Nov 12 Pharma news

FDA declines the approval of Lipocine’s testosterone drug; Novartis Sandoz to buy Aspen Pharmacare Japanese Unit; FDA approves first therapy to treat a rare blood disorder

The US FDA for the third time has refused to give approval to Lipocine’s oral testosterone drug, Tlando.

The drug is an oral testosterone replacement therapy in clinical trials for the treatment of Primary and Secondary hypogonadism in males. The drug contains containing Testosterone Undecanoate (TU) which helps in restoring normal levels of testosterone.

This is the third time the drug has been disapproved by the regulatory body as the therapy failed to meet the three secondary goals. This led to the falling of the company’s shares to a record low to 34%.

In a review by Sterling et al. titled “Hypogonadism: Easy to define, hard to diagnose, and controversial to treat” it was revealed that Hypogonadism affects up to 4 million American men, and as the population ages, this number is expected to rise.

At present, the hypogonadism therapy market comprises Injectable formulations, Transdermal formulations, other testosterone formulations and alternative therapies like Dihydrotestosterone gel, Human chorionic gonadotropin, Clomiphene citrate, Aromatase inhibitors, and Selective androgen receptor modulators.

Novartis Sandoz has announced to buy the Japanese branch of Aspen Pharmacare for up to 400 Million Euros.

Novartis, through this acquisition, plans to expand its business in the Japanese pharmaceutical market. Initially, the company will pay 300 Million Euros and a deferred amount of at most 100 Million Euros.

Aspen Pharmacare will use the funds to pay off its debt.

The Aspen’s portfolio comprises 20 off-patent drugs worth an annual sale of 130 Million Euros including Xylocaine, which is an anaesthetic along with immune-suppressing drug Imuran, which is used to treat multiple sclerosis.

The US FDA has approved the first-ever drug, Reblozyl for the treatment of beta-thalassemia, a rare blood disorder.

The drug, Reblozyl, is developed by Celgene with its biotech partner Acceleron Pharma. The drug is one of the five drugs in which Pharma giant BMS is interested in its aim to buy Celgene.

As per Delveinsight estimates, there were 64,655 prevalent cases of β-thal in 2017 in 10 emerging markets. Among these 10 emerging markets, China accounts for the highest number of cases among eastern countries.

Russia is a “white spot” in the prevalence of hemoglobinopathies. While among Latin-American countries, Brazil accounts for the majority of diagnosed cases of β-thalassemia.

The pharmacological treatment in Beta-thalassemia is regular blood-transfusion therapy. The aim of transfusion is mainly to suppress erythroid expansion. The drug follows the same approach. It is a first-in-class erythroid maturation agent (EMA) that treats transfusion-dependent beta-thalassemia-associated anaemia.

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