Baxter's Clinimix and Clinimix E Injections Receive FDA Nod

Baxter International Inc. BAX recently announced that it has received FDA approval of new formulations of Clinimix (amino acids in dextrose) Injections and Clinimix E (amino acids with electrolytes in dextrose and calcium) Injections. These new formulations offer up to 60% more protein (amino acid) compared to current Clinimix formulations, while delivering less dextrose.

Notably, Clinimix and Clinimix E (both sulfite-free) Injections are indicated as a source of calories and protein (electrolytes in case of Clinimix E) for patients who need parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. Both these injections can be utilized to treat negative nitrogen balance in patients.

This approval is likely to provide a boost to Baxter’s Clinical Nutrition portfolio.

Parenteral Nutrition in Brief

Parenteral nutrition (PN) is an intravenous administration of nutrition, which has a crucial role in lowering malnutrition and can include proteins, carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements.

Significance of the Approval

The introduction of Clinimix and Clinimix E formulations offers the highest protein in a multi-chamber bag in the United States, thereby providing clinicians more flexibility in meeting their patients’ nutritional targets. In fact, these injections augment Baxter’s broad and diverse portfolio of formulations that particularly focus on boosting care with respect to critically ill patients.

Additionally, Baxter will continue to offer existing formulations of Clinimix and Clinimix E for patients with lower protein requirements. Moreover, this FDA approval follows the introduction of Clinolipid (20% Lipid Injectable Emulsion) — Baxter’s own olive oil-based lipid emulsion — in the United States.

It is important to mention here that both Clinimix and Clinimix E with Higher Protein are presently available in the United States.

Market Prospects

Per a report by Grand View Research, the global parenteral nutrition market was valued at $5.3 billion in 2018 and is anticipated to witness a CAGR of 5.8% over the forecast period (2019-2026). Considering the abundant market prospects, the FDA approval is well-timed for Baxter.

Recent Developments

In August, Baxter, a global leader in clinical nutrition, collaborated with COSMED srl to commercialize Q-NRG+, which is a metabolic monitoring device using indirect calorimetry technology. Per the agreement, Baxter will introduce Q-NRG+ to 18 key countries across the world with potential for further expansion. Notably, Q-NRG+ is expected to be available from Baxter in September as part of a phased launch in select European countries, Canada and Australia, with introductions in additional markets subject to pending future regulatory approval.

In July, the company inked a deal with VIPUN Medical — a company developing technology solutions to help improve medical nutrition — to commercialize the VIPUN Gastric Monitoring System. Per the agreement, Baxter will provide support to clinical studies necessary to achieve regulatory approval in key markets globally and attain worldwide distribution rights. Notably, the VIPUN Gastric Monitoring System will become an important addition to Baxter’s nutrition portfolio, thereby boosting its Clinical Nutrition business.

Price Performance

Over the past year, shares of this Zacks Rank #4 (Sell) company have lost 9.7% compared with the industry’s decline of 3.3%.

Stocks to Consider

Some better-ranked stocks from the broader medical space include Merit Medical Systems, Inc. MMSI, Thermo Fisher Scientific Inc. TMO and PerkinElmer, Inc. PKI. While PerkinElmer sports a Zacks Rank of 1 (Strong Buy), both Merit Medical and Thermo Fisher carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

PerkinElmer has a projected long-term earnings growth rate of 17.4%.

Merit Medical has a projected long-term earnings growth rate of 12%.

Thermo Fisher has an estimated long-term earnings growth rate of 15%.

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