ORLANDO, Fla., May 18, 2013 /PRNewswire/ — Although colonoscopy exams prevent many colon cancer deaths¹ and are considered the most sensitive method for detecting colorectal cancers², the procedure is not completely effective in preventing cancer cases³. EndoChoice Inc. today unveiled research that shows that its new Fuse™ system significantly improves the accuracy of this procedure and greatly reduces the number of adenomas missed by colonoscopists. EndoChoice will be discussing these clinical trial results and featuring the Fuse system that recently received FDA 510(k) clearance at Digestive Disease Week (DDW) May 18-21 in Orlando.

EndoChoice’s Fuse system is a proprietary arrangement of three small cameras at the tip of a flexible GI endoscope. By using three cameras, the Fuse system allows doctors to see nearly twice as much surface area as they can with traditional endoscopes that only use one camera. Because of the folds that occur naturally in the colon and stomach anatomy, problem areas can easily go undetected when using traditional endoscopes. The Fuse system allows GI doctors to see into and behind those folds.

In a multi-center trial conducted in the U.S., Europe and Israel, Prof. Ian Gralnek and a team of researchers performed a series of colonoscopies comparing traditional endoscopes and the new Fuse system. The endoscope used in the first examination was selected randomly. After the first inspection, each patient immediately underwent a second colonoscopy performed by the same doctor, but with the competing endoscope. The 185 patient trial showed traditional colonoscopes missed 42% of adenomas, while the Fuse system missed just 8%. After 28 adenomas were found using traditional endoscopes another 20 were found by Fuse for an incremental find rate of 71%.

“Traditional endoscopes provide up to 170 degrees of forward vision. The advantage of Fuse is that it allows endoscopists to examine twice the anatomy with a wide 330 degree view,” said Ian Gralnek, MD, MSHS, FASGE, Rappaport Faculty of Medicine, Technion-Israel Institute of Technology and Department of Gastroenterology, Rambam Health Care Campus. “Our findings are compelling and support the data from previous studies showing the limitations of traditional endoscopes. EndoChoice’s innovative Fuse technology dramatically improves the effectiveness of this life-saving procedure.”

At the same meeting, EndoChoice announced the FDA had cleared its 510(k) submission for the Fuse system. EndoChoice plans to expand the use of their Fuse system beyond the current pilot sites to more centers around the world this year.

“Since we announced the expansion of our company in January, our teams in Israel, Germany and the U.S. have been working diligently to develop and launch the revolutionary Fuse endoscopy system. This FDA milestone brings us yet another step closer to our mission of serving the GI professionals so they can give the best possible care to their patients,” said Mark Gilreath, Founder and CEO “EndoChoice”.

About DDW

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

About EndoChoice
Based in Atlanta, EndoChoice is a platform-technology company that provides devices, diagnostics, infection control and imaging for specialists treating a wide range of gastrointestinal diseases. EndoChoice currently has over 2,000 customers and distribution in 34 countries worldwide, and has been recognized for three consecutive years as one of the fastest growing companies in the U.S. by Inc. Magazine. To learn more, visit www.endochoice.com.

“EndoChoice” and “Fuse” are trademarks of EndoChoice, Inc.

For more information on “Fuse”
www.endochoice.com/fuse

SOURCE EndoChoice

SYDNEY and BEDMINSTER, N.J., May 17, 2013 /PRNewswire/ — QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today the US Food and Drug Administration (FDA) has set 17 July 2013 as the date of the Advisory Committee meeting to consider the Company’s resubmitted MOXDUO New Drug Application (NDA).

“The timing is within the expected date range of late June to late July,” said Dr. John Holaday, Managing Director and Chief Executive Officer, QRxPharma. “Formal notification of the Advisory Committee date finalises the sequence of events which lead to the previously announced PDUFA date of 26 August 2013,” added Holaday.

The Advisory Committee is open to the public and will be held from 8.00am to 5.00pm at the FDA White Oak Campus, in Building 31, the “Great Room” (Rm. 1503), White Oak Conference Center, 10903 New Hampshire Avenue, Silver Spring, Maryland. The meeting will also be streamed live through a webcast details of which will be provided by the FDA in advance of the meeting.

Additional information can be found on the FDA’s web site at http://www.fda.gov/AdvisoryCommittees/default.htm or by calling the FDA Advisory Committee Information Line, +1 800 741 8138 (301 443 0572 in the Washington, DC area).

The NDA is the basis for recommencing the MOXDUO approval process for the treatment of moderate to severe acute pain, a $2.5 billion segment of the $8 billion spent annually on prescription opioids in the US. MOXDUO, an immediate release Dual Opioid pain therapy, is a patented 3:2 fixed ratio combination of morphine and oxycodone.

About QRxPharma
QRxPharma Limited is an Australian based, commercial-stage specialty pharmaceutical company focused on the development and commercialisation of new treatments for pain management. The Company’s product portfolio includes both late and early stage clinical drug candidates with the potential for reduced risk, abbreviated development paths, and improved patient outcomes. The Company’s lead product candidate, immediate release MOXDUO for the treatment of acute pain, is presently under review at the US Food and Drug Administration. QRxPharma entered into strategic collaborations with Actavis Inc. in December 2011 and Paladin Labs Inc. in October 2012 for the commercialisation of immediate release MOXDUO in the US and Canadian acute pain markets respectively. Additionally, the Company’s clinical pipeline includes an intravenous (IV) and continuous release (CR) formulation of MOXDUO. For more information, visit www.qrxpharma.com.

Forward Looking Statements
This release contains forward-looking statements. Forward-looking statements are statements that are not historical facts; they include statements about our beliefs and expectations. Any statement in this release that states our intentions, beliefs, expectations or predictions (and the assumptions underlying them) is a forward-looking statement. These statements are based on plans, estimates and projections as they are currently available to the management of QRxPharma. Forward-looking statements therefore speak only as of the date they are made, and we undertake no obligation to update publicly any of them in light of new information or future events. By their very nature, forward-looking statements involve risks and uncertainties. A number of important factors could therefore cause actual results to differ materially from those contained in any forward-looking statement. Such factors include risks relating to the stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialisation of the Company’s proposed products.

SOURCE QRxPharma Limited

PLEASANTON, Calif., May 17, 2013 /PRNewswire/ — Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market the HeartMate II Pocket Controller™, the small, smart, safe face of the HeartMate II LVAD System.

“In offering HeartMate II LVAD patients our next-generation Pocket Controller device, we are providing a product that has been extensively tested and is designed for greater ease of use and safety,” said Gary F. Burbach, President and Chief Executive Officer. “We have a significant amount of clinical experience and patient feedback from Europe that has highlighted the Pocket Controller’s ability to deliver meaningful benefits in everyday living with this therapy.”

The Pocket Controller is designed to support the active lifestyles that patients with HeartMate II LVADs are leading. The Pocket Controller is lighter and more compact than previous LVAD system controllers, and it features an intuitive user interface with enhanced information content. Additionally, with a single-side cable design, the device can slide easily and discreetly into a front pocket. The Pocket Controller has also been designed to promote patient safety, through features including prioritized visual alarms, on-screen instructions, and a backup battery, which can provide at least 15 minutes of full power during periods of inadvertent disconnections from power sources.

“Patients are living for extended periods of time on HeartMate II support, either while they wait for a transplant or as a long-term, destination therapy,” noted Burbach. “The launch of the Pocket Controller provides an attractive option for these patients and advances Thoratec’s mission, which is to improve the lives of individuals suffering from advanced heart failure.”

Thoratec will begin training U.S. implanting centers on the Pocket Controller during the week of May 20^th. Following clinician training, the Pocket Controller will be available for new patients as well as for current HeartMate II patients eligible to upgrade their existing system controllers. Patients should contact their centers to learn more about the HeartMate II system and the new Pocket Controller. To find an implant center near you, please visit www.hearthope.com.

About HeartMate II
HeartMate II is the most widely used and extensively studied LVAD in the world. Featuring innovative design elements, including proprietary textured surfaces, blood immersed ruby bearings and open flow paths, HeartMate II has proven to be a highly durable device capable of long-term circulatory support.¹ In clinical testing, over 80 percent of HeartMate II recipients became virtually free of heart failure symptoms shortly after implant and sustained those improvements for the full two-year follow-up period.² Moreover, controlled clinical trials as well as large-scale commercial experience have demonstrated significant improvement in patients’ functional capacity, with 94 percent of HeartMate II recipients able to perform the 6-minute walk test after six months of support. ^3,4 Overall, many patients report returning to active living, with meaningful improvements in their quality of life. To date, over 14,000 patients have been implanted with HeartMate II, including over 6,000 currently on support.⁵ HeartMate II is the only continuous-flow LVAD approved by the FDA for both Bridge-to-Transplantation and Destination Therapy, or permanent support.

About Thoratec
Thoratec is the world leader in mechanical circulatory support with the broadest product portfolio to treat the full range of clinical needs for patients suffering from advanced heart failure. The company’s products include the HeartMate LVAS and Thoratec VAD, with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures and distributes the CentriMag and PediMag / PediVAS product lines. Thoratec is headquartered in Pleasanton, California. For more information, visit www.thoratec.com.

Thoratec, the Thoratec logo, HeartMate and HeartMate II are registered trademarks of Thoratec Corporation, and Pocket Controller and IVAD are trademarks of Thoratec Corporation. CentriMag and PediMag are registered trademarks of Thoratec LLC, and PediVAS is a registered trademark of Thoratec Switzerland GmbH.

Many of the preceding paragraphs contain forward-looking statements within the meaning of Sections 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements can be identified by the words, “believes,” “views,” “expects,” “plans,” “projects,” “hopes,” “could,” “will,” “intends,” and other similar words. Actual results, events or performance could differ materially from these forward-looking statements based on a variety of factors, many of which are beyond Thoratec’s control. Therefore, readers are cautioned not to put undue reliance on these statements. Investors are cautioned that all such statements involve risks and uncertainties, including risks related to regulatory approvals, the development of new products and new markets, the growth of existing markets for our products, customer and physician acceptance of Thoratec products, the effects of FDA regulatory requirements, and the effects of competition. Forward-looking statements contained in this press release should be considered in light these factors and those factors discussed from time to time in Thoratec’s public reports filed with the Securities and Exchange Commission, such as those discussed under the heading, “Risk Factors,” in Thoratec’s most recent annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other SEC filings. These forward-looking statements speak only as of the date hereof. Thoratec undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events.

SOURCE Thoratec Corporation

PITTSBURGH, May 17, 2013 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has shipped Fenofibrate Tablets, 48 mg and 145 mg. Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is the generic version of Abbvie Inc.’s Tricor Tablets. Fenofibrate Tablets are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia or mixed dyslipidemia. Fenofibrate Tablets also are indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Fenofibrate at a dose equivalent to 145 mg has not been shown to reduce coronary heart disease morbidity and mortality in a controlled trial of patients with type 2 diabetes mellitus.

Fenofibrate Tablets, 48 mg and 145 mg, had U.S. sales of approximately $1.2 billion for the 12 months ending March 31, 2013, according to IMS Health.

Currently, Mylan has 178 ANDAs pending FDA approval representing $83.1 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.4 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don’t take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.

JERUSALEM, May 17, 2013 /PRNewswire/ –

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that the United States Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application(IND) for ORMD-0801, its oral insulin capsule.

“We are very pleased to have the FDA clearance to proceed,” stated Nadav Kidron, CEO of Oramed. “The upcoming trial is a major milestone for Oramed and we look forward to continuing to progress ORMD-0801′s clinical development in the US.”

About ORMD-0801 Oral Insulin

Oramed’s ORMD-0801 is an orally ingestible insulin capsule indicated for the early stages of type 2 diabetes, when it can still slow the rate of degeneration of the disease by providing additional insulin to the body and allowing pancreatic respite. Moreover, orally administered insulin has the potential benefit of enhanced patient compliance at this crucial stage as well as the advantage of mimicking insulin’s natural location and gradients in the body by first passing through the liver before entering the bloodstream.

For more information on ORMD-0801, the content of which is not part of this press release, please visit http://oramed.com/index.php?page=14

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed’s technology is based on over 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently initiating Phase 2 clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), currently approaching Phase 2a trials. The company’s corporate and R&D headquarters are based in Jerusalem.

For more information, the content of which is not part of this press release, please visit http://www.oramed.com

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss ORMD-0801 slowing the rate of diabetes, increasing patient compliance, and our products approaching Phase 2 trials. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and final that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’s reports filed from time to time with the Securities and Exchange Commission.

Company Contact:
Oramed Pharmaceuticals
Aviva Sherman
Mobile: +972-54-792-4438
Office: +972-2-566-0001
Email: aviva@oramed.com

SOURCE Oramed Pharmaceuticals Inc.

YOKNEAM, Israel, May 16, 2013 /PRNewswire/ –

Expands treatment capabilities, reduces treatment time, and improves overall experience with UltraShape and VelaShape systems

Syneron Medical Ltd. (NASDAQ:ELOS), the leading global aesthetic device company, announced today the introduction of new enhancements to its innovative body shaping products, including the UltraShape V3 system, which is currently available in Canada, Europe, Latin America, and Asia, and the VelaShape II system, which has a market leading installed base and is available globally. The enhancements, which are based on physician and patient feedback, are designed to significantly increase the return on investment for physicians, reduce number of treatments, and improve patient experience and comfort.

The UltraShape V3 system is a clinically proven non-invasive solution for fat reduction and body contouring using “non-thermal” focused ultrasound technology. This unique fat selective technology gives physicians a comprehensive body sculpting solution that enables targeted, non-invasive fat destruction. The enhancements to the UltraShape V3 system include:

• U-Sculpt transducer (delivers focused ultrasound treatment) – the new U-Sculpt transducer is smaller and 50% lighter than the current full-size transducer. The U-Sculpt is ergonomically designed, includes more treatment pulses, and is easily interchangeable with the full-size transducer during treatment sessions.
• Re-usable strap sets (used to gather skin and fat tissue at the treatment area) -designed to quickly and effectively lift and gather tissue in the target area to increase treatment efficiency.
• Ultrasonic treatment gel (allows focused ultrasound energy to be delivered through the skin) – designed to reduce treatment preparation time and provide patients with a cleaner, more streamlined procedure compared to the previous option.

The UltraShape V3 enhancements will be available to current UltraShape customers beginning in May 2013 and will also be included in all new UltraShape V3 system purchases.

“As a long time and satisfied UltraShape user, I find the new U-Sculpt transducer a great enhancement,” commented Mr. Christopher Inglefield BSc, MBBS, FRCS. “U-Sculpt is light and easy to move around and enables me to treat small areas which were not reachable with the larger transducer. In addition, the new treatment set up using the gel and straps, minimizes the preparation time significantly, a fact that is well appreciated by both my patients and my staff.”

The VelaShape system, featuring Syneron’s proprietary elōs technology, was the first FDA cleared device for non-invasive Circumferential Reduction. VelaShape has an installed base of more than 7,000 systems worldwide, has been clinically proven in over a dozen studies, and there have been more than 5 million independent VelaShape treatments globally. The enhancements to the VelaShape II system include:

• New treatment protocol and disposable cover for circumferential reduction – offers patients the same efficacy with 50% fewer treatment sessions.

The new VelaShape II disposable treatment cover will be available in May 2013 and will be featured in product demonstrations at the Company’s booth #709 at THE Aesthetics Show multidisciplinary medical education meeting, May 17-19, 2013 in Las Vegas, NV.

Dr. Shimon Eckhouse, Chief Executive Officer of Syneron, said, “VelaShape is the best-selling product in the history of Syneron. We believe we have made the system even more attractive to our customers and their patients by enabling faster, more effective circumferential reduction treatment capabilities. Combined with UltraShape, we have the most innovative and broadly used body shaping product portfolio on the market and are well positioned to lead the global market of non-invasive body contouring.”

To learn more about the UltraShape and VelaShape Systems, visit http://www.Syneron-Candela.com.

About Syneron Medical Ltd.

Syneron Medical Ltd. (NASDAQ: ELOS) is the leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint. The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, rejuvenation of the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under two distinct brands, Syneron and Candela. Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. are located in Israel. Syneron also has R&D and manufacturing operations in the US. The Company markets, services and supports its products in 90 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, China, Japan, and Hong Kong and distributors worldwide.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS

Any statements contained in this document regarding future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Further, any statements that are not statements of historical fact (including statements containing “believes,” “anticipates,” “plans,” “expects,” “may,” “will,” “would,” “intends,” “estimates” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, such as the company’s ability to effectively market the new enhancements, as well as the risks set forth in Syneron Medical Ltd.’s most recent Annual Report on Form 20-F, and the other factors described in the filings that Syneron Medical Ltd. makes with the SEC from time to time. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Syneron Medical Ltd.’s actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.

In addition, the statements in this document reflect the expectations and beliefs of Syneron Medical Ltd. as of the date of this document. Syneron Medical Ltd. anticipates that subsequent events and developments will cause its expectations and beliefs to change. However, while Syneron Medical Ltd. may elect to update these forward-looking statements publicly in the future, it specifically disclaims any obligation to do so. The forward-looking statements of Syneron Medical Ltd. do not reflect the potential impact of any future dispositions or strategic transactions that may be undertaken. These forward-looking statements should not be relied upon as representing Syneron Medical Ltd.’s views as of any date after the date of this document.

Contacts:

Syneron Public Relations
pr@syneron.com

Hugo Goldman, Chief Financial Officer
Email: hugo.goldman@syneron.com

Zack Kubow, The Ruth Group
+1-646-536-7020
Email: zkubow@theruthgroup.com

SOURCE Syneron Medical Ltd.

TAIPEI, Taiwan, May 16, 2013 /PRNewswire/ — TaiGen Biotechnology Company, Limited (“TaiGen”) today announced that they have submitted New Drug Application (NDA) for the oral formulation of nemonoxacin with the Taiwan Food and Drug Administration (TFDA) and China Food and Drug Administration (CFDA). Approval is expected in the first half of 2014. Nemonoxacin is the first pharmaceutical product to fall under the Cross-Strait Cooperation Agreement on Medicine and Public Health Affairs of the Economic Cooperation Framework Agreement (ECFA) between Taiwan and mainland China. It is also the first new drug from Taiwan to meet the requirements of CFDA’s Category 1.1 New Drug. Drugs under this classification have to be new chemical entities (NCEs) that have not been marketed in any country in the world. Nemonoxacin, thus, represents a landmark in the continued development of cross-strait relationship between the pharmaceutical industry and regulatory agencies.

Nemonoxacin is a NCE, broad spectrum antibiotic with excellent efficacy and safety profile. The NDA submission for nemonoxacin is supported by a pivotal Phase 3 trial with 532 patients in community-acquired pneumonia (CAP). The trial was conducted in both Taiwan and mainland China (441 patients from mainland China and 91 patients from Taiwan) that met all primary and secondary endpoints including non-inferiority to the comparator, levofloxacin. TaiGen is currently conducting Phase 2 trial for the intravenous formulation of nemonoxacin in moderate to severe CAP patients. In addition to CAP, nemonoxacin has also shown efficacy in diabetic foot infections in a Phase 2 trial conducted in the US, Taiwan, and South Africa. In the clinical trials conducted to this point, nemonoxacin have demonstrated excellent activity against drug-resistant bacteria such as methicillin-­resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumoniae. TaiGen owns the worldwide patent portfolio of nemonoxacin that protects composition, use, and processes until 2029.

Dr. Ming-Chu Hsu, President and Chief Executive Officer of TaiGen, said, “Since the founding of TaiGen, we have been focusing on the development of First-in-class and Best-in-class novel drugs. The submission of the NDA for nemonoxacin is the culmination of efforts by our experienced management team and all the staff at TaiGen. I am very pleased with the groundbreaking achievement of using one NDA dossier for submissions to TFDA and CFDA. Not only nemonoxacin is our first product to the market, it is also an indication that a world class medicine can be discovered and developed in Taiwan. TaiGen is well positioned to advance in the world’s fastest pharmaceutical market, mainland China.”

In June 2012, TaiGen signed an agreement with Zhejiang Medicine Company, Limited (“ZMC”) to out-license the exclusive marketing and manufacturing rights of nemonoxacin in China. ZMC is a leading manufacturer and marketer of antibiotics in China and is a publicly listed company in the Shanghai Stock Exchange. This partnership combines TaiGen’s R&D expertise and ZMC’s antibiotic marketing knowhow to compete in China‘s US$11 billion antibiotic market.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and product-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, mainland China. In addition to nemonoxacin, TaiGen has two other in-house discovered NCEs in clinical development under IND with US FDA: TG-0054, a chemokine receptor antagonist for stem cell transplantation and chemosensitization, in Phase 2 and TG-2349, a HCV protease inhibitor for treatment of chronic hepatitis infection, in Phase 2. Both TG-0054 and TG-2349 are currently in clinical trials in patients in the US.

Disclaimer

Certain statements in this press release are forward-looking. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend,” among others. These forward-looking statements are based on TaiGen’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain regulatory authority clearances or approvals and noncompliance with regulatory regulations. As with any drugs under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. TaiGen does not undertake an obligation to update or revise any forward-looking statement.

TaiGen Contact:

Peter W. Tsao, PhD, Vice President of Business Development
Tel: +886-2-8177-7072 ext 1705
ptsao@taigenbiotech.com.tw

PJ (Joe) Hsueh, Vice President of Operations
Tel: +886-2-8177-7072 ext 1704
pjhsueh@taigenbiotech.com.tw

SOURCE TaiGen Biotechnology Co., Ltd.

HORSHAM, Pa., May 15, 2013 /PRNewswire/ — Janssen Biotech, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SIMPONI (golimumab) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine. SIMPONI is the first and only subcutaneously administered anti-tumor necrosis factor (TNF)-alpha therapy approved to induce and maintain clinical response and improve endoscopic appearance of the mucosa during induction. In addition, SIMPONI is indicated to induce clinical remission and achieve and sustain clinical remission in induction responders. As many as 700,000 people in the United States are affected by UC¹, a chronic inflammatory bowel disease (IBD) marked by inflammation and ulceration of the innermost lining of the colon.

“The FDA approval of SIMPONI brings an important, new subcutaneous therapeutic option to adults living with moderate to severe ulcerative colitis, a disease where treatment options have been limited,” said William Sandborn, MD, professor and chief of the Division of Gastroenterology at the University of California, San Diego (UCSD) School of Medicine, director of the UCSD Inflammatory Bowel Disease Center, and lead study investigator. “SIMPONI has demonstrated significant benefits in the treatment of ulcerative colitis, a chronic inflammatory bowel disease, and represents a meaningful addition to the treatment armamentaria for gastroenterologists.”

For the treatment of UC, the SIMPONI dose regimen consists of 200 mg subcutaneously injected at week 0, followed by 100 mg at week 2 and then 100 mg every 4 weeks, thereafter.

The approval is supported by data from the Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) clinical trials, evaluating patients with moderately to severely active UC who had previously failed or were intolerant to conventional treatments. Significantly greater proportions of patients who received SIMPONI 200 mg/100 mg achieved clinical response, clinical remission and improvement of the endoscopic appearance of the mucosa at week 6 compared with patients receiving placebo. Through week 54, significantly greater proportions of patients in the SIMPONI 100 mg group maintained clinical response compared with the placebo group. The proportion of patients in clinical response following SIMPONI induction treatment who went on to demonstrate clinical remission at both weeks 30 and 54, without demonstrating a loss of response at any time point through week 54, were significantly greater in the SIMPONI 100 mg group compared with the placebo group.

“The approval of SIMPONI for the treatment of UC is a notable milestone for adults living with this chronic, devastating disease for which there is no cure,” said Cindy Guzzo, M.D., Vice President, Medical Affairs, Janssen Biotech, Inc. “As leaders in the treatment of IBD for more than a decade, we are proud to offer a new subcutaneous treatment option to patients and healthcare providers where unmet need continues to exist.”

SIMPONI is also approved by the FDA for the treatment of moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate and active ankylosing spondylitis.

About PURSUIT
The Program of Ulcerative Colitis Research Studies Utilizing an Investigational Treatment (PURSUIT) included Phase 3 multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of subcutaneous induction and every-four-week maintenance regimens of SIMPONI in adults with moderately to severely active UC. All trial patients had failed to respond to or tolerate treatment with 6-mercaptopurine (6-MP), azathioprine (AZA), corticosteroids and/or 5-aminosalicylate (5-ASA), or were corticosteroid dependent. Study participants were naive to treatment with TNF inhibitors and had a baseline Mayo score between 6 and 12 and an endoscopic subscore of 2 or more. The Mayo score is a 12-point clinical assessment and colonoscopy-based measure of disease activity, which assesses improvement in symptoms based on rectal bleeding, endoscopic findings, stool frequency and a physician’s global assessment.

The induction trial (PURSUIT-SC) had an adaptive design with a Phase 2 dose-finding portion followed by a Phase 3 dose-confirming component. The primary endpoint was clinical response at week 6. Secondary endpoints at week 6 included clinical remission and mucosal healing (improvement of endoscopic appearance of mucosa) – Mayo endoscopy score of 0 or 1. Overall, 1,065 patients were treated in the study; 774 of these patients were randomized into the Phase 3 component of the study.

Patients responding to induction treatment with SIMPONI were eligible to be randomized in the Phase 3 PURSUIT-Maintenance study. The primary endpoint in this study was maintenance of clinical response through week 54, and secondary endpoints included clinical remission and mucosal healing (improvement of endoscopic appearance of mucosa) – Mayo endoscopy score of 0 or 1 – at both weeks 30 and 54.

The safety results of SIMPONI observed in the PURSUIT studies were consistent with the known safety profile of SIMPONI in labeled rheumatologic indications. For more information regarding the safety profile for SIMPONI, please see “Important Safety Information” below.

About Ulcerative Colitis
Ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD) affecting as many as 700,000 individuals in the United States is marked by the inflammation and ulceration of the colonic mucosa, or innermost lining, which may lead to bloody stools, severe diarrhea and frequent abdominal pain.¹ Tiny open sores, or ulcers, form on the surface of the lining, where they bleed and produce pus and mucus.¹ Symptoms of the disease may lead to loss of appetite, subsequent weight loss and fatigue.¹ On average, people are diagnosed with UC in their mid-30s, but the disease can occur at any age. As many as 30 percent of people living with UC will require surgery at some point in their life.² UC is a chronic disease, and there is no cure. Although progress has been made in IBD research, researchers do not know what causes this disease.³

About SIMPONI (golimumab)
SIMPONI is a human monoclonal antibody that targets and neutralizes excess TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage and tissue. SIMPONI is approved for the treatment of moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate, active psoriatic arthritis alone or with the medicine methotrexate, active ankylosing spondylitis and moderately to severely active ulcerative colitis. For more information about SIMPONI visit www.SIMPONI.com.

Janssen Biotech, Inc. discovered and developed SIMPONI.

Important Safety Information
SIMPONI (golimumab) is a prescription medicine. SIMPONI can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI, the chances for getting lymphoma or other cancers may increase. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking other TNF blockers with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI, tell your doctor.

Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI . Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI . Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.

Rarely, people using TNF blockers, including SIMPONI, can have nervous system problems such as multiple sclerosis or Guillain-Barre syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

Serious liver problems can happen in people using TNF blockers, including SIMPONI. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers, including SIMPONI. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

Common side effects of SIMPONI include: upper respiratory tract infection, reaction at site of injection, and viral infections.

Please read the Medication Guide for SIMPONI and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

About Janssen Biotech, Inc.
Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com.

Janssen Biotech is one of the Janssen Pharmaceutical Companies of Johnson & Johnson which are dedicated to addressing and solving some of the most important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to people throughout the world. Follow us on Twitter at www.twitter.com/JanssenUS.

References:

1. Crohn’s & Colitis Foundation of America. What is Ulcerative Colitis? Available at: http://www.ccfa.org/info/about/ucp. Accessed March 18, 2013.
2. Crohn’s & Colitis Foundation of America. Colitis Treatment Options. Available at: http://www.ccfa.org/what-are-crohns-and-colitis/what-is-ulcerative-colitis/colitis-treatment-options.html. Accessed March 18, 2013.
3. World IBD Day. About Us. Available at: http://www.ibdday.bvsalud.org/. Accessed March 18, 2013.

SOURCE Janssen Biotech, Inc.

PITTSBURGH, May 15, 2013 /PRNewswire/ — Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zolmitriptan Tablets, 2.5 mg and 5 mg. This product is the generic version of IPR Pharmaceuticals Inc.’s Zomig Tablets and is indicated for the acute treatment of migraine with or without aura in adults. Zolmitriptan Tablets are for use only where a clear diagnosis of migraine has been established. If a patient does not respond after the first dose, a healthcare provider should reconsider the diagnosis before re-administering. The product is not indicated for the prevention of migraine attacks or cluster headaches.

Zolmitriptan Tablets, 2.5 mg and 5 mg, had U.S. sales of approximately $152.8 million for the 12 months ending March 31, 2013, according to IMS Health. Mylan has begun shipping this product.

Currently, Mylan has 178 ANDAs pending FDA approval representing $83.1 billion in annual sales, according to IMS Health. Thirty-four of these pending ANDAs are potential first-to-file opportunities, representing $22.4 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.

Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what’s right, not what’s easy; and impact the future through passionate global leadership. We offer a growing portfolio of approximately 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately 40% of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 140 countries and territories. Our workforce of more than 20,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don’t take our word for it. See for yourself. See inside. mylan.com

SOURCE Mylan Inc.

WAYNE, N.J., May 15, 2013 /PRNewswire/ — Intended for U.S. Media Only — Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) approved Xofigo (radium Ra 223 dichloride) for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease. Xofigo is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal Phase III ALSYMPCA trial.¹

The commercial production of Xofigo is underway, and first doses are expected to be ready for patient treatment within a few weeks. Bayer has worldwide exclusive marketing rights for Xofigo. Algeta US, LLC and Bayer Healthcare will co-promote the product in the U.S.

“Most men with castration-resistant prostate cancer develop bone metastases, which can decrease overall survival,” said Oliver Sartor, MD, North American Principal Investigator for the pivotal trial and medical director of the Tulane Cancer Center. “Xofigo has demonstrated an anti-tumor effect on bone metastases and will be an important addition to the treatment of this cancer.”

Bone is the most common site in the body to be affected by metastatic cancer, and bone metastases are particularly prevalent in patients with prostate cancer.³ Approximately 90% of patients with metastatic prostate cancer show evidence of bone metastases.^{4, 5, 6, 7} Bone metastases can lead to an increase in frequency of skeletal events and are shown to be the main cause of morbidity and death in patients with CRPC.^{2, 8}

“At Bayer, we remain committed to our mission of delivering innovative ways to help patients and physicians, and to bring new treatment options in cancer,” said Pamela A. Cyrus, MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals. “We are pleased to add Xofigo to our oncology franchise for the treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastases.”

Jan Manarite, senior educational facilitator for the Prostate Cancer Research Institute also added, “It is encouraging to have a new treatment for men with castration-resistant prostate cancer who are dealing with bone metastases. Xofigo provides another new option to treat this cancer using a different approach.”

Efficacy and Safety Data Supporting Xofigo (radium Ra 223 dichloride) Approval
The approval of Xofigo is based on data from the pivotal Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, Xofigo significantly improved overall survival (OS) [HR=0.695 (95% CI 0.552-0.875), p=0.00185]; median OS was 14.0 months with Xofigo plus best standard of care vs. 11.2 months with placebo plus best standard of care.¹ Additionally, at the interim analysis there was a delay in time to first symptomatic skeletal event (SSE) for patients treated with Xofigo vs. placebo.

An updated analysis, conducted after the study was unblinded, showed improvement in overall survival (OS), with a median OS of 14.9 months vs. 11.3 months; HR=0.695 (95% CI 0.581-0.832).¹

The most common adverse reactions (greater than or equal to 10%) in patients receiving Xofigo in the ALSYMPCA trial were nausea, diarrhea, vomiting and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia and neutropenia.¹

About Xofigo (radium Ra 223 dichloride) Injection
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

Xofigo is an alpha particle-emitting radioactive therapeutic agent with an anti-tumor effect on bone metastases. The active ingredient in Xofigo is the alpha particle-emitting isotope radium-223, which mimics calcium and forms complexes with the bone mineral hydroxyapatite at areas of increased bone turnover, such as bone metastases. The high linear energy transfer of Xofigo may cause double-strand DNA breaks in adjacent cells, resulting in an anti-tumor effect on bone metastases. The alpha particle range from radium-223 dichloride is less than 100 micrometers which may limit the damage to the surrounding normal tissue.¹

In September 2009, Bayer signed an agreement with Algeta ASA (Oslo, Norway) for the development and commercialization of Xofigo. Under the terms of the agreement, Bayer will develop, apply for health authority approvals worldwide and commercialize Xofigo globally.

Important Safety Information for Xofigo (radium Ra 223 dichloride) Injection
Xofigo is contraindicated in women who are or may become pregnant. Xofigo can cause fetal harm when administered to a pregnant woman.

In the randomized trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (less than 1%) was similar for patients treated with Xofigo and placebo. Myelosuppression – notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia – has been reported in patients treated with Xofigo.

Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure.

Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be greater than or equal to 1.5 × 10⁹/L, the platelet count greater than or equal to 100 × 10⁹/L, and hemoglobin greater than or equal to 10 g/dL. Prior to subsequent administrations, the ANC should be greater than or equal to 1 × 10⁹/L and the platelet count greater than or equal to 50 × 10⁹/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care.

Safety and efficacy of concomitant chemotherapy with Xofigo have not been established. Outside of a clinical trial, concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued.

Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations.

The most common adverse reactions (greater than or equal to 10%) in patients receiving Xofigo were nausea, diarrhea, vomiting, and peripheral edema. Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in Xofigo-treated patients (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

For full prescribing information visit www.xofigo-us.com.

About the ALSYMPCA Trial
The ALSYMPCA trial was a Phase III, randomized, double-blind, placebo-controlled international study of Xofigo with best standard of care vs. placebo with best standard of care in symptomatic CRPC patients with bone metastases. The trial enrolled 921 patients in more than 100 centers in 19 countries. The study treatment consisted of up to six intravenous injections of Xofigo or placebo each separated by an interval of four weeks.

The primary endpoint of the study was overall survival (OS). A key secondary endpoint was time to first symptomatic skeletal event (SSE), as defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention.

About CRPC and Bone Metastases
Prostate cancer is the most common cancer among men in the United States (other than skin cancer).⁹ Approximately 4% of prostate cancer cases are considered distant, which means that the cancer has spread beyond the prostate to distant areas of the body (metastasized).¹⁰ If prostate cancer starts to spread to other areas of the body, it most commonly goes to the bone.⁸

About the Patient Assistance Program
Bayer and Algeta offer patient assistance through Xofigo Access Services(SM) which will assist with obtaining coverage and patient support of Xofigo. Patients and providers may contact the program at 1-855-6XOFIGO (1-855-696-3446) for additional information.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer now includes three oncology products and several other compounds in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world’s leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women’s Healthcare. The company’s aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Bayer and the Bayer Cross and Xofigo are registered trademarks of Bayer. Xofigo Access Services(SM) is a service mark of Bayer.

Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

¹ XOFIGO Prescribing information. May 2013.
² Saad, MD, et. al. “Guidelines for the management of castration-resistant prostate cancer.” Can Urol Assoc J 2010;4(6):380-4.
³ Coleman R. Metastatic bone disease: clinical features, pathophysiology and treatment strategies. Cancer Treat Rev. 2001;27:165-176.
⁴ Tannock IF, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-1512.
⁵ Petrylak DP, et al. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004;351:1513-1520.
⁶ Scher, HI, et al. Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy. N Engl J Med. 2012;DOI10.1056
⁷ Fizazi, K, et al. Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol 2012; 13:983-92.
⁸ Lange PH, Vasella RL. “Mechanisms, hypotheses and questions regarding prostate cancer metastatic to bone.” Cancer & Metastasis Reviews.1999;17:331-336
⁹American Cancer Society. Prostate Cancer: Detailed Guide. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003134-pdf.pdf.
¹⁰ National Cancer Institute, Surveillance Epidemiology and End Results (SEER). SEER Stat Facts: Prostate; Survival & Stage, 2002-2008.

SOURCE Bayer HealthCare Pharmaceuticals Inc.