OPENING OF A CALL FOR TENDER TO PROVIDE A CONTINUATION OR SALE PLAN IN THE FRAME OF REOGANIZATION PROCEEDINGS

COMMUNIQUE DE PRESSE · COMMUNIQUE DE PRESSE · COMMUNIQUE DE PRESSE

OPENING OF A CALL FOR TENDER TO PROVIDE A CONTINUATION OR SALE PLAN IN THE FRAME OF REOGANIZATION PROCEEDINGS

The deadline for submission of all tenders is January 10th, 2020 before 04:00pm  

Paris and Boston, December 6th,  2019 – 05h45pm  CET – Neovacs (Euronext Growth Paris : ALNEV) announces the launch of a call for tender opened from now until January 10th, 2020 before 4:00 pm, to provide a continuation plan through partners or investors (articles L.626-1 and L.626-3 of the French Commercial code) or a sale plan by one or more buyers (Articles L.642-1 et seq. of the French Commercial Code).

Candidates are invited to submit their offer before January 10th, 2020 at 04:00pm at the following law office:  SELARL 2M and associates, to Maître Carole Martinez, judicial administrator, 22 rue de l’Arcade 75008 Paris, France. Email: a.dekoninck@aj-2m.com

Access to information for auditing the company (electronic data room), will be granted upon reasoned written request to the judicial administrator along with the appropriate financial, industrial or commercial capacity proofs.

As a reminder, on November 26th, 2019 the Commercial Court of Paris decided the opening of reorganization proceedings of the company, as requested by Neovacs (press release of November 27th, 2019).

Neovacs is a French biotech company listed on Euronext Growth since 2010. The Company is focused on therapeutic vaccines targeting the treatment of autoimmune diseases. Its innovative technology named Kinoid™, patented until 2038, induces a polyclonal immune response, applicable in several indications. Neovacs has developed the IFNα KINOID to treat lupus in a clinical phase IIb study, the main study is now ended and the full results have been presented at the 13th international Lupus Congress 2019. The Company also carries out preclinical work on IL-4/ IL-13 Kinoid, another therapeutic vaccine for the treatment of allergies. The aim of this “KINOID approach” is to enable patients to better cope with a life-long treatment that would be more effective.  For more information : www.neovacs.fr

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Tauriga Sciences, Inc. Completes Initial Tauri-Gummies Production Run; CBD Isolate Concentration Increased to 25mg per Each Vegan Gum Drop  

NEW YORK, NY, Dec. 06, 2019 (GLOBE NEWSWIRE) — via NEWMEDIAWIRE — Tauriga Sciences, Inc. (OTCQB: TAUG) (“Tauriga” or the “Company”), a revenue generating Company that operates through the development, distribution, and licensing of proprietary products as well as the evaluation of potential acquisition opportunities and equity investments, today announced that it has completed its initial Tauri-Gummies™ production run.  The Company increased the concentration of CBD Isolate from 15mg to 25mg per each Vegan Gum Drop and from 360mg to 600mg per each Tauri-Gummies™Jar (“Jar”).  Each Jar will be comprised of 24 Vegan Gum Drops; 6 Cherry Flavor (Colored Red), 6 Lemon Flavor (Colored Yellow), 6 Orange Flavor (Colored Orange), and 6 Lime Flavor (Colored Green).  This initial Tauri-Gummies™production run yielded an inventory of 1,000 Jars (24,000 Gum Drops).  The Company expects that its Tauri-Gummies™ product will be available to the retail marketplace, within the next few weeks. The anticipated Manufacturer’s Suggested Retail Price (“MSRP”) has been set at $24.99 per Jar.      

The Company is currently completing its graphic design and artwork for the final   Tauri-Gummies™ label as well as the logo.  The Company is pleased to report that it has secured a Certificate of Analysis (“C of A”) for its Tauri-Gummies™ product, from San Diego, California based Infinite Chemical Analysis Labs. In addition, there is $3,000,000 in product liability insurance coverage – in place – for the Tauri-Gummies™ product.  The Company is in the process of obtaining a Kosher Certification for Tauri-Gummies™, and has contacted Star-K to complete this task (Star-K is the Kosher Authority that certified Tauri-Gum™ on January 29, 2019).

Tauriga Sciences Inc. formulated and developed its Tauri-Gummies™ product to be Vegan.  This was accomplished by substituting plant based gelling and thickening agent(s) (i.e. Pectin) as a replacement for Gelatin. There is NO Gelatin in the Tauri-Gummies™ product!

ABOUT TAURIGA SCIENCES INC.

Tauriga Sciences, Inc. (TAUG) is a revenue generating Company that operates through the development, distribution, and licensing of proprietary products as well as the evaluation of potential acquisition opportunities. One such opportunity on which the Company has acted, involves the Company having entered into the cannabidiol (or “CBD”) infused chewing gum product business, as more fully described above and in prior press releases.  This CBD infused chewing gum product has been branded under the following name: Tauri-Gum™.  The Company is currently in production of three distinct flavors of Tauri-Gum™: MINT, BLOOD ORANGE, and POMEGRANATE.  On December 6, 2019 the Company announced that it completed the initial production run (thereby expanding its existing product lines) with the introduction of a 25mg Vegan CBD Isolate Infused vegan gummy (“gum drop”), branded under the name: Tauri-Gummies™.  Further, the Company continues to identify and evaluate additional potential opportunities to generate revenue, as well as shareholder value, and leverage its resources and expertise to build a diversified and sustainable business model. Please visit our corporate website at www.tauriga.com.

In addition, on March 11, 2019, the Company announced the official launch of its E-Commerce site – as part of its Tauri-Gum™ commercialization strategy.  This site can be accessed by visiting the following URL address:  www.taurigum.com

The Company has established corporate offices in both New York City (USA) and Barcelona (Spain).  

DISCLAIMER — Forward-Looking Statements

This press release contains certain “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995 which represent management’s beliefs and assumptions concerning future events. These forward-looking statements are often indicated by using words such as “may,” “will,” “expects,” “anticipates,” believes, “hopes,” “believes,” or plans, and may include statements regarding corporate objectives as well as the attainment of certain corporate goals and milestones. Forward-looking statements are based on present circumstances and on management’s present beliefs with respect to events that have not occurred, that may not occur, or that may occur with different consequences or timing than those now assumed or anticipated. Actual results may differ materially from those expressed in  forward looking statements due to known and unknown risks and uncertainties, such as are not guarantees of general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to consummate successful acquisition and licensing transactions, fluctuations in exchange rates, and other factors over which Tauriga has little or no control. Many of these risks and uncertainties are discussed in greater detail in the “Risk Factors” section of Tauriga’s Form 10-K and other filings made from time to time with the Securities and Exchange Commission. Such forward-looking statements are made only as of the date of this release, and Tauriga assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. You should not place undue reliance on these forward-looking statements.

Contact:

CONTACT INFORMATION

Tauriga Sciences, Inc.
555 Madison Avenue, 5th Floor
New York, NY  10022
Chief Executive Officer
Mr. Seth M. Shaw
Email:  sshaw@tauriga.com
cell # (917) 796 9926
Corp. Website:   www.tauriga.com

E-Commerce Website:  www.taurigum.com

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Radius Health Announces Scientific Presentations at 2019 San Antonio Breast Cancer Symposium (SABCS)

WALTHAM, Mass., Dec. 06, 2019 (GLOBE NEWSWIRE) — Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) today announced its scientific presentations on elacestrant and RAD140 at the upcoming 2019 San Antonio Breast Cancer Symposium, which will take place from December 10 – 14 in San Antonio, Texas.

The EMERALD Phase 3 study is currently enrolling ER+, HER2- metastatic breast cancer patients in multiple countries with a majority of sites open and activated. Radius expects to complete patient recruitment in the third quarter of 2020.

“Radius has committed to advance and complete the EMERALD Phase 3 study, which is evaluating elacestrant, the first oral selective estrogen receptor degrader (SERD) in a pivotal registrational study,” said Charles Morris, M.D., Chief Medical Officer of Radius. “We look forward to presenting data that highlights elacestrant’s preclinical and clinical profile and potential to benefit patients at this important meeting.”

Radius Health will be presenting the following abstracts at SABCS:

Final analysis of phase 1 study of elacestrant (RAD1901), a novel selective estrogen receptor degrader (SERD), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer

Poster Spotlight Discussion
Program Number: PD7-07
Session Title: Spotlight Session 7
Session Date: Thursday, December 12, 2019
Session Time: 5-7 PM

EMERALD: A randomized, open-label, phase 3 trial to evaluate the efficacy and safety of elacestrant (RAD1901), a novel oral selective estrogen receptor degrader (SERD), vs investigator’s choice of endocrine therapy for ER+/HER2- advanced breast cancer following CDK4/6 inhibitor therapy

Program Number: OT1-04-04
Session Title: Ongoing Clinical Trials: Endocrine Therapy
Session Date: Wednesday, December 11, 2019
Session Time: 5-7 PM

Elacestrant (RAD1901) inhibits growth of ex vivo cultured circulating tumor cells derived from hormone receptor-positive metastatic breast cancer (mBC) patients including those harboring ESR1 mutations

Program Number: P4-01-06
Session Title: Poster Session 4
Session Date: Friday, December 13, 2019
Session Time: 7-9 AM

Phase 1 dose escalation study of a novel selective androgen receptor modulator (SARM), RAD140, in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer

Program Number: P5-11-01
Session Title: Poster Session 5
Session Date: Friday, December 13, 2019
Session Time: 5-7 PM

Novel mechanisms of action of selective androgen receptor modulator RAD140 in AR+/ER+ breast cancer models

Program Number: P5-05-01
Session Title: Poster Session 5
Date: Friday, December 13, 2019
Time: 5-7 PM

Genomic alterations detected by circulating tumor DNA and correlation with response to treatment with elacestrant, an oral selective estrogen receptor degrader, in phase 1 trials in postmenopausal women with ER+/HER2- advanced/metastatic breast cancer

Program Number: P5-01-05
Session Title: Poster Session 5
Date: Friday, December 13, 2019
Time: 5-7 PM

About Elacestrant (RAD1901)
Elacestrant is a selective estrogen receptor degrader (SERD), which is being evaluated for potential use as a once daily oral treatment for hormone-receptor positive breast cancer. Elacestrant is currently being investigated for potential use in patients with advanced or metastatic estrogen receptor positive, HER2 negative, breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer.

About RAD140

RAD140 is an oral Selective Androgen Receptor Modulator (SARM) for the potential treatment of hormone receptor positive advanced or metastatic breast cancer. AR is expressed in approximately 90% ER+ breast cancer tumors.

About Radius

Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics. Radius’ lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes an investigational abaloparatide-patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-receptor positive breast cancer; and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone-receptor positive breast cancer. For more information, please visit www.radiuspharm.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide-patch, elacestrant and RAD140; and our expectations regarding our clinical trials, including the design and timing thereof and our expectations to complete recruitment in our Phase 3 EMERALD trial of elacestrant in the third quarter of 2020.

These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products; risks related to our ability to successfully enter into collaboration or partnership agreements and any executed collaboration or partnership agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2018 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  Any such forward-looking statements represent management’s estimates as of the date of this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor Relations & External Communications Contact:
Elhan Webb, CFA
Email: ewebb@radiuspharm.com
Phone: 617-551-4011

Media Contact:
Tiffany H. Burke
Email: tburke@radiuspharm.com
Phone: 484-582-6476

Akers Biosciences to Attend Hemp Industry Daily Forum in Las Vegas, Nevada

Thorofare, New Jersey, Dec. 06, 2019 (GLOBE NEWSWIRE) — Akers Biosciences, Inc. (the “Company”) (NASDAQ: AKER), a developer of rapid health information technologies, today announced that Executive Chairman Christopher Schreiber will attend the “Hemp Industry Daily Forum” on Tuesday, December 10, 2019 as part of MJBizCon Week at the Las Vegas Convention Center in Las Vegas, Nevada. Akers Advisory Board member Bob Hoban is a featured speaker presenting on “International Opportunities” for Hemp operations within the Textiles to Cannabidiol (CBD) space.

Christopher Schreiber added, “MJBizCon is the largest gathering of cannabis related business professionals in the world and a great opportunity for Akers to continue strategic dialogue with potential partners and broaden its relationships in the Hemp and minor cannabinoid space. I look forward to sharing more information on our growth strategy with investors in the near future.”

About Akers Biosciences Inc

Akers Biosciences develops, manufactures, and supplies rapid, point of care screening and testing products designed to bring health related information directly to the patient or clinician in a timely and cost-efficient manner.

Forward-Looking Statements

Statements in this press release relating to plans, strategies, trends, specific activities or investments, and other statements that are not descriptions of historical facts and may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include the Company’s expectation regarding the offering and the exercise of the preferred stock warrants, and the risk that the proposed public offering will not be consummated, the need for additional financing, and any risks detailed from time to time in Akers’ reports filed with the Securities and Exchange Commission, Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Forward-looking statements may be identified by terms such as “may,” “will,” “expects,” “plans,” “intends,” “estimates,” “potential,” or “continue,” or similar terms or the negative of these terms. Although Akers believes the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that future results, levels of activity, performance or achievements will be obtained. Akers does not have any obligation to update these forward-looking statements other than as required by law.

Additional information on the company and its products can be found at www.akersbio.com.

Contact:
Investor Relations:      Hayden IR
                                    Brett Mass, Managing Partner
                                    Phone: (646) 536-7331
                                    Email: brett@haydenir.com
                                    www.haydenir.com

Aptevo Therapeutics Receives Orphan Drug Designation for APVO436 for the Treatment of Acute Myelogenous Leukemia

SEATTLE, Dec. 06, 2019 (GLOBE NEWSWIRE) — Aptevo Therapeutics Inc. (Nasdaq: APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, announced today that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to APVO436, a bispecific antibody candidate intended for the treatment of acute myelogenous leukemia (AML). APVO436 is currently being evaluated in a Phase 1/1b clinical trial in patients with AML and myelodysplastic syndrome (MDS).

The U.S. Orphan Drug Act is intended to encourage companies to develop safe and effective therapies for the treatment of rare diseases and conditions, specifically those expected to affect fewer than 200,000 people in the United States. Orphan drug designation provides important benefits to companies such as eligibility for a special seven-year period of market exclusivity upon approval, potential tax credits for research, potential grant funding for research and development, reduced filing fees for marketing applications, and assistance with clinical trial protocol review.

“We are making steady progress in our ongoing Phase 1/1b clinical trial of APVO436 and are pleased to have been granted orphan drug designation for APVO436, as this designation affords important benefits as we continue to advance APVO436 through clinical development,” said Marvin L. White, President and Chief Executive Officer of Aptevo. “We look forward to providing future updates on the APVO436 clinical development program as additional data from the Phase 1/1b clinical trial becomes available.”

About APVO436

APVO436 is an optimized bispecific antibody candidate designed to simultaneously target CD123 and CD3 and redirect T-cell cytotoxicity to the tumor. It is currently being evaluated in a Phase 1/1b open-label, dose-escalation study evaluating safety and pharmacokinetics. APVO436 was built on Aptevo’s proprietary ADAPTIR™ protein therapeutic platform. Focused on generating novel, targeted bispecific antibody-based immunotherapies for cancer the ADAPTIR platform offers key advantages over other bispecific formats, derived in part from the flexible and modular nature of the ADAPTIR structure. These advantages include: (i) achieving potent biological activity and extended half-life while retaining desirable manufacturing characteristics; (ii) ability to achieve target-dependent induction of redirected T-cell cytotoxicity (RTCC) at lower concentrations than other bispecific antibody formats; and (iii) flexibility to build ADAPTIR candidates with diverse mechanisms of action, including RTCC and T-cell co-stimulation.

About Aptevo Therapeutics Inc.

Aptevo Therapeutics Inc. is a clinical-stage biotechnology company focused on developing novel oncology and hematology therapeutics to meaningfully improve patients’ lives. Aptevo has a commercial product, IXINITY® coagulation factor IX (recombinant), approved and marketed in the United States for the treatment of Hemophilia B, and a versatile core technology – the ADAPTIR™ modular protein technology platform capable of generating highly-differentiated bispecific antibodies with unique mechanisms of action for the treatment of different types of cancer. For more information, please visit www.aptevotherapeutics.com

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including, without limitation, statements regarding potential milestone payments, Aptevo’s outlook, financial performance or financial condition, Aptevo’s technology and related pipeline, collaboration and partnership opportunities, commercial portfolio, milestones, and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “forecasts,” “estimates,” “will” and similar expressions are forward-looking statements. These forward-looking statements are based on Aptevo’s current intentions, beliefs and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo’s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause Aptevo’s actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo’s business or prospects; adverse developments in research and development; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social and political conditions. Additional risks and factors that may affect results are set forth in Aptevo’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as filed on March 18, 2019 and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo’s expectations in any forward-looking statement.

Source:
Aptevo Therapeutics
Stacey Jurchison
Senior Director, Investor Relations and Corporate Communications
206-859-6628
JurchisonS@apvo.com

MediPharm Labs Australia Granted State Licences, Completes Construction of Specialized Production Facility

BARRIE, Ontario, Dec. 06, 2019 (GLOBE NEWSWIRE) — MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm Labs” or the “Company”) a global leader in specialized, research-driven cannabis extraction, distillation and purification, today announced that its subsidiary, MediPharm Labs Australia Pty. Ltd. (“MediPharm Labs Australia”), has received State Licences for cannabis substances from the Department of Health and Human Services in Victoria, Australia and completed the initial phases of construction of its specialized extraction facility in Wonthaggi.

Under these State Licences, MediPharm Labs Australia is allowed to store, test and supply cannabis for research purposes at its newly built facility. Construction of the 10,000 square foot plant began 18 months ago. The final stage of regulatory approvals is now underway and is expected in H1 2020, which will make MediPharm Labs Australia a first mover in the Australian market for the manufacture of cannabis derivative products.

“We envisioned that MediPharm Labs Australia would be a pioneering leader in the supply of high-quality, pharmaceutical-like cannabis derivative products for the domestic Australian and international export markets,” said Warren Everitt, Chief Executive Officer, Asia Pacific, MediPharm Labs. “The achievements we mark today reflect tremendously well on our domestic engineering, project management and regulatory affairs capabilities, and provide tangible evidence that our vision will soon be realized for the benefit of our customers, shareholders and the Australian economy.”

MediPharm Labs Australia was designed to have annual capacity of 75,000 kg and to replicate the high-quality standards of the Company’s Canadian production facility. It features multi-phase supercritical CO2 extraction equipment, clean rooms and testing laboratories.  Both facilities were built to achieve GMP certifications. A GMP certificate from the Australian Therapeutic Goods Administration is the next priority start-up step, with the regulatory audit process already proceeding.

“Starting a business is never easy but the skilled team at MediPharm Labs Australia under Warren’s direction has made it look that way,” said Pat McCutcheon, Chief Executive Officer, MediPharm Labs. “I congratulate everyone involved for quickly bringing us to this advanced pre-production phase. We’re now starting the final countdown to commercialization of the asset.”

To mark the completion of facility construction, Mr. Everitt hosted a ribbon-cutting ceremony today where Daniel Andrews, the Premier of Victoria, Australia, John Skerritt, the Deputy Secretary of the Commonwealth Department of Health, and Brett Tessari, Mayor of Wonthaggi addressed the audience.

“Victoria is continuing to lead the way in medicinal cannabis in Australia and we are proud to support MediPharm Labs in calling Wonthaggi, Gippsland its Australian home”, said Daniel Andrews, Premier of Victoria, Australia. “We’re proud to be actively attracting investment in this ground-breaking industry that will not only improve the lives of patients around the world, but also create local jobs.”

MediPharm Labs Group Milestones to Date in Australia:

  • June 18, 2018 – Breaks ground on 10,000 sq.ft. purpose-built facility, 127 km southeast of Melbourne, in Wonthaggi, Victoria.
  • Feb 21, 2019 – Signs first international private label two-year sales agreement with AusCann Operations Pty. Ltd. (“AusCann”) for cannabis concentrate to be exported to Australia from Canada; Cannabis concentrate to be used for hard-shell capsules to research and treat chronic pain.
  • Mar-Aug, 2019 – Recruits senior leadership team from leading companies within the Australian pharmaceutical industry.
  • May 21, 2019 – Receives Cannabis Manufacturing Licence from the Australian Office of Drug Control (ODC) under the Narcotic Drugs Act 1967.
  • June 24, 2019 – Announces first export of medical cannabis concentrate to Australia in accordance with Health Canada export and Australian ODC import permits.
  • Aug 1, 2019 – Wins INNOVATION AWARD at the Australian Cannabis Industry Awards, for role defining a new extraction-specialist segment in the medical cannabis industry.
  • Sept 3, 2019 – Enters a manufacturing agreement with a licensed Australian entity; Signs three multi-year supply agreements with ODC-approved cultivators (including BBS Pharmaceuticals).
  • Sept 27, 2019 – Receives multi-phase supercritical CO2 extraction equipment.
  • Oct 1, 2019 – Announces second set of larger exports of medical cannabis concentrate from Canada to Australia in accordance with Health Canada export and Australian ODC import permits.
  • Dec 5, 2019 – Receives State Licences for cannabis substances from the Department of Health and Human Services in Victoria, Australia.
  • Dec 6, 2019 – Celebrates the completion of construction of facility in Wonthaggi, Victoria.

For more detail, visit https://www.medipharmlabs.com/news/press-releases

About MediPharm Labs

Founded in 2015, MediPharm Labs specializes in the production of purified, pharmaceutical-like cannabis oil and concentrates and advanced derivative products utilizing a Good Manufacturing Practices designed facility and ISO standard built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, they formulate, process, package and distribute cannabis extracts and advanced cannabinoid-based products to domestic and international markets. As a global leader, MediPharm Labs has completed commercial exports to Australia and is nearing commercialization of its Australian extraction facility. MediPharm Labs Australia was established in 2017.

For further information, please contact:
Laura Lepore, VP, Investor Relations
Telephone: 705-719-7425 ext 216
Email: investors@medipharmlabs.com    
Website: www.medipharmlabs.com   

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION:

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, commercialization and GMP certification of the Australian facility and timing thereof, use of cannabis concentrate by AusCann, performance of the agreements as intended and disclosed herein; expected processing capacity of the Australian facility and production of active pharmaceutical ingredients and cannabinoid-based medicines. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm Labs to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm Labs’ filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm Labs assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

Photos accompanying this announcement are available at: 

https://www.globenewswire.com/NewsRoom/AttachmentNg/a65db3aa-1bbe-4715-8d2b-ab97eb10b67a

https://www.globenewswire.com/NewsRoom/AttachmentNg/60c608a6-dd13-4137-a9a0-f1f37c9ffb45

https://www.globenewswire.com/NewsRoom/AttachmentNg/91b15b24-b003-4b11-8779-76dda3116ab2

Assembly Biosciences Announces Plenary Lecture at HEP DART 2019

SOUTH SAN FRANCISCO, Calif., Dec. 06, 2019 (GLOBE NEWSWIRE) — Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome, today announced that Richard Colonno, PhD, Executive Vice President and Chief Scientific Officer Virology, will present a Plenary Lecture, “Eliminating Residual HBV Replication – A Critical Gateway to Cure” at the HEP DART Meeting on Tuesday, Dec 10, 2019 at 5:30pm HST in Kauai, HI. The presentation will include an in-depth review of interim long-term data from the ongoing Phase 2 study of ABI-H0731, Assembly’s lead core inhibitor, for the treatment of chronic Hepatitis B infection, which were reported at AASLD 2019 last month.

Following the lecture, Dr. Colonno’s slides will be available on the Events & Presentations page in the Investors section of the company’s website at assemblybio.com.  

About Assembly Biosciences
Assembly Biosciences, Inc. is a clinical-stage biotechnology company developing innovative therapeutics targeting hepatitis B virus (HBV) and diseases associated with the microbiome. The HBV program is focused on advancing a new class of potent, oral core inhibitors that have the potential to increase cure rates for chronically infected patients. The microbiome program is developing novel oral live microbial biotherapeutic candidates with Assembly’s fully integrated platform, including a robust process for strain identification and selection, GMP-compliant banking and production, and targeted delivery to the lower gastrointestinal tract with the GEMICEL® technology. For more information, visit assemblybio.com.

Contacts
Assembly Biosciences, Inc.
Investors:
Lauren Glaser
(415) 521-3828
lglaser@assemblybio.com

IntelGenx Announces Issuance of Shares in Payment of Interest on Outstanding Debentures

SAINT LAURENT, Quebec, Dec. 06, 2019 (GLOBE NEWSWIRE) — IntelGenx Technologies Corp. (TSXV: IGX) (OTCQX: IGXT) (the “Company” or “IntelGenx”) announces that it intends to issue 415,178 common shares of the Corporation (the “Common Shares”) at a deemed price of CAD $0.73 per Common Share in payment of an aggregate of $303,080 in interest owing on the Corporation’s 8.00% convertible unsecured subordinated debentures due June 30, 2020 (the “Debentures”).

Under the terms of the trust indenture governing the Debentures (the “Indenture”), the Corporation has the option to pay the semi-annual interest on the Debentures in either cash or Common Shares, subject to customary conditions set forth in the Indenture. The issuance of the Common Shares in payment of interest on the Debentures is subject to the acceptance by the TSX Venture Exchange Inc. The Common Shares issued in payment of interest on the Debentures will be issued pursuant to exemptions from the prospectus requirements of applicable securities laws.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, securities in any jurisdiction where not permitted by law.

About IntelGenx

IntelGenx is a leading drug delivery company focused on the development and manufacturing of pharmaceutical films.

IntelGenx’s superior film technologies, including VersaFilm®, VetaFilm™ and transdermal, allow for next generation pharmaceutical products that address unmet medical needs. IntelGenx’s innovative product pipeline offer significant benefits to patients and physicians for many therapeutic conditions.

IntelGenx’s highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx’s state-of-the-art manufacturing facility offers full service by providing lab-scale to pilot- and commercial-scale production. For more information, visit www.intelgenx.com.  

Forward-Looking Information and Statements

This document may contain forward-looking information or forward-looking statements within the meaning of applicable U.S. and Canadian securities laws. These statements are statements that are not purely historical. No assurance can be given that the issuance of the Common Shares in payment of interest owing will be completed. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx’s actual results could differ materially from those expressed or implied by these forward-looking statements.

Factors that could cause or contribute to such differences include, but are not limited to, failure to obtain TSX Venture Exchange acceptance of the issuance of the Common Shares in payment of interest owing, failure to satisfy the conditions to issuance provided for in the Indenture and those discussed under the heading “Risk Factors” in the Registration Statement and in IntelGenx’s annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities and www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Although the Company believes that the expectations and assumptions on which Forward-Looking Information is based are reasonable, readers of this press release are cautioned not to rely unduly on this Forward-Looking Information since no assurance can be given that they will prove to be correct. The Company does not undertake any obligation to update or revise any Forward-Looking Information, whether as a result of events or circumstances occurring after the date of this press release, unless so required by legislation.

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

No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer or solicitation of sale would be unlawful.

For more information, please contact:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com

OR

Andre Godin, CPA, CA
President and CFO
IntelGenx Technologies Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

TR-1: Standard form for notification of major holdings

NOTIFICATION OF MAJOR HOLDINGS (to be sent to the relevant issuer and to the FCA in Microsoft Word format if possible)i
 
1a. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attachedii: Acacia Pharma Group plc
1b. Please indicate if the issuer is a non-UK issuer  (please mark with an “X” if appropriate)
Non-UK issuer  
2. Reason for the notification (please mark the appropriate box or boxes with an “X”)
An acquisition or disposal of voting rights X
An acquisition or disposal of financial instruments  
An event changing the breakdown of voting rights  
Other (please specify)iii:  
3. Details of person subject to the notification obligationiv
Name The Novo Nordisk Foundation
City and country of registered office (if applicable) Tuborg Havnevej 19, 2900 Hellerup, Denmark
4. Full name of shareholder(s) (if different from 3.)v
Name Novo Holdings A/S
City and country of registered office (if applicable) Tuborg Havnevej 19, 2900 Hellerup, Denmark
5. Date on which the threshold was crossed or reachedvi: 5 December 2019
6. Date on which issuer notified (DD/MM/YYYY): 6 December 2019
7. Total positions of person(s) subject to the notification obligation
  % of voting rights attached to shares (total of 8. A) % of voting rights through financial instruments
(total of 8.B 1 + 8.B 2)
Total of both in % (8.A + 8.B) Total number of voting rights of issuervii
Resulting situation on the date on which threshold was crossed or reached 3.997%   3.997% 54,888,198
Position of previous notification (if
applicable)
4.98%   4.98% 54,888,198

8. Notified details of the resulting situation on the date on which the threshold was crossed or reachedviii
A: Voting rights attached to shares
Class/type of
shares

ISIN code (if possible)
Number of voting rightsix % of voting rights
Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1)
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1)
Direct
(Art 9 of Directive 2004/109/EC) (DTR5.1)
Indirect
(Art 10 of Directive 2004/109/EC) (DTR5.2.1)
Ordinary Shares
GB00BYWF9Y76
2,194,007   3.997%  
         
         
SUBTOTAL 8. A 2,194,007 3.997%
 

 

B 1: Financial Instruments according to Art. 13(1)(a) of Directive 2004/109/EC (DTR5.3.1.1 (a))
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Number of voting rights that may be acquired if the instrument is
exercised/converted.
% of voting rights
         
         
         
    SUBTOTAL 8. B 1    
 

 

B 2: Financial Instruments with similar economic effect according to Art. 13(1)(b) of Directive 2004/109/EC (DTR5.3.1.1 (b))
Type of financial instrument Expiration
date
x
Exercise/
Conversion Period
xi
Physical or cash
settlementxii
Number of voting rights % of voting rights
           
           
           
      SUBTOTAL 8.B.2    
 

 

 

9. Information in relation to the person subject to the notification obligation (please mark the
applicable box with an “X”)
Person subject to the notification obligation is not controlled by any natural person or legal entity and does not control any other undertaking(s) holding directly or indirectly an interest in the (underlying) issuerxiii  
Full chain of controlled undertakings through which the voting rights and/or the
financial instruments are effectively held starting with the ultimate controlling natural person or legal entityxiv (please add additional rows as necessary)
X
Namexv % of voting rights if it equals or is higher than the notifiable threshold % of voting rights through financial instruments if it equals or is higher than the notifiable threshold Total of both if it equals or is higher than the notifiable threshold
The Novo Nordisk Foundation 3.997%    
Novo Holdings A/S 3.997%    
       
       
       
 
10. In case of proxy voting, please identify:
Name of the proxy holder  
The number and % of voting rights held  
The date until which the voting rights will be held  
 
11. Additional informationxvi
The shares are held by Novo Holdings A/S, the holding company in the Novo Group. Novo Holdings A/S is wholly-owned by the Novo Nordisk Foundation.

Place of completion Hellerup, Denmark
Date of completion  6 December 2019

Inceptua Medicines Access and Onconova Therapeutics Announce Pre-approval Access Collaboration for Rigosertib in Selected Countries Outside the US

NEWTOWN, Pa. and LUXEMBOURG, Dec. 06, 2019 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), and Inceptua Medicines Access (a business unit of the Inceptua Group), a global pharmaceutical company and service partner, today announced that they have entered into a collaboration to make available intravenous rigosertib via a Pre-approval Access Program in selected countries around the world.

Pre-approval Access Programs (also known as expanded access, early access, compassionate use, named patient supply) are regulatory-compliant processes permitting experimental agents in development to be made available upon the request of a physician or a patient for appropriate patients for whom no alternative treatment option exists in their country. Rigosertib is a small molecule that inhibits cellular signaling in cancer cells by acting as a RAS mimetic. Current clinical development of rigosertib is centered upon the therapeutic management of MDS, a heterogeneous group of bone marrow disorders characterized by ineffective hematopoiesis that often develop into acute myeloid leukemia (AML). Rigosertib, in its intravenous formulation, is currently in Phase 3 clinical development for the treatment of higher-risk MDS.

The rigosertib Pre-approval Access Program is expected to launch in first half of 2020 and will allow Inceptua to supply intravenous rigosertib within designated countries, primarily and initially concentrated in selected countries in Europe, in response to physician requests for patients with higher-risk MDS who have exhausted all available treatment options, and are not eligible for or have no access to the INSPIRE study. Under the terms of this agreement, Inceptua will support Onconova through the pre-approval provision of intravenous rigosertib initially into a number of countries including: Australia, Denmark, Finland, France, Ireland, Italy, the Netherlands, Portugal, South Africa, Spain, and the UK.

“Inceptua Medicines Access is delighted to be selected as Onconova’s partner for the Pre-approval Access Program for rigosertib. Higher-risk MDS is a disease with significant unmet need, and we are pleased to be able to support healthcare professionals seeking access to rigosertib, ahead of its commercial launch,” said Mark Corbett, EVP, Inceptua Medicines Access.

Steven M. Fruchtman, M.D., President and Chief Executive Officer of Onconova, said, “The rigosertib Pre-approval Access Program is a key strategic initiative for Onconova. We are pleased that intravenous rigosertib will be made compliantly available to suitable patients with higher-risk MDS through their physicians in designated countries. The program will run alongside our ongoing Phase 3 INSPIRE Trial, and is expected to continue until commercial launch in such countries. We are pleased to work with Inceptua, given their strong record of administering such programs successfully.”

Please note: Inceptua can only respond to unsolicited requests from bona fide healthcare professionals. Healthcare professionals can obtain information about the rigosertib Pre-approval Access Program by contacting Inceptua either by telephone +44 20 3910 7600 or by email: Access@inceptua.com.

About Onconova Therapeutics, Inc. 

Onconova Therapeutics, Inc. is a Phase 3-stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with an initial focus on Myelodysplastic Syndromes (MDS). Using a proprietary chemistry platform, Onconova has created a pipeline of targeted agents designed to work against specific cellular pathways that are important in cancer cells. Advanced clinical trials with the Company’s lead compound, rigosertib, are aimed at what the Company believes are unmet medical needs of patients with MDS. Onconova has conducted trials with two other research compounds and has a pre-clinical program with a CDK4/6 and Ark5 inhibitor, ON 123300.

For more information, please visit http://www.onconova.com

About Myelodysplastic Syndromes

Myelodysplastic syndromes (MDS) are conditions that can occur when the blood-forming cells in the bone marrow become dysfunctional and thus produce an inadequate number of circulating blood cells. It is frequently associated with the presence of blasts or leukemic cells in the marrow. This leads to low numbers of one or more types of circulating blood cells, and to the need for blood transfusions. In MDS, some of the cells in the bone marrow are abnormal (dysplastic) and may have genetic abnormalities associated with them. Different cell types can be affected, although the most common finding in MDS is a shortage of red blood cells (anemia). Patients with higher-risk MDS may progress to the development of acute leukemia. 

About Rigosertib

Rigosertib, Onconova’s lead candidate, is a proprietary Phase 3 small molecule. A key publication in a preclinical model demonstrated rigosertib’s ability to block cellular signaling by targeting RAS effector pathways (Divakar, S.K., et al., 2016: “A Small Molecule RAS-Mimetic Disrupts RAS Association with Effector Proteins to Block Signaling.” Cell 165, 643). Onconova is currently in the clinical development stage with oral and IV rigosertib, including clinical trials studying single agent IV rigosertib in second-line higher-risk MDS patients (pivotal Phase 3 INSPIRE trial) and oral rigosertib plus azacitidine in first-line and refractory higher-risk MDS patients (Phase 2). Patents covering oral and injectable rigosertib have been issued in the US and are expected to provide coverage until at least 2037.

About the INSPIRE Phase 3 Clinical Trial

The clinical trial INternational Study of Phase 3 IV RigosErtib, or INSPIRE, was finalized following guidance received from the U.S. Food and Drug Administration and European Medicines Agency. INSPIRE is a global, multi-center, randomized, controlled study to assess the efficacy and safety of IV rigosertib in higher-risk MDS (HR-MDS) patients who had progressed on, failed to respond to, or relapsed after previous treatment with a hypomethylating agent (HMA) within nine cycles over the course of one year after initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. Patients are randomized at a 2:1 ratio into two study arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival. The trial continued beyond the pre-specified interim analysis and is nearing its conclusion. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443). 

About IV Rigosertib

The intravenous form of rigosertib has been studied in Phase 1, 2, and 3 clinical trials involving more than 1000 patients, and is currently being evaluated in a randomized Phase 3 international INSPIRE trial for patients with HR-MDS after failure of HMA therapy. 

About Oral Rigosertib 

The oral form of rigosertib was developed to provide a potentially more convenient dosage form for use where the duration of treatment may extend to multiple years. This dosage form may also support combination therapy modalities. To date, over 400 patients have been dosed with the oral formulation of rigosertib in clinical trials. Combination therapy of oral rigosertib with azacitidine, the standard of care in HR-MDS, has also been studied. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy. A Phase 1/2 trial of the combination therapy has been fully enrolled, and the preliminary efficacy and safety data was presented at The American Society of Hematology (ASH) Annual Meeting in December 2018. The data will be updated at the upcoming 2019 ASH Annual Meeting next week.

About Inceptua

Inceptua is a pharmaceutical company and service partner spanning throughout the product lifecycle – from comparator sourcing for clinical trials, through early access programs to licensing and commercialization for products.

We partner with life science companies of all sizes, drawing on over 20 years of industry experience. Our pharma and biotech offering includes registration and commercialization of products through in-licensing and flexible partnerships. We have leading expertise in strategy and operational implementation of pre-approval access programs making pharmaceutical products under clinical development available for patients and Inceptua’s clinical trial services business offers high quality clinical comparator sourcing and manufacturing services with an agile global supply chain to ensure that products are delivered exactly when needed. 

Inceptua Medicines Access is a business unit of the Inceptua Group. It offers full access solutions for the design, implementation and delivery of Pre-approval and Medicines Access Programs on behalf of biopharmaceutical companies.

Inceptua has global operations with local offices across Europe, USA, and Asia. 

www.inceptua.com 

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova expectations regarding the INSPIRE Trial and Onconova’s other development plans. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements.  These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including Onconova’s ability to continue as a going concern, maintain its Nasdaq listing, the need for additional financing, the success and timing of Onconova’s clinical trials and regulatory approval of protocols, our collaborations, and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q.  Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. 

General Contacts:
Mark Corbett
Executive Vice President
Inceptua Medicines Access
+44 20 3910 7600
mark.corbett@inceptua.com

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
http://www.onconova.com/contact/