Boehringer Buys ViraTherapeutics to Develop Viral-Based Oncology Therapy

• Boehringer Ingelheim exercises its option to acquire all shares of oncolytic virus company ViraTherapeutics
• ViraTherapeutics will operate in Innsbruck, Austria as a distinct unit of Boehringer Ingelheim’s Discovery Research organization, maintaining its innovative biotech heritage and close connections to the Medical University of Innsbruck and the regional scientific community
• Acquisition strengthens Boehringer Ingelheim’s commitment to research and development of viral-based immuno-oncology treatment options aimed at transforming the lives of patients

Boehringer Ingelheim today announced that it has acquired all shares of ViraTherapeutics, a biopharmaceutical company specializing in the development of oncolytic viral therapies. ViraTherapeutics developed the lead candidate VSV-GP (Vesicular Stomatitis Virus (VSV) with modified glycoprotein (GP)), which is being investigated alone and in combination with other therapies. The total transaction value of EUR 210 million is based on an option and share purchase agreement signed between the companies in August 2016.

Oncolytic viral therapy is a cancer treatment approach with two modes of action. First, the virus specifically replicates in and kills cancer cells. Second, viral infection stimulates the immune system to recognize these same cancer cells, leading to immune-mediated killing of both infected and non-infected cancer cells, further enhancing tumor control. Boehringer Ingelheim and ViraTherapeutics are working to develop a next generation oncolytic viral therapy platform. The lead investigational candidate leveraging the platform, VSV-GP, has shown promising results in pre-clinical models, especially in combination with key immune modulatory principles Boehringer Ingelheim is developing.

“The acquisition of ViraTherapeutics with its exciting oncolytic virus platform is the conclusion of a trusting and close cooperation over two years,” said Dr. Heinz Schwer, CEO of ViraTherapeutics. “We are highly optimistic that our VSV-based development programs and technology will complement Boehringer Ingelheim’s immuno-oncology franchise and will serve as a source of innovative, new treatment options for patients living with cancer.”

“I want to thank the team around scientific founder Dorothee von Laer, CEO Heinz Schwer and COO Lisa Egerer for their dedication to research and scientific progress that led to a productive collaboration with Boehringer Ingelheim and ultimately to the early exercise of the purchase option,” said Dr. Klaus Schollmeier, Chairman of ViraTherapeutics’ advisory board. “I also want to thank the investors and my fellow board members for their hands-on commitment to this project. I am convinced that ViraTherapeutics’ research will become core to Boehringer Ingelheim’s oncology product pipeline.”

Using a dual approach for potential treatment options, specifically combining immuno-oncology approaches with tumor cell-directed treatments, is central to Boehringer Ingelheim’s cancer immunology research strategy. Oncolytic virus-based therapies are consistent with and complement that strategy.

“Our approach is rooted in transforming ‘cold’ tumors – or immunologically inactive tumors that are not responsive to the checkpoint blockers – to ‘hot‘ tumors – those that are most susceptible to immune system attack,” said Dr. Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors responsible for Boehringer Ingelheim’s Research and Development. “We are committed to investing in early research with promise and where our expertise best complements the strengths of our partners. Together, we aim to discover breakthrough medical treatments to transform the lives of patients and win the fight against cancer.”

ViraTherapeutics was a portfolio company of the two venture investors EMBL Ventures and the Boehringer Ingelheim Venture Fund (BIVF). BIVF is focused on strategic investment in highly innovative biotechnology and start-up companies to help drive innovation in medical science. The BIVF has EUR 250 million under management and currently supervises a portfolio of 22 active companies and is one of the most active investors in immuno-oncology world-wide.

https://www.biospace.com/article/releases/boehringer-ingelheim-acquires-all-viratherapeutics-shares-to-develop-next-generation-viral-based-immuno-oncology-therapies/

FDA to Review EYLEA Injection for the Treatment of Diabetic Retinopathy

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA^® (aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. The target action date for the FDA decision is May 13, 2019.

The sBLA submission is based on results from the Phase 3 PANORAMA trial investigating EYLEA as a treatment for patients with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) without diabetic macular edema (DME). Positive six-month topline results from PANORAMA were announced in March 2018. One-year results from PANORAMA are expected to be shared later this year.

The safety and efficacy of the potential use of EYLEA in DR without DME has not been fully evaluated by any regulatory authority.

EYLEA is administered as a 2 mg intravitreal injection and currently indicated to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, DME, and DR in patients with DME.

https://www.biospace.com/article/releases/fda-to-review-eylea-aflibercept-injection-for-the-treatment-of-diabetic-retinopathy/

Ironwood Gets FDA Fast Track for Praliciguat for Heart Failure

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF). Praliciguat is an investigational, orally administered soluble guanylate cyclase (sGC) stimulator currently in Phase II clinical trials.

“An ever-increasing number of people are suffering from HFpEF, a disease characterized by exercise intolerance, frequent hospitalizations, and increased risk of death, yet there are no approved treatment options,” said Christopher Wright, M.D., Ph.D., senior vice president of global development and chief development officer of Ironwood. “We believe praliciguat has the potential to be a new treatment option for these patients and are researching its ability to provide multi-dimensional impact on this disease by increasing tissue blood flow and decreasing cardiac vascular inflammation and fibrosis. The Fast Track Designation underscores the seriousness of this disease and that praliciguat has potential to address unmet needs in HFpEF. We look forward to working closely with the FDA to rapidly progress the development of praliciguat for the treatment of HFpEF.”

The FDA grants Fast Track Designation to facilitate the development and expedite the review of drugs that have the potential to treat serious or life-threatening diseases. A drug granted Fast Track Designation is eligible for several benefits, including more frequent meetings with and communications from the FDA and potentially for Rolling Review of the New Drug Application (NDA) and Priority Review if relevant criteria are met.1

Ironwood is currently enrolling patients in a randomized, double-blind, placebo-controlled Phase II trial evaluating praliciguat for the potential treatment of HFpEF. Ironwood expects to enroll approximately 175 patients into the Phase II trial, which is designed to evaluate the safety and efficacy of praliciguat in patients with HFpEF. Topline data from this study are expected in the second half of 2019. Further details about the trial can be found at clinicaltrials.gov using the identifier number NCT03254485.

https://www.streetinsider.com/Corporate+News/Ironwood+Pharma+%28IRWD%29+A

Sanofi ‘Refocus’: New ‘Primary Care,’ ‘China & Emerging Markets’ Units

Sanofi (NYSE: SNY) will change the organizational structure of two of its Global Business Units (GBU) to provide greater focus on its operations in mature markets and across emerging markets.[1] The company will create a new Primary Care GBU that combines the product portfolios of Sanofi’s existing Diabetes and Cardiovascular (DCV) GBU with Established Products, which are currently part of the General Medicines & Emerging Markets (GEM) GBU. The new Primary Care unit will focus exclusively on mature markets. To help build and lead the new Primary Care business, Sanofi is appointing Dieter Weinand as Executive Vice President. Effective November 1st, Mr. Weinand will report directly to Sanofi CEO Olivier Brandicourt and become a member of the Executive Committee. He will be based in the Bridgewater, New Jersey, United States. Stefan Oelrich, currently head of the DCV GBU, has decided to leave Sanofi and will join Bayer AG as a member of the Board of Management and head of the Pharmaceuticals division, replacing Mr. Weinand effective November 1st. “Dieter is a seasoned professional with significant experience in the pharmaceutical sector, having successfully launched and marketed some of the most innovative medicines in the last few years. He has a proven track record in change management and helping challenged businesses reach their full potential,” said Dr. Brandicourt. “As we welcome Dieter into the organization, I would like to thank Stefan for his excellent contributions to Sanofi over the years and wish him all the best in his next endeavor.”Sanofi is creating a second new global business unit called China & Emerging Markets to be led by Olivier Charmeil, currently head of the GEM GBU. This newly-formed business will focus on the unique characteristics and tremendous growth opportunities in emerging markets, particularly in China which is Sanofi’s second largest market after the United States. Mr. Charmeil will continue to be a member of the Executive Committee reporting directly to Dr. Brandicourt. Sanofi expects to launch the new Primary Care and China & Emerging Markets global business units by the beginning of 2019. Sanofi’s other GBUs-Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare-remain unchanged.

A U.S. citizen, Mr. Weinand has 30 years’ experience in the biopharmaceutical industry. He held various responsibilities in commercial, operational and strategic roles at a number of pharmaceutical companies including Warner Lambert, Pfizer and Bristol-Myers Squibb. Before moving to Bayer, he was President, Global Commercialization & Portfolio Management at Otsuka Pharmaceutical Development & Commercialization Inc. in Princeton, New Jersey, U.S. Mr. Weinand joined Bayer in 2014 as head of the Pharmaceuticals Division and was a member of the Bayer HealthCare Executive Committee. In 2016, he was appointed to the Board of Management of Bayer AG. Mr. Weinand holds a M.S. in Pharmacology and Toxicology from Long Island University, New York and a B.A. in Biology from Concordia College in Valhalla, New York.

https://www.streetinsider.com/Management+Comments/Sanofi+%28SNY%29+Ann

Bayer’s pharma unit head Weinand quits to join Sanofi

Bayer, which is revamping its drug development activities, is losing the head of its pharmaceuticals division Dieter Weinand, who will join Sanofi to stem a decline in prices in the French drugmaker’s anti-diabetics and established drugs.

In a statement on Thursday, Germany’s Bayer said Weinand would be succeeded by Stefan Oelrich, currently a member of Sanofi’s executive committee in charge of diabetes and cardiovascular businesses.

For Bayer, the job swap comes in the midst of talk on job cuts and outsourcing as part of a review of its drug research and development operations, which investors say has produced few promising products.

Bayer, which has acquired U.S. seed maker Monsanto, is looking to bolster its development pipeline because revenue from its top two drugs, blood thinner Xarelto and eye drug Eylea, peak over the next six years.

At Sanofi, Weinand will head a Primary Care unit that will comprise diabetes and cardiovascular treatments as well as established products in Western markets, both businesses with declining revenue due to strong competition and price pressure from healthcare systems.

He will be based in Bridgewater, New Jersey, and report to Chief Executive Olivier Brandicourt.

“(Weinand) has a proven track record in change management and helping challenged businesses reach their full potential,” Brandicourt said in a statement.

Bayer added that Hartmut Klusik, its labor director and board member responsible for technology, was given a contract extension by one year until the end of 2019, confirming a Reuters report.

Two sources familiar with the company have said an extension of Klusik’s contract had been in doubt because drug production at Bayer’s Leverkusen plant in Germany was found to be substandard by U.S. regulators in February and this fell under his remit.

But Bayer hung on to him to have an experienced head of personnel oversee the “very tangible” overhaul of the R&D operations, one said. First results of the review are expected as early as November.

Bayer said that Weinand, who was based in Germany, is leaving for family reasons.

Liam Condon, who was recently picked to lead Bayer’s enlarged Crop Science unit and oversee the integration of seeds maker Monsanto, would get a new five-year contract, Bayer added.

https://www.reuters.com/article/us-bayer-sanofi-executives/bayers-pharma-unit-head-weinand-quits-to-join-sanofi-idUSKCN1LT1KN

Humana initiated at Barclays

Humana initiated with an Overweight at Barclays. Barclays analyst Steven Valiquette started Humana with an Overweight rating and $370 price target.

https://thefly.com/landingPageNews.php?id=2789719

ObsEva initiated at JPMorgan

ObsEva initiated with an Overweight at JPMorgan. JPMorgan analyst Eric Joseph started ObsEva with an Overweight rating and $29 price target. The analyst views ObsEva as an “underappreciated, emerging clinical-stage player” in the women’s health space. The company has two pivotal stage assets addressing “significant commercial opportunities, and wholly owned rights in major markets,” Joseph tells investors in a research note.

https://thefly.com/landingPageNews.php?id=2789723