On December 21, 2021 EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported it has completed its acquisition of Intouch Group, a full-service global agency network serving the pharmaceutical industry (Press release, EVERSANA, DEC 21, 2021, View Source [SID1234597525]). The acquisition immediately propels EVERSANA’s position as a $1 billion commercial services leader with more than 40 locations and 5,500 employees worldwide, poised to solve any global pricing, access, reimbursement, promotion, adherence, or product delivery challenge.

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"Today marks a milestone day for not only our employees and clients, but for an industry desperately in need of a better way to bring innovations to market, create long-term value, and improve patient lives," said Jim Lang, CEO of EVERSANA. "With the added power of Intouch and millions more invested in data, analytics and digital transformation, we are reinventing commercial approaches for the benefit of our clients and their patients."

Under terms of the agreement announced in October 2021, Intouch’s industry-leading creative and media services, enterprise solutions and data analytics will join EVERSANA’s fully integrated commercialization services platform. Agencies from both firms will integrate, as EVERSANA ENGAGE joins forces with the Intouch agency network. Faruk Capan, CEO of Intouch Group, now reports to Jim Lang.

"This is so much more than an integration. This is our opportunity to improve every sector of product commercialization," said Capan. "Over the last 20 years we transformed pharmaceutical promotion and digital engagement. Imagine what the next 20 years will bring as we set our sights even higher, unafraid to transform healthcare as we know it."

Financial details will not be disclosed. Houlihan Lokey served as the exclusive financial advisor to Intouch Group.

On December 21, 2021 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a commercial-stage biopharmaceutical company developing innovative medicines to improve the lives of people with cancer, reported that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for QINLOCK (ripretinib) in the UK for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib1 (Press release, Deciphera Pharmaceuticals, DEC 21, 2021, View Source [SID1234597524]).

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"The approval of QINLOCK in the UK is an important milestone for patients with advanced GIST who have been waiting for a new treatment option," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "The results from the INVICTUS study underscore the potential for QINLOCK to transform the treatment of advanced GIST and establish a new standard of care in the UK for fourth-line GIST."

The QINLOCK approval was supported by efficacy results from the primary analysis of the pivotal Phase 3 INVICTUS study in patients with advanced GIST as well as combined safety results from INVICTUS and the Phase 1 study of QINLOCK. In INVICTUS, QINLOCK demonstrated a median progression-free survival of 6.3 months compared to 1.0 month in the placebo arm and significantly reduced the risk of disease progression or death by 85% (hazard ratio of 0.15, p<0.0001)2. Secondary endpoints include Objective Response Rate (ORR) as determined by independent radiologic review using modified RECIST and Overall Survival (OS). QINLOCK demonstrated an ORR of 9.4% compared with 0% for placebo (p =0.0504)2 In addition, QINLOCK demonstrated a median overall survival of 15.1 months compared to 6.6 months in the placebo arm and reduced the risk of death by 64% (hazard ratio of 0.36)2.

The most frequently observed adverse drug reactions (≥25%) in a pooled safety population (n=392) treated with QINLOCK were fatigue, alopecia, nausea, myalgia, constipation, diarrhea, palmar-plantar erythrodysesthesia syndrome (PPES), weight decreased, and vomiting1,2.

In the INVICTUS study, adverse reactions resulting in permanent discontinuation occurred in 8% of patients, dosage interruptions due to an adverse reaction occurred in 24% of patients and dose reductions due to an adverse reaction occurred in 7% of patients who received QINLOCK2.

About QINLOCK (ripretinib)

QINLOCK is a switch-control tyrosine kinase inhibitor that was engineered to broadly inhibit KIT and PDGFRA mutated kinases by using a dual mechanism of action that regulates the kinase switch pocket and activation loop. QINLOCK inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18 involved in GIST, as well as the primary exon 17 D816V mutation3,4. QINLOCK also inhibits primary PDGFRA mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, involved in a subset of GIST3,4.

On December 21, 2021 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible small molecules to treat and improve the lives of patients with genetically defined cancers, reported that it will present at the upcoming virtual 40th Annual J.P. Morgan Healthcare Conference (Press release, Biomea Fusion, DEC 21, 2021, View Source [SID1234597523]). Thomas Butler, Chief Executive Officer and Chairman of the Board, is scheduled to present on Wednesday, January 12, 2022, at 12:00pm Pacific Time.

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A live audio webcast of the presentation can be accessed at www.biomeafusion.com and will be available for 30 days following the presentation.

On December 21, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported William A. Geist has been appointed President, Protein Sciences Segment, effective January 3, 2022 (Press release, Bio-Techne, DEC 21, 2021, View Source [SID1234597522]). Mr. Geist succeeds N. David Eansor, who will be retiring from the Company. Mr. Eansor will remain with Bio-Techne through the end of February 2022 to ensure a smooth transition.

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Mr. Geist has over two decades of experience as a senior life science tools leader, most recently serving as Chief Operating Officer for Quanterix, where he was responsible for enterprise-wide operations and strategy deployment. Previously Mr. Geist was Vice President & General Manager for two of Thermo Fisher Scientific’s largest Business Units, Protein & Cell Analysis and qPCR. Prior to Thermo Fisher Scientific, Mr. Geist was Vice President of QuantaBiosciences, a QIAGEN company, where he held various roles of increasing responsibility from the company’s inception through its acquisition.

"I want to personally thank Dave for his leadership and significant contributions over the last seven years at Bio-Techne. He has played an integral role in the Company’s success, and I wish him the best in his retirement," said Chuck Kummeth, President and Chief Executive of Bio-Techne. "Will is joining Bio-Techne at a very exciting point in the Company’s growth trajectory. His experience running life science tools businesses generating over $1 billion in annual revenue make him the ideal candidate to take the Protein Sciences Segment through its next phase of growth."

On December 21, 2021 Apollo Endosurgery, Inc. ("Apollo") (NASDAQ: APEN), a global leader in less invasive medical devices for gastrointestinal and bariatric procedures, reported that it has entered into a debt financing agreement with an affiliate of Innovatus Capital Partners, LLC ("Innovatus") to provide Apollo with up to $100 million in term loan financing (Press release, Apollo Endosurgery, DEC 21, 2021, View Source [SID1234597520]).

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"We are pleased to partner with a long-term strategic investor such as Innovatus in this transaction," said Chas McKhann, president and CEO. "This new loan facility provides us flexibility to invest in our business and fund our growth initiatives through minimally-dilutive financing. Importantly, with this additional capital source, our management team can focus on unlocking the value in our business through continued execution."

The new term loan reduces Apollo’s cost of capital, extends amortization by an additional 33 months over the prior term loan and decreases debt service cash requirements by nearly $30 million over the next three years.

"Innovatus is excited to work with Apollo and its management team," said Claes Ekstrom, Managing Director. "We believe this transaction enables Apollo to accelerate the adoption of its portfolio of highly differentiated products across a wide range of patient needs."

On December 21, 2021, Apollo entered into a loan and security agreement (the "Loan Agreement") pursuant to which Innovatus has agreed to make certain term loans in the aggregate principal amount of up to $100 million, with the first $35 million tranche (Term A Tranche) to be funded at closing and used to retire Apollo’s existing term debt facility with SLR Capital Partners.

Apollo will be eligible to draw on additional tranches commencing June 30, 2022 as follows:
•Term B Tranche of $15 million between July 1, 2023 and December 31, 2023, upon achievement of certain revenue milestones;
•Term C Tranche of $25 million between July 1, 2024 and December 31, 2024, upon achievement of certain revenue milestones; and
•Term D Tranche of up to $25 million second between June 30, 2022 and June 30, 2024, for the purposes of financing all or part of any approved acquisition.

Borrowing under the Loan Agreement will bear interest at the greater of the Wall Street Journal Prime Rate or 3.25%, plus 4.0% (currently, 7.25%). Apollo is entitled to make interest-only payments for 60 months, followed by monthly payments of principal and interest through maturity on the sixth anniversary of the initial funding date.

The Loan Agreement is secured by substantially all of Apollo’s assets.

Prior to December 21, 2025, Innovatus will have the right, but not the obligation, to make a one-time election to convert up to 10% of the outstanding aggregate principal amount of the term Loans into shares of common stock of Apollo. Such shares shall be issued at a price per share equal to $11.50.

Credo 180 acted as sole financial advisor to Apollo on this transaction.

Additional details regarding the financing will be included in a Current Report on Form 8-K, which Apollo will file with the Securities and Exchange Commission within four business days of the date of this press release.