Emergent Bio receives EMA agreement for chikungunya vaccine candidate

Emergent BioSolutions (NYSE:EBS) has received agreement from the European Medicines Agency (EMA) to pursue the proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate.

The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.

Emergent’s CHIKV VLP vaccine candidate is currently being investigated in a Phase 2 parallel-group, dose-finding study of approx. 430 healthy adults at three U.S. sites. It is licensed from the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

https://seekingalpha.com/news/3531243-emergent-bio-receives-ema-agreement-for-chikungunya-vaccine-candidate

Bausch Health sees cash flow ops as high as $1.6B in 2019

Highlights from Bausch Health Companies’ (NYSE:BHC) presentation at JPM20:

2019: Revenue growth should be above mid-point of guidance. Cash flow ops should be $1.5B – 1.6B (more than $1B will be used to pay down debt and/or fund “bolt-on” acquisitions).

R&D investments up ~15% versus 2018.

“Significant Seven” sales expected to about double.

2020 objectives/catalysts:

B + L:

Launch SiHy daily, enhanced enVista Toric and preloaded enVista in U.S.

EM-100 approval.

Refile Xipere application.

Salix:

Launch probiotic.

Several key data readouts.

Ortho Dermatologics:

Duobrii full-year launch.

Launch Arazlo in H1.

Launch Solodyn and BenzEFoam on dermatology.com.

Expand Thermage FLX globally.

#JPM20

https://seekingalpha.com/news/3531221-bausch-health-sees-cash-flow-ops-high-1_6b-in-2019

Adaptimmune T-cell platform delivers initial responses in 4 solid tumors

Adaptimmune Therapeutics (NASDAQ:ADAP) is up 60% premarket after reporting two confirmed Partial Responses (PRs) – one in a patient with liver cancer and one in a patient with melanoma.

There are also two unconfirmed PRs – one in a patient with gastro‑esophageal junction cancer and one in a patient with head and neck cancer. These data further confirm the potential of company’s SPEAR T-cell platform for patients with multiple solid tumors.

A decrease of 100% and 42% in target lesions was observed in a patient with hepatocellular carcinoma and metastatic rectal mucosal melanoma, respectively.

A decrease of 42% and 36% in target lesions was seen in a patient with metastatic gastro-esophageal junction cancer and head and neck cancer treated in the expansion phase of the Phase 1 ADP A2M4 trial, respectively.

#JPM20

https://seekingalpha.com/news/3531197-adaptimmunes-spear-t-cell-platform-delivers-initial-responses-in-four-solid-tumors-shares-up

Biogen to acquire neurological disease candidate from Pfizer

Biogen (NASDAQ:BIIB) has agreed to acquire Pfizer’s (NYSE:PFE) PF-05251749, a novel CNS-penetrant small molecule casein kinase 1 (CK1) inhibitor, for the potential treatment of behavioral and neurological symptoms associated with a range of psychiatric and neurological disorders.

It plans to develop the asset for the treatment of sundowning (late-day confusion) in Alzheimer’s disease and irregular sleep-wake rhythm disorder in Parkinson’s disease. A Phase 1b trial should launch in Q4.

Under the terms of the agreement, Biogen will pay Pfizer $75M upfront, up to $635M in milestones and tiered high single-digit-to-sub-teen royalties on net sales.

Biogen expects to close the transaction later this quarter.

BIIB is down 1% premarket while PFE is up a fraction.

https://seekingalpha.com/news/3531234-biogen-to-acquire-neurological-disease-candidate-from-pfizer

Axsome in-licenses U.S. rights to Pfizer’s reboxetine

Axsome Therapeutics (NASDAQ:AXSM) inks an agreement with Pfizer (NYSE:PFE) for U.S. rights to reboxetine, the active ingredient in AXS-12, its candidate for narcolepsy.

The deal also includes exclusive U.S. rights to esreboxetine, now called AXS-14, for the potential treatment of fibromyalgia.

Under the terms of the contract, Pfizer will receive $3M upfront, up to $323M in milestones and tiered mid-single-to-low-double digit royalties on net sales. It will also receive $8M in Axsome common stock and the right of first negotiation for any future strategic transactions involving AXS-12 and AXS-14.

Axsome will host a conference call today at 8:30 am to discuss the agreement.

https://seekingalpha.com/news/3531172-axsome-in-licenses-u-s-rights-to-pfizers-reboxetine

Acasti Pharma’s pain is Amarin’s gain

Acasti Pharma (NASDAQ:ACST) craters 60% premarket on modest volume (thus far) in response to unsuccessful results from a Phase 3 clinical trial, TRILOGY 1, evaluating lead candidate CaPre (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia.

CaPre failed to sufficiently separate from placebo in terms of reducing triglyceride levels. Specifically, the median reduction in the CaPre arm was 30.5% versus 27.5% in the control arm at week 12. The mean reductions in patients on background statin therapy were 42.2% and 31.5%, respectively, at week 12.

At week 26, the end of the study, the median reduction of triglycerides in CaPre group was 36.7% compared to 28.0% in the placebo group.

None of the differences reached statistical significance.

Data on all secondary and exploratory endpoints should be available by quarter-end.

Top line results from a second Phase 3, TRILOGY 2, should be reported in mid-February.

Amarin (NASDAQ:AMRN), whose Vascepa (icosapent ethyl) was approved in the U.S. in July 2012 for severe hypertriglyceridemia, is up 12% premarket on light volume.

https://seekingalpha.com/news/3531176-acasti-pharmas-pain-is-amarins-gain-up-12-premarket

Biotech week ahead, Jan. 13

Activity in the biotech space is likely to pick up this week. Events are likely to be headlined by the annual JPMorgan Healthcare Conference.

Biotech stocks closed 2019 with gains, although they underperformed relative to the broader market. The iShares NASDAQ Biotechnology Index IBB 0.49% closed up 25.2% in 2019 compared to the S&P 500’s 29% jump.

The new year is likely to bring several challenges for biotech stocks, the chief among them being a hard political stance on drug pricing ahead of the year’s elections.

The following are key catalysts that could take the spotlight this week.

Conferences

38th Annual JPMorgan Healthcare Conference: Jan. 13-16 in San Francisco, California.

Adcom Meetings

A joint Tuesday meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will discuss Nektar Therapeutics’ NKTR 24.69% NDA for oxycodegol, a NME full mu-opioid receptor agonist, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment.

The same committees on Wednesday will discuss IntelliPharmaCeutics International Inc.’s IPCIF 12.47% NDA for an extended-release oral tablet formulation of oxycodone. The investigational candidate is being evaluated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time

The Anesthetic and Analgesic Drug Products Advisory Committee on Thursday will review DURECT Corporation’s DRRX 4.28% NDA for bupivacaine extended-release solution for the proposed indication of post-surgical analgesia.

Clinical Readouts

Cyclerion Therapeutics Inc CYCN 7.57% is likely to release Phase 1 data for IW-6463 from the study of healthy volunteers at the JPMorgan Healthcare Conference. IW-6563 is a brain-penetrant, oral sGC stimulator being evaluated for neurodegenerative diseases.

AzurRx BioPharma Inc AZRX 21.13% will present new data from five patients enrolled in its Phase 2 study for its lead development candidate MS1819-SD, which is being evaluated as an add on therapy for severe exocrine pancreatic insufficiency, at the 2020 Biotech Showcase Conference being held in San Francisco. The presentation is scheduled for 6 p.m. ET Monday.

IPOs

I-Mab, a China-based clinical-stage biopharma company focused on the development of biologics, primarily for cancers and autoimmune disorders, has filed to offer 7.41 million ADSs representing 17.04 million ordinary shares in an IPO.

The offering is expected to be priced between $12 and $15 per ADS. The company has applied for listing its ADSs on the Nasdaq under the ticker symbol “IMAB.”

https://www.benzinga.com/general/biotech/20/01/15100155/the-week-ahead-in-biotech-jpmorgan-healthcare-conference-fda-panel-reviews-opioid-pain-drugs-i-ma