Piper reiterates Overweight on Crispr after ViaCyte collaboration

Piper Jaffray analyst Edward Tenthoff reiterates an Overweight rating on Crispr Therapeutics with a $67 price target after the company announced a collaboration with ViaCyte. ViaCyte is developing the stem cell therapy for insulin deficiency, but is currently limited by host rejection, Tenthoff tells investors in a research note. He points out that Crispr will develop gene-edited immuno-evasive properties into the cells, a potentially curative therapy. The analyst believes the collaboration leverages Crispr’s gene-editing in diabetes.
https://thefly.com/landingPageNews.php?id=2791495

FDA approves first rescue stent to seal coronary artery tears in 17 years

The Berlin-based company plans to make the PK Papyrus covered stent available in the U.S. in 2019. (Biotronik)

The FDA approved a new emergency stent device to treat perforations in the blood vessels of the heart, the agency’s first new treatment option in the indication in 17 years.

Deep tears in coronary arteries can occur on rare occasions during percutaneous interventions, where stents are inserted via a catheter to expand narrowed vessels to increase blood flow to the heart.

To stop blood from leaking out to the area surrounding the heart, Biotronik’s PK Papyrus covered, ultrathin, balloon-expandable coronary stent system is inserted in a similar procedure. It provides a physical barrier with a polyurethane membrane that seals the tear from inside the artery, avoiding the need for open-heart surgery.

“Perforation is very uncommon, but physicians need to be fully prepared for this emergency event,” said Marlou Janssen, president of Biotronik, which estimated fewer than 4,000 interventions per year require rescue with a covered stent. “It’s unacceptable that this critical care area has seen no innovation in nearly two decades.”

For the approval, the FDA reviewed the PK Papyrus system under the humanitarian device exemption process, intended for conditions that affect fewer than 8,000 patients annually in the U.S. The agency considered real-world survey data from 80 patients who received PK Papyrus stents, with successful delivery reported in 76, or 95%, and successful sealing of the perforation in 73 patients, or 91.3%.

Two deaths occurred during the original percutaneous coronary intervention, with seven patients undergoing treatment to drain fluids collected around the heart, the FDA said. Five patients died in the hospital after their perforations were successfully sealed, while one patient died who did not have a successful procedure.

Available in 17 sizes, PK Papyrus previously received a CE mark in 2013. Biotronik plans to make the system available to U.S. physicians next year.

The Berlin-based company received its first FDA approval of a coronary stent in February 2017 for its bare-metal PRO-Kinetic Energy system. The cobalt-chromium alloy stent can treat coronary artery disease in vessels 2.25 to 4 mm in diameter and up to 31 mm long. It is coated with a layer of silicon carbide to lessen the release of metal ions into the surrounding tissue. Before that, the company received a 2015 approval for its Astron stent to treat peripheral artery disease.

https://www.fiercebiotech.com/medtech/fda-approves-first-rescue-stent-to-seal-coronary-artery-tears-17-years

Pfizer ‘all in’ on next-gen pneumococcal vaccine candidate: CFO

The race is on for a next-generation pneumococcal vaccine. Merck has already pushed its 15-valent candidate into phase 3, and on Thursday, Pfizer CFO Frank D’Amelio said his company is “all in” on reaching the market as soon as possible with its candidate.

At a Morgan Stanley healthcare conference Thursday, D’Amelio said after Pfizer closed its internal neuroscience program earlier this year, the company shifted resources to accelerate development for its 20-valent pneumococcal vaccine candidate. Pfizer believes it can enter the market at a competitive timeframe to Merck and its next-generation shot, D’Amelio said. Pfizer already markets pneumococcal vaccine Prevnar 13, the world’s bestselling vaccine.

On market entry timing, he said “if we are close, we think the strength of the current franchise,” plus additional protection, will allow Pfizer to retain market share and “keep the franchise growing very nicely.”

Pfizer recently completed a proof-of-concept study for its vaccine and “will start spending a bunch of money” to support its 20-valent candidate, the CFO said. Phase 2 data showed the vaccine can induce immune responses to all 20 pneumococcal serotypes, and that it was safe and well tolerated. The company is planning a phase 3 testing program.

Merck is already in phase 3 with its vaccine. In one late-stage study, Merck is testing its candidate head-to-head against Prevnar 13.

Last year, Pfizer’s Prevnar franchise generated $5.6 billion around the world, a 2% decline from 2016. Sales for the shot have flattened after fast growth in recent years, but D’Amelio said Pfizer believes it can still grow the franchise going forward due to opportunities outside of the U.S.

https://www.fiercepharma.com/vaccines/pfizer-all-advancing-next-gen-pneumococcal-vaccine-candidate-cfo

ChromaDex to Partner on Aging Research with Jiangxi Government in China

ChromaDex Corp.(NASDAQ:CDXC), an integrated, science-based, nutraceutical company devoted to improving the way people age with its flagship ingredient NIAGEN^® and consumer product TRU NIAGEN^®, today announced a strategic partnership for healthy aging research with the Jiangxi Provincial Government, People’s Republic of China.

Wu Zhongqiong, Vice Governor of the People’s Government of Jiangxi Province, commenced the ceremony at the Jiangxi Qianhu State Guesthouse on Thurs., Sept. 13. Additional presentations followed from Madame Wang of Qifeng Food Technology, Dr. Katherine Lo of the Li Ka Shing Foundation, Robert Fried of ChromaDex, and Drs. Charles Brenner and Roger Kornberg of the ChromaDex Scientific Advisory Board.

“We are grateful to have met with the leaders of the great province of Jiangxi and look forward to furthering this relationship,” says ChromaDex CEO Rob Fried. “This is an important first step in our long-term commitment to China.”

“This is a momentous occasion here in Jiangxi,” says Kornberg, who won the Nobel Prize in Chemistry in 2006. “I look forward to the research and progress in the study of aging that will come from this new initiative.”

“I’m thrilled to present the foundational science of nicotinamide riboside (NR) and the safe, evidence-based commercialization of our ingredient to Nanchang and Jiangxi Province,” says Brenner. “The global interest in our technology is exciting, and I look forward to advancing our research and development even further.” Brenner discovered NR and is the Chief Scientific Advisor at ChromaDex.

The initiative will allow Jiangxi to become a foothold for advanced scientific research and business development to solve the problem of aging. The parties continue to discuss the details of the relationship, including their respective contributions to the venture, with the anticipation of finalizing definitive agreements later this year.

In addition to the anti-aging initiative, the ceremony also celebrated the launch of the Food Technology Science Park, in collaboration with Qifeng Food Technology Co. of Beijing, to build a world-class, tech-centric science research complex in Jiangxi.

https://www.marketscreener.com/CHROMADEX-CORP-27343156/news/ChromaDex-Announces-Strategic-Partnership-for-Aging-Research-with-Jiangxi-Government-in-China-27270150/

DOJ Closes Investigation of Sinovac

Sinovac Biotech Ltd. (NASDAQ: SVA) (“Sinovac” or the “Company”), a leading provider of biopharmaceutical products in China, today announced that the U.S. Department of Justice (“DOJ”) has closed its investigation, with no charges, into possible violations of the Foreign Corrupt Practices Act related to allegations that certain Sinovac employees made improper payments to Chinese government officials. The closing of the DOJ investigation follows the SEC’s termination of its related investigation, which the Company announced on August 20, 2018.  With the closure of the DOJ’s investigation, the Company is not aware of any pending U.S. government investigations of the Company related to these matters. Sinovac is committed to conducting business in compliance with all applicable laws and cooperated fully with the DOJ. Sinovac will continue in its mission of researching, developing, manufacturing and commercializing vaccines that protect against human infectious diseases.

https://www.marketscreener.com/SINOVAC-BIOTECH-LTD-5714593/news/Sinovac-Biotech-DOJ-Closes-Investigation-of-Sinovac-27270306/

Array publishes Phase 3 data on melanoma combo

Array BioPharma Inc. (NASDAQ: ARRY) today announced the publication of detailed overall survival (OS) results from the COLUMBUS trial in The Lancet Oncology.

The pivotal Phase 3 trial evaluated the efficacy and safety of the combination of BRAFTOVI+ MEKTOVIcompared to vemurafenib monotherapy in patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation. BRAFTOVI + MEKTOVI reduced the risk of death compared to treatment with vemurafenib [hazard ratio (HR) of 0.61, (95% CI 0.47-0.79, p

https://www.marketscreener.com/ARRAY-BIOPHARMA-INC-8433/news/Array-BioPharma-Announces-Publication-of-BRAFTOVI-MEKTOVI-Phase-3-Overall-Survival-Data-in-the-L-27272225/

Regeneron: FDA to Review EYLEA for 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.marketscreener.com/REGENERON-PHARMACEUTICALS-10649/news/Regeneron-Pharmaceuticals-FDA-to-Review-EYLEA-Injection-for-the-Treatment-of-Diabetic-Retinopathy-27272256/