On October 15, 2021 Applied BioMath (www.appliedbiomath.com), the industry-leader in applying systems pharmacology and mechanistic modeling, simulation, and analysis to de-risk drug research and development, reported a collaboration with BYOMass, Inc. for systems pharmacology modeling in chronic diseases (Press release, Applied BioMath, OCT 15, 2021, View Source [SID1234591308]). BYOMass is a preclinical stage pharmaceutical company focused on the TGF-ß superfamily.

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"We chose Applied BioMath given their proven track record of helping companies identify ideal therapeutic properties and platforms," said Margaret Jackson, D.Phil., Founder and CEO of BYOMass. "We hope that this collaboration will help us identify the properties of a lead candidate as efficiently as possible and aid in the design of future studies."

Applied BioMath employs a rigorous fit-for-purpose model development process which quantitatively integrates knowledge about therapeutics with an understanding of its mechanism of action in the context of human disease mechanisms. Their approach employs proprietary algorithms and software that were designed specifically for systems pharmacology model development, simulation, and analysis.

"We often work with early-stage companies to help them understand what their therapeutic needs to look like in order to be best in class," said John Burke, PhD, Co-Founder, President, and CEO of Applied BioMath. "We look forward to collaborating with BYOMass and helping them decide next steps for this project."

On October 15, 2021 Adastra Holdings Ltd. (formerly Phyto Extractions Inc.) (CSE: XTRX) (FRA: D2EP) ("Adastra" or the "Company") reported positive operational and financial developments as the Company continues to pursue its mission to be a leader in the development and manufacture of pharma-quality, cannabis API and derivative products (Press release, Adastra Pharmaceuticals, OCT 15, 2021, View Source [SID1234591306]). These developments include record shipments in September, product portfolio expansion, and continued progress with Health Canada regarding its Controlled Substances Dealers License application.

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Record September Shipments
Adastra shipped 68,272 consumer-packaged units and 20,000g of bulk extract in September compared to 41,571 units in September 2020, a 64% increase year over year.

Psychedelics
Adastra received a request for additional information from Health Canada as part of the agency’s formal review of the Company’s application for a Controlled Drugs and Substances Dealer’s License, which was submitted and formally accepted in late August 2021. The Company believes that the request for information is the next step toward attaining approval. In addition, Health Canada advised it commits to a 270 calendar day review period from the date of receipt for processing these applications. As a result, management expects Health Canada to finish reviewing Adastra’s application by March 2022.

New Products
Adastra is moving aggressively to expand its Phyto Extraction branded products portfolio to take full advantage of the shift in Canadian consumer preference for derivative hydrocarbon extract products. Planned new products include:

THCA Diamonds & Sauce. Adastra has commenced production of a THCA diamond concentrate that it intends to introduce to the market under the Phyto Extractions brand label in December 2021. Known popularly as the "super concentrate," THCA diamond is a highly potent variety of concentrate that gives users the option to inhale nearly pure THC and is currently the best-selling concentrate product type across Canada based on recent Headset data.
White Widow Shatter. Adastra is introducing a 1g version of White Widow. This balanced hybrid strain is a cross between a Brazilian sativa landrace and a resin-heavy South Indian indica that is expected to be available across Canada in December 2021.
Vapes. Adastra is introducing a 1g Black Cherry Distillate vape cartridge that management believes will capture the market’s excitement in new vape products.
Operational Changes
Adastra is hiring to scale up and meet increasing order demand by increasing capacity across two shifts (Mon-Fri) and by adding a weekend shift primarily for packaging. Adastra Labs Inc. is actively hiring staff across two shifts to meet increasing order demand for Phyto Extraction products. In addition, a weekend shift was also added to meet the growing demand for packaged goods.

Insider Open Market Purchases of Adastra Common Stock
The Company’s Chief Executive Officer and Chief Operating Officer have recently purchased shares of the Company on the open market, the details of which will be set out in their respective SEDI reports.

Michael Forbes, Chief Executive Officer of Adastra, said, "With the downturn in industry stock prices recently, this was an opportunity to show investors that Adastra management is committed to creating long-term shareholder value. We believe the current share price does not reflect the true value of Adastra and the incredible growth we have coming in the near future."

On October 15, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the Company intends to list its shares on Nasdaq Stockholm. Isofol’s shares are currently traded on Nasdaq First North Premier Growth Market under the ticker ISOFOL (Press release, Isofol Medical, OCT 15, 2021, View Source [SID1234591301]).

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Nasdaq Stockholm’s listing committee has made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority (Finansinspektionen).

The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any actions in connection with the uplisting.

"Being listed on Nasdaq Stockholm Main Market is an important milestone in the Company’s development and growth. The listing will raise awareness among investors about Isofol’s drug development within oncology" says Ulf Jungnelius, CEO of Isofol.

Prospectus

Isofol has prepared a prospectus in connection with the admission to trading of the Company’s shares on Nasdaq Stockholm. The prospectus is expected to be approved and registered by the Swedish Financial Supervisory Authority and made public on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website www.fi.se, on or around Monday October 18, 2021.

Advisors

Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

For more information please contact

The information was submitted for publication, through the agency of the contact person set out above, at 15:30 CEST on October 15, 2021.

About arfolitixorin

Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On October 15, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Carmustine for Injection, USP, a therapeutic equivalent generic version of BiCNU (carmustine for injection) approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, OCT 15, 2021, View Source [SID1234591297]).

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The BiCNU brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health*.

Dr. Reddy’s Carmustine for Injection, USP is a lyophilized powder available as a package which includes a single-dose vial containing 100 mg Carmustine USP and a vial containing 3 mL sterile diluent.

Please click here for full prescribing information including boxed warning: View Source

WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY

Myelosuppression

Carmustine causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1)].

Do not administer a repeat course of Carmustine until blood counts recover.

Pulmonary Toxicity

Carmustine causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/m2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4)].

iCNU is a trademark owned or licensed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

*IQVIA Retail and Non-Retail MAT June 2021

RDY-0821-368

On October 15, 2021 Bio-Thera Solutions, Ltd. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and a pipeline of biosimilars, reported the company has reached licensing and supply agreements with Pharmapark LLC, for BAT2206, its ustekinumab biosimilar, under which Pharmapark will have exclusive rights to distribute and market the drug with a status of a local product in Russia and other CIS countries (Press release, BioThera Solutions, OCT 15, 2021, View Source [SID1234591296]). Bio-Thera and Pharmapark’s partnership was initiated around a licensing and supply agreement for Pharmapark to distribute and market BAT2506, a golimumab biosimilar, in Russia and other CIS countries.

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BAT2206 is a proposed biosimilar to Jansen’s Stelara1 which is currently approved in the U.S. for the treatment of active psoriatic arthritis (PsA) in adults, alone or in combination with MTX, the treatment of patients 6 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, the treatment of moderately to severely active Crohn’s disease in adults, and the treatment of moderately to severely active ulcerative colitis in adults.

Bio-Thera’s BAT2206 has completed a Phase I study and is currently being evaluated in a global Phase III clinical study including patients from China, Russia and other countries. Bio-Thera intends to file for regulatory approval with the China National Medical Products Administration (NMPA), the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). Pharmapark will be responsible for filing the dossier in Russia and other CIS countries.

This partnership will leverage Pharmapark’s strong local presence, sales and marketing capabilities in Russia and other CIS countries. Bio-Thera will be responsible for full development, and commercial supply of BAT2206 out of its manufacturing facilities in Guangzhou, China.

"Bio-Thera is pleased to expand our partnership with Pharmapark to commercialize our ustekinumab biosimilar program in Russia and other CIS countries", said Dr. Shengfeng Li, CEO of Bio-Thera. "By expanding our partnership with Pharmapark, Bio-Thera is redoubling its commitment to providing Russian patients with increased access to innovative biotherapeutics at affordable prices."

"We are extremely happy to expand our collaboration with Bio-Thera. Pharmapark intends to continue to work with the leading biosimilar developers to enable rapid entrance of biosimilar products to the Russian and CIS markets and strengthen our position in Russia as the leading player in the biosimilar market." said Vyacheslav Lebedyansky, CEO of Pharmapark.