Catalent's (CTLT) Tie-Up to Accelerate Clinical Trial Timelines

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Catalent, Inc. CTLT recently 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.

The collaboration between the two players indicates their reaching a milestone in a joint Chemistry, Manufacturing and Controls development project for the re-formulation of an investigational medicine to improve its bioavailability (the proportion of a drug which enters the circulation when introduced into the body and so is able to have an active effect).

The latest partnership is likely to significantly solidify Catalent’s Pharma and Consumer Health business on a global scale.

Rationale Behind the Collaboration

Catalent and Grünenthal (a global science-driven pharmaceutical company with strength in pain research and management) have been working together on this program since 2021, where Catalent has been assisting Grünenthal in reformulating the molecule using a lipid-based drug delivery system formulated in softgel technology to improve its bioavailability. This was done using Catalent’s OptiForm Solution Suite platform, which allowed the rapid characterization and screening of dose forms and formulation technologies to optimize dose design.

Per Catalent’s management, as innovators demand shortened drug development timeframes, the company’s offerings of a number of integrated solutions can ensure that programs can be accelerated to, and through, clinical phases as quickly and safely as possible. At the same time, it provides design and delivery technology support to give molecules the utmost chance of success.

Grünenthal’s management believes that the OptiForm Solution Suite is expected to provide an efficient approach to accelerate innovative candidates into first-in-human studies. The Catalent Xpress Pharmaceutics platform (which was used in the phase 1 studies of the molecule) will likely provide the flexibility to efficiently manage its candidates via early clinical development studies.

Industry Prospects

Per a report by Grand View Research, the global softgel capsules market was valued at $7.62 billion in 2021 and is anticipated to expand at a CAGR of 7.9% from 2022 to 2030. Factors like ease of swallowing, improved absorption and enhanced bioavailability are expected to drive the market.

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

Notable Developments in Pharma and Consumer Health

Last month, Catalent announced the completion of a $2.2 million expansion to its clinical supply facility in Singapore. This has increased the site’s footprint, thereby creating the space to install an additional 35 new freezers for ultra-low temperature storage.

The same month, Catalent announced the launch of TASCENSO orally disintegrating tablet (ODT), its first product to treat Multiple Sclerosis patients in the United States.

In January, Catalent executed a development and license agreement with Ethicann Pharmaceuticals Inc. to develop Ethicann’s clinical drug pipeline using its Zydis ODT technology.

Price Performance

Shares of Catalent have lost 34.4% in the past year compared with the industry’s 18.1% decline and the S&P 500's 13.1% fall.

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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 5.9% against the industry’s 17.3% 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 10.7% compared with the industry’s 10.1% 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 15.2% compared with the industry’s 17.3% decline over the past year.

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