ESPR, MDCO Riding High, New Uses For MRK's Old Drug, DBVT In Full Smile(e)

(RTTNews) - DBV Technologies' (DBVT) phase IIA investigator-initiated clinical trial of Viaskin Milk for the treatment of milk-induced Eosinophilic Esophagitis is now fully enrolled.

In the study, dubbed SMILEE, 20 children with milk-induced EoE have been randomized 3:1 to receive Viaskin Milk 500 µg or placebo for up to 11 months.

Results from the SMILEE study are expected in the first half of 2018.

DBVT closed Friday's trading at $33.42, down 1.50%.

Shares of Esperion Therapeutics Inc. (ESPR) surged 29% on Friday on the back of good news about Amgen's (AMGN) cholesterol lowering approved drug, Repatha.

Repatha is a PCSK9 inhibitor, and on Thursday, Amgen announced that its landmark cardiovascular outcomes study, dubbed FOURIER, met the primary and secondary key endpoints.

Another trial conducted in FOURIER patients to evaluate cognitive function, known as EBBINGHAUS trial, also achieved its primary endpoint, demonstrating that Repatha was non-inferior to placebo for the effect on cognitive function.

Esperion is also developing a cholesterol lowering drug, which goes by the name Bempedoic acid.

Bempedoic acid is an inhibitor of ATP Citrate Lyase, and in under phase III trials. A global cardiovascular outcomes trial for Bempedoic acid, known as CLEAR Outcomes CVOT, was initiated by the company as recently as last month.

The top line results from one of the phase III studies of Bempedoic acid are expected by Q2 2018.

ESPR closed Friday's trading at $16.44, up 29.25%.

Another company, whose shares gained on the good news about Amgen's (AMGN) cholesterol lowering approved drug, Repatha, is The Medicines Co. (MDCO).

The Medicines Co. is also developing a cholesterol drug known as Inclisiran, which is under phase II development.

Like Amgen's Repatha, Inclisiran is also a PCSK9 inhibitor.

Last month, the company reported positive top-line results from Day 180 interim analysis in its ongoing phase II study of Inclisiran, dubbed ORION-1.

MDCO closed Friday's trading at $45.96, up 20.95%.

Two of Merck's (MRK) supplemental Biologics License Applications seeking approval of KEYTRUDA, one for first-line use and the other for second-line use, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer, have been accepted for review by the FDA.

The regulatory agency is scheduled to announce its decision on the two applications on June 14, 2017.

KEYTRUDA is already approved by the FDA for the treatment of metastatic melanoma, metastatic non-small cell lung cancer, and recurrent or metastatic head and neck squamous cell carcinoma.

The drug brought home sales of $1.4 billion in 2016 compared to $566 million in 2015.

MRK closed Friday's trading at $64.29, up 0.17%.

Portola Pharmaceuticals Inc. (PTLA) on Friday announced that it has signed a $150 million royalty agreement with HealthCare Royalty Partners for the development and commercialization of AndexXa, an investigational Factor Xa inhibitor antidote.

As part of the agreement, Portola has received $50 million, and is entitled to receive an additional $100 million upon FDA approval of AndexXa. In turn, HealthCare Royalty Partners will receive a tiered, mid-single-digit royalty based on worldwide sales of AndexXa.

The agreement is subject to a maximum total royalty payment of 195 percent of the $150 million funded by HealthCare Royalty Partners, at which time the agreement would expire.

AndexXa was issued a complete response letter by the FDA last August. The company needs to provide additional information primarily related to manufacturing of AndexXa, among other things.

PTLA closed Friday's trading at $29.28, up 2.74%.