On November 2, 2018 Coherus BioSciences, Inc. (NASDAQ: CHRS), reported that the U.S. Food and Drug Administration (FDA) has approved UDENYCA (pegfilgrastim-cbqv), the first pegfilgrastim biosimilar approved by both the FDA and the European Commission (EC) for patients with cancer receiving myelosuppressive chemotherapy (Press release, Coherus Biosciences, NOV 2, 2018, View Source [SID1234531675]). UDENYCA is Coherus’ first drug to receive FDA or EC approval.

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"We are excited to announce that Coherus has received FDA approval for UDENYCA. I want to thank the Coherus team, our strategic partners, and the U.S. Food and Drug Administration for this extraordinary achievement," said Denny Lanfear, Chairman, CEO and President of Coherus BioSciences. "The list price of Neulasta has nearly tripled since approval in 2002 and now represents a $4 billion annual cost burden in the U.S. We believe that competition is essential in controlling burdensome price increases, and UDENYCA will play an important role in curbing that spend when launched. Our in-depth understanding of the market will allow us to deliver significant value to patients, payors, and providers in the U.S., including 340B hospitals, small clinics and small hospitals."

"For a number of reasons we believe the oncology marketplace is ideal for biosimilars, and we are committed to a vigorous product launch," said Chris Thompson, Senior Vice President of Sales. "Our oncology-focused, highly capable and fully-staffed commercial team is in place. We are confident that our U.S.-based manufacturing network has the finished goods in inventory to meet our highest expected demand for an extended period."

The approval of UDENYCA was supported by a comprehensive analytical similarity package, as well as pharmacokinetic, pharmacodynamic and immunogenicity studies, including over 600 healthy subjects.

"UDENYCA’s robust clinical package includes a dedicated immunogenicity similarity study in over 300 healthy subjects," said Barbara Finck, M.D., Chief Medical Officer of Coherus BioSciences. "In support of that study, and as part of our commitment to ensuring patient safety, we deployed a battery of sensitive immunogenicity assays. This effort not only supported the biosimilarity of UDENYCA, but also advanced the understanding of the immunogenic response of pegfilgrastim products."

The European Commission approved UDENYCA on September 21, 2018.

The company will provide additional details with respect to pricing and launch timing on the November 8 earnings call.

About UDENYCA
UDENYCA (pegfilgrastim-cbqv), formerly CHS-1701, is a PEGylated growth colony-stimulating factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. UDENYCA drug substance manufacturing is located in Boulder, Colorado. Pegfilgrastim is one of the largest selling oncology biologics with worldwide revenues in excess of $4.5 billion in 2017.

INDICATION
UDENYCA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use
UDENYCA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATION: Patients with a history of serious allergic reaction to human granulocyte colony-stimulating factors such as pegfilgrastim or filgrastim products.

WARNINGS AND PRECAUTIONS:

Fatal splenic rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
Acute respiratory distress syndrome (ARDS): Evaluate patients who develop fever, lung infiltrates, or respiratory distress. Discontinue UDENYCATM in patients with ARDS.
Serious allergic reactions, including anaphylaxis: Permanently discontinue UDENYCATM in patients with serious allergic reactions.
Fatal sickle cell crises: Have occurred.
Glomerulonephritis: Evaluate and consider dose-reduction or interruption of UDENYCATM if causality is likely.
Adverse Reactions: Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

To report SUSPECTED ADVERSE REACTIONS, contact Coherus BioSciences at 1-800-4-UDENYCA (1-800-483-3692) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On November 2, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the third quarter ended September 30, 2018 (Press release, Checkpoint Therapeutics, NOV 2, 2018, View Source [SID1234530627]).

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"In the third quarter of 2018, we announced positive interim safety and efficacy data from our ongoing Phase 1/2 clinical trial of CK-101, a third-generation EGFR inhibitor being evaluated in advanced non-small cell lung cancer (NSCLC), which was a significant milestone for the company," said James F. Oliviero, President and Chief Executive Officer of Checkpoint. "Our plans remain on-track for the rest of the year as we continue enrollment to establish the optimal dose of CK-101, after which we plan to initiate a Phase 3 trial in 2019 in treatment-naïve EGFR mutation-positive NSCLC patients. We also look forward to reporting early next year interim data from the expansion cohort phase of our Phase 1 clinical trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers."

Recent Corporate Highlights:

In September 2018, Checkpoint announced positive interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.
Financial Results:

Cash Position: As of September 30, 2018, Checkpoint’s cash and cash equivalents totaled $29.6 million, compared to $19.2 million at December 31, 2017, an increase of $10.4 million year-to-date.
R&D Expenses: Research and development expenses for the third quarter of 2018 were $7.8 million, compared to $5.0 million for the third quarter of 2017, an increase of $2.8 million.
G&A Expenses: General and administrative expenses for the third quarter of 2018 were $1.5 million, compared to $1.3 million for the third quarter of 2017, an increase of $0.2 million.
Net Loss: Net loss attributable to common stockholders for the third quarter of 2018 was $9.3 million, or $0.32 per share, compared to a net loss of $5.9 million, or $0.26 per share, for the third quarter of 2017.

On November 2, 2018 Takeda Pharmaceutical Company Limited (TOKYO: 4502) (Press release, Takeda, NOV 2, 2018, View Source [SID1234530660]):

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+4.2% growth in underlying revenue driven by growth drivers, with growth in each region

Underlying sales increased by + 4.2%, with Takeda’s growth drivers (gastroenterology, oncology, neuroscience and emerging markets) continuing to grow +9.8 %.
The key products Entyvio (+ 33.1%) and Ninlaro (+ 38.0%) contributed significantly to the growth in sales, as well as the products acquired from Ariad in 2017. Each region achieved positive growth compared to last year (USA + 9.2%, Japan + 4.1%, Europe & Canada + 4.3%, Emerging Markets + 2.4%).
Reported revenues decreased by -0.1%. Although our growth drivers maintained their strong growth, foreign currency exchange rates (-1.0 pp) and disposals (-3.2 pp) had a negative impact. The impact of the divestments included the sale of additional products to the Teva JV during the 2017 fiscal year, as well as Multilab and Techpool during the fiscal year 2018.
Underlying core earnings of + 31.8% with a margin of + 5.1 pp resulting from strict OPEX discipline

Earnings from underlying core businesses increased +31.8%, reflecting revenue growth and a 5.1pp margin increase, of which two-thirds (3.3ppm) ) were stimulated by OPEX improvements. This was the result of the global OPEX initiative fully integrated into working methods at Takeda.
Reported operating profit fell 26.6%. It was impacted by two strong non-recurring gains recorded in fiscal 2017: the sale of Wako shares for 106.3 billion yen and the sale of additional products to the Teva JV. In addition, Takeda recorded non-recurring expenses for fiscal year 2018 related to the proposed acquisition of Shire. Excluding these non-recurring items, operating income increased by +64.5%.
Core EPS was up + 32.7% and reported EPS decreased 26.9% to 162 yen per share, impacted by disposals and Shire-related costs.
The product pipeline has reached several milestones in the first half of fiscal year 2018

Maintenance of multiple myeloma after a Ninlaro stem cell transplant (TOURMALINE-MM3 study), Alukbris ALK + first line metastatic non-small cell lung cancer (ALTA-1L study), Adcetris first-line CD30 + T cell peripheral lymphoma (ECHELON-2 study) and the subcutaneous formulation in Entyvio ulcerative colitis (VISIBLE 1 study) all met their primary endpoints.
Seven new molecular entities have been integrated into the Phase 1 pipeline since April 2018.
Non-core asset disposal plan is on track

Free cash flow from operations since the beginning of the year decreased by -29.7% primarily as a result of the impact of the sale of additional products to the Teva JV during the 2017 fiscal year.
The sale of securities and real estate generated 44.2 billion yen in cash and the sale of non-core activities Techpool and Multilab generated an additional 27.2 billion yen.
The net debt / EBITDA ratio is 1.7x, an improvement of 1.8x for the fourth quarter of fiscal year 2017 and 2.7x for the fourth quarter of fiscal year 2016.
Christophe Weber, President and Chief Executive Officer, commented:

"Strategic priorities and a high quality of execution led to a solid performance in the first half of fiscal year 2018, as we are committed to meeting our key priorities to increase the portfolio, strengthen the pipeline, boost profitability. Our growth drivers contribute significantly to both earnings and earnings, and I am pleased to report that two-thirds of the 510 basis points of underlying core earnings margin improvement can be explained by the discipline in terms of costs following the global OPEX initiative.
In the first half of the year, we also achieved several important financial and regulatory milestones towards the proposed acquisition of Shire plc. I would like to emphasize that Takeda’s current strategy is working and that Takeda’s board of directors, Takeda’s management team and I are confident that the acquisition of Shire will allow Takeda to significantly accelerate the transformation. of the company to become a global leader in biopharmaceutical, R & D-based, values-based, headquartered in Japan. "

Basic earnings represent adjusted net income to exclude the tax expense, our share of capital gains or losses accounted for by the equity method, financial income and expenses, other costs and income. operating, amortization and impairment of intangible assets associated with revenue and other items that management perceives as unrelated to our core business, such as the impact of purchase accounting and transaction costs.

Underlying growth compares two periods (quarters or years) of financial results on a common basis and is used by management to evaluate the business. These financial results are calculated in constant currencies and exclude the impacts of divestitures and other amounts that are exceptional items, unusual or unrelated to our ongoing operations.

Attributable to the owners of the company.

Takeda Upgrades Velcade’s Full-Year Forecast, Dynamics of Growth Factors and OPEX Discipline

Upward revisions to underlying guidelines and reported forecasts.

Underlying guidance for fiscal year 2018: Underlying earnings guidance increased

Previous projections (% growth)
(May 14, 2018) Revised Projections (% Growth)
(October 31, 2018)
Underlying turnover Low single digit growth rate Low single digit growth rate
Earnings from underlying core businesses High single digit growth Average growth%
Underlying basic EPS Low double-digit growth rate High growth (around mid-20s)
Annual dividend per share 180 yen 180 yen
Projections maintain an additional competitor with no therapeutic equivalence in Velcade with the launch of subcutaneous and intravenous administration in the United States in March 2019, an increase of 35.5 billion yen compared to previous projections (Figure 1). global business for fiscal 2017: 129.6 billion yen, fiscal 2018: 111.0 billion yen) *
Increased underlying core earnings margin in the upper range of + 100-200bps.
These underlying projections exclude the estimated financial impact of fiscal year 2018 related to Takeda’s proposed acquisition of Shire plc.
* (application of the constant exchange rate based on the rate of the fiscal year 2018)

The revised projections in the table above include the costs incurred in the first half of fiscal year 2018 related to Takeda’s proposed acquisition of Shire plc (pre-tax earnings impact: 19.8 billion yen, net profit for the impact on the year: 16.5 billion yen); however, these do not include anticipated Shire costs for the second half of the fiscal year. In addition, the projections do not include any expected Shire earnings in the event that the closing of the acquisition is finalized during fiscal year 2018.
Takeda expects the share of Shire-related costs anticipated for fiscal year 2018 to be between 40 billion yen and 60 billion yen. This does not include integration costs, interest expense and other financial charges, since the magnitude of the impact of fiscal year 2018 will be related to the closing period of the transaction.
(Reference)

A revised financial projection that excludes costs incurred in the first half of fiscal year 2018 related to Takeda’s proposed acquisition of Shire plc is presented below. Previous projections for May 14, 2018 do not include expenses related to Shire.

Forecasts excluding the estimated financial impact of the proposed acquisition of Shire will be announced by Takeda as soon as a reasonable assumption has been confirmed.
For more information on the results of the first half of Takeda’s fiscal year 2018, as well as other financial information, please visit View Source

On November 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that it will announce its third quarter 2018 results on Tuesday, 6 November 2018 (Press release, Nordic Nanovector, NOV 2, 2018, View Source [SID1234553488]).

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A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CET on 6 November at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: HOLMENKOLLEN

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CET the same day.

On November 2, 2018 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported an upcoming poster presentation at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place from December 1-4, 2018 in San Diego, CA (Press release, Bio-Path Holdings, NOV 2, 2018, View Source [SID1234530611]). In addition, ASH (Free ASH Whitepaper) abstracts will appear in the November supplemental issue of Blood.

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Dr. Maro Ohanian, Assistant Professor of the Department of Leukemia at The University of Texas M.D. Anderson Cancer Center, will present interim data from the ongoing Phase 2 trial of prexigebersen (BP1001), the Company’s lead drug candidate, for the treatment of acute myeloid leukemia. Co-author Dr. Ana Tari Ashizawa, Vice President of Research and Development at Bio-Path, will also be available at the poster presentation

Details for the presentation are as follows:

Date: Saturday, December 1, 2018

Presentation Time: 6:15 PM – 8:15 PM Pacific Time

Location: San Diego Convention Center, Hall GH

Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Poster I

Title: Interim Safety and Efficacy of Lower Intensity Induction Therapy with Intravenous Prexigebersen (BP1001) in Patients with Untreated Acute Myeloid Leukemia (AML)