BioMarin Receives Milestone Payments from Pfizer for Talazoparib

On June 7, 2018 BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) reported that the Company received $20 million in milestone payments from Pfizer Inc (Press release, BioMarin, JUL 7, 2018, View Source [SID1234527230]). These milestone payments were triggered by the U.S. Food and Drug Administration (FDA) acceptance of Pfizer’s New Drug Application (NDA) submission for talazoparib and by the European Medicines Agency (EMA) acceptance of Pfizer’s submission of a Marketing Authorization Application (MAA) for talazoparib. These milestone payments are part of an agreement made with Medivation, Inc. when the company purchased talazoparib. Medivation was acquired by Pfizer.

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In August 2015, Medivation, Inc. and BioMarin Pharmaceutical Inc. entered into an asset purchase agreement under which Medivation acquired all worldwide rights to talazoparib, an investigational, once-daily, oral poly ADP ribose polymerase (PARP) inhibitor, which has been evaluated in clinical studies for the treatment of patients with germline BRCA 1/2-mutated locally advanced or metastatic breast cancer. Under the agreement, Medivation, acquired by Pfizer, is responsible for all research, development, regulatory and commercialization activities for all indications on a global basis.

Under the terms of the agreement, Medivation paid BioMarin $410 million upfront, and BioMarin may receive up to an additional $160 million (in aggregate) upon the achievement of regulatory and sales-based milestones as well as mid-single digit royalties for talazoparib.

Cellectar Granted U.S. Patent for the Treatment of Various Cancers and Cancer Stem Cells with CLR 131

On June 7, 2018 Cellectar Biosciences, Inc. (Nasdaq: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted treatments for cancer, reported that the U.S. Patent and Trademark Office (USPTO) has granted patent application number 15/099,977 titled, "Ether and Alkyl Phospholipid Compounds for Treating Cancer and Imaging Detection of Cancer Stem Cells (Press release, Cellectar Biosciences, JUN 7, 2018, View Source [SID1234527231])." This new patent enhances the coverage for the use of CLR 131 as a treatment for multiple cancers including gliomas, lung cancer, squamous cell carcinoma, renal cancer, melanoma, colorectal cancer, ovarian cancer, prostate cancer, breast cancer, and pancreatic cancer including cancer stem cells.

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"This patent expands protection for our PDC compounds across a number of significant cancers and importantly cancer stem cells. The ability of our PDC pipeline products, including CLR 131, to target both cancer cells and cancer stem cells for difficult to treat tumors could provide improved therapeutic benefits," stated Jim Caruso, chief executive officer of Cellectar Biosciences. "The patent also provides further coverage for CLR 131’s use in underserved pediatric diseases such as glioma, an indication that we plan to advance into the clinic in the second half of this year."

About Phospholipid Drug Conjugates

Cellectar’s product candidates are built upon a patented delivery and retention platform that utilizes optimized PDCs to target cancer cells. The PDC platform selectively delivers diverse oncologic payloads to cancerous cells and cancer stem cells, including hematologic cancers and solid tumors. This selective delivery allows the payloads’ therapeutic window to be modified, which may maintain or enhance drug potency while reducing the number and severity of adverse events. This platform takes advantage of a metabolic pathway utilized by all tumor cell types in all cell cycle stages. Compared with other targeted delivery platforms, the PDC platform’s mechanism of entry does not rely upon specific cell surface epitopes or antigens. In addition, PDCs can be conjugated to molecules in numerous ways, thereby increasing the types of molecules selectively delivered. Cellectar believes the PDC platform holds potential for the discovery and development of the next generation of cancer-targeting agents.

About CLR 131

CLR 131 is Cellectar’s investigational radioiodinated PDC therapy that exploits the tumor-targeting properties of the company’s proprietary phospholipid ether (PLE) and PLE analogs to selectively deliver radiation to malignant tumor cells, thus minimizing radiation exposure to normal tissues. CLR 131, is in a Phase 2 clinical study in relapsed or refractory (R/R) MM and a range of B-cell malignancies and a Phase 1 clinical study in patients with (R/R) MM exploring fractionated dosing. In 2018 the company plans to initiate a Phase 1 study with CLR 131 in pediatric solid tumors and lymphoma, and a second Phase 1 study in combination with external beam radiation for head and neck cancer.

Bristol-Myers Squibb to Announce Results for Second Quarter 2018 on July 26

On June 7, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported it will announce results for the second quarter of 2018 on Thursday, July 26, 2018 (Press release, Bristol-Myers Squibb, JUN 7, 2018, View Source [SID1234527217]). During a conference call at 10:30 a.m. EDT on July 26, company executives will review financial information and will address inquiries from investors and analysts.

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Investors and the general public are invited to listen to a live webcast of the call at View Source or by dialing in the U.S. toll free 323-794-2093 or international 866-548-4713, confirmation code: 4235170. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 1:30 p.m. EDT on July 26 through 1:30 p.m. EDT on, August 9, 2018. The replay will also be available through View Source or by dialing in the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 4235170.

Oncologie Launches with 16.5M USD Seed Funding Led by Pivotal bioVenture Partners China

On June 7, 2018 Oncologie, an innovative biopharmaceutical company, reported that it is launching operations in both Boston and Shanghai with $16.5M seed financing led by Pivotal bioVenture Partners China (Press release, Oncologie, JUN 7, 2018, View Source [SID1234527232]). Oncologie is committed to developing impactful cancer therapies to improve long-term survival of cancer patients worldwide. Building a pipeline of First and Best-in-Class clinical stage drug candidates through licensing and partnering, Oncologie is leveraging the recent regulatory changes in China to conduct parallel clinical development in China and the US to bring the next wave of Immuno-Oncology products to the two most important markets simultaneously.

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Oncologie is developing multiple global programs currently in Phase 2 and Phase 3 whose mechanisms are designed to combine with immune checkpoint inhibitors to improve survival benefits. The management team of Oncologie includes industry veterans from biotech and pharma with proven track records in developing innovative cancer drugs in both China and the US.

Founder, President, and CEO, Dr. Laura Benjamin said, "Oncologie has built an all-star team of creative drug developers committed to revealing the full potential of our exciting pipeline that is positioned to maximize the benefits cancer immune therapy can bring. Oncologie has created a global leading clinical pipeline since its inception earlier of this year. We look forward to working together with our partners to bring safe and effective cancer therapies to the market."

"Oncologie is leveraging the opportunity to run clinical trials in both the US and China to develop drugs for the global market," said Jimmy Wei, PhD, managing partner of the Pivotal bioVenture Partners China Fund. "We think these coordinated efforts will shorten the time between launching innovative drugs in the US and China. Since there are too many undifferentiated PD-1/PD-L1 programs in China with very few combination trials ongoing, Oncologie has positioned itself as the leader in immune combination therapies."

"We are very glad to have the opportunity to work with Dr. Benjamin to build this company," said Peter Bisgaard, managing director of Nan Fung Life Sciences. "Laura brings with her 20 years of experience as a researcher at Harvard Medical School as well as an executive in the industry, and she has built an outstanding team of experts."

Oncologie raised 16.5M USD in a seed round recently. The round was led by Pivotal bioVenture Partners China Fund and joined by Nan Fung Life Sciences, China Merchant Bank Investments and Volcanics Ventures.

Alkermes to Present at Goldman Sachs 39th Annual Global Healthcare Conference

On June 6, 2018 Alkermes plc (Nasdaq: ALKS) recorded that its Chief Executive Officer, Richard Pops, will participate in a fireside chat at the Goldman Sachs 39th Annual Global Healthcare Conference on Wednesday, June 13, 2018 at 3:20 p.m. PT (6:20 p.m. ET/11:20 p.m. BST) from Rancho Palos Verdes, Calif (Press release, Alkermes, JUN 6, 2018, View Source;p=RssLanding&cat=news&id=2353578 [SID1234527200]). The audio portion of the fireside chat may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
Jennifer Zibuda
Investor Relations
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