Vedolizumab (Entyvio®) Achieves Superior Rates of Clinical Remission vs. Adalimumab (Humira®) in First Ever Head-to-Head Biologic Clinical Study in Ulcerative Colitis

Vedolizumab superior to adalimumab in achieving clinical remission
and mucosal healing at week 52 in patients with moderately to severely
active ulcerative colitis

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)
(“Takeda”) today announced results from the Phase 3b head-to-head
VARSITY study which demonstrated that the gut-selective biologic
vedolizumab (Entyvio®) was superior to the anti-tumor
necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira®)
in achieving clinical remission* in patients with moderately to severely
active ulcerative colitis at week 52. Data showed that 31.3% (n=120/383)
of patients receiving vedolizumab intravenous (IV) achieved the primary
endpoint of clinical remission compared to 22.5% (n=87/386) of patients
treated with adalimumab subcutaneous (SC) at week 52, with the
difference being statistically significant (p=0.0061). These results
were announced as an oral presentation (OP34) on Saturday March 9, 2019
from 09:40-09:50, at the 14th Congress of the European Crohn’s and
Colitis Organisation (ECCO) in Copenhagen, Denmark.1

Furthermore, treatment with vedolizumab was associated with
significantly higher rates of mucosal healing** at week 52, with 39.7%
of patients receiving vedolizumab achieving mucosal healing compared to
27.7% treated with adalimumab (p=0.0005). A non-statistically
significant difference in favor of adalimumab was seen in the percentage
of patients using oral corticosteroids at baseline who discontinued
corticosteroids and were in clinical remission*** at week 52. While the
study was not powered to compare the safety of the two biologics,
patients treated with vedolizumab (62.7%) had a lower rate of overall
adverse events over 52 weeks than patients treated with adalimumab
(69.2%), with a lower rate of infections reported in patients treated
with vedolizumab (33.5%) as compared to adalimumab (43.5%). The rate of
serious adverse events was also lower in vedolizumab-treated patients
than adalimumab (11.0% vs. 13.7% respectively).1

“The VARSITY study addresses critical questions concerning the selection
of biologic therapy in ulcerative colitis,” said Dr. Bruce E. Sands,
primary investigator of the VARSITY study and Chief of the Dr. Henry D.
Janowitz Division of Gastroenterology at Mount Sinai Hospital and the
Icahn School of Medicine at Mount Sinai in New York. “The goal of
treatment in ulcerative colitis is to achieve clinical remission and
mucosal healing, and these results clearly highlight the benefits seen
with vedolizumab versus adalimumab on these important outcomes. The
results also showed lower rates of overall and serious adverse events
including infections in patients treated with vedolizumab than
adalimumab.”

“As the first clinical study to directly compare the efficacy and safety
of two commonly used biologic therapies in patients with ulcerative
colitis, VARSITY provides invaluable knowledge to help inform
physicians’ treatment decisions when initiating biologic therapy,” said
Jeff Bornstein, M.D., Executive Medical Director, Takeda. “This is also
the first time we have seen a direct comparison between two medicines
with distinct modes of action in ulcerative colitis, the gut-selective
anti-alpha4beta7 integrin vedolizumab and the anti-TNFα adalimumab. This
is an exciting time in the landscape of ulcerative colitis treatment, as
head-to-head clinical data has not previously been available to guide
treatment decisions around biologic therapies.”

VARSITY is a phase 3b, randomized, double-blind, double-dummy,
multi-center, active-controlled study to evaluate the efficacy and
safety of vedolizumab IV compared to adalimumab SC at week 52 in
patients with moderately to severely active ulcerative colitis. The
study randomized 769 patients (vedolizumab n=383 or adalimumab n=386),
all of whom had inadequate response with, loss of response to, or
intolerance to corticosteroids, immunomodulators, or one TNFα-antagonist
other than adalimumab prior to being enrolled. Patients were randomized
into one of two treatment groups, vedolizumab IV and placebo SC or
adalimumab SC and placebo IV. Patients in the vedolizumab group were
administered vedolizumab IV 300 mg at weeks 0, 2, 6 and every 8 weeks
thereafter until week 46, along with placebo SC at week 0 and every 2
weeks until week 50. The adalimumab group were administered adalimumab
SC 160 mg at week 0, 80 mg at week 2 and 40 mg every 2 weeks until week
50, along with placebo IV at weeks 0, 2, 6 and every 8 weeks thereafter
until week 46. Dose escalation was not permitted in either treatment arm
during the study.1,2

* Primary endpoint: Clinical remission is defined as a complete Mayo
score of ≤2 points and no individual subscore ˃1 point.2
** Secondary endpoint: Mucosal healing is defined as Mayo endoscopic
subscore of ≤1 point. Mayo score: instrument designed to measure
disease activity of ulcerative colitis.2
*** Secondary endpoint: Corticosteroid-free clinical remission is
defined as patients using oral corticosteroids at baseline (week 0)
who have discontinued oral corticosteroids and are in clinical
remission at week 52.2

About Ulcerative Colitis
Ulcerative colitis (UC) is one of
the most common forms of inflammatory bowel disease (IBD).3
UC is a chronic, relapsing, remitting, inflammatory condition of the
gastrointestinal tract that is often progressive in nature, and involves
the innermost lining of the large intestine.4,5 UC commonly
presents with symptoms of abdominal discomfort and loose bowel
movements, including blood or pus.5,6 The cause of UC is not
fully understood; however, recent research suggests hereditary,
genetics, environmental factors, and/or an abnormal immune response to
microbial antigens in genetically predisposed individuals can lead to
the condition.5,7,8

About Entyvio® (vedolizumab)
Vedolizumab
is a gut-selective biologic and is approved as an intravenous (IV)
formulation.9 It is a humanized monoclonal antibody designed
to specifically antagonize the alpha4beta7 integrin, inhibiting the
binding of alpha4beta7 integrin to intestinal mucosal addressin cell
adhesion molecule 1 (MAdCAM-1), but not vascular cell adhesion molecule
1 (VCAM-1).10 MAdCAM-1 is preferentially expressed on blood
vessels and lymph nodes of the gastrointestinal tract.11 The
alpha4beta7 integrin is expressed on a subset of circulating white blood
cells.10 These cells have been shown to play a role in
mediating the inflammatory process in ulcerative colitis (UC) and
Crohn’s disease (CD).10,12,13 By inhibiting alpha4beta7
integrin, vedolizumab may limit the ability of certain white blood cells
to infiltrate gut tissues.10

Vedolizumab IV is approved for the treatment of adult patients with
moderately to severely active UC and CD, who have had an inadequate
response with, lost response to, or were intolerant to either
conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist.9
Vedolizumab IV has been granted marketing authorization in over 60
countries, including the United States and European Union, with more
than 260,000 patient years of exposure to date.14

Therapeutic Indications

Ulcerative colitis
Vedolizumab is indicated for the
treatment of adult patients with moderately to severely active
ulcerative colitis who have had an inadequate response with, lost
response to, or were intolerant to either conventional therapy or a
tumor necrosis factor-alpha (TNFα) antagonist.

Crohn’s disease
Vedolizumab is indicated for the
treatment of adult patients with moderately to severely active Crohn’s
disease who have had an inadequate response with, lost response to, or
were intolerant to either conventional therapy or a tumor necrosis
factor-alpha (TNFα) antagonist.

Important Safety Information

Contraindications
Hypersensitivity to the active substance
or to any of the excipients.

Special warnings and special precautions for use
Vedolizumab
should be administered by a healthcare professional prepared to manage
hypersensitivity reactions, including anaphylaxis, if they occur.
Appropriate monitoring and medical support measures should be available
for immediate use when administering vedolizumab. Observe patients
during infusion and until the infusion is complete.

Infusion-related reactions
In clinical studies,
infusion-related reactions (IRR) and hypersensitivity reactions have
been reported, with the majority being mild to moderate in severity. If
a severe IRR, anaphylactic reaction, or other severe reaction occurs,
administration of vedolizumab must be discontinued immediately and
appropriate treatment initiated (e.g., epinephrine and antihistamines).
If a mild to moderate IRR occurs, the infusion rate can be slowed or
interrupted and appropriate treatment initiated (e.g., epinephrine and
antihistamines). Once the mild or moderate IRR subsides, continue the
infusion. Physicians should consider pre-treatment (e.g., with
antihistamine, hydrocortisone and/or paracetamol) prior to the next
infusion for patients with a history of mild to moderate IRR to
vedolizumab, in order to minimize their risks.

Infections
Vedolizumab is a gut-selective integrin
antagonist with no identified systemic immunosuppressive activity.
Physicians should be aware of the potential increased risk of
opportunistic infections or infections for which the gut is a defensive
barrier. Vedolizumab treatment is not to be initiated in patients with
active, severe infections such as tuberculosis, sepsis, cytomegalovirus,
listeriosis, and opportunistic infections until the infections are
controlled, and physicians should consider withholding treatment in
patients who develop a severe infection while on chronic treatment with
vedolizumab. Caution should be exercised when considering the use of
vedolizumab in patients with a controlled chronic severe infection or a
history of recurring severe infections. Patients should be monitored
closely for infections before, during and after treatment. Before
starting treatment with vedolizumab, screening for tuberculosis may be
considered according to local practice. Some integrin antagonists and
some systemic immunosuppressive agents have been associated with
progressive multifocal leukoencephalopathy (PML), which is a rare and
often fatal opportunistic infection caused by the John Cunningham (JC)
virus. By binding to the α4β7 integrin expressed on gut-homing
lymphocytes, vedolizumab exerts an immunosuppressive effect specific to
the gut. Although no systemic immunosuppressive effect was noted in
healthy subjects, the effects on systemic immune system function in
patients with inflammatory bowel disease are not known. Healthcare
professionals should monitor patients on vedolizumab for any new onset
or worsening of neurological signs and symptoms, and consider
neurological referral if they occur. If PML is suspected, treatment with
vedolizumab must be withheld; if confirmed, treatment must be
permanently discontinued. Typical signs and symptoms associated with PML
are diverse, progress over days to weeks, and include progressive
weakness on one side of the body, clumsiness of limbs, disturbance of
vision, and changes in thinking, memory, and orientation leading to
confusion and personality changes. The progression of deficits usually
leads to death or severe disability over weeks or months.

Malignancies
The risk of malignancy is increased in patients
with ulcerative colitis and Crohn’s disease. Immunomodulatory medicinal
products may increase the risk of malignancy.

Prior and concurrent use of biological products
No
vedolizumab clinical trial data are available for patients previously
treated with natalizumab. No clinical trial data for concomitant use of
vedolizumab with biologic immunosuppressants are available. Therefore,
the use of vedolizumab in such patients is not recommended.

Vaccinations
Prior to initiating treatment with vedolizumab
all patients should be brought up to date with all recommended
immunizations. Patients receiving vedolizumab may receive non-live
vaccines (e.g., subunit or inactivated vaccines) and may receive live
vaccines only if the benefits outweigh the risks.

Adverse reactions include: nasopharyngitis, headache, arthralgia,
upper respiratory tract infection, bronchitis, influenza, sinusitis,
cough, oropharyngeal pain, nausea, rash, pruritus, back pain, pain in
extremities, pyrexia, fatigue and anaphylaxis.

Please consult with your local regulatory agency for approved
labeling in your country
.

For U.S. audiences, please see the full Prescribing
Information
 including Medication
Guide
 for ENTYVIO®.

For EU audiences, please see the Summary
of Product Characteristics (SmPC)
for ENTYVIO®.

Takeda’s Commitment to Gastroenterology
Gastrointestinal
(GI) diseases can be complex, debilitating and life-changing.
Recognizing this unmet need, Takeda and our collaboration partners have
focused on improving the lives of patients through the delivery of
innovative medicines and dedicated patient disease support programs for
over 25 years. Takeda aspires to advance how patients manage their
disease. Additionally, Takeda is leading in areas of gastroenterology
associated with high unmet need, such as inflammatory bowel disease,
acid-related diseases and motility disorders. Our GI Research &
Development team is also exploring solutions in celiac disease and liver
diseases, as well as scientific advancements through microbiome
therapies.

About Takeda Pharmaceutical Company Limited
Takeda
Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)
is a global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed to bringing Better Health and a
Brighter Future to patients by translating science into
highly-innovative medicines. Takeda focuses its R&D efforts on four
therapeutic areas: Oncology, Gastroenterology (GI), Neuroscience, and
Rare Diseases. We also make targeted R&D investments in Plasma-Derived
Therapies and Vaccines. We are focusing on developing highly innovative
medicines that contribute to making a difference in people’s lives by
advancing the frontier of new treatment options and leveraging our
enhanced collaborative R&D engine and capabilities to create a robust,
modality-diverse pipeline. Our employees are committed to improving
quality of life for patients and to working with our partners in health
care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com

###

References

1 Schreiber S, Peyrin-Biroulet L, Loftus EV Jr, et al.
VARSITY: A double-blind, double-dummy, randomised, controlled trial of
vedolizumab versus adalimumab in patients with active ulcerative
colitis. Presented at the 14th Congress of the Crohn’s and
Colitis Organisation (ECCO), Copenhagen, Denmark. Oral presentation
#OP34 (Saturday March 9, 2019, 09:40-09:50).
2 An
efficacy and safety study of vedolizumab intravenous (IV) compared to
adalimumab subcutaneous (SC) in participants with ulcerative colitis.
ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02497469.
Last updated: February 28, 2019. Last Accessed: February 2019.
3
Baumgart DC, Carding SR. Inflammatory bowel disease: cause and
immunobiology. Lancet. 2007;369:1627-1640.
4
Torres J, Billioud V, Sachar DB, et al. Ulcerative colitis as a
progressive disease: the forgotten evidence. Inflamm Bowel Dis.
2012;18:1356-1363.
5 Ordas I, Eckmann L, Talamini M, et
al. Ulcerative colitis. Lancet. 2012;380:1606-1619.
6
Sands BE. From symptom to diagnosis: clinical distinctions among various
forms of intestinal inflammation. Gastroenterology.
2004;126:1518-1532.
7 Henckaerts L, Pierik M, Joossens
M, et al. Mutations in pattern recognition receptor genes modulate
seroreactivity to microbial antigens in patients with inflammatory bowel
disease. Gut. 2007;56:1536-1542.
8 Kaser A,
Zeissig S, Blumberg RS. Genes and environment: How will our concepts on
the pathophysiology of IBD develop in the future? Dig Dis.
2010;28:395-405.
9 European Medicines Agency. Entyvio
EPAR product information. EMEA/H/C/002782 – IB/0030 ANNEX 1 Summary of
Product Characteristics. Available at: https://www.ema.europa.eu/documents/product-information/entyvio-epar-product-information_en.pdf
Last updated: September 3, 2018. Last accessed: February 2019.
10
Soler D, Chapman T, Yang LL, et al. The binding specificity and
selective antagonism of vedolizumab, an anti-α4β7 integrin therapeutic
antibody in development for inflammatory bowel diseases. J Pharmacol
Exp Ther
. 2009;330:864-875.
11 Briskin M,
Winsor-Hines D, Shyjan A, et al. Human mucosal addressin cell adhesion
molecule-1 is preferentially expressed in intestinal tract and
associated lymphoid tissue. Am J Pathol. 1997;151:97-110.
12
Eksteen B, Liaskou E, Adams DH. Lymphocyte homing and its roles in the
pathogenesis of IBD. Inflamm Bowel Dis. 2008;14:1298-1312.
13
Wyant T, Fedyk E, Abhyankar B. An overview of the mechanism of action of
the monoclonal antibody vedolizumab. J Crohns Colitis.
2016;10:1437-1444.
14 Takeda Data on File. 2019.

Contacts

Media Contacts:
Media outside Japan
Luke Willats
luke.willats@takeda.com
+41-44-555-1145

Japanese Media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81
(0) 3-3278-2095

Sinovac Update on the Exchange of Rights for Common and Series B Preferred Shares

BEIJING–(BUSINESS WIRE)–Sinovac Biotech Ltd. (NASDAQ:SVA) (“Sinovac” or the “Company”), a
leading provider of biopharmaceutical products in China, today issued an
update on the Exchange of Rights for Common and Series B Preferred
Shares announced February 22, 2019.

On February 22, 2019, as announced by press
release
, the Sinovac Board of Directors effectuated an Exchange of
Rights held by certain Sinovac’s shareholders for a combination of
approximately 27.8 million Common Shares and approximately 14.6 million
Series B Preferred Shares (the “Exchange Shares”), all of which the
company issued into a trust for the benefit of the holders of the valid
and outstanding Rights.

The Company now expects to hold the Exchange Shares in the Shareholder
2019 Rights Exchange Trust in the name of Wilmington Trust, National
Association (the “Trustee”) until the Court of Chancery of the State of
Delaware has determined whether the conduct of 1Globe Capital, LLC,
Chiangjia Li, OrbiMed Advisors LLC and those additional shareholders who
voted with the foregoing at the annual general meeting held in February
2018 (the “Collaborating Shareholders”) triggered the Rights Agreement.
The Exchange Shares remain issued and outstanding and holders of valid
Rights may continue to submit certifications to verify that they are
eligible for the Exchange.

On March 6, 2019, the Delaware Chancery Court entered a Status Quo
order providing that Sinovac not distribute any of the Exchange Shares
to rights holders until the final disposition of the pending Delaware
litigation or further order of the Court. The trial in the Delaware
Chancery Court is expected to be held within 60 to 90 days.

The Company will work with the Nasdaq Stock Market LLC to resume trading
of the Common Shares as expeditiously as possible, but is unable to
currently estimate when trading will resume.

About Sinovac

Sinovac Biotech Ltd. is a China-based biopharmaceutical Company that
focuses on the research, development, manufacturing and
commercialization of vaccines that protect against human infectious
diseases. Sinovac’s product portfolio includes vaccines against
enterovirus71, or EV71, hepatitis A and B, seasonal influenza, H5N1
pandemic influenza (avian flu), H1N1 influenza (swine flu), and mumps.
Healive, the hepatitis A vaccine manufactured by the Company has passed
the assessment under WHO Prequalification procedures in 2017. The EV71
vaccine, an innovative vaccine developed by Sinovac against hand foot
and mouth disease caused by EV71, was commercialized in China in 2016.
In 2009, Sinovac was the first company worldwide to receive approval for
its H1N1 influenza vaccine, which it has supplied to the Chinese
Government’s vaccination campaign and stockpiling program. The Company
is also the only supplier of the H5N1 pandemic influenza vaccine to the
government stockpiling program. The Company is developing a number of
new products including a Sabin-strain inactivated polio vaccine,
pneumococcal polysaccharides vaccine, pneumococcal conjugate vaccine and
varicella vaccine. Sinovac primarily sells its vaccines in China, while
also exploring growth opportunities in international markets. The
Company has exported select vaccines to over 10 countries in Asia and
South America. For more information please see the Company’s website at www.sinovacbio.com.

Safe Harbor Statement

This press release contains “forward-looking statements” within the
meaning of the United States federal securities laws. Such statements
involve known and unknown risks, uncertainties and other factors that
may cause our actual results, levels of activity, performance or
achievements to differ materially from any future results, levels of
activity, performance or achievements expressed or implied by these
forward-looking statements. Factors that might cause such a difference
include our inability to compete successfully in the competitive and
rapidly changing marketplace in which we operate, failure to retain key
employees, cancellation or delay of projects, disruptions to our
operations, the results of any pending litigation, potential litigation
relating to our shareholder rights plan, any potential halt in trading
of the Company’s securities, and adverse general economic conditions in
China, the United States and elsewhere. These risks and other factors
include those listed under “Risk Factors” and elsewhere in our Annual
Report on Form 20-F as filed with the Securities and Exchange
Commission. In some cases, you can identify forward-looking statements
by terminology such as “may,” “will,” “should,” “expects,” “intends,”
“plans,” “anticipates,” “believes,” “estimates,” “predicts,”
“potential,” “continue,” or the negative of these terms or other
comparable terminology. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we cannot
guarantee future results, levels of activity, performance or
achievements. The Company assumes no obligation to update the
forward-looking information contained in this release.

Contacts

Sinovac Biotech Ltd.
Helen Yang
Tel: +86-10-5693-1886
Tel:
+86-10-8279-9871
Fax: +86-10-6296-6910
ir@sinovac.com

Media:
Abernathy MacGregor
Sheila Ennis,
+1-415-745-3294
sbe@abmac.com

Sydney Isaacs, +1-713-999-5104
sri@abmac.com

Investors:
MacKenzie Partners, Inc.
Paul
Schulman, +1-212-929-5364
pschulman@mackenziepartners.com

ICR Inc.
Bill Zima, +1-646-308-1707
william.zima@icrinc.com

CORRECTING and REPLACING Luma Therapeutics Announces Positive Clinical Data for the Illuvinate System, a New In-Home Treatment for Psoriasis

Results Demonstrate Significant Healing That Is Maintained Even
Following Treatment

MILLBRAE, Calif. & WASHINGTON–(BUSINESS WIRE)–URL in the Luma Therapeutics boilerplate of release dated Mar. 6, 2019
should read www.lumatherapeutics.com.

The corrected release reads:

LUMA THERAPEUTICS ANNOUNCES POSITIVE CLINICAL DATA FOR THE ILLUVINATE
SYSTEM, A NEW IN-HOME TREATMENT FOR PSORIASIS

Results Demonstrate Significant Healing That Is Maintained Even
Following Treatment

Luma Therapeutics, a company dedicated to eradicating suffering from
inflammatory skin disease, today announced positive results from three
clinical studies evaluating in-home treatment of patients with plaque
psoriasis. Findings from the studies, which assessed the company’s
FDA-cleared illuvinate™ System, were presented during the annual meeting
of the American Academy of Dermatology Annual meeting in Washington, D.C.

The results of the third study, presented by Tina Bhutani, M.D., of the
UCSF Medical Center in San Francisco, Calif., demonstrated significant
improvement in symptoms and appearance for plaques treated with
illuvinate, with healing that was maintained eight weeks following
treatment.

The multi-site study measured clinical outcomes from 52 target psoriasis
plaques in 26 patients, with an untreated plaque on each patient serving
as the control. In the study, Target Plaque Assessment (TPA) score was
assessed at the beginning of the study and over a period of six weeks
while using illuvinate. This score included assessments of scale,
redness and thickness of plaques. Findings showed a 66% reduction in TPA
score at six weeks for plaques treated with illuvinate compared with a
15% reduction for untreated plaques. At 14 weeks (eight weeks following
treatment), results showed a 70% reduction in TPA score, suggesting a
therapeutic effect sustained beyond the treatment period. Nearly
one-third of patients had complete clearance of plaque at 14 weeks.

“These data suggest that illuvinate provides Goeckerman-like healing for
patients with plaque psoriasis, which continues even beyond the
treatment period,” said Dr. Bhutani. “I believe illuvinate offers an
exciting new prospect for many patients looking for an alternative to
biologics and creams.”

“Psoriasis is a challenging condition to manage, and many patients feel
disheartened by the inability to find a treatment option that works and
provides lasting long relief,” said Dr. Jeffrey Sugarman, M.D., Ph.D.,
of Redwood Family Dermatology who served as the principal investigator
of the study. “I have been impressed by the results, and particularly
the durability of results, that I have seen in patients who have used
the system.”

“As a psoriasis sufferer myself, I know the frustration these patients
feel with the treatment options currently available to them,” said
founder and CEO Evan Anderson. “We are pleased that the positive results
of these studies show illuvinate’s innovative light therapy system
delivers significant benefit including sustained, durable healing,
suggesting that illuvinate has the potential to improve quality of life
for these patients.”

About illuvinate™

The FDA-cleared illuvinate System is an innovative treatment
designed to provide lasting relief from psoriasis symptoms. Inspired by
the Goeckerman Regimen, a 100-year-old proven therapy that results in
long periods of remission lasting over a year.1 However this
treatment is only available at a handful of specialized centers and
often requires multiple day-long clinic visits over a period of weeks,
creating barriers to widespread adoption. Luma Therapeutics has
redesigned the key elements of the Goeckerman Regimen to make it
available to patients in their own home.

Illuvinate has been demonstrated to reduce local inflammation, rehydrate
the skin and restore normal skin cells. The system includes patented
hydrating technology, a narrowband UV LED light system, and a
proprietary app-based dosing algorithm. The therapy is applied for just
minutes each day over a six-week period from the comfort and convenience
of home. The system can now be prescribed either by a dermatologist or
via Luma’s telehealth provider, HealthLens.

About Luma Therapeutics

Based in Silicon Valley, Luma Therapeutics is a privately held medical
technology company committed to developing innovative and convenient
therapies for the millions of people around the world suffering from
inflammatory skin disease. In collaboration with Mayo Clinic, Luma
Therapeutics developed the FDA-cleared illuvinate™ System to offer
patients with psoriasis an effective treatment option that can be used
at home. The company has also been supported by StartX accelerator and
the Rosenman Institute at QB3. For more information visit www.lumatherapeutics.com.

1 Gupta, Rishu, et al. “The Goeckerman Regimen for the
Treatment of Moderate to Severe Psoriasis.” Journal of
Visualized Experiments
, no. 77, 2013, doi:10.3791/50509.

Contacts

Durae Hardy
durae@healthandcommerce.com
707.337.1903

CORRECTING and REPLACING Luma Therapeutics Announces Data Presentations from Studies of the Illuvinate System for the Treatment for Plaque Psoriasis at AAD Annual Meeting

MILLBRAE, Calif.–(BUSINESS WIRE)–URL in the Luma Therapeutics boilerplate of release dated Feb. 27, 2019
should read www.lumatherapeutics.com.

The corrected release reads:

LUMA THERAPEUTICS ANNOUNCES DATA PRESENTATIONS FROM STUDIES OF THE
ILLUVINATE SYSTEM FOR THE TREATMENT FOR PLAQUE PSORIASIS AT AAD ANNUAL
MEETING

Luma Therapeutics, a company dedicated to eradicating suffering from
inflammatory skin disease, today announced that new data from studies of
the company’s illuvinate™ System will be presented at the American
Academy of Dermatology Annual Meeting taking place March 1 to 4 in
Washington, D.C.

Clinical trials conducted to demonstrate the safety and efficacy of the
product will be presented by Tina Bhutani, M.D., of the UCSF Medical
Center in San Francisco, Calif., as part of the following presentations
(all times local):

  • Phototherapy
    Presented by Henry W. Lim, M.D., Anna Chien,
    M.D., Benjamin Stoff, M.D., Elizabeth A. Buzney, M.D., and Tina
    Bhutani, M.D.
    Friday, March 1, 9:00 a.m., Room 201
  • Psoriasis and Atopic Dermatitis: Advances in Immunology and Therapy
    Presented
    by Jashin J. Wu, M.D., Emma Guttman, M.D., Ph.D., Lawrence F.
    Eichenfield, M.D., Paul Steven Yamauchi, M.D., Ph.D., Tina Bhutani,
    M.D.
    Saturday, March 2, 3:30 p.m., Salon H

Luma Therapeutics will also hold a cocktail reception hosted by founder
and CEO Evan Anderson and Chief Medical Officer Jeffrey Sugarman, M.D.,
on Thursday Feb. 28, 4:30 to 7:00 p.m., at Convivial, 801 O Street NW,
Washington, D.C. Click
here
to RSVP.

The company will be exhibiting at the conference in booth #2347.

About the illuvinate™ System

The FDA-cleared illuvinate System is an innovative treatment
designed to provide lasting relief from psoriasis symptoms. Inspired by
the Goeckerman Regimen, a 100-year-old proven therapy that results in
long periods of remission lasting over a year.1 However this
treatment is only available at a handful of specialized centers and
often requires multiple day-long clinic visits over a period of weeks,
creating barriers to widespread adoption. Luma Therapeutics has
redesigned the key elements of the Goeckerman Regimen to make it
available to patients in their own home.

Illuvinate has been demonstrated to reduce local inflammation, rehydrate
the skin and restore normal skin cells. The system includes patented
hydrating technology, a narrowband UV LED light system, and a
proprietary app-based dosing algorithm. The therapy is applied for just
minutes each day over a six-week period from the comfort and convenience
of home. The system can now be prescribed either by a dermatologist or
via Luma’s telehealth provider, HealthLens.

About Luma Therapeutics

Based in Silicon Valley, Luma Therapeutics is a privately held medical
technology company committed to developing innovative and convenient
therapies for the millions of people around the world suffering from
inflammatory skin disease. In collaboration with Mayo Clinic, Luma
Therapeutics developed the FDA-cleared illuvinate™ System to offer
patients with psoriasis an effective treatment option that can be used
at home. The company has also been supported by StartX accelerator and
the Rosenman Institute at QB3. For more information visit www.lumatherapeutics.com.

1 Gupta, Rishu, et al. “The Goeckerman Regimen for the
Treatment of Moderate to Severe Psoriasis.” Journal of
Visualized Experiments
, no. 77, 2013, doi:10.3791/50509.

Contacts

Durae Hardy
Health+Commerce
Tel: 707.337.1903

Exicure, Inc. Reports Full Year 2018 Financial Results and Corporate Progress

Completed Phase 1 clinical trials of two drugs and began public
trading

SKOKIE, Ill.–(BUSINESS WIRE)–Exicure, Inc. (OTCQB: XCUR), a pioneer in gene regulatory and
immunotherapeutic drugs utilizing spherical nucleic acid (SNA™)
constructs, today reported full year financial results for the year
ended December 31, 2018 and provided an update on corporate progress.

We’re very proud of our achievements on each of our strategic
priorities for 2018,” said Dr. David Giljohann, Chief Executive Officer
of Exicure. “We drove two programs through Phase 1 clinical trials while
laying the foundation for expanding our pipeline in neurology, rare
dermatology, ophthalmology and gastroenterology. We also strengthened
the management of our company and our access to capital. In the coming
year, we expect to execute and advance our ongoing clinical programs,
while expanding into new therapeutic areas,” Giljohann concluded.

Corporate Progress

Key achievements for Exicure during 2018 include:

  • Completed the Phase 1 clinical trial of AST-008, a TLR9 agonist for
    immuno-oncology applications showing activation of the immune system
    and robust cellular response
  • Completed a successful Phase 1 clinical trial of XCUR17 showing
    clinical effect in patients with psoriasis
  • Demonstrated, in preclinical animal models, superior
    bio-distribution and prolonged survival when administering nusinersen
    in SNA format versus nusinersen in linear format
  • Strengthened management team with addition of Dr. Matthias Schroff
    as Chief Operating Officer
  • Commenced public trading on the OTCQB market
  • Completed $22.0 million financing in August of 2018 at $4.50/share

Pipeline Updates

AST-008: AST-008 is an SNA consisting of toll-like receptor 9, or
TLR9, agonists designed for immuno-oncology applications. The company
began subject dosing of AST-008 in a Phase 1 clinical trial during the
fourth quarter 2017 and the trial completed in September of 2018.
AST-008 was shown to be safe and tolerable in all subjects, with no
serious adverse events and no dose limiting toxicity. During the fourth
quarter of 2018, the FDA opened the IND for AST-008 and informed
the Company that our proposed Phase 1b/2 trial may proceed. During early
2019, we opened four clinical sites and began dosing and recruiting
patients in that trial.

XCUR17: XCUR17 is an antisense SNA that targets the mRNA
encoding IL-17RA, a protein that is considered essential in the
initiation and maintenance of psoriasis. In the fourth quarter of 2018,
we reported results from the Phase 1 trial of XCUR17. Of the twenty-one
treated patients, eleven treated with the highest strength XCUR17 gel
were observed to have a reduction in redness and improvement in healing
as determined by blinded physician assessments. Further, the highest
strength XCUR17 gel showed a statistically significant improvement in
psoriasis symptoms versus the vehicle gel. By comparison, seventeen of
the twenty-one patients treated with the positive comparator showed a
clinical response, while four patients treated with the placebo vehicle
had a clinical response.

2018 Financial Results and Financial Guidance

Cash Position: As of December 31, 2018, Exicure had cash and cash
equivalents of $26.3 million compared to $25.8 million as of December
31, 2017. In 2018, Exicure raised approximately $22.0 million in gross
proceeds from the private placement of common stock.

Research and Development Expense: Research and development
expense was $14.1 million for the year ended December 31, 2018 compared
to $13.1 million for the year ended December 31, 2017. The increase in
research and development expense of $1.0 million was primarily due to
higher employee-related expense of $1.2 million and higher platform and
discovery-related expense of $0.6 million, partially offset by a net
decrease of $0.9 million in costs related to our clinical development
programs.

General and Administrative Expense: General and administrative
expense was $7.8 million for the year ended December 31, 2018 and $7.0
million for the year ended December 31, 2017, an increase of $0.8
million. This increase was due to higher costs of $0.9 million
associated with being a public company, including higher expense for
investor and public relations and director and officer insurance, as
well as higher compensation and related expense of $0.5 million
associated with salary increases and the addition of an executive during
2018, partially offset by lower legal and accounting costs of $0.7
million resulting from a change in mix of transaction support in 2018 as
compared to 2017.

Net Loss: Net loss was $22.4 million for the year ended December
31, 2018, compared to net loss of $11.0 million for the year ended
December 31, 2017. Net loss reflects the changes in expenses discussed
above and also reflects that revenue for the year ended December 31,
2018 decreased $9.6 million compared to revenue for the year ended 2017.
Revenue in 2017 was primarily related to the Purdue Collaboration and
reflects the amortization of the upfront payment on the Collaboration
which did not reoccur in 2018.

Cash Runway Guidance: Exicure believes that, based on its current
operating plans and as of the date of this press release, its existing
cash and cash equivalents as of December 31, 2018 is sufficient to meet
its anticipated cash requirements into early 2020.

About Exicure, Inc.

Exicure, Inc. is a clinical-stage biotechnology company developing
therapeutics for immuno-oncology, inflammatory diseases and genetic
disorders based on our proprietary Spherical Nucleic Acid, or SNA
technology. We believe Exicure’s proprietary SNA architecture has
distinct chemical and biological properties that may provide advantages
over other nucleic acid therapeutics and may have therapeutic potential
to target diseases not typically addressed with other nucleic acid
therapeutics. Exicure’s lead program is in a Phase1b/2 trial in patients
with advanced solid tumors. Exicure is based outside of Chicago, IL. www.exicuretx.com

Forward Looking Statements

This press release contains forward-looking statements (including within
the meaning of Section 21E of the United States Securities Exchange Act
of 1934, as amended, and Section 27A of the United States Securities Act
of 1933, as amended) concerning the Company, the Company’s technology,
potential therapies, cash requirements and other matters.
Forward-looking statements generally include statements that are
predictive in nature and depend upon or refer to future events or
conditions, and include words such as “may,” “will,” “should,” “would,”
“expect,” “plan,” “believe,” “intend,” “look forward,” and other similar
expressions among others. Statements that are not historical facts are
forward-looking statements. Forward-looking statements are based on
current beliefs and assumptions that are subject to risks and
uncertainties and are not guarantees of future performance. Actual
results could differ materially from those contained in any
forward-looking statement as a result of various factors, including,
without limitation: unexpected costs, charges or expenses that reduce
cash runway; that Exicure’s pre-clinical or clinical programs do not
advance or result in approved products on a timely or cost effective
basis or at all; the cost, timing and results of clinical trials; that
many drug candidates that have completed Phase 1 trials do not become
approved drugs on a timely or cost effective basis or at all; the
ability to enroll patients in clinical trials; possible safety and
efficacy concerns; regulatory developments; and the ability of Exicure
to protect its intellectual property rights. Risks facing the Company
and its programs are set forth in the Company’s filings with the SEC.
Except as required by applicable law, the Company undertakes no
obligation to revise or update any forward-looking statement, or to make
any other forward-looking statements, whether as a result of new
information, future events or otherwise.

         

EXICURE, INC.
UNAUDITED CONSOLIDATED BALANCE SHEETS
(in
thousands, except share and per share data)

 
December 31,
2018
December 31,
2017
 
ASSETS
Current assets:
Cash and cash equivalents $ 26,268 $ 25,764
Unbilled revenue receivable 3 13
Receivable from related party 10 17
Prepaid expenses and other assets 1,382   1,844  
Total current assets 27,663 27,638
Property and equipment, net 1,061 1,317
Other noncurrent assets 32   32  
Total assets $ 28,756   $ 28,987  
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 500 $ 1,049
Accrued expenses and other current liabilities 1,543 1,273
Current portion of deferred revenue   1,034  
Total current liabilities 2,043 3,356
Long-term debt, net 4,925 4,855
Common stock warrant liability 797 523
Other noncurrent liabilities 39   278  
Total liabilities $ 7,804 $ 9,012
 
Stockholders’ equity:
Common stock, $0.0001 par value per share; 200,000,000 shares
authorized, 44,358,000 issued and outstanding, December 31, 2018;
39,300,823 shares issued and outstanding, December 31, 2017
4 4
Additional paid-in capital 75,942 53,586
Accumulated deficit (54,994 ) (33,615 )
Total stockholders’ equity 20,952   19,975  
Total liabilities and stockholders’ equity $ 28,756   $ 28,987  
 
     

EXICURE, INC.
UNAUDITED CONSOLIDATED STATEMENTS OF
OPERATIONS

(in thousands, except share and per share
data)

 

Year Ended
December 31,

2018     2017
Revenue:
Collaboration revenue

$

118   $ 9,719  
Total revenue 118 9,719
Operating expenses:
Research and development expense 14,119 13,080
General and administrative expense 7,818   7,046  
Total operating expenses 21,937   20,126  
Operating loss (21,819 ) (10,407 )
Other income (expense), net:
Interest expense (672 ) (795 )
Other income (loss), net 78   191  
Total other income (loss), net (594 ) (604 )
Net loss $ (22,413 ) $ (11,011 )
 
Basic and diluted loss per common share $ (0.54 ) $ (1.09 )
Basic and diluted weighted-average common shares outstanding 41,189,177 10,119,569
 

Contacts

MacDougall Biomedical Communications
Karen Sharma
781-235-3060
ksharma@macbiocom.com

EmpiRx Health Selected as Finalist for Health Value Award

MONTVALE, N.J.–(BUSINESS WIRE)–Validation Institute, an organization focused on delivering better
health value and stronger outcomes than conventional healthcare,
announced today that EmpiRx Health has been selected as a finalist for a
Health Value Award in the Pharmaceutical Benefits Manager category.

“Being recognized as a finalist is an acknowledgement of your commitment
to high-quality healthcare initiatives,” said RD Whitney, CEO,
Validation Institute.

Health Value Award candidates complete a lengthy and rigorous
application process, particularly those nominated for validated program
categories who participate in an in-depth evaluation to ensure the
accuracy of performance claims.

“We’re excited to be recognized by Validation Institute for our
commitment to true alignment with advisors, clients, physicians, and
members, which leads to lower costs and better outcomes,” said Karthik
Ganesh, Chief Operating Officer at EmpiRx Health.

Winners will be announced at the Health Value Awards Ceremony during
World Healthcare Congress on April 28, which EmpiRx Health will be
attending.

About the Validation Institute:

The Validation Institute is a membership organization made up of a
network of healthcare vendors, health benefits advisors, and purchaser
benefit managers focused on delivering better health value and stronger
outcomes than conventional healthcare. To learn more about the
Validation Institute, visit: https://validationinstitute.com/

About EmpiRx Health

As a risk-bearing pharmacy benefit management (PBM) company, EmpiRx
Health offers its partners a model based on risk-based accountability,
data-informed clinical care, and concierge human touch. Our
sophisticated, personalized, and holistic approach to pharmacy care and
health management allows us to optimize care for members while reducing
pharmacy costs for clients. At EmpiRx Health, it’s about doing the right
thing—for members, providers, clients, advisors, and each other. To
learn more about EmpiRx Health, visit: www.empirxhealth.com.

Contacts

For more information about EmpiRx Health, please call Glenn Herdling at
201-746-6902 or email gherdling@empirxhealth.com.

For
information about the Validation Institute or the Health Value Awards,
please call Aimee O’Brien at 781-939-2507 or email aimee.o’brien@healthvalueinstitute.org.

Kelvyn Cullimore, President and CEO, BioUtah, Statement on Introduction of Legislation in the United States Senate to End the Medical Device Tax

SALT LAKE CITY–(BUSINESS WIRE)–Kelvyn Cullimore, President and CEO of BioUtah, issued the following
statement after the introduction of the Protect Medical Innovation
Act,
bipartisan legislation introduced by Senators Pat Toomey (R-PA)
and Amy Klobuchar (D-MN), to permanently repeal the medical device tax.

“BioUtah and its Utah-based members of the life sciences industry
applaud the bipartisan introduction of the Protect Medical Innovation
Act
to fully repeal the 2.3% excise tax on medical device sales
first enacted as part of the Affordable Care Act,” said Kelvyn
Cullimore, President and CEO of BioUtah. “We’re very pleased that
Senator Mitt Romney has cosponsored the legislation and is adding his
voice to supporting much-needed repeal.

“With the current moratorium expiring at the end of this year, now is
the time for Congress to end this misguided tax once and for all.
Medical device companies need the certainty of permanent repeal to make
long-term investments in research and development that will propel the
next generation of life-changing medical technology.

“The medical device sector, when combined with other life science
sectors such as pharmaceuticals, diagnostic and biotech, account for a
significant segment of Utah’s diverse and growing life sciences
industry, which, overall, supports 130,000 jobs and creates $13 billion
in state GDP. The device tax is ultimately a punitive tax on innovation
and growth, which has real consequences for patients and jobs.”

About BioUtah

BioUtah is an independent 501(c)(6) trade association serving Utah’s
life sciences industry. Its member companies reflect a broad spectrum of
the industry with strengths in medical device manufacturing and
services, research and testing, biotechnology, pharmaceuticals,
diagnostics and healthcare IT, amongst others; and are a key driver of
Utah’s economy. Together we create an ecosystem that fosters
collaboration, promotes innovation, and accelerates healthcare advances.
BioUtah is committed to growing Utah into a global leader in the life
sciences sector.

Contacts

Denise Bell
denise@bioutah.org
202-680-3030

SCIEX Honors International Women’s Day with Donation to World Cancer Research Fund

2019 contribution highlights awareness of breast cancer prevention
with a new blog post series

FRAMINGHAM, Mass.–(BUSINESS WIRE)–SCIEX,
a global leader in life science analytical technologies, announced today
that the company again partnered with the World Cancer Research Fund
(WCRF), one of the world’s leading cancer prevention charities. Since
2015, SCIEX has donated over $41,000 to WCRF – and, together, they are
releasing today the first of a three-part, female-centered blog series
exploring breast cancer and offering new insights into the future of
cancer prevention.

The WCRF supports groundbreaking research into the links between cancer
and diet, nutrition, and physical activity. Hundreds of thousands of
cancer cases could be prevented each year through reducing exposure to
risk factors, including those related to food and body weight1.
However, greater public awareness of how to manage these risk factors
will be required to reduce preventable cancers. The new blog series is
one of several initiatives that SCIEX has developed, to help raise such
awareness.

“We greatly value our partnership with SCIEX,” said Adam Daly,
Corporate Fundraising Partnerships Manager, WCRF
. “The company’s
continued fundraising efforts have made a significant contribution to
our work over the years and will help to achieve our vision of living in
a world where no one develops a preventable cancer.”

The first
part of the blog
takes an in-depth look at breast cancer from a
survivor’s viewpoint. The second part, which will be published on March
15th, examines new WCRF-funded research into how a woman’s
body mass index throughout her life affects her risk of breast cancer.
The blog series concludes on March 22nd with a focus on how
cancer prevention has evolved over the years, and future possibilities
for reducing disease occurrence.

“SCIEX is honored to be able to support healthcare research and
discoveries that will help to deliver life-changing answers for people
around the world,” says Inese Lowenstein, President, SCIEX. “As a
result of our outstanding employee participation in SCIEX annual
engagement activities, we are again able to continue to raise awareness
of preventable cancers affecting women.”

In addition to this partnership, SCIEX Australia and New Zealand are
also highlighting International Women’s Day with a newsletter featuring
ten inspiring women customers, celebrating their successes. See
here for their stories.

1. World Health Organization; Cancer Prevention. Accessed February 2019 https://www.who.int/cancer/prevention/en/

For Research Use Only. Not for use in diagnostic procedures.
RUO-MKT-12-9165-A

AB Sciex is operating as SCIEX.

© 2019 AB Sciex. The trademarks mentioned herein are the property of the
AB Sciex Pte. Ltd. or their respective owners. AB Sciex™ is being used
under license.

About SCIEX

SCIEX helps to improve the world we live in by enabling scientists and
laboratory analysts to find answers to the complex analytical challenges
they face. The company’s global leadership and world-class service and
support in the capillary electrophoresis and liquid chromatography-mass
spectrometry industry have made it a trusted partner to thousands of the
scientists and lab analysts worldwide who are focused on basic research,
drug discovery and development, food and environmental testing,
forensics and clinical research.

With over 40 years of proven innovation, SCIEX excels by listening to
and understanding the ever-evolving needs of its customers to develop
reliable, sensitive and intuitive solutions that continue to redefine
what is achievable in routine and complex analysis. For more
information, please visit sciex.com.

SCIEX social: Twitter: @SCIEXnews,
LinkedIn
and Facebook.

About World Cancer Research Fund

World Cancer Research Fund is one of the world’s leading cancer
prevention charities, and the only UK charity dedicated to funding
life-changing research into the prevention of cancer through diet and
lifestyle. We cut through the jargon to turn the latest global research
on cancer prevention and survival into practical, straightforward advice
and information, helping anyone who wants to reduce their risk of
developing cancer to make fully informed lifestyle choices.

Find out more: www.wcrf-uk.org

Take our Cancer Health Check: www.wcrf-uk.org/cancertool

Contacts

SCIEX
Lulu VanZandt
Program Manager, Brand, Public Relations
and Social Media, SCIEX
lulu.vanzandt@sciex.com
+1
(508) 383-7163
M: +1 (508) 782-9484

World Cancer Research Fund
Maxine Lenza
m.lenza@wcrf.org
0044
20 7343 4235

Global Preclinical Stage Partnering Terms & Agreements in Pharma & Biotech, 2014 to 2019 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global
Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech
2014-2019”
report has been added to ResearchAndMarkets.com’s
offering.

This report provides a detailed understanding and analysis of how, why
and what terms companies enter preclinical stage partnering deals. These
deals tend to be multicomponent, starting with collaborative R&D, and
commercialization of outcomes.

This report provides details of the latest preclinical agreements
announced in the healthcare sector.

Understanding the flexibility of a prospective partner’s negotiated
deals terms provides critical insight into the negotiation process in
terms of what you can expect to achieve during the negotiation of terms.
Whilst many smaller companies will be seeking details of the payments
clauses, the devil is in the detail in terms of how payments are
triggered – contract documents provide this insight where press releases
and databases do not.

This report contains a comprehensive listing of over 2,000 preclinical
stage partnering deals announced since 2014 including financial terms,
where available, including links to online deal records of actual
preclinical partnering deals as disclosed by the deal parties. In
addition, where available, records include contract documents as
submitted to the Securities Exchange Commission by companies and their
partners.

Contract documents provide the answers to numerous questions about a
prospective partner’s flexibility on a wide range of important issues,
many of which will have a significant impact on each party’s ability to
derive value from the deal.

The initial chapters of this report provide an orientation of
preclinical stage deal making and business activities. Chapter 1
provides an introduction to the report, whilst chapter 2 provides an
overview of why companies partner preclinical stage compounds/products.

Chapter 3 provides an overview of preclinical stage deals strategy and
deal structure including numerous case studies. Chapter 4 provides an
overview of the various payment strategies used in preclinical stage
deals.

Chapter 5 provides a review of preclinical stage deal making since 2014.
Deals activity is reviewed by year, stage of development at signing,
therapeutic area, technology type, as well as most active dealmakers.

Chapter 6 provides a detailed analysis of preclinical stage payment
terms including headline, upfront, milestone and royalty rates.

Chapter 7 provides a review of the leading preclinical stage deal by
headline value. Each deal title links via Current Agreements deals and
alliances database to an online version of the full deal record, and
where available, the actual contract document, providing easy access to
each deal record on demand.

Chapter 8 provides a comprehensive listing of the top 50 most active
preclinical stage dealmaker companies. Each deal title links via Current
Agreements deals and alliances database to an online version of the full
deal record, and where available, the actual contract document,
providing easy access to each deal record on demand.

Chapter 9 provides a comprehensive and detailed review of preclinical
stage partnering deals signed and announced since 2014, where a contract
document is available in the public domain.

Chapter 10 provides a comprehensive directory of preclinical stage
partnering deals since 2014.

The report includes deals announced by hundreds of life science
companies including big pharma such as Abbott, Abbvie, Actavis, Amgen,
Astellas, AstraZeneca, Baxter, Bayer, Biogen Idec, BMS, Celgene, Eisai,
Eli Lilly, Gilead, GSK, J&J, Kyowa Hakko, Merck, Mitsubishi, Mylan,
Novartis, Pfizer, Roche, Sanofi, Shire, Takeda, Teva, and Valeant,
amongst many others.

The report also includes numerous tables and figures that illustrate the
trends and activities in preclinical stage partnering and deal making
since 2014.

In addition, a comprehensive appendix of all preclinical deals since
2014 is provided organized by partnering company A-Z, deal type, therapy
focus and technology type. Each deal title links via Weblink to an
online version of the deal record and where available, the contract
document, providing easy access to each contract document on demand.

In conclusion, this report provides everything a prospective dealmaker
needs to know about partnering in the research, development and
commercialization of preclinical stage products and compounds.

Key Benefits

  • In-depth understanding of preclinical stage deal trends since 2014
  • Access to headline, upfront, milestone and royalty data
  • Analysis of the structure of preclinical stage agreements with
    numerous real life case studies
  • Insight into the terms included in a preclinical stage agreement,
    together with real world clause examples
  • Understand the key deal terms companies have agreed in previous deals
  • Undertake due diligence to assess suitability of your proposed deal
    terms for partner companies

Report Scope

Global Preclinical Stage Partnering Terms and Agreements in Pharma and
Biotech 2014-2019 is intended to provide the reader with an in-depth
understanding and access to preclinical stage deal trends and structure
of deals entered into by leading companies worldwide.

Global Preclinical Stage Partnering Terms and Agreements in
Pharma and Biotech 2014-2019 includes:

  • Trends in preclinical stage dealmaking in the biopharma industry since
    2014
  • Analysis of preclinical stage deal structure
  • Access to headline, upfront, milestone and royalty data
  • Case studies of real-life preclinical stage deals
  • Access to over 2,000 preclinical stage deals
  • The leading preclinical stage deals by value since 2014
  • Most active preclinical stage dealmakers since 2014
  • The leading preclinical stage partnering resources

In Global Preclinical Stage Partnering Terms and Agreements in
Pharma and Biotech 2014-2019, the available contracts are listed by:

  • Company A-Z
  • Headline value
  • Stage of development at signing
  • Deal type
  • Specific therapy target

Each deal title links via Weblink to an online version of the deal
record and where available, the contract document, providing easy access
to each contract document on demand.

The Global Preclinical Stage Partnering Terms and Agreements in Pharma
and Biotech 2014-2019 report provides comprehensive access to available
deals and contract documents for over 2,000 preclinical stage deals.

Analyzing actual contract agreements allows assessment of the
following:

  • What are the precise rights granted or optioned?
  • What is actually granted by the agreement to the partner company?
  • What exclusivity is granted?
  • What is the payment structure for the deal?
  • How are sales and payments audited?
  • What is the deal term?
  • How are the key terms of the agreement defined?
  • How are IPRs handled and owned?
  • Who is responsible for commercialization?
  • Who is responsible for development, supply, and manufacture?
  • How is confidentiality and publication managed?
  • How are disputes to be resolved?
  • Under what conditions can the deal be terminated?
  • What happens when there is a change of ownership?
  • What sub-licensing and subcontracting provisions have been agreed?
  • Which boilerplate clauses does the company insist upon?
  • Which boilerplate clauses appear to differ from partner to partner or
    deal type to deal type?
  • Which jurisdiction does the company insist upon for agreement law?

For more information about this report visit https://www.researchandmarkets.com/research/zpb8n4/global?w=4

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: Biotechnology,
Clinical
Trials

Namenda – Drug Insight, 2019-2021 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Namenda
– Drug Insight, 2019”
report has been added to ResearchAndMarkets.com’s
offering.

Namenda Drug Insight, 2019 highlights the drug marketed details
and the Global API Manufacturers details across the globe along with the
location.

The report covers the Global Market Assessment of the Namenda covering
the historical global sales and also provides the Namenda sales
estimation during the forecasted period (2019-2021).

The report also covers the patents information and market exclusivity
data, route of synthesis, market competition, and API manufacturers by
country.

In addition to this, the report also provides the SWOT analysis for
Namenda and emerging therapies in this space.

Scope

  • A review of the Namenda, based on information derived from company and
    industry-specific sources
  • Product details on the basis of MOA, target, dosage, route of
    administration, molecule type, strength, Chemical type and ATC
    Classification
  • Coverage of the Drug Master Files and API Manufacturers by country
  • Patent Expiry Timeline and Exclusivity Details
  • Route of Synthesis of the API
  • Forecasted Sales Figure from 2019-2021
  • Market competition and emerging therapies
  • SWOT Analysis

Reasons to Buy

  • Establish a comprehensive understanding of Namenda
  • Access to drug`s API manufacturers details to devise API procurement
    strategy for generic development
  • Plan developmental timelines around drug`s patents for the major
    markets – US and EU
  • Understand Namenda`s current and future growth through its historical
    and forecasted sales
  • Identify and understand the current in-market competitors for the drug
  • Identify the product attributes and use it for target finding, drug
    repurposing, and precision medicine
  • Identify and plan ahead for prospective emerging players and their
    products operating in the same space as the drug
  • Identify opportunities in the same area as Namenda with the SWOT
    analysis

Topics Covered

1. Report Introduction

2. Namenda – Overview

  • Product Description
  • Route of Synthesis
  • Mechanism of Action
  • Pharmacology
  • Pharmacodynamics
  • Pharmacokinetics
  • Adverse Reactions
  • Regulatory Milestones by Region
  • Deals and Partnerships

3. Product Details

4. Namenda Sales Assessment

  • Historical Sales
  • Forecasted Sales

5. Patent Details

6. Global API Manufacturers Assessment

  • Active Pharmaceutical Ingredient (API) Manufacturers by Country
  • Active Pharmaceutical Ingredient (API) Manufacturers by Region

7. Market Competition

8. Emerging Therapies

  • Product Description
  • Research and Development
  • Product Development Activities

9. SWOT Analysis

For more information about this report visit https://www.researchandmarkets.com/research/ntb4c7/namenda_drug?w=4

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: Central
Nervous System Drugs
, Alzheimer’s
Disease Drugs