Reprieve Cardiovascular Announces Late-Breaking Acute Heart Failure Clinical Trial Data

Potential New Treatment for Acute Heart Failure Presented at the
Heart Failure 2019 Congress

  • TARGET-1 and TARGET-2 trials: safe decongestion using first fully
    automated fluid management system
  • Significant increase in diuresis, net negative fluid balance,
    improvement of kidney function and improvement in clinical symptoms
  • Significant drop in CVP while systolic BP remained stable

MILFORD, Mass.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/ADHF?src=hash” target=”_blank”gt;#ADHFlt;/agt;–Reprieve
Cardiovascular
™, a pioneering medical device company focused on
improving outcomes for patients suffering from Acute Decompensated Heart
Failure (ADHF), today announced the results of two non-randomized,
prospective clinical trials in patients hospitalized with Acute Heart
Failure (AHF). The two studies demonstrate that using Reprieve-Guided
Diuretic Therapy, the first fully automated fluid management system,
allows for safe decongestion for patients with AHF. The results were
presented today at the Heart Failure 2019 Congress, 25-28 May, in
Athens, Greece.

The 19-patient TARGET-1 and TARGET-2 clinical trials were designed to
determine whether the Reprieve-Guided Diuretic Therapy system could
achieve safe net volume reduction while significantly alleviating
related symptoms in ADHF patients.

The data reported a significant increase in diuresis, net negative fluid
balance, improved kidney function and improvement in clinical symptoms.

Patients served as their own controls with each patient undergoing 24
hours of standard diuretic therapy with intravenous furosemide followed
by 24 hours of diuresis with the automated Reprieve-Guided System. The
average urine output increased from 1986 ml in the standard therapy to
6284 ml during a 24-hour therapy period. In addition, there were
improvements in net fluid loss, and renal function accompanied by
favorable hemodynamic changes.

“The therapy appears to be safe and quite effective,” said Professor
Piotr Ponikowski, Professor of Cardiology at Wroclaw Medical University,
Poland. “Reprieve’s automated fluid management technology provided
faster, more controlled fluid removal while protecting acute heart
failure patients from dangerous drops in blood pressure. It maintained
optimal intravascular fluid volume and with it, cardiac output and renal
perfusion.”

ADHF is a sudden onset of heart failure symptoms, which typically
include difficulty breathing (dyspnea), swelling in the extremities, and
fatigue. The signs and symptoms of fluid overload are responsible for
90% of heart failure hospital admissions. Current treatment for ADHF
includes diuretic therapy that aims to restore healthy fluid levels in
the kidneys and throughout the body. Standard diuretic therapy, however,
can be unpredictable and lose effectiveness as a patient’s condition
deteriorates. In some patients, diuretics can trigger a condition called
“diuretic resistance,” which blunts the function of diuretics and can
exacerbate the severity of fluid overload, potentially resulting in
acute kidney injury.

“Reprieve-Guided Diuretic Therapy is among the first non-pharmacologic
advance in treating fluid overload in Acute Heart Failure patients since
diuretics were introduced in the 1960s,” said Jim Dillon, Reprieve
Cardiovascular’s President and CEO. “These results support our continued
efforts to evaluate the impact of our therapy on alleviating the pain
points clinicians continuously tell us about that complicate care of
patients with acute heart failure. These include long hospital stays,
high readmission rates, and ultimately poor long-term patient prognosis.”

Problems and Optimization of Volume Management in AHF: Symposium 25
May, 12:15 pm (Session 2120, Agora 1)

Leading heart failure experts Howard Levin, M.D., Prof. Piotr Ponikowski
and Jeffrey Testani, M.D. will discuss the latest advances in AHF
treatment, including a novel physiological approach to volume management.

About Reprieve Cardiovascular’s Guided Diuretic Therapy
Reprieve
Cardiovascular’s Guided Diuretic Therapy is designed to manage fluids
during diuretic therapy for patients with Acute Decompensated Heart
Failure (ADHF) and may relieve a number of symptoms related to this
condition. The therapy has the potential to enable precise and
predictable management of a patient’s fluid levels, guarding against
dangerous fluid imbalances and enabling better control over diuretic
therapy, thus increasing diuretic efficiency. Potential benefits include
speeding decongestion while protecting core organ function, reducing
symptoms of congestive heart failure such as shortness of breath,
ascites, and swelling, reduced time in hospital, reduced readmission
rates, and a better quality of life for patients.

About Reprieve Cardiovascular
Reprieve Cardiovascular is a
pioneering medical device company focused on automated fluid management
technologies for acute heart failure. The company’s Reprieve technology
is being investigated as an innovative fluid management treatment.
Providing clinicians with the ability to precisely control a patient’s
fluid volume may enable improved cardiac care with safe, effective
decongestion of acute decompensated heart failure patients (ADHF).
Reprieve Cardiovascular, Inc. and RenalGuard Solutions, Inc. are
subsidiaries of parent company CardioRenal Systems, Inc. For more
information, visit www.reprievecardio.com
and follow Reprieve Cardiovascular on Twitter at @ReprieveCardio.

Please visit us at HF2019 Booth I1 Level 1

Contacts

Edna Kaplan
KOGS Communication
+1-781-639-1910
kaplan@kogspr.com

BridgeBio Pharma Announces Filing of Registration Statement for Proposed Initial Public Offering

PALO ALTO, Calif.–(BUSINESS WIRE)–BridgeBio Pharma, Inc., a clinical-stage biopharmaceutical company
focused on genetic diseases, today announced that it has filed a
registration statement on Form S-1 with the U.S. Securities and Exchange
Commission (SEC) relating to a proposed initial public offering of
shares of its common stock. The number of shares to be offered and the
price range for the proposed offering have not yet been determined.
BridgeBio has applied to list its common stock on the Nasdaq Global
Market under the symbol “BBIO.”

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, SVB
Leerink LLC, KKR Capital Markets LLC, Piper Jaffray & Co., Mizuho
Securities USA LLC, BMO Capital Markets Corp. and Raymond James &
Associates, Inc. will act as book-running managers for the proposed
offering.

The proposed offering will be made only by means of a prospectus. Copies
of the preliminary prospectus relating to the proposed offering may be
obtained, when available, for free by visiting EDGAR on the SEC’s
website at www.sec.gov.
Alternatively, copies of the prospectus, when available, may be obtained
for free from the offices of J.P. Morgan Securities LLC, Attention:
Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY
11717, telephone: 1-866-803-9204 or by emailing prospectus-eq_fi@jpmchase.com;
Goldman, Sachs & Co., Attention: Prospectus Department, 200 West Street,
New York, NY 10282, telephone: 1-866-471-2526 or by emailing prospectus-ny@ny.email.gs.com;
Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520
Madison Avenue, 2nd Floor, New York, NY 10022, telephone:
1-877-547-6340, or by emailing Prospectus_Department@Jefferies.com;
or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street,
37th Floor, Boston, Massachusetts 01220, telephone: 1-800-808-7525, ext.
6132, or by emailing syndicate@svbleerink.com.
The offering is subject to market and other conditions, and there can be
no assurance as to whether or when the offering may be completed.

A registration statement relating to these securities has been filed
with the SEC but has not yet become effective. These securities may not
be sold nor may offers to buy be accepted prior to the time the
registration statement becomes effective. This press release shall not
constitute an offer to sell or the solicitation of an offer to buy these
securities, nor shall there be any sale of these securities in any state
or jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the securities
laws of any such state or jurisdiction.

About BridgeBio Pharma

BridgeBio is a team of experienced drug discoverers, developers and
innovators working to create life-altering medicines that target
well-characterized genetic diseases at their source. BridgeBio was
founded in 2015 to identify and advance transformative medicines to
treat patients who suffer from Mendelian diseases, which are diseases
that arise from defects in a single gene, and cancers with clear genetic
drivers. BridgeBio’s pipeline of over 15 development programs includes
product candidates ranging from early discovery to late-stage
development.

Contacts

Alberto Gestri
AGestri@theoutcastagency.com

QIAGEN launches first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer

Innovative therascreen® PIK3CA RGQ PCR Kit
receives U.S. regulatory approval for use in guiding treatment decisions
from tissue and liquid biopsy for newly approved therapy PIQRAY
®
(alpelisib) from Novartis

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)–QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the
immediate launch of its therascreen® PIK3CA RGQ
PCR Kit (therascreen PIK3CA Kit) after it received U.S.
regulatory approval as a companion diagnostic to aid in identifying
breast cancer patients eligible for treatment with PIQRAY (alpelisib), a
newly approved therapy developed and marketed by Novartis.

The therascreen PIK3CA Kit is the first companion diagnostic
assay to obtain premarket approval from the U.S. Food and Drug
Administration (FDA) for use in any cancer indication for detection of
activating mutations in the PIK3CA gene. It is also the first FDA
approved assay for guiding treatment decisions in breast cancer using
plasma specimens as a liquid biopsy. The assay detects 11 PIK3CA
mutations, which are estimated to be present in approximately 40% of
hormone receptor-positive (HR+) advanced or metastatic breast cancer
patients. The real-time qualitative PCR kit is processed on QIAGEN’s
Rotor-Gene Q MDx, a member of the modular QIAsymphony family of
automation solutions. The test leverages QIAGEN’s worldwide co-exclusive
license from Johns Hopkins University for PCR-based companion
diagnostics based on mutations in the PIK3CA gene.

QIAGEN’s therascreen PIK3CA Kit was co-developed in collaboration
with Novartis and co-approved with PIQRAY (alpelisib) by the FDA. The
Novartis drug is indicated in combination with fulvestrant for the
treatment of postmenopausal women and men ,with hormone receptor
(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative,
PIK3CA-mutated, advanced or metastatic breast cancer as detected by an
FDA-approved test following progression on or after an endocrine-based
regimen. Further detail about the Kit is available at www.qiagen.com/PIK3CA.

Please find the full press release here

###

Contacts

QIAGEN

Investor Relations
John Gilardi +49 2103 29 11711
Phoebe
Loh +49 2103 29 11457
e-mail: ir@QIAGEN.com

Public Relations
Thomas Theuringer +49 2103 29 11826
e-mail:
pr@QIAGEN.com

Vapotherm to Present at the William Blair 39th Annual Growth Stock Conference

EXETER, N.H.–(BUSINESS WIRE)–Vapotherm, Inc. (NYSE: VAPO), a global medical technology company
focused on the development and commercialization of its proprietary
Hi-VNI® Technology products that are used to treat patients of all ages
suffering from respiratory distress, today announced that its management
team will be presenting at the William Blair 39th Annual Growth Stock
Conference on Wednesday, June 5th at the Loews Chicago Hotel
in Chicago, Illinois.

Vapotherm is scheduled to present at 3:20pm Central Time. The
presentation will be accessible via a live webcast at: http://wsw.com/webcast/blair55/vapo/

A webcast replay of the presentation will be available for 90 days
following the presentation in the Event Archive section of Vapotherm’s
Investor website at http://investors.vapotherm.com/.

Vapotherm, Inc. (NYSE: VAPO) is a publicly traded developer
and manufacturer of advanced respiratory technology based in Exeter, New
Hampshire, USA. The company develops innovative, comfortable,
noninvasive technologies for respiratory support of patients with
chronic or acute breathing disorders. Over 1.8 million patients have
been treated with Vapotherm Hi-VNI Technology. For more information,
visit www.vapotherm.com.

Hi-VNI® Technology is mask-free noninvasive ventilation for
spontaneously breathing patients and a front-line tool for relieving
respiratory distress—including hypercapnia, hypoxemia, and dyspnea. It
allows for the fast, safe treatment of undifferentiated respiratory
distress with one user-friendly tool. Hi-VNI Technology’s mask-free
interface delivers optimally conditioned breathing gases, making it
comfortable for patients and reducing the risks and care complexities
associated with mask therapies. While being treated, patients can talk,
eat, drink and take oral medication.

Website Information Vapotherm routinely posts important
information for investors on the Investor Relations section of its
website, http://investors.vapotherm.com/.
Vapotherm intends to use this website as a means of disclosing material,
non-public information and for complying with Vapotherm’s disclosure
obligations under Regulation FD. Accordingly, investors should monitor
the Investor Relations section of Vapotherm’s website, in addition to
following Vapotherm’s press releases, Securities and Exchange Commission
filings, public conference calls, presentations and webcasts. The
information contained on, or that may be accessed through, Vapotherm’s
website is not incorporated by reference into, and is not a part of,
this document.

Contacts

Investor Relations Contact: Mark Klausner or Mike Vallie,
Westwicke, an ICR Company, ir@vtherm.com,
+1-(603)-658-0011

Immunomic Therapeutics to Participate at Sach’s 5th Annual Immuno-oncology BD&L and Investment Forum

ROCKVILLE, Md.–(BUSINESS WIRE)–lt;a href=”https://twitter.com/hashtag/allergies?src=hash” target=”_blank”gt;#allergieslt;/agt;–Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based
biotechnology company, announced today that the company will present at
the 5th Annual Immuno-oncology BD&L and Investment Forum
being held in Chicago, IL, May 31, 2019. Sia Anagnostou, Immunomic’s
Senior Director of Corporate Development, will present a company
overview and will discuss ITI’s recently expanded, investigational
UNiversal Intracellular Targeted Expression (UNITE) platform and its
application in immuno-oncology, specifically glioblastoma multiforme
(GBM). ITI’s technology platform has the potential to utilize the body’s
natural biochemistry to develop a broad immune response and is currently
being employed in a Phase II clinical trial as a cancer immunotherapy.

Presentation details are as follows:

Title: Immunomic Therapeutics, Pioneering Vaccines That Transform
Lives
Panel Date and Time: Friday, May 31, 2019 10:30 AM
Track
& Room:
 PR Track C, Room Sinclair North
Place:
Waldorf Astoria Chicago Hotel, Chicago, Illinois

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular
Targeted Expression, is thought to work by encoding the Lysosomal
Associated Membrane Protein, an endogenous protein in humans. In this
way, ITI’s vaccines (DNA or RNA) have the potential to utilize the
body’s natural biochemistry to develop a broad immune response including
antibody production, cytokine release and critical immunological memory.
This approach could put UNITE technology at the crossroads of
immunotherapies in a number of illnesses, including cancer, allergy and
infectious diseases. UNITE is currently being employed in Phase II
clinical trials as a cancer immunotherapy. ITI is also collaborating
with academic centers and biotechnology companies to study the use of
UNITE in cancer types of high mortality, including cases where there are
limited treatment options like glioblastoma and acute myeloid leukemia.
ITI believes that these early clinical studies may provide a proof of
concept for UNITE therapy in cancer, and if successful, set the stage
for future studies, including combinations in these tumor types and
others. Preclinical data is currently being developed to explore whether
LAMP nucleic acid constructs may amplify and activate the immune
response in highly immunogenic tumor types and be used to create immune
responses to tumor types that otherwise do not provoke an immune
response.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage
biotechnology company pioneering the development of vaccines through its
proprietary technology platform, UNiversal Intracellular Targeted
Expression (UNITE), which is designed to utilize the body’s natural
biochemistry to develop vaccines that generate broad immune responses.
ITI’s UNITE platform could potentially have broad therapeutic
applications in oncology, including viral antigens, cancer antigens,
neoantigens and antigen-derived antibodies as biologics and ITI has
built a large pipeline from UNITE with six oncology programs and two
allergy programs. ITI has entered into a significant allergy partnership
with Astellas Pharma and has formed several academic collaborations with
leading Immuno-oncology researchers at Fred Hutchinson Cancer Research
Institute, Johns Hopkins University of Medicine, Duke University. ITI
maintains its headquarters in Rockville, Maryland. For more information,
please visit www.immunomix.com.

Contacts

Company Contact:
Sia Anagnostou
sia@immunomix.com
717-327-1822

Media Contact:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243

Five Prime Therapeutics to Present at Two Upcoming Healthcare Conferences

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Five
Prime Therapeutics, Inc.
(NASDAQ: FPRX), a clinical-stage
biotechnology company focused on discovering and developing innovative
immuno-oncology protein therapeutics today announced that Aron
Knickerbocker, Chief Executive Officer, is scheduled to present at the
following two investor conferences:

  • The Jefferies Healthcare Conference, on Thursday, June 6th
    at 9:30am ET / 6:30am PT
  • The 40th Annual Goldman Sachs Global Healthcare Conference
    on Wednesday, June 12th at 1:00pm ET / 10:00am PT

The presentations will be webcast and may be accessed at the “Events &
Presentations” section of the Company’s website at: http://investor.fiveprime.com/events.cfm.
Five Prime will maintain an archived replay of the webcast on its
website for 30 days after the conference.

About Five Prime

Five Prime Therapeutics, Inc. discovers and develops innovative protein
therapeutics to improve the lives of patients with serious diseases.
Five Prime’s product candidates have innovative mechanisms of action and
address patient populations in need of better therapies. The company
focuses on researching and developing immuno-oncology and targeted
cancer therapies paired with companion diagnostics to identify patients
who are most likely to benefit from treatment with Five Prime’s product
candidates. Five Prime has entered into strategic collaborations with
leading global pharmaceutical companies and has promising product
candidates in clinical and preclinical development. For more
information, please visit www.fiveprime.com or
follow us on LinkedInTwitter and Facebook.

Source: Five Prime Therapeutics, Inc.

Contacts

Media and Investor Contact
Martin Forrest
VP, Investor
Relations & Corporate Communications
Five Prime Therapeutics,
Inc.
415-365-5625
martin.forrest@fiveprime.com

Pfizer Announces Top-Line Results from Phase 3 Trial of LYRICA® (pregabalin) in Primary Generalized Tonic-Clonic Seizures

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess
the use of LYRICA® (pregabalin) as adjunctive therapy for
epilepsy patients 5 to 65 years of age with primary generalized
tonic-clonic (PGTC) seizures did not meet its primary endpoint.
Treatment with LYRICA did not result in a statistically significant
reduction in seizure frequency versus placebo. Lyrica is not indicated
in any population for the treatment of PGTC seizures. The study was a
post-marketing commitment to the U.S. Food and Drug Administration (FDA).

“Pfizer is committed to the study of patient populations with unmet
treatment needs, including pediatric and adult patients experiencing
generalized tonic-clonic seizures,” said Juan Ovalle, M.D., Global Chief
Medical Officer, R&D and Medical, Upjohn, a division of Pfizer. “These
data contribute to our growing understanding of pediatric epilepsy and
reflect our responsibility to advance scientific knowledge through
post-marketing research.”

The LYRICA Pediatric Epilepsy Program is composed of six studies in
patients with epilepsy evaluating LYRICA as adjunctive therapy, five of
which have been completed. For more information, visit www.clinicaltrials.gov.

About the Study

This Phase 3 study was a 12-week randomized, double-blind,
placebo-controlled, multi-center study evaluating the efficacy of two
doses of LYRICA in patients 5 to 65 years of age with PGTC seizures. The
study was conducted at 70 sites in 21 countries with 219 patients.
Patients were randomized in a 1:1:1 ratio to receive placebo, or one of
two fixed doses of LYRICA twice daily: LYRICA 5 mg/kg/day (7 mg/kg/day
for subjects with body weight <30 kg, and 300 mg/day for those 17 years of age and older) or LYRICA 10 mg/kg/day (14 mg/kg/day for subjects with body weight <30 kg, and 600 mg/day for those 17 years of age and older).

The safety profile observed in this study was comparable to the known
profile of LYRICA in prior epilepsy studies in pediatric and adult
patients. The most common adverse events observed with LYRICA were
dizziness, headache and somnolence.

About Epilepsy

Epilepsy is a chronic disorder characterized by recurrent, unprovoked
seizures and occurs in both adults and children. Sixty-five million
people worldwide have epilepsy. In the U.S., more than three million
people, including 470,000 children are living with epilepsy. Epilepsy is
associated with increased morbidity and mortality and can profoundly
affect multiple daily life activities. Primary generalized tonic-clonic
seizures, formerly referred to as grand mal seizures, are the most
common type of generalized seizures and involve loss of consciousness.

About LYRICA

LYRICA® is currently approved for various indications in more
than 130 countries and regions globally.

In the U.S., LYRICA is indicated to treat fibromyalgia, diabetic nerve
pain, spinal cord injury nerve pain and pain after shingles in adults.

In the U.S., LYRICA is approved as adjunctive therapy for the treatment
of partial onset seizures in patients four years of age and older.
LYRICA is also indicated to treat partial onset seizures in patients 4
years of age and older with epilepsy who take 1 or more other drugs for
seizures.

Please click here
for the full prescribing information and Medication Guide for LYRICA or
visit http://www.lyrica.com/.

Important Safety Information

LYRICA is not for everyone. LYRICA may cause serious, even life
threatening, allergic reactions. Stop taking LYRICA and call your doctor
right away if you have any signs of a serious allergic reaction. Some
signs are swelling of your face, mouth, lips, gums, tongue, throat or
neck or if you have any trouble breathing, or have a rash, hives or
blisters.

Drugs used to treat seizures increase the risk of suicidal thoughts or
behavior. LYRICA may cause suicidal thoughts or actions in a very small
number of people, about 1 in 500. Patients, family members or caregivers
should call the doctor right away if they notice suicidal thoughts or
actions, thoughts of self harm, or any unusual changes in mood or
behavior. These changes may include new or worsening depression,
anxiety, restlessness, trouble sleeping, panic attacks, anger,
irritability, agitation, aggression, dangerous impulses or violence, or
extreme increases in activity or talking. If you have suicidal thoughts
or actions, do not stop LYRICA without first talking to your doctor.

LYRICA may cause swelling of your hands, legs and feet, which can be
serious for people with heart problems. LYRICA may cause dizziness and
sleepiness. You should not drive or work with machines until you know
how LYRICA affects you. Also, tell your doctor right away about muscle
pain or problems along with feeling sick and feverish, or any changes in
your eyesight including blurry vision or if you have any kidney problems
or get dialysis.

Some of the most common side effects of LYRICA are dizziness, blurry
vision, weight gain, sleepiness, trouble concentrating, swelling of your
hands and feet, dry mouth, and feeling “high.” If you have diabetes,
tell your doctor about any skin sores.

You may have a higher chance for swelling and hives if you are also
taking angiotensin-converting enzyme (ACE) inhibitors so tell your
doctor if you are taking these medications. You may have a higher chance
of swelling of your hands or feet or gaining weight if you are also
taking certain diabetes medicines. Do not drink alcohol while on LYRICA.
You may have a higher chance for dizziness and sleepiness if you take
LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.

Before you start LYRICA, tell your doctor if you are planning to father
a child, or if you are pregnant, or plan to become pregnant.
Breastfeeding is not recommended while taking LYRICA. If you have had a
drug or alcohol problem, you may be more likely to misuse LYRICA.

In studies, a specific type of blood vessel tumor was seen in mice, but
not in rats. The meaning of these findings in humans is not known.

Do not stop taking LYRICA without talking to your doctor. If you stop
suddenly you may have headaches, nausea, diarrhea, trouble sleeping,
increased sweating, or you may feel anxious. If you have epilepsy, you
may have seizures more often.

Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world’s
best-known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world’s
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com.
In addition, to learn more, please visit us on www.pfizer.com and
follow us on Twitter at @Pfizer and @Pfizer_NewsLinkedInYouTube and
like us on Facebook at Facebook.com/Pfizer.

DISCLOSURE NOTICE: The information contained in this release is as of
May 24, 2019. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new information or
future events or developments.

This release contains forward-looking information about LYRICA
(pregabalin), including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results to
differ materially from those expressed or implied by such statements.
Risks and uncertainties include, among other things, the uncertainties
inherent in research and development, including the ability to meet
anticipated clinical trial commencement and completion dates and
regulatory submission dates, as well as the possibility of unfavorable
study results, including unfavorable new clinical data and additional
analyses of existing clinical data; the risk that clinical trial data
are subject to differing interpretations, and, even when we view data as
sufficient to support the safety and/or effectiveness of a product
candidate, regulatory authorities may not share our views and may
require additional data or may deny approval altogether; whether
regulatory authorities will be satisfied with the design of and results
from our clinical studies; decisions by regulatory authorities regarding
labeling and other matters that could affect the availability or
commercial potential of LYRICA; and competitive developments.

A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended December
31, 2018 and in its subsequent reports on Form 10-Q, including in the
sections thereof captioned “Risk Factors” and “Forward-Looking
Information and Factors That May Affect Future Results,” as well as in
its subsequent reports on Form 8-K, all of which are filed with the U.S.
Securities and Exchange Commission and available at 
www.sec.gov
and www.pfizer.com.

Contacts

Media Contact:
Steve Danehy
(212) 733-1538
Steven.Danehy@Pfizer.com

Investor Contact:
Ryan Crowe
(212) 733-8160
Ryan.Crowe@Pfizer.com

China Pharmaceutical Packaging Industry Report, 2019-2025 Featuring 4 Foreign Companies & 16 Chinese Companies – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “China
Pharmaceutical Packaging Industry Report, 2019-2025”
report has
been added to ResearchAndMarkets.com’s offering.

In China, the high-end pharmaceutical packaging market is currently
carved up by multinational corporations, typically BD, Gerresheimer,
SCHOTT, Nipro and Amcor; Chinese companies just focus on low- and
mid-end markets, but they tend to move toward the high-end by lavishing
more on research and development as pharmaceutical packaging standards
grow stricter.

A total of over 1,500 Chinese pharmaceutical packaging companies fall
into three kinds: a handful of pharmaceutical giants that concentrate on
independent production, like Sichuan Kelun Pharmaceutical Co., Ltd.;
players which not only work on pharmaceutical packaging but have
offerings for food, healthcare products and consumer goods packaging,
such as Shandong Linuo Technical Glass Co., Ltd., Heilongjiang Tongyu
Pharmaceutical Packaging Co., Ltd. and Shanghai Haishun New
Pharmaceutical Packaging Co., Ltd.; and those committing themselves to
the R&D, production and sales of pharmaceutical packaging materials, for
instance, Shandong Pharmaceutical Glass Co., Ltd., Guizhou Chienyeh
Pharmaceutical Packaging Co., Ltd., Shanxi Hongguang Medicine Packaging
Co., Ltd. and Hebei First Rubber Medical Technology Co., Ltd.. In the
lowly concentrated pharmaceutical packaging market of China, even the
pharmaceutical glass bellwether Shandong Pharmaceutical Glass Co., Ltd.
takes a tiny share of 2.4% in 2018.

China’s pharmaceutical packaging industry holds the following
trends:

New types of pharmaceutical packaging materials emerge.

China has built a standard system for the pharmaceutical industry over
the years. The country pays more and more attention to the stability of
pharmaceutical packaging materials during the drug storage period, and
safety when used. Under this background, new types of green, degradable
and easy-to-use pharmaceutical packaging materials and vessels are in
the palmy days.

The industry is becoming more concentrated.

Mergers and acquisitions among pharmaceutical packaging companies
occurred frequently in recent years, thanks to favorable policies like
the Guidance on Accelerating the Merger and Reorganization of
Enterprises in Key Industries. For instance, Shandong Pharmaceutical
Glass Co., Ltd. acquired Sichuan Mianzhu Chengxin Pharmaceutical Glass
Co. Ltd.; Anhui BBCA Pharmaceutical Co., Ltd. acquired Chengdu PUSH
Pharmaceutical Co., Ltd.; China Jianyin Investment Ltd. (JIC) acquired
SGD Pharma; and Guizhou Chienyeh Pharmaceutical Packaging Co., Ltd.
acquired Nanchong Sanying Medicinal Packaging Material Co., Ltd.,
Accordingly, Chinese pharmaceutical packaging market is increasingly
concentrated.

Neutral borosilicate products substitute for low borosilicate products.

As people lead a better life, they require better quality of
pharmaceutical packaging materials. A growing number of companies have
applied international standard-based neutral borosilicate glass. Several
companies including Shandong Pharmaceutical Glass Co., Ltd., Chongqing
Zhengchuan Glass Co., Ltd., Cangzhou Four Stars Glass Co., Ltd., Anhui
Huaxin Medicinal Glass Products Co., Ltd., Baoji Tongli Pharmaceutical
Glass Co., Ltd. and Ningbo Zhengli Pharmaceutical Packing Co., Ltd. have
been approved to roll out their neutral borosilicate glass products.
Driven by companies that have passed consistency evaluation, neutral
borosilicate products will become an alternative to low borosilicate
products in China. The injection packaging materials field alone will
see RMB3 billion to RMB9 billion be replaced.

China Pharmaceutical Packaging Industry Report, 2019-2025
highlights the following:

  • China pharmaceutical packaging industry (development status, market
    size, competitive pattern, import & export, market segments,
    downstream demand, and development trend)
  • 4 foreign companies (operation, pharmaceutical packaging business, and
    development in China)
  • 16 Chinese companies (operation, pharmaceutical packaging business,
    and forecast).

Key Topics Covered:

1 Overview

1.1 Definition

1.2 Classification

1.3 Industry Chain

2 Chinese Pharmaceutical Packaging Industry

2.1 Status Quo

2.2 Market Size

2.3 Competitive Landscape

2.3.1 Foreign Companies

2.3.2 Chinese Companies

2.4 Import & Export

2.4.1 Import

2.4.2 Export

2.4.3 Comparison between Unit Prices of Imports and Exports

2.5 Market Segments

2.5.1 Medicinal Glass Packaging

2.5.2 Medicinal Plastic Packaging

2.5.3 Medicinal Rubber Packaging

2.5.4 Composite Packaging Materials

2.6 Downstream Demand

2.6.1 Vaccine

2.6.2 Blood Product

2.6.3 Insulin

2.6.4 Heparin

2.7 Development Trends

2.7.1 Population Aging and Two-child Policy Conduce to the Development
of Pharmaceutical Industry

2.7.2 Favorable Policies Promote the Development of Pharmaceutical
Packaging Industry

2.7.3 Rapid Development of Biological Agents is in Favor of
Pharmaceutical Packaging Industry

2.7.4 Neutral Borosilicate Pharmaceutical Glass Tube Will Substitute for
Low Borosilicate Products Gradually

2.7.5 New Pharmaceutical Packaging Materials Grow Up

2.7.6 Pharmaceutical Packaging Industry Concentration Gets Improved
Further

2.7.7 Injection Packaging Materials Tend to be Neutral Borosilicate

3 Foreign Companies

3.1 Becton, Dickinson and Company

3.1.1 Profile

3.1.2 Operation

3.1.3 Revenue Structure

3.1.4 Pharmaceutical Packaging Business

3.1.5 Development in China

3.2 Gerresheimer AG

3.3 SCHOTT AG

3.4 Nipro Medical Corporation

4 Chinese Companies

4.1 Shandong Pharmaceutical Glass Co, Ltd.

4.1.1 Profile

4.1.2 Operation

4.1.3 Revenue Structure

4.1.4 Gross Margin

4.1.5 R&D and Investment

4.1.6 Development Strategy

4.2 Sichuan Kelun Pharmaceutical Co, Ltd.

4.3 Guizhou Chienyeh Pharmaceutical Packaging Co, Ltd.

4.4 Shandong Weigao Group Medical Polymer Co, Ltd (WEGO)

4.5 Hongguang Medicine Packaging Company

4.6 Tongyu Pharmaceutical Packaging Co, Ltd.

4.7 Linuo Glassworks Group

4.8 Shanghai Haishun New Pharmaceutical Packaging Co, Ltd.

4.9 Chongqing Zhengchuan Glass Co, Ltd

4.10 Hebei First Rubber Medical Technology Co, ltd

4.11 J.S. Yunkang Officinal Package Co, Ltd

4.12 Shanghai Jiatian Pharmaceutical Packaging Co, Ltd

4.13 Cangzhou four stars glass co, ltd.

4.14 Lindu yao yong bao zhuang

4.15 Global Printing

4.16 Jiangsu Hualan New Pharmaceutical Material Co, Ltd.

For more information about this report visit https://www.researchandmarkets.com/r/pi0bqf

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For
E.S.T. Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Pharmaceutical
Packaging

FDA Approves Jakafi® (ruxolitinib) for the Treatment of Patients with Acute Graft-Versus-Host Disease

Jakafi is the first and only FDA-approved treatment for patients with
steroid-refractory acute graft-versus-host disease (GVHD)

WILMINGTON, Del.–(BUSINESS WIRE)–Incyte Corporation (Nasdaq:INCY) today announced that the U.S.
Food and Drug Administration (FDA) has approved Jakafi®
(ruxolitinib) for the treatment of steroid-refractory acute GVHD in
adult and pediatric patients 12 years and older. Jakafi is the first and
only FDA-approved treatment for this indication.

“For the first time, patients with steroid-refractory acute GVHD, and
the physicians that treat them, have an FDA-approved treatment for this
serious disease,” stated Hervé Hoppenot, Chief Executive Officer,
Incyte. “This approval is also an important milestone for Incyte, as it
marks the third indication for Jakafi in the United States, further
underscoring Incyte’s commitment to delivering innovative medicines for
patients in need. We are proud of the impact Jakafi has had on patients’
lives to-date and are dedicated to advancing our ongoing research in JAK
inhibition to serve more GVHD patients in the future.”

The approval was based on data from REACH1, an open-label, single-arm,
multicenter study of Jakafi in combination with corticosteroids in
patients with steroid-refractory grade II-IV acute GVHD. Of the 71
patients recruited into REACH1, 49 patients were refractory to steroids
alone, 12 patients had received two or more prior anti-GVHD therapies
and 10 patients did not otherwise meet the FDA definition of
steroid-refractory. Jakafi was administered at 5 mg twice daily, and the
dose could be increased to 10 mg twice daily after three days in the
absence of toxicity.

The efficacy of Jakafi was evaluated based upon Day 28 overall response
rate (ORR), defined as a complete response (CR), very good partial
response or partial response based on the Center for International Blood
and Marrow Transplant Research (CIBMTR) criteria. The Day 28 ORR in the
49 patients refractory to steroids alone was 57 percent with a CR rate
of 31 percent. The most frequently reported adverse reactions among all
71 study participants were infections (55 percent) and edema (51
percent), and the most common laboratory abnormalities were anemia (75
percent), thrombocytopenia (75 percent) and neutropenia (58 percent).

GVHD is a condition that can occur after an allogeneic stem cell
transplant (the transfer of stem cells from a donor) where the donated
cells initiate an immune response and attack the transplant recipient’s
organs, leading to significant morbidity and mortality. There are two
major forms of GVHD, acute and chronic, that can affect multiple organ
systems including the skin, gastrointestinal (digestive) tract and
liver. Patients who develop steroid-refractory acute GVHD can progress
to severe disease, with one-year mortality rates of approximately 70
percent.1

“Every year in the United States, about half of the people who develop
acute GVHD do not respond adequately to steroids, making it an extremely
challenging disease to treat,” said Madan Jagasia, M.B.B.S., M.S.,
M.M.H.C., a lead investigator on the REACH1 trial and Professor of
Medicine, Vanderbilt University Medical Center, Department of Medicine,
Division of Hematology-Oncology and Chief Medical Officer,
Vanderbilt-Ingram Cancer Center. “While allogeneic stem cell transplants
have the potential to transform people’s lives, the onset of acute GVHD
can significantly impact their prognosis. I am excited that we now have
Jakafi as a new treatment option for acute GVHD patients that do not
respond to corticosteroids who, until now, have had limited choices.”

Previously, the FDA granted Jakafi Breakthrough Therapy Designation and
Orphan Drug Designation for the treatment of patients with
steroid-refractory acute GVHD, and the supplemental New Drug Application
(sNDA) was reviewed under the FDA’s Priority Review program.

Jakafi will be made available to appropriate patients with
steroid-refractory acute GVHD immediately. Incyte is committed to
supporting patients and removing barriers to access medicines. Eligible
patients in the U.S. who are prescribed Jakafi have access to
IncyteCARES (Connecting to Access, Reimbursement, Education and
Support), a comprehensive program offering patient support, including
financial assistance and ongoing education and resources to eligible
patients. More information about IncyteCARES is available by visiting www.incytecares.com
or calling 1-855-4-Jakafi (855-452-5234).

About REACH

The REACH clinical trial program is evaluating Jakafi in patients with
steroid-refractory GVHD. The REACH program includes the Incyte-sponsored
REACH1 trial, a prospective, open-label, single-cohort, multicenter,
pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in combination
with corticosteroids in patients with steroid-refractory grade II-IV
acute GVHD. For more information about the REACH1 trial, please visit https://clinicaltrials.gov/show/NCT02953678.

The REACH clinical program also includes the collaborative
Novartis-sponsored randomized pivotal Phase 3 trials in patients with
steroid-refractory acute GVHD (REACH2) and steroid-refractory chronic
GVHD (REACH3). Results from both REACH2 and REACH3 are currently
expected before the end of 2019.

About Jakafi® (ruxolitinib)

Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the U.S. FDA
for treatment of steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older.

Jakafi is also indicated for treatment of polycythemia vera (PV) in
adults who have had an inadequate response to or are intolerant of
hydroxyurea as well as intermediate or high-risk myelofibrosis (MF),
including primary MF, post-polycythemia vera MF and post-essential
thrombocythemia MF in adults.

Jakafi is marketed by Incyte in the United States and by Novartis as
Jakavi® (ruxolitinib) outside the United States. Jakafi is a
registered trademark of Incyte Corporation. Jakavi is a registered
trademark of Novartis AG in countries outside the United States.

Important Safety Information

Jakafi can cause serious side effects, including:

Low blood counts: Jakafi® (ruxolitinib) may cause your
platelet, red blood cell, or white blood cell counts to be lowered. If
you develop bleeding, stop taking Jakafi and call your healthcare
provider. Your healthcare provider will perform blood tests to check
your blood counts before you start Jakafi and regularly during your
treatment. Your healthcare provider may change your dose of Jakafi or
stop your treatment based on the results of your blood tests. Tell your
healthcare provider right away if you develop or have worsening symptoms
such as unusual bleeding, bruising, tiredness, shortness of breath, or a
fever.

Infection: You may be at risk for developing a serious infection
during treatment with Jakafi. Tell your healthcare provider if you
develop any of the following symptoms of infection: chills, nausea,
vomiting, aches, weakness, fever, painful skin rash or blisters.

Skin cancers: Some people who take Jakafi have developed certain
types of non-melanoma skin cancers. Tell your healthcare provider if you
develop any new or changing skin lesions.

Increases in cholesterol: You may have changes in your blood
cholesterol levels. Your healthcare provider will do blood tests to
check your cholesterol levels during your treatment with Jakafi.

The most common side effects of Jakafi include: for certain types
of MF and PV – low platelet count, low red blood cell count, bruising,
dizziness, and headache; and for acute GVHD – low red blood cell counts,
low platelet counts, low white blood cell counts, infections and fluid
retention.

These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider for more information. Tell your
healthcare provider about any side effect that bothers you or that does
not go away.

Before taking Jakafi, tell your healthcare provider about: all
the medications, vitamins, and herbal supplements you are taking and all
your medical conditions, including if you have an infection, have or had
tuberculosis (TB), or have been in close contact with someone who has
TB, have or had hepatitis B, have or had liver or kidney problems, are
on dialysis, have a high level of fat in your blood (high blood
cholesterol or triglycerides), had skin cancer or have any other medical
condition. Take Jakafi exactly as your healthcare provider tells you. Do
not change or stop taking Jakafi without first talking to your
healthcare provider.

Women should not take Jakafi while pregnant or planning to become
pregnant. Do not breast-feed during treatment with Jakafi and for 2
weeks after the final dose.

Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at
www.jakafi.com.

About Incyte

Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical
company focused on the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte, please
visit the Company’s web site at www.incyte.com.

Follow @Incyte on Twitter at https://twitter.com/Incyte.

Forward-Looking Statements

Except for the historical information set forth herein, the matters set
forth in this release contain predictions, estimates and other
forward-looking statements, including statements regarding efforts to
advance the Company’s ongoing research in JAK inhibition and to help
more GVHD patients in the future, the potential efficacy, safety and
therapeutic value of Jakafi® (ruxolitinib) in patients with
steroid-refractory GVHD and expected timing of initial results of the
REACH2 and REACH3 trials. These forward-looking statements are based on
Incyte’s current expectations and subject to risks and uncertainties
that may cause actual results to differ materially, including those
risks detailed from time to time in Incyte’s reports filed with the
Securities and Exchange Commission, including its Form 10-Q for the
quarter ending March 31, 2019. Incyte disclaims any intent or obligation
to update these forward-looking statements.

1 Shapira MY, Klimov A, Vipul S, et al. Regional
intra-arterial steroid treatment in 120 patients with steroid-resistant
or -dependent GvHD. Bone Marrow Transplant. 2017;52(10):1416-1422.

Contacts

Media
Jenifer Antonacci
+1 302-498-7036
jantonacci@incyte.com

Catalina Loveman
+1 302-498-6171
cloveman@incyte.com

Investors
Michael Booth, DPhil
+1 302-498-5914
mbooth@incyte.com

Pakistan Healthcare and Pharmaceutical Market Report 2019 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Healthcare
and Pharmaceutical Market in Pakistan”
report has been added to ResearchAndMarkets.com’s
offering.

This report on the Healthcare and Pharmaceutical Market in Pakistan
provides comprehensive coverage of the entire sector from 2012 till 2022.

The pharmaceutical industry in Pakistan is growing at a rapid pace,
contributing significantly to the national economy. In the last couple
of years, the Pakistani economy has been suffering due to bad economic
conditions and also been under strain due to the war against terrorism.
The economy is also facing the problem of domestic inflation, slow
economic growth, as well as the devaluation of the Pakistani rupee
against other major currencies.

Pakistani pharmaceutical and healthcare industries are very competitive
and challenging. There are nearly 600 pharmaceutical companies operating
in Pakistan, with major global leaders having a presence in the country.
The industry presents a lot of growth opportunities for drug makers,
with the opportunities being driven by the rising burden of chronic
disease and launch of the Pakistani national health insurance program.

However, there are many challenges that the industry faces, with
regulatory and pricing challenges being at the top of the list. With the
government’s focus on boosting the pharmaceutical and healthcare market,
the industry is poised for good growth, with many opportunities present
for drawing in foreign investment.

In this industry scenario, the author presents an analysis of the
Healthcare and Pharmaceutical Market in Pakistan.

The report analyzes the following points:

  • Analysis of the healthcare and pharmaceutical market through an
    industry overview, overview of the healthcare segment, an overview of
    the pharmaceutical sector, the prevalence of diseases in Pakistan,
    industry drivers, investment, market distribution, healthcare
    expenditure, etc.
  • Competition in the industry and generic players in Pakistan
  • Major market activity by the leading drug makers
  • Global trends and how the Pakistani industry compares
  • SWOT analysis of the Pakistani healthcare and pharmaceutical market
  • Regulatory landscape governing the industry in Pakistan
  • A look at the industry research and development
  • Industry challenges
  • Forecast of the industry including a separate forecast for healthcare
    and pharmaceutical sector forecast
  • Analysis of the major industry players with a company profile,
    presence in Pakistan, and a SWOT analysis

Key Topics Covered:

1. Executive Summary

2. Healthcare and Pharmaceutical Market in Pakistan

2.1 Industry Overview

2.2 Healthcare Segment

2.3 Pharmaceutical Sector

2.4 Prevalence of Diseases in Pakistan

2.5 Industry Drivers

2.6 Industry Investment

2.7 Market Distribution

2.8 Healthcare Expenditure

2.9 Competition in the Industry

2.10 Generic Players in Pakistan

2.11 Market Activity by Major Drug Makers

2.12 Global Trends and how the Pakistani Industry Measures

3. Healthcare and Pharmaceutical Market in Pakistan: SWOT
Analysis

3.1 Overview

3.2 Strengths

3.3 Weaknesses

3.4 Opportunities

3.5 Threats

4. Regulatory Landscape

4.1 Overview

4.2 Drug Pricing

4.3 Issue over Intellectual Property Rights

4.4 Reimbursement Policy

5. Industry Research and Development

5.1 Overview

5.2 Technology Adaptation in the Industry

5.3 Clinical Trials

5.4 Pharmaceutical R&D

6. Industry Challenges

6.1 No Health System Governance

6.2 No Health Equity in Pakistan

6.3 Lack of Resources and Poor Infrastructure

6.4 Other Challenges

7. Healthcare and Pharmaceutical Market in Pakistan: Forecast

7.1 Healthcare Forecast

7.2 Pharmaceutical Forecast

7.3 Future Trends

7.3.1 Healthcare Trends

7.3.2 Pharmaceutical Trends

8. Industry Players

  • Abbott Laboratories (Pakistan)
  • Efroze Chemical Industries
  • Ferozsons Laboratories
  • Getz Pharma
  • GlaxoSmithKline Pakistan
  • Hilton Pharma
  • Novartis Pakistan
  • Pfizer Pakistan Limited
  • Sanofi-Aventis
  • SEARLE Company Limited

For more information about this report visit https://www.researchandmarkets.com/r/j1fw6f

Contacts

ResearchAndMarkets.com
Laura Wood, Senior Press Manager
press@researchandmarkets.com
For
E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call
1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related
Topics: Healthcare
Services
, Pharmaceuticals