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;p=RssLanding&cat=news&id=2310980 [SID1234521152]). 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 Swedish Orphan Biovitrum AB (publ) (Sobi) reported its results for the third quarter 2017 (Press release, Swedish Orphan Biovitrum, OCT 25, 2017, View Source;Media/News/RSS/?RSS=View Source [SID1234521139]). Total revenues amounted to SEK 1,601 M, an increase of 37 per cent. Product sales amounted to SEK 1,459 M, an increase of 45 per cent. Elocta sales were SEK 417 M and Alprolix sales were SEK 98 M.

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Business highlights Q3 2017

Focus on future growth
37 per cent sales growth in the quarter
601 per cent product sales growth in Haemophilia
Solid development for Orfadin 20 mg and oral suspension in the US
Financial summary Q3 2017 (Q3 2016)

Total revenue was SEK 1,601 M (1,171), an increase of 37 per cent (41 per cent at CER)
Product revenue was SEK 1,459 M (1,009), an increase of 45 per cent (48 per cent at CER)
Gross margin was 70 per cent (67)
EBITA was SEK 536 M (282)
Cash position SEK 1,758 M (SEK 786 M as of 31 December 2016)
Earnings per share 1.20 SEK (0.50)
Financial summary Jan-Sep 2017 (Jan-Sep 2016)

Total revenue was SEK 4,636 M (3,913), an increase of 18 per cent (16 per cent at CER)
Product revenue was SEK 4,171 M (3,404), an increase of 23 per cent (20 per cent at CER)
Gross margin was 72 per cent (71)
EBITA was SEK 1,434 M (1,333)
Earnings per share 2.94 SEK (2.71)
Outlook 2017(1,2) – updated
Sobi now expects total revenues for the full year to be in the range of SEK 6,300 to 6,400 M (6,100-6,200).
Gross margin is expected to be around 70 per cent, unchanged.
Sobi now expects EBITA for the full year to be in the range of SEK 1,900 to 2,000 M (1,700-1,800).

(1) At current exchange rates.

(2) The latest outlook was published on 19 July 2017.

Guido Oelkers, CEO:
"A strong business performance was shown across the portfolio in the third quarter, with the main contributors being Elocta and Alprolix. Elocta sales increased more than 600 per cent compared to the same period last year and Alprolix sales increased with approximately 500 per cent. This strong growth momentum encourages us to be confident around the prospects of our Haemophilia franchise.

Our growth strategy has been designed to capitalise on the substantial potential in Haemophilia. Based on this solid platform we will further balance the business with a broader Specialty Care portfolio to ensure a sustainable company in both the short and long-term".

Financial summary
Q3 Q3 Jan-Sep Jan-Sep Full year
Amounts in SEK M 2017 2016 Change 2017 2016 Change 2016
Total revenues1 1,601 1,171 37% 4,636 3,913 18% 5,204
Gross profit2 1,129 782 44% 3,320 2,791 19% 3,651
Gross margin 70% 67% 72% 71% 70%
EBITA 536 282 90% 1,434 1,333 8% 1,543
EBIT (Operating profit/loss) 426 171 149% 1,092 1,033 6% 1,133
Profit for the period 324 135 141% 791 728 9% 801
(1)Jan-Sep 2016 revenues include a one-time credit received in Q1 of SEK 322 M relating to the first commercial sales of Elocta, and a one-time credit received in Q2 of SEK 386 M relating to first commercial sales of Alprolix.
(2)Jan-Sep 2017 includes a one-time inventory adjustment of SEK 59 M in Q1 due to delayed release of Kineret drug substance manufactured in 2016.
Telephone conference

Financial analysts and media are invited to participate in a telephone conference, which will include a presentation of the results, today at 14:00 CET. The event will be hosted by Sobi’s CEO and President, Guido Oelkers, and the presentation will be held in English.

The presentation can be followed live, or afterwards on www.sobi.com. Slides used in the presentation will be made available on Sobi’s website prior to the telephone conference.

To participate in the telephone conference, please call:

UK: +44 203 008 9809
SE: +46 8 566 426 94
US: +1 855 831 5948

Live audience URL:
View Source

(The recording will be made available via the audience URL within three hours after the live broadcast.)

Sobi’s report for the third quarter 2017 can be found on View Source;Media/Financial-Reports/

On October 25, 2017 Baxter International Inc. (NYSE:BAX) reported results for the third quarter of 2017 and updated its financial outlook for full-year 2017.
"Baxter’s solid performance in the third quarter reflects our continued focus on disciplined execution," said José (Joe) E. Almeida, chairman and chief executive officer. "We are advancing innovation and operational excellence across the organization to deliver positive results for our stakeholders — even as we respond to extraordinary challenges like the recent natural disasters across the Americas and the Caribbean. I’m proud of how our employees continuously step up to make a difference for our patients, healthcare providers, global communities and fellow colleagues."

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 2

Third-Quarter Financial Results
In the third quarter, worldwide sales totaled $2.7 billion, an increase of 6 percent on a reported, constant currency and operational basis as compared to the prior-year period. Operational sales adjust for the impact of foreign exchange, generic competition for U.S. cyclophosphamide, the Claris Injectables (Claris) acquisition and the previously communicated select strategic product exits the company is undertaking.
Sales within the U.S. were approximately $1.1 billion, advancing 8 percent. International sales totaled approximately $1.6 billion, representing a 5 percent increase on a reported basis and a 4 percent increase on a constant currency basis. Baxter’s operational sales rose 7 percent in the U.S. and 6 percent internationally.
Global sales for Hospital Products totaled $1.7 billion in the third quarter, advancing 7 percent on both a reported basis and constant currency basis and 6 percent operationally as compared to the prior-year period. Performance in the quarter benefited from continued strength in our U.S. fluid systems business as well as favorable demand for injectable pharmaceuticals reflecting a contribution of approximately $27 million of sales from the July 27 acquisition of Claris. Sales in the quarter also benefited from increased sales of anesthesia and critical care products as well as hospital pharmacy compounding services.
Baxter’s third quarter Renal sales were approximately $1 billion, representing an increase of 3 percent on both a reported basis and constant currency basis. Operationally, Renal sales advanced 6 percent in the quarter driven by improved performance across all major product lines and therapies globally.

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 3

Baxter reported income from continuing operations of $248 million, or $0.45 per diluted share, on a GAAP (Generally Accepted Accounting Principles) basis for the third quarter. These results included special items totaling $149 million ($108 million net after-tax), primarily related to business optimization, intangible asset amortization, product-related reserves, Claris integration expenses and Puerto Rico-related expenses post Hurricane Maria.
On an adjusted basis, excluding special items, Baxter’s third quarter income from continuing operations totaled $356 million, or $0.64 per diluted share, exceeding the company’s previously issued guidance of $0.58 to $0.60 per diluted share.
Business Highlights
In support of its strategy to accelerate profitable growth and deliver meaningful innovation for patients and healthcare professionals around the world, Baxter has achieved a number of recent operational, pipeline and commercial milestones.

•
Completed the acquisition of Claris Injectables Limited, a global generic injectables pharmaceutical company. The transaction significantly broadens Baxter’s presence in the generic pharmaceuticals space. Baxter is in the process of fully integrating Claris into its systems.

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 4

•
Enrolled the first patients in two new clinical trials for a unique expanded hemodialysis (HDx) therapy enabled by THERANOVA. HDx therapy extends the range of molecules that can be cleared from the blood during hemodialysis (HD), resulting in a clearance profile that more closely mimics the natural kidney.1 The U.S. trial will support submission for marketing authorization from FDA. THERANOVA is currently available in several markets worldwide, including Colombia, where the company also launched a second multi-center, prospective trial of the technology. These efforts are part of Baxter’s growing investment in generating compelling scientific evidence supporting the approval of and access to innovative therapies.

•
Launched the first 3-in-1 set for use in continuous renal replacement therapy (CRRT) and sepsis management protocols in select markets across Europe, Middle East and Africa. With this new indication, the oXIRIS set, which is used on the company’s leading PRISMAFLEX system, can now be employed to help remove excessive levels of cytokines, endotoxin and other inflammatory mediators from a patient’s blood.

Puerto Rico Update
In follow up to the company’s Oct. 12 press release, Baxter remains in limited production across all three manufacturing sites in Puerto Rico and is continuing to work with infrastructure providers to advance reliable restoration activities for power, communications and transportation.

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BAXTER REPORTS THIRD-QUARTER 2017 RESULTS AND UPDATES FINANCIAL OUTLOOK FOR FULL-YEAR 2017 — PAGE 5

The company remains focused on helping ensure patients have continued access to the products and therapies they need. To this end, Baxter has been working with FDA and has recently been granted regulatory discretion for temporary special importation of certain products from Baxter facilities in Ireland, Australia, Canada and Mexico to help support product supply for the U.S. market. While these actions will help mitigate some of the projected shortfall in supply, they will not be adequate to fully bridge the gap in the fourth quarter.
2017 Financial Outlook
Baxter currently projects fourth quarter revenues to be negatively impacted by approximately $70 million due to the temporary manufacturing disruptions resulting from Hurricane Maria.
For full-year 2017: Baxter now expects sales growth of approximately 4 percent on a reported basis, approximately 4 percent on a constant currency basis, and approximately 4 to 5 percent operationally. Earnings from continuing operations, before special items, are now expected to be $2.40 to $2.43 per diluted share.
For the fourth quarter: The company expects sales growth of 4 to 5 percent on a reported basis, approximately 2 percent on a constant currency basis and 1 to 2 percent operationally. The company expects earnings from continuing operations, before special items, of $0.56 to $0.59 per diluted share.
Please see the schedules accompanying this press release for reconciliations between the projected 2017 operational sales and adjusted earnings per diluted share to the projected GAAP sales and earnings per diluted share.

On October 25, 2017 2X Oncology, Inc. ("2X" or the "Company"), a precision medicine company developing targeted therapeutics to address significant unmet needs in hard-to-treat cancers, reported that the Company will participate in the Life Sciences Summit 2017 on November 1-2 in New York City and the Jefferies 2017 London Healthcare Conference on November 15-16 (Press release, 2X Oncology, OCT 25, 2017, View Source [SID1234526101]).

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Chief Executive Officer George O. Elston will participate in and hold 1x1s with investors at both conferences, joined by Chief Financial Officer Jarne Elleholm.

Additionally, Mr. Elston will present in the Emerging Company Showcase at the Life Sciences Summit on Thursday, November 2, 2017 at 3:30pm EDT, with a discussion period to follow.

Investors wishing to meet with 2X Oncology at or around either conference should notify the respective conference one-on-one desk, or contact Amy Raskopf to schedule a meeting.

On October 25, 2017 Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM) ("Actinium" or "the Company"), a clinical-stage biopharmaceutical company focused on developing and commercializing targeted therapies for safer myeloablation and conditioning of the bone marrow prior to a bone marrow transplant (BMT) and for the targeting and killing of cancer cells reported that the Company has successfully activated fifteen clinical trial sites in the pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia) trial (Press release, Actinium Pharmaceuticals, OCT 25, 2017, View Source [SID1234521146]).

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The SIERRA trial is planned to enroll 150 patients with relapsed or refractory acute myeloid leukemia (AML) who are age 55 and above and will compare Iomab-B and a BMT to physician’s choice of salvage chemotherapy. The primary end point is durable complete remission (dCR) of at least 6 months. Iomab-B is intended to provide safer myeloablation of the bone marrow prior to a bone marrow transplant, thus providing a potentially curative treatment option for this patient population and for patients with other leukemias, lymphomas, myelomas and other blood disorders. The following medical institutions are clinical trial sites in the Iomab-B Phase 3 clinical trials:

Center Location
MD Anderson Cancer Center Houston, Texas
Memorial Sloan Kettering Cancer Center New York, New York
Mayo Clinic Rochester, Minnesota
Mayo Clinic Jacksonville, Florida
Washington University School of Medicine Saint Louis, Missouri
Yale Cancer Center New Haven, Connecticut
Baylor Charles A. Sammons Cancer Center Dallas, Texas
The University of Kansas Cancer Center Westwood, Kansas
Roswell Park Cancer Institute Buffalo, New York
University Hospitals Cleveland Medical Center Cleveland, Ohio
The Ohio State University Comprehensive Cancer Center Columbus, Ohio
Penn State Hershey Cancer Institute Hershey, Pennsylvania
Loyola University Medical Center Maywood, Illinois
Banner MD Anderson Cancer Center Gilbert, Arizona
Fred Hutchinson Cancer Research Center Seattle, Washington
Dr. Mark Berger, Actinium’s Chief Medical Officer said, "I am delighted to be working with these world-renowned investigators and institutions in this important SIERRA trial for Iomab-B. Their interest and enthusiasm for Iomab-B further motivates my team as we work on this trial to bring Iomab-B to patients who could benefit from safer myeloablation prior to a bone marrow transplant. In many blood cancers and disorders a bone marrow transplant is the only potentially curative treatment option for patients and it is our goal to improve outcomes for these patients with Iomab-B by getting them to their transplant faster and with less complications than currently available myeloablative regimens allow. We are looking forward to adding additional clinical trial sites located in the U.S. and Canada to make this trial available to a greater range of patients and to expedite completion of the trial."

Actinium also announced that it will provide an update on the Iomab-B SIERRA trial by year end. The SIERRA trial will have three safety analyses by an independent Data Monitoring Committee when 25%, 50% and 75% patient enrollment has been reached. Also, two ad-hoc efficacy analyses may be requested by Actinium after 70 and/or 110 patients have engrafted and given enough time to achieve the primary endpoint of durable complete remission at six months post treatment.

Sandesh Seth, Actinium’s Chairman & CEO said, "Until this trial, Iomab-B had only been studied in a single center and Actinium is proud to have facilitated use of this important therapeutic option in most of the leading transplant centers in the U.S. via the SIERRA trial. These fifteen centers perform approximately a third of all AML related bone marrow transplants. Our ability to introduce Iomab-B in these centers bodes well for enrollment in the trial and also the commercial opportunity for Iomab-B as the top fifty centers account for approximately eighty percent of bone marrow transplants. There is no visible competition for Iomab-B from any drug or drug candidate that can provide safer myeloablation and enable improved outcomes of bone marrow transplant. Actinium intends to build on the clinical experience, infrastructure and supply chain capabilities that we have established thus far to complete the trial in accordance with prior guidance and, assuming a successful outcome, establish Iomab-B as the standard of care in providing safer myeloablation first in in AML and then in the other hematologic indications in which it has shown positive results."

About Iomab-B

Iomab-B is Actinium’s lead product candidate that is currently being studied in a 150-patient, multicenter pivotal Phase 3 clinical trial in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above. Upon approval, Iomab-B is intended to prepare and condition patients for a bone marrow transplant, also referred to as a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders. Iomab-B targets cells that express CD45, a pan-leukocytic antigen widely expressed on white blood cells with the monoclonal antibody, BC8, labeled with the radioisotope, iodine-131. By carrying iodine-131 directly to the bone marrow in a targeted manner, Actinium believes Iomab-B will avoid the side effects of radiation on most healthy tissues while effectively killing the patient’s cancer and marrow cells. In a Phase 2 clinical study in 68 patients with advanced AML or high-risk myelodysplastic syndrome (MDS) age 50 and older, Iomab-B produced complete remissions in 100% of patients and patients experienced transplant engraftment at day 28. Iomab-B was developed at the Fred Hutchinson Cancer Research Center where it has been studied in almost 300 patients in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM). Iomab-B has been granted Orphan Drug Designation for relapsed or refractory AML in patients 55 and above by the U.S. Food and Drug Administration and the European Medicines Agency.