Audit body warns of risks to medicine supplies in no-deal Brexit, despite preparations

Pharmaphorum | September 27, 2019

Amid the political chaos and bitter recriminations in Westminster in the build-up to Brexit, there is still a risk of delays to health and social care supplies if the UK leaves the EU without a deal, the UK’s National Audit Office (NAO) has warned. An independent Parliamentary body, the NAO audits central government departments, government agencies, and non-departmental public bodies as well as assessing value for money audits of public policy. In a report published today the NAO reviewed the Department for Health and Social Care’s (DHSC) preparations to ensure a steady flow of supplies for the sector when it leaves the EU, and acknowledged the considerable efforts made so far to mitigate the impact of a no-deal Brexit. Although the NAO said there are huge uncertainties about the impact of a no-deal Brexit, it noted the government’s “reasonable worst case” assumption that flow of goods across the Channel could be reduced to 40-60% of current levels at day one. According to the NAO, suppliers said that they had only found shipping arrangements away from the short channel crossings for 25% of medicine product lines, as of 20th September. According to the NAO, suppliers have at least six weeks’ stock for 72% of product lines, and 91% of additional freight capacity procured by the government so far is for priority supplies to the health and social care sector.

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Aequus Announces Health Canada Notice of Compliance (NOC) for Zimed® Preservative Free (Bimatoprost 0.03%)

Aequus Pharmaceuticals | December 21, 2022

Aequus Pharmaceuticals Inc. is pleased to announce that Health Canada has approved Zimed® PF for the reduction of elevated intraocular pressure in patients with open-angled glaucoma or ocular hypertension. Affecting more than 700,000 people in Canada, glaucoma is one of the leading causes of blindness in North America. Zimed® PF is the first prostaglandin analog that is preservative free and offered in an easy-to-use multi-dose bottle in Canada. PGAs are commonly prescribed first-line to reduce IOP. The vast majority of medications currently available include preservatives such as Benzalkonium Chloride. Chronic exposure to BAK has been found to increase the likelihood of experiencing Ocular Surface Disease and reduce patient adherence. “We have heard from the eyecare professionals that there is a need for preservative-free alternatives. The PGA market continues to grow year-over-year and we are excited to provide a new option for Canadian health care providers and their patients.” Grant Larsen, CCO of Aequus Pharma Zimed PF is contained in a unique multi-dose bottle that leverages a unidirectional valve and air filter technology to eliminates the need for a preservatives. In addition, this packaging format significantly reduces the amount of plastic used compared to single-use alternatives. “Medicom is excited by this news and looks forward to launching Zimed® PF in the Canadian market with Aequus,” says Simon Martin, CEO of Medicom. “Globally we have seen the strong uptake for Zimed® PF and pleased it will soon be available to Canadian patients.” Doug Janzen, CEO of Aequus Pharma said, “We want to thank Medicom for their support through the approval process with Health Canada. This is our third product we’ve brought to Canada in this partnership. We look forward to launching Zimed® PF in 2023 and providing Canadians with more treatment options.” ABOUT AEQUUS PHARMACEUTICALS INC. Aequus Pharmaceuticals Inc. is a specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus has grown its sales and marketing efforts to include several commercial products in ophthalmology and optometry. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license, remaining focused on highly specialized therapeutic areas.

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BUSINESS INSIGHTS, PHARMACY MARKET

Tetris Pharma signs service agreement with Syneos Health

Tetris Pharma Ltd | December 13, 2022

Tetris Pharma Ltd a subsidiary of biopharmaceutical company, Arecor Therapeutics plc announces that it has signed a service agreement with Syneos Health® the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success, to support the build out of Tetris Pharma’s commercial platform across Europe. Through this partnership, Syneos Health will provide commercial support through an outsourced contract sales services to accelerate healthcare practitioner awareness of Tetris Pharma’s flagship product, Ogluo®, for people living with diabetes across initial launch territories. “Following the recent launch of Ogluo® in Germany, we are focused on continuing its accelerated roll-out across Europe. Syneos Health was one of several potential partners that were evaluated during the process of partnering with an organisation that would provide a multitude of commercial options to help establish the product across Europe. Partnering with Syneos Health, a leader in clinical research, medical affairs, and commercialisation services for the pharmaceutical industry, is key to building our reputation as specialists in the marketing, sales, and distribution of commercial-stage specialty hospital products across the UK and Europe.” Dr. Shafiq Choudhary, Managing Director, Tetris Pharma

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BUSINESS INSIGHTS

Cambrex to Acquire Snapdragon Chemistry, a Leader in Continuous Flow API Development Services

Cambrex | November 22, 2022

Cambrex, a leading global contract development and manufacturing organization providing drug substance, drug product, and analytical services across the entire drug lifecycle, today announced that it has entered into a definitive agreement to acquire Snapdragon Chemistry, a leading US-based provider of chemical process development services to a broad range of emerging and established biopharma customers. Snapdragon specializes in active pharmaceutical ingredient batch and continuous flow process development, utilizing state-of-the-art automation technology and proprietary equipment to solve complex process and analytical development challenges. The team of scientists and engineers apply deep process understanding afforded by data-rich experimentation to design and rapidly execute efficient GMP and non-GMP manufacturing processes. With R&D and manufacturing headquartered in Waltham, Massachusetts, Snapdragon's 74 employees come with strong ties to the local scientific community, with 31 PhD scientists on staff. "The acquisition of Snapdragon will accelerate our growth in the area of continuous flow process development and manufacturing, complementing our recent organic investments in our High Point, North Carolina facility. With R&D and manufacturing capabilities in the heart of Boston's biopharma hub, Snapdragon will continue to focus on solving their customers' most difficult process development challenges." Tom Loewald, CEO of Cambrex "We are excited to be joining Cambrex, a company with over 40 years of drug substance development and manufacturing expertise," said Matt Bio, CEO of Snapdragon. "Partnering our best-in-class process development capabilities with Cambrex's larger scale manufacturing facilities in North America and Europe is a natural fit, both for our employees and our customers." Snapdragon recently opened its second facility, a new 51,000-square-foot facility to manufacture experimental pharmaceutical products for human clinical trials. The new facility expanded the company's capacity for supplying clinical intermediates and drug substances. The transaction is expected to close following the completion of customary regulatory approvals. This will be Cambrex's second acquisition within a year along with Q1 Scientific, consistent with its strategy to expand its portfolio of specialized solutions for pharmaceutical development and manufacturing. About Cambrex Cambrex is a leading global contract development and manufacturing organization that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,300 experts servicing global clients from North America and Europe, Cambrex is a trusted partner in branded and generic markets for API and finished dosage form development and manufacturing. Cambrex offers a range of specialized drug substance technologies and capabilities, including biocatalysis, continuous flow, controlled substances, solid-state science, material characterization, and highly potent APIs. In addition, Cambrex can support conventional dosage forms, including oral solids, semi-solids, and liquids, and has the expertise to manufacture specialty dosage forms such as modified-release, fixed-dose combination, pediatric, bi-layer tablets, stick packs, topicals, controlled substances, sterile, and non-sterile ointments.

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BUSINESS INSIGHTS, PHARMACY MARKET

Phio Pharmaceuticals Announces New Clinical Program to Study PH-762 for the Treatment of Cutaneous Squamous Cell Carcinoma

Phio Pharmaceuticals Corp. | December 22, 2022

Phio Pharmaceuticals Corp., today announced it expects to file an IND in the US in the first half of 2023 for a Phase 1b clinical trial of its INTASYL™ compound, PH-762. Phio is a clinical stage biotechnology company whose proprietary INTASYL self-delivering RNAi technology is designed to make immune cells more effective in killing tumor cells. PH-762 has been shown to reduce the expression of PD-1, a protein that inhibits T cells' ability to kill cancer cells. When administered intratumorally in preclinical models PH-762 primes an anti-tumor immune response, and inhibits tumor growth. Phio is currently conducting a Phase 1b clinical trial of PH-762 for the treatment of advanced melanoma at the Gustave Roussy Institute, one of the largest cancer centers in Europe. Phio expects to commence a US Phase 1b clinical trial early in the 2nd half of 2023. The initial US trial is expected to focus on the treatment of cutaneous squamous cell carcinoma and other selected cutaneous malignancies, following successful regulatory review of the IND. "Therapeutic interventions for cSCC are limited, and there is increasing unmet medical need. As cSCC tumors comprise approximately 51% of the total incidence of solid tumors in the US, excluding basal cell cancers, we recognize the growing need for alternative therapies for cSCC," said Robert Bitterman, Phio's Principal Executive Officer and Executive Chairman. Mr. Bitterman has over 25 years of executive leadership experience in the pharmaceutical and biologic life science industry with a proven track record in operations, finance and investor relations. "While monoclonal antibody therapies are available for the treatment of cSCC, mechanistically they only block the interaction between PD-1 and PD-L1 on the cell surface. PH-762 also has the potential to address PD-1 inside the T cell, essentially further enhancing the activity of the T cell to kill the tumor cells," said Dr. James Cardia, Phio's Vice President of Scientific Operations. Dr. Cardia led the team that discovered INTASYL. "PH-762 has the potential to meet a significant medical need in patients who have failed to respond to mAbs, as well as those with resectable and metastatic solid tumors. Phio is committed to advancing the study of PH-762 to provide a meaningful therapy for patients with a broad range of solid tumors." Dr. Mary Spellman, Phio's Medical and Clinical Development Advisor About INTASYL INTASYL compounds are chemically modified siRNAs that are designed to provide efficient, spontaneous cellular uptake and potent, long lasting intracellular activity targeting a broad range of cell types and tissues. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems. INTASYL has demonstrated preclinical efficacy in both Direct-to-Tumor and Adoptive Cell Therapy applications. In comparison to biologics and cell and gene therapies, INTASYL has a favorable pre-clinical toxicity and safety profile, and a streamlined chemical synthesis that reduces costs and offers substantial convenience to the prescriber and patient. Phio believes that INTASYL is the only self-delivering RNA interference technology focused on immuno-oncology therapeutics. About Phio Pharmaceuticals Phio Pharmaceuticals Corp. is a clinical stage biotechnology company whose proprietary INTASYL™ RNAi technology is designed to make immune cells more effective in killing tumor cells. Phio believes that INTASYL is the only self-delivering RNAi technology focused on immuno-oncology therapeutics. INTASYL drugs precisely target specific proteins that reduce the body's ability to fight cancer, without the need for specialized formulations or drug delivery systems.

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