On January 8, 2018 Foundation Medicine (NASDAQ:FMI) reported preliminary unaudited total revenue of approximately $48.9 million for the fourth quarter of 2017 and approximately $152.9 million for the full year ended December 31, 2017, representing a 70% and 31% increase from the $28.8 million and $116.9 million recorded in the fourth quarter and full year ended December 31, 2016, respectively (Press release, Foundation Medicine, JAN 8, 2018, View Source [SID1234522944]).

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"2017 was a year of significant milestones for Foundation Medicine, including posting record revenue and achieving our largest annual increase in recorded clinical volume," stated Troy Cox, chief executive officer of Foundation Medicine. "Our most notable achievement was the successful completion of the parallel review process during the fourth quarter which culminated with FDA approval and a preliminary National Coverage Determination (NCD) for FoundationOne CDx from CMS. This approval and preliminary NCD are transformational for our company, clinicians, biopharma partners and most importantly, for patients with advanced cancer, as we continue to meaningfully improve access to personalized cancer care."

Revenue from biopharmaceutical companies is expected to be approximately $33.4 million in the fourth quarter of 2017 and approximately $99.7 million for the full year ended December 31, 2017, compared to $19.0 million and $78.8 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 6,206 tests to biopharmaceutical customers in this year’s fourth quarter.

Revenue from clinical testing is expected to be approximately $15.5 million in the fourth quarter of 2017 and approximately $53.1 million for the full year ended December 31, 2017, compared to $9.8 million and $38.1 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 20,044 clinical tests to ordering physicians in the fourth quarter of 2017, compared to a total of 12,788 tests reported during the fourth quarter of 2016, an increase of 57%. A total of 67,375 clinical tests were reported to ordering physicians for the full year ended December 31, 2017, compared to 43,686 clinical tests reported in 2016, an increase of 54%.

Based on the new revenue reporting the company initiated during 2017, Molecular Information Services revenue is expected to be approximately $37.4 million in the fourth quarter of 2017 and approximately $117.1 million for the full year ended December 31, 2017, compared to $20.4 million and $81.8 million in the fourth quarter and full year ended December 31, 2016, respectively. Pharma Research and Development Services revenue is expected to be approximately $11.5 million in the fourth quarter of 2017 and approximately $35.8 million for the full year ended December 31, 2017, compared to $8.4 million and $35.1 million in the fourth quarter and full year ended December 31, 2016, respectively.

Cash and cash equivalents at December 31, 2017 was approximately $71.4 million, including $30 million in new borrowings received during the fourth quarter under the company’s Credit Facility Agreement with Roche Finance.

2017 Enterprise Highlights:

Received approval from the U.S. Food & Drug Administration (FDA) under the parallel review process for FoundationOne CDx, the first broad genomic profiling test incorporating multiple companion diagnostics.

Simultaneously, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary NCD for FoundationOne CDx, which is expected to improve access to molecular information for personalized healthcare. The NCD is expected to be finalized during the first quarter of 2018.

Grew the biopharma business with new and expanded collaborations for molecular information solutions including companion diagnostics, molecular profiling, data insights, and biomarker discovery.

Presented validation data for a novel assay measuring tumor mutational burden in blood (bTMB) providing evidence that response to immunotherapy can be predicted using a blood sample. Based on these findings, Foundation Medicine’s bTMB assay is being integrated as part of Roche/Genentech’s prospective, randomized Phase III Blood First Assay Screening Trial (BFAST) as a companion diagnostic assay investigating the use of bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced NSCLC patients.

Received approval from the State of New York Department of Health for FoundationACT, the company’s liquid biopsy assay.

Announced a collaboration with the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) to identify patients for its Targeted Agent and Profiling Utilization Registry (TAPUR) study.

Announced a collaboration with the National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group to identify patients for the NCI-Match (Molecular Analysis for Therapy Choice) study.
Increased FoundationCORE, the company’s molecular information database, to nearly 180,000 clinical cases.
Expanded the company’s global footprint and patient access to personalized healthcare by commencing operations at the company’s laboratory in Penzberg, Germany. The Penzberg location is supporting continued growth and expansion in Europe through the company’s commercial collaboration with Roche.

Published 95 peer-reviewed manuscripts in top medical and scientific journals and presented 141 podium talks and posters at scientific and medical meetings.

Complete 2017 fourth quarter and full year financial results will be announced during the company’s fourth quarter and fiscal year 2017 financial results conference call. The company also anticipates providing 2018 financial guidance at that time. This press release contains certain unaudited financial results for the company. These unaudited results could change as a result of further review by the company’s management and its independent auditors.

Mr. Cox is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2017, at 3:30 p.m. PST, in San Francisco. Additionally, Mr. Cox will participate in a panel discussion focused on the FDA and CMS parallel review process on Monday, January 8, 2018 at 5:15 p.m. PST. Live, listen-only webcasts of these presentations and the breakout session may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of these webcasts will be available shortly after the conclusion of the presentations and will be archived on the company’s website for two weeks.

On January 8, 2018 Emergent BioSolutions presented Corporate slide deck, dated January 9, 2018 (Presentation, Emergent BioSolutions, JAN 8, 2018, View Source [SID1234522992]).

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On January 8, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, and Mirati Therapeutics (NASDAQ:MRTX), a clinical-stage targeted oncology company, reported an exclusive license agreement for the development, manufacturing and commercialization of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and New Zealand (Press release, BeiGene, JAN 8, 2018, View Source;p=RssLanding&cat=news&id=2325285 [SID1234523004]). Mirati will retain exclusive rights for the development, manufacturing and commercialization of sitravatinib for the rest of world.

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Sitravatinib is an investigational tyrosine kinase inhibitor that has demonstrated potent inhibition of receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, MER), split family receptors (VEGFR2, KIT) and RET. It is being evaluated by Mirati as a single agent in a Phase 1b expansion trial in patients whose tumors harbor specific genetic alterations in non-small cell lung cancer (NSCLC) and other tumors types. Sitravatinib has shown encouraging interim results in an ongoing Phase 2 trial in combination with nivolumab in NSCLC patients who have progressed after prior treatment with a checkpoint inhibitor.

"We are delighted to enter into this exclusive clinical development and commercialization agreement for sitravantinib and look forward to working with the experienced team at Mirati. Sitravatinib is an exciting compound that has demonstrated a unique tyrosine kinase inhibition profile and promising clinical activity both as a single agent and in combination with a checkpoint inhibitor in non-small cell lung cancer. This collaboration complements our portfolio and will allow us to investigate sitravatinib in combination with tislelizumab, our investigational anti-PD-1 antibody, in China and the rest of the licensed territory," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

"We are excited to begin a partnership with BeiGene, which has built a world-class global development organization with a strong presence in Asia-Pacific, as well as an established commercial organization in China. They have demonstrated an ability to enroll patients quickly in a variety of indications which will augment our development capabilities and expand the evaluation of sitravatinib to additional tumor types for patients who are checkpoint inhibitor naïve or who have been previously treated with a checkpoint inhibitor," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati Therapeutics.

Under the agreement Mirati will receive an upfront cash payment of $10 million from BeiGene. Additionally, Mirati is eligible to receive up to $123 million of additional payments based upon the achievement of certain development, regulatory and sales milestones as well as significant royalties on future sales of sitravatinib in the licensed territory.

About Sitravatinib

Sitravatinib (MGCD-0516) is a spectrum-selective kinase inhibitor which potently inhibits receptor tyrosine kinases (RTKs) including RET, TAM family receptors (TYRO3, Axl, MER), and split family receptors (VEGFR2, KIT). Sitravatinib is being evaluated as a single agent in a Phase 1b expansion trial enrolling patients that harbor RET, CHR4Q12, and CBL genetic alterations in NSCLC and other tumors.

As an immuno-oncology agent, sitravatinib is being tested in combination with anti PD-1 checkpoint inhibitor nivolumab in NSCLC patients who have progressed after prior treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family receptors may help overcome resistance to checkpoint inhibitor therapy through enhancement of dendric cell-dependent antigen presentation, targeted depletion of immunosuppressive T regulatory cells and myeloid-derived suppressor cells, and conversion of tumor associated macrophages to an immune-enhancing Type I composition, in the tumor microenvironment.

About Tislelizumab (BGB-A317)

Tislelizumab is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. Tislelizumab has demonstrated high affinity and specificity for PD-1. It is differentiated from the currently approved PD-1 antibodies in an engineered Fc region, which is believed to minimize potentially negative interactions with other immune cells. Tislelizumab is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers. BeiGene and Celgene Corporation have a global strategic collaboration for tislelizumab for solid tumors outside of Asia (except Japan).

On January 8, 2018 STORM Therapeutics, the leading drug discovery company focused on small molecule therapies modulating RNA modifying enzymes, reported that it has raised an additional £4 million of funding from Taiho Ventures, LLC the strategic corporate venture capital arm of Taiho Pharmaceutical Co., Ltd (Press release, STORM Therapeutics, JAN 8, 2018, View Source [SID1234561046]). This is an addition to the £12 million Series A Financing announced in June 2016. Taiho Ventures joins the existing blue chip investor syndicate of Merck Ventures, Cambridge Innovation Capital, Pfizer Venture Investments and Touchstone Innovations with an equal size of investment. Sakae Asanuma, President of Taiho Ventures, joins STORM Therapeutics’ Board of Directors.

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Following encouraging progress to date, the financing will enable STORM Therapeutics to expand and accelerate its pipeline, pursue emerging therapeutic opportunities, and build a broader drug discovery platform encompassing new drug targets from additional academic collaborators and its scientific founders.

Commenting on the fundraising, Keith Blundy, CEO of STORM Therapeutics, said: "We are pleased to welcome Taiho Ventures to our existing investor syndicate. This extended investment represents further validation and support of our strategy to harness the power of RNA epigenetics as a new area of important biology. As the first company tackling disease through modulating RNA modifying enzymes, we believe we are well positioned to build a world leading company."
Sakae Asanuma, President of Taiho Ventures, added: "We are excited to join this experienced management team and investor syndicate to help STORM Therapeutics fulfil its ambition to become the leading therapeutics company in RNA epigenetic modulation. Our strategy is to invest globally in companies that discover and develop innovative first-in-class therapeutic products that demonstrate a clear potential to benefit cancer patients, and as our first investment in Europe we believe that STORM’s innovative approach has the potential to significantly improve the way the world treats cancer."

On January 7, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX), a biotechnology company focused on neurological and endocrine related disorders, reported that Christopher O’Brien, M.D., Chief Medical Officer, has notified the Company he plans to retire in February 2018, after a transition period with his successor (Press release, Neurocrine Biosciences, JAN 7, 2018, View Source;p=RssLanding&cat=news&id=2325239 [SID1234522940]). Dr. O’Brien joined Neurocrine in 2005, and has led the clinical development and medical affairs activities for more than 12 years. Dr. O’Brien will remain as an exclusive consultant for Neurocrine.

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"On behalf of the board, shareholders and our employees, I want to thank Chris for his tremendous contributions as Chief Medical Officer of Neurocrine," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "With his considerable expertise and leadership, we successfully developed and obtained FDA approval of INGREZZA capsules for the treatment of adults with tardive dyskinesia and advanced our clinical development programs for Tourette syndrome, Parkinson’s disease, endometriosis and congenital adrenal hyperplasia. I am very pleased that Chris will continue to be a part of the Neurocrine team for the foreseeable future."

Eiry W. Roberts, M.D., will join the company as Chief Medical Officer, effective January 8, 2018.

"We are very pleased to welcome Eiry to Neurocrine as she brings extensive senior leadership and pharmaceutical management experience to the team," Dr. Gorman said. "Eiry’s strong background in implementing strategic clinical development programs and navigating the regulatory approvals process across phases of drug development from research to commercialization in multiple therapeutic areas, including neuroscience, will be valuable as we execute on our commercialization and clinical plans and advance our pipeline in support of our commitment to relieve patient suffering and enhance lives."

Dr. Roberts has over 25 years of research and development experience in the pharmaceutical industry across all phases of drug development from research through commercialization in multiple therapeutic areas, including neuroscience, inflammation, oncology and metabolic diseases. She joins Neurocrine from Eli Lilly and Company where she held various positions during her tenure, including Vice President, Clinical Pharmacology and Vice President of R&D, BioMedicines Business Unit.

Dr. Roberts was the Chair of the Medical Review Committee, where she was responsible for review and approval of all the integrated clinical plans for molecules in the Lilly portfolio. She was also a member of Lilly’s Corporate Portfolio Management Committee and Lilly Ventures Steering Committee. Dr. Roberts was accountable for early clinical development programs across all therapeutic areas within Lilly, as well as registration for new chemical entities and biproducts in Phase III development. During her time at Lilly, Dr. Roberts established a new therapeutic area, which resulted in the development of five potential novel medicines from Phase I through to approval, with two of them successfully receiving regulatory approval. Dr. Roberts also has extensive leadership and business development experience, including the management of strategic alliances, business partnerships and venture capital collaborations.

Dr. Roberts is a physician who trained in pharmacology and medicine in the UK, qualifying from the University of London in 1987. Her post-graduate clinical training was in clinical pharmacology and cardiology at St. Bartholomew’s Hospital and the Royal London Hospital.

Neurocrine also announced the grant of an inducement award to Dr. Roberts pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules. In connection with her employment by Neurocrine, Dr. Roberts will be granted an inducement award consisting of a stock option to purchase 70,000 shares of Neurocrine common stock. The stock option will vest over a period of four years, with 25% vesting on the first anniversary of its grant date and the balance vesting each month over the remaining three years. Dr. Roberts also received 20,000 restricted stock units which vest in equal increments over four years, with 25% vesting each year. These awards are subject to the terms and conditions of Neurocrine’s Inducement Plan, and will be effective on January 8, 2018. The stock option grant will have an exercise price equal to the closing price of Neurocrine’s common stock on the NASDAQ Global Select Market on that date. These awards were granted as an inducement material to Dr. Roberts’ employment pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.