On September 21, 2017 Merck KGaA, Darmstadt, Germany, and Pfizer Inc. (NYSE: PFE) reported that the European Commission (EC) has granted marketing authorization for BAVENCIO (avelumab) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer (Press release, Pfizer, SEP 21, 2017, View Source [SID1234520590]).[1] BAVENCIO will have marketing authorization in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. BAVENCIO is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.

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"The EC’s decision is significant for BAVENCIO and, more importantly, for European patients living with this very challenging skin cancer," said Luciano Rossetti, M.D., Executive Vice President, Global Head of Research & Development at the biopharma business of Merck KGaA, Darmstadt, Germany, which operates as EMD Serono in the US and Canada. "Our alliance with Pfizer continues to demonstrate the power of working together, and we are grateful to everyone who has helped to bring the first and only approved immunotherapy for mMCC to European patients."

"This European approval further establishes our continued momentum, building on the accelerated approvals BAVENCIO received in the US earlier this year," said Liz Barrett, Global President, Pfizer Oncology. "Importantly, we are now one step closer to our goal of making BAVENCIO available to patients around the world."

Approximately 2,500 Europeans are affected by MCC each year, with metastatic disease diagnosed in 5-12% of patients with MCC. Fewer than 20% of patients with metastatic MCC survive beyond 5 years. [2]-[6]

"Merkel cell carcinoma is a particularly aggressive form of skin cancer with very poor outcomes, especially for those with metastatic disease," said Dirk Schadendorf, MD, Director of Dermatology, University Hospital Essen, Germany. "This approval is a meaningful development for patients and their families suffering from this devastating disease."

The EC approval is based on data from JAVELIN Merkel 200, an international, multicenter, single-arm, open-label, Phase II study; with two parts:[1]

Part A included 88 patients with mMCC whose disease had progressed after at least one chemotherapy treatment. The objective response rate was 33%, with 11% of patients experiencing a complete response and 22% of patients experiencing a partial response. At the time of analysis, tumor responses were durable, with 93% of responses lasting at least 6 months (n=25) and 71% of responses lasting at least 12 months (n=13). Duration of response (DOR) ranged from 2.8 to more than 24.9 months.

Part B, at the time of the data cut-off, included 39 patients with histologically confirmed mMCC who were treatment-naïve to systemic therapy in the metastatic setting. The objective response rate was 62%, with 14% of patients experiencing a complete response (CR) and 48% of patients experiencing a partial response (PR). Sixty-seven percent of patients experienced a progression-free survival (PFS) rate of 3 months.

The safety of avelumab has been evaluated in 1,738 patients with solid tumours including metastatic MCC (N=88) receiving 10 mg/kg every 2 weeks of avelumab in clinical studies.[1]

1,738 patients with solid tumors received 10 mg/kg every 2 weeks. In this patient population, the most common adverse reactions were fatigue (32.4%), nausea (25.1%), diarrhea (18.9%), decreased appetite (18.4%), constipation (18.4%), infusion-related reactions (17.1%), weight decreased (16.6%), and vomiting (16.2%). The most common Grade ≥ 3 adverse reactions were anaemia (6.0%), dyspnoea (3.9%), and abdominal pain (3.0%). Serious adverse reactions were immune-related adverse reactions and infusion-related reaction.

The EC’s decision follows the US Food and Drug Administration’s (FDA) accelerated approval* for BAVENCIO earlier this year for the treatment of mMCC and patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy. BAVENCIO was also granted marketing authorization by Swissmedic on September 05, 2017, in Switzerland for the treatment of patients with mMCC, whose disease has progressed after at least one chemotherapy treatment.

The clinical development program for BAVENCIO, known as JAVELIN, involves at least 30 clinical programs and more than 6,300 patients evaluated across more than 15 different tumor types. In addition to mMCC, these cancers include breast, gastric/gastro-esophageal junction, head and neck, Hodgkin’s lymphoma, emelanoma, mesothelioma, non-small cell lung, ovarian, renal cell carcinoma and urothelial carcinoma.

About Metastatic Merkel Cell Carcinoma
Metastatic MCC is a rare and aggressive disease in which cancer cells form in the top layer of the skin, close to nerve endings.[7]-[8] MCC, which is also known as neuroendocrine carcinoma of the skin or trabecular cancer, often starts in those areas of skin that are most often exposed to the sun, including the head and neck, and arms.[7],[9] Risk factors for MCC include sun exposure and infection with Merkel cell polyomavirus. Caucasian males older than 50 are at increased risk.[7],[9] MCC is often misdiagnosed as other skin cancers and grows at an exponential rate on chronically sun-damaged skin.[9-11] Current treatment options for MCC in Europe include surgery, radiation and chemotherapy.[8] Treatment for metastatic or Stage IV MCC is generally palliative.[8]

On September 21, 2017 Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, reported that the pricing of its follow-on public offering of 6,100,000 shares of its common stock at a price to the public of $41.00 per share (Press release, Juno, SEP 21, 2017, View Source;p=RssLanding&cat=news&id=2302262 [SID1234520595]). In addition, Juno has granted the underwriters a 30-day option to purchase up to an additional 915,000 shares of common stock. Juno intends to use the net proceeds of the offering for general corporate purposes and working capital.

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The offering is expected to close on September 26, 2017, subject to customary closing conditions. Concurrent with the completion of the follow-on public offering, Juno will complete a private placement of 659,415 shares of its common stock, at a price of $41.00 per share, to a subsidiary of Celgene Corporation. Aggregate gross proceeds from the follow-on public offering and concurrent private placement, before deducting underwriting discounts and commissions, in the case of the follow-on public offering, and expenses payable by Juno will be $277.1 million (or approximately $318.7 million if the underwriters exercise their option to purchase additional shares in full).
Morgan Stanley and J.P. Morgan are acting as joint book-running managers for the offering. Barclays and Leerink Partners are acting as co-lead managers and Wells Fargo Securities, Raymond James and Wedbush PacGrow are acting as co-managers.

A registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on September 20, 2017 and was automatically effective upon filing. The offering is being made only by means of a written prospectus that forms a part of the registration statement. Copies of the final prospectus related to the offering may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014 and J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, Attn: Prospectus Department, or by telephone at (866) 803-9204.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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.

On September 20, 2017 Eagle Pharmaceuticals, Inc. (Nasdaq:EGRX) ("Eagle" or "the Company") and SymBio Pharmaceuticals Limited ("SymBio") (Tokyo Stock Exchange/JASDAQ 4582) reported that the Company has licensed to SymBio rights under Eagle’s intellectual property to develop, market and sell Eagle’s bendamustine hydrochloride ("bendamustine HCl") ready-to-dilute ("RTD") and rapid infusion ("RI") injection products in Japan (Press release, Eagle Pharmaceuticals, SEP 20, 2017, View Source [SID1234540126]).

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SymBio will be responsible for securing regulatory approval of the RTD and RI injection products using the licensed technology in Japan with a target for approval of a product in 2020. SymBio currently markets TREAKISYM in Japan, a lyophilized powder formulation of bendamustine HCl indicated for chronic lymphocytic leukemia ("CLL"); relapsed or refractory low-grade Hodgkin’s lymphoma ("NHL"); mantle cell lymphoma ("MCL"); and as a first line treatment of low-grade NHL and MCL. According to SymBio, 12-month sales ended June 30, 2017 in Japan for TREAKISYM were $52 million, due to the approval of first line treatment for NHL and MCL in December 2016. SymBio has estimated that sales of TREAKISYM are estimated to grow to $90 million in 2018.

A 50 ml RI or rapid infusion presentation of bendamustine hydrochloride injection is currently marketed in the U.S. by Teva Pharmaceutical Industries, Ltd. ("Teva") as BENDEKA (bendamustine HCl) Injection. BENDEKA currently has a 97% market share of the bendamustine market, and Teva has forecasted the North American market for bendamustine to be approximately $600 – $660 million in sales in 2017. BENDEKA’s low volume infusion and short infusion time represents an important benefit to both patients and healthcare providers.

Pursuant to the terms of the license with SymBio, Eagle will receive a $12.5 million upfront milestone payment, and may be entitled to additional milestone payments upon approval and the achievement of cumulative sales thresholds. The Company will also receive royalties on future net sales of the licensed bendamustine products.

"This is an important example of the value of the Eagle portfolio to patients worldwide and a first step in expanding outside the U.S. for our differentiated products. We look forward to SymBio’s future approval and successful commercialization of bendamustine HCI in Japan," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

Mr. Fuminori Yoshida, President and Chief Executive Officer of SymBio, stated, "In-licensing Eagle’s ready-to-dilute and rapid infusion injection products will enable SymBio to extend the product life and continue to maximize the value of TREAKISYM over the product life while bringing significant benefits to patients and healthcare providers in Japan."

On September 19, 2017 Petra Pharma, a drug development company focused on novel enzyme targets, and Schrödinger, Inc., a privately-held company dedicated to revolutionizing drug discovery through advanced computational methods, reported a multi-target research collaboration to develop novel therapeutics for the treatment of cancer and metabolic diseases (Press release, Schrodinger, SEP 19, 2017, View Source [SID1234525274]).

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Under the terms of the agreement, the companies will work together to leverage Petra’s pipeline of unique enzyme targets and Schrödinger’s computational drug discovery platform in the design of novel small molecules for the treatment of cancer and metabolic diseases. Schrödinger will receive preclinical, clinical and commercial-stage milestone payments, as well as equity in Petra. Additional details and financial terms of the collaboration were not disclosed.

"Collaborating with Schrödinger gives us access to cutting-edge computational tools for drug design," said Brian O’Callaghan, President and Chief Executive Officer at Petra Pharma. "Combined with our expertise in novel enzyme targets, we look forward to leveraging this partnership to design and develop new treatment options for people with limited treatment options who suffer from cancer and metabolic diseases."

"We are looking forward to working with Petra’s highly talented team to accelerate the discovery of novel therapies." said Ramy Farid, Schrödinger’s President and CEO. "This partnership highlights the versatility of our computational drug discovery platform, which will support and enable Petra’s efforts to design innovative new drugs that may have an important impact on the lives of patients."

Petra Pharma is backed by a group of investors including AbbVie, Alexandria Venture Investments, ARCH Venture Partners, Eli Lilly and Company, 180 Degree Capital Corp., Empire State Development’s Innovate NY Fund, Johnson & Johnson Innovation – JJDC, Inc., Partnership Fund for New York City, Pfizer Venture Investments, Watson Fund and WuXi PharmaTech.

On September 19, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company), a biotech company developing REOLYSIN, a first-in-class, intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems, reported that it will present at the Phacilitate Immuno-Oncology Frontiers Conference (Press release, Oncolytics Biotech, SEP 19, 2017, View Source [SID1234520576]). Dr. Andres Gutierrez, Oncolytics’ Chief Medical Officer, will present at 4:00 pm CEST on September 21, 2017 at the Maritim Proarte Hotel. The conference takes place on September 20th and 21st in Berlin, Germany.

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Dr. Gutierrez will highlight the role of REOLYSIN in the activation of the immune system and the induction of an inflamed tumor phenotype in the tumor microenvironment. His presentation will also review certain historical clinical programs, highlight the positive survival data from the IND 213 study in metastatic breast cancer (mBC) and the pooled safety database – the largest of any oncolytic virus.

"We want to share our extensive experience with REOLYSIN in the clinic to illustrate the specific expertise and efforts required to develop an oncolytic virus for intravenous administration and systemic exposure in oncology," said Dr. Gutierrez. "This experience helped us define a clear regulatory pathway for registration in metastatic breast cancer. With an overall agreement with the FDA on the phase 3 study design, details of the pivotal registration study will be made available following evaluation and completion of discussions with clinical advisors and potentially partners, as well as European regulators."

The Phacilitate Immuno-Oncology Frontiers conference hosts over 300 industry decision-makers and key external stakeholders to come together discuss and define a strategic roadmap to success for immuno-oncology developers, ensuring European patients gain access to the game-changing biotherapeutics of tomorrow. Immuno-Oncology frontiers Berlin is the only European event that offers extensive coverage of the latest emerging science whilst placing it in its wider strategic context as the basis of tomorrow’s successful business and commercialisation models.

About REOLYSIN
REOLYSIN is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.