Flexion Therapeutics Announces Publication of Phase 2 Diabetes Data

• Phase 2 data evaluating ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension) in patients with Type 2 diabetes demonstrated lower blood glucose levels following ZILRETTA injection compared to TAcs injection
• Approximately 30% of patients with Type 2 diabetes also have osteoarthritis of the knee

Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that data from a Phase 2 study of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) evaluating blood glucose levels in patients with osteoarthritis knee pain and Type 2 diabetes were published in the online edition of Rheumatology. The Phase 2, double-blind, randomized study met its primary endpoint demonstrating the change in blood glucose levels was significantly lower following ZILRETTA injection than immediate-release triamcinolone acetonide in crystalline suspension (TAcs) injection in people with osteoarthritis knee pain and Type 2 diabetes.

An estimated 29 million Americans are living with Type 2 diabetes and approximately 30% of them also have osteoarthritis of the knee.^1,2 Intra-articular corticosteroids are commonly used to manage osteoarthritis pain and inflammation and may affect blood glucose levels. Changes in blood glucose levels can pose critical clinical challenges for people with Type 2 diabetes. Recurrent and unaddressed hyperglycemia can lead to ketoacidosis (diabetic coma), kidney damage, heart disease and other serious complications.

“These data show that ZILRETTA did not significantly disrupt glycemic control, an important factor when considering a treatment option to help manage osteoarthritic knee pain for people with diabetes,” said Steven J. Russell, M.D., Ph.D., Associate Professor of Medicine, Massachusetts General Hospital Diabetes Research Center. “Osteoarthritis pain can have a serious impact on people’s lives and those with diabetes face the additional challenge of managing their blood glucose levels to avoid complications from the disease. Therefore it is valuable to have a treatment option that may avoid the blood glucose elevations commonly encountered with intra-articular injection of corticosteroids.”

The primary endpoint compared the change in average glucose values from the period of 72 hours before to the period 72 hours after injection with ZILRETTA versus TAcs. Key findings and conclusions showed:

• Change in average daily glucose levels were significantly lower in the 72 hours following injection of ZILRETTA compared to TAcs with a difference of 19.2mg/dL (p=0.0452);
• Blood glucose increase after injection was statistically significant in those treated with TAcs (p=0.0354), but not in those treated with ZILRETTA (p=0.6665);
• Average daily and hourly blood glucose levels 1-3 days following ZILRETTA injection were well within the American Diabetes Association-recommended target range; and
• ZILRETTA administration appeared to be associated with minimal disruption of glycemic control in people with osteoarthritis knee pain and Type 2 diabetes.

https://www.marketscreener.com/FLEXION-THERAPEUTICS-INC-15749853/news/Flexion-Therapeutics-Announces-Publication-of-Phase-2-Diabetes-Data-in-September-Issue-of-Rheumatolo-27237091/

Five Prime Starts Phase 3 for Gastric Cancers Med

• Five Prime plans to submit Phase 1 lead-in data for presentation at medical conference in the first half of 2019

Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a biotechnology company discovering and developing innovative immuno-oncology protein therapeutics, today announced that the company completed the Phase 1 safety lead-in portion and has initiated the Phase 3 portion of the FIGHT Phase 1/3 clinical trial of bemarituzumab (FPA144), an isoform-selective anti-FGF receptor 2b antibody, in combination with chemotherapy in patients with previously untreated, advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer.

“We are very pleased to have completed the safety lead-in and move into the Phase 3 registrational portion of the bemarituzumab trial in patients with gastric cancer,” said Helen Collins, M.D., Senior Vice President and Chief Medical Officer of Five Prime. “Patients with advanced gastric cancer are in dire need of new treatment options. Bemarituzumab is a targeted therapy and we are using state-of-the-art diagnostic tools to help us identify patients with FGFR2b overexpression, which is associated with a worse prognosis. Bemarituzumab has demonstrated encouraging monotherapy activity as a late-line treatment for gastric cancer and we believe that combining with chemotherapy in the front-line setting should provide the greatest patient benefit.”

In December 2017, Five Prime initiated the Phase 1 portion (NCT03343301) of the Phase 1/3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial. The Phase 1 portion tested bemarituzumab doses of 6 mg/kg and 15 mg/kg in combination with modified FOLFOX6 (mFOLFOX6) with no overlapping toxicities identified.

The randomized, controlled, double-blinded Phase 3 portion of the FIGHT trial will evaluate bemarituzumab plus mFOLFOX6 versus placebo plus mFOLFOX6 in approximately 550 patients with gastric cancer (GC) or gastroesophageal junction (GEJ) cancer whose tumors overexpress FGFR2b. The Phase 3 trial will include approximately 250 sites in the U.S., Europe and Asia, including China, South Korea and Japan, where the incidence of gastric cancer is high. Zai Lab will manage the Phase 3 portion of the FIGHT trial in China.

https://www.marketscreener.com/FIVE-PRIME-THERAPEUTICS-I-14297720/news/Five-Prime-Therapeutics-Completes-Phase-1-Safety-Lead-In-and-Initiates-Phase-3-Global-Registratio-27237218/

HCA Healthcare price target raised to $150 from $130 at RBC Capital

RBC Capital analyst Frank Morgan raised his price target on HCA Healthcare to $150 and kept his Outperform rating, citing the financial contribution from “several pending transitions” that are yet to close. The analyst highlights the $1.5B deal to acquire Mission Health in North Carolina and North Cypress in Houston, stating that these will add to the company’s anticipated tailwinds in 2019. Morgan is also positive on the “improved performance” from HCA Heathcare’s other Houston-area hospitals that were acquired from Tenet last year.
https://thefly.com/landingPageNews.php?id=2787965

Boston Scientific price target raised to $43 from $39 at Needham

Needham analyst Mike Matson raised his price target on Boston Scientific to $43 and kept his Strong Buy rating. The analyst cites the company’s latest $500M bid Augmenix, whose SpaceOAR reduces side effects associated with prostate radiotherapy. While the company expects “immaterial” earnings impact from the deal through 2019, Matson believes that it will strengthen its Urology & Pelvic Health business longer term, with added potential “revenue synergies given BSX’s NxThera acquisition and legacy GreenLight XPS system”.
https://thefly.com/landingPageNews.php?id=2787973

Acorda patent invalidity appeal for Ampyra denied by court

Acorda Therapeutics (ACOR) holds New Drug Application No. 022250, approved by the U.S. FDA, and pursuant to that approval markets Ampyra. In the FDA’s Orange Book, Acorda has listed, as claiming methods of using Ampyra, four patents that Acorda owns: U.S. Patent No. 8,007,826; No. 8,663,685; No. 8,354,437; and No. 8,440,703. The U.S. Court of Appeals for the Federal Circuit affirm a lower court’s judgment that the asserted Acorda patent claims are invalid. Roxane Laboratories, Mylan Pharmaceuticals (MYL), and Teva Pharmaceuticals (TEVA) have submitted Abbreviated New Drug Applications seeking FDA approval to market generic versions of Ampyra, the Federal Circuit Appeals court ruling noted.
https://thefly.com/landingPageNews.php?id=2788021

Incyte offering a ‘buying opportunity on weakness’ says RBC Capital

RBC Capital analyst Brian kept his Outperform rating on Incyte, saying that Friday’s selloff on the announced departure of its CFO is a “buying opportunity” as the stock remains a “compelling value”. The analyst notes that the recent rise in the stock price reflects the recognition of its “solid commercial and broad pipeline assets”, further pointing out the potential for the company to improve efficiencies in its business model.
https://thefly.com/landingPageNews.php?id=2787841

Walgreens to purchase pharmacy files of 185 Fred’s pharmacies for $165M

Walgreens (WBA) and Fred’s (FRED) announced they have entered into a definitive asset purchase agreement, pursuant to which Walgreens will acquire pharmacy patient prescription files and related pharmacy inventory of 185 Fred’s stores located across 10 Southeastern states. Under the agreement, the aggregate consideration to be paid by Walgreens to Fred’s is $165M, subject to adjustment, plus an amount equal to the value of related pharmacy inventory. The transaction is part of a previously announced plan by Fred’s to unlock shareholder value by monetizing non-core assets through strategic transactions. Fred’s will continue to operate its retail stores at most of these locations after the pharmacies close. Once the transaction is complete, Fred’s will continue to operate approximately 162 pharmacies across nearly 600 stores. Fred’s pharmacy staff at the closing locations will have an opportunity to apply for any available positions at Walgreens. The transaction is subject to the expiration or termination of applicable waiting periods under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the satisfaction or waiver of certain other customary closing conditions. The companies expect the file transfers to begin in 4Q18 and be completed in 1Q19.
https://thefly.com/landingPageNews.php?id=2787843