partnerships.

Forward Looking Information
This news release includes
certain forward-looking statements, which may include, but are not
limited to, the completion of financing transactions and the licensing
and development of drugs and medical devices. Any statements contained
herein that are not statements of historical facts may be deemed to be
forward-looking, including those identified by the expressions “will”,
“anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”,
“propose” and similar expressions. Forward-looking statements involve
known and unknown risks and uncertainties that could cause actual
results, performance, or achievements to differ materially from those
expressed or implied in this news release. Factors that could cause
actual results to differ materially from those anticipated in this news
release include, but are not limited to, the Company’s ability to secure
additional financing, its ability to execute its business strategy and
successfully compete in the market, and risks associated with drug and
medical device development generally. Antibe Therapeutics Inc. assumes
no obligation to update the forward-looking statements or to update the
reasons why actual results could differ from those reflected in the
forward-looking statements except as required by applicable law.


Antibe Therapeutics Inc.
Dan Legault
Chief Executive Officer
473 4095

The Recombinant Human Interferon a2b Market in China (2018-2022): Injections, Capsules and Gels Take Up a Large Market Share –

DUBLIN–(BUSINESS WIRE)–The “Investigation
Report on China’s Recombinant Human Interferon a2b Market, 2018-2022”

report has been added to’s

The report estimates that by the end of 2018, more than 90 million
people in China were infected with hepatitis B virus and 8 million
carried hepatitis C virus.

With the increasing incidence of herpes, 80%-90% of the Chinese
population are infected with herpes zoster virus, and 30% of the
infected may develop chickenpox, and the rest 70% will be attacked by
herpes zoster when they are weak. Furthermore, over 40% of married women
in China are suffering from cervical erosion.

According to market research, the sales value of Recombinant Human
Interferon a2b showed an upward trend after the drug was launched in
China, reaching about CNY 271 million in 2017. The injections, capsules
and gels take up a large market share, with Shanghai Huaxin High
Biotechnology Inc., Zhaoke Pharmaceutical (Hefei) Co. Ltd. and
Schering-Plough as the top market players by sales value.

Topics Covered

  • Status of China’s Recombinant Human Interferon a2b market
  • Major manufacturers of Recombinant Human Interferon a2b in China
  • Prices of Recombinant Human Interferon a2b in China
  • Major factors influencing the development of Recombinant Human
    Interferon a2b in China
  • Prospect of China’s Recombinant Human Interferon a2b market from 2018
    to 2022

Companies Featured

  • Anhui Anke Biotechnology (Group)
  • Beijing Kawin Technology Share-Holding (Kawin Yisheng)
  • Schering-Plough (Intron A)
  • Shanghai Huaxin High Biotechnology (Xinhuanuo)
  • Tianjin Sinobioway Biomedicine (Alfaron)
  • Zhaoke Pharmaceutical (Hefei) (Yallaferon)
  • Zhejiang Beisheng Medicine Industry Hansheng Pharmaceutical

For more information about this report visit

Laura Wood, Senior Press Manager
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Topics: Central
Nervous System Drugs

Global Women’s Health Drugs Market 2019-2024 – 277 Pipeline Products in Active Development –

Women’s Health Drugs Market to 2024 – Influx of New Products Including
Orilissa, Relugolix and Bremelanotide to Diversify Landscape and Drive
report has been added to’s

“Global Women’s Health Drugs Market to 2024 Influx of New Products
Including Orilissa, Relugolix and Bremelanotide to Diversify Landscape
and Drive Growth” covers all indications within women’s health with a
particular focus on five key indications: endometriosis, polycystic
ovarian syndrome (PCOS), cervical intraepithelial neoplasia (CIN),
menopausal disorders and infertility.

The women’s health market represents a small but growing therapy area.
There are currently 277 pipeline products in active development for
women’s health, making it the 16th largest therapy area by pipeline
size. Key indications within the area include endometriosis, polycystic
ovarian syndrome (PCOS), cervical intraepithelial neoplasia, menopausal
disorders and infertility.

The global market is projected to grow at a compound annual growth rate
(CAGR) of 5.16% till 2024. This relatively strong growth will be driven
by a number of factors. These include the strong growth projected for
human papillomavirus (HPV) vaccines, which are administered to girls and
women in order to prevent development of CIN, an abnormality of the
cells on the surface of the cervix, which can progress to cervical
cancer in some cases.

The women’s health therapy area covers medical disorders that affect
females only, primarily disorders of the female reproductive system,
including those associated with menstruation, conception, pregnancy,
childbirth and menopause. Many of these disorders are highly prevalent
among the female population.

Some 246 licensing deals have been completed within the women’s health
therapy area since 2006, demonstrating a relatively high level of
activity, considering the small size of the therapy area. Co-development
deal activity has been much lower, with only 78 deals completed since

The strategic consolidations landscape was largely dominated by small
molecule products and products acting on G-protein coupled receptors
(GPCR). The majority of deals identified were relatively low value
although a small number of deals exceeded $500m in value, demonstrating
that women’s health products are capable of attracting high levels of

Key Topics Covered:

1 Tables & Figures

2 Introduction

3 Key Marketed Products

4 Pipeline Landscape Assessment

5 Multi-scenario Market Forecast to 2024

6 Company Analysis and Positioning

7 Strategic Consolidations

8 Appendix

Companies Mentioned

  • AbbVie Inc
  • Allergan Plc
  • Bayer AG
  • GlaxoSmithKline
  • Merck & Co.
  • Pfizer
  • Therapeutics MD

For more information about this report visit

Laura Wood, Senior Press Manager
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
For GMT Office Hours Call +353-1-416-8900
Topics: Women’s
, Gastrointestinal
, Endocrine
and Metabolic Disorders Drugs

Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease

Lumacaftor/ivacaftor is the first and only approved medicine in
Europe to treat the underlying cause of cystic fibrosis for
approximately 1,500 children aged 2 to 5 with two copies of the F508del


LONDON–(BUSINESS WIRE)–Vertex Pharmaceuticals (Europe) Limited today announced that the
European Commission has granted approval of the label extension for
ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children
with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of
the F508del mutation, the most common form of the disease.

Today’s approval by the European Commission brings us one step closer
to our goal of bringing treatment to all people living with CF,” said
Reshma Kewalramani, MD, Executive Vice President, Global Medicines
Development and Medical Affairs and Chief Medical Officer at Vertex.
‘‘By treating the underlying cause of disease early, we can potentially
modify its course and offer patients the chance of improved outcomes.’’

The label update is based on data from a Phase 3 open-label safety study
in 60 patients that showed treatment with lumacaftor/ivacaftor was
generally well tolerated for 24 weeks, with a safety profile in these
pediatric patients generally consistent with that in patients aged 6
years and older.

Lumacaftor/ivacaftor is already approved in the EU for the treatment of
CF in patients aged 6 and older who have two copies of the F508del mutation.

About CF
Cystic fibrosis is a rare, life-shortening genetic
disease affecting approximately 75,000 people in North America, Europe
and Australia.

CF is caused by a defective or missing CFTR protein resulting from
mutations in the CFTR gene. Children must inherit two defective CFTR
genes — one from each parent — to have CF. There are approximately
2,000 known mutations in the CFTR gene. Some of these mutations,
which can be determined by a genetic test, or genotyping test, lead to
CF by creating non-working or too few CFTR proteins at the cell surface.
The defective function or absence of CFTR protein results in poor flow
of salt and water into and out of the cell in a number of organs. In the
lungs, this leads to the build-up of abnormally thick, sticky mucus that
can cause chronic lung infections and progressive lung damage in many
patients that eventually leads to death. The median age of death is in
the mid-to-late 20s.

About the Phase 3 open-label safety study
This European
Commission approval is based on a Phase 3 open-label safety study in 60
patients that showed treatment with lumacaftor/ivacaftor was generally
well tolerated for 24 weeks, with a safety profile similar to that in
patients aged 6 years and older. Improvements in sweat chloride, a
secondary endpoint, were observed at week 24 (mean decrease in sweat
chloride from baseline of 31.7 mmol/L; 95% CI: -35.7, -27.6, n=49).
Researchers also saw changes in key growth parameters, which were also
secondary endpoints in the study. The most common adverse event (≥30%
overall) was cough (63%); most adverse events were mild or moderate in
severity. Four patients experienced serious adverse events (2 infective
pulmonary exacerbations of cystic fibrosis, 1 gastroenteritis viral, 1
constipation) and three patients discontinued treatment due to elevated
transaminases without concurrent elevations in total bilirubin. These
findings were presented at the 41st European Cystic Fibrosis
Society Conference in June 2018.

About ORKAMBI® (lumacaftor/ivacaftor)
is a combination of lumacaftor, which is designed to increase the amount
of mature protein at the cell surface by targeting the processing and
trafficking defect of the F508del-CFTR protein, and ivacaftor,
which is designed to enhance the function of the CFTR protein once it
reaches the cell surface.

About Vertex
Vertex is a global biotechnology company that
invests in scientific innovation to create transformative medicines for
people with serious and life-threatening diseases. In addition to
clinical development programs in CF, Vertex has more than a dozen
ongoing research programs focused on the underlying mechanisms of other
serious diseases.

Founded in 1989 in Cambridge, Mass., Vertex’s headquarters is now
located in Boston’s Innovation District. Today, the company has research
and development sites and commercial offices in the United States,
Europe, Canada, Australia and Latin America. Vertex is consistently
recognized as one of the industry’s top places to work, including being
named to Science magazine’s Top Employers in the life sciences
ranking for nine years in a row.

Special Note Regarding Forward-looking Statements
This press
release contains forward-looking statements as defined in the Private
Securities Litigation Reform Act of 1995, including, without limitation,
Dr. Kewalramani’s statement in the second paragraph of this press
release. While Vertex believes the forward-looking statements contained
in this press release are accurate, there are a number of factors that
could cause actual events or results to differ materially from those
indicated by such forward-looking statements. Those risks and
uncertainties include, among other things, risks related to
commercializing ORKAMBI® for people with cystic fibrosis aged
2 to 5 years old and the other risks listed under Risk Factors in
Vertex’s annual report and quarterly reports filed with the Securities
and Exchange Commission. Vertex disclaims any obligation to update the
information contained in this press release as new information becomes



Vertex Pharmaceuticals Incorporated
Partridge, +1-617-341-6108
Eric Rojas, +1-617-961-7205
Barber, +1-617-341-6470 or

Sarah D’Souza, +1-617-341-6341
Europe &
Patricia Dessert, +44 7543 237825

Alnylam Pharmaceuticals and Medison Pharma Partner to Commercialize RNAi Therapeutics in Israel

ZUG, Switzerland & PETACH TIKVA, Israel–(BUSINESS WIRE)–Alnylam
Pharmaceuticals, Inc.
(Nasdaq: ALNY), the leading RNAi therapeutics
company, and Medison Pharma, Israel’s leading commercial partner for
innovative pharmaceuticals, announced today an exclusive agreement to
commercialize ONPATTRO®, the first-ever commercialized RNAi
therapeutic, as well as other investigational therapeutics under
development in the Alnylam RNAi portfolio.

“Our partnership with Medison marks an important step in our global
commercial expansion and signals our intent to ensure that patients
suffering from serious rare diseases have access to our medicines,
regardless of location,” said Theresa Heggie, SVP and Head of Europe,
Middle East and Africa, and Canada, Alnylam Pharmaceuticals. “Medison
has a strong organization with a proven track record of commercializing
orphan products successfully, together with an infrastructure uniquely
suited to supporting patients suffering from rare diseases in Israel and
providing access to our potentially transformational therapies. We look
forward to partnering with Medison to bring ONPATTRO and potential
future therapies to patients.”

“We are proud to partner and collaborate with Alnylam in Israel,” said
Meir Jakobsohn, Founder and CEO, Medison Pharma. “Alnylam’s portfolio of
ONPATTRO and potentially ground-breaking medicines in late stage
development will strengthen our rare disease portfolio, fulfilling
Medison’s vision to provide innovative treatments to patients in Israel.
Patients with hATTR amyloidosis with polyneuropathy in Israel deserve to
have the earliest possible access to novel new treatments and we look
forward to making this a reality, beginning with ONPATTRO. Patients and
physicians in Israel are waiting for potentially disease modifying
treatments and we will do everything in our capabilities to secure their

The agreement between Alnylam and Medison includes ONPATTRO, approved in
the EU in August 2018 for the treatment of hATTR amyloidosis in adults
with stage 1 or stage 2 polyneuropathy; givosiran, a late-stage
investigational RNAi therapeutic for the treatment of acute hepatic
porphyria (AHP); and lumasiran, a late-stage investigational RNAi
therapeutic for the treatment of Primary Hyperoxaluria Type 1 (PH1).
These medicines are not currently approved for use in Israel and
givosiran and lumasiran have not yet been approved by any regulatory

About ONPATTRO® (patisiran)

Patisiran, based on Nobel Prize-winning science, is an intravenously
administered RNAi therapeutic targeting transthyretin (TTR) for the
treatment of hereditary ATTR amyloidosis. It is designed to target and
silence specific messenger RNA, potentially blocking the production of
TTR protein before it is made. Patisiran blocks the production of
transthyretin in the liver, reducing its accumulation in the body’s
tissues in order to halt or slow down the progression of the disease. In
August 2018, patisiran received U.S. Food and Drug Administration (FDA)
approval for the treatment of the polyneuropathy of hATTR amyloidosis in
adults, as well as European Medicines Agency marketing authorization for
the treatment of hATTR amyloidosis in adults with Stage 1 or Stage 2

Important Safety Information (ISI) for ONPATTRO

Infusion-Related Reactions

Infusion-related reactions (IRRs) have been observed in patients treated
with patisiran. In a controlled clinical study, 19% of patisiran-treated
patients experienced IRRs, compared to 9% of placebo-treated patients.
The most common symptoms of IRRs with patisiran were flushing, back
pain, nausea, abdominal pain, dyspnoea, and headache.

To reduce the risk of IRRs, patients should receive premedication with a
corticosteroid, paracetamol, and antihistamines (H1 and H2 blockers) at
least 60 minutes prior to patisiran infusion. Monitor patients during
the infusion for signs and symptoms of IRRs. If an IRR occurs, consider
slowing or interrupting the infusion and instituting medical management
as clinically indicated. If the infusion is interrupted, consider
resuming at a slower infusion rate only if symptoms have resolved. In
the case of a serious or life-threatening IRR, the infusion should be
discontinued and not resumed.

Reduced Serum Vitamin A Levels and Recommended Supplementation

Patisiran treatment leads to a decrease in serum vitamin A levels.
Patients receiving patisiran should take oral supplementation of
approximately 2500 IU vitamin A per day to reduce the potential risk of
ocular toxicity due to vitamin A deficiency. Doses higher than 2500 IU
vitamin A per day should not be given to try to achieve normal serum
vitamin A levels during treatment with patisiran, as serum levels do not
reflect the total vitamin A in the body. Patients should be referred to
an ophthalmologist if they develop ocular symptoms suggestive of vitamin
A deficiency (e.g. including reduced night vision or night blindness,
persistent dry eyes, eye inflammation, corneal inflammation or
ulceration, corneal thickening or corneal perforation).

Adverse Reactions

The most common adverse reactions that occurred in patients treated with
patisiran were peripheral oedema (30%) and infusion-related reactions

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing
that represents one of the most promising and rapidly advancing
frontiers in biology and drug development today. Its discovery has been
heralded as “a major scientific breakthrough that happens once every
decade or so,” and was recognized with the award of the 2006 Nobel Prize
for Physiology or Medicine. By harnessing the natural biological process
of RNAi occurring in our cells, a new class of medicines, known as RNAi
therapeutics, is now a reality. Small interfering RNA (siRNA), the
molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic
platform, function upstream of today’s medicines by potently silencing
messenger RNA (mRNA) – the genetic precursors – that encode for
disease-causing proteins, thus preventing them from being made. This is
a revolutionary approach with the potential to transform the care of
patients with genetic and other diseases.

About Alnylam

Alnylam (Nasdaq:ALNY) is leading the translation of RNA interference
(RNAi) into a new class of innovative medicines with the potential to
improve the lives of people afflicted with rare genetic,
cardio-metabolic, hepatic infectious, and central nervous system
(CNS)/ocular diseases. Based on Nobel Prize-winning science, RNAi
therapeutics represent a powerful, clinically validated approach for the
treatment of a wide range of severe and debilitating diseases. Founded
in 2002, Alnylam is delivering on a bold vision to turn scientific
possibility into reality, with a robust discovery platform. ONPATTRO® (patisiran)
lipid complex injection, available in the U.S. for the treatment of the
polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis
in adults, is Alnylam’s first U.S. FDA-approved RNAi therapeutic. In the
EU, ONPATTRO is approved for the treatment of hATTR amyloidosis in
adults with stage 1 or stage 2 polyneuropathy. Alnylam has a deep
pipeline of investigational medicines, including three product
candidates that are in late-stage development. Looking forward, Alnylam
will continue to execute on its “Alnylam 2020” strategy of building a
multi-product, commercial-stage biopharmaceutical company with a
sustainable pipeline of RNAi-based medicines to address the needs of
patients who have limited or inadequate treatment options. Alnylam
employs over 1,000 people worldwide and is headquartered in Cambridge,

About Medison

Medison, Israel’s leading innovative pharmaceutical partner, is an
exclusive Israeli partner for global healthcare companies such as Amgen,
Biogen, Ipsen, Vertex and more. Backed by three generations of
experience in the healthcare industry since 1937, Medison has built and
maintained long-standing relations with HMOs, local medical centers and
physicians. Medison is uniquely qualified to provide the complete
spectrum of integrated services for international companies looking to
enter or expand their presence in the Israeli market. Medison runs
Medison Ventures, a corporate arm with a dedicated research team
boasting deep scientific and commercial backgrounds. Medison Ventures
operates a scouting program to cater its partners and is an active
investor in life science projects around drug development and digital

Alnylam Forward Looking Statements
Various statements
in this release concerning Alnylam’s future expectations, plans and
prospects, including, without limitation, Alnylam’s views with respect
to the potential for RNAi therapeutics, including without limitation
ONPATTRO, givosiran and lumasiran, plans to make ONPATTRO available in
additional countries and to continue the filings for regulatory approval
and launch of ONPATTRO for hATTR patients with polyneuropathy around the
world, and expectations regarding its “Alnylam 2020” guidance for the
advancement and commercialization of RNAi therapeutics, constitute
forward-looking statements for the purposes of the safe harbor
provisions under The Private Securities Litigation Reform Act of 1995.
Actual results and future plans may differ materially from those
indicated by these forward-looking statements as a result of various
important risks, uncertainties and other factors, including, without
limitation, Alnylam’s ability to discover and develop novel drug
candidates and delivery approaches, successfully demonstrate the
efficacy and safety of its product candidates, the pre-clinical and
clinical results for its product candidates, which may not be replicated
or continue to occur in other subjects or in additional studies or
otherwise support further development of product candidates for a
specified indication or at all, actions or advice of regulatory
agencies, which may affect the design, initiation, timing, continuation
and/or progress of clinical trials or result in the need for additional
pre-clinical and/or clinical testing, delays, interruptions or failures
in the manufacture and supply of its product candidates, obtaining,
maintaining and protecting intellectual property, Alnylam’s ability to
enforce its intellectual property rights against third parties and
defend its patent portfolio against challenges from third parties,
obtaining and maintaining regulatory approval, pricing and reimbursement
for products, progress in establishing a commercial and ex-United States
infrastructure, successfully launching, marketing and selling its
approved products globally, Alnylam’s ability to successfully expand the
indication for ONPATTRO in the future, competition from others using
technology similar to Alnylam’s and others developing products for
similar uses, Alnylam’s ability to manage its growth and operating
expenses, obtain additional funding to support its business activities,
and establish and maintain strategic business alliances and new business
initiatives, Alnylam’s dependence on third parties for development,
manufacture and distribution of products, the outcome of litigation, the
risk of government investigations, and unexpected expenditures, as well
as those risks more fully discussed in the “Risk Factors” filed with
Alnylam’s most recent Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (SEC) and in other filings that
Alnylam makes with the SEC. In addition, any forward-looking statements
represent Alnylam’s views only as of today and should not be relied upon
as representing its views as of any subsequent date. Alnylam explicitly
disclaims any obligation, except to the extent required by law, to
update any forward-looking statements.

With the exception of ONPATTRO (patisiran), none of Alnylam’s
investigational therapeutics have been approved by the U.S. Food and
Drug Administration, European Medicines Agency, or any other regulatory
authority and no conclusions can or should be drawn regarding the safety
or effectiveness of such investigational therapies.


Alnylam Pharmaceuticals, Inc.
Christine Regan Lindenboom
and Media)

Fiona McMillan
(Media, Europe)
+44 1628 244960

Medison Pharma
Gil Gurfinkel
Vice President, Corporate
+972 (0) 39250374

SanBio: Addition of a Cerebral Hemorrhage Program for SB623 Regenerative Cell Medicine

TOKYO–(BUSINESS WIRE)–At a meeting held today, the Board of Directors of SanBio Co., Ltd.
(hereinafter, the “Company”) resolved to add a program for treatment of
chronic motor deficit from cerebral hemorrhage as a new indication for
SB623, a regenerative cell medicine developed by the Group.
(Hereinafter, the “Group” refers to two companies, SanBio Co., Ltd., and
SanBio, Inc.)

1. Details of the Decision

As part of its mission to introduce new therapeutic drugs for the
central nervous system, the Group is moving forward with the development
of programs for chronic motor deficit from traumatic brain injury (TBI)
and chronic motor deficit from ischemic stroke, centering on the United
States and Japan. Regarding the program for treatment of chronic motor
deficit from TBI, positive results were announced on November 1, 2018,
with respect to a Phase 2 clinical trial, namely that “Patients
administered SB623 demonstrated a statistically significant improvement
in their motor function compared to the control group, confirming that
the study has met its primary endpoint.” Regarding the program targeting
chronic motor deficit from ischemic stroke, the Company expects to
announce results of a Phase 2b clinical trial in the first half of the
fiscal year ending January 31, 2020 (from February 1, 2019 to July 31,

Given the positive results of the program targeting chronic motor
deficit from TBI mentioned above, the Group has reevaluated the scope of
indications for SB623. Consequently, the Company has decided to initiate
a program for treatment of chronic motor deficit from cerebral
hemorrhage, which is similar to TBI, as a new indication for SB623. The
Company is considering Japan and the United States as development
regions for this program.

Ischemic stroke is caused by the blockage of blood vessels, whereas
cerebral hemorrhage results from ruptured blood vessels. Both can result
in hemiplegia, sensory impairment, or memory impairment. Currently, no
definitive therapy exists.

As of today, the Company expects to commence clinical trials for this
program from Phase 2 or Phase 3. However, the development details and
timing are not yet decided. The Company will provide these as soon as
they become available.

2. Outlook

This decision does not affect the Company’s consolidated operating
performance for the fiscal year ending January 31, 2019.


SanBio Co., Ltd.
Yoshihiro Kakutani, Corporate Officer of
Management Administration
(TEL. +81-3-6264-3481)

US FDA Approves ONTRUZANT® (trastuzumab-dttb), Samsung Bioepis’ First Oncology Medicine in the United States

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug
Administration (FDA) has approved ONTRUZANT® (trastuzumab-dttb),
a biosimilar referencing HERCEPTIN® 1 (trastuzumab), across
all eligible indications, namely adjuvant treatment of
HER2-overexpressing breast cancer, metastatic breast cancer and
metastatic gastric cancer or gastroesophageal junction adenocarcinoma in
patients who have not received prior treatment for metastatic disease.
Please see Boxed Warnings and Important Safety Information for ONTRUZANT®

ONTRUZANT® is Samsung Bioepis’ first oncology biosimilar to
receive FDA approval, and will be marketed and distributed in the United
States (US) by Merck, which is known as MSD outside of the US and Canada.

“For many cancer patients in the US, battling cancer has not only been a
health issue, but a considerable financial burden brought on by cancer
treatment. Biosimilars are intended to be lower cost, high-quality
treatment options that have the potential to alleviate such burden. We
sincerely hope our trastuzumab biosimilar will do exactly that,” said
Sang-Jin Pak, Senior Vice President and Head of Commercial Division,
Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate
our enduring commitment to biosimilars by further strengthening our
pipeline and widening the availability of approved treatments for cancer
patients across the US.”

ONTRUZANT® was also approved by the European Commission (EC)
in November 2017, and has since been launched in a growing number of
European countries.

About ONTRUZANT (trastuzumab-dttb)
ONTRUZANT is indicated
for adjuvant treatment of HER2-overexpressing node-positive or
node-negative (ER/PR-negative or with one high-risk feature*) breast

  • As part of a treatment regimen containing doxorubicin,
    cyclophosphamide and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
* High-risk is defined as
ER/PR positive with one of the following features: tumor size >2 cm, age
<35 years, or tumor grade 2 or 3.
ONTRUZANT is indicated:

  • In combination with paclitaxel for the first line treatment of
    HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer
    in patients who have received one or more chemotherapy regimens for
    metastatic disease

Select patients for therapy based on an FDA-approved companion
diagnostic for a trastuzumab product.
ONTRUZANT is indicated, in
combination with cisplatin and capecitabine or 5-fluorouracil, for the
treatment of patients with HER2 overexpressing metastatic gastric or
gastroesophageal junction adenocarcinoma, who have not received prior
treatment for metastatic disease.
Select patients for therapy based
on an FDA-approved companion diagnostic for a trastuzumab product

Select Important Safety Information


  • ONTRUZANT administration can result in sub-clinical and clinical
    cardiac failure manifesting as congestive heart failure and decreased
    left ventricular ejection fraction with greatest risk when
    administered concurrently with anthracyclines. Evaluate cardiac
    function prior to and during treatment. Discontinue ONTRUZANT for

Infusion Reactions; Pulmonary Toxicity

  • Administration can result in serious and fatal infusion reactions
    and pulmonary toxicity. Symptoms usually occur during or within 24
    hours of administration. Discontinue ONTRUZANT for anaphylaxis,
    angioedema, interstitial pneumonitis, or acute respiratory distress

Embryo-Fetal Toxicity

  • Exposure to ONTRUZANT during pregnancy can result in
    oligohydramnios in some cases complicated by pulmonary hypoplasia,
    skeletal abnormalities, and neonatal death. Advise patients of these
    risks and the need for effective contraception

Exacerbation of Chemotherapy-Induced Neutropenia

  • In randomized, controlled clinical trials, the per-patient incidences
    of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were
    higher in patients receiving trastuzumab products in combination with
    myelosuppressive chemotherapy as compared to those who received
    chemotherapy alone. The incidence of septic death was similar among
    patients who received trastuzumab and those who did not

Most Common Adverse Reactions

  • The most common adverse reactions for trastuzumab products in breast
    cancer were fever, nausea, vomiting, infusion reactions, diarrhea,
    infections, increased cough, headache, fatigue, dyspnea, rash,
    neutropenia, anemia, and myalgia
  • The most common adverse reactions for trastuzumab products in
    metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia,
    stomatitis, weight loss, upper respiratory tract infections, fever,
    thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

These are not all of the risks associated with ONTRUZANT®.
For additional information on ONTRUZANT® indications, as
well as Important Safety Information related to its use, including Boxed
WARNINGS, please see the ONTRUZANT® Prescribing Information HERE

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung
Bioepis is a biopharmaceutical company committed to realizing healthcare
that is accessible to everyone. Through innovations in product
development and a firm commitment to quality, Samsung Bioepis aims to
become the world’s leading biopharmaceutical company. Samsung Bioepis
continues to advance a broad pipeline of biosimilar candidates that
cover a spectrum of therapeutic areas, including immunology, oncology,
ophthalmology and hematology. Samsung Bioepis is a joint venture between
Samsung BioLogics and Biogen. For more information, please visit:

# # #


1HERCEPTIN® is a registered
trademark of Genentech Inc.


Mingi Hyun

ALLERGAN SHAREHOLDER ALERT by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Reminds Investors with Losses in Excess of $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against Allergan plc. – AGN

NEW ORLEANS–(BUSINESS WIRE)–lt;a href=”” target=”_blank”gt;$AGNlt;/agt; lt;a href=”” target=”_blank”gt;#AGNlt;/agt;–Kahn Swick & Foti, LLC (“KSF”) and KSF partner, former Attorney General
of Louisiana, Charles C. Foti, Jr., remind investors that they have until
February 19, 2019
to file lead plaintiff applications in a
securities class action lawsuit against Allergan plc. (NYSE: AGN), if
they purchased the Company’s shares between February 24, 2017, and
December 19, 2018, inclusive (the “Class Period”). This action is
pending in the United States District Court for the Southern District of
New York.

What You May Do

If you purchased shares of Allergan and would like to discuss your legal
rights and how this case might affect you and your right to recover for
your economic loss, you may, without obligation or cost to you, contact
KSF Managing Partner Lewis Kahn toll-free at 1-877-515-1850 or via email
or visit
to learn more. If you wish to serve as a lead plaintiff in this class
action, you must petition the Court by February 19, 2019.

About the Lawsuit

Allergan and certain of its executives are charged with failing to
disclose material information during the Class Period, violating federal
securities laws.

On December 19, 2018, the Company announced that it had halted the sale
of its textured breast implants in the European market following a
compulsory recall request from the French regulatory authority, Agence
Nationale de Sécurité du Médicament, after the product’s CE Mark
certification expired, amid concerns of a link to a rare form of cancer.

On this news, the price of Allergan’s shares plummeted.

The case is Cook v. Allergan Plc et al, No. 18-cv-12089.

About Kahn Swick & Foti, LLC

KSF, whose partners include the former Louisiana Attorney General
Charles C. Foti, Jr., is a law firm focused on securities, antitrust and
consumer class actions, along with merger & acquisition and breach of
fiduciary litigation against publicly traded companies on behalf of
shareholders. The firm has offices in New York, California and Louisiana.

To learn more about KSF, you may visit


Kahn Swick & Foti, LLC
Lewis Kahn, Managing Partner

MEDIA ADVISORY: Fabric Genomics™ Senior Scientist to Discuss Role of Genomics and Artificial Intelligence in Advancing Precision Medicine – Tuesday, January 22nd

OAKLAND, Calif.–(BUSINESS WIRE)–Precision Medicine World Conference – Fabric Genomics:



Presentation, How Genomics and Artificial Intelligence are
Enabling Precision Medicine
, highlighting how artificial
intelligence can enhance genomics’ value in accelerating
improvements in precision medicine.

WHEN: Tuesday, January 22nd, 2:30 – 2:45 p.m. PST
WHERE: Precision Medicine World Conference


Santa Clara Convention Center – Track 1


Santa Clara, California

WHO: Francisco M. De La Vega, DSc, Fabric Genomics’ Senior Vice
President of Genomics, is a geneticist and computational biologist
with interests in clinical and population genetics. He also serves
as Adjunct Professor at the Stanford University School of Medicine’s
Department of Biomedical Data Science. Dr. de la Vega has
participated in several breakthrough international projects such as
the 1000 Genomes Project and the International Cancer Genome
Consortium. He has co-authored more than 100 scientific
publications, including papers in top journals such as Nature,
Nature Genetics, Science and Genome Research,
receiving more than 20,000 citations.
INFO: As genomic medicine becomes more critical to delivering precision
diagnoses and targeted therapies, there is a need for artificial
intelligence approaches that will help clinicians cope with the
rapidly increasing volumes of genomic data. This session will focus
on how AI can be integrated within clinical genome interpretation,
significantly increasing scale while reducing costs and avoiding
“black-box” approaches.

About Fabric Genomics

Fabric Genomics is making genomics-driven precision medicine a reality.
The company provides clinical-decision support software that enables
clinical labs, hospital systems and country-sequencing programs to gain
actionable genomic insights, resulting in faster and more accurate
diagnoses and reduced turnaround time. Fabric’s end-to-end genomic
analysis platform incorporates proven AI algorithms, and has
applications in both hereditary disease and oncology. Headquartered in
Oakland, California, Fabric Genomics was founded by industry veterans
and innovators with a deep understanding of bio-informatics, large-scale
genomics and clinical diagnostics. To learn more, visit
and follow us on Twitter, LinkedIn, and Facebook.


Charlene Son Rigby, 510-595-0800, ext. 106

Navitus Launches a New Website and Refreshed Brand to Further Its Mission to Make Prescription Benefits More Affordable

MADISON, Wis.–(BUSINESS WIRE)–Navitus Health Solutions, a full-service prescription benefit manager
(PBM), is pleased to announce the launch of its new website and
refreshed brand at
The new site features a modern design, improved functionality and easy
access to essential information to help benefit purchasers make
well-informed prescription benefit decisions. The site will also more
effectively convey the company’s mission and capabilities as it
continues to make prescription benefits more affordable.

We are excited about our new website launch and the robust information
it provides for potential customers as well as the easy access it offers
members, pharmacies, prescribers and others to their portals,” said
Byron Mickle, Senior Vice-President of Sales and Marketing. “We believe
this new website will allow our guests to have a very informative
experience where they can learn more about our unique approach to
prescription benefits and make a more educated decision when it comes to
selecting a PBM.”

The new website offers robust resources to assist benefit purchasers as
they evaluate complex PBM contracts, business models and pricing.
Resources range from informative e-books, webinars and podcasts to
in-depth reports and client case studies.

The refreshed branding, featured on the new website, positions the
company as a modern, alternative solution to traditional PBMs and
demonstrates its ability to meet today’s rapidly changing healthcare
needs. The brand’s story capitalizes on the company’s strengths to
deliver a unique, client-centric experience. When combined with its 100
percent pass-through model, lowest-net-cost philosophy and clinical care
model, clients receive a substantial savings, while improving member
health. The overall experience in working with Navitus is captured
through its vibrant brand imagery and new tagline: Pharmacy Benefits
Although the tagline is new, as a pioneer in pass
through, Navitus has been reinventing pharmacy benefits for over 15

We believe we offer a better, more affordable solution and we simply
want more plan sponsors to know about it and realize there’s an
alternative to traditional PBM business models —and our new rebranding
and website help us do that,” added Mickle. “Like any PBM, we work with
pharmacies and manufacturers to secure the best drug pricing and rebates
possible for our clients. However, we’re reinventing pharmacy benefits
with our full pass-through model and focus on delivering the
lowest-net-cost medications. We pass 100 percent of all money, including
rebates we receive, directly back to our clients. As a result, our
clients experience lower year-over-year drug spend, typically 10-15%
lower, which shows up in decreased PMPM expenses and reduced overall
costs. For example, in 2017 we provided substantially lower costs for
our clients, achieving an industry leading net cost per-member-per-month
(PMPM) of $76.56 across our commercial business, which is 15.5 percent
lower than the industry average of the largest PBMs at $90.66 PMPM.”

Navitus’ new website will be updated regularly to provide the latest
news and perspectives on prescription benefits, insightful tools and
informative events. Guests are encouraged to peruse the new website at
and sign up for blogs and email alerts.

About Navitus

Navitus Health Solutions, LLC, a division of SSM Health, is a
full-service, URAC-accredited pharmacy benefit management company. As a
zero-spread, full pass through pharmacy benefit manager (PBM), Navitus
aligns performance with plan sponsors’ benefit goals to deliver
comprehensive clinical programs and cost-saving strategies that lower
drug trend and promote good member health. Navitus provides its flexible
services to government entities, self-funded employers, coalitions,
labor organizations, third-party administrators, and health plans,
including managed Medicaid, Exchanges, and Medicare Part D. For more
information about Navitus’ tangible solutions to the rising cost of
pharmaceutical care, visit
or call 877-571-7500.


Debi Lerkins at 480.498.6255 or