Glaukos Submits New Drug Application to FDA

 Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for iDose^® TR. iDose TR is a micro-invasive intraocular implant designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost from within the eye for extended periods of time. iDose TR is intended to address ubiquitous patient non-compliance and chronic side effects associated with topical glaucoma medications.

“The submission of the iDose TR NDA represents a significant milestone for our company, resulting from more than a decade of our teams’ unrelenting research, development and clinical efforts to bring this potential game-changing therapy one step closer to patients who may need a new glaucoma treatment alternative,” said Thomas Burns, Glaukos chairman and chief executive officer. “We look forward to working closely with the FDA in their pending review process and continue to believe iDose TR can be a transformative novel technology able to fundamentally improve the treatment paradigm for patients with glaucoma.”

The NDA submission includes data from two Phase 3 pivotal trials of iDose TR, which both successfully achieved the pre-specified primary efficacy endpoints through 3 months and demonstrated a favorable tolerability and safety profile through 12 months. In addition, the submission also includes data from the iDose TR exchange trial, which included a second administration of iDose TR and removal of the original iDose TR, with the second iDose TR administration demonstrating a favorable safety profile over a 12-month evaluation period.

Administered during a micro-invasive procedure, the iDose TR contains a novel formulation of travoprost, a prostaglandin analog used to lower intraocular pressure. The iDose TR is designed such that it can be removed and replaced with a new iDose TR, thus potentially offering a long-term dropless alternative to daily eye drop treatment.

https://www.biospace.com/article/releases/glaukos-submits-new-drug-application-to-u-s-fda-for-idose-tr/

FDA Action Alert: Cytokinetics, Reata, Regeneron, Pfizer and GSK

 The FDA is expected to cap off February with a trio of verdicts, including one for a heart failure treatment and another potential first approval for a rare, neurodegenerative disease.

Keep reading for details.

Moment of Truth for Cytokinetics’ Heart Failure Drug

On Feb. 28, the FDA is set to decide on Cytokinetics’ omecamtiv mecarbil (OM), a novel, selective cardiac myosin activator being evaluated for heart failure with reduced ejection fraction.

The regulatory agency accepted the New Drug Application for OM in February 2022 and initially set a target action date of Nov. 30, 2022. However, in May, the company announced the FDA planned to hold an advisory committee meeting for the application. 

A month later, the FDA requested additional pharmacokinetic information for OM. The supplementary data qualified as a major amendment to the NDA, which pushed the target action date back to Feb. 28, 2023.

In December, a panel of external experts on the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8-3 against backing OM, citing its mixed efficacy results and safety concerns.

Will Reata Score First Friedreich's Ataxia Nod?

Reata Pharmaceuticals is expecting a Feb. 28 decision for its Friedreich's ataxia hopeful, omaveloxolone. The drug activates Nrf2, a transcription factor that helps resolve inflammation by restoring mitochondrial function, reducing oxidative stress and inhibiting pro-inflammatory signaling.

The company first completed its rolling NDA for omaveloxolone in March 2022. In August, the FDA pushed the target action date back by three months after additional confirmatory data submitted by Reata was deemed a major amendment to the application.

Regeneron Seeks New Eylea Dosing Regimen

Also on Feb. 28, Regeneron is anticipating the FDA’s decision on a new dosing regimen for its blockbuster eye drug Eylea (aflibercept).

In a supplemental Biologics License Application filed June 2022, Regeneron proposed administering its 2-mg Eylea injections every 16 weeks after initial monthly doses in patients with diabetic retinopathy.

The sBLA was supported by data from the Phase III PANORAMA study, which found that compared with sham injections, 16-weekly dosing still improved Diabetic Retinopathy Severity Scale scores by at least two steps in enough patients.

Eylea is currently approved for diabetic retinopathy at 4- and 8-week doses, as well as wet age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema. Earlier this month, Eylea was approved by the FDA as the first pharmacologic therapy for retinopathy of prematurity in preterm infants.

FDA Convenes AdComm for Pfizer and GSK’s RSV Shots

The FDA has lined up two advisory committee meetings to discuss the efficacy and safety of two respiratory syncytial virus vaccine (RSV) candidates. On Feb. 28, experts will look at Pfizer’s vaccine, while GSK will get its chance on March 1.  

GSK is slightly ahead of Pfizer in the RSV race. In November, the company snagged priority review for its RSV candidate in older adults, with a target action date of May 3, 2023. The application was supported by data from the pivotal AReSVi-006 trial, which demonstrated the vaccine could significantly protect against RSV-associated lower-respiratory tract diseases in adults aged 60 years and above.

Pfizer secured priority review for its own candidate a month later, in December 2022, with an action date also in May 2023. Pfizer’s application was supported by the Phase III RENOIR study, which showed an overall efficacy of 87.5% in adults aged 60 or older.

Both Pfizer and GSK are gunning to be the first to see an RSV vaccine through to the market.

https://www.biospace.com/article/fda-action-alert-cytokinetics-reata-regeneron-pfizer-and-gsk-/

AbbVie Receives Positive CHMP Opinion for Crohn's Therapy

 

• The positive CHMP opinion for upadacitinib is based on results from two induction studies and one maintenance study1-4

• Crohn's disease is a chronic, systemic disease that manifests as inflammation within the gastrointestinal tract, causing persistent diarrhea and abdominal pain5,6

• If approved by the European Commission (EC), this will be the seventh indication for upadacitinib in the European Union (EU), and the first JAK inhibitor for Crohn's disease, adding to AbbVie's gastroenterology portfolio

https://finance.yahoo.com/news/abbvie-receives-positive-chmp-opinion-070000590.html

Viatris: Strong Financial Results, 2023 Guidance

 

• Company Meets its 2022 Adjusted Guidance After Incorporating the Fourth Quarter Impact of the Biosimilars Transaction and Acquired IPR&D

• 2023 Guidance Midpoint Reflects Revenue Growth Over 2022, Excluding Full-Year Impact of Biosimilars

• Reaffirms 2024 Phase 2 Outlook from November 7 Strategic Update

• Company Increases Return of Capital to Shareholders by Completing $250 Million in Share Repurchases

• Board of Directors Approves 2023 Dividend Policy of Forty-Eight Cents ($0.48) per Share and Declares First Quarter Dividend of Twelve Cents ($0.12) per Share

• Paid Down Debt of Approximately $3.3 Billion in 2022, Retiring $5.4 Billion of Debt Since 2021

• Remains on Track to Execute Planned Divestitures

Financial Impact of Completion of the Biosimilars Transaction and Acquired IPR&D

The 2022 financial guidance metrics were impacted by the Biosimilars Transaction and acquired IPR&D as follows:

(In millions)		2022 Guidance Ranges(1) (November 7, 2022)		Biosimilars Transaction		Acquired IPR&D		Adjusted 2022 Guidance Ranges(1)		2022 Results
Total Revenues		$16,200 - $16,700		$(86)		$—		$16,100 - $16,600		$16,263
Adjusted EBITDA		$5,800 - $6,200		$(31)		$(36)		$5,725 - $6,125		$5,777(2)
Free Cash Flow		$2,500 - $2,900		$(274)		$(36)		$2,200 - $2,600		$2,547(2)

___________

(1) Viatris did not provide forward-looking guidance for comparable U.S. GAAP net earnings (loss) or a quantitative reconciliation of its 2022 adjusted EBITDA guidance. U.S. GAAP net cash provided by operating activities was estimated to be between $3,100 million and $3,300 million (without adjustment for the Biosimilars Transaction). Please see "Non-GAAP Financial Measures" for additional information. https://finance.yahoo.com/news/viatris-reports-strong-fourth-quarter-110000906.html

CIA Director: US 'Confident' China Mulling Weapons Deliveries To Russia

 CIA Director William Burns has weighed in directly on Biden administration assertions that China is mulling providing Russia with lethal aid to further its military action in Ukraine. 

Burns told CBS' "Face the Nation" on Sunday that the US is "confident" that Beijing is considering it at this point. "We’re confident that the Chinese leadership is considering the provision of lethal equipment," he said.

"We also don’t see that a final decision has been made yet, and we don’t see evidence of actual shipments of lethal equipment."

Burns went on to say in reference to recent warnings from Secretary of State Antony Blinken, "That’s why, I think, Secretary Blinken and the President have thought it important to make very clear what the consequences of that would be as well … because it would be a very risky and unwise bet."

This means that clearly at the very least the US has no evidence that such aid has actually been delivered, despite some ambiguous media accusations reaching back to last summer. CBS also noted...

Earlier this month, Burns told students at Georgetown University that Xi had been "very reluctant to provide the kind of lethal weapons to Russia to use in Ukraine that the Russians are very much interested in."

Additionally, the whole accusations theater seems more by design to act as a preemptive warning against what Beijing might contemplate in the future. Ultimately it seems a big nothingburger. 

But it's China's silence amid G20 meetings that speaks loudest at this point: 

Finance ministers of the world's largest economies have failed to agree on a closing statement following a summit in India, after China refused to condemn Russia's invasion of Ukraine.

Beijing declined to accept parts of a G20 statement that deplored Russia's aggression "in the strongest terms".

Moscow said "anti-Russian" Western countries had "destabilized" the G20. It comes after China this week published a plan to end the conflict that was viewed by some as pro-Russian.

A G20 statement condemning the war included a footnote which said it was "agreed to by all member countries except Russia and China".

https://www.zerohedge.com/geopolitical/cia-director-us-confident-china-mulling-weapons-deliveries-russia

Flu Cases Surge in China, Leaving Antivirals in Short Supply

 

• Country deals with influenza’s rise after Covid reopening
• Empty drugstore shelves reminiscent of pandemic-era shortages

A spike in flu cases is fueling a shortage of antivirals at Chinese pharmacies, with empty shelves reminiscent of the drug frenzy triggered by the explosive Covid outbreak that accompanied the country’s reopening. 

Supplies of the medicine, known by its generic name oseltamivir and sometimes sold as Tamiflu, have appeared to run low at both brick-and-mortar and online pharmacies across parts of China in recent days, with some stores selling out their floor stocks and only offering deliveries that will take days to arrive, local media reported over the weekend. 

https://www.bloomberg.com/news/articles/2023-02-27/flu-cases-surge-in-china-leaving-antivirals-in-short-supply

Pfizer in Talks to Acquire Seagen in Deal Likely Valued at More Than $30 B

 Pfizer Inc. PFE -1.30%

decrease; red down pointing triangle is in talks to acquire biotech Seagen Inc., SGEN -0.51%decrease; red down pointing triangle according to people familiar with the matter, the latest potential deal for a big drug company aimed at adding a promising class of targeted cancer therapies.

The talks are at an early stage and there is no guarantee there will be a deal, the people said. A number of hurdles would need to be overcome, including the potential for a stringent antitrust review of any proposal. If there is a deal, it would be big: Seagen has a market value of some $30 billion and would be expected to command a premium over that.

https://www.wsj.com/articles/pfizer-in-early-stage-talks-to-acquire-seagen-3f53309e