1stOncology™: Cancer Intelligence Service – Page 16077 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Hospira, JUL 29, 2015, View Source [SID:1234506736])

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Galena Biopharma Launches Zuplenz® (ondansetron) Oral Soluble Film

On July 29. 2015 Galena Biopharma reported the product launch for Zuplenz(R) (ondansetron) Oral Soluble Film in the United States (Press release, MonoSol Rx, JUL 29, 2015, View Source [SID:1234508917]).

Zuplenz is now available nationwide and is supplied in both 4 mg and 8 mg strengths. Zuplenz is clinically bioequivalent to ondansetron orally disintegrating tablets (ODT) with a safety profile equivalent to ondansetron. The novel, PharmFilm(R) oral soluble film technology utilized by Zuplenz provides for convenient delivery and several key patient benefits including:

Rapidly dissolves in the mouth in about 10 seconds
Eliminates the burden of swallowing pills during emesis and in cases of oral irritation
Does not require water to administer
Pleasant peppermint flavor with no gritty aftertaste
Non-sedating

"Ondansetron is the gold-standard treatment option for patients suffering from nausea and vomiting due to chemotherapy, radiation treatments, and surgical procedures; and, we believe the unique and innovative product attributes of Zuplenz will be a valuable treatment option for patients and physicians to relieve these debilitating side-effects," said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. "With the launch of Zuplenz, we will leverage our existing commercial infrastructure including our outsourced Galena Patient Services (GPS) program to work directly with the patient, prescriber, insurance provider, and pharmacy to help guide the process of getting the patient their medication once prescribed by the physician."

Zuplenz is approved in adult patients for the prevention of highly and moderately emetogenic chemotherapy-induced nausea and vomiting (CINV), radiotherapy-induced nausea and vomiting (RINV), and post-operative nausea and vomiting (PONV). Zuplenz is also approved for moderately emetogenic CINV in pediatric patients four years and older.

The active pharmaceutical ingredient in Zuplenz, ondansetron, is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery. The National Comprehensive Cancer Network (NCCN) 2014 guidelines recommend the use of ondansetron in patients with highly and moderately emetogenic cancer chemotherapy-induced and radiotherapy-induced nausea and vomiting. Ondansetron belongs to a class of medications called serotonin 5-HT3 receptor antagonists and works by blocking the action of serotonin, a natural substance that may cause nausea and vomiting. According to data from both IMS and Wolters Kluwer, the branded 5-HT3 market exceeded $1 billion in the U.S. in 2014. The product was licensed from MonoSol Rx, LLC, the developer of the oral soluble film technology, PharmFilm(R), and manufacturer of the product.

Hanmi pharmaceutical enters in to exclusive license agreement with Boehringer Ingelheim to develop 3rd generation EGFR targeted therapy in lung cancer

On July 29, 2015 Hanmi Pharmaceutical Co. Ltd and Boehringer Ingelheim reported an exclusive license and collaboration agreement for the development and commercialisation rights, except South Korea, China and Hong Kong, of HM61713, a novel 3rd generation EGFR targeted therapy for the treatment of a specific type of lung cancer (Press release, Hanmi, JUL 29, 2015, View Source;hanmiEnglishNewsDtlSeq=123 [SID:1234508098]). Under the terms of the agreement Hanmi will receive an initial payment of USD50 million and is entitled to potential milestone payments of more than USD700 (600) million plus tiered double-digit royalties on future net sales. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, similar requirements outside the U.S., and other customary closing conditions.

Jee Woong Son, Vice president, of Hanmi Pharmaceutical said, "We are excited at the potential this license agreement with Boehringer Ingelheim will bring to the successful development of HM61713 and the possibilities this will offer to lung cancer patients. Boehringer Ingelheim has significant expertise in the field of lung cancer, specifically with EGFR mutations, and with a strong pipeline which demonstrates long-term commitment to the successful development of lung cancer treatments, we are confident we have found the right partner to make the potential of HM61713 a reality."

HM61713 is a novel 3rd generation, orally active, irreversible EGFR mutation selective tyrosine kinase inhibitor (TKI). Currently in Phase II clinical development for patients with T790M mutation-positive non-small cell lung cancer (NSCLC) who have developed resistance to previous EGFR targeting agents. The interim results of the Phase I/II clinical trial presented at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting showed strong efficacy signals, combined with a favourable safety profile, leading to the preparation of a Phase III trial programme to be initiated in 2016.

Dr Jörg Barth, Corporate Senior Vice President, Therapy Area Head Oncology, Boehringer Ingelheim said, "This exclusive license agreement with Hanmi Pharmaceutical is a significant step towards our vision of providing a wide-range of lung cancer treatments to patients in an area of significant unmet medical need. The in-licensing of a 3rd generation EGFR agent bolsters our existing lung cancer portfolio and reiterates our commitment towards innovation and tailored treatment options for patients."

Varian Medical Systems Acquiring Claymount to Expand Imaging Components Portfolio

On July 29, 2015 Varian Medical Systems, Inc., (NYSE:VAR) reported it has, through one of its European subsidiaries, agreed to acquire Claymount, a privately-held, Netherlands-based supplier of components and subsystems for X-ray imaging equipment manufacturers (Press release, Varian Medical Systems, JUL 29, 2015, View Source [SID:1234506750]). Varian’s subsidiary in the Netherlands will pay approximately €50 million in cash for Claymount. The transaction is expected to close early in August.

Claymount is one of the world’s leading suppliers of high voltage connectors, ionization chambers and solid state automatic exposure control systems for controlling dose during medical X-ray imaging. It also supplies buckies for digital radiography equipment, mammography paddles, X-ray collimators, and high-voltage generators for powering radiography equipment. Claymount is a strategic supplier to many global medical X-ray equipment manufacturers and has annual revenues of nearly €30 million.

"Claymount’s products complement our offerings and are a perfect fit for our Imaging Components business with great customer and channel synergies," said Varian CEO Dow Wilson. "This acquisition will enhance our ability to support a continuing industry-wide transition from analog to digital X-ray imaging. We are excited to expand our line of components and integrated subsystems that can help X-ray OEMs get their products to market faster and more cost efficiently. This acquisition has the added benefit of being able to provide lower cost components for our Oncology Systems and Particle Therapy businesses."

"We are impressed with the Claymount team," said Sunny Sanyal, president of Imaging Components for Varian. "Claymount extends our technical expertise while giving us additional cost-efficient manufacturing capabilities. Together, we will expand our addressable market with new integrated offerings that should help us grow our share of the global imaging components market. We are excited to have them as a part of our team."

"There is a great strategic fit between both companies," said Joel Nijenhuis, managing director of Claymount. "We market a complementary product portfolio and can benefit from each other’s knowledge and strengths. With a strong team on board and support from Varian, we can accelerate product development and expand our business. We look forward to this opportunity."

Claymount has about 250 employees with manufacturing sites in the Netherlands, Philippines and the United States as well as offices in Switzerland, Italy and China. The Claymount team will operate under Nijenhuis who will report to Sanyal as part of Varian Imaging Components.

Varian Medical Systems Reports Results for Third Quarter of Fiscal Year 2015

On July 29, 2015 Varian Medical Systems (NYSE: VAR) today is reporting net earnings of $1.13 per diluted share in the third quarter of fiscal year 2015 (Press release, Varian Medical Systems, JUL 29, 2015, View Source [SID:1234506749]). Third quarter net earnings per diluted share rose 11 percent versus the year-ago period when the company recorded a $0.06 per diluted share charge related to the impairment of a portion of the company’s investment in Augmenix. Varian’s company-wide revenues totaled $784 million for the third quarter, up 5 percent from the year-ago quarter and up 11 percent in constant currency. The company ended the third quarter with a $3.1 billion backlog, up 9 percent from the end of the third quarter of fiscal year 2014.

"The third quarter was mixed for Varian with double-digit constant currency gross orders growth in Oncology Systems, significant challenges in Imaging Components, and strong performance in Particle Therapy," said Dow R. Wilson, CEO of Varian Medical Systems. "The stronger U.S. dollar continued to have a big impact on our performance, contributing to lower margins. Excellent cost controls enabled us to deliver solid earnings for the period."

The company finished the third quarter of fiscal year 2015 with $951 million in cash and cash equivalents and $494 million of debt. Cash flow from operations for the third quarter was $184 million. During the quarter, the company spent $92 million to repurchase about 1 million shares of common stock.

Oncology Systems

Oncology Systems’ third quarter revenues totaled $559 million, down 3 percent from the same quarter of fiscal year 2014, but up mid-single digits on a constant currency basis. Third-quarter Oncology gross orders were $635 million, up 2 percent versus the year-ago quarter and up 10 percent in constant currency. Oncology gross orders rose 4 percent in the Americas in both U.S. dollars and constant currency. EMEA gross orders were down 2 percent, but up 13 percent in constant currency. APAC gross orders rose 8 percent and were up 21 percent in constant currency.

"Continued global demand for versatile, reliable, efficient accelerators and integrated software systems gave Varian a competitive advantage and drove solid growth in the quarter," said Wilson. "We were selected to replace several older machines and software systems from competitors as customers moved to modernize their treatment capabilities."

Imaging Components

Third quarter revenues for Imaging Components were $135 million, down 17 percent from the year-ago quarter while third quarter gross orders decreased by 25 percent to $122 million.

"Continued weak demand for security and inspection products as well as pricing pressure and product mix in flat panels were the prime factors in a challenging quarter for Imaging Components," said Wilson. "The global market for high energy border protection systems appears to have slowed significantly. Imaging product customers are actively looking for lower pricing and alternatives to dollar-based products."

Today, the company announced that it is acquiring Claymount, a Netherlands-based supplier of X-ray imaging components, for approximately €50 million (see separate press release).

Other

The company’s Other category, including the Varian Particle Therapy business and the Ginzton Technology Center, recorded revenues of $91 million and gross orders of $131 million. During the quarter, we announced that we booked orders for installations at the University of Maryland and at the HollandPTC in the Netherlands. The company recognized a substantial amount of revenues from the Maryland installation as well as revenues from several other proton projects that made the particle therapy business profitable in the quarter.

"We have generated real momentum in particle therapy," said Wilson. "We booked two orders during the third quarter and subsequently booked additional orders for three proton systems in the UK and in New York. We now have 11 systems in backlog."

Outlook

"We expect that revenues for the full fiscal year will increase by about 2 percent in dollars and by about 6 percent in constant currency," said Wilson. "We ended the second quarter with earnings guidance for fiscal 2015 in the range of $4.02 to $4.14 per diluted share. As of the end of the third quarter, with the approximately $0.22 per diluted share for the booking of the Maryland proton therapy system partially offset by ongoing challenges in our Imaging Components business, we now believe that our earnings for fiscal 2015 could be in the range of $4.20 to $4.25 per diluted share."

Given recent acquisitions, including Claymount, as well as historical one-time activities that make quarter-over-quarter comparisons difficult, the company will show non-GAAP results starting in its fiscal fourth quarter. Non-GAAP earnings for fiscal year 2015 should be higher than the GAAP range by approximately $0.16 per diluted share, comprised of restructuring charges in the first half of fiscal year 2015, acquisition related costs, and amortization of acquisition related intangibles.