A USD 4.2 Billion Myovant/ Pfizer Deal; Audentes Therapeutics’ ASPIRO Trial Free to Proceed; First Generic of Drug for Severe Hypoglycemia Gets Approval; Teleflex Acquires Z-Medica

Posted on Dec 29, 2020 by Delveinsight

Myovant Pfizer Deal_Generic for Severe Hypoglycemia_Teleflex

A USD 4.2 Billion Myovant/ Pfizer Deal

Myovant Sciences have decided to put their forces and efforts together to advance the Prostate cancer market as they announced their partnership deal to develop and market relugolix for prostate cancer and women’s health. 

Relugolix is a once-daily, oral gonadotropin-release hormone (GnRH) receptor antagonist. If approved, it will be marketed under the brand name Orgovyx for prostate cancer as well as in women’s health in combination with estradiol 1.0 mg and norethindrone acetate (0.5 mg) in the US and Canada. However, for geographies other than the US and Canada, Pfizer has received an exclusive right to develop the drug in oncology except in certain Asian countries.

While Myovant is planning to handle regulatory interactions, drug supply, and advance the relugolix combination program, Pfizer is managing monetary needs by paying Myovant up to USD 4.2 billion – a deal that is split into upfront payments, and sales and regulatory milestone payments.

Audentes Therapeutics’ ASPIRO Trial Free to Proceed 

After almost a tough year of holds, the U.S. The Food and Drug Administration (FDA) decided to lift the clinical ban from  Audentes Therapeutics’ ASPIRO trial, which was aimed at investigating its AT132 for the treatment of X-linked myotubular myopathy (XLMTM), a rare neuromuscular disease. 

The ASPIRO trial is a two-part, open-label ascending dose study, and is examining the safety and preliminary efficacy of AT132 in children with XLMTM younger than five years old. X-linked myotubular myopathy (XLMTM) is a rare genetic neuromuscular disorder and leads to muscle weakness, respiratory failure, and early death. Approximately 1 in 40,000 to 50,000 newborn males are diagnosed with the disease.

The clinical hold was put after the death of three enrolled patients during the trial. However, as an early New year gift, the company can proceed with the trial keeping in mind a comprehensive view of past events. 

Welcome the First Generic of Drug for Severe Hypoglycemia

The U.S. Food and Drug Administration has given a green signal to the first generic of glucagon for injection USP, 1 mg/vial packaged in an emergency kit, for the treatment of severe hypoglycemia

Severe hypoglycemia is a condition associated with very low blood glucose and is referred to as a diabetic emergency. It is a complication associated with diabetic patients who take insulin and certain anti-diabetic tablets. To overcome this, Glucagon, a hormone in the body, helps the liver to quickly increase blood sugar levels. Thus, the same idea is behind the injection which is a synthetic version of human glucagon. The most common side effects associated with glucagon for injection are nausea and vomiting, a temporary increase in heart rate, as well as redness and swelling of the injection site.

The USFDA continually takes steps and initiatives to make high-quality generics available to people at affordable rates, and approval is another step in the direction. 

Teleflex Acquires Z-Medica

Teleflex Incorporated has finally completed the acquisition of Z-Medica, an industry-leading manufacturer of hemostatic products.

Teleflex is a global manufacturer of medical technologies and equipment aiming to add value to the healthcare and pharmaceutical industry. The company boasts of its wide spectrum of portfolio ranging from solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology, and respiratory care. Acquisition of Z-Medica, is a Wallingford-based medical device company, will help bolster Teleflex’s overall armamentarium. 

Teleflex a few months back had announced a definitive agreement to acquire Z-Medica. As per the terms and conditions of the agreement, Teleflex will pay an upfront cash payment of USD 500 million at closing along with an additional sum of USD 25 million on achieving certain commercial milestones. Teleflex also took home certain tax attributes that might prove fruitful to the company.

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