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Tuesday, July 10, 2018

Achaogen to Update on Plans Post FDA OK of Anti-Infective


Achaogen, Inc. (NASDAQ:AKAO), a biopharmaceutical company developing and commercializing innovative antibacterial agents to address multi-drug resistant (MDR) gram-negative infections, will host a lunch updating investors on the market opportunities for plazomicin, including the treatment of serious bacterial infections due to MDR Enterobacteriaceae with perspectives from key opinion leaders Steven Burdette, M.D. and Joshua Rosenberg, M.D., on Thursday, July 12, from 12:00pm – 1:30pm Eastern Time in New York City.
Achaogen management will present an update on the commercial strategy for ZEMDRITM(plazomicin), which recently received U.S. Food and Drug Administration (FDA) approval for treating adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by certain Enterobacteriaceae in patients who have limited or no alternative treatment options. Key opinion leaders Dr. Burdette and Dr. Rosenberg will discuss their perspectives on current and novel approaches to treating these infections.
Dr. Burdette is a Professor of Medicine at Wright State University Boonshoft School of Medicine where he serves as the program director for the Infectious Diseases Fellowship. He is the medical director of antimicrobial stewardship for Miami Valley Hospital and Premier Health. He also serves as medical director of infection prevention for Miami Valley Hospital (which includes three acute care hospitals), Indu and Raj Soin Medical Center and Greene Memorial Hospital. He has authored 15 book chapters and 36 PubMed referenced articles. Research interests currently include management of bacteremia and the role of rapid diagnostics in antimicrobial stewardship. Dr. Burdette completed his Internal Medicine Residency and Infectious Diseases Fellowship through Wright State University.
Dr. Joshua Rosenberg is the Chair of Critical Care, Director of Surgical Intensive Care, and Infection Control at The Brooklyn Hospital Center in Brooklyn, New York. He currently practices both Critical Care Medicine and Infectious Diseases in a hospital-based setting. Dr. Rosenberg is Board Certified in Critical Care Medicine, Infectious Diseases, and Internal Medicine. Dr. Rosenberg completed his Internal Medicine Residency and fellowships in Infectious Diseases and Critical Care Medicine at SUNY Downstate Medical Center in Brooklyn, New York. He received his medical degree from Sackler School of Medicine, Tel Aviv University, Tel Aviv, IsraelDr. Rosenberg has been in practice in Brooklyn NY since graduation from his critical care fellowship. His training brought him to multiple hospitals in Brooklyn and Staten Island. He currently also serves as Clinical Associate Professor with St. George’s School of Medicine in Grenada, West Indies and is the clinical site advisor for medical students rotating at The Brooklyn Hospital. Dr. Rosenberg has designed and implemented adult sepsis protocols in multiple institutions as well as supervising clinical document improvement hospital wide. His interests lie in prevention and treatment of health care acquired infections, antimicrobial stewardship, and treatment of complex multi-drug resistant gram-negative infections.
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay of the event will be accessible here.

Trump says Pfizer is rolling back drug price hikes


 U.S. President Donald Trump on Tuesday said Pfizer Inc was rolling back drug prices after he spoke with Pfizer’s chief executive officer and U.S. Health and Human Services Secretary Alex Azar.

“We applaud Pfizer for this decision and desire other companies do the same,” Trump said in a tweet. On Monday, Trump took aim at Pfizer and other U.S. drugmakers after they raised prices on some of their medicines on July 1, saying his administration would act in response.

Japan’s Takeda gains U.S. approval for $62 billion Shire buy


Takeda Pharmaceutical Co Ltd on Tuesday said it has received U.S. approval for its $62 billion acquisition of London-listed Shire Plc, taking the Japanese firm one step closer to its goal of becoming a global top 10 drugmaker.

Takeda in a press release said it received unconditional clearance from the United States Federal Trade Commission.
The Tokyo-listed firm is still awaiting approval from regulators in China, the European Union and elsewhere, as well from shareholders of both parties.
Chief Executive Christophe Weber has been working to persuade investors about the deal’s cost-saving merits. However, concerns of the financial burden the combined company will carry has weighed heavily on Takeda’s stock price.
Takeda shares closed flat on Tuesday ahead of the announcement. The stock is down 16 percent since the firm first said at the end of March it was considering bidding for Shire.
The drugmaker expects the deal to close in the first half of 2019.

Risk adjuster suspension positive for Centene and Molina, says Piper


Centers for Medicare & Medicaid Services suspending risk adjusters for the health exchange will likely cost the government and consumers more, but it could be positive for Centene (CNC) and Molina Healthcare (MOH), Piper Jaffray analyst Sarah James tells investors in a research note. Both companies are in a net payable position for 2017 and not having to pay these funds would allow the plans to retain cash, the analyst adds. James also sees a positive read-through for UnitedHealth (UNH), Aetna (AET) and Cigna (CI). The analyst finds it most likely that CMS will seek to adjust the risk adjusters in the end rather than cancel the program, but she adds the agency only has a few weeks for them to sort this out, which she feels is not enough time.

Concert well positioned into Q4 data catalyst, says Mizuho


Concert Pharmaceuticals is expected to report top-line data from CTP-543 in patients with moderate-to-severe alopecia areata in Q4, Mizuho analyst Difei Yang tells investors in a research note. The analyst expects the readout will be an important catalyst for Concert shares and remains confident in the potential of CTP-543. The company is well positioned relative to most alopecia areata competitors from a timeline perspective, Yang contends. She keeps a Buy rating on Concert Pharmaceuticals with a $27 price target.

Rocket Pharma started at buy by Blair


Rocket Pharmaceuticals initiated with an Outperform at William Blair. William Blair analyst Raju Prasad started Rocket Pharmaceuticals with an Outperform rating. Rocket is a “multi-platform gene therapy company ready for launch” with up to four clinical programs in 2019, the analyst contends

MyoKardia started at buy by B of A


MyoKardia initiated with a Buy at BofA/Merrill. BofA/Merrill analyst Tazeen Ahmad initiated MyoKardia with a Buy and $71 price target saying the company focuses on treating cardiovascular diseases and has two clinical assets, mavacamten and MYK-491, that could become the first FDA therapies approved in hypertrophic and dilated cardiomyopathy. Ahmad believes MyoKardia’s investment by Sanofi in mavacamten as a de-risking event.