LHC, LifePoint Finalize JV Purchase of Wilson Home Health Provider

LHC Group (NASDAQ: LHCG) and LifePoint Health® (NASDAQ: LPNT) have finalized the purchase of Wilson County Home Health. The two organizations will share ownership of the home health provider, serving patients and families in Wilson County, NC, and the surrounding region.

The provider was purchased – effective Sept. 1 – from Wilson County by the existing joint venture partnership between LHC Group and LifePoint Health. The name has changed to Home Health of Wilson, and the agency is operating from a new location at 1901 Tarboro St., SW, Suite 304, in Wilson.

With the completion of the acquisition by LHC Group and LifePoint Health, Home Health of Wilson will be affiliated with Wilson Medical Center, enabling a seamless coordination of care for the patients they serve. Wilson Medical Center is a 294-bed facility that is affiliated with LifePoint through Duke LifePoint Healthcare, the network of which Wilson Medical Center is a part.

Hospital and home health/hospice partnerships focus on delivering patient-centered care in the comfort of the patient’s home. They are a key component in helping patients recover, manage chronic conditions, deal with the challenges and complexities of terminal illness, and achieve the best possible outcome. LHC Group is the joint venture partner of choice for 76 health systems consisting of 337 hospitals across the United States.

LHC Group and LifePoint Health formed their partnership in January 2017. Together, they currently operate 31 home health and 14 hospice locations in 10 states as part of the joint venture partnership, and continue creating new opportunities to develop and expand post-acute services in the communities they serve.

https://www.marketscreener.com/LIFEPOINT-HEALTH-INC-9908/news/LifePoint-Health-LHC-Group-and-LifePoint-Health-Finalize-Joint-Venture-Purchase-of-Wilson-Home-Hea-27213932/

Bayer Adjusts Guidance as 2Q Net Profit Drop

Bayer on Wednesday adjusted its 2018 guidance to reflect the acquisition of Monsanto as it reported a sharp decline in second-quarter earnings.

Net profit for the quarter was 799 million euros ($925.1 million) down from EUR1.22 billion a year earlier, largely due to the deconsolidation of Covestro, which now reports as a separate company, Bayer said.

Sales rose 8.8% to EUR9.48 billion from a restated figure of EUR8.71 billion in the second quarter last year.

The German conglomerate issued new financial guidance to reflect the Monsanto acquisition and the divestment of several businesses, including its vegetable-seeds unit.

“As the acquisition of Monsanto closed later than anticipated, Bayer’s 2018 earnings will be lower than it had projected in its February forecast due to the seasonality of Monsanto’s business,” the company said.

Core earnings per share should be between EUR5.70 and EUR5.90, compared with a restated 2017 figure of EUR6.64 a share, Bayer said.

However, the company said it expects 2018 sales of more than EUR39 billion, compared with a previous estimate of below EUR35 billion. Monsanto should contribute sales of around EUR5 billion to the group total, Bayer said.

https://www.marketscreener.com/BAYER-436063/news/Bayer-Adjusts-Guidance-as-2Q-Net-Profit-Drops-27209893/?countview=0

Bausch + Lomb: Med met primary endponts in eye surgery pain study

Bausch + Lomb, a wholly owned subsidiary of Bausch Health, announced that the Journal of Cataract and Refractive Surgery has published results of a pivotal Phase 3, multicenter, double-masked, vehicle-controlled, randomized, parallel-group study that evaluated the clinical safety and efficacy of submicron loteprednol etabonate ophthalmic gel, 0.38%. In the study, this investigational formulation of loteprednol etabonate met both of the primary efficacy endpoints in that it was significantly more effective than vehicle in completely resolving ocular inflammation and pain following cataract surgery. Additionally, the results showed that submicron loteprednol etabonate ophthalmic gel, 0.38% had an acceptable safety profile regardless of whether it was administered two or three times per day. Submicron loteprednol etabonate ophthalmic gel, 0.38% has a reduced concentration and reduced dosing frequency versus existing formulations of loteprednol etabonate. The published Phase 3 study, which enrolled 514 patients, showed that a significantly greater proportion of patients who received submicron loteprednol etabonate ophthalmic gel, 0.38% dosed twice daily or three times daily had complete resolution of anterior chamber cells on postoperative day 8 compared with the vehicle group. Similarly, a significantly greater proportion of patients who received submicron loteprednol etabonate ophthalmic gel, 0.38% twice daily or three times daily had no ocular pain on day 8 compared with the vehicle group. For patients in the submicron loteprednol etabonate ophthalmic gel, 0.38% group, statistically significant differences in both anterior chamber cells and ocular pain were sustained at all subsequent visits relative to vehicle. Additionally, significantly fewer patients in the submicron loteprednol etabonate ophthalmic gel, 0.38% twice daily group and three times daily group required rescue medication by day 8 compared with those in the vehicle group. The most common ocular adverse events were eye pain, photophobia, and foreign body sensation. The U.S. Food and Drug Administration has accepted the New Drug Application for submicron loteprednol etabonate ophthalmic gel, 0.38% with a Prescription Drug User Fee Act action date of Feb. 25, 2019.

https://thefly.com/landingPageNews.php?id=2786161

CVS-Aetna, Cigna-Express Scripts deals nearing approval from DOJ, WSJ says

CVS Health (CVS) and Aetna (AET) will need to divest some Medicare assets to gain approval, but Cigna (CI) and Express Scripts (ESRX) are unlikely to need to make divestitures, according to Dow Jones headlines.

https://thefly.com/landingPageNews.php?id=2786171

After Multiple Failures, Teva Returns Laquinimod Rights to Active Biotech

Active Biotech, headquartered in Lund, Sweden, regained the global development and commercialization rights to laquinimod from Israel-based Teva Pharmaceutical Industries.

Teva indicates it did not plan on continuing clinical development of the drug, which it has been conducting since 2004. All rights, including data created in its preclinical and clinical programs, will be picked up by Active.

Laquinomid is an orally-available small molecule developed primarily for neurodegenerative diseases like multiple sclerosis (MS) and Huntington’s disease (HD). The drug was in three completed Phase IIII trials in relapsing remitting MS (RRMS) and a single Phase II trial in Huntington’s. The drug showed a consistent effect on endpoints and MRI parameters in RRMS as well as a “pronounced effect on brain trophy” in both RRMS and HD. The drug has a good safety profile.

“We are grateful for the good collaboration with Teva and for the broad development program that has been carried out for laquinimod,” said Helen Tuvesson, chief executive officer of Active Biotech, in a statement. “The pronounced effect of laquinimod on brain atrophy demonstrated in both RRMS and HD patients supports our belief in the potential of laquinomod as a possible treatment for neurodegenerative diseases, a disease area where the medical need remains high. Therefore, we will assess all opportunities for a continuation of the development of laquinimod.”

Laquinimod is an orally-available selective aryl hydrocarbon receptor (AhR) activator that targets neurodegeneration and inflammation. In addition to MS and HD, clinical studies have been performed in Crohn’s disease and Lupus.

It seems a little peculiar that Active is putting a positive spin on this drug. On July 31, Teva and Active announced that the Phase II LEGATO-HD clinical trial in HD failed to meet its primary endpoint of change from baseline after 12 months of treatment. The secondary endpoint, decrease of brain atrophy, was met. The trial was sponsored by Teva in collaboration with the Huntington Study Group and the European Huntington’s Disease Network.

And on December 1, 2017, the two companies announced that the drug’s Phase II proof-of-concept study of the drug in Primary Progressive MS did not meet the primary endpoint of brain atrophy, nor was the secondary endpoint of time to confirmed disability progression. A reduction in new T2 lesions observed in patients treated with 0.6 mg of laquinimod.

Teva originally went after laquinimod as a possible drug to follow Copaxone, Teva’s blockbuster drug for relapsing MS. That clearly isn’t going to happen, and Teva seemed slow to come to the realization, even if most analysts gave up on the drug some time ago.

Teva has struggled in recent years, including having debt ranging from $30 to $35 billion. It acquired Allergan’s generics business for $40.5 billion back in 2015, but the generics business has struggled because of price competition in the U.S. There has been a fairly steady price erosion in company stock as well. Its high was $70.32 on August 7, 2015, which steadily dropped to a low of $11.40 on November 3, 2017. It’s been slowly recovering, currently trading at $22.67 per share.

The company underwent a reorganization and new leadership in late November 2017, which is about the time the stock started its slow recovery. Part of that reorganization included the company no longer having two separate global organizations for generics and specialty medicines. They were integrated into a single commercial organization that operates through three regions—North America, Europe and Growth Markets. The Generic R&D and Specialty R&D groups were combined into a single global group. It formed a new Marketing & Portfolio group to oversee the interface between regions, R&D and operations. Several executives retired and a new group of managers came in, including Mike McClellan as executive vice president and chief financial officer, Hafrun Fridriksdottir as executive vice president, Global R&D and several others.

https://www.biospace.com/article/-am6a-teva-relinquishes-laquinimod-rights-to-active-biotech/

Biohaven deal with AstraZeneca enhances leadership, says Piper Jaffray

Piper Jaffray analyst Tyler Van Buren says Biohaven Pharmaceutical (BHVN) has licensed a Phase III-ready central nervous system asset from AstraZeneca (AZN) that appears to have $500M-plus potential and “further broadens the company’s pipeline.” Based on his follow-up with management, the analyst believes the upfront cash payment is modest and that the Phase III trial will be efficient and require an estimated additional spend of $20M. Van Buren thinks the deal is an “attractively structured, efficient and opportunistic” that enhances Biohaven’s leadership in CNS drug development. He keeps an Overweight rating on the shares with a $48 price target.

https://thefly.com/landingPageNews.php?id=2786039

Emirates plane ‘quarantined’ as passengers report ‘feeling sick’ in NY

ng an Emirates flight from Dubai to New York reported feeling ill on a flight to JFK airport, forcing authorities to quarantine the plane.

Emirates flight 203 has been quarantined at JFK (Image: LARRY COBEN)

Emirates flight 203 was met at John F Kennedy airport by New York Port Authority Police and officials from the US Centre for Disease Control and Prevention when it landed.

The New York Mayor’s office confirmed the plane had been quarantined at the aiport after landing shortly after 9am local time.

The plane’s pilot had earlier notified the authorities around 100 of his 500 passengers had started to feel sick with fevers and some were coughing, according to initial reports from New York media outlets.

An Emirates spokeswoman later confirmed 10 passengers fell ill on the flight from Dubai to New York.

Larry Cohen, who identified himself as one of the passengers aboard the plane, uploaded photos on Twitter showing dozens of police and emergency vehicles waiting outside the plane on the tarmac.

Mr Cohen told Reuters via Twitter messaging: “All we have been told is that there are some sick passengers and that we need to remain on board.”

An Emirates spokewoman said: “Emirates can confirm that about 10 passengers on board flight EK203 from Dubai to New York were taken ill,” .

“On arrival at JFK, as a precaution, they were immediately checked by local health authorities and those needing medical attention will be attended to.”

She said all other passengers would be allowed to leave the plane shortly.

Officials from the Port Authority Police Department and the US Centre for Disease Control and Prevention are on scene, the New York’ mayor office confirmed.

https://www.express.co.uk/news/world/1013406/new-york-news-jfk-airport-emirates-flight-passengers-sick