1stOncology™: Cancer Intelligence Service – Page 16743 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Allergan Accelerates Transformation to Branded Growth Pharma Leader by Divesting Global Generics Business to Teva for $40.5 Billion

On July 27, 2015 Allergan plc (NYSE: AGN) reported that it has entered into a definitive agreement under which Teva Pharmaceutical Industries Ltd. will acquire Allergan’s global generic pharmaceuticals business for $40.5 billion (Press release, Actavis, JUL 27, 2015, View Source;p=RssLanding&cat=news&id=2071091 [SID:1234506706]). Allergan will receive $33.75 billion in cash and $6.75 billion in Teva stock. In addition, Allergan retains 50 percent of Teva’s future economics from generic lenalidomide (Revlimid). The transaction has been unanimously approved by the Boards of Directors of Allergan and Teva and is strongly supported by the management teams of both companies.

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!

Logo – View Source

Under the agreement, Teva will acquire Allergan’s legacy Actavis global generics business, including the U.S. and international generic commercial units, third-party supplier Medis, global generic manufacturing operations, the global generic R&D unit, the international over-the-counter (OTC) commercial unit (excluding OTC eye care products) and some established international brands.

Allergan will retain its dynamic global branded pharmaceutical and medical aesthetic businesses, as well as its biosimilars development programs and the Anda distribution business.

"This transaction will accelerate Allergan’s evolution into a branded Growth Pharma leader, enable a sharpened focus on expanding and enhancing our global branded pharmaceutical business and strengthen our financial position to build on our proven track-record of value creation led by effective capital deployment," said Brent Saunders, CEO and President of Allergan.

"Allergan expects to have 2015 pro forma sales of approximately $15.5 billion, a simplified operating model and a strong position in seven therapeutic areas, including Eye Care, Gastroenterology (GI), Aesthetics, Women’s Health, CNS, Urology and Anti-infectives. Allergan will have a simplified manufacturing network of 12 plants globally, an industry-leading mid-to-late-stage R&D pipeline with 70 projects and a global commercial operating model engineered to drive double-digit branded product sales with compelling profit margins.

"The transaction results in after tax net cash and equity proceeds of approximately $36 billion that we intend to deploy to further accelerate the robust growth prospects of our branded business. We will have the potential to add scale in existing therapeutic areas, expand into new therapeutic areas and geographies and evaluate strategic transformational deals as we continue to build on our position as the most dynamic branded growth pharma company.

"Over the years, our global team of highly capable and dedicated employees has dramatically expanded our generics portfolio, capabilities and footprint, with over 220 ANDAs pending FDA approval with 74 confirmed First-to-File opportunities, creating one of the most dynamic generics businesses in the world today. While we were not actively seeking a buyer for our generics business, Teva presented an offer at a very compelling valuation that reflects and recognizes the significant value that our global generics team has generated in creating and managing a world-class generics business. As a result of the transaction, we will also obtain a minority equity interest in Teva, to share in the upside of the generic R&D pipeline we are transferring in this combination."

Leading Brand Pharmaceutical Portfolio Supported by a World-Class Sales and Marketing Organization

The new Allergan will maintain its exceptional global brand pharmaceutical business with leading positions in key therapeutic categories. The company has blockbuster franchises in Eye Care, CNS, Aesthetics, GI and Women’s Health including world-renowned brands such as BOTOX, RESTASIS, JUVEDERM, NAMENDA XR, LINZESS and LO LOESTRIN Fe among others.

The company’s experienced sales and marketing organization will continue to deliver exceptional product support and service to our customers.

Strong Commercial Presence across Global Markets

Allergan will continue to have significant international commercial opportunities in all priority therapy areas, including GI, Women’s Health and the legacy Allergan businesses. The company’s commercial presence will extend across the globe with a significant presence across the UK, Canada, Europe, Southeast Asia and Latin America and a growing footprint in the Nordics, Russia, Eastern Europe, China and India. Allergan also maintains exceptional global brand equity, industry-leading consumer marketing capabilities and strong consumer awareness of key Allergan products in global markets, including VISTABEL, RESTASIS, JUVEDERM, ASACOL, OZURDEX, OPTIVE and others.

Leading Growth Pharma R&D Pipeline

Allergan will maintain its strong commitment to R&D, with 2015 pro forma investment of approximately $1.4 billion, focused on the development of innovative and durable value-enhancing global products within our brands and biologics portfolios. Allergan has a strong record of successful drug development and currently has more than 70 innovative products in mid-to-late stage development. The company’s pipeline is strategically focused within its core therapeutic areas, with key candidates for global development in Eye Care, Aesthetics, CNS, GI, Anti-infectives, Women’s Health and Urology.

Allergan’s innovative development-focused R&D organization places an emphasis on the strategic, late-stage development of important durable products that will drive long-term value, and on being the partner of choice for new and existing development collaborations.

The Company is also planning to add significant depth across its pipeline this year with the pending acquisitions of:

Naurex, a clinical-stage biopharmaceutical company developing therapies utilizing a compelling new mechanism to target areas of significant unmet medical need in Major Depressive Disorder;
Merck’s small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists for Migraine, an intensely debilitating and immobilizing condition for patients worldwide;
Oculeve, which adds novel, complementary dry eye development programs to Allergan’s current eye care research and development programs; and
Kythera, which immediately enhances Allergan’s global facial aesthetics portfolio with the addition of KYBELLA (deoxycholic acid) injection, the first and only approved non-surgical treatment for contouring moderate to severe submental fullness, commonly referred to as double chin.

Financially Compelling Transaction

Allergan will receive $33.75 billion in cash and $6.75 billion in Teva stock. The number of shares received will be based on the 20-day volume weighted average price (VWAP) ending Friday, July 31, 2015 and will be subject to a 12-month lock-up. The transaction is expected to have minimal tax leakage of approximately 10 percent with anticipated net cash/equity proceeds of approximately $36 billion which can be deployed to accelerate the company’s growth prospects. Allergan expects to have double-digit topline growth, expanding operating margins and strong free cash flow. Allergan expects to use a portion of the sale proceeds to pay down debt, including certain credit facilities and bonds. The transaction is structured to maintain the existing bond issuer and guarantor structure and compliance with bond covenants. Teva will not assume any of the bonds. Allergan remains committed to its investment grade ratings.

Beginning with its third quarter earnings report, Allergan will report its generics business as discontinued operations and expects to provide an updated 2015 forecast by mid-to-late September.

Additional Details

The transaction contains customary conditions to closing, including antitrust clearance in the U.S. and the EU and certain other jurisdictions. Following an initial period of 15 business days, there will be no financing contingency related to the transaction. No shareholder vote is required at either Allergan or Teva. The transaction is expected to close in the first quarter of 2016.

J.P. Morgan is acting as sole financial advisor to Allergan and Latham & Watkins LLP is serving as Allergan’s lead legal advisor.

Varian Signs Contracts to Equip Two National Proton Therapy Centers in England

On July 27, 2015 Varian Medical Systems UK Ltd reported it had signed contracts with the National Health Service to equip and service two new national NHS proton therapy centers in England with the Varian ProBeam proton therapy system (Press release, Varian Medical Systems, JUL 27, 2015, View Source [SID:1234506705]). Earlier this year, Varian announced that it was selected as the preferred supplier for two three-room NHS centers to be constructed in London and Manchester. Varian expects to book the equipment portion of the order in its fiscal fourth quarter with the remainder of the order to be booked in accordance with the company’s policies over the term of the agreements.

The UK government is investing £250m in building and equipping the two NHS centres at UCLH (University College London Hospitals NHS Foundation Trust) in London and The Christie NHS Foundation Trust in Manchester. Varian is contracted for up to £80 million for equipment supply and service. Equipment installation is expected to take place from August 2017, with patient treatments expected to begin from 2018.

"Varian is proud to have been contracted to equip and service the national NHS proton therapy centers at UCLH and The Christie," said Dow Wilson, Varian’s chief executive officer. "ProBeam was selected after an extremely rigorous and thorough tender process that identified Varian’s technology as the most suitable for the country’s future proton therapy needs. As the leading supplier of radiotherapy equipment and software to the NHS we will be able to leverage our existing UK-based engineering and logistics infrastructure to deliver industry leading technology while meeting the NHS requirements for value for money."

"Unlike some single room facilities, the ProBeam systems here in the UK will provide a flexible solution with a total of six treatment rooms, all with a full 360 degrees of gantry rotation which means the tumor can be targeted from more directions," added David Scott, regional sales director for Varian Medical Systems. "The ProBeam system also leverages much of the technological advances already employed on the TrueBeam linear accelerator, providing high patient throughput combined with high precision image-guided treatment. The result is an easily upgradeable platform designed for long-term viability that should enable the NHS to meet capacity projections for patients that may benefit from proton therapy, without compromise, today and into the future."

Proton therapy makes it possible to treat certain types of cancer more precisely and with potentially fewer side effects than is possible with conventional radiation therapy. With proton therapy, the risk of damage to healthy tissues and potential side effects are reduced because proton beams can be controlled so that they deposit their energy within the tumor site rather than passing all the way through the patient. In pediatric patients the risk of developing a new, radiation-induced cancer later in life may be reduced.

Varian’s ProBeam system with Dynamic Peak Scanning is uniquely capable of high-speed intensity modulated proton therapy (IMPT) which is the most precise form of proton therapy available. ProBeam technology is being used to treat patients at the Scripps Proton Therapy Center in San Diego, the Rinecker Proton Therapy Center in Munich, and the Paul Scherrer Institute in Switzerland. Varian also has contracts for system installations at 10 other sites around the world.

"In the 18 months since the first ProBeam room at Scripps was commissioned, we have completed three new software releases that were designed to increase the efficiency of operations while enhancing functionality and patient comfort," said Moataz Karmalawy, general manager of Varian’s particle therapy business. "And we’ve been able to make the upgrades to the system without causing downtime or negatively impacting clinical operations. Varian’s commitment to ongoing partnership with customers and continual improvement of the systems we provide, are, I believe, major factors in our having been selected to equip the national NHS centers in the UK."

In keeping with historical practice, Varian will not recognize revenues for the two UK projects until commencement of production of the systems. Revenues for Varian Particle Therapy are recognized based on the percentage of completion of the manufacture, installation and commissioning of the systems.

Celator® Pharmaceuticals to Present on Fixed-Ratio Nanomedicines at the 2015 Controlled Release Society Annual Meeting

On July 27, 2015 Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, reported that Dr. Lawrence Mayer, Founder, President and Chief Scientific Officer, will chair and present at a mini-symposia today, July 27, 2015, at 10:00am ET, at the 42nd Annual Meeting and Exposition of the Controlled Release Society (Press release, Celator Pharmaceuticals, JUL 27, 2015, View Source [SID:1234506704]).

The mini-symposia will discuss Therapeutic Cancer Nanomedicines and Dr. Mayer’s presentation is titled, "Development of Fixed-Ratio Anticancer Drug Combination Nanomedicines That Markedly Improve Efficacy and Survival Outcomes."

Teva Reports Preliminary Second Quarter 2015 Results

On July 27, 2015 Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) reported preliminary financial results for the second quarter of 2015:
Revenues of approximately $4.97 billion, down 2% compared to the second quarter of 2014 (Press release, Teva, JUL 27, 2015, View Source;p=RssLanding&cat=news&id=2071092 [SID:1234506703]). Excluding the impact of foreign exchange fluctuations and the sale of U.S. OTC plants in July 2014, revenues increased 6% compared to the second quarter of 2014.

Non-GAAP diluted earnings per share (EPS) of $1.43 in the second quarter of 2015, up 15% compared to the second quarter of 2014.

Non-GAAP operating income of $1.6 billion, an increase of 16% compared to the second quarter of 2014.

Cash flow from operations of $1.5 billion, an increase of 41% compared to the second quarter of 2014.

Free cash flow of $1.3 billion, up 51% compared to the second quarter of 2014.

Erez Vigodman, President and CEO of Teva, said, "Our preliminary results for the second quarter further demonstrate Teva’s continuous momentum and significantly strengthened fundamentals, improved generics and specialty businesses and ability to drive organic growth. We are confident that our key franchises, along with our transformational acquisition of Allergan Generics, will enable Teva to reinforce our already strong position and continue to generate stockholder value."

Full Year 2015 EPS Guidance
Teva is raising its EPS guidance for the full year 2015, reflecting the positive momentum across the business. For the full year 2015, the Company now expects EPS to be in the range of $5.15 to $5.40, as compared to the previously provided EPS range of $5.05 to $5.35.

Teva Second Quarter 2015 Earnings Conference Call

Teva will report full second quarter 2015 financial results on Thursday, July 30, 2015. The Company will discuss its results on its quarterly earnings conference call and live webcast on the same day, at 8:00 a.m. ET.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-966-9439; Canada 1-866-966-0399 International +44(0) 1452 555566; passcode: 76780072. For a list of other international toll-free numbers, click here.

A live webcast of the call will also be available on Teva’s website at: www.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until August 30, 2015, 10:00 a.m. ET by calling United States 1-866-247-4222; Canada 1-866-878-9237 or International +44(0) 1452550000; passcode: 76780072.

University of Colorado Cancer Center and Loxo Oncology Announce Publication That Provides Clinical Validation For LOXO-101 Against TRK Fusion Cancer

On July 27, 2015 The University of Colorado Cancer Center and Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, reported the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development (Press release, Loxo Oncology, JUL 27, 2015, View Source [SID:1234506711]).

Additional contributors to the paper include the Knight Cancer Institute at Oregon Health & Science University and Foundation Medicine, Inc. (Nasdaq:FMI).

The peer-reviewed research brief describes a female patient with advanced soft tissue sarcoma widely metastatic to the lungs. The patient’s physician submitted a tumor specimen to Foundation Medicine for comprehensive genomic profiling with FoundationOne Heme, where her cancer was demonstrated to harbor a TRK gene fusion. Following multiple unsuccessful courses of treatment, the patient was referred to the University of Colorado for enrollment in the Phase 1 trial of LOXO-101 in March 2015. On study, the patient’s shortness of breath rapidly resolved and she was able to discontinue her supplemental oxygen and resume activities of daily living. Imaging studies following one month of treatment, the first imaging studies conducted post-treatment, confirmed that her tumors had substantially regressed, meeting a partial response (PR) definition by standard RECIST 1.1 criteria. As discussed in the publication, with four months of treatment, additional CT scans demonstrated almost complete tumor disappearance of the largest tumors. After four months of dosing, the patient did not have any adverse events that were attributed to LOXO-101.

"It is exciting to think that TRK fusions may join a relatively short, but growing, list of actionable oncogenic drivers found across human cancer," said lead author Robert C. Doebele, M.D., Ph.D., LOXO-101 clinical investigator, and University of Colorado Cancer Center member. "To see a rapid and unequivocal response in the first TRK fusion patient treated with LOXO-101 provides early but encouraging validation of this target. Of course, it will be important to see repeatable and durable results as more patients with TRK fusions are treated over time. This case study also illustrates the clinical value of multiplex genetic testing in patients with advanced cancer. Broad testing for all known actionable molecular alterations gives patients the best opportunity to find commercially available or investigational targeted therapies that have been rationally designed to treat their cancers."

The publication also describes novel assays for assessing LOXO-101’s impact on TRK signaling, patient-derived TRK fusion models in vitro and in vivo which illustrate LOXO-101’s TRK inhibition, and the first-ever description of the molecular epidemiology of TRK fusions in soft tissue sarcoma.

LOXO-101, built specifically to inhibit TRK, is currently being studied in a Phase 1 trial of patients with advanced solid tumors. The trial continues to enroll patients at escalating oral doses of fixed once-daily and twice-daily regimens. As reported at the 2015 American Association for Cancer Research (AACR) (Free AACR Whitepaper) meeting, LOXO-101 has been well tolerated with no drug-related adverse event signals reported at doses that consistently achieve systemic drug exposures anticipated to inhibit TRK signaling by over 90%. For more information on the Phase 1 trial, including study sites and eligibility criteria, visit clinicaltrials.gov (study identifier NCT02122913), or contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123. Loxo Oncology’s Policy for Access to Investigational Agents can be found on the Loxo Oncology web site.

"TRK is increasingly recognized for its role in cancer biology, and this first peer-reviewed clinical validation is an important step forward," said Jennifer Low, M.D., Ph.D., chief medical officer of Loxo Oncology. "We continue to be encouraged by the safety and pharmacokinetics we have seen so far in the LOXO-101 Phase 1 trial, and we look forward to sharing more information about our clinical program later this year."

"Our goal is to better understand the genetic drivers of sarcoma to improve treatment options for patients," said Lara E. Davis, M.D., a medical oncologist and sarcoma specialist with the OHSU Knight Cancer Institute. "These early results validate that further study of TRK in the complex field of sarcoma is warranted."

The research presented in the publication is funded by a V Foundation Scholar Award and a Loxo Oncology research grant awarded to Dr. Robert C. Doebele. Also, the State of Colorado and University of Colorado Technology Transfer Office Bioscience Discovery Evaluation Grant Program, the University of Colorado Lung Cancer SPORE (funded by the National Cancer Institute (NCI) of the National Institutes of Health (NIH) grant P50CA058187 provided funding to Dr. Doebele and the NIH/NCI CCSG P30CA046934 (Molecular Pathology Shared Resource) provided funding to Drs. Varella-Garcia and Aisner.

About LOXO-101

LOXO-101 is a potent, oral, selective inhibitor of tropomyosin receptor kinase (TRK) signaling molecules. The TRK family (TRKA, TRKB, and TRKC) has been implicated in diverse tumor types such as lung cancer, head and neck cancer, melanoma, colorectal cancer, sarcoma, and breast cancer. LOXO-101 was built specifically to inhibit TRK and is currently the only selective TRK inhibitor in clinical development. LOXO-101 is currently being evaluated in a Phase 1 dose escalation trial for patients with advanced solid tumors.