(Filing, 10-Q, Celgene, JUL 28, 2015, View Source [SID:1234506730])

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On July 28, 2015 Purdue Research Foundation reported that Federal funding will help further develop technology discovered at Purdue University and licensed by a life sciences startup that could help cancer researchers with improved target detection and the discovery of novel pharmaceuticals (Press release, Purdue Research Foundation, JUL 28, 2015, View Source [SID:1234506728]).

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Tymora Analytical Operations has received a two-year SBIR Phase II grant of $900,000 from the National Cancer Institute to further develop its pIMAGO technology. The National Cancer Institute is part of the National Institutes of Health.

Anton Iliuk, chief technology officer, said the pIMAGO technology allows for a better understanding of what type of cancer a patient has and which therapy could be the most effective in treating the cancer.

"In a typical screening, gene mutations are regarded as the primary indications of what type of cancer an individual has. The problem is that there are often hundreds or thousands of mutations present, most of which do not progress to cancer," he said. "pIMAGO analyzes the outcomes of these mutations, which is protein phosphorylation, or the addition of a phosphate group to a protein. Examining this change on different cancer targets can often pinpoint the molecular fingerprint of the cancer, which could be used to select therapy in a more personalized manner."

The National Cancer Institute funding will develop the technology’s ability to look at a more comprehensive signaling network, rather than only one or a few proteins.

"We can examine what other pathways are active and try to target those," he said. "This could be particularly useful to check how well a drug is working, such as in cancer resistance, and to pinpoint the primary reasons for relapse and make new therapy decisions."

The pIMAGO product line has been developed through funding of other SBIR grants from the National Institutes of Health and the National Science Foundation.

Tymora Analytical Operations licenses intellectual property discovered by W. Andy Tao through the Purdue Research Foundation Office of Technology Commercialization. Tao is the company’s chief scientific officer and a professor of biochemistry at Purdue University. The company is based at Purdue Research Park of West Lafayette.

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]).

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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."

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.

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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.

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.

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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.