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.

Humanigen to Present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

On September 22, 2020 Humanigen, Inc., (Nasdaq: HGEN) ("Humanigen"), reported that management will present a company overview and business update at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit at 10:50 a.m. EDT, Wednesday, September 23, 2020 (Press release, Humanigen, SEP 22, 2020, View Source [SID1234565498]).

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The conference is being held in a virtual format. A live webcast of the presentation may be accessed at View Source Archived replay will be available on the Company website for 30 days following the event.

CURE Media Group Announces Winners of the Inaugural 2020 Lung Cancer Heroes™ Awards

On September 22, 2020 CURE Media Group, the industry-leading multimedia platform devoted to cancer updates and research that reaches more than 1 million patients, reported the four winners of the inaugural 2020 Lung Cancer Heroes awards and the winner of the Lifetime Achievement award (Press release, CURE Media Group, SEP 22, 2020, View Source [SID1234565497]).

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"Each of these esteemed individuals has contributed to improving the lives of lung cancer patients," said Mike Hennessy Jr., president and CEO of MJH Life Sciences, parent company of CURE Media Group. "We are so grateful to work with supporters such as Takeda and our advocacy groups to bring together the lung cancer community and celebrate these remarkable heroes for their amazing efforts."

The inaugural recognition event, which will be held in a virtual format, will recognize the heroes who have gone above and beyond, making a difference in the lives of those affected by lung cancer. The Lifetime Achievement award, which honors those who over the long term have made a significant impact and inspiring contributions to a large number of individuals and organization in the lung cancer community, also will be presented.

The 2020 Lung Cancer Heroes winners are:

Carolyn Baggett, RN, is a lung cancer screening program coordinator at Baptist MD Anderson Cancer Center (BMDACC) in Jacksonville, Florida. Baggett started working at Baptist Medical Center in 2014 as an oncology nurse navigator caring for several stage 4 lung cancer patients and assisting their families. When lung cancer screening was recommended by the U.S. Preventive Services Task Force in 2013, Baggett was very motivated to develop a program to help find lung cancer at an early stage. In December 2015, the program launched and has grown substantially. As of July 2020, BMDACC has completed almost 10,000 screenings at 10 locations and found 129 lung cancers, of which almost 70% were early stage. For the last two years, Baggett has been an American Lung Association cabinet member, which has helped her to expand this work.
Jennifer L. Garst, M.D., is a thoracic medical oncologist and professor of medicine at Duke Cancer Center Raleigh in North Carolina. As a lung cancer specialist, Garst has provided extraordinary cancer care, and, as a tireless advocate for her patients, she has made significant and lasting contributions to the lung cancer advocacy community. She is the founder and current board chair of the Lung Cancer Initiative (LCI) of North Carolina and was the founding chair of LCI’s Scientific Advisory Committee. Garst has numerous publications, including 42 refereed journals, eight non-refereed, one book chapter and more than 30 published scientific reviews and selected abstracts. She has also received numerous awards, honors and recognitions throughout her career.
Fred R. Hirsch, M.D., Ph.D., is executive director of the Center for Thoracic Oncology in The Tisch Cancer Institute (TCI) at Mount Sinai and the Richard Stein, Joe Lowe and Louis Price Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York. As an internationally renowned authority on lung cancer treatment and research for more than 25 years, Hirsch has received several awards and honors, including the International Association for the Study of Lung Cancer (IASLC) Mary J. Matthews Award for Translational Research in Lung Cancer in 2007 and the Addario Foundation Lectureship Award in 2015. The IASLC also has established an annual Fred R. Hirsch Lectureship Award in Translational Lung Cancer Science. Hirsch’s research has helped identify and validate prognostic markers for lung cancer outcomes and biomarkers for personalized lung cancer therapies that illustrate how these therapies work and who is most likely to benefit from them.
Deborah Pickworth was diagnosed with stage 4 lung cancer in 2013 when she was 43 and has undergone several treatments and surgical procedures over the last seven years. In between and during treatments, Pickworth has been highly motivated to find better treatment options, better trial protocols and more patient support groups, and to raise money for additional lung cancer research. In 2014, she started Team Pickworth for the annual LUNG FORCE Walk in Detroit, and she has raised more than $17,300 over the past six years. Pickworth founded the Michigan Lung Cancer and BRAF Bombers groups on Facebook, and she is an Imerman Angels mentor. She also is a member of IASLC and the American Lung Association’s Patient Advisory Group.
The winner of the Lifetime Achievement award is Bonnie J. Addario, lung cancer survivor, cofounder and board chair of GO2 Foundation for Lung Cancer. As an activist, advocate and educator, Addario has empowered patients and given them a voice since she received a stage 3B lung cancer diagnosis more than a decade ago. Recognizing the need to provide hope through education, empowerment, advocacy and research for patients and families, Addario and her family founded the Bonnie J. Addario Lung Cancer Foundation (ALCF) in 2006. In 2019, ALCF and the Lung Cancer Alliance merged, forming the GO2 Foundation for Lung Cancer, dedicated to saving, extending, and improving the lives of those vulnerable, at risk, and diagnosed with lung cancer. Addario acts as an adviser to industry leaders, clinicians and policy makers, and she is a member of the Personalized Medicine Coalition board.

In addition, Addario founded the Addario Lung Cancer Medical Institute (ALCMI) in 2008 as an international research consortium driving research otherwise not possible. Working with the GO2 Foundation, ALCMI powers collaborative initiatives in genetic (molecular) testing, therapeutic discoveries, targeted treatments and early detection of lung cancer.

"At Takeda, we remain committed to developing effective and personalized medicines for people diagnosed with non-small cell lung cancer." said Fatima Scipione, head of Takeda Oncology Patient Advocacy and Engagement. "We’re proud to be the sponsor of the Lung Cancer Heroes program, a collaborative effort with CURE and the patient advocacy community, to honor and recognize the incredible work being done in the lung cancer community to advance research and improve patient outcomes."

The 2020 Lung Cancer Heroes virtual celebration will take place Thursday, Oct. 15, 6-7:30 p.m. EDT, in conjunction with IASLC 2020 North America Conference on Lung Cancer, a worldwide virtual event taking place Oct. 16-17.

For more information on the winners and to register to attend, click here.

This event is supported and partner by Takeda and in partnership with The American Lung Association, GO2 Foundation for Lung Cancer, Lung Cancer Foundation of America, Lung Cancer Research Foundation, and LUNGevity.