Welcome to the latest edition of the  BioLines Weekender

Thank you to everyone who joined us last week at BIO 2019 in Philadelphia. New Jersey's delegation of more than 75 participants -- led by BioNJ, Choose New Jersey and the New Jersey Economic Development Authority -- featured representatives from New Jersey's full life sciences ecosystem. Our pavilion showcased New Jersey and all that it offers to this industry and it was a beehive of activity throughout the conference with meetings of prospects interested in locating in New Jersey, potential partners for our academic institutions and hundreds of members of BioNJ who stopped in to say hello! It was an extraordinary time! Click here for photos.

From bus tours of some of the Garden State's world-renowned research institutions to a Meet and Greet with 10-year old Patient Advocate Max Schill, boardwalk fare during a regional reception with our colleagues at DelawareBIO and PA Life Sciences and the presentation of BIO's 2019 Governor of the Year Award to Governor Phil Murphy, the great state of New Jersey was in the spotlight throughout the conference which brought together over 17,000 attendees from around the world.

To add to the excitement, on Wednesday, BioNJ released a white paper, entitled "A Framework for Demonstrating the Value of Medical Innovation." Authored by Shailja Dixit, M.D., M.S., M.P.H., President & Founder, ApexBio, and Robert Goldberg, Ph.D., Vice President & Founder, Center for Medicine in the Public Interest, the paper outlines a structure for innovator companies to assess and demonstrate "Differential Value" for a medical innovation prior to bringing it to market. Covered by nearly 150 media outlets throughout the country, we invite you to click here to read

In other exciting ecosystem news, congratulations to BioNJ Member Hackensack Meridian Health on the opening of the new Center for Discovery and Innovation. During the ribbon cutting ceremony, Dr. Andrew Pecora, who is credited with conceiving the facility along with Hackensack Meridian Health CEO Bob Garrett, shared "Our greatest hope is that our scientists will discover things that someday lead to Nobel Prizes and, at the same time, the creation of Fortune 100 companies that will stay in New Jersey to create and facilitate the innovative ecosystem." "This is the place where diseases that are now considered untreatable will meet their match," added Governor Murphy.

And for more future fun, please join us on Thursday, July 18, as BioNJ and NewYorkBIO host the 2019 BioCruise on the New York Harbor. Click here for details. 

Finally, please accept our sincere thanks from the BioNJ Team for all you do to contribute to the vibrant ecosystem we have here in the great Garden State!

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

New X2 BioCruise with NewYorkBIO
New York Harbor
World Yacht at Pier 81, Manhattan
July 18, 2019

Manufacturing Briefing
NJII, Newark, NJ
September 20, 2019
Patient Advocacy Summit 
Celgene, Summit, NJ
October 4, 2019
C-Suite Summit
Bridgewater Marriott, Bridgewater, NJ
November 8, 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 [email protected]. Plus, click here for valuable tools and resources on the Value of Medical Innovation.

Covered by nearly 150 media outlets, take a look at BioNJ's just released white paper.

BioNJ , the trade association for New Jersey's life sciences industry, released  "A Framework for Demonstrating the Value of Medical Innovation,"  a white paper authored by Dr. Shailja Dixit, President and Founder of  ApexBio , and Dr. Robert Goldberg, Vice President and Founder of the  Center for Medicine in the Public Interest The white paper outlines a structure for innovator companies to assess and demonstrate "differential value" for a medical innovation prior to bringing it to market.

AveXis, an  East Hanover-based BioNJ Member  Novartis company, announced innovative access programs for Zolgensma ®  (onasemnogene abeparvovec-xioi) for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 ( SMN1 ) gene. AveXis is working closely with payers to offer pay-over-time options up to 5 years and outcomes-based agr ments up to 5 years, as well as providing a patient program to support affordability and access.

Debuting for the first time this year, patient advocates, industry leaders and BIO experts discussed emerging trends from the convention show floor. Please click here for patient advocate and industry veteran Michael Becker's blog. 

BioNJ in the News

A ll of the speakers at the ribbon-cutting for the  Center for Discovery and Innovation  talked about the facility's ability to produce world-class breakthroughs in the fight against some of the world's most difficult diseases, such as cancer, diabetes and antibiotic resistant infections. In doing so, the facility -- at the ON3 complex on the Nutley/Clifton border, where it joins the Hackensack Meridian School of Medicine at Seton Hall University -- could help some of the State's economic ills, serving as one of the building blocks of the innovative economy Gov. Phil Murphy has been touting for the State. "The Center for Discovery and Innovation is incredibly meaningful to the state of New Jersey, to innovation, to the industry and, most importantly, to patients," said BioNJ President and CEO, Debbie Hart. "It harkens back to the days of original research that has happened here over so many years."

Experts say cutting-edge, regional innovation ecosystems generally feed from a bevy of factors, including, but not limited to: talented employees, geographic location, capital funding and collaboration between industry and higher education institutions. New Jersey has pros and cons in all of the above spheres, and many entities are striving to bolster the State's scenario. Debbie Hart, President and CEO of the biotechnology trade organization BioNJ, tells New Jersey Business, "We need more early stage innovation, and we need VC money to match it. [However], one of the increasing [benefits] is connectedness of angel investors. We have seen more angel investors than in previous years, and more of them are willing to collaborate together -- and to invest in life sciences. I think that's a definite plus. But, it takes 10 to 12 years, and $2.6 billion, to bring a drug to market. Lots of money is needed. It is never enough." 

Hosted by the Biotechnology Innovation Organization (BIO), this year's Convention drew 17,307 attendees from 49 states, the District of Columbia, Puerto Rico and 65 countries. "The past four days of programming have enabled the leading visionaries, problem solvers and innovators across the Tri-State region and biotech ecosystem to connect, collaborate and address the industry's top issues," said Debbie Hart, President and CEO, BioNJ and co-chair of the 2019 BIO International Convention. "We now set our sights on the future of biotech innovation, inspired by the progress of the past week."

Showing Our NJ Pride

Governor Phil Murphy received the 2019 Governor of the Year award from the Biotechnology Innovation Organization (BIO) in recognition of his dedication and leadership to strengthening New Jersey's bioscience industry.  "I thank BIO for this prestigious award, which is truly a tribute to the thousands of New Jersey entrepreneurs working to create life-saving and life-enhancing therapies and medical devices that will benefit the global community for decades to come," said Governor Murphy. "Through our vision for New Jersey as the State of Innovation, we have committed to supporting biotechnology start-ups and companies of all sizes as they choose to locate and grow in the Garden State. We greatly appreciate the partnership of the biotechnology sector as we work to ensure that scientists, researchers and other innovators have the resources they need to succeed."

Governor Phil Murphy was honored to be given the Governor of the Year Award in Philadelphia, but happier about the fact he got to pitch the State as a place for life sciences innovation before a global audience. Speaking at the annual international BIO conference, Murphy highlighted the State's past and what he hopes will be its future. "We are the state where, more than 130 years ago, Johnson & Johnson opened its doors and started us on the path to becoming the 'Medicine Chest to the World,'" Murphy said. "We are home to 13 of the world's 20 largest biopharmaceutical companies. We are where immunotherapy was born, where the cure for Hepatitis C was discovered and where the first-ever FDA approvals for both CAR-T therapy and a 3-D printed drug were won, among countless other advances."

ResearchwithNJ.com helps businesses and entrepreneurs identify and collaborate with our top universities and experts. This free database will help you discover thousands of experts in science, technology, engineering and mathematics (STEM) as well as their professional backgrounds, publications and achievements. It will also help you learn about the research departments and specializations of our six participating universities: New Jersey Institute of Technology, Princeton University, Rutgers University, Rowan University, Stevens Institute of Technology and Montclair State University. 

Representatives from New Jersey's higher education institutions were on display at the BIO International Convention...

In addition to providing a feeder pipeline of new scientists and other STEM employees for the Garden State's biopharma and biotech industries, our State's colleges and universities at times specifically incubate fledgling biotechnology companies and also leverage their institutional research prowess to solve problems in human health and other spheres. An exhibitor in the New Jersey Pavilion,  Haro Hartounian, Ph.D., Senior Executive Director, BioPharma Innovation, New Jersey Innovation Institute, NJIT, shared that  the Cell and Gene Therapy Development Center is slated to open soon at the New Jersey Institute of Technology, bringing industry, academia, technology developers and regulatory agencies together to address cell and gene therapy manufacturing and processing challenges.

New Jersey's delegation of some 75 participants, led by BioNJ, Choose New Jersey and the New Jersey Economic Development Authority, made an impressive display and outreach regarding what the Garden State has to offer life sciences companies around the globe.
Tim Sullivan, CEO, New Jersey Economic Development Authority, said  "We have a lot of good things to talk about, including: the NJ Ignite program (which provides early stage technology and life sciences companies rent support); and the NJ Innovation Evergreen Fund (a $500 million effort that will raise funds over five years by auctioning off state tax credits and then leveraging partnerships with the state and private venture capital funds to co-invest in New Jersey startups). "We have everything from discovery to development to commercialization to delivery here, including a robust offering in data science and an increased offering in cell and gene therapy," added President and CEO, BioNJ, Debbie Hart.

The  New Jersey Economic Development Authority (NJEDA)  announced that it has rebranded its 50-acre research park in central New Jersey from The Technology Centre of New Jersey to the  New Jersey Bioscience Center (NJBC) - North BrunswickThe new name more accurately reflects the park's life sciences focus and the spectrum of companies located there.  Strategically situated in the heart of the State's research corridor between Rutgers and Princeton universities, the NJBC campus offers a multitude of lab and office space options for companies at all stages of growth. 

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.

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced that the  U.S. Food and Drug Administration  ( FDA ) approved the company's supplemental New Drug Application (sNDA) for Emflaza® (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy who are between 2- and 5-years-old. Duchenne is a rare childhood genetic disorder that causes progressive irreversible muscle deterioration and weakness. Emflaza was first approved by the  FDA  in  February 2017  for the treatment of Duchenne in patients 5-years and older.

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced that it approved non-statutory stock options to purchase an aggregate of 76,250 shares of its common stock to 15 new employees. The awards were made pursuant to the NASDAQ inducement grant exception as a component of the new hires' employment compensation. The inducement grants were approved by PTC's Compensation Committee and are being made as an inducement material to each employee's acceptance of employment with the company in accordance with NASDAQ Listing Rule 5635(c)(4).

Princeton-based BioNJ Member  Soligenix, Inc.  announced that Soligenix will be participating in a biodefense contract for the development of medical countermeasures against bacterial threat agents, with Soligenix awarded a subcontract of approximately  $600,000  over 3 years. Innate Defense Regulators (IDRs) regulate the innate immune system to simultaneously reduce inflammation, eliminate infection and enhance tissue healing. 

Pennington-based BioNJ Member OncoSec Medical Incorporated  and Emerge Health Pty (Emerge) have entered into a collaboration agreement commercializing OncoSec's proprietary TAVO (enhanced IL-12 DNA-plasmid) and making it available under Australia's Special Access Scheme (SAS) in 2019. As a specialized Australian pharmaceutical company focused on the marketing and sales of high-quality medicines to the hospital sector, Emerge has previously made numerous other products successfully available under Australia's SAS.

Pivotal Phase 3 ICARIA-MM trial results demonstrated that Bridgewater-based BioNJ Member Sanofi's isatuximab added to pomalidomide and dexamethasone (isatuximab combination therapy) showed statistically significant improvements compared to pomalidomide and dexamethasone (pom-dex) alone in patients with relapsed/refractory multiple myeloma (RRMM). Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.

Hampton-based BioNJ Member  Celldex Therapeutics, Inc.   presented results  from the CDX-3379 clinical program . To date, three studies of CDX-3379 have enrolled patients with head and neck squamous cell carcinoma (HNSCC), including the ongoing Phase 2 exploratory study of CDX-3379 in combination with Erbitux ®  (cetuximab) in patients with cetuximab-resistant, advanced human papillomavirus (HPV) negative HNSCC who have previously been treated with an anti-PD1 checkpoint inhibitor.

Berkeley Heights-based BioNJ Member  PDS Biotechnology Corporation  announced that it has entered into a  Cooperative Research  and Development Agreement (CRADA) with the  National Cancer Institute  (NCI) for the development of the PDS0101 HPV cancer immunotherapy in combination with other immune-modulating agents as a potential treatment for advanced HPV-related cancers.

Cranbury-based BioNJ Member Palatin Technologies, Inc. announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for PL-8177 for the treatment of non-infectious intermediate, posterior, pan and chronic anterior uveitis. Non-infectious uveitis is a group of inflammatory diseases that produces swelling and destroys eye tissue and can result in vision loss.  Palatin has conducted a single and multiple ascending-dose Phase 1 study with PL-8177 under an investigational new drug (IND) application for ulcerative colitis. 

Princeton-based BioNJ Member Bristol-Myers Squibb Company  announced first results from the  Opdivo  (nivolumab) plus  Yervoy  (ipilimumab) cohort of the Phase 1/2 CheckMate -040 study, evaluating the Immuno-Oncology combination in patients with advanced hepatocellular carcinoma (HCC) previously treated with sorafenib. With a minimum follow-up of 28 months, the blinded independent central review (BICR) objective response rate (ORR) was 31% per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). 

Summit-based BioNJ Member Celgene Corporation announced the U.S. Food and Drug Administration (FDA) approved REVLIMID ® (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin's lymphoma (NHL) that does not include chemotherapy.

Summit-based BioNJ Member Celgene Corporation a nnounced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis (RMS) in the United States. The European Medicines Agency (EMA) also accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) in the European Union. 

Summit-based BioNJ Member Celgene Corporation  and Acceleron Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted Celgene's Biologics License Application (BLA) for luspatercept, an investigational erythroid maturation agent, for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. 

Princeton-based BioNJ Member Genmab announced that the U.S. Food and Drug Administration (U.S. FDA) granted a Priority Review for the supplemental Biologics License Application (sBLA) for the use of daratumumab (DARZALEX®) in combination with bortezomib, thalidomide and dexamethasone (VTd) as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant (ASCT).

Bridgewater-based BioNJ Member Allergan Plc's Vraylar won U.S. regulatory approval to treat depressive episodes of bipolar I disorder, making it a treatment option for a full spectrum of the condition's cyclical symptoms, the company said. Vraylar, which recorded a 70.3% year-over-year sales jump in the first quarter, is an approved treatment in the United States for schizophrenia in adults and for manic or mixed episodes associated with bipolar I disorder.

East Hanover-based BioNJ Member  Novartis announced new early stage histology data in kidney transplantation, suggesting that with investigational compound iscalimab (CFZ533) it may be possible to prolong the durability of transplanted kidneys as well as to potentially improve long-term outcomes for kidney transplant patients.  The data examines whether calcineurin-free treatment with iscalimab preserves the quality of transplanted kidney grafts.

East Hanover-based BioNJ Member  Novartis announced the US Food and Drug Administration (FDA) has approved Piqray® (alpelisib, formerly BYL719) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-), PIK3CA-mutated, advanced or metastatic breast cancer, as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

East Hanover-based BioNJ Member Novartis announced new data and clinical trial updates. This includes primary efficacy results from the GEOMETRY mono-1 Phase II clinical trial demonstrating that investigational MET inhibitor capmatinib (INC280) shows promise as a potential treatment option for patients with locally advanced or metastatic NSCLC that harbor MET exon-14 skipping mutation. There are currently no approved targeted therapies to treat this particularly aggressive form of NSCLC.

East Hanover-based BioNJ Member Novartis announced statistically significant overall survival (OS) results for Kisqali in combination with endocrine therapy. The Phase 3 MONALEESA-7 trial evaluated Kisqali plus endocrine therapy (goserelin plus either an aromatase inhibitor or tamoxifen) as initial treatment compared to endocrine therapy alone in pre-and perimenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. 

East Hanover-based BioNJ Member Novartis' STEP (Solutions to Empower Patients) Program will fund five non-profit organizations that address some of the most pressing concerns in the  sickle cell disease  (SCD) community. Nearly $250,000 will be divided up among patient advocacy organizations and research institutions. Started in 2017, the STEP program funds innovative efforts that empower patients with unmet needs to chart courses to improved care. The focus this year is SCD. 

Kenilworth-based BioNJ Member Merck & Co. and AstraZeneca presented full results from the Phase 3 SOLO3 trial which evaluated LYNPARZA, compared to chemotherapy, for the treatment of platinum-sensitive relapsed patients with germline BRCA1/2-mutated (gBRCAm) advanced ovarian cancer, who have received two more prior lines of chemotherapy. The results from the trial showed a statistically-significant and clinically-meaningful improvement in objective response rate (ORR) in the LYNPARZA arm compared to the chemotherapy arm (ORR; 72.2% for LYNPARZA vs 51.4% for chemotherapy; 95% CI: 1.40 to 4.58; p=0.002

Kenilworth-based BioNJ Member Merck & Co. an AstraZeneca announced detailed results from the Phase 3 POLO trial evaluating LYNPARZA tablets as a first-line maintenance monotherapy for patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease had not progressed following platinum-based chemotherapy. 

Kenilworth-based BioNJ Member  Merck & Co. announced the presentation of the final analysis of the pivotal Phase 3 KEYNOTE-048 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy and in combination with chemotherapy, for the first-line treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). Data include the first-time presentation of certain overall survival (OS) hypotheses from the KEYTRUDA in combination with chemotherapy study arm based on PD-L1 expression and the KEYTRUDA monotherapy study arm in the total patient population.

Kenilworth-based BioNJ Member  Merck & Co. announced the presentation of five-year efficacy and safety data for KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) from the first KEYNOTE trial (Phase 1b KEYNOTE-001). In this study, KEYTRUDA demonstrated a five-year overall survival (OS) rate of 23.2% in treatment-naïve patients (n=101) and 15.5% in previously treated patients (n=449). 

BioNJ Member  Merck & Co.'s Formulation, Laboratory and Experimental Center (FLEx), scheduled to open on Merck's Rahway, New Jersey, campus in 2021, will speed up the process between product development and manufacturing for clinical trials. The estimated $300 million-plus facility will include "modular" and "podular" configurations, providing flexibility to accommodate evolving product needs and pipelines.

Parsippany-based BioNJ Member The Medicines Company announced interim results from the ongoing ORION-3 open-label extension study (Group 1, n=290) which showed that twice-a-year dosing with inclisiran sodium 300 mg resulted in consistent lowering of low density lipoprotein cholesterol (LDL-C) by more than 50 percent with overall follow-up of up to three years. Inclisiran was well tolerated, and no material safety issues were observed in the study. 

Parsippany-based The Medicines Company announced presentation of analyses of two clinical studies of inclisiran at the 87 th  European Atherosclerosis Society (EAS) Congress. A combined analysis (N=279) from the Phase 2 ORION-1 and Phase 1 ORION-7 trials demonstrated that patients across a range of renal function levels achieved consistent reductions in low-density lipoprotein cholesterol (LDL-C) with no dose adjustment necessary for patients with renal impairment. 

Somerville-based BioNJ Member Symphogen announced the publication of discovery and preclinical data on the first-in-man chicken-derived antibody directed at the immune checkpoint target PD1. Chickens are evolutionarily more distant from humans than rodent species typically used to generate therapeutic antibodies. Symphogen has demonstrated that its humanized chicken-derived antibodies have unique properties compared to antibodies generated by traditional means.  

New Brunswick-based BioNJ Member Johnson & Johnson announced that full enrollment has been achieved in a Phase 2b proof-of-concept efficacy study evaluating an investigational preventive vaccine against HIV-1 infection. Sponsored by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson, in collaboration with a consortium of global partners, the Imbokodo study is evaluating a mosaic-based vaccine regimen in 2,600 young women across five southern African countries where women and girls experience high rates of HIV infection.

Raritan-based BioNJ Member  The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the supplemental New Drug Application (sNDA) for INVOKANA ®  (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), the doubling of serum creatinine, and renal or cardiovascular (CV) death in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD). 

Raritan-based BioNJ Member  The Janssen Pharmaceutical Companies of Johnson & Johnson announced the publication of data from the randomized, open-label Phase 3 MAIA (MMY3008) study that showed DARZALEX® (daratumumab) plus lenalidomide and dexamethasone (Rd) resulted in a significant increase in progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT).

Raritan-based BioNJ Member  The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings from the investigational Phase 3 TITAN study, which showed the addition of ERLEADA® (apalutamide) to androgen deprivation therapy (ADT) compared with placebo plus ADT significantly improved the dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) in patients with metastatic castration-sensitive prostate cancer (mCSPC).

Raritan-based BioNJ Member The Janssen Pharmaceutical Companies of Johnson & Johnson presented a new cost-efficiency analysis that illustrates the value of SPRAVATO™ (esketamine) CIII nasal spray for treatment-resistant depression (TRD), for patients, U.S. payers, and society. The analysis showed that for people living with TRD, which is defined as having cycled through two or more oral antidepressant treatments in the same depressive episode without relief, SPRAVATO™ in conjunction with an oral antidepressant is a cost-efficient alternative to an oral antidepressant plus placebo.

Parsippany-based BioNJ Member Teva Pharmaceutical Industries Ltd.   announced the launch of a generic version of Ranexa®1 (ranolazine) Extended-Release Tablets, 500 mg and 1000 mg, in the U.S.  Ranolazine Extended-Release Tablets are indicated for the treatment of chronic angina. "We're pleased to add to our portfolio of generic medicines that offer another treatment option for people living with chronic conditions like angina," said Brendan O'Grady, EVP and Head of North America Commercial.

Bridgewater-based BioNJ Member Insmed Incorporated announced that it priced a registered underwritten public offering of 9,615,385 shares of its common stock, at a price to the public of  $26.00  per share before underwriting discounts and commissions. Gross proceeds from the offering of these shares, before deducting underwriting discounts and commissions, are expected to be approximately  $250.0 million .  

Whippany-based Bayer announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for Aliqopa (copanlisib) for the treatment of adult patients with relapsed marginal zone lymphoma (MZL) who have received at least two prior therapies. MZL is an indolent form of non-Hodgkin's Lymphoma (iNHL) and accounts for about 10% of all non-Hodgkin's Lymphoma in the U.S.

GlaxoSmithKline plc, with offices in Warren, announced that the National Medical Products Administration (NMPA) has approved Shingrix for the prevention of shingles (herpes zoster) in adults aged 50 years or older. Shingrix is a recombinant subunit adjuvanted vaccine given intramuscularly in two doses. The approval is in response to last year's inclusion of Shingrix on a list of 48 'clinically urgently needed new medicines' in China designated for expedited review, reflecting the country's prioritization of critical new prevention and treatment options.

BrainStorm Cell Therapeutics Inc., with offices in  Hackensack,  announced that the  Stanford University School of Medicine  will serve as the second contracted clinical study site for the Company's Phase 2 open-label, multicenter study of repeated intrathecal administration of autologous MSC-NTF cells in participants with progressive Multiple Sclerosis (MS) (NCT03799718).

Boehringer Ingelheim, with offices in New Brunswick, and Gubra announce a second collaboration and license agreement for the development of novel poly-agonist peptides to treat obesity. It will bring together Gubra's established expertise in the design, synthesis, pharmaceutical characterization and in vivo testing of therapeutic peptides with Boehringer Ingelheim's expertise in the research and development of innovative medicines in cardiometabolic diseases.

People in the News

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced the promotion of Emily Hill to Chief Financial Officer. Ms. Hill joined  PTC Therapeutics  in November 2013 and was most recently Senior Vice President and Head of Investor Relations. "It is my pleasure to announce Ms. Hill's promotion to CFO," said  Stuart W. Peltz , Ph.D., CEO of  PTC Therapeutics, Inc.  "She has a deep knowledge of our industry and has strong relationships and understanding of the investor community."  

BioNJ Member Pfizer Inc., with offices in Madison,  announced that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading all early oncology research, from discovery to proof of concept clinical studies. Dr. Settleman, a leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, will report directly to Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer.

Bedminster-based  BioNJ Member Amarin Corporation plc announced that Gwen Fisher has joined the company in a newly created role as Vice President of Corporate Communications. In this role, Ms. Fisher will be responsible for leading internal and external communications for the company. Specifically, she is charged with advancing and implementing an integrated, progressive corporate communications strategy designed to educate key stakeholders about the company and its lead product, Vascepa®.

BioNJ Member Jazz Pharmaceuticals plc, with offices in Ewing,  announced the appointment of Robert Iannone , M.D., M.S.C.E., as Executive Vice President, Research and Development.  Dr. Iannone will lead Jazz's growing global R&D organization, including the pre-clinical development, clinical development, clinical operations, biostatistics, medical affairs, regulatory affairs, pharmacovigilance and safety functions.

Parsippany-based  Castle Creek Pharmaceuticals LLC, has appointed Mary Spellman as Chief Medical Officer and Senior Vice President of Research and Development.  Before Castle Creek, Dr. Spellman served as the Chief Medical Officer at Menlo Therapeutics. Before that, she was a medical consultant providing safety support for multiple biopharmaceutical and device development companies.

Woodcliff Lake-based  Eisai Inc. announced it has appointed Patrick Coyle as Vice President and Chief Financial Officer.  In this role, Mr. Coyle, who will serve on Eisai's executive committee, will be responsible for overseeing the company's financial operations in the U.S. and Canada. Mr. Coyle, who has more than two decades of experience in financial planning and analysis, operations and strategy development, most recently served as Vice President, Financial Planning and Analysis at Insmed Inc. 

Woodcliff Lake-based  Eisai Inc. announced it has appointed Adriana Herrera as Senior Vice President, Americas commercial oncology. In this role, Ms. Herrera will be responsible for developing and implementing the company's commercial strategy to help grow its oncology business in the Americas region. She will also head the oncology commercial organization. Prior to Eisai, Ms. Herrera was at Novartis Oncology for 12 years, most recently as Vice President, Global Disease Lead Lung Cancer. Before that, she held marketing, sales and operations roles of increasing responsibility at Novartis and Bristol Myers Squibb.

Institution and Education News

Rutgers University and its leading health insurer,  Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ), announced they have teamed up to create a medical research partnership.  The partners are collaborating on more than 14 projects including research that may bring breakthroughs that make cancer screenings more conclusive; improve the effectiveness of flu vaccinations; adapt to the health consequences of climate change; or deploy virtual reality devices as a pain treatment alternative to opioids.

Targeting a key gene before birth could eventually help lead to a treatment for Down Syndrome by reversing abnormal embryonic brain development and improving cognitive function after birth, according to a Rutgers-led study.  Using stem cells that can turn into other cells in the brain, researchers developed two experimental models -- a living 3-D "organoid" model of the brain and a mouse brain model with implanted human cells -- to investigate early brain development linked to Down Syndrome. 

Hackensack Meridian Health Hackensack University Medical Center  is offering patients a new treatment for a potentially fatal cardiovascular condition known as an aortic dissection, in which the inner layer of the aorta, the large blood vessel branching off the heart, tears. Blood surges through the tear, causing the inner and middle layers of the aorta to separate. Following FDA approval, surgeons at the Heart and Vascular Hospital at Hackensack University Medical Center became one of the first hospitals the United States to use Cook Medical's Zenith Dissection Endovascular System to treat an emergent complicated Type B aortic dissection. 

Cooper University Health Care  is participating in a clinical trial -- the Brain Oxygen Optimization in Severe TBI, Phase 3 (BOOST-3) -- with a goal of improving outcomes of those victims of severe traumatic brain-injuries (TBI). Cooper was accepted into this National Institutes of Health-sponsored study as a participating site because of its experience in treating severe TBI patients. The BOOST-3 study is a randomized clinical trial to determine the comparative effectiveness of two strategies for monitoring and treating patients with TBI in the intensive care unit (ICU). 

Special Programs from Our Partners for BioNJ Members

June 12, 2019 | New Brunswick, NJ

Enjoy a breakfast discussion moderated by Assemblyman Andrew Zwicker. Participants include James Barood, President and CEO, New Jersey Tech Council; Jay Bhatti, Partner, BrandProject LP; S. David Kimball, Ph.D., Vice President for Innovation and Research Commercialization, Rutgers University; Christopher Paladino, President, DEVCO; Stephen Socolof, Managing Partner, Tech Council Ventures and Gina Tedesco, Board Member, Jumpstart New Jersey Angel Network. RSVP to [email protected].

September 18, 2019 l New Brunswick
The  U.S. Small Business Administration  is hitting the road and Middlesex County's own New Brunswick has been announced as a stop on the 16 spot tour. The SBA's excursion aims to connect entrepreneurs to its Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, according to the organization the largest source of early stage funding in the country. The SIBR Road Tour will arrive in New Brunswick on Sept. 18 to be hosted by an as yet unnamed local organization. The SBA said host groups will be involved in next-generation research and development and supporting entrepreneurs.

November 14, 2019 | Princeton

Save the date! Annual evening reception highlighting the innovative research  emerging from our labs and working spaces and the translation of that research through entrepreneurship, technology transfer and engagement with industry. We invite you to join us as we strengthen connections, exchange ideas and build our innovation ecosystem among our external partners and our world-renowned faculty, research teams, students and alumni. The reception will be held at the Frick Chemistry Laboratory, Princeton University, Princeton NJ 08544. See technologies from previous events at Celebrate Princeton Innovation.

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. 

Please contact BioNJ at [email protected] or call 609-890-3185 
with any questions.