Dr. Reddy’s Laboratories Announces the Launch of Deferasirox Tablets for Oral Suspension, in the U.S. Market

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Deferasirox Tablets for Oral Suspension, a therapeutically equivalent generic version of Exjade® (deferasirox) Tablets for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA).

The Exjade® brand had U.S. sales of approximately $113 million MAT for the most recent twelve months ending in September 2019 according to IQVIA Health*.

Dr. Reddy’s Deferasirox Tablets for Oral Suspension, are available in 125 mg, 250 mg, and 500 mg dosage strengths in bottle count sizes of 30.

 

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

  • Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
  • Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m2. Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with preexisting renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation [see Dosage and Administration (2.1, 2.4,2.5), Warnings and Precautions (5.1), Adverse Reactions (6.1, 6.2)].

Hepatic Failure

  • Deferasirox can cause hepatic injury including hepatic failure and death.
  • Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
  • Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child-Pugh B) hepatic impairment [see Dosage and Administration (2.4), Warnings and Precautions (5.2)].

Gastrointestinal Hemorrhage

  • Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
  • Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)].

Please refer to the Package Insert for the full prescribing information including boxed warning.

Exjade® is a trademark of Novartis Pharma AG.

*IQVIA Retail and Non-Retail MAT September 2019.

RDY-0819-261

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com.

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization , including related integration issues.

The company assumes no obligation to update any information contained herein.

Contacts

INVESTOR RELATIONS

AMIT AGARWAL

amita@drreddys.com
(PH: +91-40-49002135)

MEDIA RELATIONS

MITALI SARKAR

mitali.sarkar@drreddys.com
(PH: +91-40-49002121)

Dr. Reddy’s Laboratories Announces the Launch of Deferasirox Film-Coated Tablets, in the U.S. Market

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Deferasirox Film-Coated Tablets, 90 mg and 360 mg, a therapeutically equivalent generic version of Jadenu® (deferasirox) Film-Coated Tablets, 90 mg, 180 mg, and 360 mg, approved by the U.S. Food and Drug Administration (USFDA).

The Jadenu® brand had U.S. sales of approximately $470 million MAT for the most recent twelve months ending in September 2019 according to IQVIA Health*.

Dr. Reddy’s Deferasirox Film-Coated Tablets are available in 90 mg and 360 mg dosage strengths in bottle count sizes of 30.

 

WARNING: RENAL FAILURE, HEPATIC FAILURE, AND GASTROINTESTINAL HEMORRHAGE

Renal Failure

  • Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.
  • Evaluate baseline renal function prior to starting or increasing deferasirox dosing in all patients. Deferasirox is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m2. Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with preexisting renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation [see Dosage and Administration (2.1, 2.4,2.5), Warnings and Precautions (5.1), Adverse Reactions (6.1, 6.2)].

Hepatic Failure

  • Deferasirox can cause hepatic injury including hepatic failure and death.
  • Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter.
  • Avoid use of deferasirox in patients with severe (Child-Pugh C) hepatic impairment and reduce the dose in patients with moderate (Child-Pugh B) hepatic impairment [see Dosage and Administration (2.4), Warnings and Precautions (5.2)].

Gastrointestinal Hemorrhage

  • Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.
  • Monitor patients and discontinue deferasirox for suspected GI ulceration or hemorrhage [see Warnings and Precautions (5.3)].

Please refer to the Package Insert for the full prescribing information including boxed warning.

Jadenu® is a trademark of Novartis AG.

*IQVIA Retail and Non-Retail MAT September 2019.

RDY-0719-259

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates , interest rates , persistency levels and frequency / severity of insured loss events (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization , including related integration issues.

The company assumes no obligation to update any information contained herein.

Contacts

INVESTOR RELATIONS
AMIT AGARWAL

amita@drreddys.com
(PH: +91-40-49002135)

MEDIA RELATIONS
MITALI SARKAR

mitali.sarkar@drreddys.com
(PH: +91-40-49002121)

Ipsen Initiates Partial Clinical Hold for Palovarotene IND120181 and IND135403 Studies

PARIS–(BUSINESS WIRE)–Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following discussions with the U.S. Food and Drug Administration (FDA), that a partial clinical hold effective immediately, for the pediatric population under the age of 14 was issued for studies conducted under IND120181 and IND135403 evaluating the investigational drug candidate palovarotene for the chronic treatment of fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO), respectively. The partial clinical hold applies to the pediatric population (patients under the age of 14 years) currently participating in the Phase 2 (PVO-1A-202/204 and PVO-2A-201) and Phase 3 (PVO-1A-301) studies in all clinical sites at global level. The FDA is allowing the studies to continue to treat patients 14 years of age and older.

The partial clinical hold was issued following recent safety reports submitted by the company to the FDA of cases of early growth plate closure in pediatric patients with FOP treated with palovarotene. The FDA has placed the studies on partial clinical hold pending review of additional details regarding these events and plans to issue additional requests for information within the next 30 days. Although no serious adverse events (SAEs) related to early growth plate closure in the MO study have been reported to date, this study has been included in this hold due to the occurrence of these events with chronic dosing in the FOP program. Since the MO study is a primarily pediatric study with the upper age of enrollment at 14 years, all subjects currently participating in the study will have interruption of treatment until further notice and no new patients will be enrolled while the partial clinical hold is in effect.

At Ipsen, the safety of patients is always a top priority, and the company is committed to ensuring the safe and effective use of its medicines. Ipsen is committed to researching and developing therapies for children and adults living with FOP and MO, two rare and devastating bone diseases with no current therapeutic treatment options.

Ipsen is committed to working diligently with the FDA to provide all requested information with the goal of resolving the partial clinical hold. Ipsen continues to prepare the FDA New Drug Application (NDA) filing for palovarotene in acute/flare-up FOP.

About Ipsen

Ipsen is a global specialty-driven biopharmaceutical group focused on innovation and Specialty Care. The Group develops and commercializes innovative medicines in three key therapeutic areas – Oncology, Neuroscience and Rare Diseases. Its commitment to oncology is exemplified through its growing portfolio of key therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and pancreatic cancer. Ipsen also has a well-established Consumer Healthcare business. With total sales over €2.2 billion in 2018, Ipsen sells more than 20 drugs in over 115 countries, with a direct commercial presence in more than 30 countries. Ipsen’s R&D is focused on its innovative and differentiated technological platforms located in the heart of the leading biotechnological and life sciences hubs (Paris-Saclay, France; Oxford, UK; Cambridge, US). The Group has about 5,800 employees worldwide. Ipsen is listed in Paris (Euronext: IPN) and in the United States through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.

Ipsen—Cautionary Note Regarding Forward-Looking Statements

The forward-looking statements, objectives and targets contained herein are based on the Group’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words “believes”, “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements, including the Group’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by the Group. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising product in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. The Group must face or might face competition from generic products that might translate into a loss of market share. Furthermore, the Research and Development process involves several stages each of which involves the substantial risk that the Group may fail to achieve its objectives and be forced to abandon its efforts with regards to a product in which it has invested significant sums. Therefore, the Group cannot be certain that favorable results obtained during pre-clinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the product concerned. There can be no guarantees a product will receive the necessary regulatory approvals or that the product will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the Group’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Group’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The Group also depends on third parties to develop and market some of its products which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to the Group’s activities and financial results. The Group cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of the Group’s partners could generate lower revenues than expected. Such situations could have a negative impact on the Group’s business, financial position or performance. The Group expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. The Group’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to the Group’s 2018 Registration Document available on its website (www.ipsen.com).

Contacts

Media
Christian Marcoux, M.Sc.

Senior Vice President, Global Communications

+33 (0)1 58 33 67 94

Christian.marcoux@ipsen.com

Karla MacDonald

Vice President, Communications, North America

+1 (857) 332-3467

Karla.macdonald@ipsen.com

Financial Community
Eugenia Litz

Vice President, Investor Relations

+44 (0) 1753 627721

eugenia.litz@ipsen.com

Myriam Koutchinsky

Investor Relations Manager

+33 (0)1 58 33 51 04

myriam.koutchinsky@ipsen.com

Wave Neuroscience Completes Major Brain Treatment Technology Asset Purchase

U.S. – Based Ownership of Underlying Assets, IP and Key Personnel Focused on Greater Care Access for Core Patients, Including U.S. Military

NEWPORT BEACH, Calif.–(BUSINESS WIRE)–Wave Neuroscience – a provider of non-invasive neuromodulation technology aimed at addressing neurological disorders and enhancing cognitive brain function – announces the completion of an asset purchase from Newport Brain Research Laboratory (NBRL). In June 2019, Wave Neuroscience purchased substantially all of the assets from the many different onshore and offshore holding companies under NBRL. Now a wholly owned and operated U.S. corporation chartered in Delaware, Wave Neuroscience is focused on leadership in brain health and its restoration.

In addition, key NBRL personnel – all U.S. persons – were hired into new roles at Wave Neuroscience. The company is concentrating growth efforts on aiding those who are candidates for its patented treatments – including veterans and active military servicemembers. Since June, Wave Neuroscience’s military commitment is exemplified by more than $500K of free treatments pledged to U.S. military members. 

“Two of our core focus areas are lessening the often-devastating impacts of Traumatic Brain Injuries (TBI) and Post-Traumatic Stress Disorder (PTSD), and for this reason, we have committed to putting American servicemembers first,” said Fred Walke, Wave Neuroscience CEO. “We believe our ground-breaking treatment methods are a powerful restorative tool when the fight becomes a personal one.”

The crux of Wave Neuroscience’s research revolves around the premise that the brain can be treated by non-pharmaceutical and non-surgical means. It asserts that with the exploration of the relationship between cognition and neural activity, an innovative and informed approach to non-invasive neuromodulation is possible. The company’s dedicated team of neuroscientists and physicians has put their talents towards delivering individualized treatment aimed at achieving a healthier life for people with various neurological issues.

Wave Neuroscience offers a personalized treatment platform for addressing neurological abnormalities and has treated more than 7,000 patients using its patented, non-invasive, drug-free MeRT℠ process, which is licensed by a network of independently owned medical facilities.

The MeRT℠ process involves four key steps: 1) recording a patient’s EEG/EKG; 2) processing this biometric data with computational neuroanalytics; 3) generation of an individualized treatment protocol delivered by a technician using FDA-cleared equipment; and 4) continual progress evaluation using sequential measurements to inform protocol adjustment. At present, Wave Neuroscience has five ongoing clinical trials, including an FDA-grade trial for persistent post-concussion syndrome (PCS), and strategic partnerships with organizations including the USC Neurorestoration Center and Cedars-Sinai Center for Sports Neurology at Kerlan-Jobe. The company’s work is fueled by ten wholly owned and U.S.-held patents with 6 applications pending.

 “As Americans, we owe our servicemembers an unending debt of gratitude. One of the ways we believe we can help is by making them feel whole, mentally, again. By taking a truly bespoke and data-driven approach, we view ourselves as the vanguard of progress in researching and striving to treat the root causes of TBI, PTSD and other neurological disorders,” said Dr. Erik Won, President. 

About Wave Neuroscience: Wave Neuroscience’s goal is to empower and optimize brain function. The company’s patented MeRT℠ process improves non-invasive neuromodulation technology by precisely adjusting neural networks to address a wide range of neurological disorders, as well as enhance cognitive performance, using non-pharmacological methods. The company’s precise, personalized therapy analyzes brainwave activity using machine-learning that helps guide decisions on treatment stimulation parameters. MeRT℠ treatments are administered to patients by skilled physicians using FDA-cleared equipment at 14 locations worldwide, including 12 in the United States. On the web: http://waveneuro.com/.

Contacts

Spencer Vigoren

949-851-3086

spencer@waveneuro.com

FerGene Announces Pivotal Phase 3 Study of Nadofaragene Firadenovec Met Its Primary Endpoint With More Than Half of Patients With High-Grade Non-Muscle Invasive Bladder Cancer (CIS ± Ta/T1) Achieving a Complete Response at Three Months

  • The multi-center study met its primary endpoint with 53% of CIS ± Ta/T1 patients achieving a complete response (CR) at three months, and 24% continuing to show a CR at 12 months
  • Additional data show 73% high-grade recurrence free (HGRF) survival in patients with papillary disease at three months and 44% HGRF survival at 12 months
  • Clinical results also support a favorable safety and tolerability profile for nadofaragene firadenovec
  • Nadofaragene firadenovec is administered intravesically once every three months

WASHINGTON–(BUSINESS WIRE)–FerGene, a new gene therapy company formed by Ferring Pharmaceuticals and Blackstone Life Sciences, announced today positive results from the pivotal Phase 3 clinical trial evaluating nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy, for the treatment of high-grade, Bacillus Calmette-Guérin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC). FKD Therapies Oy (FKD) has led the development and regulatory filing of nadofaragene firadenovec, which has been studied in 33 centers across the U.S. in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC). The results were presented during the bladder cancer session at the Society of Urologic Oncology 20th Annual Meeting in Washington D.C.

The Phase 3 study of 157 patients from the U.S. met its primary endpoint with 53% of CIS ± Ta/T1 patients (carcinoma in situ; bladder cancer that is confined to the superficial layer, with or without concomitant high-grade Ta or T1 papillary disease) achieving a CR at three months, and 24% continuing to show a CR at 12 months. Moreover, the study also demonstrated broad efficacy in this difficult to treat patient population with a 73% HGRF survival in patients with papillary disease at three months and 44% HGRF survival at 12 months. In the study, nadofaragene firadenovec was instilled directly into the patients’ bladder every three months. All responses at 12 months were confirmed by protocol-mandatory five-point biopsies.

Bladder cancer is one of the most frequently occurring cancers with an estimated 699,450 people living with bladder cancer and more than 80,000 new cases diagnosed each year in the U.S. alone.1 In high-grade NMIBC patients, BCG is the standard treatment, and, although effective, over 60% of these tumors eventually re-occur. 2,3

“Currently, patients living with high-grade NMIBC who are unresponsive to BCG have few treatment options and often face bleak outcomes, including complete bladder removal, known as cystectomy,” said Colin P. N. Dinney, MD, Professor and Chairman of the Department of Urology at The University of Texas M.D. Anderson Cancer Center. “Cystectomy is a complex and life-altering surgical procedure for patients, so these positive results from the Phase 3 trial of nadofaragene firadenovec are highly promising for patients. It would be gratifying to provide an alternative that addresses the critical unmet need for effective second-line therapy for patients facing radical cystectomy.”

Efficacy Analysis*

Assessment

Period

CIS ± Ta/T1 Disease (n=103) CR

(% [n])

High-Grade Ta/T1 Papillary Disease (non CIS)

(n=48) HGRF Survival (% [n])

Month 3

53.4% (55)

72.9% (35)

Month 6

40.8% (42)

62.5% (30)

Month 9

35.0% (36)

58.3% (28)

Month 12

24.3% (25)

43.8% (21)

*151 patients

In the Phase 3 trial, the most common adverse events (AEs) included fatigue, bladder spasm and discharge around the catheter, micturition urgency, hematuria, chills, fever, headache, painful urination, urinary tract infection, and diarrhea. No grade 4 or 5 treatment-related AEs were reported in the study. Study drug-related AEs were transient and local in nature, with a median duration of less than two days, with the exception of fatigue, which had a median duration of 11 days and urinary frequency which had a median duration of 41 days. There was a 1.9% percent rate of discontinuations due to study drug-related AEs.

“We are pleased with these Phase 3 data results, including the complete response rates and favorable safety profile seen with nadofaragene firadenovec,” said Nigel R. Parker4, PhD, of FKD Therapies Oy. “These data were part of our submission package to the FDA, and we look forward to continuing to work with the agency to potentially bring nadofaragene firadenovec to patients with BCG unresponsive disease.”

“As a practicing urologist and trial investigator, it’s encouraging to see these types of efficacy and safety results in patients with high-grade NMIBC, an area that’s been in need of new innovative treatment options for more than 20 years,” said Neal Shore, MD, FACS, Medical Director, Carolina Urologic Research Center. “These robust clinical results further demonstrate the potential of nadofaragene firadenovec as a valuable treatment option for NMIBC patients.”

The U.S. Food and Drug Administration (FDA) has validated FKD’s Biologics License Application (BLA) and granted Priority Review for nadofaragene firadenovec, which previously received Fast Track and Breakthrough Therapy Designations.

About nadofaragene firadenovec

Nadofaragene firadenovec (rAd-IFN/Syn3) is an investigational gene therapy being developed as a treatment for patients with high-grade, BCG unresponsive, NMIBC. It is an adenovirus vector-based gene therapy containing the gene interferon alfa-2b, administered by catheter into the bladder every three months. The vector enters the cells of the bladder wall, where, it breaks down, releasing the active gene to do its work. The internal gene/DNA machinery of the cells ‘picks up’ the gene and translates its DNA sequence, resulting in the cells secreting high quantities of interferon alfa-2b protein, a naturally occurring protein the body uses to fight cancer. This novel gene therapy approach thereby turns the patient’s own bladder wall cells into multiple interferon microfactories, enhancing the body’s natural defenses against the cancer.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

NMIBC is an early form of bladder cancer which is present in the superficial layer of the bladder and has not invaded deeper into the bladder or spread to other parts of the body.5 It is estimated that there will be 80,000 new cases of bladder cancer in the U.S. in 2019; more than 70% of these cases present as NMIBC.2,6 In patients with high-grade NMIBC, intravesical BCG is the recommended treatment; however, between 30% and 50% cases with high-grade disease will recur.7 The outcome for BCG unresponsive patients is poor, with total cystectomy (complete removal of the bladder) often being the next treatment option.8

About FerGene

FerGene, a new gene therapy company and Ferring subsidiary, has been created to potentially commercialize nadofaragene firadenovec in the U.S. and to advance the global clinical development. FerGene’s goal is to bring this promising therapy to a patient population which has seen little improvement in their standard of care over the past twenty years. Blackstone Life Sciences will invest $400 million USD and Ferring will invest up to $170 million USD in FerGene. Ferring will also potentially launch and commercialize nadofaragene firadenovec outside of the U.S.

About FKD Therapies Oy

FKD Therapies Oy is a specialist gene therapy company based in Kuopio, Finland originally conceived by scientific and medical founders, Dr Nigel R Parker and Professor Seppo Yla-Herttuala4, for the specific purpose of undertaking the development of adenovirus mediated interferon alfa-2b. FKD has led the overall development of nadofaragene firadenovec through manufacturing at FinVector Oy, late stage clinical trials and the current BLA filing. FinVector Oy and FKD Oy are part of the Trizell Group.

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Founded in 1950, Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

______________________________

1 National Cancer Institute. Cancer Stat Facts: Bladder Cancer. Available at: https://seer.cancer.gov/statfacts/html/urinb.html. Last accessed: December 2019.

 

2 Maruf, M et al., Non invasive bladder cancer: a primer on immunotherapy. Cancer Biol Med. 2016;13(2):194-205.

 

3 Derré, L et al., Intravesical Bacillus Calmette Guerin Combined with a Cancer Vaccine Increases Local T-Cell Responses in Non-muscle-Invasive Bladder Cancer Patients. Clin Cancer Res. 2017;23(3):717-725.

 

4 AIV Institute for Molecular Sciences, Kuopio, Finland.

 

5 Anastasiadis A, de Reijke TM. Best practice in the Treatment of Nonmuscle Invasive Bladder Cancer. Ther Adv Urol. 2012;4(1):13-32

 

6 Ghatalia, Pooja et al. “Approved checkpoint inhibitors in bladder cancer: which drug should be used when?.” Therapeutic advances in medical oncology vol. 10 1758835918788310. 30 Jul. 2018, doi:10.1177/1758835918788310.

 

7 Cambier S et al. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non–Muscle-invasive Stage Ta–T1 Urothelial Bladder Cancer Patients Treated with 1–3 Years of Maintenance Bacillus Calmette-Guérin. European Urolology. 2016, Vol. 69(1): 60-69.

 

8 Cookson, M et al.,Use of intravesical valrubicin in clinical practice for treatment of nonmuscle-invasive bladder cancer, including carcinoma in situ of the bladder. Therapeutic Advances in Urology. 2014, Vol. 5(5):181-191.

 

Contacts

Media:
Terri Mueller

Head, Communications & Advocacy

Ferring Pharmaceuticals

terri.mueller@ferring.com

Magellan Health Board of Directors Appoints James Murray as President and Chief Operating Officer of Magellan Health

PHOENIX–(BUSINESS WIRE)–Magellan Health, Inc. (NASDAQ: MGLN) today announced that the Company’s Board of Directors has appointed James Murray as president and chief operating officer of Magellan Health. In this role, he will lead the Magellan Behavioral and Specialty Health and Magellan Complete Care business segments, effective December 9, 2019.

“Jim is the right person to lead the Magellan Behavioral and Specialty Health and Magellan Complete Care business segments given his significant healthcare experience and proven ability to drive results in the commercial and government sector markets,” said Ken Fasola, chief executive officer, Magellan Health. “The Board and I look forward to working with Jim and know that his strong commitment to operational excellence and delivering value will benefit members, customers and shareholders alike.”

“It will be a privilege and an honor to join Magellan Health and lead these business segments as we capitalize on the opportunities to improve quality of care and member outcomes, reduce cost of care for both members and customers, and transform the delivery system in the rapidly evolving healthcare industry,” said Murray.

Murray will join Magellan Health after serving as president of PrimeWest Health, a Dallas-based company which supports physician shift to value based care. From 2017-2019, he served as chief executive officer of LifeCare HealthPartners, a Dallas-based hospital system.

Prior to these roles, Murray held significant leadership roles at Humana over a career spanning nearly three decades. As executive vice president and chief operating officer, Murray served on Humana’s executive team and was responsible for all lines of business which included Medicare, Commercial, Medicaid and Tricare.

In previous Humana leadership roles, Murray had oversight of sales, underwriting, actuarial, network and clinical management, customer service and information technology. He also held the role of chief financial officer for nine years.

Before joining Humana, Murray served as partner, specializing in the insurance industry, with Coopers & Lybrand, now PriceWaterhouseCoopers. He has a bachelor’s degree in accounting from the University of Dayton and is a certified public accountant.

In order to provide additional time for Fasola and Murray to review the business strategy and operations, Magellan Health plans to defer release of its financial guidance for 2020. The Company will announce the specific date for communicating guidance in early 2020.

About Magellan Health: Magellan Health, Inc., a Fortune 500 company, is a leader in managing the fastest growing, most complex areas of health, including special populations, complete pharmacy benefits and other specialty areas of healthcare. Magellan supports innovative ways of accessing better health through technology, while remaining focused on the critical personal relationships that are necessary to achieve a healthy, vibrant life. Magellan’s customers include health plans and other managed care organizations, employers, labor unions, various military and governmental agencies and third-party administrators. For more information, visit MagellanHealth.com.

Forward-Looking Statements

This release is intended to be disclosure through methods reasonably designed to provide broad, non-exclusionary distribution to the public in compliance with the Securities and Exchange Commission’s Fair Disclosure Regulation. This release contains forward-looking statements within the meaning of the Securities Exchange Act of 1934 and the Securities Act of 1933, as amended, which involve a number of risks and uncertainties, many of which are out of our control. All statements, other than statements of historical information provided herein, may be deemed to be forward-looking statements including, without limitation, statements regarding growth and strategy. These statements are based on management’s analysis, judgment, belief and expectation only as of the date hereof, and are subject to uncertainty and changes in circumstances. Without limiting the foregoing, the words “believes,” “anticipates,” “plans,” “expects,” “may,” “should,” “could,” “estimate,” “intend” and other similar expressions are intended to identify forward-looking statements. Actual results could differ materially due to, among other things, the possible election of certain of the Company’s customers to manage the healthcare services of their members directly; changes in rates paid to and/or by the Company by customers and/or providers; higher utilization of healthcare services by the Company’s risk members; delays, higher costs or inability to implement new business or other Company initiatives; the impact of changes in the contracting model for Medicaid contracts; termination or non-renewal of customer contracts; the impact of new or amended laws or regulations; governmental inquiries; litigation; competition; operational issues; healthcare reform; and general business conditions. Additional factors that could cause actual results to differ materially from those reflected in the forward-looking statements include, but are not limited to, the risks discussed in the “Risk Factors” section included within the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, filed with the Securities and Exchange Commission on February 28, 2019, and the Company’s subsequent Quarterly Reports on Form 10-Q filed during 2019. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date of this release. Segment profit, adjusted net income, and adjusted EPS information referred to herein may be considered a non-GAAP financial measure. Further information regarding these measures, including the reasons management considers this information useful to investors, are included in the Company’s most recent Annual Report on Form 10-K and on subsequent Form 10-Qs.

(MGLN-GEN)

Contacts

Media Contact: Lilly Ackley, ackleyl@magellanhealth.com, (860) 507-1923

Investor Contact: Joe Bogdan, jbogdan@magellanhealth.com, (860) 507-1910

Bristol-Myers Squibb Announces Dividend Increase

NEW YORK–(BUSINESS WIRE)–$BMY–The Board of Directors of Bristol-Myers Squibb Company (NYSE:BMY) today declared an increase of 9.8% percent in the company’s quarterly dividend, beginning in the first quarter of 2020.

The dividend increase will result in a quarterly dividend of forty-five cents ($0.45) per share on the $.10 par value Common Stock of the corporation. The next quarterly dividend will be payable on February 3, 2020, to stockholders of record at the close of business on January 3, 2020.

The directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable March 2, 2020 to stockholders of record at the close of business on February 4, 2020.

The directors indicated an expected dividend for the full year of 2020 of $1.80 per share on the $.10 par value Common Stock of the corporation, subject to the normal quarterly review by the Board.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

Contacts

Media:
media@bms.com
609-252-3345

Investors:
Tim Power, 609-252-7509, timothy.power@bms.com
Nina Goworek, 908-673-9711, ngoworek@celgene.com

Enzo Biochem Issues Open Letter to Shareholders

Short-Term Activist Harbert, With No Sector Experience and No Plan for Enzo, Seeks Fire Sale of Company at Depressed Prices

Harbert’s Two Nominees Lack Relevant Experience and Declined to Participate in Standard Nominee Interview Process

Enzo’s Vertically Integrated Strategy Positions Company to Unlock Deep Value and Fuel Future Growth

Three-Prong Strategy Yielding Results; New Governance Initiatives Instituted

Vote Today on the WHITE Proxy Card for the Board’s Highly Experienced Nominees Dr. Bruce Hanna, Ph.D. and Barry Weiner

NEW YORK–(BUSINESS WIRE)–Enzo Biochem, Inc. (NYSE:ENZ), an integrated diagnostics and life sciences company focusing on delivering and applying advanced technology capabilities to produce affordable, reliable products and services that enable its customers to meet their clinical needs, today issued an open letter to shareholders. Full text below:

Dear Fellow Shareholders,

Enzo Biochem, Inc. will hold its 2019 Annual Meeting of Shareholders on January 31, 2020. This year’s meeting is particularly critical, as Harbert Discovery Fund (“Harbert”) – a short-term oriented activist hedge fund with no experience in our industry – is seeking to replace two highly qualified directors up for election. We have attempted to work constructively with Harbert in order to understand their perspectives and integrate their director nominees into our Board refreshment process. However, they have steadfastly thrown up roadblocks at every step since they made their demands a few months ago. They refused to provide the names of their nominees while simultaneously demanding that the Board replace without shareholder vote two duly elected independent directors with these then-unnamed candidates. They rejected our offer for the Nominating/Governance Committee to conduct standard interviews of their candidates. They declined to provide any plan to improve the business despite our consistent private engagement with them, probably because as they stated during one of our discussions with them, “Harbert doesn’t know anything about the laboratory business.” We can only interpret their behavior as an indication that their true intent in obtaining Board seats is to abandon Enzo’s long-term strategy and attempt to drive a fire sale of the Company at depressed valuations. As a result, our Board of Directors encourages you to reject Harbert’s nominees and support the Company’s experienced nominees Dr. Bruce Hanna, Ph.D., and Barry Weiner by voting “FOR” these nominees on the WHITE proxy card.

Our History and Our Strategy

Enzo is a pioneer in modern biological research. We have a legacy as a life sciences innovator and industry disruptor, setting aside convention by creating and investing in new platforms, processes and products designed to enhance value. A vast number of diagnostic systems in use today by laboratories, medical facilities, hospitals, pharmaceutical companies and research institutions use some component of intellectual property developed by Enzo in our labs and research facilities. Our legacy and position in the market as a groundbreaking leader endures today.

We have been issued more than 400 patents worldwide with 75 patents pending and regularly file new patents (74 in 2019 alone) on account of our continued commitment to innovation. As a result, we are well positioned to capitalize on our strategy going forward. Our deep intellectual property has enabled Enzo to generate $1.3 billion in revenues over the last 15 years.

Recognizing and anticipating the challenges that would face the laboratory industry and leveraging our deep strength in life sciences, we made the strategic decision to reinvent ourselves and build a new model of a modern diagnostics company. We saw not just the challenge facing the industry: how to combat rising costs in a rapidly declining reimbursement environment, we also saw the pathway forward. We saw the opportunity, understood the imbalance inherent in the marketplace and developed and invested in a solution and structure that had eluded so many well-funded and large-scale organizations. Our stated goals were, and continue to be, to develop and validate platforms focused on high-value areas that can reduce costs 30-50%, and satisfy clinical demand for fully automated platforms and products while retaining margin for our modern diagnostic company.

To accomplish these important goals, we invested in a complex, dynamic, vertically integrated infrastructure: enhancing and expanding our facilities and physical plant, investing significantly in personnel across the organization, addressing all segments of the four platforms that Enzo has developed – from sample collection, sample preparation and the analytical process of attaining results. And at the same time, to handle the high-volume capacity needs that make this automated system work, we combined our intellectual property and manufacturing to modify all processes. This was a significant achievement.

We are well positioned. We have a validated platform that reduces costs significantly, we have been granted approval by New York State for a broad menu of diagnostic tests on our platforms and we have gained acceptance in the marketplace for our model. We are proceeding with the FDA and European Community to secure approvals to fully commercialize. We believe there is substantial, unrealized value in these new platforms – well more than the total value of the Company today.

We are proud of the truly vertically integrated approach we have built to address the foremost issue confronting the laboratory marketplace – focusing on managing costs while investing in technological innovation. This unique vertical integration has enormous tangible benefits: we run our own clinical trials much more cost-effectively in-house vs. hiring an expensive outsourced contract research organization; our R&D is self-funded; we can manufacture our own reagents.

We are making measurable progress against all the elements of this plan. We have hired the investment banking firm Lazard to assist in forming strategic relationships and/or new venture creation across our four core platforms. Testing activity and volume continue to increase. All of this is set against the backdrop of significantly declining reimbursement rates, which has been a headwind for our business but validates the long-term value proposition of our business model.

In close collaboration with our experienced and engaged Board, earlier this year we articulated our three-pronged strategy designed to unlock shareholder value and drive future growth:

  • Forming Strategic Relationships for Diagnostic Growth

    Enzo is in active discussions with several leading global life sciences, heath care and medical device companies, as well as manufacturers of automated systems to develop strategic relationships in four key platforms pioneered by Enzo’s proprietary products and intellectual property: molecular diagnostics, immunohistochemistry, cytology and immunology. These discussions involve developing long-term relationships in automation, manufacturing, distribution, marketing and product sales.

  • Building a New Model for the Diagnostic Marketplace

    As a lower cost and vertically integrated manufacturer and service provider of molecular testing in the U.S., Enzo has rolled out a new business model for its labs to labs business whereby Enzo will serve as the “central capability” for smaller labs, capitalizing on its scale in high value and lower cost operations, proprietary intellectual property and products, decades of innovation and commitment to medical solutions.

  • Return to Operating Profitability and Growth in the Lab Segment

    Enzo is highly focused on returning its lab segment to profitability and growth. Enzo is working aggressively to control operational costs in its lab segment, which have been negatively impacted by a declining reimbursement environment through, amongst others, consolidating supply chain functions, as well as realigning customer support teams to create greater efficiencies without sacrificing service levels and as discussed above rollout of its “labs to labs” business. Enzo will also continue to pursue through licensing, business development and litigation, revenue opportunities derived from our strong intellectual property estate. We are disruptors in our industry and our focus is to generate the appropriate balance between investment in the future and operational profitability today. We are one of the few organizations to be in a position to do this successfully. We are in active discussions with potential strategic partners as well as smaller labs who are considering the Enzo solution to help them control costs.

We are fully committed to a thoughtful and expansive shareholder engagement strategy that has yielded powerful feedback that we have implemented across our operations, our capital allocation and growth strategies and our governance practices. As fellow shareholders, we share in your disappointment in the recent performance of our equity. However, looking forward we believe there is substantial value to be generated by Enzo as we continue to execute against our plan.

Our Execution and Performance

Enzo’s structure and business strategy represent the culmination of years of extensive planning and productive work. The Company has the ability to offer low cost, high performance products and services in molecular diagnostics, immunohistochemistry, immunology and cytology. While reimbursement pressures facing diagnostic labs remain a headwind for Enzo and all our competitors in the short term, our unique, vertically integrated offering positions us well to capitalize on these secular trends over the long term. Our pioneering work in genomic analysis coupled with our extensive and expanding patent estate and enabling platforms have positioned the Company to continue to play an important role in the rapidly growing molecular medicine marketplace.

In fiscal 2019, the Company was awarded 74 patents worldwide, demonstrating our leadership position as a prolific innovator. And over the past five years, Enzo has systematically introduced its technology onto its clinical production floor through Lab Development Tests (“LDTs”) validated by the New York State Department of Health. Over this period, Enzo has run over 100,000 of these Enzo LDTs, resulting in estimated savings of over $5M by substituting third-party vendor tests with Enzo’s own internally developed tests. Enzo expects the annual savings from these tests to increase in fiscal year 2020 to $3M and to $5M in fiscal year 2021. Enzo’s expanding panel of sexually transmitted infections (STI) testing, enhanced by recent diagnostic test approvals, is one of the most extensive available.

History of Open Engagement with Shareholders

We have a strong history of engaging with and listening to our shareholders. In addition to our normal course Investor Relations program, for the past several years we have conducted outreach to our top shareholders as part of our commitment to be responsive to shareholder concerns. In 2018, for example, we engaged with 68% of our top 25 shareholders that collectively own approximately 60% of our common stock. In response to shareholder feedback from these meetings regarding our compensation program, the Compensation Committee made changes to the structure of the compensation program, resulting in significantly increased support for the Company’s Say-on-Pay vote at the 2018 annual shareholder meeting.

These shareholder engagements have become more focused on Board and governance matters. As a result, the Board’s regular reviews of Board and governance practices have increasingly incorporated the feedback that has been received on these topics. In response to this feedback, the Board has taken the following actions:

  • approved a proposal to implement a majority vote standard in uncontested elections, contingent upon shareholder approval at the upcoming Annual Meeting.
  • adopted a Board diversity policy.
  • enhanced the robustness of the responsibilities of the Lead Independent Director role.

Our Board will continue to evaluate its Board and governance practices in light of feedback received from shareholders.

Harbert and its Nominees

In the spirit of engagement and soliciting shareholder feedback, we have attempted to engage constructively with Harbert. We have met with Harbert many times. We have never met with Harbert’s nominees because they rejected our invitation to meet with them. Our good faith attempts to advance the dialogue have been stymied by Harbert’s lack of knowledge of our industry and short-term priorities that we believe would harm long-term, achievable value creation opportunities that would benefit all shareholders. Harbert’s unconstructive actions include:

  • demanding the immediate appointment of two outside unnamed directors of their choosing to immediately replace without shareholder vote two existing independent Enzo directors, along with observer rights for a representative of Harbert.
  • after subsequently disclosing the identity of their nominees, ignoring our requests to conduct standard interviews of these nominees, even after we waived our requirement for these nominees to complete a routine director questionnaire.
  • failing to provide to us any plan to improve the business despite our consistent private engagement with them.

Based on our interactions with Harbert and their public demands for unidentified “strategic alternatives”, we can only assume that Harbert has sought two Board seats and a Board observer seat in an attempt to drive the sale of the Company at depressed valuations. Harbert has no experience in our industry and no plan for the Company. As far as we can tell, Harbert’s track record consists of aggressively targeting highly illiquid, small cap companies outside of the healthcare sector and, through back-door pressure tactics, forcing these companies to install Harbert-designated appointees to the Board to implement changes designed only to advance Harbert’s short-term interests. It was highly instructive – but perhaps not surprising given Harbert’s lack of a plan for Enzo – that in one of our discussions, they stated that “Harbert doesn’t know anything about the laboratory business.”

Months later, after Harbert eventually disclosed the identity of their candidates to us, they nominated these two men to stand for election as directors at this year’s upcoming Annual Meeting. Based on a review of their resumes (our sole basis for evaluating them, given they refused to participate in a standard interview process or complete a customary questionnaire), both lack any identifiable experience with a laboratory diagnostics or biotech company like Enzo. Furthermore, it is worth pointing out that one of these nominees resides in Germany with no connection to the US diagnostic biotech industry while the other appears to be a home-town friend of Harbert from Alabama. One of the nominees has never even served on a public company Board, while the other’s sole public directorship experience is on the Board of a public company based in Georgia – the country, not the state. Their resumes are a far cry from the deeply experienced candidates nominated and endorsed by your Board up for reelection this year.

Enzo’s Experienced Nominees

The two Board members up for reelection at this year’s Annual Meeting have strong experience that is directly relevant to Enzo’s business and have been integrally involved in the development of Enzo’s strategy, operational progress, governance reforms and shareholder engagement.

  • Bruce Hanna, Ph.D. has been a director of the Company since 2017 and is deeply qualified to remain on the Board. He is Enzo’s most recently added independent director and his appointment followed a thoughtful and robust search process that specifically sought experience in diagnostics and clinical innovation. He is currently the chairman of the Board’s Nominating and Corporate Governance Committee and a member of the Audit and Compensation committees. Dr. Hanna’s extensive scientific experience adds meaningful value and perspective to Enzo’s Board. He is currently a Clinical Professor of Pathology and Clinical Professor of Microbiology at the New York University School of Medicine, Adjunct Professor of Science at New York University College of Dentistry, and Adjunct Professor of Biology, Long Island University. Dr. Hanna has been a leading scientist and educator in the fields of pathology and microbiology, having completed a 32-year career at NYU Langone Medical Center, in addition to his ownership in the Village Lab, a NYC tropical diseases laboratory. He is the author of approximately 100 research papers, book chapters and presentations at international symposia on Clinical Laboratory Medicine.
  • Barry Weiner is President, Chief Financial Officer, Principal Accounting Officer and is also a founder of Enzo Biochem. And as a significant, long-term shareholder of Enzo, Mr. Weiner’s interests are fully aligned with those of our investors. He has served as the Company’s President since 1996, and previously held the position of Executive Vice President. Mr. Weiner is an active member of the New York Biotechnology Association. Mr. Weiner has played a key role in not only executing the strategy of the company designed to unlock shareholder value but also in developing its proud legacy of innovation, funding the company’s growth without dilution of shareholders, managing a transparent and open investor relations program and instituting governance reforms. Mr. Weiner manages the three operating businesses at Enzo, each of which are unique and differentiated in their focus and goals, bringing strategic and hands-on leadership and an in-depth knowledge and vision.

This is why we urge you to vote the WHITE proxy card “FOR” the re-election of Enzo’s director nominees: Dr. Bruce Hanna, Ph.D. and Barry Weiner.

Questions? Need Help Voting?

Please contact our Strategic Shareholder Advisor and Proxy Solicitation Agent,

Kingsdale Advisors

CONTACT US:

Kingsdale Advisors

1-888-518-1554 (toll-free in North America)

(416) 867-2272 (outside of North America)

email: ENZ@kingsdaleadvisors.com

Important Additional Information and Where to Find It

Enzo Biochem, Inc. (the “Company”) has filed, and is mailing to shareholders, a definitive proxy statement on Schedule 14A and accompanying WHITE proxy card with the Securities and Exchange Commission (the “SEC”) in connection with the solicitation of proxies from the Company’s shareholders with respect to its 2019 Annual Meeting of Shareholders. SHAREHOLDERS ARE STRONGLY ENCOURAGED TO READ THE COMPANY’S PROXY STATEMENT, ACCOMPANYING WHITE PROXY CARD AND ALL OTHER DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION. Shareholders may obtain a free copy of the proxy statement, any amendments or supplements to the proxy statement and other documents that the Company files with the SEC at the SEC’s website at www.sec.gov or the Company’s website at http://www.enzo.com/corporate/investor-information as soon as reasonably practicable after such materials are electronically filed with, or furnished to, the SEC.

Certain Information Regarding Participants to the Solicitation

The Company, its directors and certain of its executive officers are participants in the solicitation of proxies from shareholders in connection with the Company’s 2019 Annual Meeting of Shareholders. Information regarding the direct and indirect interests, by security holdings or otherwise of the Company’s participants is set forth in the Company’s definitive proxy statement for the 2019 Annual Meeting of Shareholders filed with the SEC on December 5, 2019. The Company’s definitive proxy statement can be found on the SEC’s website at www.sec.gov or the Company’s website at http://www.enzo.com/corporate/investor-information.

Forward-Looking Statements

Except for historical information, the matters discussed in this release may be considered “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management, including those related to cash flow, gross margins, revenues, and expenses which are dependent on a number of factors outside of the control of the Company including, inter alia, the markets for the Company’s products and services, costs of goods and services, other expenses, government regulations, litigation, and general business conditions. See Risk Factors in the Company’s Form 10-K for the fiscal year ended July 31, 2018. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this release.

Contacts

Elliot Sloane, ESPR LLC

Elliot.ESPR@gmail.com
917-291-0833

Bioasis Announces Annual General Meeting Results

GUILFORD, Conn.–(BUSINESS WIRE)–BIOASIS TECHNOLOGIES INC. (OTCQB:BIOAF; TSX.V:BTI), (the “Company” or “Bioasis”), a pre-clinical, research-stage biopharmaceutical company developing its proprietary xB3 ™ platform technology for the delivery of therapeutics across the blood-brain barrier (“BBB”) and the treatment of central nervous system (“CNS”) disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases, is pleased to announce that all resolutions were passed by the requisite majority at its annual general meeting (“AGM”) held earlier today in Toronto, Ontario.

The four incumbent directors, Dr. Deborah A. Rathjen, John E. Curran, David M. Wurzer and Dr. Mario Saltarelli, were nominated for election and were re-elected by shareholders. Shareholders also approved the re-appointment of Manning Elliott LLP as auditors of the Company for the ensuing year.

About Bioasis

Bioasis Technologies Inc. is a biopharmaceutical company developing the xB3 ™ platform, a proprietary technology for the delivery of therapeutics across the blood brain barrier and the treatment of CNS disorders in areas of high unmet medical need, including brain cancers and neurodegenerative diseases. The delivery of therapeutics across the blood brain barrier represents the final frontier in treating neurological disorders. The in-house development programs at Bioasis are designed to develop symptomatic and disease-modifying treatments for brain-related diseases and disorders. The Company maintains headquarters in Guilford, Conn., United States. Bioasis trades on the TSX Venture Exchange under the symbol “BTI” and on the OTCQB under the symbol “BIOAF.” For more information about the company, please visit www.bioasis.us.

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Contacts

On behalf of the Board of Directors of Bioasis Technologies Inc.
Deborah Rathjen, Ph.D., Executive Chair of the Board

deborah@bioasis.us
+1-203-533-7082

IVERIC bio, Inc. Announces Proposed Offering of Common Stock

NEW YORK–(BUSINESS WIRE)–IVERIC bio, Inc. (Nasdaq: ISEE) (the “Company”), today announced that it is commencing an underwritten public offering of shares of its common stock (or pre-funded warrants to purchase its common stock in lieu thereof). In addition, the Company intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15 percent of the number of shares of its common stock plus the shares of common stock underlying the pre-funded warrants sold in connection with the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All of the shares are to be offered by the Company.

Cowen is acting as the book-running manager for the offering.

A shelf registration statement on Form S-3 (File No. 333-226497) relating to the shares of common stock to be offered in the public offering was filed with the Securities and Exchange Commission (the “SEC”) and was declared effective on August 15, 2018. The offering will be made only by means of a prospectus supplement and accompanying prospectus that form a part of the registration statement. A preliminary prospectus supplement related to the offering is being filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may also be obtained by contacting: Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at PostSaleManualRequests@broadridge.com, or by telephone at (833) 297-2926.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About IVERIC bio, Inc.

IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission.

Forward-Looking Statements

Any statements in this press release about the Company’s future expectations, plans and prospects, including statements regarding the proposed public offering, constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company’s strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to market and other financial conditions, the potential completion of the proposed public offering or the size or terms thereof, satisfaction of customary closing conditions related to the proposed public offering, the design, initiation, conduct and outcomes of research programs and clinical trials, establishment of manufacturing capabilities, availability of data from these programs, reliance on university collaborators and other third parties, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions, whether the Company’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements on its expected timelines, and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that the Company files with the SEC. Any forward-looking statements represent the Company’s views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

ISEE-G

Contacts

Investors:

IVERIC bio

Kathy Galante, 212-845-8231

Vice President, Investor Relations and Corporate Communications

kathy.galante@ivericbio.com

or

Media:

SmithSolve

Alex Van Rees, 973-442-1555 ext. 111

alex.vanrees@smithsolve.com