Welcome to the latest edition of the  BioLines  Weekender. 

With great enthusiasm we opened registration this week for BioNJ's 26th Annual Dinner Meeting and Innovation Celebration taking place February 7, 2019 at the Hilton East Brunswick. Plan to j oin us as we celebrate the innovation coming  from New Jersey's life sciences community, including the presentation of the Dr. Sol J. Barer Award to Global Head of Johnson & Johnson, External Innovation Dr. William N. Hait by Dr. Sol Barer himself.  Register by December 27 and save.     

Next up, BioNJ will host our Fourth Annual Inspiring Women in STEM Conference on Friday, December  7, at Sanofi and our  Third Annual Patient Advocacy Summit on Thursday, December 13 at Celgene. We hope to see you at one of our end of year events!

Meanwhile, here's a look at some of the other exciting activities that have kept us running. We...
  • Submitted comments to HRSA on 340B Civil Monetary Penalties and Penny Pricing Regulation
  • Announced BioNJ's Second Entrepreneurship Fellowship Program
  • Attended a BIO 2019 briefing for the Philadelphia Consulate Corps 
  • Met with the Luxembourg Trade & Investment Office
  • Attended the Council on State Biotech Associations Meeting in Austin, TX
  • Gave a New Jersey Life Sciences Ecosystem Update at the JP Morgan Private Banking Team Meeting
  • Held a "Future Member Webinar: Why Membership Matters" (click here to view)
Finally, if you aren't a BioNJ Member, contact us today at BioNJ@BioNJ.org to learn about the many benefits of Membership. Thank you. 

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

Inspiring Women in STEM Conference
Sanofi , Bridgewater, NJ

December 7, 2018
BioNJ's Patient Advocacy Summit
Celgene Corporation, 181 Passaic Ave, Summit, NJ

December 13, 2018
BioNJ's Annual Dinner Meeting & Innovation Celebration
Hilton East Brunswick, East Brunswick, NJ

February 7, 2019

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.

Summit-based BioNJ Member Celgene Corporation announced the selection of PhageNova Bio, Inc. as the first client in the Thomas O. Daniel Research Incubator and Collaboration Center. The center was first announced earlier this year and offers state-of-the-art lab space, resources and support for promising scientists and companies with potentially transformational approaches to accelerate medical discoveries and innovations. PhageNova Bio, Inc. is an early stage biotechnology company developing a unique approach to systemically administered targeted gene delivery. 

Summit-based BioNJ Member Celgene and Lyfebulb, a chronic disease-focused, patient-empowerment platform that connects patients with industry and investors to support user-driven innovation, announced it is joining forces to launch Addressing Unmet Needs in MS: An Innovation Challenge, to seek new solutions aimed at addressing the daily challenges associated with multiple sclerosis (MS). The Innovation Challenge will take place in May 2019 and will be open to patient entrepreneurs -- those who have been affected by MS as either a patient, loved one or support partner -- whose companies are helping develop solutions to address an unmet need in multiple sclerosis. 

Lung cancer remains the leading cause of cancer-related death in both men and women in the United States. And for America's veterans, that risk is even higher as they are 25 percent more likely to be diagnosed with lung cancer than those who did not serve in the military.  Laurie Fenton Ambrose, President and CEO of  Lung Cancer Alliance , explains how early detection and the  treatment of lung cancer  is evolving and benefiting the veteran community, and what still needs to be done to improve the care for the men and women who have served our country.

Over the past year, doctors have seen promising results from studies investigating new treatment approaches using chemotherapy for patients with  pancreatic cancer , a disease that remains among the deadliest of cancers. Yet 38 percent of pancreatic cancer patients received no treatment at all within one year of diagnosis, according to study findings. "Those results are not surprising as therapy for pancreatic cancer is rarely curative," said Gabriela Chiorean, M.D., a gastrointestinal oncologist and researcher at the University of Washington. "Most pancreatic cancers are diagnosed at a stage where the goal is to prolong survival-not to cure the disease."

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.

BioNJ Member Pfizer Inc., with offices in Madison, announced that the U.S. Food and Drug Administration (FDA) approved DAURISMO™ (glasdegib), a once-daily oral medicine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is taken in combination with low-dose cytarabine (LDAC), a type of chemotherapy. DAURISMO has not been studied in patients with severe renal impairment or moderate-to-severe hepatic impairment.

BioNJ Member Pfizer Inc., with offices in Madison, announced that the U.S. Food and Drug Administration (FDA) has granted pediatric exclusivity for LYRICA®. This grant extends the period of U.S. market exclusivity for LYRICA by an additional six months, to June 30, 2019. LYRICA is currently approved in the U.S. for fibromyalgia, diabetic nerve pain, spinal cord injury nerve pain and pain after shingles in adults. LYRICA is also approved as adjunctive therapy for the treatment of partial onset seizures in patients four years of age and older.

East Hanover -based BioNJ Member  Novartis announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Promacta® (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard immunosuppressive therapy (IST). Promacta, which is marketed as Revolade® in most countries outside the U.S., is an oral thrombopoietin receptor agonist (TPO-RA) that is already approved for SAA for patients who have had an insufficient response to IST. 

East Hanover-based BioNJ Member Novartis announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending an expanded indication for Kisqali® (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent, superior and sustained efficacy compared to endocrine therapy alone. CHMP recommended Kisqali for the treatment of women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy and in women who have received prior endocrine therapy.

Plainsboro-based BioNJ Member Novo Nordisk announced the headline results from PIONEER 9, a 52-week trial with oral semaglutide vs. Victoza® (0.9 mg liraglutide) and vs. placebo, all as monotherapy, in Japanese adults with type 2 diabetes. Oral semaglutide is an investigational GLP-1 taken once daily as a tablet. PIONEER 9 was a phase 3a safety and efficacy trial investigating 3, 7 and 14 mg oral semaglutide compared with Victoza® and with placebo in 243 Japanese adults with type 2 diabetes.

Plainsboro-based BioNJ Member Novo Nordisk announced the headline results from the last global Phase 3a trial, PIONEER 6, for oral semaglutide, an investigational GLP-1 analogue taken once daily as a tablet. This double-blinded trial investigated the cardiovascular safety of oral semaglutide 14 mg compared with placebo, both in addition to standard of care, in 3,183 adults with type 2 diabetes at high risk of cardiovascular events.

Princeton-based BioNJ Member   Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of the Opdivo (nivolumab) plus low- dose Yervoy (ipilimumab) combination to include first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC). 

Titusville-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. 

Bridgewater-based BioNJ Member  Allergan  announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam), seeking to expand the label to include the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), in combination with metronidazole, in pediatric patients 3 months to less than 18 years of age.

BioNJ Member Edge Therapeutics and  PDS Biotechnology announced they are planning to merge.  The merger between Berkeley Heights-based Edge Therapeutics Inc. and North Brunswick-based PDS Biotechnology Corp. will create a new clinical-stage cancer immunotherapy company. Under terms of the deal, all of PDS's outstanding shares of common stock will be converted into Edge's common stock. Immediately following the completed merger, former PDS security holders will own 70 percent of the combined company and existing Edge security holders will own 30 percent.

 A new Expert Consensus Decision Pathway issued by the  American College of Cardiology  (ACC) recommends Jardiance® (empagliflozin) -- marketed by Bridgewater-based BioNJ Member Eli Lilly and Company and Boehringer Ingelheim -- as the preferred SGLT2 inhibitor for its proven benefit in reducing the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. The recommendation is part of the ACC's first Expert Consensus Decision Pathway on novel therapies for cardiovascular risk reduction in adults with type 2 diabetes and atherosclerotic cardiovascular disease. 

The 2018 NJBIZ Reader Ranking Awards have been announced. Congratulations to the winning BioNJ Members, including Advance Realty Group, American Cancer Society, CBRE, Choose New Jersey, Cushman & Wakefield of NJ, Ernst Young, Hackensack University Medical Center, Johnson & Johnson, JP Morgan, Merck & Co., New Jersey Economic Development Authority,  New Jersey Institute of Technology (NJIT)
PNC Bank,  Princeton University,  Princeton Public Affairs Group,  Rutgers and WithumSmith & Brown, P.C.

BrainStorm Cell Therapeutics Inc., with offices in  Hackensack,  announced that it has submitted an Investigational New Drug (IND) application with the  U.S. Food and Drug Administration  ( FDA ) to initiate a Phase 2 study of NurOwn ®  in patients with progressive multiple sclerosis (MS). "This important step toward the development of NurOwn® in progressive MS confirms our commitment to bring to the market innovative cellular therapies for neurodegenerative disease," said Chaim Lebovits , President and CEO of BrainStorm. 

Jersey City-based Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced that Mitsubishi Tanabe Pharma group companies will present pharmacokinetic (PK) data on an investigational oral suspension formulation of edaravone for the treatment of amyotrophic lateral sclerosis (ALS) at the 29th International Symposium on ALS/MND. The Phase 1 study showed oral edaravone is expected to have similar PK parameters to the current intravenous infusion.

Boehringer Ingelheim, with offices in North Brunswick, and Epizyme, Inc. announced a new global collaboration focused on the research, development and commercialization of novel small molecule inhibitors directed toward two previously unaddressed epigenetic targets as potential therapies for people with cancer. Specifically, these targets are enzymes within the helicase and histone acetyltransferase (HAT) families that when dysregulated have been linked to the development of cancers that currently lack therapeutic options. 

BeiGene, Ltd., with offices in Ridgefield Park, announced that Center for Drug Evaluation of China's National Medical Product Administration (NMPA, formerly known as CFDA) has granted priority review status to the New Drug Applications (NDAs) for the company's investigational BTK inhibitor zanubrutinib in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and for its investigational anti-PD-1 antibody tislelizumab in patients with R/R classical Hodgkin's lymphoma (cHL).

BeiGene, Ltd., with offices in Ridgefield Park, announced the presentation of preliminary clinical data from an ongoing Phase 1/2 trial of its investigational PARP inhibitor, pamiparib, in combination with radiation therapy (RT) and/or temozolomide (TMZ) in patients with newly diagnosed or recurrent/refractory (R/R) glioblastoma multiforme (GBM). Discovered by  BeiGene  scientists in  Beijing , pamiparib is currently in Phase 3 trials globally and in  China  as a monotherapy and in Phase 1/2 trials in combination with chemotherapy or immunotherapy for a variety of solid tumors.

BeiGene, Ltd., with offices in Ridgefield Park, and Zymeworks Inc. announced that the two companies have entered into a strategic collaboration for the clinical development and commercialization of Zymeworks' investigational ZW25 and ZW49 HER2-targeted bispecific antibodies. In addition, Zymeworks granted BeiGene a license to Zymeworks' proprietary Azymetric™ and EFECT™ platforms to develop and commercialize globally up to three other bispecific antibodies using the platforms.

Franklin Lakes-based  BD (Becton, Dickinson and Company) announced the U.S. Food and Drug Administration 510(k) clearance of the BD Phoenix  CPO detect test, which will allow hospitals to identify infections caused by carbapenemase-producing organisms (CPOs). The test may help hospitals contain the spread of antimicrobial resistance (AMR) by shortening the time it takes to detect CPOs, thereby enabling the earlier implementation of infection control procedures and the initiation of appropriate antibiotic therapies designed for treating these infections.

Eatontown-based  Eagle Pharmaceuticals, Inc. announced positive results of a proof-of-concept (POC) study in a Total-Body Radiation Animal Model. The objective of the study was to evaluate the efficacy of intravenous administration of RYANODEX® to prevent or mitigate Acute Radiation Syndrome (ARS) in a total body irradiated C57BL/6 male mouse hematopoietic model.

Eatontown-based  Hikma Pharmaceuticals PLC announced a five-year licensing and supply agreement with Hansoh Pharmaceutical Group Co., Ltd., one of the few research and development-driven Chinese pharmaceutical companies with leading franchises in multiple large and fast-growing therapeutic areas. The agreement provides Hikma with exclusive rights to market a suite of Hansoh's injectable oncology medicines within the US for the next five years. Hansoh expects to file these products for approval with the FDA within the next 12 months. 

Woodcliff Lake-based  Eisai Co., Ltd. announced that based on topline results, the primary efficacy endpoint was met in a Phase III clinical study (Study 342) conducted for submission in Japan, which evaluated its in-house discovered antiepileptic drug (AED) Fycompa ® (perampanel) as monotherapy for partial-onset seizures. Based on the results of this study, Eisai plans to file an application seeking approval of Fycompa as monotherapy for partial onset seizures in Japan during fiscal 2018.

Takeda Pharmaceutical Company Limited, with offices in East Windsor,  announced that the European Commission (EC) granted marketing authorization for ALUNBRIG (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 20, 2018.

Cherry Hill-based  Adaptive Clinical Systems , a provider of cloud-based services that provides interoperability and data integration, has partnered with  Medidata , an eClinical software service company that develops solutions for research collaboration in clinical trials.  Adaptive Clinical Systems helps pharmaceutical and biotechnology companies, hospitals and academic research centers with integration of clinical study data from multiple systems and platforms.

Oldwick-based Provention Bio, Inc. announced that the company has joined the Critical Path Institute's Type 1 Diabetes (T1D) Consortium. Founded in March 2017 by the Critical Path Institute (C-Path), C-Path's T1D Consortium is focused on understanding the scientific and regulatory expectations associated with the application of biomarkers used to optimize clinical trial designs in this disease. Currently, the T1D Consortium is actively engaged in the regulatory qualification of islet autoantibodies as susceptibility/risk biomarkers to be used as enrichment criteria in the development of therapies for the treatment, and ultimately the prevention, of T1D.

East Rutherford-based Cambrex Corp., a life sciences company that provides products and services for small molecule therapeutics and generic active pharmaceutical ingredients, entered into a definitive agreement to acquire Avista Pharma Solutions, a contract development, manufacturing and testing organization, for about $252 million.  In a statement, Cambrex said that with the acquisition, Cambrex will enter the large and growing market for early stage small-molecule development and testing services.

Bridgewater-based Valeritas Holdings Inc. announced a pricing of $36 million for its underwritten public offering, expected to close Nov. 20, subject to customary conditions.  At a public offering price of $0.48 per share, the offering includes 75 million shares of its common stock; series A warrants for 75 million shares of common stock with an exercise price of $0.60 per share, immediately exercisable and set to expire on the fifth anniversary of the date of issuance; and series B warrants to purchase 75 million shares of common stock, with an exercise price of $0.48 per share, also immediately exercisable, and set to expire on the nine-month anniversary of issuance.

CarePoint Health , based in Jersey City, and digital health startup  Onduo  have agreed to develop a partnership designed to bring a diabetes management system to the health system's patients.  Onduo is a virtual diabetes program that provides tools, coaching and access to specialty doctors.

People in the News

Foamix Pharmaceuticals Ltd., an Israel-based clinical stage specialty pharmaceutical company with its U.S. headquarters in Bridgewater, announced it has appointed Matt Wiley its new Chief Commercial Officer.  In this newly-created role, Mr. Wiley will be responsible for developing and executing commercial strategies for the company's product portfolio of dermatological topical foams.

Institution and Education News

The Coriell Institute for Medical Research, Cooper University Health Care and Cooper Medical School of Rowan University (CMSRU) are launching the Camden Opioid Research Initiative (CORI), a first-of-its-kind undertaking to investigate the genetic and biological factors that contribute to the development of opioid use disorder. CORI will capitalize on Coriell's expertise in genomics, biobanking and personalized medicine, Cooper University Health Care's clinical infrastructure and expertise in treating opioid use disorder (OUD) patients, and Cooper Medical School of Rowan University's reputation for scientific excellence in genetics, the neurosciences and addiction research.

Princeton University has teamed up with Microsoft to collaborate on the leading edge of microbiology and computational modelling research.  In this project, Microsoft is helping Princeton to better understand the mechanisms of biofilm formation by providing advanced technology that will greatly extend the type of research analysis capable today. Biofilms -- surface-associated communities of bacteria -- are the leading cause of microbial infection worldwide and kill as many people as cancer does. They are also a leading cause of antibiotic resistance, a problem highlighted by the World Health Organization as "a global crisis that we cannot ignore." 

The Princeton Catalysis Initiative's (PCI) first industrial partnership, a 10-year, $6 million commitment from BioNJ Member Celgene was signed Nov. 1. "PCI will be an academic incubator for new fields of research that will have significant benefit for society," said David MacMillan, the James S. McDonnell Distinguished University Professor of Chemistry and Director of PCI. "Princeton is uniquely positioned to be the leader in this movement, and in collaboration with Celgene we expect to make discoveries that will significantly impact human health over the next 10 years and beyond."

Gov. Phil Murphy unveiled a new program for three of New Jersey's urban high schools aimed at preparing the State's students for careers in science and technology. Speaking at the Panther Academy in Paterson, Gov. Murphy unveiled the Pathway in Technology Early College High School (P-TECH) program where a student, upon completion, will graduate with both a high school diploma and associate degree.

A five-year, $2,074,932 grant from the  National Cancer Institute was awarded to Sharon Manne,  Rutgers Cancer Institute of New Jersey's Associate Director for Cancer Prevention, control and population research.  The grant will support the expansion of behavioral intervention delivered through social media, via Facebook. The aim is to improve skin exams and sun protective behaviors among young melanoma survivors and their families.

Hackensack Meridian  Health  has named Joseph Underwood, M.D. as Chair of Emergency Medicine at Hackensack University Medical Center. "A strategic and innovative leader, Underwood will help to further our mission to transform health care and serve as a leader of positive change," said Mark D. Sparta, FACHE, President, Hackensack University Medical Center, Executive Vice President, Population Health, Hackensack Meridian Health. "Our caring community will be enriched by his skilled and dedicated approach to patient care."

Four schools from New Jersey made the list: Seton Hall (No. 41), Rutgers-Newark (No. 38), Stevens Institute of Technology (No. 12) and New Jersey Institute of Technology (No. 9).
The previously unheralded Missouri University of Science & Technology in Rolla, Missouri, took the top spot.

Funding News

The New Jersey Economic Development Authority (NJEDA) is now accepting applications for a new round of funding for municipalities and counties to develop plans to build or augment their local innovation ecosystems. This second round of the Innovation Challenge follows an impressive response to round one of the Challenge, under which nine New Jersey communities were each awarded $100,000 to advance their planning projects in partnership with higher education institutions and other strategic partners. 

The NJBAC is a state agency offering free and confidential assistance to help your business grow. As a "one-stop shop," NJBAC can help businesses of all sizes and types to manage the state's regulatory processes, boost exports, gain access to financial resources where applicable and tackle other obstacles along the way. You can download the NJBAC guide by clicking here or contact their business advocates at 1-800 JERSEY 7. 
Special Programs from Our Partners for BioNJ Members

December 12, 2018 | Boston

The 13th annual New England Venture Summit, presented by youngStartup Ventures, is an 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. 

January 18-20, 2019 | The College of New Jersey

The College of New Jersey will be hosting the Conference for Undergraduate Women in Physics for the Mid-Atlantic states on January 18-20, 2019. The goal of the conference is to inspire, empower, and enable young women scientists to pursue their career aspirations by equipping them with the skills and resources needed to achieve success in physics. The conference will host 200 undergraduate students and 50 high school students, and it will feature lectures by prominent women physicists, student research presentations, a networking fair featuring graduate schools, industries, and nonprofits, and workshops and panel discussions on professional development. For more information, please visit http://cuwip.tcnj.edu. If you would like to get involved, please contact us at cuwip@tcnj.edu.  

June 3-6, 2019 | Philadelphia Convention Center

The BIO International Convention is hosted by the Biotechnology Innovation Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. The key benefits of attending the 2019 BIO International Convention are access to global biotech and pharma leaders via BIO One-on-One Partnering, exposure to industry thought-leaders with over 500 education sessions at your fingertips and unparalleled networking opportunities with 16,000+ attendees from 67 countries. 

BIO is offering BioNJ Members the opportunity to lock in a significant discount on two premier registration packages for the 2019 BIO International Convention and Convention Access & Partnering. Click here for details.