Welcome to the latest edition of the  BioLines Weekender !  
Since toasting in the New Year, the BioNJ Team has been busy. Just this week, we co-hosted the Wine with BIO Friends Reception a t the J.P. Morgan Healthcare Conference and Biotech Showcase in San Francisco and the Governor's State of the State Address.

In preparation for BioNJ's 27th Annual Dinner Meeting and Innovation Celebration, taking place on February 6, we've been working hard to make sure everything is perfect for our guests -- from the food to the presentations, awards and special surprises. We've been on the road interviewing thought leaders throughout New Jersey for our video in honor of Kenneth C. Frazier, the 2020 Dr. Sol J. Barer Award for Vision, Innovation and Leadership honoree. We hope you'll join us for an evening of celebration and recognition as we recognize the pillars of New Jersey's life sciences ecosystem! (Click here for more information and to register.)

Meanwhile, we are excited to share that BioNJ Members SAVED $11 million on Fisher Scientific products and services in 2019! If you haven't checked out BioNJ's Purchasing Consortium -- featuring a number of important saving s from lab supplies and shipping to health benefits -- do so now by  clicking here

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. 

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

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.

"BioNJ applauds the Governor in his action to protect the Affordable Care Act and the Legislators who sponsored the legislation to protect its provisions. The Affordable Care Act has provided a pathway for millions of Americans to secure health insurance and to be able to access the care and the therapies that they need. This is exciting for New Jersey as the Governor and the Legislature lead the way on this critical front." 
~Debbie Hart, President and CEO, BioNJ  

Governor Phil Murphy signed a package of bills to safeguard the provisions of the Affordable Care Act (ACA) in New Jersey. The bills, which will codify into state law the basic protections for health care consumers that are part of the Affordable Care Act, include protections for no-cost preventative care and contraception, prohibit exclusions for pre-existing conditions, allow children to stay on their parents' plan until age 26, and incorporate mental health and maternity care as part of essential benefits, among others. The Governor highlighted the importance of these bills during an armchair discussion with Hackensack Meridian Health Chief Executive Officer Bob Garret. 

New Jersey doctors know the fight against cancer is far from over, but for the moment they're celebrating new statistics released by the American Cancer Society, which point to the largest ever single-year decline in the cancer death rate nationwideContributing to a 29% overall decline since 1991, the death rate dropped by 2.2% from 2016 to 2017, ACS reported.  "When we're dealing with millions of lives ... that translates into big numbers on an absolute basis," Dr. Maurice Cairoli, a medical oncologist with Virtua Health.  Dr. Janice Mehnert, Director of the Developmental Therapeutics Research Program at the Rutgers Cancer Institute of New Jersey, added "Now more than ever, patients will demand access to clinical trials early in their disease course, because it's often a way to access a lifesaving medicine. Mehnert strongly believes much of the death-rate decline can be attributed to the advent of new therapies, specifically immunotherapy, that are far more effective than what had been utilized in the past.

Much is made of the cost of drugs in the U. S., a topic that is in the crosshairs of both political parties. Particularly galling for Americans is that drugs are cheaper around the world than they are here. The reason that drugs are cheaper elsewhere is that foreign governments have single payer systems. In most countries, biopharmaceutical companies must negotiate prices with each nation in order to be able to market their drug in said country. The U.S. operates in a completely different system where biopharmaceutical companies negotiate with the various different payers that exist in our system, mainly the federal government and insurance companies. 

U.S. insurers and providers spent more than $800 billion in 2017 on administration, or nearly $2,500 per person -- more than four times the per-capita administrative costs in Canada's single-payer system, a new study finds.  Over one third of all health care costs in the U.S. were due to insurance company overhead and provider time spent on billing, versus about 17% spent on administration in Canada, researchers reported in Annals of Internal Medicine.  Cutting U.S. administrative costs to the $550 per capita (in 2017 U.S. dollars) level in Canada could save more than $600 billion, the researchers say.

Nearly 50% of total spending on brand medicines - the sum of all payments made at the pharmacy or paid on a claim to a health care provider - went to the supply chain and other entities in 2018, according to a  new analysis from the Berkeley Research Group (BRG). Click here for the full analysis. 

Starting a fresh, new year with resolutions to improve our health and be smarter with our money is a time-honored American tradition. Keeping these resolutions is usually a matter of personal discipline. Unfortunately, that satisfying sense of self-reliance and clarity could disappear quickly for a lot of seniors taking medication to help with high cholesterol when they pick up their prescriptions in 2020. Many will be surprised to discover that their out-of-pocket costs for their PCSK9 inhibitor prescriptions are significantly higher than they were last year.  The immediate impulse will be to blame drug companies for this increase, but in this case, this blame would be misplaced, and the truth behind the cause far more complicated than most could imagine.

Standard treatment options had failed, and the young woman was given only a few months to live. An aggressive tumor had spread from the muscles of her back, to her pelvis and throughout her abdominal cavity. Desperate for more time, the woman volunteered to receive an experimental drug compound called  SM-88, a novel oral compound that targets the rampant spreading of tumors and tricks cancer cells into consuming a modified dysfunctional metabolite.  The effect on the woman's disease was profound. The drug shrunk the tumors to the point that they could be safely excised. The woman lived another five years, thanks to this experimental anti-cancer agent.

BioNJ in the News

As featured in NJBIZ

In 2019, 50 percent of all new novel FDA drug approvals -- 24 out of 48 new molecular entities -- came from companies with a footprint in New Jersey.  BioNJ will honor each of these companies with an Innovator Award during its  27th Annual Dinner Meeting & Innovation Celebration  on Feb. 6 at the Hilton East Brunswick.  "We are so proud of New Jersey's robust life sciences ecosystem which is responsible for exactly half of all of the 2019 novel innovations now making their way to patients with cancer, Parkinson's disease, heart disease, multiple sclerosis and more, reinforcing the fact that the Garden State is the drug development capital of the world," said BioNJ President and CEO Debbie Hart. 

NJ Company News

Bedminster-based BioNJ Member Tyme Technologies, Inc. announced that the first pancreatic cancer patient has been dosed in Part 2 of the TYME-88-Panc pivotal trial designed to support approval of SM-88 (racemetyrosine) for the third-line treatment of patients with metastatic pancreatic cancer. CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells' protein synthesis, leading to a breakdown of the cancer's key defenses and cell death. 

Bedminster-based BioNJ Member Tyme Technologies, Inc. and Woodcliff Lake-based Eagle Pharmaceuticals, Inc. announced the formation of a U.S. strategic collaboration focused on the co-promotion of TYME's lead CMBT candidate oral SM-88 in advanced cancers. CMBTs are proprietary investigational compounds that are believed to disrupt cancer cells' protein synthesis, leading to a breakdown of the cancer's key defenses and cell death. In clinical trials, oral SM-88 has demonstrated complete or partial responses across 15 different cancers, including pancreatic, prostate, sarcoma, breast, lung, and blood cancers with minimal serious grade 3 or higher adverse events.

Chester-based BioNJ Member Hillstream BioPharma Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to salinomycin based on nonclinical pharmacology data from HSB-1216 (QUATRAMER salinomycin), a new chemical entity for the treatment of small cell lung cancer. "We are very excited and pleased that HSB-1216 received orphan designation from the FDA," stated Randy Milby, Hillstream's Chief Executive Officer. "Now is an exciting time for the development of medicines for small cell lung cancer. We believe treatment with HSB-1216 may represent a complementary approach to other potential therapies by inhibiting cancer stem cells."

Princeton-based BioNJ Member Soligenix, Inc. issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. " It is truly an exciting time for the Company. As many of you are aware, we have a number of significant and potentially transformational events ahead of us this quarter and over the next six months. Most notably, top-line final results are imminent from two pivotal Phase 3 clinical trials." Click here for the full letter.

Princeton-based BioNJ Member Oyster Point Pharma, Inc. announced the positive top-line results from its Phase 2 MYSTIC study in Dry Eye Disease. "The results from the MYSTIC study further validate the novel mechanism of action of OC-O1 nasal spray and its ability to stimulate natural tear production via the trigeminal parasympathetic pathway," said Dr. Preeya Gupta, Associate Professor of Ophthalmology at Duke University Eye Center and member of Oyster Point Pharma's medical advisory board. "

Jersey City based BioNJ Member SCYNEXIS, Inc. announced positive results from its second interim efficacy analysis of the ongoing Phase 3 open-label FURI study. The study is evaluating oral ibrexafungerp as a salvage treatment in patients with difficult-to-treat mucocutaneous and invasive fungal infections that are refractory to or intolerant of current standards of care, or require a non-azole oral step-down therapy for treatment of azole-resistant Candida species

Princeton-based BioNJ-Member  Advaxis, Inc. announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the initiation of a Phase 1 clinical study of ADXS-504, the Company's ADXS-HOT candidate for prostate cancer.  ADXS-HOT is the Company's off-the-shelf neoantigen clinical program targeting hotspot mutations that currently includes over ten cancer-type specific drug constructs in various stages of development.

Basking Ridge-based BioNJ Member Ipsen announced that the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a license update for Dysport®  for the symptomatic treatment of focal spasticity of upper limbs in pediatric cerebral palsy patients, two years of age and older. Spasticity in children is most commonly associated with cerebral palsy (CP). Approximately 17 million people worldwide are affected by cerebral palsy, with an estimated 1 in 400 babies born with cerebral palsy in the UK, 75-91% of whom will have a specific type known as spastic cerebral palsy.

Bedminster-based BioNJ Member Kyowa Kirin Co., Ltd. announced that it has submitted a supplemental application for LUMICEF® (code name: KHK4827, generic name: brodalumab (genetic mutation)) for the treatment of axial spondyloarthritis (axSpA). The supplemental application is based on the result of a phase 3 clinical trial in patients with axSpA (Ankylosing Spondylitis and Non-radiographic axSpA) in Japan, South Korea and Taiwan. LUMICEF met the primary endpoint, and efficacy and safety in patients with axSpA were confirmed in this study.

Ramsey-based BioNJ-Member  ADMA Biologics, Inc. announced its entry into a 5-year manufacturing and supply agreement with an undisclosed partner to produce and sell plasma-derived intermediate fractions from ADMA's U.S. Food and Drug Administration (FDA) approved Immune Globulin (IG) manufacturing process. "A core element of our business strategy is to leverage and maximize the revenue we generate from the available manufacturing capacity at our FDA-approved plasma-derived products production facility.  Through the production of our own marketed assets, BIVIGAM®, ASCENIV™ and NABI-HB®, we will now be able to generate additional revenue over and above the sales of the FDA-approved drugs themselves," said Adam Grossman, ADMA's President and CEO.

To kick off the new year, BioNJ Member Visikol has announced that it has expanded its footprint in New Jersey by moving its headquarters to a 6,400 square-foot space in Hampton, NJ with room to grow. The new Visikol facility will be in the Perryville III building which is a 288,000 square-foot class A office building  off of I-78 that is home to several pharmaceutical and life science companies.  Visikol started off as a university spin out from Rutgers University almost four years ago and has been rapidly growing its business ever since. 

Bridgewater-based BioNJ Member  Eli Lilly and Company  announced plans to add two more cost-saving options to its suite of solutions for people who use Lilly insulin by introducing lower-priced versions of Humalog® Mix75/25 KwikPen® (insulin lispro protamine and insulin lispro injectable suspension 100 units/mL) and Humalog® Junior KwikPen® (insulin lispro injection 100 units/mL). Both insulins will have 50 percent lower list prices compared to the branded versions and will be available by mid-April.

Bridgewater-based BioNJ Member  Eli Lilly and Company  jointly announced with Innovent Biologics, Inc. the results of a Phase 3 study in China; the ORIENT-11 trial of Tyvyt® (sintilimab injection) in combination with ALIMTA® (pemetrexed) and platinum in first-line advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC), without sensitive EGFR mutation or ALK rearrangement, met the predefined primary endpoint of progression-free survival (PFS) in an interim analysis.

Bridgewater-based BioNJ Member  Eli Lilly and Company  and  Dermira, Inc.  announced a definitive agreement for Lilly to acquire  Dermira  for  $18.75  per share, or approximately  $1.1 billion , in an all-cash transaction.  Dermira  is a biopharmaceutical company dedicated to developing new therapies for chronic skin conditions. The acquisition will expand Lilly's immunology pipeline with the addition of lebrikizumab, a novel, investigational, monoclonal antibody designed to bind IL-13 with high affinity that is being evaluated in a Phase 3 clinical development program for the treatment of moderate-to-severe atopic dermatitis in adolescent and adult patients, ages 12 years and older. 

Kenilworth-based BioNJ Member Merck & Co. announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck's anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Kenilworth-based BioNJ Member Merck & Co. announced that the Phase 3 KEYNOTE-604 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC). In the study, treatment with KEYTRUDA in combination with chemotherapy (etoposide plus cisplatin or carboplatin) resulted in a statistically significant improvement in PFS compared to chemotherapy alone (HR=0.75 [95% CI, 0.61-0.91]), which was observed at a prior interim analysis. 

Kenilworth-based BioNJ Member Merck & Co. announced an exclusive worldwide research collaboration and license agreement with Taiho Pharmaceutical Co, Ltd. and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical Co., Ltd., focused on the development of small molecule inhibitors against several drug targets, including the KRAS oncogene, which are currently being investigated for the treatment of cancer.

Princeton-based BioNJ Member  Evotec SE announced that the company received a US $6 m payment from BioNJ Member Bristol-Myers Squibb Company following the decision to expand the collaboration to include additional cell lines. Evotec and Celgene, which is now a Bristol-Myers Squibb company, initiated the collaboration in December 2016 to identify disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of patients' symptoms and there is a huge unmet medical need for therapies that slow down or reverse disease progression in the field of neurodegenerative diseases. 

Princeton-based BioNJ Member Bristol-Myers Squibb Company and  Nektar Therapeutics  announced the companies have agreed to a new joint development plan to advance bempegaldesleukin (bempeg) plus Opdivo  (nivolumab) into multiple new registrational trials. The revision to the strategic collaboration agreement includes a new joint development plan under which Nektar and Bristol-Myers Squibb will expand the active clinical development program for bempeg plus nivolumab from three ongoing registrational trials in first-line metastatic melanoma, first-line cisplatin-ineligible metastatic urothelial cancer and first-line metastatic renal cell carcinoma (RCC) to include two additional registrational trials in adjuvant melanoma and in muscle-invasive bladder cancer.

East Hanover-based BioNJ Member  Novartis announced mechanistic study results showing ligelizumab is more effective at inhibiting the major pathogenic IgE/FcεRI pathway in chronic spontaneous urticaria (CSU), than current therapy Xolair® (omalizumab). Ligelizumab can bind to IgE with an 88-fold higher affinity than Xolair. The data show ligelizumab and Xolair recognize and bind differently to IgE, with ligelizumab resulting in a significantly enhanced blockade of IgE/FcεRI signaling.

East Hanover-based BioNJ Member  Novartis announced that it has completed the acquisition of The Medicines Company through the consummation of a merger of its indirect wholly-owned subsidiary, Medusa Merger Corporation, with and into the company, with the company surviving the merger, without a vote of the company's stockholders in accordance with Section 251(h) of the Delaware General Corporation Law. 

CARB-X is awarding Monmouth Junction-based BioNJ Member  Taxis Pharmaceuticals up to $3.2 million in non-dilutive funding to develop efflux pump inhibitors (EPI), a new drug class designed to destroy a major mechanism of multi-drug-resistant Pseudomonas aeruginosa bacteria.  Taxis is eligible for additional funding of up to $11.4 million if the project achieves certain milestones. If successful, the Taxis EPI would enable existing antibiotics to once again be effective against drug-resistant bacterial infections that cannot currently be treated effectively.

Bedminster-based BioNJ-Member  Matinas BioPharma Holdings, Inc. announced the closing of its underwritten registered public offering of 32,260,000 shares of its common stock, offered at a price to the public of $1.55 per share for gross proceeds of approximately $50.0 million, before deducting underwriting discounts and commissions and other estimated offering expenses.

Bedminster-based BioNJ Member  Amgen  announced the successful closing of the transaction to enter into a strategic collaboration with  BeiGene  that will significantly accelerate  Amgen's  plans to expand its oncology presence in  China , the world's second-largest pharmaceutical market. "There continues to be substantial unmet medical need in  China , particularly for patients with cancer," said  Robert A. Bradway Amgen's  Chairman and Chief Executive Officer. 

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.

Princeton-based Certara® announced that its Simcyp® Population-based Simulator was used to support Galderma's successful U.S. Food and Drug Administration (FDA) new drug application (NDA) for AKLIEF (trifarotene) Cream, 0.005% for the topical treatment of acne. Trifarotene is the first new retinoid molecule to receive FDA approval to treat acne in more than 20 years. The use of the Simcyp Simulator allowed Galderma to expedite and inform its drug development program, while also providing safety label claim and pediatric dosing information without the need for testing in clinical patients.

Woofcliff Lake-based Eagle Pharmaceuticals, Inc. announced that the Company has resubmitted its New Drug Application ("NDA") for RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke ("EHS"), in addition to body cooling, to the U.S. Food and Drug Administration ("FDA"). Eagle believes that this submission addresses the Complete Response Letter received in July 2017.

Chatham-based AB Science SA announces that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application to conduct its masitinib Phase 3 study (AB12003) in metastatic castrate-resistant prostate cancer (mCRPC) eligible to chemotherapy. Study AB12003 is an international, multicenter, randomized, double blind, placebo-controlled, 2-parallel group, Phase 3 study in metastatic castrate resistant prostate cancer (mCRPC) eligible to chemotherapy. 

Florham Park-based Cellectar Biosciences, Inc. announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug Designation (ODD) to CLR 131 in Lymphoplasmacytic Lymphoma (LPL). CLR 131 is the company's lead Phospholipid Drug Conjugate™ (PDC) product candidate currently in a Phase 2 clinical study in relapsed or refractory select B-cell lymphomas, including Lymphoplasmacytic Lymphoma (LPL).

Florham Park-based  Eisai Co., Ltd. announced that it has launched the in-house developed anticancer agent Halaven® in China. Halaven is a halichondrin class microtubule dynamics inhibitor with a distinct binding profile. In addition to its mechanism of action of inhibiting the growth of microtubule dynamics, non-clinical studies showed Halaven's unique actions on the tumor microenvironment such as increasing vascular perfusion and permeability in tumor cores,1 promotion of the epithelial state and decrease in the capacity of breast cancer cells to migrate.

Basking Ridge-based  Regeneron Pharmaceuticals, Inc.  announced results from LUMINA-1, a 44-patient, Phase 2, double-blind placebo-controlled trial evaluating garetosmab (REGN2477) in patients with fibrodysplasia ossificans progressiva (FOP). FOP is an ultra-rare genetic disorder with no approved treatments that leads to abnormal bone formation resulting in skeletal deformities, progressive loss of mobility and premature death. 

New Providence-based ADC Therapeutics SA announced positive results from the pivotal 145-patient Phase 2 clinical trial of loncastuximab tesirine (ADCT-402) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). To date, loncastuximab tesirine has achieved an overall response rate (ORR) of 45.5% (66/145 patients), including 20% complete responses and 25.5% partial responses, across a broad population of relapsed or refractory DLBCL patients, even those who are difficult to treat. 

Summit-based DBV Technologies announced positive topline results of the three-year, open-label extension of the Phase III PEPITES trial (PEOPLE) evaluating the long-term efficacy and safety of investigational Viaskin® Peanut in peanut-allergic children ages 4 to 11 years. The results demonstrate long-term clinical benefit as shown by an increase in eliciting dose (ED), which may decrease the chance of reacting to an accidental peanut exposure. 

North Brunswick-based Boehringer Ingelheim's Ingelvac CircoFLEX®  was the first PCV2 vaccine that could be freshly mixed with an M hyo vaccine and is still considered one of the most revolutionary PCV2 vaccines on the market. Due to its unique features, it has built a reputation for providing safe, effective control of porcine circovirus associated disease (PCVAD) in pigs three weeks of age or older from a single dose. 

North Brunswick-based Boehringer Ingelheim and Enleofen Bio Pte. Ltd. announced the acquisition of worldwide exclusive rights to Enleofen's preclinical interleukin-11 (IL-11) platform by Boehringer Ingelheim to develop first-in-class therapies across a broad range of fibro-inflammatory diseases. The new partnership combines Boehringer Ingelheim's leading expertise and comprehensive pipeline in fibrotic diseases with Enleofen's world-leading expertise in IL-11 biology and the company's extensive range of therapeutic antibodies targeting this pathway.

Bridgewater-based Ortho Dermatologics announced that the Journal of Drugs in Dermatology (JDD) published positive results from two large Phase 3, multicenter, double-blind, placebo-controlled clinical trials (Studies 1 and 2) demonstrating the efficacy, safety and tolerability of ARAZLO™ (tazarotene) Lotion, 0.045%, the first FDA approved tazarotene in lotion form for patients with moderate to severe acne. The first primary endpoint in the pivotal studies (Studies 1 and 2) was treatment success (defined as those with at least a two-grade improvement in Evaluator's Global Severity Score (EGSS), and 'clear' or 'almost clear' skin) measured at week 12. 

Warren-based Nicox SA  announced that its partner, Bausch + Lomb, has received approval for VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% in Mexico.  The approval in Mexico follows approvals of VYZULTA in the U.S. and Canada. VYZULTA is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Gavin Spencer, Chief Business Officer of Nicox, said "VYZULTA is now approved in three major markets."

Eatontown-based Hikma Pharmaceuticals PLC and Arecor Ltd. announce they have entered into an exclusive agreement to co-develop a new, ready-to-use injectable medicine in the U.S. through Hikma's affiliate, Hikma Pharmaceuticals USA Inc. The product, which will be announced prior to launch, is being developed using Arecor's proprietary drug formulation technology platform Arestat™, which enhances the properties of approved therapeutic proteins and peptides to deliver new reformulations of existing, complex products. 

Bridgewater-based  Osmotica Pharmaceuticals plc  announced the pricing of its public offering of 6,000,000 ordinary shares at a price to the public of  $5.00  per share. All of the shares will be offered by Osmotica. In addition, Osmotica has granted the underwriters a 30-day option to purchase up to an additional 900,000 ordinary shares at the public offering price less underwriting discounts and commissions.

Princeton-based Slayback Pharma LLC announced an agreement with The Everstone Group to invest up to $50 million in Series B funding. The new capital will be used to expand and accelerate Slayback's already rich and differentiated pipeline of complex generic and specialty pharmaceutical products. Ajay Singh, Founder & CEO of Slayback, said: "We are delighted to partner with Everstone in our quest for smart solutions to complex pharmaceutical challenges." 

People in the News

The New Jersey Chapter of the National Association of Corporate Directors will recognize three board members and two boards at its second annual Director of Year Awards this spring, including f ormer Johnson & Johnson Chairman and Chief Executive Officer William Weldon. Mr. Weldon will receive 2020's Lifetime Achievement in Governance award, which recognizes retired or sitting independent directors participating in one of more corporate or non-profit boards for "integrity and leadership at the highest levels over an extended career." 

Princeton-based BioNJ Member Vyome Therapeutics announced the appointment of Craig Tooman as the Chief Operating Officer and Chief Financial Officer. Mr. Tooman brings more than 25 years of operating, financial and M&A experience in the biotechnology and pharmaceutical industries. Prior to his position at Vyome, Mr. Tooman served as Chief Executive Officer of Aratana Therapeutics, a pet therapeutics company which merged with Elanco Animal Health in July, 2019. He also spent six years as the Chief Financial Officer and treasurer of Aratana. 

Iselin-based BioNJ Member Helsinn announces that Eric Cornut and Lonnie Moulder have been appointed as members of the Board of Directors of the Helsinn Group. Eric Cornut is rejoining the Helsinn Group Board, having previously held a Board role from May 2017 - October 2018. He has over 27 years of pharmaceutical management experience. Lonnie Moulder is a highly experienced leader and Board level advisor with over three decades of experience. Most recently, he served as CEO of Tesaro, Inc. a biopharmaceutical company he cofounded which was purchased by GlaxoSmithKline.

Oldwick-based Provention Bio Inc. has named a new Chief Commercial Officer. 
Provention Bio, which is a clinical-stage firm aiming to intercept and prevent immune-mediated diseases, said Jason Hoitt will now serve as its CCO. Mr. Hoitt, who has 18 years of commercial experience in the biotechnology sector, will be part of the senior leadership team, responsible for development and execution of the company's global commercial strategy for its teplizumab product, PRV-031. Mr. Hoitt was most recently Chief Commercial Officer for Dova Pharmaceuticals.

Florham Park-based Cellectar Biosciences, Inc.  announced it has appointed Dr. Igor Grachev as Chief Medical Officer.  "I am excited to welcome Igor to our senior management team as Chief Medical Officer. Igor possesses outstanding academic training and a track record of professional success with highly relevant experiences including multiple global oncology drug approvals," said Jim Caruso, CEO of Cellectar. Igor Grachev, M.D., Ph.D., brings nearly 20 years of industry experience to Cellectar having led clinical development programs at both multinational pharmaceutical and biotech organizations.

Woofcliff Lake-based  PDI  announced it has named Mariano Balaguer as Chief Financial Officer and David Eberson as Chief Human Resources Officer. "We are thrilled to welcome Mariano and Dave to our team," Kent Davies, President and Chief Operating Officer, PDI, said. "Both leaders will contribute new perspectives, capabilities, and capacity as we continue to grow and develop the business in service of our mission to 'Be the Difference.'" Davies continued, "the ongoing growth of PDI brings new opportunities at every level of the organization as we take on the challenges of a larger and more complex business and provide more diverse and valuable infection prevention solutions to our customers."

Florham Park-based  Phathom Pharmaceuticals Inc. announced the appointment of Martin Gilligan as Chief Commercial Officer.  In a press release, Phathom said that Mr. Gilligan most recently served as Corporate Vice President at Celgene Corp., where he led marketing, market access and business development for the Inflammation and Immunology Franchise. "Martin brings deep biopharmaceutical sales, marketing and market access expertise, and we're thrilled to have him join our executive team as we prepare for the potential commercialization of vonoprazan," said Terrie Curran, CEO of Phathom.

Summit-based DBV Technologies announced the appointment of Ramzi Benamar as its Chief Financial Officer. Mr. Benamar will serve as a member of the Executive Committee and report to Daniel Tassé, Chief Executive Officer of DBV Technologies. Mr. Benamar brings more than two decades of experience in biopharmaceutical finance and business operations roles. He most recently served as Vice President and Head of Financial Planning and Analysis for Spark Therapeutics, where he reported directly to the CFO, providing financial leadership across the company and supporting the design and implementation of product launch plans, including pricing strategy, marketing, sales, market access, contracting and distribution.

East Rutherford-based Cambrex Corp. announced it has made changes to its management team and board of directors to "accelerate growth and further operational excellence." 
Effective immediately, they include:  Robert Green to Executive Vice President and Chief Financial Officer;  Shawn Cavanagh to President and Chief Operating Officer; and  Stephan Haitz to President, CDMO Sales & Marketing.  The board will now be comprised of Chairman Wayne Hewett, CEO Steven Klosk, President Shawn Cavanagh, Claes Glassell, and Permira's John Coyle and Henry Minello, Partners, and Laura O'Donnell, Principal.

Institution and Education News

The M urphy administration unveiled the details of its new "Jobs NJ" program, whose mission according to the governor is to ensure that the state's workforce is prepared, and employable, in the event of another economic recession down the road.  Job NJ will focus on boosting the number of industry-credentials, training programs and graduates by the hundreds of thousands by 2025. Jobs NJ will focus on eight industries that the Murphy administration has repeatedly highlighted over the past 15 months: life sciences, information technology, clean energy, advanced manufacturing, transportation and logistics, food and beverage, finance and insurance, and film and digital media.

The state Senate approved Judith Persichilli as commissioner of the New Jersey Department of Health. Ms.  Persichilli, the first nurse to become commissioner, has been the acting commissioner for the past six months, replacing Dr. Shereef Elnahal who left to become President and Chief Executive Officer of University Hospital in Newark. Ms. Persichilli is a veteran health care executive who has held leadership and executive positions in hospitals and health systems.

When he worked in pharma, Christopher Molloy said, trying to work with academics was very difficult. Today, as the chancellor of Rutgers University, Dr. Molloy credits the integration of Rutgers with the University of Medicine and Dentistry of New Jersey to create the Rutgers School of Biomedical and Health Sciences in 2013 with much-improved coordination. That has led to public-private partnerships, such as with RWJBarnabas Health, and increased funding for clinical research, such as the school's recent $29 million Clinical and Translational Science Award from the National Institutes of Health. 

Want to up those tech skills in 2020? If so,  Codecademy, an interactive online learning community, recently polled 1,000 U.S. employees to pinpoint the Top 5 skills-based New Year's resolutions related to technology.  The survey found New Jersey (66%) was one of the Top 5 U.S. states where residents are planning to make resolutions to improve their tech skills.

University Hospital and First Lady Tammy Murphy hosted Surgeon General Dr. Jerome Adams for a Maternal Mortality & Morbidity Listening Session. Dr.  Adams moderated a panel discussion in Newark with health care providers, state and local leaders, and other stakeholders on efforts underway in New Jersey to address these issues. With over 40 clinic physicians and labor and delivery registered nurses, more than 1,600 annual deliveries and over 24,000 prenatal patient visits per year, University Hospital's Regional Perinatal Center handles the most complicated pregnancies and most medically fragile newborns. 

Funding News

Thought Leadership from BioNJ Members

A life sciences e-book created by BioNJ Member Baker Tilly

Data is the lifeblood of businesses across the life sciences industry. Whether a company manufactures medical devices, biotechnology, pharmaceuticals, nutraceuticals, cosmeceuticals, diagnostics tools or environmental solutions -- data about employees, products, customers and the marketplace is essential to improve both ROI and patient outcomes. Baker Tilly's data-driven decisions e-book will help life sciences companies prepare for valuable conversations about maintaining and protecting your key data.

A podcast by BioNJ Member Simphotek Medical Devices, Inc.

The use of radiation therapy to treat cancer has improved the long-term outcome of thousands of patients but is associated with serious side effects. Photodynamic therapy (PDT), a targeted light-based technique, has been approved as an effective treatment for some forms of cancer with fewer side effects than radiotherapy. However, the effectiveness of this technique depends on fine-tuning its application to the patient.  Simphotek, a US-based company founded by world leaders in biophysics and computer modelling, together with its collaborative partners at Roswell Park Comprehensive Cancer Center and the Hospital of the University of Pennsylvania, is focused on expanding novel technologies of PDT as a cancer treatment for solid tumours.

Special Programs from Our Partners for BioNJ Members

January 23, 2020 | Princeton

Triumvirate Environmental's EHS Regulatory Summit is packed with educational content for environmental, health and safety (EHS) professionals. This event provides a comprehensive look at EHS regulatory compliance and offers practical solutions to the challenges that industry professionals face today. Sign up now for this free event here

January 31, 2020 | Edison

The New Jersey Council of County Colleges (NJCCC) and the New Jersey Council for the Humanities (NJCH) will host an Essential Skills Summit on January 31, 2020 to begin a statewide discussion of the skills that will be essential for the future and how these skills can be delivered both in and out of the classroom. 

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.