Welcome to the first edition of the  BioLines Weekender  for 2020!  
2019 proved to be an exciting year for the industry with
50% of all new novel FDA drug approvals (48 new molecular entities) coming from companies with a footprint in New Jersey

Join us as we celebrate those companies and honor New Jersey's robust life sciences ecosystem during BioNJ's 27th Annual Dinner Meeting & Innovation Celebration, taking place February 6, 2020 at the Hilton East Brunswick. Bringing together 700 biopharma professionals, you'll enjoy a fun evening of networking -- including a Cocktail Reception, Dinner Program and Dessert Reception -- and award presentations! Be on hand as Dr. Sol Barer presents Chairman of the Board and Chief Executive Officer of Merck & Co. Kenneth C. Frazier with the 2020 Dr. Sol J. Barer AwardClick here for details and to register. The deadline for Early Bird savings is January 6!
Of important note, just prior to the New Year, the New Jersey Commission on Science, Innovation and Technology announced that Judith Sheft will serve as the Executive Director and that the Commission is now accepting applications for the New Jersey SBIR/STTR Support Program. The SBIR program enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. The STTR program funds cooperative R&D partnerships between small businesses and research institutions such as universities, federal R&D centers or non-profits. Click here for details and deadlines. 
Finally, if you aren't a BioNJ Member, contact us today at BioNJ@BioNJ.org to learn about the many benefits of Membership. Please join us in our mission to help our Members help Patients. Thank you and cheers to a happy, healthy 2020. 
Because Patients Can't Wait®,
The BioNJ Team
BioNJ Calendar

WEBINAR: A Demo of BioNJ's Talent Services Career Portal
From the comfort of your own office!
January 14, 2020
2020 Annual Dinner Meeting & Innovation Celebration
Hilton East Brunswick, NJ
February 6, 2020
BioNJ's 10th Annual BioPartnering Conference
Somerset, NJ
Save the date!
May 13, 2020
Putting Patients First: The Value of Medical Innovation

Medical innovation enables longer and better quality lives and, in turn, reduces the costs of health care. Share with our community how your medical innovation is improving lives and impacting health care 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.

For all the flak the pharmaceutical industry has taken for its exorbitant pricing practices, there's no getting around the fact that it's been a pretty stunning decade for medical progress.  Multiple new categories of medicines have moved from dreams and lab benches into the market and people's lives, and investors who came along for the ride often reaped extraordinary profits. The Nasdaq Biotech Index is up 360% over the last 10 years to the S&P 500's 190%. And that's without mentioning the hundreds of billions of dollars in takeovers that rewarded shareholders with windfalls.

For biopharma, 2019 can be described as a terrific year -- with a few asterisks. The financial markets were flourishing, with venture capital dollars, in particular, flowing to the sector, while dealmaking reached historic proportions. Meanwhile, scientific breakthroughs led the way as cell and gene therapies gained ground, the first signs of success emerged with new technologies like CRISPR and the long-awaited promise of genomics found its way to the front lines of health care. Before we start looking ahead to 2020, here's quick look back at some of the top trends and news stories from the biopharma sector for 2019, starting with a decade-busting M&A record.

In recent years, rapid advances in scientific discovery have ushered in a new era of medicine, transforming our ability to treat, and in some cases cure, some of the most challenging diseases, including  cancer rare diseases  and  autoimmune conditions . These advancements are due to the productivity of the United States' biomedical research ecosystem, which is sustained by a  policy framework  that is designed to support and advance America's leadership in the innovation of new medicines. Central to the success of this ecosystem is the leadership that comes from America's biopharmaceutical research companies.

When a process works, it's natural to try to repeat it rather than recreate or rethink it. This holds true in running clinical trials to develop new drugs: the main path to FDA drug approval is often the same path that led to the prior drug's approval.  For decades, the foundational basis for determining if a drug should be approved is whether its benefits outweigh its known and potential risks for the intended population. At its core, this is a quantitative risk-benefit analysis. It is not a patient-centric evaluation and it does not emphasize individual patient quality of life as a significant factor.

For many of the 54 million Americans who live with a rheumatic disease, simple tasks such as walking up a flight of stairs can be painful and challenging endeavors. To manage disease symptoms and help make activities of daily living safer and easier, patients often turn to rheumatologists, who can prescribe treatments that provide relief. But despite my years of intensive study and clinical expertise, the ability to diagnose and treat patients quickly is too often hindered by insurance utilization practices such as step therapy that are geared more toward having policyholders use medications on negotiated formularies than providing evidence-based care. 

BioNJ in the News

NJ Company News

Madison-based BioNJ Member  Allergan plc  announced that the  U.S. Food and Drug Administration  has approved a New Drug Application (NDA) for UBRELVY™ (ubrogepant) for the acute treatment of migraine with or without aura in adults. UBRELVY™ is the first and only orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the treatment of migraine attacks once they startIn clinical trials supporting the  FDA's  approval, UBRELVY™ provided quick pain relief for the majority of migraine patients. UBRELVY™ also met co-primary endpoints of freedom from pain and freedom from the most bothersome symptom (nausea, hypersensitivity to light, or hypersensitivity to sound), a recent, more stringent standard of efficacy the  FDA  set in 2018. 

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Patients will be selected for therapy based on an FDA approved companion diagnostic for LYNPARZA.

Morris Plains-based BioNJ Member Immunomedics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the company's Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020. Sacituzumab govitecan has been awarded both Fast Track Designation and Breakthrough Therapy Designation by the FDA.

Bedminster-based BioNJ Member Kyowa Kirin Co., Ltd. announced that it has received the partial change approval for ORKEDIA® for the treatment of hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy from the Ministry of Health, Labor and Welfare (MHLW) in Japan. The approval is based on the result of the Phase 3 clinical trial that evaluates the efficacy of ORKEDIA for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

Pennington-based BioNJ Member OncoSec Medical Incorporated announced the release of a detailed presentation highlighting the company's strategic rationale -- and benefits for shareholders -- of the proposed transaction with Grand Decade Developments Limited, a wholly owned subsidiary of China Grand Pharmaceutical and Healthcare Holdings Limited ("CGP") and its U.S. affiliate, Sirtex Medical U.S. Holdings, Inc. ("Sirtex") (the "Transaction").

Princeton-based BioNJ-Member  Genmab A/S and CureVac AG announced that Genmab and CureVac have entered into a research collaboration and license agreement. This strategic partnership will focus on the research and development of differentiated mRNA-based antibody products by combining CureVac's mRNA technology and know-how with Genmab's proprietary antibody technologies and expertise. Under the terms of the agreement Genmab will provide CureVac with a USD 10 million upfront payment. Genmab will also make a 20 million euro equity investment in CureVac.

Princeton-based BioNJ Member Bristol-Myers Squibb Company announced that the European Commission (EC) has approved a new indication for Revlimid  (lenalidomide), in combination with rituximab (anti-CD20 antibody), for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). This combination of Revlimid  and rituximab (R2 ) is the first chemotherapy-free combination regimen approved for patients with FL by the EC. FL is a subtype of indolent, but incurable, non-Hodgkin lymphoma (NHL) which is associated with immune system dysfunction.

U.S. health care giant New Brunswick-based  BioNJ Member Johnson & Johnson announced the acquisition of TARIS Biomedical, a privately-owned U.S. biotechnology company specializing in the development of a novel drug delivery technology for the treatment of bladder diseases including cancer.  The company's lead clinical-stage product, TAR-200, uses the proprietary TARIS System, which features a silicone-based drug delivery device that allows for the continuous release of medication into the bladder.

New Brunswick-based BioNJ Member Johnson & Johnson said it will acquire the remaining stake in Verb Surgical Inc., a device and robotics company it formed four years ago in collaboration with Verily, an Alphabet company.  The transaction is expected to close in the first half of 2020, subject to antitrust clearance and customary closing conditions.  In a statement, J&J said Verb Surgical's robotics and data science capabilities combined with the buyer's health care business and global reach would help make medical interventions smarter, less invasive and more personalized.

Princeton-based  Polaryx Therapeutics Inc announced that the company has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration for the treatment of patients with LINCL. Neuronal Ceroid Lipofuscinoses are a group of autosomal recessive neurodegenerative lysosomal storage disorders. Among them, LINCL is caused by gene mutations in cln2 leading deficiency/loss of tripeptidyl peptidase 1 (TPP1) enzyme function, which is pivotal for degrading peptides. Subsequent intracellular accumulation of abnormal auto-fluorescent lipoproteins results in deterioration of neurons in the brain. Such accumulations also occur in other organs and can lead to loss of organ function, such as the retina. 

Basking Ridge-based  Daiichi Sankyo and AstraZeneca announced that the U.S. Food and Drug Administration has approved ENHERTU® (fam-trastuzumab deruxtecan-nxki), a HER2 directed antibody drug conjugate (ADC), for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Bedminster-based A erie Pharmaceuticals, Inc.  announced that the European Medicines Agency (EMA) has accepted for review the marketing authorisation application (MAA) for Roclanda® (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%. Roclanda® is currently marketed as Rocklatan® in the United States , where it is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. An opinion from the EMA's Committee for Medicinal Products for Human Use on the MAA for Roclanda® is expected in late 2020. 

Bridgewater-based Amarin Corporation plc is pleased to announce that Health Canada has approved the use of VASCEPA® (icosapent ethyl) to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor . This is the first and only approval by Health Canada of any drug for this important indication. 

Ewing-based  Jazz Pharmaceuticals plc  announced that the first patient has been enrolled in the pivotal Phase 2/3 clinical study for JZP-458, a recombinant Erwinia asparaginase molecule that uses a novel Pseudomonas fluorescens expression platform. The study, conducted in collaboration with the  Children's Oncology Group (COG), is evaluating JZP-458 as a potential treatment for pediatric and adult patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) who are hypersensitive toE. coli-derived asparaginases.

Ridgefield Park-based  BeiGene, Ltd.  announced that the National Medical Products Administration (NMPA) in China has approved its PD-1 inhibitor tislelizumab for the treatment of patients with classical Hodgkin's lymphoma (cHL) who received at least two prior therapies. Following this nod, tislelizumab became BeiGene's first drug to be approved in the country. The recommended approved dose of tislelizumab is 200 mg, which is to be administered intravenously every three weeks, until disease progression or intolerable toxicity.

Piscataway-based  Novadoz Pharmaceuticals  has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets. The product is AB rated to the brand Uloric©, marketed by Takeda Pharmaceuticals America, Inc. The company has commenced shipping of the product that is available in bottles of 30 tablets. Febuxostat brand and generic sales are trending over $430MIL over the previous 12 months according to recent published sales data. 

Woodcliff Lake-based Eisai Co., Ltd. and Gilead Sciences, Inc.  announced that they entered into an agreement for the distribution and co-promotion of filgotinib, an investigational, oral, selective JAK1 inhibitor, in Japan, pending regulatory approval for the treatment of rheumatoid arthritis (RA). Through this collaboration, Gilead Japan will retain responsibility for manufacturing and marketing approval of filgotinib, while Eisai will be responsible for product distribution in Japan in RA and other potential future indications. The companies will jointly commercialize the medicine if approved.

The 2019  NJBIZ Reader Rankings feature more than 60 categories, recognizing leaders across a range of industries -- from banking to education, employment, pharmaceuticals, hospitality, philanthropy, real estate and more. Among the winners throughout the year were BioNJ Members. Congrats to them one and all.
  • ChooseNJ
  • Cushman & Wakefield
  • ExecuSearch
  • EY
  • Hackensack Meridian
  • Johnson & Johnson
  • Jones Lang Lasalle
  • Langan
  • NJIT
  • Princeton Legal Search
  • Princeton Public Affairs Group
  • Rutgers University
  • Withum

People in the News

The New Jersey Commission on Science, Innovation and Technology (CSIT) has named Judith A. Sheft as its Executive Director. Ms. Sheft, who has an extensive background in fostering opportunities for early-stage New Jersey companies and for the next generation of New Jersey entrepreneurs, will officially take the helm of the CSIT beginning Jan. 13, 2020. Ms. Sheft brings nearly two decades of expertise in New Jersey's innovation ecosystem to her new position. She spent the past 18 years as an associate vice president at NJIT. 

Princeton-based BioNJ-Member A gile Therapeutics, Inc.  announced the appointment of  Kimberly Whelan  as Vice President of Market Access. Ms. Whelan has over 35 years of experience in the health care industry working in finance, sales, marketing, business development and managed markets.  Ms. Whelan is responsible for overseeing the development and execution of Agile's market access strategy in preparation for the potential commercialization of the company's lead product candidate, Twirla ®  (AG200-15), which has a PDUFA goal date of  February 16, 2020 .

Princeton-based  Bioclinica announces that  David Herron , Bioclinica's President and Chief Executive Officer, will be leaving the company to pursue other business interests.  Euan Menzies , the Chairman of Bioclinica's Board of Directors, will assume the role of Executive Chairman and interim Chief Executive Officer. To ensure a seamless transition of leadership responsibilities, Mr. Herron will remain with the Company in an advisory capacity until the end of January 2020.

Institution and Education News

Rutgers Cancer Institute gynecologic oncologist Ruth Stephenson, DO, FACOG, discusses prevention, early detection and treatment of cervical cancer during this Cervical Cancer Awareness Month. Click here to watch the video.

Hackensack Meridian  Health has received an award from the Centers for Medicare and Medicaid Services (CMS) in the amount of $15.8 million to be distributed over seven years to establish the New Jersey Integrated Care for Kids (InCK) Model.  An Alternative Payment Model (APM) will be tested for the Medicaid program supporting multi-sectoral integrated case management and pediatric practice capacity-building in Monmouth and Ocean Counties. Hackensack Meridian  Health  is the administrative lead organization and is partnering with co-lead organizations, the VNA of Central Jersey (VNA), the New Jersey Medicaid Agency and the New Jersey Health Care Quality Institute (Quality Institute) on this initiative.

Hackensack Meridian Health Hackensack University Medical Center announced it is the first hospital in New Jersey to implement Intuitive Surgical's  Ion, a cutting-edge, robotic-assisted technology that will enhance the care of patients with lung abnormalities, detect lung cancer earlier and improve outcomes.  Ion's robotic-assisted platform allows for a minimally invasive biopsy of the lung.  The system's precision and flexibility enable optimal lung navigation and produce more accurate biopsies. Ion will be used for lung cancer screening and early diagnosis by providing more access to small airways or hard-to-reach nodules that other technologies are unable to achieve, as well as for patients who are not surgical candidates but need biopsies to treat cancers.

Five RWJBarnabas Health facilities were each awarded a $10,000 grant from The Allergan Foundation for a total of $50,000. C lara Maass Medical Center in Belleville, Robert Wood Johnson University Hospital (RWJUH) New Brunswick, RWJUH Somerset in Somerville, RWJUH Rahway and Monmouth Medical Center in Long Branch each received a grant for community benefit programs. Clara Maass Medical Center received the Allergan grant for the Center of Excellence for Latino Health (CELH) program. The program serves as a hub of health and wellness information for Latino families and is focused on addressing the unmet needs of the local Latino community.

Funding News

Special Programs from Our Partners for BioNJ Members

January 14, 2020 | Allentown High School

Showcase your college/university, technical program, military service branch and more! Set up a table or demonstration!  This year's event will be held during the school day to enable all students to explore the variety of careers offered to them within Science, Technology, Engineering & Math (STEM).  Please RSVP to Dale Cruzan at cruzand@ufrsd.net or 609-259-7292 ext. 1443 by December 16, 2019. 

Jun 8-11, 2020 | San Diego

The BIO International Convention is hosted by the  Biotechnology Innovation Organization  (BIO). BIO 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. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. The BIO International Convention offers a range of opportunities to increase your brand exposure and connect with a global audience of 17,000+ attendees from 65+ countries. 

BioNJ Member Services Provider Directory

BioNJ recognizes the vital role that our Service Provider Members play in the growth of New Jersey's robust life sciences ecosystem. For this reason, we are delighted to remind our community about BioNJ's Member Service Provider Directory, a categorical listing of BioNJ Members by service sector. By working with fellow BioNJ Member organizations, you are not only supporting our community, but benefiting from a wide variety of high quality organizations.  To learn how you can become a Member and be featured on this resource tool, please contact Kim Minton at KMinton@BioNJ.org, or 609-890-3185. Find providers in these categories:

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 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.

Please contact BioNJ at BioNJ@BioNJ.org or call 609-890-3185 
with any questions.