On April 7, 2019 WuXi AppTec, a leading global pharmaceutical and medical device open-access capability and technology platform company, reported the appointment of Dr. Frederick H. Hausheer as Chief Medical Officer for the company (Press release, WuXi AppTec, APR 7, 2019, View Source [SID1234535031]).

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In this executive role, Dr. Hausheer will provide medical, scientific and operational leadership to WuXi Clinical operations in the United States, China and other territories. In addition, he will play a key role in forging and maintaining strong connections between our customers and WuXi’s business units by providing inputs on medical and clinical development strategies aimed at seamless integration from preclinical translational research and development into first-in-human studies, as well as for Phase I-IV clinical development plans for our customers.

Dr. Hausheer brings more than 30 years’ experience in global oncology clinical drug development and translational science and medicine in commercial and academic settings. He has extensive experience in translational/IND programs, clinical trial design, commercial clinical development, and involvement in regulatory interactions for novel agents spanning from pre-IND and Phase I-III development in the United States, China, Europe, Japan and other territories.

"We’re very excited to welcome Dr. Hausheer onboard as our Chief Medical Officer," said Mr. Edward Hu, Co-CEO of WuXi AppTec. "Dr. Hausheer’s rich experience in global oncology clinical drug development and translational science and medicine makes him ideally suited to taking this role. We are confident in his leadership to strengthen WuXi’s clinical development capabilities and capacity globally, and enable more customers to develop better medicine faster to benefit patients around the world."

Prior to joining WuXi, Dr. Hausheer held CEO and CMO positions with several Biopharma companies, and was the Founder and Chairman of BioNumerik Pharmaceuticals. He has also served as a business advisory board member to JP Morgan Chase, the Whittaker Institute at Johns Hopkins, and the National Cancer Institute. Early in his career he served on the National Cancer Institute (NCI) Experimental Therapeutics Section, the NCI Decision Network Panel, and the NCI Institutional Review Board, followed by extensive involvement in national and international Phase I-III clinical trials involving novel treatments for lung, breast, ovarian and other malignancies.

Dr. Hausheer obtained his MD at the University of Missouri, School of Medicine and then became a faculty member at the Johns Hopkins Oncology Center, where he focused on the development of novel experimental therapeutics and pharmacology. He currently holds adjunct professorships at the University of Missouri in Internal Medicine and Oncology and The Johns Hopkins Oncology Center in Medical Oncology. He is an inventor/co-inventor on more than 400 issued United States and international patents.

On April 7, 2019, XOMA Corporation ("XOMA"), through its wholly-owned subsidiary, XOMA (US) LLC (the "Company"), reported that it has entered into a Royalty Purchase Agreement (the "Royalty Purchase Agreement") with Aronora, Inc., a private research and development company headquartered in Portland, Oregon ("Aronora") (Filing, 8-K, Xoma, APR 7, 2019, View Source [SID1234535038]). Pursuant to the terms of the Royalty Purchase Agreement, the Company, subject to certain customary closing conditions, will purchase from Aronora the rights to potential royalty payments and a portion of the potential milestone payments associated with five hematology drug products in development: three anti-thrombotic candidates subject to Aronora’s collaboration with Bayer Pharma AG ("Bayer"), one of which is subject to an option by Bayer (the "Bayer Licensed Products") and two additional early clinical hematology candidates (the "non-Bayer Licensed Products," together with the Bayer Licensed Products, the "Products").

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Under the terms of the Royalty Purchase Agreement, the Company will make an initial $6 million payment to Aronora at the closing of the transaction (the "Closing Amount") subject to the fulfillment of certain pre-closing conditions contained in the Royalty Purchase Agreement. The transaction is expected to close no later than the 3rd Quarter of 2019, and the Royalty Purchase Agreement will terminate if all pre-closing conditions are not fulfilled within ninety days and the parties do not extend the Royalty Purchase Agreement prior thereto. The Company is required to make an additional $1,000,000 payment (up to a total of $3 million) for each of the three Bayer Licensed Products that are active as of September 1, 2019.

The Company will receive, on average, low single-digit royalties on future sales of the Bayer Licensed Products (net of certain royalties payable to third parties) and 10% of all future developmental, regulatory and sales milestones related to the Bayer Licensed Products payable after the closing of the transaction excluding the payment of any milestone associated with Bayer exercising its option on one of the Bayer Licensed Products. In addition, the Company will purchase from Aronora the right to receive low single digit royalties on potential sales of the non-Bayer Licensed Products and 10% of all future payments, including upfront payments, option payments and developmental, regulatory and sales milestone payments on potential future sales of the non-Bayer Licensed Products. The above percentages will be reduced to 5% upon the Company’s receipt of two times the total cumulative amount of consideration paid by the Company to Aronora.

Pursuant to the Royalty Purchase Agreement, if the Company receives over $250 million in cumulative royalties on net sales per Product, the Company will be required to pay associated tiered milestones payments to Aronora in an aggregate amount of up to $85 million per Product.

The Royalty Purchase Agreement contains customary representations, warranties, covenants and indemnities. The Royalty Purchase Agreement will terminate six (6) months following receipt by the Company of all royalty payments to which it is entitled thereunder. Aronora can terminate the Royalty Purchase Agreement if the Company fails to make payments thereunder in a timely fashion (after the expiration of any applicable cure period).

The foregoing description of the Royalty Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Royalty Purchase Agreement, which will be filed as an exhibit to a future XOMA periodic report under the Securities Exchange Act.

On April 5, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported that it has priced its concurrent underwritten public offerings of (i) 8,667,333 shares of its common stock and accompanying Class A warrants to purchase up to 1,951,844 shares of its common stock, at a combined price to the public of $7.50 per common share and accompanying Class A warrant and (ii) 666 shares of its Series A convertible preferred stock, which are convertible into 666,000 shares of its common stock, and accompanying Class A warrants to purchase up to 166,500 shares of its common stock, at a combined price to the public of $7,500 per Series A share and accompanying Class A warrant (Press release, Syros Pharmaceuticals, APR 5, 2019, View Source [SID1234535019]). Each Class A warrant will have an exercise price of $8.625 per share and will expire 3.5 years from the date of issuance. The Class A warrants sold in each offering will have the same terms. The gross proceeds of the offerings are expected to be approximately $70 million, prior to deducting the underwriting discounts and estimated offering expenses.

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The offerings are expected to close on or about April 9, 2019, subject to customary closing conditions.

Cowen and Piper Jaffray & Co. are acting as joint book-running managers for the offerings. JMP Securities is acting as lead manager and Roth Capital Partners is acting as co-manager.

The securities are being offered by Syros pursuant to a shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on July 20, 2017 and declared effective by the SEC on July 31, 2017. The offerings are being made only by means of the prospectuses and prospectus supplements that form a part of the registration statement.

Copies of the final prospectus supplements and the accompanying prospectuses relating to each offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies can also be obtained from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone: 800-747-3924, or by email: [email protected].

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

On April 5, 2019 UroGen Pharma Ltd. (Nasdaq: URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in uro-oncology, reported a new presentation from the pivotal Phase 3 OLYMPUS trial of UGN-101 (mitomycin gel) for instillation, an investigational formulation for the primary non-surgical treatment of patients with low-grade upper tract urothelial cancer (LG UTUC) (Press release, UroGen Pharma, APR 5, 2019, View Source [SID1234535020]). The analysis, which discusses the minimally invasive chemoablation approach of UGN-101 to potentially treat LG UTUC tumors, including those that are unresectable, will be presented on Sunday, May 5, 2019 in an oral presentation during the plenary session at the 114th American Urological Association (AUA) Annual Meeting in Chicago. The text for the abstract is available online through the Journal of Urology website.

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Details of AUA Oral Presentation
Abstract #: LBA-16
Session: Plenary Session, Next Frontier
Title: Nephron-sparing Management of Low Grade (LG) UTUC With UGN-101 (mitomycin gel) for Instillation: The Olympus Trial Experience
Presenter: Seth Paul Lerner, M.D., FACS, Professor of Urology, Baylor College of Medicine
Date and Time: Sunday, May 5, 2019; 3:17 – 3:26 PM CDT
Location: MCP: W375d

"The treatment of LG UTUC remains a technical challenge for urologists, given the anatomical complexity of the kidney and the physical limits of endoscopic instrumentation," said Mark P. Schoenberg, M.D., Chief Medical Officer of UroGen. "UroGen is committed to raising the standard of care for this typically elderly patient population whose current options consist of repetitive endoscopic surgical intervention or complete loss of a kidney. We look forward to presenting this UGN-101 analysis that further underscores the unmet need in patients with new and recurrent LG UTUC."

About UGN-101

UGN-101 (mitomycin gel) for instillation is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade upper tract urothelial cancer (LG UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-101 is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-101 is delivered to patients using standard ureteral catheters. The Company initiated its rolling submission of the UGN-101 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2018. The FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to UGN-101 for the treatment of UTUC. If approved, UGN-101 would be the first drug approved for the non-surgical treatment of LG UTUC.

On April 5, 2019 Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) reported that Celgene has submitted a Biologics License Application (BLA) for luspatercept, an erythroid maturation agent, for the treatment of adult patients with very low to intermediate risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions (Press release, Celgene, APR 5, 2019, View Source [SID1234535021]).

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The submission is based on the safety and efficacy results of the pivotal phase 3 studies MEDALIST and BELIEVE, both recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, where MEDALIST was included in the plenary session.

"There remains a high unmet medical need for patients with MDS or beta-thalassemia who suffer from the effects of their disease-related anemia. The primary treatment option for these patients currently is chronic transfusion of red blood cells which can be associated with complications such as iron overload," said Jay Backstrom, M.D., Chief Medical Officer for Celgene. "New treatment options are urgently needed for these patients. With this submission, we look forward to working with the Agency to deliver luspatercept to patients with these serious blood diseases."

The companies also plan to submit a marketing application to the European Medicines Agency in the second quarter of 2019.

"The BLA submission is a key milestone for Acceleron and a credit to our longstanding collaboration with Celgene," said Habib Dable, President and Chief Executive Officer of Acceleron. "We believe luspatercept’s positive clinical trial results demonstrate its potential as a novel treatment for patients with lower-risk MDS as well as in beta-thalassemia. All involved have worked diligently to develop luspatercept for patients with chronic anemias associated with these serious blood disorders."

Luspatercept is an investigational therapy that is not approved for any use in any country for any indication.

About Luspatercept

Luspatercept is a first-in-class erythroid maturation agent (EMA) that regulates late-stage red blood cell maturation. Acceleron and Celgene are jointly developing luspatercept as part of a global collaboration. A phase 3 trial (COMMANDS) in ESA-naïve, lower-risk MDS patients, the BEYOND phase 2 trial in non-transfusion-dependent beta-thalassemia, and a phase 2 trial in myelofibrosis are ongoing. For more information, please visit www.clinicaltrials.gov.

About MEDALIST

MEDALIST is a phase 3, randomized, double blind, placebo-controlled, multi-center study evaluating the safety and efficacy of luspatercept in adults with very low-, low-, or intermediate-risk myelodysplastic syndromes (MDS). All patients were RBC transfusion dependent and were either refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) therapy or were ESA naïve with endogenous serum erythropoietin ≥ 200 U/L and had no prior treatment with disease modifying agents. The median age of the patients enrolled in the trial was 71 years in the luspatercept treatment group and 72 years in the placebo group. Median transfusion burden in both treatment arms was 5 RBC units/8 weeks. 229 patients were randomized to receive either luspatercept 1.0 mg/kg (153 patients) or placebo (76 patients) by subcutaneous injection once every 21 days. The study was conducted at 65 sites in 11 countries.

About BELIEVE

BELIEVE is a phase 3, randomized, double blind, placebo-controlled multicenter study comparing luspatercept + best supportive care (BSC) versus placebo + BSC in adults with beta-thalassemia patients who require regular RBC transfusions. The median age of the patients was 30 years in both treatment arms. 336 patients were randomized to receive either luspatercept 1.0 mg/kg (224 patients) or placebo (112 patients) by subcutaneous injection every 21 days for up to 48 weeks. Crossover to the luspatercept treatment groups was allowed after unblinding based on the recommendation of an independent Data Safety Monitoring Committee; patients treated with luspatercept will be followed for up to 3 years. The study was conducted at 65 sites in 15 countries.