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Thursday, July 13, 2023

CureVac Strengthens Ongoing Patent Litigations

 

  • Cases in Germany and the U.S. broadened by asserting additional, new intellectual property rights
  • Three new intellectual property rights added to infringement lawsuit against Pfizer/BioNTech in Germany, increasing number of asserted intellectual property rights to eight
  • Tenth patent added to CureVac's counterclaim against Pfizer/BioNTech in the U.S., covering innovations in mRNA purification methods highly relevant to the manufacturing of Comirnaty®

Labcorp Finalizes Strategic Relationship with Jefferson Health

  LabCorp (NYSE: LH), a global leader in innovative and comprehensive laboratory services, today announced the completion of the previously announced transaction that establishes a strategic relationship with Jefferson Health (Jefferson), the largest health system serving the greater Philadelphia and Southern New Jersey region.

"This groundbreaking agreement between Jefferson and Labcorp will better serve providers and patients throughout the greater Philadelphia and southern New Jersey region by increasing access, breadth of testing and affordability, as well as enriching the academic prowess and reach of Jefferson Health," said Bill Haas, senior vice president of Labcorp's Northeast Division. "This transaction further demonstrates our commitment to advancing our laboratory services model with leading academic health systems, and we are looking forward to building upon Jefferson's longstanding track record of delivering comprehensive diagnostic care to its patients."

Through this collaboration, the scope and productivity of Jefferson's current offerings will expand, and healthcare access will be improved for underserved communities in Philadelphia and the surrounding areas. This new relationship will also help standardize laboratory testing across the entire health system, creating consistency and optimizing patient care and safety at all locations. Leveraging Jefferson's pathology and laboratory expertise, the Jefferson laboratory will continue to provide services for all inpatients and outpatients along with select specialty testing, including anatomic pathology, genomics and molecular virology. Additionally, Labcorp and Jefferson will work together to establish the Innovation Driving Excellence in Academics (IDEA) initiative, which will foster innovation and advance testing capabilities and technologies to improve health outcomes.

https://www.biospace.com/article/releases/labcorp-finalizes-strategic-relationship-with-jefferson-health/

Grifols in Phase 3 Study of Two Dose Regimens of Prolastin®-C in Emphysema

 

  • Target of 339 patients enrolled has been met in the SPARTA clinical trial, designed to evaluate efficacy and safety of two separate weekly doses of Grifols’ Prolastin®-C (Alpha1-Proteinase Inhibitor [Human]) to slow emphysema progression in patients with alpha-1-antitrypsin (AAT) deficiency (known as alpha-1)
  • Alpha-1 is the most common genetic risk factor for chronic obstructive pulmonary disease (COPD), a group of respiratory diseases that includes emphysema. COPD is the third leading cause of death worldwide1
  • Grifols’ advances in the science of alpha-1 underscore its robust innovation pipeline and commitment to testing and treatment for the alpha-1 community

'NIH Awards $3.6 m to Rosalind Franklin U R&D on Rejection Sensitivity in Sexual Minority Adolescents'

 Rosalind Franklin University (RFU) psychologist Brian Feinstein, PhD, is determined to improve the health of one of the nation’s most vulnerable populations — sexual minority youth, who are at higher risk of suicide and depression than their heterosexual peers. Those disparities, Dr. Feinstein says, are “rooted in exposure to rejection, discrimination and victimization.”

 

“I hope our research will shine a light on the need to understand and address the mental health challenges facing sexual minority youth,” he said. “We need to let them know they’re not alone.”

 

Dr. Feinstein, associate professor and director of the Sexuality, Health, and Gender Lab, has been awarded a five-year, $3.6 million grant by the National Institute of Mental Health to investigate the effects of sexual orientation-related rejection sensitivity — the expectation of rejection and accompanying feelings of anxiety — on the mental health of sexual minority adolescents.

 

“What we see with sexual minority people is that having a history of experiencing rejection because of one’s identity can contribute to developing a sense that people are going to continue to reject you in your day-to-day life,” Dr. Feinstein said. “That mindset can undermine mental health.”

 

The longitudinal and experience-sampling study will provide researchers with real-time data. A diverse cohort of 500 sexual minority adolescents ages 14-17 from across the U.S. will complete online surveys for 18 months, answering questions four times a day for six weeks via an app.

https://www.biospace.com/article/nih-awards-3-6-million-to-fund-rosalind-franklin-university-research-on-rejection-sensitivity-in-sexual-minority-adolescents/

Inogen Expands Respiratory Products with Acquisition of Physio-Assist; Quarterly Update

Acquisition Enables Evolution to a Global Respiratory Care Company by Adding a Sizable, Growing and Underserved Airway Clearance Market Opportunity

Inogen Provides Preliminary, Unaudited Second Quarter Financial Update

Inogen to Announce Second Quarter Financial Results on August 7, 2023

 

Inogen, Inc. (Nasdaq: INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced that the company has entered into a definitive agreement to purchase Physio-Assist SAS, a privately-held company headquartered in France.

Physio-Assist developed and manufactures Simeox, a technology-enabled airway clearance device with a proven efficacy and safety profile, currently used outside of the United States, to treat a condition in the lungs known as bronchiectasis, where the lung’s bronchi become damaged and widened, that is often present in cystic fibrosis and chronic obstructive pulmonary disease. Simeox is used in pulmonary rehabilitation centers, as well as at home. Simeox has been cleared under CE mark in the EU and is currently being sold in Europe, Asia, and the Middle East.

“This acquisition aligns with our strategy to diversify our portfolio to globally improve patient lives through respiratory care,” said Nabil Shabshab, President and Chief Executive Officer of Inogen. “Simeox imminently expands our product offering in EMEA, and potentially in the US to serve COPD and other chronic disease patients who suffer from bronchiectasis with an innovative, non-invasive, and next generation airway clearance solution. We believe this is a compelling transaction, as it expands our addressable market opportunity, enhances our long-term growth and profitability, and is expected to generate an attractive return on investment.”

“I am very excited about Physio-Assist becoming a part of the Inogen organization and view this as a significant milestone in the journey to scale the Simeox differentiated product offerings globally in service of bronchiectasis and cystic fibrosis patients with unmet needs,” said Adrien Mithalal, Chief Executive Officer of Physio-Assist.

Strategic Rationale

  • Aligns with Inogen’s strategy to diversify its portfolio and expand market opportunities imminently in the rest of the world and potentially in the US.
  • Aligns with Inogen’s long-term financial goals.
  • Leverages Inogen’s commercial infrastructure and capabilities.
  • Provides a differentiated and clinically proven innovative airway clearance technology with capital sales and desirable recurring revenue from disposables.
  • Provides access potentially to a large growing bronchiectasis market opportunity with 400,000 to 490,000 patients in the US upon regulatory clearance.

Financial Details

Inogen will pay approximately $32 million in cash net of debt payable at closing, plus potential future cash performance-based milestone payments based on achievement of goals related to FDA clearance of the device. The total consideration, if all milestones are achieved, will not exceed $45 million. The amount of the performance-based milestones may also be adjusted net of related development costs.

In 2023, the acquisition is expected to be immaterial to Inogen’s revenue and immediately accretive to gross margin. Given the clinical and commercial investment required to obtain FDA clearance and launch Simeox in the US, the transaction is expected to be accretive to adjusted earnings beginning in 2027. The transaction, which has been approved by the Board of Directors of Inogen and Physio-Assist, is subject to the satisfaction of customary closing conditions, including Foreign Investment Authority approval from the French Ministry of Economy. The transaction is expected to close in the fourth quarter of 2023.

In connection with the acquisition and to facilitate the operations of Physio-Assist between signing and expected close of the transaction, Inogen will be providing Physio-Assist a short-term loan in the amount of up to $500,000. Upon close, assuming the full $500,000 has been drawn, $250,000 will be used to reduce the purchase price and $250,000 will be forgiven.

Preliminary, Unaudited Second Quarter Financial Update

Inogen estimates preliminary, unaudited total revenue in the second quarter of 2023 to be in the range of $83 million to $84 million. Revenue was lower than expected in US and International business-to-business, and lower direct-to-consumer revenue despite continued productivity gains. This performance was partially offset by growth in rental revenue reflecting the company’s strategic focus on US prescribers.

These preliminary, unaudited estimates are based solely upon information available to management as of the date of this press release. Inogen’s actual results may differ from these estimates due to the completion of its quarter-end closing procedures, final adjustments and developments that may arise between now and the time its financial results for the quarter ended June 30, 2023, are finalized. In light of these preliminary results, the Company intends to provide updated 2023 guidance on the second quarter earnings call.

Quarterly Conference Call Information

Inogen will issue second quarter 2023 financial results after the market closes on Monday, August 7, 2023. On the same day, the Company will host a conference call at 1:30 p.m. PT / 4:30 p.m. ET.

Individuals interested in listening to the conference call may do so by dialing:

US domestic callers (877) 841-3961
Non-US callers (201) 689-8589

Please reference Inogen to join the call. To listen to a live webcast, please visit the Investor Relations section of Inogen's website at: http://investor.inogen.com/. This webcast will also be archived on the website for 6 months.

https://www.biospace.com/article/releases/inogen-expands-its-respiratory-product-portfolio-with-acquisition-of-physio-assist/

Ardelyx: Acceptance of NDA Submission triggers as $2 million milestone payment

 Ardelyx Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A potential approval of the NDA submission in China is expected by the end of 2024.

https://www.biospace.com/article/releases/ardelyx-announces-acceptance-of-new-drug-application-for-tenapanor-for-hyperphosphatemia-in-chinaacceptance-of-nda-submission-triggers-as-2-million-milestone-payment-to-ardelyx-by-fosun-pharma/

Coherus and Superior Biologics Announce National Distribution Agreement for YUSIMRY

 

  • First formal distribution agreement for YUSIMRY™, a biosimilar of Humira®, at $995 per carton (two 40 mg/0.8 mL autoinjectors) representing a discount of more than 85% compared to Humira
  • Innovative distribution plan provides employers a low-cost, high-quality treatment option from Coherus and the highest quality of patient service and care from leading independent specialty pharmacy Superior Biologics

 Coherus BioSciences Inc. (“Coherus”, Nasdaq: CHRS) and specialty pharmacy Superior Biologics, Inc. (“Superior Biologics”) today announced a national distribution agreement for YUSIMRY™ (adalimumab-aqvh) at a price of $995 per carton of two autoinjectors, a discount of more than 85% compared to Humira® (adalimumab), currently priced at $6,922 per carton of two pens.

“Coherus is pleased to work with Superior Biologics for nationwide distribution of YUSIMRY, providing patients and their plan sponsors access to a high-quality, safe, and effective treatment at significant savings compared to Humira,” said Denny Lanfear, Coherus’ Chairman and Chief Executive Officer. “Superior Biologics is an ideal partner for the distribution of YUSIMRY based on their commitment to quality patient service and care, their extensive experience working with manufacturers, patients, physicians, and plan sponsors, and their nationwide reach. Through this unique distribution partnership, we can bring YUSIMRY immediately to patients throughout the United States.”

https://www.biospace.com/article/releases/coherus-and-superior-biologics-announce-national-distribution-agreement-for-yusimry-/