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Catalent (CTLT) Inks Deal for Nasal Spray for Opioid Overdoses

Catalent, Inc. CTLT signed a commercial supply agreement with Harm Reduction Therapeutics. Per the agreement terms, Catalent will manufacture Harm Reduction Therapeutics’ naloxone nasal spray, RiVive (3.0 mg), for the emergency treatment of known or suspected cases of opioid overdose.

Harm Reduction Therapeutics is a 501(c)(3) non-profit pharmaceutical company, which aims to prevent opioid overdose deaths by making low-cost naloxone available to everyone.

Catalent expects the FDA’s approval for RiVive in July 2023 and the U.S. launch in early 2024.

The latest deal is likely to significantly solidify Catalent’s Inhalation Strategy business.

Rationale Behind the Agreement

The commercial supply agreement follows the FDA’s grant of Priority Review status to Harm Reduction Therapeutics in December 2022 for its over-the-counter (OTC) naloxone nasal spray, New Drug Application. Naloxone, which is a safe and effective opioid antagonist, was originally approved by the FDA in 1971. Since then, it has been used extensively by medical professionals and the general public to effectively reverse opioid overdoses. However, access to existing naloxone nasal sprays is currently limited to behind-the-counter pharmacy distribution via a prescriber or a Health Department’s standing order.

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Per Catalent’s management, the agreement with Harm Reduction Therapeutics is a significant step forward in tackling a major national public health issue, which will likely enable it to be part of a potentially life-changing program.

Harm Reduction Therapeutics’ management believes that amid the ongoing national tragedy of the opioid epidemic and for OTC naloxone to address this unmet need, the company’s need for a manufacturing partner with the capability to help make naloxone more widely and easily accessible to save lives will likely be met. These lives would otherwise be lost to opioid overdose.

Industry Prospects

Per a report by Coherent Market Insights published on GlobeNewswire, the global naloxone market was estimated to be $1,118.3 million in 2022 and is anticipated to see a CAGR of 10.4% between 2022 and 2030. Factors like the increasing prevalence of opioid overdoses and favorable reimbursements for naloxone products are expected to drive the market.

Given the market potential, the latest agreement seems to have been timed well.

Recent Agreements

This month, Catalent announced a licensing agreement with Bhami Research Laboratory (BRL). The deal is expected to provide Catalent with access to BRL’s formulation technology to help enable the subcutaneous delivery of high-concentration biologic therapies.

The same month, Catalent announced its successful formulation design and clinical-phase manufacturing collaboration with Grünenthal for an orally dosed small molecule in the latter’s pipeline. Through the tie-up, Catalent is expected to provide integrated development platforms to facilitate trials and accelerate early development to aid Grünenthal in progressing its research and development portfolio.

Price Performance

Shares of Catalent have lost 41.5% in the past year compared with the industry’s 19.3% decline and the S&P 500's 14.1% fall.

 

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Zacks Investment Research


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Zacks Rank & Key Picks

Currently, Catalent carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Hologic, Inc. HOLX, Henry Schein, Inc. HSIC and Avanos Medical, Inc. AVNS.

Hologic, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 15.2%. HOLX’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 30.6%.

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Hologic has gained 3.3% against the industry’s 16% decline in the past year.

Henry Schein, carrying a Zacks Rank #2 at present, has an estimated long-term growth rate of 8.1%. HSIC’s earnings surpassed estimates in three of the trailing four quarters and matched the same in the other, the average beat being 2.9%.

Henry Schein has lost 11.1% compared with the industry’s 10.9% decline over the past year.

Avanos, carrying a Zacks Rank #2 at present, has an estimated growth rate of 1.8% for 2023. AVNS’ earnings surpassed estimates in all the trailing four quarters, the average beat being 11%.

Avanos has lost 15.5% compared with the industry’s 16% decline over the past year.

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