U.S. judge says may order halt to integration of CVS-Aetna

A federal judge who has been asked to sign off on the government’s decision to approve CVS Health Corp’s (CVS.N) acquisition of insurer Aetna Inc indicated on Monday he may ask the companies to halt integration pending his decision.

Judge Richard Leon of the U.S. District Court for the District of Columbia complained at a hearing last week that the two sides had treated him as a “rubber stamp” for the deal. CVS closed the $69 billion transaction last week and began the integration process.

Leon said at a hearing on Monday that he would issue an order asking the two sides to argue why he should not require CVS and Aetna to be held separate until he decides whether he will approve the consent agreement reached in October between the companies and the U.S. Justice Department.

Makan Delrahim, the assistant attorney general for antitrust, declined comment after the hearing.

A CVS spokesman said in an email after the hearing: “CVS Health and Aetna are one company, and our focus is on transforming the consumer health experience.”

Leon said during the brief hearing that he was “concerned” the Justice Department’s filing with the court pointed to antitrust issues. In October, the Justice Department approved the merger of CVS, a pharmacy chain and benefits manager, and Aetna on condition that the health insurer sell its Medicare Part D drug plan business to WellCare Health Plans Inc (WCG.N).

Most deals struck between the government and companies to resolve antitrust concerns are approved by federal courts with little fuss under the 1974 Tunney Act, which requires courts to ensure the agreement is in the public interest.

Companies generally do not wait for final court approval before closing their transactions.

https://www.reuters.com/article/us-aetna-m-a-cvs-health/u-s-judge-says-may-order-halt-to-integration-of-cvs-aetna-idUSKBN1O22B5

Vanda Pharma gains on positive tradipitant data

Vanda Pharmaceuticals (VNDA +16.3%) is up on below-average volume in early trade following its announcement of successful results from a 141-subject Phase 2 clinical trial evaluating tradipitant in patients with idiopathic (cause unknown) and diabetic gastroparesis.

The study met the primary endpoint of change in nausea score versus placebo (-1.2 vs. -0.7; p=0.0099). Patients in the treatment group also experienced a statistically significant improvement in the proportion of nausea-free days compared to control (28.8% vs. 15.0%; p=0.0160).

On the safety front, tolerability was similar between tradipitant and placebo.

The company plans to meet with regulatory authorities to clarify a path to registration.

Vanda in-licensed the neurokinin 1 antagonist from Eli Lilly in 2012.

Previously: Vanda’s tradipitant shows mixed results in mid-stage dermatitis study (Sept. 13, 2017)

https://seekingalpha.com/news/3413905-vanda-pharma-16-percent-positive-tradipitant-data

FDA approves Atossa endoxifen for “expanded access” preop cancer therapy

Atossa Genetics (NASDAQ:ATOS) announces that the FDA has approved an “expanded access” of Atossa’s oral Endoxifen in the preoperative setting in a U.S. patient awaiting surgery for breast cancer.

Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials.

https://seekingalpha.com/news/3413877-fda-approves-atossa-genetics-endoxifen-expanded-access-preoperative-systemic-endocrine

Sienna Bio’s pegcantratinib flunks mid-stage psoriasis study

Thinly traded micro cap Sienna Biopharmaceuticals (SNNA -27.2%) is down on average volume following its announcement of topline data from a Phase 2b clinical trial evaluating SNA-120 (pegcantratinib) in patients with mild-to-moderate psoriasis with at least moderate pruritis (itchy skin).

The study failed to achieve the primary endpoint of the change from baseline to week 8 in a scale of pruritis severity called I-NRS. Specifically, patients treated with SNA-120 experienced a mean 4.3-point reduction in I-NRS compared to a 4.0-point reduction for vehicle (placebo) (p=0.244). The results were similar between the 0.05% and 0.5% strengths.

On a positive note, 27% of treated patients achieved a 75% reduction in symptoms (PASI 75) compared to 13% for vehicle (p=0.045).

No safety signals were observed.

A Phase 2 study in atopic dermatitis should launch in H2 2019.

https://seekingalpha.com/news/3413943-sienna-bios-pegcantratinib-flunks-mid-stage-psoriasis-study-shares-27-percent

Unilever to buy GlaxoSmithKline’s Horlicks business for EUR3.3B

https://thefly.com/landingPageNews.php?id=2830876

Spectrum announces ‘positive’ results from Phase 2 trial of leucovorin

Spectrum Pharmaceuticals announced results from a prospective Phase 2 single-arm, open-label, multicenter clinical trial studying the management of oral mucositis with the use of oral leucovorin as adjunct to FOLOTYN in patients with hematological malignancies, including PTCL and CTCL. Study results with a total of 35 patients demonstrated that use of leucovorin 25 mg tablets by oral administration for two days, initiated 24 hours after each FOLOTYN dose reduced the rate of Grade 2 or greater mucositis significantly, to 5.7 percent from historic rate associated with FOLOTYN use. There were no reports of greater than or equal to Grade 3 oral mucositis. Grade 1 oral mucositis was reported only in 4 patients. No patient omitted, delayed or reduced FOLOTYN dose due to oral mucositis with adjunct leucovorin therapy. The occurrence of mucositis, an impediment of FOLOTYN, has previously been reported at a rate of 52 percent at Grade 2 or higher in patients undergoing treatment with FOLOTYN in a registration study.

https://thefly.com/landingPageNews.php?id=2830951

Tesaro to be acquired by Glaxo for aggregate consideration of approx. $5.1B

https://thefly.com/landingPageNews.php?id=2830958