On December 2, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) is scheduled to review data supporting the company’s New Drug Application (NDA) requesting accelerated approval for tazemetostat, an oral, first-in-class EZH2 inhibitor, at a meeting on Dec. 18, 2019 at 1:00 p.m. ET (Press release, Epizyme, DEC 2, 2019, View Source [SID1234551839]). The proposed indication to be discussed at this upcoming ODAC meeting is for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery.

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ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of a product is made solely by the FDA.

Epizyme announced on July 25, 2019 that the FDA had accepted for filing the NDA for tazemetostat for the treatment of patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery with Priority Review and a Prescription Drug User-Fee Act (PDUFA) action date of Jan. 23, 2020. Epizyme’s NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat.

On December 2, 2019 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported its intention to offer and sell 4,000,000 shares of its common stock in an underwritten offering pursuant to its existing automatic shelf registration statement (Press release, Arrowhead Pharmaceuticals, DEC 2, 2019, View Source [SID1234551881]). All of the shares in the proposed offering are to be sold by Arrowhead. Arrowhead intends to grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Goldman Sachs & Co. LLC, Jefferies LLC and Piper Jaffray & Co. are acting as bookrunning managers for the offering, Cantor Fitzgerald & Co. is acting as passive joint bookrunner for the offering and Robert W. Baird & Co. Incorporated and B. Riley FBR, Inc. are acting as co-managers for the offering. Arrowhead intends to use the net proceeds from this offering for general corporate purposes, including working capital, capital expenditures, research and development expenditures and clinical trial expenditures. A portion of the net proceeds may also be used for the acquisition of complementary businesses, products and technologies, or for other strategic purposes.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock described above was filed with the Securities and Exchange Commission (the "SEC") and became automatically effective upon filing on December 2, 2019. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s web site at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus may also be obtained from Goldman Sachs & Co. LLC by mail at 200 West Street, New York, NY 10282, Attention: Prospectus Department, by telephone at (866) 471-2526, or by email at [email protected]; from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or from Piper Jaffray & Co., Attn: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

On December 2, 2019 Baxter International Inc. (NYSE:BAX), a leading global medical products company, reported that it has entered into a definitive agreement to acquire Seprafilm Adhesion Barrier and related assets from Sanofi (Press release, Baxter International, DEC 2, 2019, View Source [SID1234551917]). The agreement is the latest example of Baxter’s continued focus on acquiring products and technologies that have a strong strategic fit with the company’s leading portfolio across the hospital, including in the operating room. The transaction contemplates a cash purchase price at closing of $350 million and is expected to close no later than the first quarter of 2020, following satisfaction of closing conditions.

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"Seprafilm will be a strong complement to our leading hemostat and sealant portfolio, helping us continue to advance the art of healing with optimized patient care in the operating room," said Wil Boren, general manager, Baxter’s Advanced Surgery business. "While Seprafilm is clinically recognized among surgeons globally, we plan to provide commercial support for the product through our dedicated surgery salesforce and pursue opportunities for expansion in certain countries."

Adhesion prevention products, hemostats and sealants are important tools surgeons use to manage intraoperative bleeding and reduce adhesions. Adhesions can occur in any surgery1 when scar tissue develops and binds to nearby tissue. Adhesions can be a source of major post-surgical complications and often require revision, or a second surgery to remove the adhesions. Up to 93% of patients have been shown to develop adhesions following laparotomy,2 a large, surgical incision into the abdominal cavity. Approximately 20% of abdominal surgery patients return for adhesion-related complications, with annual surgical costs of more than $2 billion in the U.S. alone.3

Seprafilm currently has a global commercial presence including sales in the U.S., Japan, China, South Korea and France, among others. Sales of the proposed acquired products are expected to be approximately $100 million in the 12 months following close.

Important Safety Information

Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

Important Risk Information

Seprafilm Adhesion Barrier is contraindicated in patients with a history of hypersensitivity to Seprafilm and/or to any component of Seprafilm. Seprafilm Adhesion Barrier is contraindicated for use wrapped directly around a fresh anastomotic suture or staple line; as such use increases the risk of anastomotic leak and related events (fistula, abscess, leak, sepsis, peritonitis). The number of sheets used should be just adequate to cover the under surface of the abdominal wall or uterine incision in a single layer. In patients who have ovarian, primary peritoneal or fallopian tube malignancies, Seprafilm use has been reported to have an increased risk of intra-abdominal fluid collection and/or abscess, particularly when extensive debulking surgery was required. The safety and effectiveness of Seprafilm Adhesion Barrier has not been evaluated in clinical studies for the following: Patients with frank infections in the abdominopelvic cavity; patients with abdominopelvic malignancy; device placement in locations other than directly beneath an abdominal wall incision following laparotomy, or directly on the uterus following open myomectomy (not laparoscopic); patients with ongoing local and/or systemic inflammatory cell responses; device use in the presence of other implants, e.g. surgical mesh; patients requiring re-operation within four weeks of Seprafilm placement – during anticipated time of peak adhesion formation. Foreign body reactions have occurred with Seprafilm Adhesion Barrier.

On December 2, 2019 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, and Pierre Fabre reported that they have agreed to extend the terms of the license agreement in which Puma granted Pierre Fabre exclusive rights to develop and commercialize NERLYNX (neratinib) within Europe and part of Africa (Press release, Puma Biotechnology, DEC 2, 2019, View Source [SID1234551808]). The amended agreement extends Pierre Fabre’s commercial rights for NERLYNX to the Middle East, South Africa, Sudan and Turkey.

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Under the terms of the agreement, Puma will receive an upfront payment of $4 million, as well as additional regulatory and sales-based milestone payments totaling up to $3 million. Net sales of NERLYNX from the countries in this extension territory will be included in the calculation of payments related to sales milestones and royalties from the original license agreement signed earlier this year.

"The expansion of our license agreement with Pierre Fabre is indicative of our belief in their robust commercial infrastructure across these additional territories," said Alan H. Auerbach, Chief Executive Officer and President of Puma. "Puma remains committed to providing access to NERLYNX to patients around the world. By expanding Pierre Fabre’s commercial territory, we believe HER-2 positive breast cancer patients in these territories will have access to this much-needed therapy."

"We are pleased to confirm this expanded partnership with Puma Biotechnology," stated Jean-Luc Lowinski, Chief Executive Officer, Pierre Fabre Pharmaceuticals. "It will bring NERLYNX to patients seeking adjuvant treatment options for breast cancer in these new countries where Pierre Fabre is committed to making a difference in the long term."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

On December 2, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported that data from its ongoing studies utilizing Cchek, its artificial intelligence (AI) driven early cancer detection technology will be presented during a poster session at the San Antonio Breast Cancer Symposium (SABCS) (Press release, Anixa Biosciences, DEC 2, 2019, View Source [SID1234551824]).

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The symposium takes place December 10 – 14, 2019 in San Antonio, TX, and is designed to provide state-of-the-art information on the experimental biology, etiology, prevention, diagnosis, and therapy of breast cancer and premalignant breast disease. The meeting will be attended by both U.S. and international researchers and healthcare professionals who are involved in breast cancer research and clinical care.

Poster presentation details are as follows:

Title: Combining HyperVOX with pattern recognition neural networks: A new method for analyzing flow cytometry-based immunophenotyping data for increased early detection of stage I/II breast cancer (BCa)

Authors: George A. Dominguez, Ph.D.; John Roop; Alex Polo; Anthony J. Campisi; Dmitry I. Gabrilovich, MD, Ph.D.; Amit Kumar, Ph.D.

Poster Session and Number: Session 5, P5-01-16

Location: Henry B. Gonzalez Convention Center, Hall 1

Date and Time: Friday, December 13, 2019 (5:00 PM – 7:00 PM CT)

To receive a copy of the presentation, please email your request to [email protected] starting December 14, 2019 and include your name, title, and contact information.

About Cchek
Cchek is an early cancer detection technology, that measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method that offers improved affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed. The first such test, a prostate cancer confirmation test, is slated for commercial launch by the end of 2019.