On September 23, 2020 Eagle Pharmaceuticals, Inc. ("Eagle" or the "Company") (NASDAQ: EGRX) reported that its marketing partner, SymBio Pharmaceuticals Limited ("SymBio"), has received regulatory approval for TREAKISYM ready-to-dilute ("RTD") (250 ml) liquid formulation from the Pharmaceuticals and Medical Devices Agency ("PMDA") in Japan (Press release, Eagle Pharmaceuticals, SEP 23, 2020, View Source [SID1234565511]). The approval covers all indications for which TREAKISYM is currently approved (low-grade non-Hodgkin’s lymphoma, mantle cell lymphoma, and chronic lymphocytic leukemia). Approval for the additional indication of r/r DLBCL is currently under review by the PMDA, which will create another large market opportunity beyond the current indications. As a result of the approval of TREAKISYM, Eagle will receive a $5 million milestone payment.

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With this approval, SymBio will convert its current lyophilized formulation of TREAKISYM to the new RTD liquid formulation upon launch in January 2021.

In addition, SymBio is currently conducting a clinical safety trial for the ten-minute RI (50 ml) liquid formulation and will seek approval in the second half of 2022. Upon approval of the RI formulation, SymBio intends to convert from the RTD product to the new 50 ml liquid version licensed from Eagle. The RTD and RI liquid formulations bring key benefits to patients and healthcare providers in Japan by eliminating the need for manual reconstitution and significantly reducing preparation time.

"We are pleased that SymBio has received regulatory approval for TREAKISYM in Japan. SymBio is an innovator, and we look forward to their successful commercialization of the ready-to-dilute bendamustine product, enabling patients in Japan to benefit from TREAKISYM’s key advantages. This approval represents another significant extension of the durability of this important franchise and the successful execution of our business development activities to bring value for Eagle and our shareholders," stated Scott Tarriff, Chief Executive Officer.

According to SymBio, sales in Japan for its current TREAKISYM product totaled $84.8 million in the twelve months ended June 30, 2020. Together, milestones and royalty payments for the RTD and RI formulations could generate from $10 million to $25 million annually for Eagle.

In September 2017, Eagle licensed to SymBio intellectual property necessary to develop, market and sell RTD and RI formulations of TREAKISYM in Japan utilizing Eagle’s proprietary technology. As part of the agreement, SymBio assumed responsibility for securing regulatory approval of the TREAKISYM RTD and RI products using the licensed technology in Japan.

The $5 million milestone payment due upon approval of TREAKISYM RTD is in addition to a $12.5 million upfront milestone payment Eagle received upon execution of the agreement with SymBio. Eagle is entitled to royalties on future net sales and an additional milestone payment upon achievement of a cumulative sales threshold.

On September 23, 2020 LabCorp (NYSE:LH), a leading global life sciences company that is focused on advancing health and guiding patient care decisions, reported that it has launched a new, non-invasive test for patients with non-small cell lung cancer (NSCLC) (Press release, LabCorp, SEP 23, 2020, View Source [SID1234565510]). Resolution ctDx Lung is a fast and accurate liquid biopsy test that was developed and will be run by Resolution Bioscience. The test is performed on a standard blood sample and detects actionable mutations in genes associated with NSCLC, providing valuable information to help select the most effective targeted treatments for individual patients. The test is covered by Medicare.

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"Oncology is an area of intense focus for LabCorp, across our entire organization," said Dr. Brian Caveney, president of LabCorp Diagnostics. "The Resolution ctDx Lung test is the latest example of our commitment to provide patients and clinicians with cutting-edge testing and personalized information to make the best possible treatment decisions. This innovative test is an outstanding addition to our industry leading offerings for oncology patients."

"This commercial partnership with LabCorp is an important step in our quest to enable broad access to our lung cancer test and improve clinical outcomes for more people battling NSCLC," said Mark Li, CEO of Resolution Bioscience. "The Resolution ctDx Lung test consistently detects more driver and resistance mutations than competing platforms. We are excited to be joining forces with LabCorp to provide more physicians with the actionable information needed to guide NSCLC therapy selection and patient care."

To order the test, please contact LabCorp Oncology at 1-800-710-1800 or visit the LabCorp Oncology website for more information.

The Resolution ctDx Lung test relies on the Resolution Bioscience patented cell-free DNA (cfDNA) analysis platform, which includes proprietary targeted capture next-generation sequencing (NGS) biochemistry and tightly coupled, cloud-based bioinformatics. Studies have demonstrated that the test offers greater sensitivity than other currently available liquid biopsy tests for NSCLC. The test has been cited in several important scientific publications and presentations and is now being used to select the appropriate plasma-directed therapy in an ongoing study of more than 1,000 patients with stage II, III, or IV NSCLC. Thus far, the study has resulted in a positive clinical response of greater than 95%, indicating that the test has significant utility in the choice of appropriate therapy. For more information about the test, please visit View Source

On September 23, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported an important publication in BMC Urology, entitled A urine-based Exosomal gene expression test stratifies risk of high-grade prostate Cancer in men with prior negative prostate biopsy undergoing repeat biopsy (available here) (Press release, Bio-Techne, SEP 23, 2020, View Source [SID1234565509]). Principal investigator Dr. James McKiernan, Professor of Urology at Columbia University, and colleagues demonstrated that using the ExoDx Prostate test, or EPI, resulted in good performance ruling out high-grade (Gleason 7 or higher) prostate cancer (HGPCa) in prior negative biopsy patients with the previously validated 15.6 cut point that was developed on an initial biopsy cohort. The EPI test yielded a negative predictive value (NPV) of 92% independent of other clinical features and would have avoided 27% of unnecessary prostate biopsies in men while missing only five patients with HGPCa (2.1%).

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Initial prostate biopsy often fails to identify prostate cancer, resulting in patient anxiety especially when clinical features such as prostate specific antigen (PSA) remain elevated, and leading to the need for repeat biopsies. For example, in the landmark PROMIS trial study, results showed that a 12-core TRUS-biopsy failed to correctly identify high-grade prostate cancer (Gleason 7 and higher) 37% of the time when cancer was present. These concerns drive many men to undergo repeat biopsy. In fact, the Surveillance, Epidemiology, and End Results (SEER) data indicates that ~12% of men with a prior negative biopsy have a repeat biopsy within 1 year and 44% of men younger than 70 years old have a repeat biopsy.

The EPI test was previously validated in patients presenting for an initial biopsy, and previous data demonstrated that EPI would benefit men with a prior negative biopsy. This study confirms that the ExoDx Prostate test performs exceptionally well in a cohort of men with prior negative biopsies.

Prostate cancer (PCa) is a leading cause of cancer death among men in the United States, with more than 3.6 million men living with prostate cancer. It is estimated that 174,650 newly diagnosed cases occurred in 2019. Prostate needle biopsies are typically recommended for men with elevated serum PSA levels and/or a suspicious digital rectal exam (DRE) with added considerations based on family history, age, and race. The anxiety, pain, and potential complications associated with prostate biopsy are well documented. Furthermore, a large percentage of newly diagnosed prostate cancers are indolent, clinically insignificant, and with low metastatic potential. These cancers typically do not require definitive treatment and may be managed most effectively with Active Surveillance (AS). The low specificity of PSA which contributes to the high frequency of newly-diagnosed low-risk PCa suggests that 60–70% of men may be able to avoid biopsy.

Dr. Johan Skog, Chief Scientific Officer for Exosome Diagnostics, stated, "This study builds upon the results of the original validation study evaluating men considering initial biopsy. Here we further demonstrated the clinical benefit for men with a prior negative biopsy to utilize the EPI test. A score below the validated cut-point of 15.6 indicates lower risk for finding high-grade prostate cancer on biopsy, with an NPV of 92% indicating a biopsy can be avoided with a high degree of confidence."

"This study has especially important implications for men who have had a prior negative biopsy but where clinical factors suggest a repeat biopsy may be necessary," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne Corporation. "The ExoDx Prostate test use in the prior negative biopsy population can increase confidence in both the patient and the physician to determine if an additional biopsy is warranted or if it can be safely deferred. The ExoDx Prostate Test provides the information necessary for men to make more informed decisions about initial or repeat biopsies."

On September 23, 2020 DLA Piper represented MEDNAX, Inc., the national health solutions partner and leading provider of maternal-fetal, newborn and pediatric subspecialty care, in the sale of MEDNAX Radiology Solutions to Radiology Partners, a leading physician-led and physician-owned radiology practice, for US$885 million (Press release, DLA Piper (US), SEP 23, 2020, View Source [SID1234565198]).

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Founded in 2015, MEDNAX Radiology Solutions is an integrated provider of seamless on-the-ground and in-the-cloud radiology services, delivering scale and value to hospitals, clinics, imaging centers and referring physicians through a combination of highly innovative physician groups and vRad, the nation’s leading teleradiology organization.

"We were pleased to advise our long-time client MEDNAX in its sale of MEDNAX Radiology Solutions. Our extensive experience advising healthcare clients on strategic M&A initiatives and our long-term relationship with MEDNAX were important assets in our handling of this transaction," said Joshua Samek, the DLA Piper partner who led the firm’s deal team. "We appreciate the opportunity to work with the entire MEDNAX team as they support the company’s mission of taking great care of the patient, every day and in every way."

In addition to Samek (Miami), the DLA Piper team representing MEDNAX included partners Russell Sass (Miami), Brian Gordon, Jamie Konn (both of Atlanta), Rita Patel, Jennifer Kashatus (both of Washington, DC), Jordan Bailowitz (Baltimore), Jamie Knox, Paolo Morante (both of New York), Randy Peak (Dallas) and Nathaniel McKitterick (Silicon Valley); of counsel Sanjay Beri (Northern Virginia) and Nia Brown (Washington, DC); senior attorney Michelle Winbush (Baltimore); associates Julia Zaft, Summer Galitz, Adriana Valldejuly (all of Miami), James Rusert, Alvin Johnson, Julie Franki (all of Atlanta), Mary Claire Blythe (Baltimore), Michael Goldstein (Short Hills), Jessica Wright (New York) and Tiffany Nguyen (Northern Virginia); and attorneys Renae Flowers (Austin) and Virginia Lewey (Chicago).

The transaction is expected to close in the fourth quarter of 2020 subject to customary closing conditions, including regulatory review.

With more than 1,000 corporate lawyers globally, DLA Piper helps clients execute complex cross-border transactions seamlessly while supporting clients across all stages of development. The firm has been rated number one in global M&A volume for ten consecutive years, according to Mergermarket.

The firm’s global Healthcare sector consists of a multidisciplinary legal team with niche experience in health-related business and legal issues. The team regularly works with corporations and financial institutions, private investors, private equity groups, venture capital funds, institutional investors and portfolio companies in all types of healthcare transactions.

On September 22, 2020 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, reported the pricing of two concurrent but separate underwritten public offerings (together, the "Offerings") of (i) 4,600,000 shares of its common stock and (ii) 4,148 shares of its non-voting Series 1 Convertible Preferred Stock (the "Series 1 preferred stock") (Press release, Protara Therapeutics, SEP 22, 2020, View Source [SID1234573134]). The public offering price of each share of common stock is $16.87 and the public offering price of each share of Series 1 preferred stock is $16,873.54. In addition, Protara has granted the underwriters a 30-day option to purchase additional shares of common stock of up to 15% of the aggregate number of shares offered in the common stock offering. The Offerings are expected to close on September 24, 2020, subject to customary closing conditions. Cowen and Guggenheim Securities are acting as joint book-running managers. Oppenheimer & Co. is acting as lead manager for the Offerings and H.C. Wainwright & Co. is acting as co-manager for the Offerings.

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Each share of Series 1 preferred stock is convertible into approximately 1,000 shares of common stock as set forth in the certificate of designation for the Series 1 preferred stock, at any time at the option of the holder, subject to certain restrictions and limitations.

Protara expects to receive combined gross proceeds of $147.6 million from the Offerings, before deducting underwriting discounts and offering expenses. Protara intends to use the net proceeds from the Offerings primarily for development activities associated with TARA-002 in non-muscle invasive bladder cancer, lymphatic malformations and potential exploration of additional indications, and the remainder of the net proceeds for general corporate purposes and working capital.

The securities described above are being offered by Protara pursuant to an effective shelf registration statement on Form S-3 filed with the Securities and Exchange Commission ("SEC"), which became effective on May 26, 2020. A preliminary prospectus supplement relating to each of the Offerings has been, and a final prospectus supplement related to each of the Offerings will be, filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary and final prospectus supplements relating to the Offerings may be obtained, when available, by contacting Cowen at c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York, 11717, Attention: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or Guggenheim Securities at 330 Madison Avenue, New York, NY 10017, Attention: Equity Syndicate Department, by telephone at (212) 518-9544 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.