Hitachi Chemical to Buy apceth Biopharma, Grow Cell, Gene Contracting

Hitachi Chemical Advanced Therapeutics Solutions, LLC announces an agreement by which apceth Biopharma GmbH (“apceth Biopharma”), a contract manufacturer of cell and gene therapy products, will join Hitachi Chemical’s PCT global services platform.

apceth Biopharma manufactures cell and gene therapy products for American and European clients through two manufacturing sites in Munich, Germany, certified for GMP manufacture since 2010. These facilities are fully compliant with all current EU regulations (ATMP regulation (EC) No.1394/2007) and ICH guidelines. The company’s strength lies in its experience and comprehensive quality management systems allowing the manufacturing and development of a wide range of complex cell and gene therapy products. Through this deal, Hitachi Chemical will acquire two state-of-the-art GMP/BSL2 production facilities including 600 m² of cleanroom area.

“The addition of apceth Biopharma to Hitachi Chemical will strengthen our presence in the second-largest cell and gene therapy market in the world, and enable us to offer a truly harmonized global operation, providing our customers with ready access to new markets and maximizing the value we bring to the industry,” said Robert A. Preti, PhD, CEO and President of Hitachi Chemical Advanced Therapeutics Solutions, LLC and General Manager of the Hitachi Chemical Regenerative Medicine Business Sector.

https://www.biospace.com/article/releases/hitachi-chemical-co-ltd-to-acquire-apceth-biopharma-gmbh-expanding-global-footprint-of-its-cell-and-gene-therapy-contract-development-and-manufacturing-services/

Tilray® Announces Global Senior Leadership Appointments

Tilray, Inc. (NASDAQ:TLRY), a global pioneer in cannabis production, research, cultivation and distribution, announces the expansion of its global senior leadership team with four strategic hires: Greg Christopher as EVP of Operations, formerly with Nestle; Rita Seguin as EVP of Human Resources, formerly with Diageo; Dara Redler as General Counsel, formerly with The Coca-Cola Company; and Charlie Cain as VP of Retail, formerly with Starbucks Corporation.

Greg Christopher, Rita Seguin, Dara Redler, Charlie Cain (Photo: Business Wire)

“We are pleased to have these experienced leaders join our team as we continue to disrupt the global pharmaceutical, alcohol, CPG and functional food and beverage industries,” says Brendan Kennedy, Tilray CEO. “Greg, Rita, Dara and Charlie come to Tilray with robust expertise in their respective fields and we look forward to their contributions as we pioneer the future of cannabis around the world.”

Each of the recently hired senior leaders bring invaluable expertise to Tilray’s growing leadership team. Their roles will directly drive the development of Tilray’s robust operations, which have enabled Tilray to distribute its products in 12 countries, as well as accelerate the company’s aggressive global expansion strategy.

• Greg Christopher, Executive Vice President, Operations, joins Tilray with over 30 years of global experience in operations and supply chain across the many product categories at Nestle SA most recently serving as Senior Vice President of Supply Chain Operations for Nestle in Canada. Greg will oversee the strategic development and expansion of the company’s global operations and cannabis value chain across Tilray and all its subsidiaries.
• Rita Seguin, Executive Vice President, Human Resources, served as the Senior Vice President of Human Resources for Diageo North America and most recently as Vice President of Human Resources for Southern Glazers Wine & Spirits Distributors. Rita’s appointment represents Tilray’s commitment to the long-term growth and success of the people within the organization. She will oversee the synchronization of the company’s growing global team and recruitment of talent all over the world.
• Dara Redler, General Counsel, most recently served as Vice President and Senior Counsel for Coca-Cola North America and held a number of leadership roles in the legal division during her tenure at The Coca-Cola Company. In her role as Tilray General Counsel, Dara will oversee the strategic global growth of Tilray and all its subsidiaries with the legal team and work cross-functionally with all teams within the organization.
• Charlie Cain, Vice President, Retail, served as Vice President of Concept Development and Franchising for Starbucks Corporation before joining the cannabis industry as CEO of Dockside Cannabis, one of Washington state’s original and most respected cannabis retail chains. Charlie brings more than 15 years of retail strategy, innovation, and operations experience to the development and oversight of Tilray and High Park’s North American retail strategy.

https://www.biospace.com/article/releases/tilray-announces-global-senior-leadership-appointments/

AVEO Oncology Announces NDA Timing Update

AVEO Oncology (NASDAQ: AVEO) today announced that it has accepted the recommendation of the U.S. Food and Drug Administration (FDA) not to submit a New Drug Application (NDA) for tivozanib (FOTIVDA®) with the preliminary overall survival (OS) results from the Phase 3 TIVO-3 trial. The FDA indicated that these preliminary OS results do not allay their concerns about the potential detriment in OS outlined in the complete response letter dated June 6, 2013. The Company now plans to make a NDA filing decision following the availability of more mature OS results.

As disclosed in November 2018, a preliminary analysis of the secondary endpoint of OS in the TIVO-3 trial showed a hazard ratio (HR) > 1. The Company previously planned to conduct the final OS analysis in August 2019. Due to the longer-than-expected median OS in both arms, and following discussions with the FDA, the Company plans to designate the August 2019 OS analysis as interim. Results of this analysis are expected to be reported in the fourth quarter.

Since initially conducting the preliminary analysis of the OS endpoint in November 2018, the Company has identified the survival status of a group of patients that were previously lost to follow up. With the identification of these OS events, the October 4, 2018 preliminary OS HR was revised from 1.06 to 1.12. The Company has not performed any OS analyses beyond the preliminary October 4, 2018 data cut-off date.

AVEO intends to present detailed results of the TIVO-3 study, the Company’s Phase 3 randomized, controlled, multi-center, open-label study comparing tivozanib to sorafenib in 350 subjects with highly refractory advanced or metastatic Renal Cell Carcinoma (RCC) during an oral session at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) being held February 14-16, 2019 in San Francisco.

“We are hopeful that the positive PFS outcome will translate into an improved hazard ratio when we evaluate a more mature interim OS outcome in the fourth quarter of 2019,” said Michael Bailey, president and chief executive officer of AVEO. “We look forward to continuing to work with the FDA to determine tivozanib’s benefit-risk profile as a single agent in RCC patients.”

https://www.biospace.com/article/releases/aveo-oncology-announces-nda-timing-update/

Audentes’ Next Steps After Collaborative Initial Meeting with FDA

Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, today provided an update following the receipt of minutes from its Regenerative Medicine and Advanced Therapy (RMAT)/Type B meeting with the U.S. Food and Drug Administration (FDA) held in December 2018, regarding the company’s lead gene therapy candidate, AT132, for the treatment of X-linked Myotubular Myopathy (XLMTM).

The goal of the meeting was to review nonclinical, clinical, and chemistry, manufacturing, and controls (CMC) data generated to date in the AT132 program, and to align with the FDA on program next-steps to enable submission of a Biologics License Application (BLA) for AT132.

“We’re pleased that our first discussion with the FDA under RMAT was both collaborative and productive, and provided a potential path toward BLA submission for AT132,” stated Matthew R. Patterson, Chairman and Chief Executive Officer.  “We appreciate the constructive feedback provided by the Agency and look forward to working with the FDA to advance AT132 to registration as quickly as possible.”

Following the meeting, Audentes is proceeding with its previously announced plan to enroll an additional 3-5 patients in Cohort 2 (3×10¹⁴ vector genomes per kilogram dose level) of ASPIRO, the Phase 1/2 study of AT132.  Optimal dose selection is expected to occur in the second quarter of 2019, after the evaluation of the six-month biopsy results from the first three patients dosed in Cohort 2.  Subsequent to the determination of the optimal dose, Audentes plans to provide an updated data package to FDA to facilitate final agreement on the path to BLA submission.  Audentes also received preliminary feedback on its CMC characterization and validation plans and will submit the requested information to the Investigational New Drug (IND) application on a continuing basis.

In pursuit of global regulatory approvals for AT132, Audentes also initiated discussions with the European Medicines Agency (EMA) in the fourth quarter of 2018 under the recently granted Priority Medicines (PRIME) designation.  In the first quarter of 2019, Audentes anticipates receiving scientific advice from the EMA that will begin to define the path toward submission of a European Marketing Authorization Application.

https://www.biospace.com/article/releases/audentes-therapeutics-announces-next-steps-in-the-development-of-at132-to-treat-xlmtm-following-collaborative-initial-meeting-with-fda-under-rmat-designation/

FDA Rejects Sunovion Pharmaceutical’s Parkinson’s Disease Treatment

The U.S. Food and Drug Administration (FDA) rejected Sunovion Pharmaceuticals’ experimental treatment for OFF episodes of Parkinson’s disease.

The regulatory agency issued a Complete Response Letter to the Marlborough, Mass.-based Sunovion, the company said this morning. After reviewing the New Drug Application, which was submitted in March 2018, the FDA said it could not approve the application for the apomorphine sublingual film in its present form. The FDA requested additional information and analyses, but no new clinical studies are required, Sunovion said in its brief announcement.

Antony Loebel, Sunovion’s chief medical officer and head of global clinical development for Sumitomo Dainippon Pharma Group, Sunovion’s parent company, said Sunovion is committed to working with the FDA to address its requests, in order to “bring apomorphine sublingual film to patients as expeditiously as possible.”

Sunovion’s apomorphine sublingual film was being developed for the treatment of OFF episodes of Parkinson’s disease. People diagnosed with Parkinson’s often deal with times classified as “ON” and “OFF.” OFF periods are characterized by the reemergence of Parkinson’s symptoms. In OFF times, patients experience periods of decreased mobility.

APL-130277, a novel formulation of apomorphine and a dopamine agonist, is being developed for the on-demand management of OFF episodes associated with Parkinson’s disease. Apomorphine is currently FDA approved for the acute, intermittent treatment of hypomobility, “OFF” episodes associated with advanced PD. It is currently available in the U.S. as a subcutaneous injection. APL-130277 is intended to “rapidly convert” Parkinson’s disease patients from the OFF to the ON state, Sunovion said.

Prior to submitting the NDA to the FDA, Sunovion’s apomorphine film (CTH-300) was evaluated in a 12-week, placebo-controlled Phase III trial. After 12 weeks of dosing, the treatment hit its primary endpoint of a mean change in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III Motor Examination at 30 minutes. The key secondary endpoint the trial hit was the percentage of patients with a patient-rated full ON response within 30 minutes at the 12-week point.

“OFF episodes are a common and challenging part of Parkinson’s disease with few existing treatment options,” Loebel said in a statement.

Sunovion licensed apomorphine sublingual film from Warren, N.J.-based Aquestive Therapeutics. This morning, Aquestive said interest in apomorphine film is high, despite the FDA’s CRL. Although no longer part of its pipeline, Aquestive said that additional treatment options for Parkinson’s disease patients experiencing OFF episodes are important to that community. The company said that apomorphine sublingual film “remains indicative of the future value” in its intellectual property license with Sunovion.

https://www.biospace.com/article/fda-rejects-sunovion-pharmaceutical-s-parkinson-s-disease-treatment/

FDA approval of Mylan’s Advair ‘overdue,’ says Wells Fargo

Wells Fargo analyst David Maris believes that while “overdue,” FDA’s approval of Mylan’s (MYL) generic Advair is good news. Many investors were expecting this to be further delayed, he notes, adding that he currently has $50M generic Advair in his model for Q1. The analyst believes GlaxoSmithKline (GSK) will launch an authorized generic, and with Advair’s already declining revenue, the generic Advair opportunity may turn out to be a great-to-have since it shows Mylan’s ability to get complex generics approved, but may not be a game changer. Maris reiterates an Outperform rating on Mylan’s shares.
https://thefly.com/landingPageNews.php?id=2856919

Evolent relationship with Passport Health going well, says Piper Jaffray

An article last week from Insider Louisville reported on the financial challenges of Passport Health and pinned the blame on Evolent Health (EVH), Piper Jaffray analyst Sean Wieland tells investors in a research note. The article, titled “Passport’s finances being dragged down by $220M in ‘management fees’ to Evolent Health,” suggests Evolent is largely to blame for Passport’s financial challenges, explains the analyst. However, after catching up with Mark Carter, CEO of Passport Health, Wieland learned that the Evolent Health relationship is going well and meeting objectives. While Passport is wrangling with regulators over capitation rates, the issue is not tied to the Evolent relationship, the analyst notes. He lowered his price target for Evolent Health to $33 from $34 and keeps an Overweight rating on the name.

https://thefly.com/landingPageNews.php?id=2856469