AEterna Zentaris Inc. (USA) (NASDAQ:AEZS) announced it has successfully completed patient recruitment for the confirmatory Phase 3 clinical trial of Macrilen™ (macimorelin) as a growth hormone stimulation test for the evaluation of growth hormone deficiency in adults (“AGHD”). The Company also confirmed that it expects to file a New Drug Application for Macrilen™ with the United States Food and Drug Administration (the “FDA”) during the first half of 2017, if the results of the trial warrant doing so. Macrilen™ is the Company’s proposed tradename for macimorelin. The proposed tradename is subject to approval by the FDA.
Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “We are committed to the development of Macrilen™ because of the medical need for such a convenient test in the absence of an FDA-approved diagnostic test for AGHD. Patients who are suspected of having AGHD are now very often evaluated by means of the insulin tolerance test (“ITT”). While the ITT is the historical gold-standard for the evaluation of AGHD, the procedure is inconvenient for patients and physicians and contraindicated in certain patients, such as patients with coronary heart disease or seizure disorder, because it requires the patient to experience hypoglycemia to obtain a result. In addition, it is not an FDA-approved procedure. Furthermore, administration of the ITT is expensive because the patient must be constantly monitored by a physician for the 2- to 4-hour duration of the test and the test must be administered in a setting where emergency equipment is available and where the patient may be quickly hospitalized, if necessary. With the completion of recruitment for our confirmatory Phase 3 clinical trial of Macrilen™ for the evaluation of AGHD, we are another step closer to being able to provide this important product to clinicians and patients.”
The Company believes that, in the US alone, approximately 40,000 confirmatory tests for AGHD will be conducted each year after the introduction of Macrilen™, if it is approved by the FDA, which represents the target market for Macrilen™ at the time of its anticipated commercialization. Furthermore, the Company believes that Macrilen™, if it is approved, is likely to be rapidly adopted by physicians as the preferred means of evaluating AGHD for the following reasons:
- it is safer than the ITT because it does not require the patient to become hypoglycemic and thus avoids the symptoms and potential complications of hypoglycemia;
- Macrilen™ is administered orally, while the ITT requires an intravenous infusion of insulin;
- the evaluation of AGHD using Macrilen™ is significantly less time consuming and labor intensive than the ITT and, therefore, it is less expensive to conduct; and
- the evaluation can be conducted in the physician’s office rather than in a hospital setting.
As a result, the Company believes that Macrilen™, if it is approved, may be used for 40% to 50% of AGHD evaluations in the U.S. during the first year after its introduction and that the percentage could grow to as high as 85% within the first three years of commercialization. (Original Source)
Shares of Aeterna Zentaris closed yesterday at $4.55, down $0.31 or -6.38%. AEZS has a 1-year high of $15.70 and a 1-year low of $2.60. The stock’s 50-day moving average is $3.58 and its 200-day moving average is $3.57.
On the ratings front, AEZS has been the subject of a number of recent research reports. In a report issued on August 22, Canaccord analyst Neil Maruoka reiterated a Buy rating on AEZS, with a price target of $9.00, which represents a potential upside of 98% from where the stock is currently trading. Separately, on August 11, Maxim’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $11.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Neil Maruoka and Jason Kolbert have a total average return of -39.3% and -14.6% respectively. Maruoka has a success rate of 14% and is ranked #4071 out of 4197 analysts, while Kolbert has a success rate of 26% and is ranked #4070.
Ãterna Zentaris, Inc. operates as a specialty biopharmaceutical company that is engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. The company’s pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. It focuses on the development of Perifosine, Cetrotide, Ozarelix, AEZS-108 and AEZS-130.