Recro Pharma Provides Regulatory Update for IV Meloxicam

Company Anticipates NDA Resubmission by the End of September 2018

Recro Pharma, Inc. (Nasdaq:REPH), a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today provided a regulatory update following receipt of the official meeting minutes from a July 2018 Type A meeting with the U.S. Food and Drug Administration (FDA)relating to a path forward for intravenous (IV) meloxicam, the Company’s lead product candidate for the management of moderate to severe pain.

Recro had requested this Type A meeting with the FDA to address a Complete Response Letter (CRL) it received from the FDA regarding the New Drug Application (NDA) for IV meloxicam. During the meeting, Recro discussed data from ad hoc analyses and selective secondary endpoints of Recro’s clinical trials which the FDA had highlighted in the CRL, as well as CMC related questions on extractable and leachable data provided in the NDA.  Based upon the discussion with the FDA as reflected in the official meeting minutes, Recro anticipates resubmitting the IV meloxicam NDA by the end of September. The NDA resubmission will incorporate revised language relating to the product label and, additional information relating to extractable and leachable items.

“We are pleased with the constructive nature of our interactions with the FDA regarding IV meloxicam, and we expect to resubmit the NDA for IV meloxicam by the end of September,” said Gerri Henwood, President and Chief Executive Officer of Recro. “We remain fully committed to IV meloxicam and to bringing this new non-opioid treatment option for the management of moderate to severe pain to the physicians and patients who need it.”

https://www.biospace.com/article/recro-pharma-provides-regulatory-update-for-iv-meloxicam/

Celltrion: FDA Panel to Meet on Proposed Biosimilar to Rituxan® (Rituximab)

Celltrion, Inc. (KRX:068270) today announced that the U.S. Food and Drug Administration (FDA) has scheduled the Biologics License Application (BLA) for CT-P10, a proposed monoclonal Antibody (mAb) biosimilar to Rituxan®¹ (rituximab), for discussion by the Oncologic Drugs Advisory Committee (ODAC) on October 10, 2018. Rituxan® is a Biogen and Genentech USA, Inc.’s rituximab product.

The ODAC reviews and evaluates data concerning the safety and effectiveness of investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA.

“We are fully committed to preparing for this advisory committee meeting and look forward to the discussion about CT-P10,” said Woosung Kee, Chief Executive Officer of Celltrion. “The development of biosimilars is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal and to increase accessibility to therapies for patients at an affordable price.”

Celltrion and Teva Pharmaceutical Industries, Ltd. entered into an exclusive partnership to commercialize CT-P10 in the U.S. and Canada in October 2016.

¹ Rituxan® is a registered trademark of Biogen and Genentech USA, Inc.

https://www.biospace.com/article/releases/celltrion-announces-fda-oncologic-drugs-advisory-committee-meeting-schedule-for-proposed-biosimilar-to-rituxan-rituximab-/

Cushman & Wakefield: Life Sciences Drive Improved NJ Office Fundamentals

Sector Generates Significant Year-to-Date Leasing Volume – with More to Come

Even before Teva Pharmaceuticals USA Inc., represented by Cushman & Wakefield, signed a 345,000-square-foot commitment in Parsippany in July – marking the largest office lease year-to-date in Northern and Central New Jersey – the life sciences sector had emerged as a key driver in the state’s improving market fundamentals.

At mid-year, the Cushman & Wakefield research team had tracked more than 564,000 square feet in office activity involving life sciences tenants. “That impressive statistic represents 11.4 percent of the state’s total office leasing through the first six months of the year,” noted Jason Price, director of tri-state suburbs research for the commercial real estate services firm. “Add the Teva Pharmaceuticals transaction and other sizable office deals in the pipeline, and the influence of life sciences in 2018 will be even more marked by the end of the third quarter.”

Cushman & Wakefield’s Dan Johnsen represented Teva in its long-term lease at P3 Properties’ MCCBLUE (400 Interpace Parkway). JLL served as landlord broker in that blockbuster deal. “Companies within the life sciences sector, in particular pharmaceutical companies, are increasingly attracted to New Jersey due to its highway system and mass transit connectivity, EDA tax incentive programs and access to a highly educated workforce,” said Johnsen. Johnsen also represented Octapharma for its US Headquarters, where the firm signed a long-term lease for 64,000 square feet at 117 West Century Road in Paramus, where Cushman & Wakefield’s Marc Trevisan, David Sherman, David DeMatteis and Mark Zaziski served as landlord representative for Onyx Equities and Garrison Investments.

Cushman & Wakefield was also involved in other life sciences leasing transactions this year including Integra Life Sciences’ 166,791-square-foot headquarters lease at 1100 Campus Road in Princeton. Led by Cushman & Wakefield’s Robert Rudin, Marc Trevisan and David Sherman as well as a Boston-based team led by Rory Murray, that deal marked the state’s largest office lease of the second quarter. And in Morristown, Cushman & Wakefield’s Bill Brown, Jon Williams and Heather Polhamus represented Marcus Partners in Alvogen’s 84,000- square-foot lease at 44 Whippany Road.

While the volume of activity in 2018 is significant, the presence of life sciences in New Jersey is deeply rooted. The state houses more than 3,200 life sciences facilities (both office and R&D), employing approximately 117,000 people. The industry’s annual contribution to the state economy is estimated at $47.5 billion – 86.0 percent higher than the national average, noted Andrew Judd, Cushman & Wakefield’s New Jersey market leader.

“Thirteen of the top 20 global bio-pharma companies are headquartered in New Jersey,” Judd added. “These companies are attracted to the state by our skilled and talented labor pool, and 60-plus colleges that produce more than 20,000 life sciences graduates each year. In turn, the life sciences industry continues to fuel not only the New Jersey economy, but also the commercial real estate market. The state always has enjoyed the benefit of attracting tenants from diverse industries. While that remains unchanged, 2018 may well go down in recent history as the year of life sciences.”

At mid-year, the Cushman & Wakefield research team had recorded 3.8 million square feet of total office leasing activity in Northern and Central New Jersey, slightly ahead of last year’s pace. This helped push the state’s office vacancy rate lower, to 18.4 percent, and contributed to Class A average rents climbing by 5.6 percent year-over-year to $33.54 per square foot – a historic high.

https://www.biospace.com/article/cushman-and-wakefield-life-sciences-driving-improved-office-fundamentals-in-n-j-/

Doctor survey shows Allergan could be big player in wet-AMD: Deutsche Bank

Deutsche Bank analyst Gregg Gilbert says his survey of 30 ophthalmologists that treat wet age-related macular degeneration suggests Allergan could be a meaningful player in the market. Abicipar is one of Allergan’s most important pipeline assets, but the Street seems lukewarm on the drug, as evidenced by the stock reaction after the company reported Phase 3 results on July 19, Gilbert tells investors in a research note titled “Abicipar survey: Docs more bullish than Street.” He notes the doctors surveyed like the fixed 12 week dosing of abicipar and that despite the inflammation hurdle, they predict significant share for abicipar of their wet-AMD patients. Gilbert keeps a Buy rating on Allergan with a $210 price target.
https://thefly.com/landingPageNews.php?id=2789259

Siemens Healthineers announces first global installation of Acuson Sequoia

Siemens Healthineers has announced the first global installation of its newest ultrasound system, the Acuson Sequoia, at Baptist Health South Florida. With ten facilities and five “centers of excellence” in the South Florida region, Baptist Health South Florida purchased numerous Acuson Sequoia systems in order to enhance its imaging capabilities within the scope of gastroenterology, primary care, and bariatric specialties. With its powerful architecture and innovative features, the new Acuson Sequoia expands precision medicine by enabling high-resolution imaging that adapts to patients’ size and personal physical characteristics, contributing to more confident diagnosis. Siemens Healthineers built the entirely new Acuson Sequoia system to adapt to the “BioAcoustic Variations” of each patient, characteristics that include tissue density, stiffness, and absorption. With its new Deep Abdominal Transducer (DAX), a new high-powered architecture, and innovative updates to elastography and contrast-enhanced ultrasound, the new Acuson Sequoia produces penetration up to 40cm without image quality degradation often caused by attenuating echo signals, an industry first.
https://thefly.com/landingPageNews.php?id=2789283

Zogenix initiated at Northland

Zogenix initiated with an Outperform at Northland. analyst Carl Byrnes initiated Zogenix with an Outperform and $70 price target saying ZX008 is positioned to emerge as the 1st-line adjunctive therapy for patients with Dravet syndrome, achieving high market penetration. Byrnes is forecasting peak us US sales from the Dravet syndrome indication of $225M, with peak global sales for the indication at $500MM. Importantly, ZX008 has peak global sales potential greater than $2B, inclusive of other epileptic indications, the analyst wrote in a note to investors.
https://thefly.com/landingPageNews.php?id=2789281

Evolent Health to acquire New Century Health for up to $217M

 Evolent Health and New Century Health announced that they have entered into a definitive agreement for Evolent to acquire New Century Health's business for up to $217M. The combination of Evolent and New Century Health brings together two companies that support provider organizations and health plans with clinical management and operational capabilities. Evolent was founded in 2011 to support providers in moving to a population health model of care delivery and to manage performance-based payment arrangements. Founded in 2002 and headquartered in Massachusetts, New Century Health is a technology-enabled, specialty care management company focused primarily on cancer and cardiac care. Utilizing its proprietary technology platform, New Century Health brings together clinical capabilities, pharmacy management and physician engagement to assist its customers in managing the large specialties of cancer and cardiac care. New Century Health manages approximately 462,000 Medicare Advantage lives under performance-based arrangements and provides administrative services, or ASO, to several partner organizations. New Century Health serves 12 long-term operating partners across multiple states; these partners include at-risk provider organizations, as well as national and regional health plans. Together, the organizations will be able to offer comprehensive specialty care management services and technology across Medicare Advantage, Medicaid and commercial populations in support of both New Century Health and Evolent's clients. Upon closing this transaction, the organizations together will serve more than 3.5M lives across more than 40 long-term operating partners. The purchase price is up to $217M and consists of 3.1M shares of Evolent Class B common stock and $120M in cash at closing. The purchase price includes an earn-out of up to $20M, payable in cash and Evolent Class B common stock, tied to future new business activity. Shares to be issued in relation to the earn-out are limited to 1M shares with full payment expected to be made in Q1 of 2020. The shares at closing and in the earn-out will be issued in transactions exempt from registration under the Securities Act of 1933, as amended. Evolent expects the acquired business, on a standalone basis, to generate adjusted revenues and adjusted EBITDA of approximately $177M and $20M, respectively for the latest twelve months ended June 30, however, Evolent will consolidate the results of the acquired business only for the period subsequent to the close of the transaction. The companies expect the transaction to close within the next 120 days, subject to regulatory approvals and certain closing conditions set forth in the agreement.


https://thefly.com/landingPageNews.php?id=2788959