Kratom Industry to Congress: Protect Safe, Natural Botanical Products and Consumer Choice in Pending Drug Legislation

Millions relying on botanicals to manage their well-being are
threatened by 11
th hour addition of new
language in House Bill directed at Synthetic Opioids

WASHINGTON–(BUSINESS WIRE)–#Kratom–The Kratom Trade Association (KTA) urges Congress to reconcile the
Opioid Crisis Response Act of 2018 (OCRA, S. 2680) with the Substance
Use-Disorder Prevention that Promotes Opioid Recovery and Treatment
(SUPPORT, H.R. 6) while resisting demands to add language from the “Stop
the Importation and Trafficking of Synthetic Analogues” (SITSA) Act H.R.
2851, which could restrict access to natural botanical products such as
Kratom, which millions of American consumers benefit from as an
alternative to manage their own health and well-being.

SITSA is aimed at banning chemical cousins or “analogues” of fentanyl, a
powerful synthetic opioid responsible for thousands of overdose deaths
that is increasingly appearing on the black market. It gives the
Attorney General the power to list “a drug or substance” under a new
schedule of controlled substances with “a chemical structure that is
substantially similar to the chemical structure of a controlled
substance in schedule I, II, III, IV, or V.”

Kratom is a natural botanical ingredient derived from the Mitragyna
plant, part of the coffee family and has been used safely
for decades in the United States. As currently written, SITSA could be
used to ban Kratom, something the Drug Enforcement Administration tried
unsuccessfully to do in 2016 when it inaccurately claimed it had “a high
potential for abuse.” Kratom is not a dangerous opioid. It has helped
millions of Americans improve their well-being.

Last week the Senate passed OCRA in a bipartisan vote of 99-1 to address
America’s opioid crisis, but some in Congress appear to be holding this
legislation hostage unless SITSA’s controversial provisions are added.
This is despite the Senate never held a hearing or debate on these
provisions. It is imperative that Congress pass this much needed opioid
legislation without threatening natural botanicals and similar organics
that offer countless benefits to millions of Americans.

The Kratom Trade Association (KTA) is dedicated to the safe and
responsible use of Kratom botanical products in the U.S. KTA is
committed to regulatory compliance and will develop and promote use of
best practices and quality standards for the industry. KTA will support
Kratom research initiatives and conduct advocacy efforts to educate
policy makers and the public about the benefits of Kratom, as well as
dispelling common misconceptions. Visit
for more information.


Kratom Trade Association (KTA)
Todd Post, 571-225-0957

Kala Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

WALTHAM, Mass.–(BUSINESS WIRE)–Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company
focused on the development and commercialization of therapeutics using
its proprietary mucus-penetrating particle (MPP) technology, today
announced that the Company granted non-statutory stock options to new
employees as inducement awards outside the Company’s 2017 Equity
Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4).

The Company granted stock options to purchase up to an aggregate of
69,500 shares of Kala Pharmaceuticals common stock to seven new
employees. The stock options were granted on September 17, 2018. The
grant was approved by the Compensation Committee and was made as an
inducement material to each employee entering into employment with Kala
Pharmaceuticals in accordance with NASDAQ Listing Rule 5635(c)(4). The
option awards have an exercise price of $10.68 per share, the closing
price of Kala Pharmaceuticals’ common stock on September 17, 2018. The
options have a ten-year term and vest over four years, with 25% of the
original number of shares vesting on the first anniversary of the
applicable employee’s new hire date and the remainder vesting in equal
monthly installments over the following three years. Vesting of each
option is subject to such employee’s continued service with Kala
Pharmaceuticals through the applicable vesting dates.

About Kala Pharmaceuticals, Inc.

Kala is a biopharmaceutical company focused on the development and
commercialization of therapeutics using its proprietary Mucus
Penetrating Particle (MPP) technology, with an initial focus on the
treatment of eye diseases. Kala has applied the MPP technology to a
corticosteroid, loteprednol etabonate, designed for ocular applications,
resulting in the recent approval of INVELTYSTM (loteprednol
etabonate ophthalmic suspension) 1% for the treatment of inflammation
and pain following ocular surgery. Kala plans to submit a New Drug
Application for KPI-121 0.25%, for the temporary relief of the signs and
symptoms of dry eye disease in the second half of 2018.


For Kala Pharmaceuticals, Inc.
Michael Schaffzin,
Watson, 781-235-3060

Anesthetic Effect – Pipeline Review, H2 2018 –

Effect – Pipeline Review, H2 2018”
drug pipelines has been
added to’s offering.

Anesthetic Effect – Pipeline Review, H2 2018, provides comprehensive
information on the therapeutics under development for Anesthetic Effect
(Central Nervous System), complete with analysis by stage of
development, drug target, mechanism of action (MoA), route of
administration (RoA) and molecule type. The guide covers the descriptive
pharmacological action of the therapeutics, its complete research and
development history and latest news and press releases.

The Anesthetic Effect (Central Nervous System) pipeline guide also
reviews of key players involved in therapeutic development for
Anesthetic Effect and features dormant and discontinued projects. The
guide covers therapeutics under Development by
Companies/Universities/Institutes, the molecules developed by Companies
in Pre-Registration, Phase III, Phase II, Phase I, IND/CTA Filed,
Preclinical, Discovery and Unknown stages are 3, 4, 2, 1, 1, 12, 1 and 3
respectively. Similarly, the Universities portfolio in Preclinical
stages comprises 1 molecules, respectively.

Anesthetic Effect (Central Nervous System) pipeline guide helps in
identifying and tracking emerging players in the market and their
portfolios, enhances decision making capabilities and helps to create
effective counter strategies to gain competitive advantage.

Key Topics Covered:

  1. Introduction
  2. Report Coverage
  3. Anesthetic Effect – Overview
  4. Anesthetic Effect – Therapeutics Development
  5. Pipeline Overview
  6. Pipeline by Companies
  7. Pipeline by Universities/Institutes
  8. Products under Development by Companies
  9. Products under Development by Universities/Institutes
  10. Anesthetic Effect – Therapeutics Assessment
  11. Assessment by Target
  12. Assessment by Mechanism of Action
  13. Assessment by Route of Administration
  14. Assessment by Molecule Type
  15. Anesthetic Effect – Companies Involved in Therapeutics Development
  • Biolab Farmaceutica Ltda
  • Crescita Therapeutics Inc
  • Drawbridge Pharmaceuticals Pty Ltd
  • Expanesthetics Inc
  • Lannett Company Inc
  • Lee’s Pharmaceutical Holdings Ltd
  • MedinCell SA
  • Paion AG
  • Phosphagenics Ltd
  • Physica Pharma
  • Recro Pharma Inc
  • Sichuan Kelun Pharmaceutical Co Ltd
  • Sphaera Pharma Pte Ltd
  • The Medicines Company
  • YiChang Humanwell Pharmaceutical Co Ltd
For more information about this drug pipelines report visit

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

Ichor’s Auctus Biologics Closes Quick $1.5MM

LAFAYETTE, N.Y.–(BUSINESS WIRE)–Auctus Biologics, Inc., a new portfolio company of Ichor
Therapeutics, Inc.
, announced today the closure of $1.5MM in seed
funding. The company will develop RPtag, a hyper-stable antibody mimetic
scaffold published
earlier this year
in the peer-reviewed journal ACS Biochemistry, to
take on conventional clinical antibody therapy as an orally bioavailable
formulation. New high priority immunosenescence and gastrointestinal
targets will also be pursued.

“The RPtag platform opens up a new frontier in biological drug discovery
and development,” said Kelsey Moody, CEO at Auctus Biologics. “Although
there may be significant opportunities to develop this platform as an
oral formulation to replace the need for conventional intravenous
infusions, we are also very excited about the prospect of deploying this
technology to modulate gut micro-flora and to go after other gut targets
that may drive age-associated disease and related processes.”

“This program is a testament to the excellence of our research teams and
their ability to identify unique value in all its manifestations,” said
Aaron Wolfe, COO at Auctus Biologics and co-inventor of the platform.
“This technology was originally developed for protein expression
applications. By following the data and affording the team an
appropriate level of scientific freedom, we have created a robust
therapeutic platform that can operate in environments where biologics
are traditionally limited.”

Press inquiries should be directed to Stephanie Martens at

About Auctus:

Auctus Biologics, Inc., a portfolio company of Ichor Therapeutics, is a
biotechnology company that creates new therapies using antibody mimetic
scaffolds based on RPtag. Founded in 2018, the company is developing
next generation biologics and is pursuing targets in extreme anatomical
environments like the gut where antibodies cannot currently be used.

About Ichor:

Ichor Therapeutics, Inc. is a vertically integrated research
organization focused on diseases and pathways of aging. R&D initiatives
that constitute Ichor’s portfolio companies include small molecule drug
discovery (Antoxerene,
), enzyme therapy (Lysoclear, Inc.), antibody mimetics (Auctus
Biologics, Inc.), and protein engineering tools (RecombiPure,
). Ichor and its portfolio companies operate from its corporate
offices and research laboratories in rural LaFayette, NY. The company is
eager to engage collaborators in the life science industry and in
academia who share its vision of delivering next generation therapies
for the illnesses of aging.


Ichor Therapeutics, Inc.
Stephanie Martens

The Global Facial Aesthetic Dermal Filler Industry (2018-2023): Focus on the Chinese Market –

Global Facial Aesthetic Dermal Filler Industry (2018-2023): Focus on the
Chinese Market”
report has been added to’s

This report provides key statistics on the market status of the Facial
Aesthetic Dermal Filler manufacturers and is a valuable source of
guidance and direction for companies and individuals interested in the

Firstly, the report provides a basic overview of the industry including
its definition, applications and manufacturing technology. Then, the
report explores the international and Chinese major industry players in
detail. In this part, the report presents the company profile, product
specifications, capacity, production value, and 2013-2018 market shares
for each company.

Through the statistical analysis, the report depicts the global and
Chinese total market of Facial Aesthetic Dermal Filler industry
including capacity, production, production value, cost/profit,
supply/demand and Chinese import/export. The total market is further
divided by company, by country, and by application/type for the
competitive landscape analysis.

The report then estimates 2018-2023 market development trends of Facial
Aesthetic Dermal Filler industry. Analysis of upstream raw materials,
downstream demand, and current market dynamics is also carried out.

In the end, the report makes some important proposals for a new project
of Facial Aesthetic Dermal Filler Industry before evaluating its
feasibility. Overall, the report provides an in-depth insight of
2013-2023 global and Chinese Facial Aesthetic Dermal Filler industry
covering all important parameters.

Key Topics Covered

1. Introduction of Facial Aesthetic Dermal Filler Industry

2. Manufacturing Technology of Facial Aesthetic Dermal Filler

3. Analysis of Global Key Manufacturers

4. 2013-2018 Global and Chinese Market of Facial Aesthetic Dermal Filler

5. Market Status of Facial Aesthetic Dermal Filler Industry

6. 2018-2023 Market Forecast of Global and Chinese Facial Aesthetic
Dermal Filler Industry

7. Analysis of Facial Aesthetic Dermal Filler Industry Chain

8. Global and Chinese Economic Impact on Facial Aesthetic Dermal Filler

9. Market Dynamics of Facial Aesthetic Dermal Filler Industry

10. Proposals for New Project

11. Research Conclusions of Global and Chinese Facial Aesthetic Dermal
Filler Industry

For more information about this report visit

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

Synergy Biomedical Announces Launch of BIOSPHERE MIS PUTTY

COLLEGEVILLE, Pa.–(BUSINESS WIRE)–Synergy Biomedical, LLC, a developer of innovative biomaterial products,
announced today that it has received FDA 510(k) clearance and is
proceeding with a full commercial launch of BIOSPHERE® MIS
PUTTY. BIOSPHERE® MIS PUTTY utilizes a pre-loaded bone graft
cannula and trigger-based delivery system specifically designed for the
unique challenges of minimally invasive surgery (MIS). The system
permits controlled placement of Synergy’s proven, next-generation bone
graft product (BIOSPHERE® PUTTY) in open, mini-open, and
percutaneous minimally invasive settings.

“BIOSPHERE® MIS PUTTY was engineered to create a functionally
ergonomic and easy to use bone graft delivery system,” stated Dr. Mark
Borden, Ph.D., President/CEO of Synergy Biomedical. “With the launch of
BIOSPHERE® MIS, surgeons now have the means to precisely
deliver BIOSPHERE® PUTTY to the surgical location.”

The BIOSPHERE® MIS PUTTY bone graft delivery system consists
of a hand-held dispenser and cannula pre-loaded with BIOSPHERE®
PUTTY. The system is easy-to-use and has a one-step assembly process
that is achieved by attaching the cannula to the dispenser. As the
trigger is engaged during delivery, a metered amount of BIOSPHERE®
PUTTY is extruded from the cannula. By design, BIOSPHERE® MIS
PUTTY can be extruded around implanted hardware or to remote anatomic
locations in a targeted fashion. Delivery is controlled and stops as
soon as the trigger is released. The dispenser and cannula were
specifically engineered with a narrow sight line profile that maximize
the surgeon’s view during graft placement. BIOSPHERE® MIS
PUTTY is available in a kit (that includes a dispenser and putty-filled
cannula), and also individual replacement cannulas to reload the
delivery system, if additional bone graft is needed.

“The BIOSPHERE® MIS PUTTY delivery system improves the
ability of a surgeon to place a bone graft material at a desired
location. The system is significantly easier to use than standard graft
funnels and allows for increased graft delivery due to the targeted
placement,” stated Dr. Derek Thomas, MD. “The BIOSPHERE® MIS
PUTTY delivery system is not only useful for MIS procedures, but also
for open procedures with hard to reach graft areas.”

BIOSPHERE® MIS PUTTY utilizes patented bioactive glass
spheres that have been shown in vivo to result in faster and more
robust bone formation. The product provides surgeons with a moldable
bone graft material that has one of the highest bioactive glass contents
on the market.

Synergy will be showcasing BIOSPHERE® MIS
and other products at Booth 2555 at the 2018 North American
Spine Society Meeting in Los Angeles (September 26
– 28

About Synergy Biomedical, LLC

Founded in 2011, Synergy Biomedical is a privately-held medical device
company focused on bringing innovative biomaterial-based products to the
musculoskeletal market. The Company’s BioSphere Technology has broad,
cross-platform surgical applications in the orthopaedic, spine, sports
medicine, and joint arthroplasty markets. This technology represents a
unique approach to advancing bone healing and improving patient outcomes.


Synergy Biomedical, LLC
Mark Borden, Ph.D.

Global Burkitt Lymphoma Therapeutics Market 2018-2022 – Key Vendors Are Biogen, F. Hoffmann-La Roche, Merck Sharp & Dohme, Novartis & Spectrum Pharmaceuticals –

Burkitt Lymphoma Therapeutics Market 2018-2022”
report has been
added to’s offering.

The Global Burkitt Lymphoma Market to grow at a CAGR of 3.07% during the
period 2018-2022.

Burkitt lymphoma market 2018-2022 has been prepared based on an in-depth
market analysis with inputs from industry experts. The report covers the
market landscape and its growth prospects over the coming years. The
report also includes a discussion of the key vendors operating in this

Increasing strategic alliances in the field of oncology will be one of
the major trends in the market as vendors in the global oncology drugs
market are regularly engaging in strategic alliances to strengthen their
market position. Such alliances help these vendors consolidate their
position and extend their geographical reach.

According to the report, one driver influencing this market is the rapid
progression of Burkitt lymphoma requires immediate medical attention.
Burkitt lymphoma is recognized as one of the fastest growing tumours in
humans and is highly fatal if left untreated during the early stages.

Further, the report states that one challenge affecting this market is
the high cost of the treatment. The chemotherapy drugs used in the
treatment of Burkitt lymphoma are expensive. The high cost of
chemotherapy drugs is one of the major challenges faced by the global
Burkitt lymphoma therapeutics market.

Key vendors

  • Biogen
  • F. Hoffmann-La Roche
  • Merck Sharp & Dohme
  • Novartis
  • Spectrum Pharmaceuticals

Key Topics Covered:






  • Market ecosystem
  • Market characteristics
  • Market segmentation analysis


  • Market definition
  • Market sizing 2017
  • Market size and forecast 2017-2022




  • Segmentation by drug class
  • Comparison by drug class
  • Biological – Market size and forecast 2017-2022
  • Small molecule – Market size and forecast 2017-2022
  • Market opportunity by drug class



  • Geographical segmentation
  • Regional comparison
  • Key leading countries
  • Market opportunity






  • Vendors covered
  • Vendor classification
  • Market positioning of vendors

For more information about this report visit

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

CoreLink Surgical Announces the launch of Articulating Expandable Posterior Lumbar System – FLXfit®15

ST. LOUIS–(BUSINESS WIRE)–#NASS–CoreLink Surgical today announces the expanded commercial launch for the
FLXfit®15 articulating-expandable intervertebral body fusion device.

FLXfit15 is a posterior lumbar expandable interbody device that offers
up to 15 degrees of controlled and continuous expansion and is one of
the only expandable cages on the market that offers articulation,
providing ease in precise anterior placement. FLXfit15’s open device
architecture enables ample space for graft material and its
bulleted-nose and single-instrument inserter/expander are designed to
streamline insertion. FLXfit15 is offered in 2 lengths – 32mm and 40mm,
and in heights from 8-13mm to accommodate diversity in anatomical need.

“The FLXfit15 Interbody device offers the surface area contact and
lordosis often desired in an ALIF procedure but obtained with a less
complicated posterior approach – this implant is inserted as a PL,
deploys as a TL, and expands to gain lordosis of up to 15 degrees. It
saves me time, is less invasive and offers optimal sagittal balance
correction. In my opinion, it’s the best posterior interbody cage on the
market,” said Grant Skidmore MD, Neurosurgeon, Norfolk, VA.

Jay Bartling, CEO, said, “The surgeon and distributor interest in
FLXfit15 has far exceeded expectations in a very short period. CoreLink
is committed to providing advanced technology with world class quality.”

“Last year, expandable devices grew to over 20% of the overall interbody
market- expandable devices are clearly here to stay. CoreLink’s offering
FLXfit15 is a great compliment to our growing product offering and
positions us well to meet the increasing needs of surgeons and
patients,” said Derek Kuyper, VP of Sales at CoreLink.

CoreLink will be exhibiting at the North American Spine Society’s annual
meeting in Los Angeles, September 26-28, booth #2038, where a full
display of FLXfit15 and our family of Foundation 3D Products will be
featured. Private appointments available.

About CoreLink

CoreLink, known as The Source for Spine™, internally designs and
manufactures more than 99% of its broad portfolio of spinal implant
systems and leverages this expertise through collaboration and a
dedication to empowering its surgeons and improving the lives of their

Be a part of something at The Source.


CoreLink, LLC
Courtney Sheedy, 888-349-7808

Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Approval in Japan for Frontline Hodgkin Lymphoma

-Approval Triggers Milestone Payment to Seattle Genetics of $10

Genetics, Inc.
(Nasdaq: SGEN) today announced that its collaborator,
Takeda Pharmaceutical Company Limited (Takeda), has received approval
from the Japanese Ministry of Health, Labour and Welfare for ADCETRIS
(brentuximab vedotin) in combination with doxorubicin, vinblastine and
dacarbazine (AVD) as a frontline treatment option for CD30-positive
Hodgkin lymphoma patients in Japan. As a result, Seattle Genetics will
receive a milestone payment from Takeda of $10 million. The approval in
Japan was based on the positive outcome from the phase 3 ECHELON-1 trial.

“This approval marks another important milestone in expanding the
ADCETRIS brand globally and redefining the way newly diagnosed Hodgkin
lymphoma patients are treated around the world,” said Clay Siegall,
Ph.D., President and Chief Executive Officer of Seattle Genetics.
“ADCETRIS is approved in 71 countries and generated global sales of
approximately $640 million in 2017, underscoring its progress toward
becoming the foundation of therapy for patients with CD30-expressing

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the
terms of the collaboration agreement, Seattle Genetics has U.S. and
Canadian commercialization rights and Takeda has rights to commercialize
ADCETRIS in the rest of the world. Seattle Genetics and Takeda are
funding joint development costs for ADCETRIS on a 50:50 basis, except in
Japan where Takeda is solely responsible for development costs. Seattle
Genetics is entitled to receive progress- and sales-dependent milestone
payments. In addition, Seattle Genetics receives tiered double-digit
royalties with percentages ranging from the mid-teens to mid-twenties
based on net sales of ADCETRIS within Takeda’s territories.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the
lymphatic system. There are two major categories of lymphoma: Hodgkin
lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is
distinguished from other types of lymphoma by the presence of one
characteristic type of cell, known as the Reed-Sternberg cell. The
Reed-Sternberg cell expresses CD30. According to the Lymphoma Coalition,
over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each
year and approximately 25,000 people die each year from this cancer.

About ADCETRIS (brentuximab vedotin)

ADCETRIS is being evaluated broadly in more than 70 clinical trials,
including the ongoing phase 3 ECHELON-2 trial in frontline peripheral
T-cell lymphomas (also known as mature T-cell lymphoma), the completed
phase 3 ALCANZA trial in cutaneous T-cell lymphoma (CTCL) and the
completed ECHELON-1 trial in previously untreated Hodgkin lymphoma, as
well as trials in many additional types of CD30-positive lymphomas.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached
by a protease-cleavable linker to a microtubule disrupting agent,
monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary
technology. The ADC employs a linker system that is designed to be
stable in the bloodstream, but to release MMAE upon internalization into
CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval
for five indications in adult patients with: (1) previously untreated
Stage III or IV classical Hodgkin lymphoma (cHL), in combination with
chemotherapy, (2) cHL at high risk of relapse or progression as
post-autologous hematopoietic stem cell transplantation (auto-HSCT)
consolidation, (3) cHL after failure of auto-HSCT or failure of at least
two prior multi-agent chemotherapy regimens in patients who are not
auto-HSCT candidates, (4) sALCL after failure of at least one prior
multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic
large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF)
who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or
refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional
approval for post-autologous stem cell transplantation (ASCT)
consolidation treatment of Hodgkin lymphoma patients at increased risk
of relapse or progression.

ADCETRIS received conditional marketing authorization from the European
Commission in October 2012. The approved indications in Europe are: (1)
for the treatment of adult patients with relapsed or refractory
CD30-positive Hodgkin lymphoma following ASCT, or following at least two
prior therapies when ASCT or multi-agent chemotherapy is not a treatment
option, (2) the treatment of adult patients with relapsed or refractory
sALCL, (3) for the treatment of adult patients with CD30-positive
Hodgkin lymphoma at increased risk of relapse or progression following
ASCT, and (4) for the treatment of adult patients with CD30-positive
cutaneous T-cell lymphoma (CTCL) after at least one prior systemic

ADCETRIS has received marketing authorization by regulatory authorities
in 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL.
See select important safety information, including Boxed Warning, below.

About Seattle Genetics

Seattle Genetics, Inc. is an emerging multi-product, global
biotechnology company that develops and commercializes transformative
therapies targeting cancer to make a meaningful difference in people’s
lives. ADCETRIS® (brentuximab vedotin) utilizes the company’s
industry-leading antibody-drug conjugate (ADC) technology and is
currently approved for the treatment of multiple CD30-expressing
lymphomas. Beyond ADCETRIS, the company has established a pipeline of
novel targeted therapies at various stages of clinical testing,
including three in ongoing pivotal trials for solid tumors. Enfortumab
vedotin for metastatic urothelial cancer and tisotumab vedotin for
metastatic cervical cancer utilize our proprietary ADC technology.
Tucatinib, a small molecule tyrosine kinase inhibitor, is in a pivotal
trial for HER2-positive metastatic breast cancer. In addition, we are
leveraging our expertise in empowered antibodies to build a portfolio of
proprietary immuno-oncology agents in clinical trials targeting
hematologic malignancies and solid tumors. The company is headquartered
in Bothell, Washington, and has a European office in Switzerland. For
more information on our robust pipeline, visit
and follow @SeattleGenetics on Twitter.

ADCETRIS (brentuximab vedotin) U.S. Select Important Safety


JC virus infection resulting in PML and death can occur in
ADCETRIS-treated patients.


ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g.,
interstitial infiltration and/or inflammation).

Warnings and Precautions

  • Peripheral neuropathy (PN): ADCETRIS causes PN that is
    predominantly sensory. Cases of motor PN have also been reported.
    ADCETRIS-induced PN is cumulative. Monitor for symptoms such as
    hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning
    sensation, neuropathic pain, or weakness. Institute dose modifications
  • Anaphylaxis and infusion reactions: Infusion-related reactions
    (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor
    patients during infusion. If an IRR occurs, interrupt the infusion and
    institute appropriate medical management. If anaphylaxis occurs,
    immediately and permanently discontinue the infusion and administer
    appropriate medical therapy. Premedicate patients with a prior IRR
    before subsequent infusions. Premedication may include acetaminophen,
    an antihistamine, and a corticosteroid.
  • Hematologic toxicities: Fatal and serious cases of febrile
    neutropenia have been reported with ADCETRIS. Prolonged (≥1 week)
    severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can
    occur with ADCETRIS. Administer G-CSF primary prophylaxis starting
    with Cycle 1 for previously untreated patients who receive ADCETRIS in
    combination with chemotherapy for Stage III or IV HL. Monitor complete
    blood counts prior to each ADCETRIS dose. Consider more frequent
    monitoring for patients with Grade 3 or 4 neutropenia. Monitor
    patients for fever. If Grade 3 or 4 neutropenia develops, consider
    dose delays, reductions, discontinuation, or G-CSF prophylaxis with
    subsequent doses.
  • Serious infections and opportunistic infections: Infections
    such as pneumonia, bacteremia, and sepsis or septic shock (including
    fatal outcomes) have been reported in ADCETRIS-treated patients.
    Closely monitor patients during treatment for bacterial, fungal, or
    viral infections.
  • Tumor lysis syndrome: Closely monitor patients with rapidly
    proliferating tumor and high tumor burden.
  • Increased toxicity in the presence of severe renal impairment: The
    frequency of ≥Grade 3 adverse reactions and deaths was greater in
    patients with severe renal impairment compared to patients with normal
    renal function. Avoid use in patients with severe renal impairment.
  • Increased toxicity in the presence of moderate or severe hepatic
    The frequency of ≥Grade 3 adverse reactions and deaths
    was greater in patients with moderate or severe hepatic impairment
    compared to patients with normal hepatic function. Avoid use in
    patients with moderate or severe hepatic impairment.
  • Hepatotoxicity: Fatal and serious cases have occurred in
    ADCETRIS-treated patients. Cases were consistent with hepatocellular
    injury, including elevations of transaminases and/or bilirubin, and
    occurred after the first ADCETRIS dose or rechallenge. Preexisting
    liver disease, elevated baseline liver enzymes, and concomitant
    medications may increase the risk. Monitor liver enzymes and
    bilirubin. Patients with new, worsening, or recurrent hepatotoxicity
    may require a delay, change in dose, or discontinuation of ADCETRIS.
  • PML: Fatal cases of JC virus infection resulting in PML and
    death have been reported in ADCETRIS-treated patients. First onset of
    symptoms occurred at various times from initiation of ADCETRIS
    therapy, with some cases occurring within 3 months of initial
    exposure. Other possible contributory factors other than ADCETRIS
    include prior therapies and underlying disease that may cause
    immunosuppression. Consider PML diagnosis in patients with new-onset
    signs and symptoms of central nervous system abnormalities. Hold
    ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is
  • Pulmonary toxicity: Fatal and serious events of noninfectious
    pulmonary toxicity including pneumonitis, interstitial lung disease,
    and acute respiratory distress syndrome have been reported. Monitor
    patients for signs and symptoms, including cough and dyspnea. In the
    event of new or worsening pulmonary symptoms, hold ADCETRIS dosing
    during evaluation and until symptomatic improvement.
  • Serious dermatologic reactions: Fatal and serious cases of
    Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
    have been reported with ADCETRIS. If SJS or TEN occurs, discontinue
    ADCETRIS and administer appropriate medical therapy.
  • Gastrointestinal (GI) complications: Fatal and serious cases of
    acute pancreatitis have been reported. Other fatal and serious GI
    complications include perforation, hemorrhage, erosion, ulcer,
    intestinal obstruction, enterocolitis, neutropenic colitis, and ileus.
    Lymphoma with preexisting GI involvement may increase the risk of
    perforation. In the event of new or worsening GI symptoms, perform a
    prompt diagnostic evaluation and treat appropriately.
  • Embryo-fetal toxicity: Based on the mechanism of action and
    animal studies, ADCETRIS can cause fetal harm. Advise females of
    reproductive potential of the potential risk to the fetus, and to
    avoid pregnancy during ADCETRIS treatment and for at least 6 months
    after the final dose of ADCETRIS.

Most Common (≥20%) Adverse Reactions: Neutropenia, anemia, peripheral
sensory neuropathy, nausea, fatigue, constipation, diarrhea, vomiting,
and pyrexia.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp
inhibitors, has the potential to affect the exposure to monomethyl
auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE
exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to
use effective contraception during ADCETRIS treatment and for at least 6
months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding
while receiving ADCETRIS.

For additional Important Safety Information, including BOXED WARNING,
please see the full Prescribing Information for ADCETRIS at

Forward-Looking Statements

Certain of the statements made in this press release are
forward-looking, such as those, among others, relating to the potential
commercial opportunity for ADCETRIS in Japan and the potential for
approval and commercialization of ADCETRIS in other countries, and the
potential of redefining the treatment of newly diagnosed Hodgkin
lymphoma patients around the world. Actual results or developments may
differ materially from those projected or implied in these
forward-looking statements. Factors that may cause such a difference
include risks that ADCETRIS will not be widely adopted by physicians in
Japan or reimbursement may be difficult to secure in Japan, or that we
may otherwise encounter challenges in commercializing ADCETRIS in the
jurisdictions in which it has been approved for use in newly diagnosed
Hodgkin lymphoma patients in combination with chemotherapy. In addition,
data from clinical trials may not support marketing approval for
submitted indications in other countries. More information about the
risks and uncertainties faced by Seattle Genetics is contained in the
company’s 10-Q for the quarter ended June 30, 2018 filed with the
Securities and Exchange Commission. Seattle Genetics disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events or


Seattle Genetics, Inc.
Peggy Pinkston, 425-527-4160
Greer, 425-527-4641

Remedy Plan Therapeutics Named Winner of MTC’s Inaugural Start-Up Pitch Contest at Bio+Tech18

Maryland Tech Council (MTC)
concluded its Bio+Tech18
yesterday in Baltimore with the announcement of Remedy
Plan Therapeutics
as the winner of its Inaugural Start-Up Pitch
Contest. Remedy Plan Therapeutics is a biotechnology company developing
drugs that target cancer stem cells to inhibit tumor growth and

“The judges were very impressed with the quality of all five companies
who pitched and were excited to see the potential these companies bring
to Maryland,” stated Anthony Millin, Start-ups and Venture Capital Chair
for Shulman Rogers and a judge of the pitch contest. “We were
specifically impressed with Remedy Plan Therapeutics and the team’s
innovative approach to cancer research.”

All five finalists, including Remedy Plan Therapeutics plus AlgometRx,
JuneBrain, Sonavex and VakSea, pitched live to the attendees and judges
during the conference’s cocktail reception last evening.

“The Inaugural Pitch Contest was a great success,” noted Marty
Rosendale, MTC Chief Executive Officer. “We aimed to highlight
innovation within the Maryland technology and life science ecosystem,
and achieved this through the participation of the start-ups and the
quality of the finalists.”

About Bio+Tech18 Conference

Kicked-off by Maryland Lt. Governor Boyd Rutherford, the popular and
highly-attended Bio+Tech18 Conference brought together industry leaders
from across the region to discuss trends, emerging markets and the
future of the industry. The conference was packed with topics that
ranged from Gene Therapy 2.0, Next Generation Biotherapeutics,
Breakthrough Research and Oncology, Cancer Immunotherapeutics, Virtual
Reality and Tech Transfer and Commercialization.

Presented by the Maryland Tech Council, Bio+Tech18 reflects the
changing landscape where life science and technology converge by
bringing together more than 400 professionals in both fields so that
they may meet and forge new partnerships that will lead to great new
discoveries. In its third year, the Bio+Tech Conference will continue to
bring together the life science and technology sectors to meet and
leverage the talents of the other to grow their organizations and their
industry. To learn more about Bio+Tech18, visit:

About Maryland Tech Council

The Maryland Tech Council (MTC) is the largest technology trade group
serving the advanced technology and biotechnology communities of
Maryland. MTC’s mission is to advocate for the interests of the
technology community, further the role of technology in the Maryland
economy, and nurture an environment where technology companies can
collaborate, grow and succeed. For more information, visit


PressComm PR
Juliette Bogus, +410-980-5687