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AMRN Makes Peace With Apotex, IDYA Cuts Deal With GSK, SLRX On Watch, NBIX, TAK Ink $2Bln Pact

pharma sept27 17jun20 lt

Today's Daily Dose brings you news about Amarin's settlement agreement with Apotex; Annovis Bio's progress in its Alzheimer's drug development program; IDEAYA's deal with GlaxoSmithKline; promising results of Lilly's monarchE study in breast cancer; Neurocrine Biosciences and Takeda's $2 billion-plus collaboration; and Salarius' big event for today.

Read on…

1. Amarin Makes Peace With Apotex

Amarin Corporation plc (AMRN) has resolved the patent litigation with Apotex Inc. related to a generic version of VASCEPA.

The brand drug Vascepa, developed by Amarin, is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and as an adjunct to statin therapy to reduce the risk of cardiovascular events.

The drug brought in annual sales of $427 million for Amarin in 2019 compared to $228 million in 2018.

In March of this year, the patents covering Vascepa were invalidated by a Nevada district judge, favoring Hikma and Dr. Reddy's Labs, paving the way for generic versions of the drug to be launched in the U.S. Amarin has appealed the ruling of the Court.

Since Apotex is not a party to the litigation, which invalidated the VASCEPA patents, it is not directly subject to related rulings, Amarin noted.

Now that a settlement has been reached, Apotex may not sell a generic version of VASCEPA in the United States until August 9, 2029 (the same such date provided for under the 2018 settlement agreement with Teva Pharmaceuticals USA, Inc. (Teva)) or earlier under certain customary circumstances.

"This settlement involves no financial payment from Amarin to Apotex and allows Amarin to avoid incremental litigation expense," said John Thero, president, and chief executive officer of Amarin.

AMRN closed Tuesday's trading at $6.89, up 0.58%. In after-hours, the stock was up 5.37% at $7.26.

2. Annovis Completes Toxicology Study Of AD Drug Candidate In Rats

Annovis Bio Inc. (ANVS) has successfully completed the rat cohort of a chronic toxicology study of its lead Alzheimer's disease therapeutic compound ANVS401, reporting no negative side effects.

The six-month rat study was part of a series of animal toxicology studies, funded by a $1.7 million grant from the National Institutes of Health that began in the fourth quarter of 2019. The safety seen in the rats corroborates the positive results from the Company's prior one-month safety studies in mice, rats, dogs, and humans.

A nine-month dog safety study remains ongoing under the NIH funded program, with results expected in the third quarter of 2020.

ANVS401 is under a phase IIa proof-of-concept study in Alzheimer's disease patients.

Annovis went public on the NYSE American Exchange on January 29, 2020, offering its shares at a price of $6.00 each.

The stock has thus far hit a low of $2.42 and a high of $10.61. ANVS closed Tuesday's trading at $5.64, up 26.17%.

3. IDEAYA Cuts A Deal With GSK

Shares of IDEAYA Biosciences Inc. (IDYA) touched a new high on Tuesday, following the Company's partnership with GlaxoSmithKline plc (GSK) in synthetic lethality, an emerging field in Precision Medicine Oncology.

Synthetic Lethality is one of four core research focus areas for GSK in oncology and IDEAYA's Synthetic Lethality programs include MAT2A, Pol Theta, and Werner Helicase programs, which are projected to reach clinical trials within the next three years.

The partnership will explore combinations between IDEAYA and GSK programs.

As part of the deal, IDEAYA will receive a $100 million upfront cash payment, and $20 million equity purchase of IDEAYA common stock in direct private placement, and a potential $50 million cash option exercise fee for the MAT2A program. IDEAYA is also entitled to receive potential preclinical, clinical, and sales milestones.

IDEAYA will earn a 50% share of the US profit for the MAT2A and Werner Helicase programs and will be responsible for 20% of global development costs for products being developed with GSK.

IDEAYA's lead asset is IDE196, under phase I/II basket trial in solid tumors harboring activating GNAQ/11 mutations. Interim data from the monotherapy arm of the phase I/II basket trial is expected in the fourth quarter of 2020.

Initiation of combination arm of the IDE196 phase I/II clinical trial is on track in mid-2020.

In other news, the Company announced that it intends to offer and sell up to $60 million of shares of its common stock in an underwritten public offering. In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $9 million of shares of its common stock.

IDYA touched an all-time high of $15.36 in intraday trading on Tuesday, before closing at $12.84, up 43.46%.

4. Lilly's monarchE Reigns Supreme

Eli Lilly and Co.'s (LLY) phase III study evaluating Verzenio in combination with standard adjuvant endocrine therapy, dubbed monarchE study, in people whose early breast cancer is at a high risk of recurrence has met the primary endpoint.

The primary endpoint was invasive disease-free survival, and the combination of Verzenio and standard adjuvant endocrine therapy significantly decreased the risk of breast cancer recurrence or death compared to standard adjuvant endocrine therapy alone.

Verzenio is approved for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

About 30 percent of people diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning, according to Lilly. And with Verzenio in combination with endocrine therapy demonstrating positive results in people with high-risk HR+, HER2- early breast cancer, it may have the potential to change the paradigm of how early breast cancer is treated.

The monarchE trial will continue through the completion date, estimated for June 2027, the Company added.

LLY touched a new high of $167.43 in intraday trading on Tuesday, before closing at $163.71, up 15.68.

5. Neurocrine Biosciences, Takeda Ink $2 Billion-Plus Collaboration

Neurocrine Biosciences Inc. (NBIX) Takeda Pharmaceutical Company Limited (TAK) have inked a strategic collaboration, valued at over $2 billion.

Under the strategic partnership agreement, Neurocrine Biosciences gains exclusive worldwide rights to early-to-mid-stage psychiatry pipeline compounds within Takeda's Neuroscience portfolio, which includes three clinical-stage assets with the most advanced molecule in phase II trial for negative symptoms of schizophrenia.

Takeda stands to receive from Neurocrine Biosciences $120 million in upfront cash, $495 million in development milestones, $1.4 billion in commercial milestones, and up to double-digit royalties on net sales. Takeda retains the ability to opt in or out of a 50:50 profit share on all clinical programs at certain development events.

TAK closed Tuesday's trading at $19.17, up 4.30%.

6. Steroid Treatment Reduces Mortality In Patients With Severe Respiratory Complications Of COVID-19

Dexamethasone, a steroid, has been found to reduce deaths in hospitalized patients with severe respiratory complications of COVID-19 in a randomized clinical trial that is testing a range of potential treatments for COVID-19, including low-dose dexamethasone in the UK, dubbed RECOVERY.

In the RECOVERY study, involving over 11,500 patients, a total of 2,104 patients were randomized to receive Dexamethasone 6 mg once per day (either by mouth or by intravenous injection) for ten days and were compared with 4,321 patients randomized to usual care alone.

According to the trial results, Dexamethasone reduced deaths by one-third in ventilated patients and by one fifth in other patients receiving oxygen only. There was no benefit among those patients who did not require respiratory support.

Commenting on the results, Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, one of the Chief Investigators, said, "These preliminary results from the RECOVERY trial are very clear - dexamethasone reduces the risk of death among patients with severe respiratory complications. COVID-19 is a global disease - it is fantastic that the first treatment demonstrated to reduce mortality is one that is instantly available and affordable worldwide."

7. Salarius To Present Information on Seclidemstat On June 17

Salarius Pharmaceuticals Inc. (SLRX) will be presenting information regarding its lead investigational compound, Seclidemstat, at the public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee on June 17.

Seclidemstat is currently in a phase I/II clinical trial for Ewing sarcoma, a rare and deadly pediatric bone cancer for which there are no approved targeted treatments available.

SLRX closed Tuesday's trading at $1.82, up 2.82%.

8. Stocks That Moved On No News

Celsion Corporation (CLSN) closed Tuesday's trading at $4.88, up 33.33%.

Xeris Pharmaceuticals Inc. (XERS) closed Tuesday's trading at $5.32, up 17.96%.

Amicus Therapeutics Inc. (FOLD) closed Tuesday's trading at $13.07, up 17.32%.

MediciNova Inc. (MNOV) closed Tuesday's trading at $5.70, down 10.38%.

Nymox Pharmaceutical Corporation (NYMX) closed Tuesday's trading at $4.15, down 9.78%.

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