BioLines Weekender

Welcome to the latest edition of the BioLines Weekender.

The BioNJ Team had a great summer -- cruising with our Members, planning future events and working with Governor Murphy and his Administration on initiatives to create new growth opportunities for our industry in the great state of New Jersey.

BioNJ is excited to be working with the BIO Team, as well as our colleagues at DelawareBio and Life Sciences PA, on the planning of next year's BIO International Conference returning to the Philadelphia Convention Center June 2019. We look forward to sharing details with our Members over the next few months.

Meanwhile, we are excited for BioNJ's fall roster of events, including:

September 21: Manufacturing in Transition - Trends, Insights & Implications
October 11: Value Frameworks Workshop: Defining the Value of Medical Innovation
October 25: C-Suite Summit: Healthcare & Biopharma in Transformation - Industry's New Edge of Opportunity

Mark your calendars and plan to join us for these timely programs focused on topics affecting the industry and your businesses. For information on BioNJ Membership, please contact Edie Esposito at EEsposito@BioNJ.org.

Because Patients Can't Wait^®,

The BioNJ Team

BioNJ Calendar

BioNJ's Manufacturing Briefing Rutgers University, Piscataway, NJ		September 21, 2018 Register now!
Beyond Value Frameworks: Defining the Value of Medical Innovation Workshop Amicus Therapeutics, Cranbury, NJ		October 11, 2018 Register now!
BioNJ's C-Suite Summit Bridgewater Marriott, Bridgewater, NJ		October 25, 2018 Register now!
BioNJ's Patient Advocacy Summit Celgene Corporation, 179 Passaic Ave, Summit, NJ		December 13, 2018 Save the date!

Putting Patients First: The Value of Medical Innovation
Brought to You by Celgene Corporation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of healthcare. Share with our community how your medical innovation is improving lives and impacting healthcare costs. Send us your Patient and related stories to BioNJ@BioNJ.org. Plus, click here for valuable tools and resources on the Value of Medical Innovation.

Incubator and Collaborative Workspace Rent Initiative Program

One of the pillars of Governor Murphy's vision of a stronger fairer economy is recreating New Jersey as a home for innovation. Fostering emerging businesses and helping them overcome barriers to commercial success is critical to achieving that vision. This new program will support entrepreneurs by providing rent support grants and collaborative workspaces by awarding new Technology and Life Science companies up to 50% off rent at a new collaborative workspace.

Help name New Jersey's "Incubator and Collaborative Workspace Rent Initiative. Click here to cast your vote!

Number of Value-based Contracts Continues to Rise

The list of publicly announced value-based contracts (VBCs) -- also called results-based contracts -- between biopharmaceutical companies and health plans continued to grow over the last quarter -- from 39 to 43 contracts. In reality, this is a conservative estimate, as this list doesn't include the many contracts that have been implemented without being publicly announced. There's reason to believe this growth in VBCs will continue. A recent survey from Avalere indicates that over a quarter of all health plans have a VBC in place, and 85 percent of those health plans are interested in pursuing additional contracts.

New Analysis in Health Affairs Reinforces One-third of Medicine List Price Rebated Back to Supply Chain

An analysis published in a Health Affairs blog post by Nancy L. Yu, Preston Atteberry and Peter B. Bach of the Memorial Sloan Kettering Cancer Center reinforces that one-third of medicine list prices are rebated back to pharmacy benefit manages (PBMs), wholesalers, health plans and other stakeholders in the biopharmaceutical supply chain. According to the analysis, in 2016 brand and generic biopharmaceutical companies retained just two-thirds ($323 billion) of total spending on medicines.

BioNJ in the News

NJ Jobs: In Big Pharma State Murphy Bets Big on Small Pharma

Naresh Jain launched NJ Biopharmaceuticals LLC this summer in a laboratory off Route 1 and promptly hired three chemists who will research new drugs for late-stage cancer patients. If his dream goes as planned, New Jerseyans could be big winners. New Jersey, a state that has depended on big pharma for research and job growth for more than a century, is turning its attention to small pharma to provide an economic jolt. As President and CEO of BioNJ, Debbie Hart, points out, "A lot of the growth is coming from new, innovative companies."

Interested in Receiving BioNJ's Biweekly Jobs Beat Featuring the Latest Job Opportunities? Click here!

BioNJ's Member Service Provider Directory

Whatever your services needs may be, BioNJ's Member Service Provider Directory can guide you to the right source. This Member-only categorical listing by service sector is your "one-stop-shop" solution to support and drive your business. Click on the RESOURCES tab at www.BioNJ.org to view the full BioNJ Member Service Provider Directory categories. Here's a sample for Contract Manufacturing, Supply Chain & Logistics Management Providers:

United Parcel Service (UPS)	AGC Biologics	Chemical and Pharmaceutical Solutions	Hovione LLC
PendoTECH	SICPA	Toxikon Corporation	Woodfield Distribution, LLC

NJ Company News

Ever proud of our ecosystem, we are pleased to share our New Jersey Company News. Be sure to click on the article titles below to read the full release.

Soligenix Announces Publication of Positive Long-Term Data Supporting Thermostability and Conformational Integrity of the RiVax® Ricin Toxin Vaccine

Princeton-based BioNJ Member Soligenix, Inc. announced publication of extended stability studies for RiVax® showing up to 100% protection in mice even after 12 months storage at 40 degrees Celsius (104 degrees Fahrenheit), as well as the identification of a potential in vitro stability indicating assay, critical to adequately confirming long-term shelf-life of the vaccine.

OncoSec Announces $15 Million at Market Investment from Alpha Holdings, Inc.

Pennington-based BioNJ Member OncoSec Medical Incorporated announced that it has secured a $15 million investment from Alpha Holdings, Inc. as part of a value focused, fundamental strategic investment centered on the clinical development of OncoSec's lead immunotherapy product candidate, TAVO (tavokinogene telseplasmid). TAVO enables the intratumoral delivery of DNA-based interleukin-12 (IL-12), a naturally occurring protein with powerful immune-stimulating functions.

Exclusive Nordic Distribution Agreement for Innovative Drug Delivery System for Bladder Cancer Patients

Princeton-based BioNJ Member Photocure announced that an exclusive distribution agreement for the Nordic area for an innovative and patented medical device has been signed with Combat Medical. The device is designed for the delivery of Hyperthermic Intra-Vesical Chemotherapy (HIVEC®) for non-muscle invasive bladder cancer and has a strong strategic and synergistic fit with current business.

PTC Therapeutics Acquires Agilis Biotherapeutics

South Plainfield-based BioNJ Member PTC Therapeutics Inc. announced that it has successfully completed the acquisition of Agilis Biotherapeutics, Inc., a private biotechnology company focused on the advancement of innovative gene therapy programs for rare genetic disorders that affect the central nervous system. With the acquisition, PTC adds GT-AADC, an adeno-associated virus (AAV) gene therapy that treats Aromatic L-Amino Acid Decarboxylase (AADC) Deficiency.

Results of Global Phase III Study With Chugai's HEMLIBRA® for Hemophilia A Without Inhibitors Published in the New England Journal of Medicine

Berkeley Heights-based BioNJ Member Chugai Pharmaceutical Co., Ltd. announced that results of the HAVEN 3 study (NCT02847637), the global Phase III study evaluating hemophilia A treatment, HEMLIBRA ® (generic name: emicizumab [genetical recombination]), were published in the New England Journal of Medicine. The study evaluated the efficacy and safety of HEMLIBRA subcutaneous injection, once a week and once every two weeks, in people with hemophilia A (12 years of age or older) without inhibitors to factor VIII.

Advaxis Licenses ADXS-HER2 to OS Therapies for Evaluation in the Treatment of Osteosarcoma

Princeton-based BioNJ Member Advaxis, Inc. announced that Advaxis has granted a license to OS Therapies for the use of ADXS31-164, also known as ADXS-HER2, for evaluation in the treatment of osteosarcoma in humans. Osteosarcoma is an aggressive cancerous tumor that forms in bone. Although it is rare, osteosarcoma is the most common type of bone cancer, and is most frequently found in children and young adults.

Otsuka Announces First Collaboration Agreement to Bring the ABILIFY MYCITE® System to the U.S. Market

Princeton-based BioNJ Member Otsuka announced that it has signed a Collaboration Agreement to facilitate access to the ABILIFY MYCITE® System to select regional provider networks contracted through Magellan Health. The Collaboration Agreement creates the opportunity for physicians and adult patients to gather experience in a real-world setting with the ABILIFY MYCITE System. The ABILIFY MYCITE System provides an opportunity for a connected care approach to treatment, and tracks if ABILIFY MYCITE (aripiprazole tablet with sensor) has been taken.

Vyxeos® Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia

BioNJ Member Jazz Pharmaceuticals, with offices in Ewing, announced that the European Commission approved Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine.

Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for esketamine nasal spray. Janssen is seeking FDA approval of esketamine for treatment-resistant depression in adults. Esketamine is an investigational, rapidly acting antidepressant that works differently than currently available therapies for major depressive disorder.

U.S. FDA Approves IMBRUVICA (ibrutinib) Plus Rituximab as First Non-Chemotherapy Combination Regimen for Patients With Waldenström's Macroglobulinemia, a Rare Blood Cancer

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced the U.S. Food and Drug Administration approval of IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of Waldenström's macroglobulinemia (WM), a rare blood cancer. The approval expands the label for IMBRUVICA in WM beyond its current approved use as a monotherapy to include combination use with rituximab.

SCYNEXIS, Inc. Presents Ibrexafungerp Data at the 2018 ESCMID/ASM Conference on Drug Development

Jersey City-based BioNJ Member SCYNEXIS, Inc. announced the presentation of data at the 2018 European Society of Clinical Microbiology and Infectious Diseases (ESCMID)/American Society for Microbiology Conference on Drug Development to Meet the Challenge of Antimicrobial Resistanc. Ibrexafungerp (formerly SCY-078), the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family, is in clinical development for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections.

U.S. Food and Drug Administration Accepts Bristol-Myers Squibb's Application for Sprycel (dasatinib) in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration accepted its supplemental Biologics License Application (sBLA) for Sprycel (dasatinib) in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).

Evotec and Celgene Enter Partnership in the Field of Targeted Protein Degradation

BioNJ Member Evotec, with offices in Princeton,announced that Evotec and Summit-based BioNJ Member Celgene Corporation have entered into a third long-term strategic drug discovery and development partnership in the field of targeted protein degradation. In this collaboration, Evotec and Celgene will leverage Evotec's Panomics platform in order to identify drug targets which are traditionally difficult to track. Evotec's Panomics platform applies in particular high-end proteomics and transcriptomics at industrial scale to profile and select promising drug candidates on the basis of comprehensive cell biological profiles.

Evotec and Centogene Sign Global Strategic Partnership on Drug Discovery Projects in Rare Genetic Diseases

BioNJ Member Evotec, with offices in Princeton, announced that CENTOGENE AG, the worldwide leader in elucidating rare disease genetics for patients, clinicians and pharmaceutical partners, and Evotec entered into a global strategic collaboration agreement for joint drug discovery projects, developing compounds to treat rare genetic diseases. Evotec and CENTOGENE initiated the collaboration to develop a strategic high-throughput platform for testing novel small molecules in rare hereditary metabolic diseases.

Evotec and CHDI Foundation Extend Ongoing Collaboration to Fight Huntington's Disease

BioNJ Member Evotec, with offices in Princeton, announced that CHDI Foundation, Inc. has extended its collaboration with Evotec through to 2023. Over this period, CHDI may fund up to 75 full-time scientists at Evotec. The collaboration was initiated in 2006 and has grown considerably over this period to fully utilise Evotec's best-in-class integrated neuroscience platform. The extension of this collaboration is a further validation of Evotec's investment in new technologies and capabilities in support of driving innovative drug discovery collaborations.

ADMA Biologics Reports FDA Compliance Status for its Manufacturing Facility has Improved

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced that the United States Food and Drug Administration inspection database classification website has been updated and confirms ADMA's compliance status has improved to Voluntary Action Indicated. "We are pleased that the FDA has acknowledged the improved current good manufacturing practice ("cGMP") conditions at our manufacturing facility and updated its database accordingly," stated Adam Grossman, President and Chief Executive Officer of ADMA Biologics, Inc.

Ferring and Celmatix Launch Ambitious Genomics Collaboration to Advance Care in Reproductive Medicine and Women's Health

Parsippany-based BioNJ Member Ferring Pharmaceuticals and Celmatix announced an ambitious genomics collaboration aimed at uncovering new insights into ovarian biology and accelerating the development of personalized interventions in reproductive medicine and women's health. This collaboration will leverage both Ferring and Celmatix's significant expertise in women's reproductive health and may unlock insights that could lead to novel interventions with a broader impact on women's health.

Pfizer Receives Breakthrough Therapy Designation from FDA for PF-04965842, an Oral JAK1 Inhibitor, for the Treatment of Patients With Alopecia Areata

BioNJ Member Pfizer, with offices in Madison, announced its investigational oral Janus kinase 3 (JAK3) inhibitor PF-06651600 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face or body. The Breakthrough Therapy designation for alopecia areata was supported by positive results from a Phase 2 study.

Tafamidis Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) Study Results Presented as Late-Breaking Data at the ESC Congress 2018

BioNJ Member Pfizer, with offices in Madison, announced the primary results from the Tafamidis Phase 3 Transthyretin Cardiomyopathy (ATTR-ACT) study, which showed tafamidis significantly reduced the hierarchical combination of both all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period (P=0.0006) in patients with wild-type or variant (hereditary) transthyretin amyloid cardiomyopathy (ATTR-CM).

Novartis Receives European Commission Approval of its CAR-T Cell Therapy, Kymriah®

East Hanover-based BioNJ Member Novartis announced that the European Commission has approved Kymriah® (tisagenlecleucel, formerly CTL019). The approved indications are for the treatment of pediatric and young adult patients up to 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse post-transplant or in second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

European Commission Approves Novartis Combination Therapy Tafinlar® + Mekinist® for Adjuvant Treatment of BRAF V600 Mutation-positive melanoma

East Hanover-based BioNJ Member Novartis announced that the European Commission has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection. This approval is the third for Tafinlar in combination with Mekinist in Europe across a variety of tumor types identified with a high level of BRAF mutation.

Novartis Announces New Data that Show Entresto® (sacubitril/valsartan) can be Initiated Early & Safely in Hospitalized Patients After an Acute Heart Failure Episode

East Hanover-based BioNJ Member Novartis' data from the TRANSITION study has shown that Entresto ® (sacubitril/valsartan) can be initiated early and safely in a wide range of heart failure patients with reduced ejection fraction (HFrEF) who have been stabilized after hospitalization due to an acute heart failure episode. Patients involved in the study included those with no prior experience of Entresto or conventional HF therapies, as well as those with prior experience of conventional HF therapies.

Genmab Announces European Marketing Authorization for DARZALEX® (daratumumab) for Front Line Multiple Myeloma

Princeton-based BioNJ Member Genmab A/S announced that the European Commission has granted marketing authorization for DARZALEX®(daratumumab) in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The EC approval follows a positive opinion issued for DARZALEX by the CHMP of the European Medicines Agency (EMA) in July 2018.

Emisphere's Proprietary Eligen Technology Supports Novo Nordisk's Oral Semaglutide

Plainsboro-based BioNJ Member Novo Nordisk announced the headline results from PIONEER 5, a Phase 3a trial with oral semaglutide in adults with type 2 diabetes and moderate renal impairment. Oral semaglutide is an investigational GLP-1 analogue taken once daily as a tablet. Novo Nordisk's oral semaglutide utilizes Roseland-based Emisphere Technologies , Inc.'s proprietary Eligen® Technology, and is subject to an exclusive license agreement that provides for payments by Novo Nordisk to Emisphere upon the achievement of specified development and sales milestones, in addition to royalty payments.

Amarin's REDUCE-IT™ Clinical Study Now Positioned to be Next Large Cardiovascular Outcomes Study to Report Results

Bedminster-based BioNJ Member Amarin Corporation plc commented that following this week's European Society of Cardiology Congress in Munich, Germany , Amarin's landmark cardiovascular outcomes study, REDUCE-IT™, is now likely to be the next large cardiovascular outcomes study to report results. As previously guided, top-line results from the REDUCE-IT study are expected to be reported before the end of September 2018 .

Cablivi™ Approved in Europe for Adults With Acquired Thrombotic Thrombocytopenic Purpura (aTTP)

The European Commission has granted marketing authorization for Bridgewater-based BioNJ Member Sanofi's Cablivi™ (caplacizumab) for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a rare blood-clotting disorder. Cablivi is the first therapeutic specifically indicated for the treatment of aTTP. Despite the current standard-of-care treatment, consisting of daily plasma exchange (PEX) and immunosuppression, episodes of aTTP are still associated with a mortality rate of up to 20%, with most deaths occurring within 30 days of diagnosis.

ThromboGenics Becomes "Oxurion"

BioNJ Member ThromboGenics NV, with offices in Iselin, announced that all name change resolutions proposed at an Extraordinary General Meeting gained shareholder approval. As a result, ThromboGenics NV will become "Oxurion NV". The company stock ticker symbol will also change from "THR" to "OXUR". The new corporate website will be www.oxurion.com. Patrik De Haes, M.D., CEO of ThromboGenics, said "The new name, Oxurion, is designed to better reflect our ambition to deliver best in class therapies for back of the eye disorders. The renaming comes at a moment when we have delivered important clinical milestones and are accelerating the development of our unique pipeline of disease modifying compounds for diabetic eye disease."

FDA Grants Priority Review to Merck's Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) for the Treatment of Merkel Cell Carcinoma, a Rare Form of Skin Cancer

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) seeking accelerated approval for KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This sBLA is based on data from the Phase 2 KEYNOTE-017 trial including overall response rate (ORR) and duration of response (DOR).

FDA Approves Merck's DELSTRIGO™ (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and PIFELTRO™ (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Appropriate Patients

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration has approved two new HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO™ (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines.

Eisai and Merck Announce China National Medical Products Administration (NMPA) Approval of LENVIMA® (lenvatinib) for Treatment of Unresectable Hepatocellular Carcinoma (HCC)

Kenilworth-based BioNJ Member Merck & Co. and Eisai Co., Ltd. announced that the China National Medical Products Administration (NMPA) approved the kinase inhibitor LENVIMA ® (lenvatinib) as a single agent for the treatment of patients with unresectable hepatocellular carcinoma (HCC) who have not received prior systemic therapy. In China, the application of LENVIMA was submitted in October 2017 and was designated for Priority Review by the NMPA due to LENVIMA's significant clinical benefit compared to existing treatments, leading to approval in approximately 10 months.

Long-Term Cardiovascular Outcomes Data for Anti-Obesity Agent BELVIQ Presented at The European Society of Cardiology and Published in the New England Journal of Medicine

Woodcliff Lake-based Eisai has announced that results from the Cardiovascular Outcomes Trial (CAMELLIA-TIMI 61) in patients treated with lorcaserin hydrochloride were highlighted in an oral presentation at the European Society of Cardiology Congress 2018 held in Munich, Germany, and concurrently published in the New England Journal of Medicine. BELVIQ is the first ever weight loss medication approved for chronic weight management which has been proven to not increase the incidence of major cardiovascular (CV) events in a dedicated long-term cardiovascular outcome trial.

Bayer's Hemophilia A Treatment Gets U.S. FDA Approval

The U.S. Food and Drug Administration approved Whippany-based Bayer AG's long-acting treatment for hemophilia A, a rare genetic disorder in which blood does not clot easily, the company said in a statement. The injection, marketed under the name Jivi has been approved for previously treated patients and adolescents aged 12 years or older and helps replace the reduced or missing protein, factor VIII, required to form blood clots.

Celsion Announces Enrollment Completion for Pivotal Phase III OPTIMA Study of ThermoDox® in Primary Liver Cancer

Lawrenceville-based Celsion Corporation announced that it has reached its enrollment objective of 550 patients in the company's pivotal, Phase III OPTIMA Study, a multinational, randomized, double-blind, placebo-controlled clinical trial of ThermoDox® in combination with radiofrequency ablation (RFA) for the treatment of patients with hepatocellular carcinoma (HCC), also known as primary liver cancer.

Eagle Pharmaceuticals Concludes Enrollment of Second Safety and Efficacy Study at Hajj to Evaluate RYANODEX for Exertional Heat Stroke

Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced completion of enrollment of the company's second clinical study to further evaluate the safety and efficacy of RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke ("EHS"), an investigational new indication for the product. The randomized and double-blinded study was conducted at four Emergency Departments in the Makkah region of Saudi Arabia during the 2018 Hajj Season.

SunGen, GRAM Team Up for Generic Injectibles

Princeton-based specialty pharmaceutical company SunGen Pharma has entered into a manufacturing agreement with Grand River Aseptic Manufacturing for the production of generic injectable pharmaceuticals. According to SunGen Co-CEO Dr. Isaac Liu, the partnership has already filed an injectable manufactured by GRAM with the U.S. Food and Drug Administration, with the anticipation of filing a second by the end of 2019. "SunGen continues to build a strong pipeline by combining our own products and those co-developed with partners around the world," he said in a release.

Aucta Pharmaceuticals Signs Commercial Manufacturing Agreement With Catalent

Somerset-based Catalent Pharma Solutions announced a commercial supply agreement with Aucta Pharmaceuticals Inc.'s vigabatrin. The agreement follows a development program to formulate vigabatrin into a novel dosage that employs Catalent's FlexDose services. Aucta's commercial partner, Upsher-Smith Laboraties LLC, will launch vigabatrin under the brand name Vigadrone.

Celularity to Buy Family Cord Blood Bank CariCord

Warren-based BioNJ Member Celularity announced it has agreed to acquire CariCord , a family cord blood bank. CariCord is the first -- and only so far -- family cord blood bank to operate inside an FDA licensed laboratory. The acquisition, Celularity said, will advance it as an innovator leader through CariCord's relationship with ClinImmune Labs, which operates the University of Chicago Cord Blood Bank, an allogenic cord blood bank supporting stem cell transplants worldwide.

Neurotrope Enters into Collaboration With the Nemours / Alfred I. duPont Hospital for Children to Initiate a Clinical Trial in Fragile X Syndrome

Princeton-based Neurotrope Inc. announced a collaboration with The Nemours / Alfred I. duPont Hospital for Children to initiate a clinical trial in children with Fragile X Syndrome. The planned protocol for the pilot open-label trial will dose Fragile X patients from 8 to less than 18 years of age, using a dosing regimen similar to that being tested in AD patients. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning and social behavior.

Hemispherx Releases Recently Manufactured Ampligen for Pancreatic Cancer Early Access Program in the Netherlands to Fill Stock Order

New Brunswick-based Hemispherx Biopharma, Inc. announced that the new Ampligen batch manufactured earlier this year is now released for patients' use in the pancreatic cancer Early Access Program in the Netherlands pursuant to the terms of our agreement with our EAP provider. This is the initial shipment (500 vials) of a previously announced 2,100 vial standing stock order issued by myTomorrows, our EAP provider in Europe.

Pharma Firm Teligent Celebrates $60M Facility Expansion, Planned Hiring of 100

Gov. Phil Murphy celebrated Teligent's $60 million expansion as another win for his plan to reinvigorate New Jersey's innovative economy. The specialty generic pharmaceutical company increased its facility space on the border of Buena and Buena Vista Township by more than 200 percent (by approximately 75,000 square feet, to 110,000), a move the company said will help it nearly double its employment, to 225.

People in the News

OncoSec Appoints Alain Algazi, MD, as Clinical Strategic Advisor

Pennington-based BioNJ Member OncoSec Medical Incorporated announced an enhancement to the company's medical and clinical leadership with the appointment of Alain Algazi, MD to the position of Clinical Strategic Advisor. A leading expert in melanoma and oncology research, Dr. Algazi will advise OncoSec on its current clinical programs and research initiatives, including the rapidly advancing PISCES/KEYNOTE-695 Phase 2b clinical trial, which is evaluating the use of TAVO (tavokinogene telseplasmid) in combination with KEYTRUDA®(pembrolizumab) for the treatment of metastatic melanoma.

Bristol-Myers Squibb Appoints Christopher Boerner Executive Vice President and Chief Commercial Officer

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that Christopher Boerner, Ph.D., has been appointed Executive Vice President and Chief Commercial Officer, effective immediately. Dr. Boerner will lead commercial strategy and execution across all geographies. He will report to Giovanni Caforio, M.D., Chairman and Chief Executive Officer, and will join the company's Leadership Team. Most recently, Dr. Boerner was head of international markets at Bristol-Myers Squibb, where he was accountable for commercial activities in all ex-U.S. markets.

Anne White Promoted to President of Lilly Oncology

Bridgewater-based BioNJ Member Eli Lilly and Company announced that Anne White has been promoted to Senior Vice President of Lilly and President of Lilly Oncology . She will become a member of Lilly's executive committee, reporting directly to Chairman and Chief Executive Offer, David A. Ricks . Ms. White is currently Vice President of Portfolio Management, Chorus and Next Generation Research & Development . She has more than 25 years of experience in the pharmaceutical industry, serving in leadership roles in oncology, neuroscience, infectious disease drug development and process transformation.

Davies in as VP at Eisai

Woodcliff Lake-based Eisai Inc. has announced the appointment of Stephen Davies as Vice President of Strategic Information Systems. The role finds Mr. Davies leading IT for Eisai's Americas region, serving as a member of the America's Executive Committee and as part of the pharmaceutical company's Global IT Steering Committee. Bringing with him more than two decades' experience in information technology in the life sciences and pharmaceutical field, Mr. Davies comes to the role from Gartner Inc. where he served as Research Director, life sciences for the past four years.

Tris Pharma Announces Hiring of New Vice President of Quality & Compliance

Monmouth Junction-based Tris Pharma, Inc. announced the joining of Jeffery Palmer as its new Vice President and Head of Quality & Compliance. Mr. Palmer has worked for both large and mid-size pharmaceutical companies, and brings more than 20 years of pharmaceutical industry experience -- including his most recent experience as site Head of Quality and his prior experience in Quality Management Systems, Compliance, Process improvement and Scale-up.

Symphogen Elects New Board Members to Support the Company's Long-term Development

Symphogen, with offices in Somerville, announced that Bernhard Ehmer was newly elected as Chairman of the Board of Directors. Mr. Ehmer brings more than 30 years of experience from the global pharmaceutical industry to the company, mainly within oncology. In addition, the following persons were newly elected to Symphogen's Board of Directors: Peter Haahr, CFO of Novo Holdings; Mads Krogsgaard Thomsen, EVP and Chief Science Officer of Novo Nordisk A/S; as well as Søren Lemonius, founding Partner of Sunstone Capital.

BrainStorm Appoints Arturo Araya as Chief Commercial Officer

Hackensack-based BrainStorm Cell Therapeutics announced that is has appointed Arturo O. Araya, M.A., M.B.A., as Chief Commercial Officer, effective immediately. Mr. Araya brings to the BrainStorm team nearly two decades of global pharmaceutical commercialization, marketing, and general management experience, including as Global Head of Commercial of Novartis' Cell and Gene Therapies Unit.

NJBIA Hires Tony Bawidamann as Vice President, Government Affairs

Tony Bawidamann, a seasoned expert in government and regulatory affairs and advocacy, has been named Vice President, Government Affairs for the New Jersey Business & Industry Association. Since 2011, Mr. Bawidamann has served as Director of Government Affairs and Alliance at Bristol-Myers Squibb (BMS), developing and implementing federal and state government affairs campaigns for the global pharmaceutical company.

Institution and Education News

HHS Unveils $1.4M Health Care Training Grants for Rowan, Rutgers

The U.S. Department of Health and Human Services has unveiled $1.4 million in grants for Rowan University and Rutgers University-Camden medical research and job training programs, U.S. Representative Donald Norcross, D-1st District. Rowan will receive $400,000 from the HHS' Health Careers Opportunity program for career training in osteopathic medicine, and $525,436 from the federal department's Primary Care Champions program to train primary care doctors. Rutgers University-Camden will receive $475,905 from the HHS' National Institute of Environmental Health Sciences for its research in toxic dental chemicals.

Rutgers Cancer Institute of New Jersey September 2018 Cancer Connection

Read the latest news on research, treatment, prevention and education from the State's National Cancer Institute-designated Comprehensive Cancer Center in Cancer Connection Monthly.

Clinical Trial Shows Best Outcomes to Date for Older Hodgkin Lymphoma Patients

Rutgers Cancer Institute of New Jersey Investigator Leads Multi-center Collaboration:

Recently published results of a Phase 2 clinical trial have shown the best outcomes to date for newly diagnosed older Hodgkin lymphoma patients treated with brentuximab vedotin given before and after doxorubicin, vinblastine and dacarbazine (AVD) chemotherapy, which is the standard of care. Causes of poor outcomes for older Hodgkin lymphoma patients are not well understood although inability to tolerate full doses of chemotherapy, the existence of co-morbidities, disease biology and other factors have often been attributed.

Data Tools Give Microscopes Unprecedented Views of Living and Physical Systems

Techniques and tools for seeing fleeting arrangements of atoms during chemical reactions are advancing rapidly, allowing unprecedented insights into both physical and living systems, according to experts in microscopy from around the world who gathered for a three-day conference at Princeton. Organized by the Imaging and Analysis Center at Princeton Institute for the Science and Technology of Materials and Nature, the conference, "Frontiers in Electron Microscopy for the Physical and Life Sciences," included more than 30 technical talks and panel discussions on emerging methods and the latest technologies.

NJIT Hires Tech Leader to Head Up Incubation, Commercialization

New Jersey Institute of Technology has added a veteran technology executive as its Vice President of Business Incubation and Executive Director of Commercialization. NJIT said Simon Nynens, former Chairman, CEO and President of Wayside Technology Group , will join the university. In his new role, he will be tasked with developing and expanding programs that spur innovation commercialization services and entrepreneurship, both nationally and around the world.

Funding News

Celsion Strengthens Its Balance Sheet With the Approval of Its Application to Sell Net Operating Losses for Up to $10 Million in Non-Dilutive Funding

Lawrenceville-based Celsion Corporation announced it has received approval from the New Jersey Economic Development Authority's (NJEDA) Technology Business Tax Certificate Transfer (NOL) program to sell the company's unused New Jersey net operating losses (NOLs) and R&D tax credits for the tax years 2011 to 2017. The exact percentage of NOL's to be sold will be determined by the NJEDA after reviewing all qualified applications.

EDA Invests in New Jersey Technology Companies

The New Jersey Economic Development Authority (EDA) is committed to nurturing the development of new technologies and ensuring that the State continues to be a leader in innovation.

Special Programs from Our Partners for BioNJ Members

SBA Office of Advocacy - Regional Regulatory Roundtable

September 11, 2018 | Princeton

Join the Office of Advocacy for a roundtable discussion of federal regulatory issues impacting your small business. Advocacy is also inviting New Jersey Congressional offices and key federal agencies to hear your concerns about federal regulations and other issues you may be facing with your small business. The Princeton roundtable will take place at the Crowne Plaza Princeton on Scudders Mill Road beginning at 8:30 a.m. on September 11.

Biotech Fireside Chat Hosted by NJEDA

September 12, 2018 | CCIT Biotech Incubator

Sponsored by BioNJ

Join the NJEDA on Wednesday, September 12, at 5:30 p.m. at the CCIT Biotech Incubator for this eye-popping talk with Modern Meadow Co-Founder & CEO Andras Forgacs. With over $50MM in funding, Modern Meadow is harnessing the power of design, biology and materials science to create the world's biofabricated materials brand.

TechLaunch BullPen #10

September 17, 2018 | Princeton Innovation Center BioLabs

The TechLaunch BullPen experience is ideal for early stage tech startup companies that have post Tech Accelerator experience, high growth potential, an experienced team, a demonstrated Minimum Viable Product (MVP), at least one potential customer who is prepared to pay for your product, an investment of 6-12 months of sweat equity and seed capital already raised, who are looking to raise $50K to $500K in additional funding, and are coachable. To learn more go to TechLaunch.

The MedTech Conference

September 24-26, 2018 | Philadelphia

The MedTech Conference is the leading North American gathering of global medtech executives. More than 2,700 attendees will network, gain access to capital and share insights in Philadelphia, PA. from September 24-26. The conference features world-class plenary speakers, networking and business development. BioNJ Members receive a 10% discount. Contact RBromberg@BioNJ.org for BioNJ's special discount code. Visit www.themedtechconference.com to learn more about the conference.

Spice Up Your Knowledge of Single-cell Technology and Come Meet the Experts

September 28, 2018 | New York Genome Center

Technologies for single-cell analysis are providing extraordinary novel insights into the complexity of biological systems such as tissue heterogeneity, gene expression dynamics, cellular development and disease progression. With these single-cell technologies, scientists can now analyze single cells instead of cell populations which makes it possible to discover mechanisms that are not detected when studying a bulk population of cells. Organized by VIB (Flemish Interuniversity Institute for Biotechnology) and the Government of Flanders, Belgium,you 'll be introduced to VIB, its research, potential collaboration options and the importance of single-cell technologies to advance life sciences research.

2018 International COPD Conference

November 7, 2018 | Philadelphia Marriott Downtown

Healthcare professionals providing diagnosis, therapy or management to patients with Chronic Obstructive Pulmonary Disease (COPD) are invited to attend the 3rd Annual International COPD Conference, one of the nation's largest continuing education programs for COPD, at the Downtown Marriott, Philadelphia.

The New England Venture Summit

December 12, 2018 | Boston

The 13th annual New England Venture Summit, presented by youngStartup Ventures, is the premier industry gathering connecting venture capitalists, corporate VCs, angel investors, technology transfer professionals, senior executives of venture backed, emerging and early stage companies, university researchers, incubators and premier service providers.