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:
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 [email protected].

Because Patients Can't Wait®,
The BioNJ Team
BioNJ Calendar

BioNJ's Manufacturing Briefing
Rutgers University, Piscataway, NJ

September 21, 2018
Beyond Value Frameworks: Defining the Value of Medical Innovation Workshop
Amicus Therapeutics, Cranbury, NJ

October 11, 2018
BioNJ's C-Suite Summit
Bridgewater Marriott, Bridgewater, NJ

October 25, 2018
BioNJ's Patient Advocacy Summit
Celgene Corporation, 179 Passaic Ave, Summit, NJ

December 13, 2018

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 [email protected]. Plus, click here for valuable tools and resources on the Value of Medical Innovation.



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! 



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. 



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



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!



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:



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.


 
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. 




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. 


 
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. 








 
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). 











 
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.




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.



 
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.


 
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."





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. 



 
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.


 
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.



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.



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.


 
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.


 
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.


 
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.   


 
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.



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





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. 



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.



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.




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. 



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



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.



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.



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. 



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.



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


 
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.



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


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.


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. 


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.


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 [email protected] for BioNJ's special discount code. Visit www.themedtechconference.com to learn more about the conference.


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.


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.


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.