1stOncology™: Cancer Intelligence Service – Page 14376 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Acorda Provides 2018 Highlights and 2019 Guidance at J.P. Morgan Healthcare Conference

On January 7, 2019 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported 2018 highlights, 2019 guidance and commercialization plans for INBRIJA at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco (Press release, Acorda Therapeutics, JAN 7, 2019, View Source [SID1234532551]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"The approval of INBRIJA is a major milestone for Acorda. We are eager to bring this much-needed therapy to the Parkinson’s community," said Ron Cohen, M.D., Acorda’s President and CEO. "Acorda has one of the pre-eminent specialty neurology sales forces in the industry. Our team will immediately begin visiting key movement disorder centers to begin demonstrations and training on the appropriate use of INBRIJA. We expect INBRIJA to be available in the first quarter of 2019."

Burkhard Blank, M.D., Acorda’s Chief Medical Officer, added, "INBRIJA represents the first FDA approval of a treatment using the ARCUS technology, a platform that allows delivery of relatively large doses of medication through inhalation. ARCUS has the potential to be used in the development of a variety of inhaled medicines. In 2019, we will continue our development of an ARCUS-based treatment for migraine."

2018 Financials

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg unaudited net sales for 2018 are expected to be greater than $430 million, subject to change based on discounts and allowances recorded in the fourth quarter of 2018.
The Company is reiterating its 2018 non-GAAP operating expense guidance of R&D $100-$110 million and SG&A $170-$180 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
2018 year-end cash and cash equivalents were approximately $445 million (unaudited).
Final results are subject to completion of the Company’s year-end audit.
2019 Guidance

During INBRIJA’s 2019 launch year, the Company expects to assess key metrics such as total and new prescriptions, unique prescribers, and managed care access, and does not expect to provide INBRIJA revenue projections.
The Company will no longer provide revenue guidance for AMPYRA, due to the unpredictable trajectory of revenue decline given the entrance of generics.
R&D expenses for the full year 2019 are expected to be $70-$80 million and SG&A expenses for the full year 2019 are expected to be $200-$210 million. This guidance is a non-GAAP projection that excludes share-based compensation as more fully described below under "Non-GAAP Financial Measures."
Presentation/Webcast Details

Dr. Cohen will provide a corporate overview at the 37th Annual J.P. Morgan Healthcare Conference on Wednesday, January 9 at 8:00 a.m. Pacific/11:00 a.m. Eastern. The presentation is available via webcast at View Source or at www.acorda.com.

Non-GAAP Financial Measures

This press release includes financial measures that were not prepared in accordance with accounting principles generally accepted in the United States (GAAP). In particular, Acorda has provided 2018 and 2019 expense guidance for R&D and SG&A on a non-GAAP basis. Reconciliations of these measures to the most directly comparable GAAP financial measures are not available at this time because our analysis of 2018 financial performance (including share-based compensation expense) is ongoing, and because the 2019 financial measures are forward looking in nature and the amount of compensation charges and benefits needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes the presentation of these non-GAAP financial measures, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because they exclude non-cash charges that are substantially dependent on changes in the market price of our common stock. The Company believes these non-GAAP financial measures help indicate underlying trends in the Company’s business and are important in comparing current results with prior period results and understanding expected operating performance. Also, management uses these non-GAAP financial measures to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance

CytomX Therapeutics Announces Technology Acquisition From Agensys, Inc., an Affiliate of Astellas Pharma Inc.

On January 7, 2019 CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody therapeutic technology platform, reported it has acquired drug conjugate linker-toxin and CD3-based bispecific technologies from Agensys, Inc., an affiliate of Astellas Pharma Inc. Under the terms of the agreement, CytomX will pay Astellas a one-time, up-front payment (Press release, CytomX Therapeutics, JAN 7, 2019, View Source [SID1234532550]).

"The clinical progress we reported throughout 2018 provided initial proof of concept for our Probody therapeutic platform. This transaction with Astellas provides us with novel payloads and CD3 binding moieties for our next wave of potent anti-cancer agents that leverage our technology, including Probody drug conjugates and Probody T cell engaging bispecifics," said W. Michael Kavanaugh, M.D. chief scientific officer and head of research and non-clinical development at CytomX.

Upcoming investor conferences

On January 7, 2019 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that it will be present at the following investor events in the first quarter 2019 (Press release, Innate Pharma, JAN 7, 2019, View Source [SID1234532549]):

– LifeSci Advisors 1×1 Meetings surrounding the J.P. Morgan Annual Healthcare Conference– San Francisco, January 7-10, 2019

– Oddo BHF Forum – Lyon, January 10-11, 2019

– Degroof Petercam’s Healthcare Seminar – Brussels, January 31, 2019

– Leerink Partners Annual Global Healthcare Conference – NYC, February 27 – March 1, 2019

– Credit Suisse Global Healthcare Conference – London, March 5-6, 2019

– Oppenheimer Annual Healthcare Conference – NYC, March 19-20, 2019

Innate Pharma is committed to meet on a regular basis with the financial community. All corporate information on the Company, such as its financial statements or its corporate presentations, is available on the Company’s websitein the Investors’ section (www.innate-pharma.com/en/investors).

Takeda Completes Acquisition of Shire, Becoming a Global, Values-Based, R&D-Driven Biopharmaceutical Leader

On January 7, 2019 Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) ("Takeda") reported the completion of its acquisition of Shire plc ("Shire"), becoming a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan (Press release, Takeda, JAN 7, 2019, View Source [SID1234532548]).

Takeda now has an attractive, expanded geographic footprint and leading position in Japan and the U.S., bringing its highly-innovative medicines to approximately 80 countries/regions with dedicated employees worldwide. Takeda’s R&D efforts are focused on its four therapeutic areas of Oncology, Gastroenterology (GI), Neuroscience and Rare Diseases, with targeted R&D investment also committed to Plasma-Derived Therapies (PDT) and Vaccines. Takeda’s strengthened, highly innovative R&D engine enables the company to have a more global, robust and modality-diverse pipeline as well as to focus on breakthrough innovation. The combined annual revenue of the company, exceeding $30 billion USD, is mainly derived from the key business areas of Oncology, GI, Neuroscience, Rare Diseases and PDT.

"We are delighted that the acquisition was approved by an overwhelming majority of our shareholders at Takeda’s extraordinary general meeting on December 5th, 2018. We are also pleased to have completed the acquisition several months earlier than expected, which was enabled through the hard work of our respective organizations and the smooth receipt of regulatory clearances," said Christophe Weber, President and Chief Executive Officer of Takeda. "We appreciate the support of our employees, partners and shareholders throughout the process. This marks a significant moment in Takeda’s history and is an exciting step forward as we accelerate our transformation journey to deliver highly-innovative medicines to patients around the world with expanded scale and geographical footprint."

Weber continued, "The execution of our integration begins today, and we are confident in our ability to execute a smooth integration under the leadership of our experienced and diverse Takeda Executive Team with a strong track record. The Operating Model we established in September last year has set a clear framework for our integration plans, and we have a highly skilled and dedicated integration team leading the process."

In order to fund the acquisition, Takeda has secured permanent financing with highly competitive rates, resulting in an overall blended interest rate for Takeda’s total debt of approximately 2.3%. The company is confident that it will retain its investment grade credit rating and return to a net debt to EBITDA ratio of 2.0x or less within three to five years following completion.

Weber will present at the J.P. Morgan Healthcare Conference at 3:30 p.m. PST on January 8, 2019.

Forbius Announces the First Patient Dosed in a Phase 1 Oncology Trial of AVID200, a Novel TGF-beta 1 & 3 Inhibitor

On January 7, 2019 Forbius, a clinical-stage company developing biologics for the treatment of cancer and fibrosis, reported that the first patient was dosed in a Phase 1 clinical trial with AVID200 (Press release, Forbius, JAN 7, 2019, View Source [SID1234532547]). The trial will evaluate safety, pharmacokinetics, pharmacodynamics, and antitumor effects of escalating doses of AVID200 in patients with solid tumors.

"Our goal is to significantly expand the number of cancer patients who benefit from checkpoint blockade and other immunotherapies. AVID200 was designed to have the potency and isoform selectivity to effectively counteract the highly immunosuppressive effects of TGF-beta in the tumor microenvironment and reverse resistance to immunotherapy," commented Dr. Maureen O’Connor-McCourt, CSO of Forbius.

AVID200 selectively neutralizes TGF-beta 1 & 3 with best-in-class pM potency, thus neutralizing the principal immunosuppressive TGF-beta isoforms. AVID200’s optimal selectivity was also designed to circumvent cardiac and other safety issues that have limited the applicability of older-generation, non-selective TGF-beta inhibitors.

TGF-beta 1 & 3 are the main oncogenic TGF-beta isoforms expressed by many solid tumors. They are believed to play a major role in T-cell suppression, fibrosis, and resistance to immunotherapeutics such as nivolumab (Opdivo) and pembrolizumab (Keytruda) (Chakravarthy et al., Nature Comm., 2018; Tauriello et al., Nature, 2018; Mariathasan et al., Nature, 2018).

AVID200’s immuno-oncology mode of action focuses on the reversal of both immunosuppression and fibrosis in the tumor stroma. In syngeneic mouse tumor models, AVID200 treatment led to T-cell activation, increased immune cell infiltration, and increased efficacy of immune checkpoint agents.