OPKO’s NGENLA (OPK) approved by MHLW of Japan for the treatment of GHD


OPKO Health, Inc. OPK, as well as Pfizer Japan Inc., a subsidiary of Pfizer Inc. PFE, recently confirmed that the Japanese Ministry of Health, Labor and Welfare (“MHLW”) has approved NGENLA (somatrogon) Inj. 24 mg pens and 60 mg pens. NGENLA, Next Generation Long-Acting Growth Hormone Injection, is a long-acting recombinant human growth hormone that is administered once weekly. It is approved for the indication of short stature resulting from growth hormone (“GHD”) deficiency without closed epiphyses (another term for the pineal gland).

OPKO had entered into a global agreement with Pfizer in 2014 for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO was to lead the clinical program while Pfizer was responsible for registering and commercializing somatrogon for GHD.

NGENLA’s latest approval in Japan follows its approval in Canada in October 2021 and Australia in November 2021. The Japanese MHLW approval is expected to significantly strengthen OPKO’s position through global sales of NGENLA, a component of the the company’s broader pharmaceutical business.

Approval Context

Approval by the MHLW of Japan was supported by results from a Phase 3 study in Japanese subjects and a global Phase 3 clinical study. Both studies were conducted in subjects with pediatric GHD , who compared the efficacy and safety of NGENLA once weekly with GENOTROPIN (somatropin) – a recombinant human growth hormone for injection, given once daily.

Both studies demonstrated the comparable efficacy of NGENLA to GENOTROPIN on the primary endpoint of annual growth rate in height at 12 months. Additionally, unlike GENOTROPIN, NGENLA was generally well tolerated in both studies with comparable safety.

Meaning of Approval

NGENLA, a new option for patients with pediatric GHD, reduces the frequency of treatment from daily injections to once a week.

According to Pfizer’s Japanese management, the recent approval of once-weekly NGENLA should lead to a reduction in the burden associated with daily administration of growth hormone.

Industry Outlook

According to a report by Allied Market Research, the Global Human Growth Hormone Market was valued at USD 3,864.00 Million in 2020 and is projected to reach USD 9,211.63 Million by 2030 with a CAGR of 9 %. Factors such as the development of recombinant human growth hormone drugs, rising instances of pituitary dysfunction, and rising instances of growth hormone deficiency and other growth disorders are expected to drive the market .

Given the market potential, the latest approval is expected to significantly boost OPKO’s global pharmaceutical business.

Recent updates

This month, OPKO signed a definitive agreement with AI-based genomic and clinical data intelligence platform company Sema4. Under the terms of the agreement, Sema4 will acquire OPKO’s wholly owned subsidiary, GeneDx, Inc.

In December 2021, the company announced early preliminary results from its Phase 2 trial with RAYALDEE for the treatment of mild to moderate COVID-19.

Also in December, OPKO received FDA approval for its 4Kscore test. The test is approved for use in men aged 45 and over who have not undergone a prostate biopsy or who have a negative biopsy, and who have an age-specific total abnormal prostate-specific antigen and/or an abnormal digital rectal examination.

Price performance

OPKO shares have lost 1.1% over the past year compared to the industry’s 6.9% plunge. The S&P 500 rose 18.4% over the same period.

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Zacks ranking and other key picks

Currently, OPKO carries a Zacks Rank #2 (Buy).

A few other stocks from the broader medical field that investors can consider are AMN Healthcare Services, Inc. AMN and Cerner Company CERN.

AMN Healthcare has an estimated long-term growth rate of 16.2%. AMN’s earnings have exceeded estimates for the past four quarters, with the average surprise being 19.51%. It currently boasts a Zacks rank #1 (Strong Buy). You can see the full list of today’s Zacks #1 Rank stocks here.

AMN Healthcare gained 28.7% against the sector’s 60.3% drop over the past year.

Cerner, carrying a Zacks Rank #2, has an estimated long-term growth rate of 12.8%. CERN earnings have exceeded estimates in three of the last four quarters, with the average surprise being 3.21%.

Cerner gained 14.5% against the industry’s 56.3% drop over the past year.

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