Welcome to the latest edition of the  BioLines Weekender...
Known as the Medicine Chest of the World, New Jersey is leading the way on COVID-19 research. Join us on Friday, June 5, for a BioNJ COVID-19 Rapid Fire Research Showcase when we bring together 10 companies to share details on their groundbreaking COVID-19 research. From vaccines, cell and gene therapy, treatments and therapeutics, our presenters will highlight the important science coming from the Garden State. 

If you are working on COVID-19 research and would like to share your story, fill out our two-question application to present. But hurry! Today is the deadline to apply. Click here for details. 
Kicking off the program,  Phyllis Arthur, Vice President of Infectious Diseases & Diagnostics Policy  at BIO,  will provide  an overview of the industry's response to this unfathomable pandemic -- including more than 400 research programs  globally.

We hope you can join us on June 5 for this important and exciting program! 

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

COVID-19 Innovations: New Jersey Meets Jerusalem
F eaturing Dr. Sol Barer & Jersey & Jerusalem Companies Doing COVID-19 Research
Register today!
June 1, 2020
The Value of Medical Innovation in the Age of COVID-19 Webinar
June 3, 2020
BioNJ COVID-19 Rapid Fire Research Showcase 
Featuring 10 New Jersey Companies Doing COVID-19 Research
Register today!
June 5, 2020
BioNJ Virtual HR Conference Series
June 23, June 30 & July 7, 2020
BioNJ's 10th Annual BioPartnering Conference
October 6, 2020
BioNJ's C-Suite Summit
October 30, 2020
BioNJ's Manufacturing Briefing
Save the date!
November 12, 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.

In the midst of the race for an effective COVID-19 treatment the Institute for Clinical and Economic Review (ICER) has performed an incomplete analysis of remdesivir in order to produce a cost estimate that is, by definition, precisely wrong. Remdesivir, produced by Gilead Sciences Inc., is an experimental antiviral medication that did not work as hoped to treat Hepatitis C, but is showing promise as a treatment for viruses such as SARS and COVID-19.

The Alliance for Aging Research released new survey findings regarding the public perception of healthcare rationing in the United States . Amid the Coronavirus, health care rationing has become a serious concern, especially surrounding ventilator access and hospital admissions. But as results of the nationwide survey show, many Americans do not realize this type of rationing has been encouraged and orchestrated by one particular organization, the Institute for Clinical and Economic Review, or ICER, for some time.

BioNJ in the News

Assembly Speaker Craig Coughlin named the members who will serve on an Economic Advisory Council he recently announced. The new working panel will advise the Speaker and other members of Assembly Leadership on efforts to ensure New Jersey can responsibly recover from the devastating impacts of COVID-19 when the pandemic subsides. The private sector panel consists of experts in the fields of government, health care, education, higher education, business, commerce, tourism, social services and more. 
Congratulations to BioNJ's President and CEO, Debbie Hart, as well as Drs. James Hughes, John Holloway and Andrew Brooks from BioNJ Member Rutgers University for being named to the Council.

Phrases like "Made in America" and "Made in New Jersey" are nothing new when it comes to the discussion on boosting the economy and making jobs. After years of moves to lower-cost locations, the old-school assembly-line factories that blanketed New Jersey and much of the United States in the mid-20th century seem like a distant memory. But manufacturing in the Garden State and its neighbors remains viable.

BioNJ, the trade group that represents the state's biopharmaceutical industry in Trenton, proposed the introduction of "grants, tax credits and deductions" to lure that kind of manufacturing in the State, "invest in a global marketing plan" for New Jersey, and the creation of a "New Jersey Pandemic Task Force" to look at some of those long-standing issues.

NJ Company News

Bedminster-based BioNJ Member Tyme Technologies, Inc. announced the results of a health economic outcomes study demonstrating that the therapeutic benefit of increasing the use of novel medicines is so great that it is driving a decrease in the actual total cost of healthcare. Health technology assessment programs are increasingly using real-world, longitudinal patient data to assess the effect of new medicines on total cost of care. This study analyzed such data to measure the impact of new pancreatic cancer therapies on other, non-drug medical expenditures.

Princeton-based BioNJ Member  Advaxis, Inc.  announced updated clinical and biomarker results from the monotherapy and combination arms of the Company's ongoing Phase 1/2 study investigating ADXS-503 in patients with non-small cell lung cancer (NSCLC). The trial is evaluating ADXS-503, alone and in combination with KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy. ADXS-503 is part of the Company's ADXS-HOT cancer-type specific immunotherapy program which leverages Advaxis' proprietary Lm technology platform to target hotspot mutations that commonly occur in specific cancer types as well as other proprietary, tumor-associated antigens.

Princeton-based BioNJ Member Soligenix, Inc. announced publication of immunogenicity studies for RiVax® (heat stable ricin toxin vaccine) identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) "Animal Rule."  The article, titled "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," has been submitted to the peer-reviewed medical journal Vaccine.

Princeton-based BioNJ Member Soligenix, Inc. announced its recent accomplishments and financial results for the quarter ended March 31, 2020Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "This has been a very rewarding year for us thus far. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301's potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL). 

South Plainfield-based BioNJ Member  PTC Therapeutics, Inc.  announced positive results from part 2 of the pivotal FIREFISH study evaluating risdiplam in infants with type 1 spinal muscular atrophy (SMA). The global study met its primary endpoint of infants sitting without support for five seconds by month 12, as assessed by the Gross Motor Scale of the Bayley Scales of Infant and Toddler Development Third Edition (BSID-III). Type 1 SMA babies do not achieve this milestone without therapy. Substantial results were demonstrated across multiple secondary and exploratory endpoints, as infants in the study achieved milestones not seen in natural history.

South Plainfield-based BioNJ Member PTC Therapeutics Inc.  announced that it approved non-statutory stock options to purchase an aggregate of 50,025 shares of its common stock and 4,470 restricted stock units ("RSUs"), each representing the right to receive one share of its common stock upon vesting, to seven new employees.  The awards were made pursuant to the NASDAQ inducement grant exception as a component of the new hires' employment compensation.

East Hanover-based BioNJ Member AveXis, a Novartis company, announced the European Commission (EC) granted conditional approval for Zolgensma® (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene. The approval covers babies and young children with SMA up to 21 kg according to the approved dosing guidance.

Bridgewater-based BioNJ Member Amarin Corporation plc announced that data from the REDUCE-IT® study showed that administration of 4 g/day of VASCEPA® (icosapent ethyl) resulted in a significant 34% reduction in first coronary revascularizations versus placebo (p<0.0001). Similar reductions of 36% were observed in total, or first and subsequent, revascularizations (p<0.0001). Coronary revascularization procedures are invasive, carry multiple risks, and can have significant direct and indirect costs.

Parsippany-based BioNJ Member Ferring Pharmaceuticals welcomes the Swissmedic approval of Carbetocin Ferring, a heat-stable formulation of carbetocin, for the prevention of excessive bleeding after childbirth following all births, both vaginal and caesarean section. Every year, 14 million women experience excessive bleeding after birth, also known as postpartum haemorrhage (PPH),2 which leads to approximately 70,000 deaths per year. Although most deaths are preventable, PPH is the leading direct cause of maternal death worldwide, 99% of which occur in low- and lower-middle income countries.

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced  it has commenced the collection of convalescent plasma through its wholly-owned subsidiary, ADMA BioCenters Georgia Inc., from individuals who have recovered from COVID-19.  ADMA is seeking U.S. citizens who have recovered from coronavirus (SARS-CoV-2) or COVID-19, to donate plasma, which can be used to produce an immune globulin to potentially help infected patients with COVID-19. People who have recovered from COVID-19 can have antibodies in their plasma that may be helpful in treating the virus. Immune globulin is a plasma-derived medicine that is comprised of polyclonal antibodies and is routinely used for the prevention and treatment of certain infectious diseases. 

Ramsey-based BioNJ Member ADMA Biologics, Inc. announced The CoVIg-19 Plasma Alliance, an unprecedented plasma industry collaboration recently established to accelerate the development of a plasma-derived hyperimmune globulin therapy for COVID-19, is rapidly building momentum. Its membership has expanded globally to include 10 plasma companies, and now also includes global organizations from outside the plasma industry who are providing vital support to encourage more people to donate plasma.

Edison-based BioNJ Member Hepion Pharmaceuticals, Inc. announced that it has completed the submission of a Phase 1 data memo and the Phase 2a protocol to the FDA, and intends to commence its Phase 2a clinical trial of CRV431 for the treatment of NASH fibrosis in June. The randomized, single-blind, placebo-controlled, multi-center study, entitled "AMBITION: A Phase 2a, Multi-center, Single-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of CRV431 Dosed Once Daily in NASH induced F2 and F3 Subjects," will enroll 18 adults with presumed NASH F2 or F3 fibrosis. 

Basking Ridge-based BioNJ Member  Caladrius Biosciences along with researchers from Cedars-Sinai (Los Angeles), Mayo Clinic (Rochester, Minn.) and The Christ Hospital (Cincinnati), today presented full data results from the ESCaPE-CMD trial of Caladrius's autologous CD34+ cell therapy, CLBS16. Data showed highly statistically significant improvement in coronary flow reserve ("CFR") correlating with symptom relief for patients with coronary microvascular dysfunction ("CMD") after a single intracoronary injection of CLBS16.

Basking Ridge-based BioNJ Member Ipsen announced that data from the matching-adjusted indirect comparison (MAIC) of Cabometyx® (cabozantinib) versus Stivarga® (regorafenib) for the second-line (2L) treatment of patients with advanced hepatocellular carcinoma (aHCC) who received sorafenib as the only prior systemic therapy were published in Advances in Therapy. The MAIC represents the first published analysis of the comparative efficacy and safety of two key 2L treatments for aHCC.

Plainsboro-based BioNJ Member Novo Nordisk announced headline results from STEP 4, the first completed phase 3a trial in the STEP program. STEP 4 is a randomized, double-blind, multicentre, placebo-controlled, withdrawal trial exploring sustained weight management with semaglutide vs placebo. The 68-week trial investigated the effect of once-weekly subcutaneous (sc) semaglutide 2.4 mg on body weight in 902 people with obesity or overweight with comorbidities. 

Cranbury-based BioNJ Member  Rafael Pharmaceuticals, Inc.  announced that it has entered into a research collaboration with Roswell Park Comprehensive Cancer Center. Through this collaboration, researchers will evaluate the effects of CPI-613® (devimistat) with or without chemotherapy agents, including oxaliplatin/cisplatin/5-FU/carboplatin/taxol, on esophageal cancer cells. Rafael has several active clinical trials focusing on cancers in the gastrointestinal tract.

Princeton-based BioNJ Member  Oyster Point Pharma, Inc. announced the pricing of its underwritten public offering of 3,750,000 shares of its common stock at a price to the public of $28.00 per share. All of the shares are being offered by Oyster Point Pharma.  The gross proceeds to Oyster Point Pharma from the offering, before deducting underwriting discounts and commissions and estimated offering expenses to be payable by Oyster Point Pharma, are expected to be $105.0 million.

BioNJ Member Pfizer Inc., with offices in Peapack, announced updated Phase 1b clinical data on PF-06939926, an investigational gene therapy being developed to treat Duchenne muscular dystrophy (DMD). The preliminary data from 9 ambulatory boys with DMD, aged 6 to 12 (mean age: 8 years) indicate that the intravenous administration of PF-06939926 was well-tolerated during the infusion period, with encouraging efficacy and manageable safety events, even when considering those adverse events that were more severe in nature. 

BioNJ Member Pfizer Inc., with offices in Peapack, announced top-line results from a second Phase 3 study (NCT03828617), which described the safety and evaluated the consistency of immune responses elicited across three different lots of its 20-valent pneumococcal polysaccharide conjugate vaccine (20vPnC) candidate in adults 18 through 49 years of age not previously vaccinated against pneumococcal disease. Responses elicited by 20vPnC for all 20 serotypes were equivalent across all three lots, meeting the primary immunogenicity objective of the study. 

Bridgewater-based BioNJ Member  Eli Lilly and Company  announced baseline results from the GERAS-US Study examining the societal costs associated with mild cognitive impairment (MCI), mild dementia (MILD), and caring for someone with Alzheimer's disease (AD). The study, published in  The Journal of Alzheimer's  Disease , is the first of its kind to show how early stages of cognitive decline economically impact both patients and caregivers. Alzheimer's is a relentless, fatal disease creating a health crisis for patients, families and society. Out of the top six diseases affecting Americans, AD is the only one with no treatment to prevent, cure or slow the disease.

Bridgewater-based BioNJ Member  Eli Lilly and Company announced that the  U.S. Food and Drug Administration  (FDA) approved Retevmo™ (selpercatinib, 40 mg & 80 mg capsules), the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer (NSCLC), and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET -mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET  fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

Bridgewater-based BioNJ Member Sanofi announced the U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi's Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients. The target action date for the FDA decision is November 13, 2020. 

Bridgewater-based BioNJ Member Sanofi announced the Phase 3 IKEMA clinical trial evaluating Sarclisa® (isatuximab) added to carfilzomib and dexamethasone met the primary endpoint at its first planned interim analysis, demonstrating significantly prolonged progression-free survival compared to standard of care carfilzomib and dexamethasone alone in patients with relapsed multiple myeloma. There were no new safety signals identified in this study.

Princeton-based BioNJ Member  Bristol Myers Squibb  announced  the FDA granted accelerated approval to pomalidomide for treatment of two forms of Kaposi sarcoma.  The approval applies to use of pomalidomide (Pomalyst, Bristol-Myers Squibb) by patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or by  patients with Kaposi sarcoma  who are HIV-negative. Pomalidomide -- a thalidomide analogue already approved for use with dexamethasone for treatment of certain patients with multiple myeloma -- is the first new treatment option for Kaposi sarcoma in more than 20 years.

Raritan-based BioNJ Member Janssen Pharmaceutical Companies of Johnson & Johnson announced updated results from the Phase 1b/2 CARTITUDE-1 study (NCT03548207) evaluating the efficacy and safety of JNJ-4528, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy in the treatment of patients with relapsed or refractory multiple myeloma. 

New Brunswick-based BioNJ Member Johnson & Johnson has formed a collaboration with Lava Therapeutics to develop gamma-delta T-cell engagers. The agreement moves J&J into an emerging corner of the immuno-oncology sector that has attracted the interest of companies including Pfizer Ventures and Takeda. Gamma-delta T cells are lymphocytes that play a role in natural and induced immunity to cancer.

Kenilworth-based BioNJ Member  Merck & Co. and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has approved LYNPARZA for the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Patients will be selected for therapy based on an FDA-approved companion diagnostic for LYNPARZA.

Kenilworth-based BioNJ Member  Merck & Co. announced positive results from the Phase 3 KEYNOTE-355 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, in combination with chemotherapy as first-line treatment in patients with metastatic triple-negative breast cancer (mTNBC). In patients whose tumors expressed PD-L1 with Combined Positive Score (CPS) ≥10, KEYTRUDA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 35% (HR = 0.65 [95% CI, 0.49-0.86], p=0.0012) and improving PFS to a median of 9.7 months compared to 5.6 months for those receiving chemotherapy alone. 

Kenilworth-based BioNJ Member  Merck & Co. announced the first presentation of results from KEYNOTE-204, a Phase 3 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). In this pivotal study, KEYTRUDA demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), one of the dual primary endpoints. KEYTRUDA reduced the risk of disease progression or death by 35% (HR=0.65 [95% CI, 0.48-0.88; p=0.00271]) and showed a median PFS of 13.2 months compared with 8.3 months for patients treated with brentuximab vedotin (BV), a current standard of care in this patient population. 

Kenilworth-based BioNJ Member  Merck & Co. announced first-time results from a Phase 2 trial evaluating the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate in Merck's oncology pipeline, for the treatment of von Hippel-Lindau (VHL) disease-associated clear cell renal cell carcinoma (ccRCC). In the trial, MK-6482 demonstrated durable responses with a confirmed objective response rate (ORR) of 27.9% (n=17/61) (95% CI: 17.1-40.8), and the median duration of response (DOR) was not yet reached (range: 9.1-39.0 weeks).

Kenilworth-based BioNJ Member  Merck & Co. announced positive results from two studies from the company's leading lung cancer research program. Initial results from the Phase 2 KEYNOTE-799 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus concurrent chemoradiation therapy (CCRT) demonstrated an objective response rate (ORR) of 67.0% in Cohort A (squamous and nonsquamous non-small cell lung cancer [NSCLC] patients who received paclitaxel plus carboplatin) and 56.6% in Cohort B (nonsquamous NSCLC patients who received cisplatin plus pemetrexed) in untreated patients with unresectable, locally advanced stage III NSCLC. 

Kenilworth-based BioNJ Member  Merck & Co. announced results from RESTORE-IMI 2, a randomized, controlled, double-blind Phase 3 clinical trial evaluating RECARBRIO™ (imipenem, cilastatin, and relebactam) for the treatment of adults with hospital-acquired or ventilator-associated bacterial pneumonia (HABP/VABP). The results demonstrated noninferiority of RECARBRIO compared to piperacillin and tazobactam (PIP/TAZ), the active comparator, in the primary and key secondary endpoints of the study, 28-day all-cause mortality and clinical response, respectively.

Kenilworth-based BioNJ Member  Merck & Co.  announced that the U.S. Food and Drug Administration (FDA) has approved an additional recommended dosage of 400 mg every six weeks (Q6W) for KEYTRUDA, Merck's anti-PD-1 therapy, across all adult indications, including monotherapy and combination therapy. This indication is approved under accelerated approval based on pharmacokinetic data, the relationship of exposure to efficacy and the relationship of exposure to safety. 

Kenilworth-based BioNJ Member  Merck & Co. announced it will acquire the U.S. rights to two Sentinel brands in the companion animal segment. For $400 million, Merck said it acquired Sentinel's Flavor Tabs and Spectrum Chews to enhance its offerings in canine parasite protection.  The deal is expected to close by mid-year 2020.  Merck Animal Health's Scott Bormann, senior vice president, North America commercial operations, said the product acquisition is anticipated to provide veterinarians with a comprehensive and continuous parasite protection for dogs in easy to use and eat formulas.

Kenilworth-based BioNJ Member  Merck & Co. announced that Infectious Disease Connect Inc., a UPMC-backed company offering telemedicine-enabled solutions to hospitals for treatment of infectious diseases, has combined with Merck's ILÚM Health Solutions, a provider of technology and services to support infectious disease management, clinical decision-support and precision antibiotic therapy.

The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Paramus-based Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam ® 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression.  The primary objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose Octagam ®  10% therapy will slow or stop respiratory deterioration in patients with severe coronavirus disease. T

Princeton-based ReGenTree, LLC  announced the results of a randomized, double masked, placebo-controlled Phase 3 clinical trial (SEER-1) using RGN-259 for the treatment of neurotrophic keratopathy (NK). The study originally planned to recruit 46 patients using RGN-259, the same eye drop formulation used in the dry eye trials. However, because of slow patient recruitment and future pricing strategy for NK as a rare disease, the trial was closed early and 18 patients were analyzed.

Warren-based  Bellerophon Therapeutics, Inc.  said the U.S. Food and Drug Administration (FDA) accepted its Investigational New Drug (IND) application, allowing it to initiate a Phase 3 study of INOpulse® inhaled nitric oxide (iNO) therapy in up to 500 patients infected with COVID-19. The IND acceptance follows an agreement by the FDA earlier this year to allow investigational treatment with INOpulse for COVID-19 patients under emergency expanded access. To date, over 50 patients with COVID-19 have received treatment with INOpulse under the care and supervision of their physicians.

Warren-based  Bellerophon Therapeutics, Inc.  announced the pricing of offerings for an aggregate of 3,076,923 shares of its common stock at a public offering price of  $13.00  per share. The Offerings consisted of an underwritten public offering of 1,923,077 shares and a registered direct offering of 1,153,846 shares to an institutional investor affiliated with a member of the company's board of directors. 

Neurotrope Inc. and Freehold-based Metuchen Pharmaceuticals LLC revealed the two merged to become Petros Pharmaceuticals Inc., a company expected to become a Nasdaq traded company focused that is solely on men's health conditions.  Petros' cornerstone product would be Metuchen's Stendra (avanafil) for erectile dysfunction (ED), and its pipeline would include Metuchen's recently in-licensed product H-100 for Peyronie's disease. Petros will include a business development program exploring various men's health products, including endothelial dysfunction, prostate cancer, psychosexual and psychosocial ailments, hormone health and substance use disorders.

Lipocine Inc., with offices in Lawrence Township, announced the results of a pre-clinical study of LPCN 1144. LPCN 1144 is an oral prodrug of bioidentical testosterone ("testosterone undecanoate" or "TU"). The pharmacological effect of LPCN 1144 was investigated in a non-genomic, five arm, 12-week high fat diet ("HFD")-induced, rabbit animal model of NASH and hepatic fibrosis. In the pre-clinical study, the HFD induced histological NASH features with fibrosis, altered key biomarkers and lowered serum testosterone levels. 

Catalent, a Somerset-based provider of  clinical supply services, announced on Thursday it has acquired a clinical packaging facility in Japan from  Teva-Takeda Pharmaceuticals.
Catalent's new facility in Minakuchi, Japan.  The 60,000-square-foot Minakuchi-based facility will establish a new clinical GMP manufacturing and distribution hub for Catalent to support clinical studies. It will also be the largest facility in the company's Asia Pacific clinical supply network and operate in partnership with Catalent's existing Japanese clinical supply facility in Kakegawa.

Bayer Fund awarded more than $4 million in grants to 250 charities and non-profit organizations throughout the United States.  Each grant from the philanthropic arm of Whippany-based  Bayer Corp.  will go toward a program that supports one or more of Bayer Fund's key focus areas: food and nutrition, STEM Education, health and wellness and community development. In addition to program grants, another $2 million will be given to help support initiatives related to COVID-19, with the first $710,000 awarded to address food insecurity. 

Princeton-based Neurotrope, Inc. and Freehold-based Metuchen Pharmaceuticals, L.L.C., announced that the two companies have entered into a definitive merger agreement under which Metuchen and Neurotrope, Inc. will merge in an all-stock transaction resulting in a newly formed holding company to be renamed Petros Pharmaceuticals, Inc. Petros is expected to become a Nasdaq traded company focused solely on men's health conditions. Petros' cornerstone product would be Metuchen's Stendra ® (avanafil) for erectile dysfunction.

Ridgefield Park-based  BeiGene, Ltd.  and Medison Pharma Ltd.  announced an exclusive distribution agreement for Medison to commercialize BeiGene's BTK inhibitor BRUKINSA™ (zanubrutinib) in Israel and the acceptance of a new drug application (NDA) in Israel for BRUKINSA for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Princeton-based  Certara® and DMTC have entered into a research collaboration to evaluate the preventative use of chloroquine in health care workers at risk of infection from the novel coronavirus strain that causes COVID-19. Certara will support the DMTC-led clinical trial by analyzing study data to develop mathematical models to understand the viral time course and factors impacting drug exposure and prophylactic response in health care workers. 

Zimmel Associates said that Health Pharma USA, which currently leases 5,000 square feet in Rahway, just nabbed an additional 10,000 square feet in the same location for more industrial space for its growing company.  Located at 1560 - 1566 Hart St., the pharmaceutical manufacturing company was able to secure additional space in the 40,000-square-foot building that it is currently in. The structure is one of five buildings that comprise the 200,000-square-foot flex building, which provides units between 5,000 to 15,000 square feet.

Woodcliff Lake-based Timber Pharmaceuticals said that the company closed its merger with BioPharmX Corp. and that the combined entity had completed a private placement financing valued at $25 million.  The biopharmaceutical company, which is focused on developing and commercializing treatments for orphan dermatologic diseases, will operate under the Timber Pharmaceuticals name and trade on the small-cap NYSE American Market. 

Thorofare-based Akers Biosciences, Inc. announced the closing of its previously announced registered direct offering of an aggregate of 1,366,856 shares of the company's common stock, at a purchase price of $3.53 per share priced at-the-market under Nasdaq rules. The gross proceeds to the company from this offering was approximately $4.8 million, before deducting the placement agent's fees and other offering expenses payable by the company.

Cranford-based  Citius Pharmaceuticals Inc. announced the closing of the previously announced registered direct offering priced at-the-market under Nasdaq rules.  In the offering, Citius sold 7,058,824 shares of its common stock, at a purchase price per share of $1.0625. Additionally, Citius issued to the investors unregistered warrants to purchase up to 3,529,412 shares of its common stock. 

Has COVID-19 Impacted Your Business or Organization? New Jersey Wants to Hear From You.

The State of New Jersey is requesting your input to better understand how to help you get back to work safely and productively. By filling out an online survey about your operations you can help inform the State's reopening strategy and upcoming business and organization assistance opportunities.
Survey questions include inquiries about COVID-19's impact on your operations, your business's or nonprofit's plans to return to work, and how the State and local governments can support you and your employees in the months ahead.

Act quickly and complete the COVID-19 Reopening/Recovery Survey to share more about how COVID-19 has impacted your operations and let New Jersey know how to best help you move forward.

People in the News

Kenilworth-based BioNJ Member  Merck & Co. announced the appointment of Matthew Walsh and Rachel Stahler as Chief Financial Officer and Chief Information Officer, respectively, for Organon & Co., its intended spinoff of its women's health, legacy brands and biosimilars businesses. In his new role, Mr. Walsh will be responsible for the development and execution of the company's overall financial strategy. Ms. Stahler will be responsible for all information technology strategy, infrastructure, operations and delivery for Organon. 

Nancy Wysenski has been appointed to Oldwick-based Provention's board of directors. Ms. Wysenski, the former Chief Commercial Officer of Vertex Pharmaceuticals, brings over 30 years of leadership in biotechnology and pharmaceuticals, and a proven track record in innovative therapeutic launches and corporate value creation, including rare life-impacting diseases with high unmet need.

Montclair-based  Theranica USA  announced the appointment of two senior executives amid growing demand for the company's prescription migraine treatment device  Nerivio® Dave Duff , formerly of Sunovion Pharmaceuticals, joins Theranica as Head of Marketing and Training, and  Jennifer Stanton  from pharmaceutical company Zogenix joins as Head of Market Access to lead all reimbursement and access initiatives for Nerivio.

Englewood-based  Enzychem Lifesciences  announced that Dr.  Cameron Robert Wolfe , Associate Professor of Medicine at  Duke University  School of Medicine, an internationally renowned specialist in infectious diseases, has been appointed to lead the company's U.S COVID-19 efforts of the development of EC-18 as a COVID-19 therapeutic drug. Dr. Wolfe has been leading Duke University Medical School's Coronavirus Task Force, where he has been on the frontlines treating COVID-19 patients.

Berkeley Heights-based CorMedix Inc. announced it has appointed Matt David as its executive vice president and Chief Financial Officer.  "I am pleased that Matt has agreed to join the company at this most exciting time," CorMedix CEO Khoso Baluch said. Before CorMedix, Mr. David was head of strategy at Ovid Therapeutics. He also has more than 15 years of experience in health care finance.

Institution and Education News

Caris Life Sciences®, a leading innovator in molecular science focused on fulfilling the promise of precision medicine, announced that Rutgers Cancer Institute of  New Jersey  has become the 37 th  member of its Caris Precision Oncology Alliance™. The Alliance is a collaborative network of leading cancer centers that demonstrate a commitment to precision medicine. These centers work together to advance comprehensive cancer profiling and establish standards of care for molecular testing in oncology through conducting research studies focused on predictive and prognostic markers that advance the clinical outcomes of patients with cancer.

Aiming to identify new therapeutic strategies for the aggressive hematological disease T-cell acute lymphoblastic leukemia (T-ALL), Rutgers Cancer Institute of New Jersey resident researcher  Daniel Herranz Benito, Ph.D. , along with collaborators from Princeton University, found a new drug that has therapeutic effect against T-ALL by inhibiting SHMT and is complementary to standard-of-care treatment.

Hackensack Meridian Health invested in regenerative medicine company EpiBone Inc. 
Brooklyn-based EpiBone focuses on the growth of personalized bone and cartilage grafts using stem cell technologies and 3-D imaging and designs.  This is HMH's fourth investment in a clinical-stage regenerative medicine company through  the Bear's Den , the health network's innovation program. EpiBone's craniomaxillofacial, or EB-CMF, product is being tested in its first trials as a treatment for ramus continuity defects in the jaw.

Drew University President MaryAnn Baenninger is leaving the Madison-based college, which said in a statement that, "She and the board of trustees together came to the decision that Drew's future direction requires a change of leadership for the long term." Ms.  Baenninger, who joined Drew in 2014, will leave at the end of her current contract - which was extended a month, from an expiry of June 30 to July 31, to assist in the transition to new leadership. A search committee, led by board member Angela Gerken, intends to name an interim President by the time Ms. Baenninger leaves.

Funding News

The New Jersey Economic Development Authority (NJEDA) announced a $50 million expansion of its Small Business Emergency Assistance Grant Program, which provides funding to small businesses facing financial challenges as a result of the COVID-19 pandemic. The expanded program will provide grants up to $10,000 to qualified businesses and relaxes eligibility criteria to include a broader variety of businesses as well as home-based businesses and sole proprietorships. To ensure equity, $15 million will be reserved for businesses in Opportunity Zone-eligible census tracts.

NJ entrepreneurs and small businesses are eligible to receive guidance and assistance in pursuing the SBIR and STTR programs. These services include help in determining whether SBIR and STTR are worth pursuing given a company's technology, core competencies, business goals and team; and coaching throughout the proposal development process.  In addition, reviews and critiques of draft proposals including suggestions for strengthening them are also available. Included in the proposal review services are reviews and critiques of required Phase I and Phase II commercialization plans, which can be particularly challenging for many applicants.
Assistance can be requested by sending an E-mail message to  randygharmon@aol.com.

Two introductory webcasts intended to introduce entrepreneurs and small businesses to the basics of SBIR & STTR and proposal writing:

Special Programs from Our Partners for BioNJ Members

June 8-12, 2020 | Virtual

For 2020, the BIO International Convention will transition to a new, virtual event format, BIO Digital. This virtual gathering of the global biotech industry will provide access to key partners via BIO One-on-One Partnering, educational resources to help drive your business, and the insights you need to continue critical research and development.  Join us, June 8-12, from wherever you are in the world, for BIO Digital 2020.

June 16, 2020 | Virtual

Students 2 Science is delighted to invite you to S2S: The Salon, a community gathering in celebration of S2S' 10-year anniversary. It will be a wonderful event with key influencers in the State of New Jersey representing both public and private sectors, including corporate leaders, educators, administrators and policy officials.  A panel discussion, led by BioNJ President and CEO Debbie Hart will engage participants in a dialogue on the urgent and important topics of equity and diversity in STEM education: "How Do We Encourage a Ready and Diversified Workforce in STEM?" For more information on tickets and sponsorship contact S2S@students2science.org. 

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.