AwesomeCapital

Wednesday, October 16, 2019

Ipsen (OTCPK:IPSEY) subsidiary Clementia Pharmaceuticals and Blueprint Medicines (NASDAQ:BPMC) have entered into an exclusive, worldwide license agreement for the development and commercialization of BLU-782, an oral, highly selective investigational ALK2 inhibitor being developed for the treatment of fibrodysplasia ossificans progressiva (FOP).

Subject to the terms of the license agreement, Blueprint Medicines will be eligible to receive up to $535M in upfront, milestone and other payments, including an upfront cash payment of $25M and up to $510M in milestone payments, plus tiered percentage royalties ranging from the low- to mid-teens.

https://seekingalpha.com/news/3506031-ipsen-licenses-blueprint-medicines-bluminus-782-treatment-fop

ViiV Healthcare files U.S. application for expanded use of HIV med Dovato

ViiV Healthcare has submitted a supplemental marketing application to the FDA seeking approval to use Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure.

The FDA approved the drug in April for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either DTG or 3TC.

ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).

https://seekingalpha.com/news/3506056-viiv-healthcare-files-u-s-application-expanded-use-hiv-med-dovato

Incyte’s Jakafi successful in late-stage Graft v Host Disease study

Incyte (NASDAQ:INCY) announces a successful outcome from a Phase 3 clinical trial, REACH2, conducted by licensee Novartis (NYSE:NVS), evaluating Jakafi (ruxolitinib) in patients with steroid-refractory acute graft-versus-host disease (GvHD).

The study met the primary endpoint of overall response rate (ORR) at day 28 compared to best available therapy.

Data analyses are ongoing. The results will be submitted for presentation at a future medical conference. Novartis plans to initiate discussions with ex-U.S. regulatory authorities in 2020 regarding marketing applications.

The FDA approved Jakafi for GvHD in May.

Incyte markets Jakafi in the U.S. while Novartis owns marketing rights ex-U.S.

https://seekingalpha.com/news/3506061-incytes-jakafi-successful-late-stage-gvhd-study

Abbott down 2% premarket after trimming EPS range

Abbott Laboratories (ABT) Q3 results: Revenues: $8,076M (+5.5%); Nutrition: $1,874M (+2.0%); Diagnostics: $1,909M (+4.7%); Established Pharmaceuticals: $1,212M (+4.4%); Medical Devices: $3,065M (+8.9%).

Net Income: $960M (+73.9%); EPS: $0.53 (+71.0%); Non-GAAP Net Income: $1,514M (+12.8%); Non-GAAP EPS: $0.84 (+12.0%).

2019 Guidance: GAAP EPS: $2.06 – 2.08 from $2.06 – 2.12; Non-GAAP EPS: $3.23 – 3.25 from $3.21 – 3.27.

Q4 Guidance: GAAP EPS: $0.59 – 0.61; Non-GAAP EPS: $0.94 – 0.96.

Shares are down 2% premarket.

https://seekingalpha.com/news/3506062-abbott-2-percent-premarket-trimming-eps-range

Lilly’s pegilodecakin flunks late-stage study

Eli Lilly (NYSE:LLY) slips 2% premarket on light volume in reaction to unsuccessful results from a Phase 3 clinical trial, SEQUOIA, evaluating pepilodecakin plus the chemo regimen FOLFOX compared to FOLFOX alone in metastatic pancreatic cancer patients who progressed during or following first-line treatment with a gemcitabine-containing regimen.

The study failed to achieve the primary endpoint of overall survival.

On the safety front, the most common serious/life-threatening treatment-emergent adverse events were neutropenia, thrombocytopenia, fatigue and anemia.

Detailed results will be submitted for presentation at a future medical conference.

Lilly acquired the rights to pegilodecakin, a long-acting (PEGylated) form of IL-10, via its acquisition of ARMO BioSciences in June 2018.

https://seekingalpha.com/news/3506048-lillys-pegilodecakin-flunks-late-stage-study-shares-2-percent-premarket

Achillion up 81% on $930M bid from Alexion

Alexion Pharmaceuticals (NASDAQ:ALXN) has agreed to acquire Achillion Pharmaceuticals (NASDAQ:ACHN) for $6.30 per share in cash for a total of ~$930M, including Achillion’s cash on hand of ~$230M.

The deal includes non-tradeable contingent value rights (CVRs) that will pay Achillion shareholders $1.00 per share if danicopan is approved in the U.S. and $1.00 per share upon the start of Phase 3 development of complement factor D inhibitor ACH-5228.

The transaction should close in H1 2020.

ACHN, which closed at $3.65 yesterday, is up 81% premarket on modest volume.

https://seekingalpha.com/news/3506037-achillion-81-percent-930m-bid-alexion