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NanoString Technologies Provides Preliminary Operational and Financial Results for Fourth Quarter and Fiscal Year 2017

On January 8, 2018 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported preliminary operational and financial results for the fourth quarter and fiscal year ended December 31, 2017 (Press release, NanoString Technologies, JAN 8, 2018, View Source [SID1234522939]).

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Financial Highlights:

Product and service revenue for fiscal year 2017 is expected to be approximately $72 million, versus prior guidance of $68 to $71 million

Product and service revenue for the fourth quarter of 2017 is expected to be approximately $21 million

Total revenue for fiscal year 2017 is expected to be in the range of $113 to $115 million, including approximately $41 to $43 million of collaboration revenue, versus prior guidance of $109 to $112 million

Cash, cash equivalents and short-term investments of approximately $82 million at December 31, 2017
Operational Highlights:

Approximately 125 nCounter Analysis Systems sold in 2016, including 54 nCounter SPRINT Profilers

Installed base of approximately 605 nCounter Analysis Systems at December 31, 2017, and increase of approximately 25% since year-end 2016

More than 1,820 cumulative peer-reviewed publications of studies based on nCounter technology as of December 31, 2017, an increase of more than 25% over the prior year
"While 2017 was a challenging year, we believe that actions we have taken helped to stabilize the business in the fourth quarter and put us on the path to improved growth over the course of 2018," said NanoString president and chief executive officer, Brad Gray. "The changes that we’ve made to our commercial channel have had a positive impact, and we achieved both solid SPRINT sales and record consumables revenue during the fourth quarter. In addition, we have taken actions to resource key development programs, extend the runway provided by our existing cash, and expand our access to additional capital."

Cost Management and Financial Resources

During the fourth quarter, the company shifted resources to its high-impact platform-development programs, Digital Spatial Profiling and Hyb & Seq, and eliminated approximately 30 positions in lower-priority areas of the business. The company now expects that its existing cash on-hand will be sufficient to fund its operations through mid-2019. Additionally, during the first week of January 2018, the company increased its access to capital by entering into a $15 million revolving credit facility and a $40 million "at-the-market" facility agreement for potential future equity financing.

NanoString president and chief executive officer, Brad Gray, will give a corporate update at the JP Morgan Healthcare conference at 8:00 a.m. PST on Thursday January 11th, 2018. A live webcast of the presentation will be available online from the investor relations page of the company’s corporate website at www.nanostring.com. After the live webcast, the presentation will remain available on the website for approximately 30 days.

These preliminary results are based on management’s initial analysis of operations for the quarter and year ended December 31, 2017 and are subject to further internal review and review/audit by the company’s external auditors.

Integra LifeSciences Announces Preliminary Fourth Quarter 2017 Financial Results

On January 8, 2018 Integra LifeSciences Holdings Corporation (Nasdaq:IART), a leading global medical technology company, reported certain unaudited preliminary fourth quarter 2017 financial results (Press release, IsoTis, JAN 8, 2018, View Source [SID1234522937]).

The company expects reported revenue for the fourth quarter 2017 to be approximately $365 million, an increase of over 40% compared to $255.7 million for the fourth quarter of 2016. The strong results in the fourth quarter were driven by outperformance in both the Derma Sciences and Codman Neurosurgery acquisitions, as well as higher than expected organic growth, including improved performance in dural repair.

"We closed the year with strong performance in revenue and adjusted earnings per share," said Peter Arduini, Integra’s president and chief executive officer. "This performance resulted from higher organic sales growth in both of our divisions and a faster recovery in our Puerto Rico manufacturing facility. We expect that this top-line performance will result in adjusted earnings per share above the high-end of our guidance range for the fourth quarter."

The company is scheduled to present at the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2018 at 3:30pm PT (6:30pm ET). A live audio webcast of the presentation will be available on the Investor section of the company’s website at www.integralife.com

The company will report its final, audited fourth quarter and full year 2017 financial results during a conference call in late February 2018. A press release with the date, time and webcast information will be provided closer to the reporting date.

Dr. Reddy’s Laboratories Limited to present at the 36th Annual J.P. Morgan Healthcare Conference

On January 6, 2018 Dr. Reddy’s Laboratories Ltd (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that the Company will be presenting at the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Dr Reddy’s, JAN 8, 2018, View Source [SID1234522935]).

Alok Sonig, Executive Vice President and Head, North America will present on Tuesday, January
9, 2018 at 2 p.m. (PST) [3:30 a.m. IST on January 10, 2018].

Presentation material will be available on the Company’s website www.drreddys.com

F1 Oncology’s International Affiliates and Sinobioway Sunterra Biotechnology Announce New Development, Manufacturing, and Supply Agreements to Support cGMP Lentivirus Supply

On January 7, 2018 Shanghai Sinobioway Sunterra Biotechnology (SSSB) and F1 Oncology reported the signing of new development, manufacturing, and supply agreements with plans to complete a new cGMP manufacturing facility in Shenzhen in support of large scale lentivirus contract manufacturing (Press release, EXUMA Biotechnology, JAN 7, 2018, View Source [SID1234619679]). The new facility, Shenzhen Biowit, which will expand from the current clinical production staff and site in Shenzhen, is scheduled for completion in 2018 and will utilize F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology and processes. The Shenzhen Biowit facility, in collaboration with F1 Oncology’s Hong Kong affiliate, will support future China gene therapy markets with clinical and commercial cGMP lentivirus for CAR-T and other gene therapies.

The new collaboration agreements between F1 Oncology’s international affiliates and Sinobioway Sunterra Biotechnology will facilitate clinical development and commercialization of F1 Oncology’s CCT3-based conditionally active biologic chimeric antigen receptor T cell (CAB-CAR-T) products in China, Hong Kong, Macau, and Taiwan. F1 Oncology retains rights to CCT3 products in all other territories and exclusive responsibility for global manufacturing and supply of certain product classes.

Upon SSSB’s closing of certain financing activities, SSSB will issue to F1 Oncology 20% equity plus 5% warrants. F1 Oncology will be responsible for lead generation, preclinical safety assessment and clinical virus manufacturing costs. Sinobioway Sunterra Biotechnology will be responsible for cGMP cell processing, clinical development, regulatory approval, and commercialization in the defined territories.

The agreement provides for certain licensing fees to be paid by SSSB upon nomination of new CAR-T products with preclinical packages delivered to SSSB for commercialization. The agreement further provides for processing of raw materials provided by F1 Oncology’s international affiliates and production to supply commercial products to the China markets.

"Biowit, a subsidiary of SSSB, has been providing the majority of cell therapy research institutions in China with virus products service over the past 7 years. Today, the introduction of F1 Oncology’s chemically defined suspension-based lentivirus manufacturing technology marks a new stage of China clinical virus manufacturing. Through our one year-old collaboration, Sunterra is leveraging the value of F1 Oncology’s CAB-CAR-T technology and proprietary industrial manufacturing processes to begin novel CAR-T clinical trials in China. We are confident that F1 Oncology’s differentiating technologies will allow us to stand out from other players in the CAR-T solid tumor space." Stated Mr. Wu Zili, Board Director and founder of SSSB.

"Reliable supply of viral gene vectors for cell and gene therapy programs is a current and growing challenge for the commercial biotechnology industry, and generally requires a different facility configuration to those used for traditional biologics" stated Tim Mayall, Ph.D. Head of Process Development at F1 Oncology. "Our early investments in the generation of serum-free well-characterized cell substrates capable of suspension-based lentivirus production supports a scalability that we believe will be beneficial from first in human through commercialization."

Celgene to Acquire Impact Biomedicines, Adding Fedratinib to Its Pipeline of Novel Therapies for Hematologic Malignancies

On January 7, 2018 Celgene Corporation (NASDAQ:CELG) and Impact Biomedicines reported the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera (Press release, Celgene, JAN 7, 2018, View Source [SID1234522934]). Under the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion in contingent payments based on regulatory approval milestones for myelofibrosis. Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.

Fedratinib, a highly selective JAK2 kinase inhibitor, was evaluated in 877 patients across 18 clinical trials. In a randomized, placebo-controlled, phase III pivotal trial (JAKARTA-1) for patients with treatment-naïve myelofibrosis, fedratinib demonstrated statistically significant improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively. In an exploratory subgroup analysis, these improvements were observed regardless of a patient’s baseline platelet count.

A multi-center, single-arm phase II trial (JAKARTA-2) evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor. In this second-line setting, fedratinib demonstrated clinically meaningful improvements in splenic response and total symptom score.

As previously reported, JAKARTA-2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration (FDA) after potential cases of Wernicke’s encephalopathy (WE) were reported in eight out of 877 patients receiving one or more doses (less than one percent of treated patients). The FDA removed the clinical hold in August 2017.

Based on the reported benefit risk profile of fedratinib from the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory applications in myelofibrosis are planned beginning in the middle of 2018.

"Myelofibrosis is a disease with high unmet medical need as the number of patients who are ineligible for or become resistant to existing therapy continues to increase," said Nadim Ahmed, President, Hematology and Oncology for Celgene. "We believe fedratinib is uniquely positioned as a potential treatment for myelofibrosis and it provides strategic options for us to build leadership in this disease with luspatercept and other pipeline assets."

"We launched Impact Biomedicines and based on our thorough review of the data, fedratinib presents a compelling risk benefit profile in both treatment-naïve patients and patients who are resistant or intolerant to other JAK2 therapies," said Dr. John Hood, Chief Executive Officer of Impact. "We believe Celgene is the ideal organization to follow through on our mission of maximizing fedratinib’s potential for patients with myelofibrosis."

Deal Terms

Under the terms of the agreement, Celgene will make an upfront cash payment of approximately $1.1 billion. In addition, Impact Biomedicines’ shareholders are eligible to receive contingent payments based on regulatory approval and sales-based milestones. The maximum aggregate amount payable for regulatory approval milestones is $1.4 billion relating to approvals for myelofibrosis and other indications. Starting from global annual net sales of $1.0 billion, aggregate tiered sales-based milestone payments could total a maximum of $4.5 billion if global annual net sales exceed $5.0 billion.

Credit Suisse acted as financial advisor and Hogan Lovells acted as legal counsel to Celgene on the transaction. PJT Partners acted as exclusive financial advisor and Latham & Watkins acted as exclusive legal counsel to Impact Biomedicines on the transaction. The acquisition is subject to customary closing conditions and applicable waiting period under the Hart Scott Rodino Antitrust Improvements Act. The transaction is expected to close in the first quarter of 2018.