BioCanRx Invests $10M in Promising New Cancer Immunotherapy Research and Biomanufacturing to Benefit Canadians

On September 22, 2020 BioCanRx, Canada’s Immunotherapy Network, reported funding of $10M for 14 cancer immunotherapy research projectsand eight core and biomanufacturing facilities (Press release, BioCanRx, SEP 22, 2020, View Source [SID1234565514]). In addition to BioCanRx’s investment, matching partner contributions of $16.5M increase the total investment in Canadian translational cancer immunotherapy research and manufacturing facilities to $26.5M.

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Cancer is one of the biggest health challenges facing Canadians. Nearly 1 in 2 Canadians is expected to develop cancer in their lifetime. BioCanRx is working to turn the tide and improve outcomes for patients by accelerating the development of promising immunotherapy treatments which could be more effective, affordable and safe than conventional cancer therapies.

"We’re collaborating and building teams across Canada to find new ways for the body’s immune system to outsmart and kill cancer. This new funding is helping to bridge the research gap between lab discoveries and clinical trials to ultimately benefit patients," said Dr. John Bell, BioCanRx’s Scientific Director and a senior cancer research scientist at The Ottawa Hospital and the University of Ottawa.

BioCanRx’s investments in the development of novel therapies continue to be guided and benchmarked by its Research Management Committee composed of internationally renowned academics and industry leaders in the field of cancer immunotherapy. The focus of the newly funded projects includes highly innovative and novel approaches to cancer treatment, targeting difficult to treat cancers where current options are limited. The project investment portfolio includes cross-disciplinary teams from across the country working on new, rational combination approaches and unique cell, vaccine/virus-based and antibody immunotherapies.Investments in Canada’s biomanufacturing capacity also feature prominently and additional sites across the country will be added to our point-of-care cell manufacturing network to enhance access to life-saving therapies to patients across the country.

Enterome to Present at Jefferies Virtual Next Generation IBD Therapeutics Summit

On September 22, 2020 ENTEROME SA, a clinical-stage biopharmaceutical company leveraging its unique knowledge of the microbiome-immunoinflammation axis to develop next-generation therapeutics, reported that Pierre Belichard, Chief Executive Officer, and Christophe Bonny, Chief Scientific Officer, will present at the Jefferies Virtual Next Generation IBD Therapeutics Summit, which will take place September 23-24, 2020 (Press release, Enterome, SEP 22, 2020, View Source [SID1234565504]).

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The presentation, in the form of a live fireside chat, will take place on Wednesday, September 23, at 11:30-12:10 Eastern Daylight Time.

Instrumentation Laboratory Receives US FDA Marketing Authorization For The First Apixaban Diagnostic Test

On September 22, 2020 Instrumentation Laboratory (IL) reported that the US Food and Drug Administration (FDA) granted De Novo marketing authorization for the HemosIL Liquid Anti-Xa test kit to measure apixaban (Press release, Instrumentation Laboratory, SEP 22, 2020, View Source [SID1234565502]). This is the first direct oral anticoagulant (DOAC) test for automated Hemostasis analyzers authorized by the FDA.

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The FDA indication for HemosIL Liquid Anti-Xa has been expanded from the current quantitative determination of unfractionated heparin and low molecular-weight heparin, to include apixaban measurement, when used with HemosIL Apixaban Calibrators. The test is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information: patients at risk for major bleeding and patients experiencing a bleeding episode.

"DOACs are essential treatment for hundreds of thousands of patients around the world. Providing a means for clinicians to assess appropriate patients who take apixaban is an important step in enhancing care," said Remo Tazzi, Director, Worldwide Marketing at IL. "We are very proud to add another milestone "first" to our 60-year history of innovation in in vitro diagnostics."

Fully validated for use on the ACL TOP Family and ACL TOP Family 50 Series Hemostasis Testing Systems, HemosIL Liquid Anti-Xa assay for apixaban measurement delivers an automated result with excellent linearity, limit of detection, precision and accuracy, for reliable results and enhanced patient management.

The HemosIL Liquid Anti-Xa assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings. Apixaban is a direct factor Xa (FXa) inhibitor, developed by Pfizer Inc. and Bristol-Myers Squibb Company, and is sold under the trademark Eliquis.

Odyssey Investment Partners To Acquire ProPharma Group

On September 22, 2020 Odyssey Investment Partners ("Odyssey") reported that it has entered into an agreement to acquire ProPharma Group (or the "Company") from Linden Capital Partners (Press release, Odyssey Pharmaceuticals, SEP 22, 2020, View Source [SID1234565501]). Financial terms of the transaction were not disclosed.

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Founded in 2001, ProPharma Group is a leading provider of regulatory and compliance services to pharmaceutical, biotechnology and medical device customers. The Company’s primary service offerings include regulatory affairs, life science consulting, pharmacovigilance and medical information services. ProPharma Group partners with its clients from early concept development through each clinical phase, product launch, and commercialization to help ensure regulatory expectations are met, business goals are achieved, and patient health and safety is improved. ProPharma Group is headquartered in Overland Park, Kansas, with 5 US-based offices and 10 additional offices across Canada, UK, Netherlands, Sweden, Germany, Japan and Australia.

Dawn Sherman, CEO, as well as the ProPharma Group management team are investing in ProPharma Group alongside Odyssey and will continue to lead the Company.

Jeffrey McKibben, a Senior Managing Principal of Odyssey, said: "ProPharma Group represents a compelling opportunity to invest in a growing business with attractive demand characteristics given its critical role in helping customers comply with regulatory and safety requirements. Dawn and the management team have done an outstanding job of establishing a comprehensive offering of services in a large, growing and fragmented industry. We have identified numerous organic and inorganic opportunities to build on ProPharma Group’s leadership position by expanding its four business verticals and expect to capitalize on these in the coming years."

Ms. Sherman said: "We are enthusiastic about our new partnership with Odyssey, given their long track record of supporting management teams looking to further drive and expand their businesses. Our team has a lot of runway in front of us, including continuing to expand our operations and customer base both domestically and internationally, and identifying new ways to assist pharma along the lifecycle of a drug. Odyssey understands our business and the opportunities that lie ahead and is well-positioned to help us build on our accomplishments to date and reach our full potential."

Tug Fisher, a Principal of Odyssey, added: "Our investment is a continuation of Odyssey’s macro thematic work in the pharma services industry, and ProPharma Group represents our second investment in the sector. We believe the business is uniquely positioned as a leading specialty player to execute on the underlying market opportunity and we are excited to support the team in achieving their growth objectives."

Closing of the transaction is expected to occur in October.

Latham & Watkins and Smith Anderson served as legal advisors and Jefferies LLC served as financial advisor to Odyssey.

Neogen reports first quarter results

On September 22, 2020 Neogen Corporation (Nasdaq: NEOG) reported that revenues for the first quarter of its 2021 fiscal year, which ended Aug. 31, were $109,325,000, an 8% increase compared to the previous year’s first quarter revenues of $101,424,000 (Press release, Neogen, SEP 22, 2020, View Source [SID1234565500]).

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Net income for the first quarter of Neogen’s 2021 fiscal year was $15,860,000, or $0.30 per share, compared to $14,652,000, or $0.28 per share, in the previous year’s first quarter.

"Considering the ongoing difficult global business climate, we are pleased to report increased revenues and net income as we continue to take the necessary measures to protect our employees and business — and the global food supply," said John Adent, Neogen’s president and chief executive officer. "Although conditions across many of our markets remain sluggish and challenging, the first quarter showed Neogen’s resilience to difficult conditions due to the diversity of our portfolio of products and services. As our food safety markets faced disruption, we continued to have strong growth in our genomics business — and we worked to meet the global demand for our biosecurity products, including cleaners, disinfectants, and hand sanitizers. We are also pleased with the tremendously positive market reaction following the recent launch of our next generation automated general microbiology test system, Soleris NG."

Neogen’s gross margin was 46.0% of sales in the first quarter of the current fiscal year, compared to 47.5% recorded in the same period a year ago, driven by a mix shift in the Food Safety segment toward lower margin products. Operating expenses declined 2%, due primarily to lower travel and customer facing activities worldwide resulting from the COVID-19 pandemic. Operating income for the quarter was $18,895,000, or 17.3% of sales, compared to $16,264,000, or 16.0% of sales, a year ago.

"The currency headwinds that we have faced in recent quarters continued to adversely affect our otherwise strong performances in Mexico and Brazil," said Steve Quinlan, Neogen’s chief financial officer. "In a constant currency environment, sales would have been $2.1 million higher in our first quarter than reported. Nonetheless, our ongoing strong cash generation and position provides Neogen the flexibility to continue to invest in all available avenues to grow our businesses going forward — including short-term operational improvements and longer-term strategic moves."

Revenues for the company’s Food Safety segment were $54,185,000 in the current quarter, compared to $51,021,000 in the prior year’s first three months. The increase was due primarily to higher sales of disinfectants, hand sanitizers and insecticides through Neogen’s international locations, the majority of which report through the company’s Food Safety segment. The segment’s first quarter revenues were also boosted by the July launch of Neogen’s new Soleris NG automated microbial system, which rapidly detects a wide variety of microorganisms that threaten the safety and quality of food and other consumer products.

The company’s innovative Listeria Right Now system also continues to gain market acceptance, recording 9% growth in sales over the prior year quarter. Sales of Neogen’s mycotoxin tests were up slightly, as there have been no major outbreaks this year and currency pressure negated volume gains in Brazil. Sales of the company’s test for histamine, a spoilage indicator in certain species of fish after harvest, grew more than 20% as the tuna industry responded to the increase in demand for canned product due to the COVID-19 pandemic. Sales of the company’s test kits to detect food allergens declined 3% and environmental sanitation products were down 7% for the quarter, as customers continued to be negatively impacted by the COVID-19 pandemic. Revenues for dairy drug residue detection products declined 33%, as customers work through distributor inventory and the company ramps up its own direct sales after ending an exclusive arrangement with a large distributor in Europe.

Revenues at Neogen’s United Kingdom operations rose 21% in U.S. dollars (17% in local currency), led by strong increases in sales of hand sanitizers, cleaners and disinfectants primarily used to fight COVID-19 in the U.K., Asia and Africa, and sales of the Raptor mycotoxin test system. In China, Neogen’s revenues more than doubled due to gains in sales across the group’s entire product portfolio, and in particular, biosecurity products as the country continues to fight COVID-19 and African swine fever. Revenues from India increased 10% in the quarter in U.S. dollars, and rose 18% in local currency.

Neogen’s revenues from its operations in Brazil and Mexico were both adversely affected by currency translations into U.S. dollars. The company’s revenues in Brazil increased 38% in local currency, led by a large non-recurring sale of insecticides to a governmental health organization, bovine and porcine genomics services, and market gains on aflatoxin test kits; when translated to U.S. dollars, revenues rose 1%. Similarly, Neogen operations in Mexico recorded a 13% quarterly increase in local currency, with particular strength in cleaners and disinfectants; when translated to U.S. dollars, revenues were down 2%.

The Animal Safety segment reported revenues of $55,140,000 for the first quarter of the 2021 fiscal year, compared to $50,403,000 in the prior year first quarter. The segment’s highlights in the quarter included a 47% increase in sales of its rodenticides, as Neogen responded to a cyclical rodent outbreak in the U.S.; a 12% increase in genomics services in North America and Australia, and a 6% increase in sales of domestic insecticides, which included the Aug. 3 acquisition of the U.S. rights to Elanco’s StandGuard Pour-on for horn fly and lice control in beef cattle.

Revenues from Neogen’s worldwide animal genomics business increased 11% in the first quarter of fiscal 2021 compared to the prior year. This was primarily the result of Neogen’s accelerating growth in companion animal genetic testing, including tests for dog parentage, breed verification, and genetic health. The growth was also aided by the recent launch of a new genomic test for whiteleg shrimp. Partially offsetting this were lower sales into the commercial dairy and beef markets, due to continued poor economic conditions and supply chain issues resulting from COVID-19 outbreaks.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in worldwide biosecurity products, animal genomics testing and the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals and veterinary instruments.

Certain portions of this news release that do not relate to historical financial information constitute forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties. Actual future results and trends may differ materially from historical results or those expected depending on a variety of factors listed in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s most recently filed Form 10-K.