On October 25, 2017 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it filed an application with the Japanese Ministry of Health, Labour and Welfare (MHLW) for the approval of anti-HER2 humanized monoclonal antibody, "Perjeta I.V. Infusion 420mg/14mL [generic name: pertuzumab (genetical recombination)] (hereafter, Perjeta)" for the additional indication of adjuvant therapy for HER2-positive early breast cancer (Press release, Chugai, OCT 25, 2017, View Source [SID1234521138]).

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"Currently, adjuvant chemotherapy with Herceptin for HER2-positive early breast cancer has been recommended in the clinical practice guidelines for breast cancer and has contributed to patients," said Dr. Yasushi Ito, Chugai’s Senior Vice President, Head of Project & Lifecycle Management Unit. "We are going to continue discussions with the health authorities so that adjuvant chemotherapy using Perjeta in combination with Herceptin, which has outperformed the current standard of care, will be used as a new treatment option for patients."

Chugai filed the application with the MHLW based on the results from the APHINITY study (Adjuvant Pertuzumab and Herceptin IN Initial TherapY in Breast Cancer) and several clinical studies. The APHINITY study is an international, phase III, randomised, double-blind, placebo-controlled, two-arm study evaluating the efficacy and safety of Perjeta plus Herceptin and chemotherapy (anthracycline medicine followed by docetaxel monotherapy / docetaxel plus carboplatin) compared to Herceptin and chemotherapy as adjuvant therapy in 4,805 patients with HER2-positive early breast cancer who undergone curative surgery. The primary endpoint of the APHINITY study is invasive disease-free survival (iDFS), which is defined as the time a patient lives without return of invasive breast cancer at any site or death from any cause after adjuvant treatment. The secondary endpoints were cardiac and overall safety, and other endpoints.

The results of the APHINITY study are as follows:

– At three years, iDFS, the primary endpoint, was 94.1% in the Perjeta arm and 93.2% in the control arm, and a statistically significant improvement was observed in the Perjeta arm. Perjeta arm significantly reduced the risk of recurrence or death by 19% compared to control arm (HR=0.81, 95%CI 0.66-1.00, stratified log-rank test, p=0.045).

– The iDFS at four years estimated by the Kaplan-Meier method showed that 92.3% (95%CI: 91.1-93.4) of people treated with the Perjeta arm did not have their breast cancer return compared to 90.6% (95%CI: 89.3-91.8) treated with control arm.

– The safety profile of Perjeta was consistent with that seen in previous studies. The incidence of cardiac events was 0.7% in the Perjeta arm and 0.3% in the control arm.

In the US and Europe, Perjeta is under review for postoperative adjuvant chemotherapy for HER2-positive breast cancer, and the US Food and Drug Administration has granted Priority Review to Perjeta for this indication. Perjeta was approved for adjuvant therapy (before surgery) for HER2-positive early breast cancer in September 2013 in the US and in July 2015 in Europe.

As the top pharmaceutical company in the field of oncology in Japan, Chugai will work for early approval to provide Perjeta as a new treatment option for patients with HER2-positive early breast cancer.

On October 25, 2017 Varian (NYSE:VAR), the world’s leading manufacturer of medical devices and software for treating and managing cancer, reported its fourth-quarter and full-year fiscal 2017 results (Press release, Varian Medical Systems, OCT 25, 2017, View Source [SID1234521176]). All fourth-quarter comparisons in this announcement are year-over-year unless noted otherwise.

Summary

($ in millions except EPS) Q4 2017 Q4 2016 FY 2017 FY 2016
Revenues (from Continuing Operations) $ 739.0 $ 747.2 $ 2,668.2 $ 2,621.1
Growth Reported (1 )% 2 %
Growth Constant Currency (2 )% 2 %
Gross Margin 42.1 % 42.6 % 43.3 % 42.5 %
GAAP Net Earnings (1) $ 82.7 $ 94.3 $ 257.1 $ 325.3
GAAP Net Earnings per Diluted Share (1) $ 0.89 $ 1.00 $ 2.75 $ 3.39
Net Cash Provided by Operating Activities $ 129.6 $ 151.9 $ 399.1 $ 356.3
Non-GAAP Net Earnings (1) (2) $ 100.6 $ 97.7 $ 335.1 $ 354.9
Non-GAAP Net Earnings per Diluted Share (1) (2) $ 1.09 $ 1.03 $ 3.60 $ 3.70

(1) GAAP Net Earnings and Earnings Per Diluted Share and Non-GAAP Net Earnings and Non-GAAP Earnings Per Diluted Share refer only to continuing operations. GAAP and Non-GAAP Earnings Per Diluted Share, for the quarter and fiscal year ended September 29, 2017, were calculated based on diluted shares of 92.6 million and 93.2 million, respectively. For the quarter and fiscal year ended September 30, 2016, the number of diluted shares was 94.5 million and 96.0 million, respectively.
(2) Non-GAAP Net Earnings and Non-GAAP Earnings Per Diluted Share are defined as GAAP Net Earnings and GAAP Earnings Per Diluted Share adjusted to exclude the amortization of intangible assets, acquisition-related expenses and benefits, restructuring and impairment charges and significant litigation charges or benefits and legal costs.

"We finished a transformative year for the company with a solid quarter highlighted by robust gross order growth," said Dow Wilson, CEO of Varian. "During the year, we extended our industry leadership with successful launches of the Halcyon and HyperArc treatment platforms, grew our global footprint and continued to build capabilities to grow beyond our core market. We also booked two more proton orders in the quarter, bringing our total for the year to six."

The company ended the quarter with $716 million in cash and cash equivalents and $350 million of debt. Net cash provided by operating activities was healthy at $130 million in the fiscal fourth quarter and $399 million for the fiscal year, supported by improved cash collections. During the fiscal fourth quarter, the company invested $25 million to repurchase 250,000 shares of common stock.

Gary Bischoping, Varian’s chief financial officer, added, "While the quarter’s profitability results came in short of our expectations, I’m pleased with our team’s ongoing operational and financial discipline. We have more work to do, but we made solid progress toward our long-term objectives. Our orders growth, improving gross margin rate this past year, and continued working capital efficiencies has me looking forward to our next fiscal year."

Oncology Systems Segment
In the fiscal fourth quarter, Oncology revenues for the segment totaled $686 million, up 1 percent in dollars and in constant currency. For the full year, revenues were up 1 percent at $2.5 billion. Gross orders were $964 million, up 7 percent in dollars and in constant currency. Gross orders in the Americas increased 1 percent in dollars and 2 percent in constant currency, with North America growing 8 percent in dollars. In EMEA, gross orders rose 32 percent in dollars and 29 percent in constant currency, to $321 million driven by robust growth in France, Germany, Poland and India; in APAC gross orders declined 10 percent in dollars and 9 percent in constant currency where strong growth across a majority of the region was offset by significant declines in Japan.

Proton Therapy Segment
Revenues in the fourth quarter were down 23 percent at $52 million. For the full year, revenues were up 12 percent at $182 million. In the quarter, the company booked orders totaling $74 million, including orders for ProBeam Compact projects in China and India. For the full fiscal year, proton therapy orders totaled $229 million, more than double the previous year.

Outlook for Full Fiscal Year 2018
We expect the following for fiscal year 2018:
· Revenues to grow by 2 to 4 percent
· Non-GAAP operating earnings to range between 18 and 19 percent of revenue
· Non-GAAP net earnings per diluted share from continuing operations to be in the $4.20 to $4.32 range
· Cash Flow from Operations to be between $475 million and $550 million

We have assumed no change to share count year over year and a tax rate of 23 percent.

Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call
Varian Medical Systems is scheduled to conduct its fourth quarter fiscal year 2017 conference call at
2 p.m. PT today. To hear a live webcast or replay of the call, visit the investor relations page on our company’s web site at www.varian.com/investor where it will be archived for a year. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering confirmation code 13669524. The telephone replay will be available through 5 p.m. PT, Friday, October 27, 2017.

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On October 25, 2017 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported preliminary results from its Phase 1 study of its proprietary oral Endoxifen (Press release, Atossa Genetics, OCT 25, 2017, View Source [SID1234521149]). All objectives were successfully met:

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– Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving oral Endoxifen.

– Tolerability: Oral Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.

– Pharmacokinetics: Oral Endoxifen demonstrated blood levels that have been associated with a therapeutic effect in the adjuvant setting in women with breast cancer.
These data demonstrate the suitability of oral Endoxifen for further clinical development.

The Phase 1 Study

The Phase 1 study was a double-blind, placebo-controlled, repeat dose study of 48 healthy female subjects. Atossa assessed safety, tolerability and the pharmacokinetics of proprietary formulations of both topical and oral Endoxifen dosage forms in varying dose levels over 28 days. The study was conducted in two parts based on route of administration. Preliminary results from the topical arm of the study were announced on September 14, 2017.

Atossa’s Proprietary Endoxifen

Endoxifen is an active metabolite of tamoxifen. Tamoxifen is an FDA-approved drug to prevent new breast cancer as well as recurrent breast cancer in breast cancer patients. Tamoxifen is a “pro-drug” meaning that it must be broken down by the liver into active compounds (metabolites), of which Endoxifen is the most active. It is these active metabolites that have the therapeutic effect.

Oral Endoxifen. Although approximately one million breast cancer survivors take tamoxifen annually, up to half of them do not fully benefit from tamoxifen, meaning they are “refractory,” for a number of reasons including that they do not properly metabolize tamoxifen into its active metabolites. Low endoxifen levels in breast cancer patients taking oral tamoxifen are associated with an increased risk of recurrence or the development of new breast tumors. Thus providing oral Endoxifen directly to the patient without having to be metabolized may help to address this problem.

Topical Endoxifen. A condition called breast density (or, MBD), typically diagnosed by a mammogram, has been shown to be an independent breast cancer risk factor. To date, 30 states require that findings of MBD be directly communicated to the patient. We believe a topical form of Endoxifen could potentially reduce MBD. Although oral tamoxifen has been shown to reduce MBD, the benefit-cost ratio is not acceptable to most physicians and their patients. For example, it is estimated that less than 5% of women at an increased risk of developing breast cancer including those with MBD take oral tamoxifen to prevent breast cancer because of the risk of, or actual side-effects of, oral tamoxifen. We are planning a Phase 2 study of topical Endoxifen in Stockholm, Sweden for the treatment of MBD.

Based on the number of women with MBD and the number of patients who have survived breast cancer but are not fully benefiting from tamoxifen, Atossa estimates that the potential markets for its proprietary oral and topical formulations of Endoxifen could potentially exceed $1 billion in annual sales.

Next Steps

“Based on these positive preliminary results, we are advancing our oral Endoxifen into Phase 2 studies,” commented Dr. Steven C. Quay, CEO and President. “We expect our initial Phase 2 study will be in women who are refractory to tamoxifen and we expect to begin that study in the first quarter of 2018,” continued Dr. Quay.

Breast Cancer Statistics

The American Cancer Society (ACS) estimates that approximately 250,000 women will be diagnosed with breast cancer in the United States this year and that approximately 40,000 will die from the disease. It is the second leading cause of cancer death in American women. Although about 100 times less common than women, breast cancer also affects men. The ACS estimates that the lifetime risk of men getting breast cancer is about 1 in 1,000; 2,470 new cases of invasive breast cancer will be diagnosed; and 460 men will die from breast cancer in 2017.

Conference Call

Atossa Genetics will host a conference call to discuss preliminary results today at 10 am Eastern time.

To listen to the call by phone, interested parties within the U.S. should call 1-844-824-3830, International callers should call 1-412-317-5140 and Canadian callers should call 1-855-669-9657. All callers should ask for the Atossa Genetics conference call. The conference call will also be available through a live webcast at www.atossagenetics.com. Details for the webcast may be found on the Company’s IR events page at View Source

A replay of the call will be available approximately one hour after the end of the call through November 24, 2017. The replay can be accessed via Atossa’s website or by dialing 877-344-7529 (domestic) or 412-317-0088 (international) or Canada Toll Free at 855-669-9658. The replay conference ID number is 10113835.

On October 25, 2017 Incyte Corporation (NASDAQ:INCY) and MacroGenics, Inc. (NASDAQ:MGNX) reported that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an investigational monoclonal antibody that inhibits programmed cell death protein 1 (PD-1) (Press release, Incyte, OCT 25, 2017, View Source [SID1234521150]). Incyte has obtained exclusive worldwide rights for the development and commercialization of MGA012 in all indications, while MacroGenics retains the right to develop its pipeline assets in combination with MGA012.

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“Anti-PD-1 therapy is becoming a mainstay of cancer treatment across multiple tumor types, and we believe the addition of MGA012 to our clinical pipeline is important to fulfilling our long-term development strategy in immuno-oncology. This collaboration with MacroGenics will allow us to rapidly explore the potential clinical benefit of developing MGA012 as a monotherapy and also combining anti-PD-1 therapy with several of our existing portfolio assets,” said Steven Stein, M.D., Chief Medical Officer of Incyte.

“We believe Incyte is the ideal partner for MGA012, given its immuno-oncology portfolio and dedication to researching and developing innovative and transformative cancer therapies and we hope that the combined resources of both companies will be able to significantly expand and accelerate the current development efforts for this promising molecule,” said Scott Koenig, M.D., Ph.D., President and Chief Executive Officer of MacroGenics. “Furthermore, we look forward to exploring the combination of MGA012 with multiple molecules in our own portfolio, including DART molecules for redirected T-cell killing, antibodies with enhanced effector function and ADCs, potentially to provide improved patient benefit.”

Enrollment in the dose escalation portion of the Phase 1 study of MGA012 has been completed and the molecule is currently being evaluated as monotherapy across four solid tumor types in the dose expansion portion of the study. Data from the dose escalation portion of the Phase 1 study have been accepted for poster presentation at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting in November 2017.

Terms of the Collaboration
Upon closing, Incyte will pay MacroGenics an upfront payment of $150 million. Incyte will receive worldwide rights to develop and commercialize MGA012 in all indications.

Per the terms of the collaboration, MacroGenics will also be eligible to receive up to $420 million in potential development and regulatory milestones, and up to $330 million in potential commercial milestones. If MGA012 is approved and commercialized, MacroGenics would be eligible to receive royalties, tiered from 15 percent to 24 percent, on future sales of MGA012 by Incyte.

Under the terms of the collaboration, Incyte will lead global development of MGA012. MacroGenics retains the right to develop its pipeline assets in combination with MGA012, with Incyte commercializing MGA012 and MacroGenics commercializing its asset(s), if any such potential combinations are approved.

In addition, MacroGenics retains the right to manufacture a portion of both companies’ global clinical and commercial supply needs of MGA012. MacroGenics intends to utilize its commercial-scale GMP facility, which is expected to be fully operational in 2018.

The transaction is expected to close in the fourth quarter of 2017, subject to the early termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act and customary closing conditions.

On October 25, 2017 Y-mAbs Therapeutics, Inc. (YmAbs), an immunotherapy company discovering and developing innovative treatments for patients with cancer, reported that it has closed a private placement among HBM Healthcare Investments and its current shareholders raising $50 million (Press release, Y-mAbs Therapeutics, OCT 25, 2017, View Source [SID1234521160]).

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YmAbs’ Founder, President and Head of Business Development and Strategy, Thomas Gad said, "We are very pleased to welcome HBM as a significant shareholder in YmAbs, together with our existing shareholders, who continue to show strong support and commitment to bringing breakthrough immunotherapies to children faced with advanced cancers and clear unmet medical needs. This new financing sets YmAbs in a strong financial position to further advance its late stage oncology pipeline."

Dr. Claus Møller, Chief Executive Officer further notes, "This funding is an important financial achievement for YmAbs, and enables us to focus on bringing our lead compounds, burtomab and naxitamab, through the final steps of the regulatory pathway towards approval."

Andreas Wicki, Chief Executive Officer of HBM Healthcare Investments added: "We are delighted to add YmAbs to our portfolio of promising healthcare companies. YmAbs’ approach to immunotherapy shows great promise and will further advance innovation and product development in the pediatric oncology field. YmAbs is a young and rapidly growing company that we are excited to support and to accompany on the way to further success."