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

Inogen price target raised to $290 from $245 at Piper Jaffray

Piper Jaffray analyst JP McKim raised his price target for Inogen to $290 after traveling with management. The “thematic shift” to portable oxygen concentrators away from tanks remains early in the conversion and all the key growth drivers for the business remain very strong, McKim tells investors in a research note. Further, the analyst believes competition, either from others entering the market or attempting to go direct-to-consumer, “remains noise at this time” with little to no impact on Inogen’s business. He believes the company’s Q3 is shaping up to be strong and has renewed confidence in its multiyear growth story. McKim keeps an Overweight rating on Inogen.

https://thefly.com/landingPageNews.php?id=2789733