Weekend News: Business, Finance and Innovations in Biotech and Pharma Industries
After the relaxing weekend we are back once again with some latest news that has happened while we were away. Check it out here;
Aurobindo Pharma receives USFDA Approval for Esomeprazole Magnesium
Aurobindo Pharma (Hyderabad, India) a company manufacturing generic pharmaceuticals and active pharmaceuticals ingredients has recently got FDA approval for Esomeprazole Magnesium delayed-release capsules USP with doses 20 mg and 40 mg. It is a proton pump inhibitor which could be used in the treatment of gastroesophageal reflux diseases. The company claimed that this new ANDA have been proven to be bioequivalent as well as therapeutically equivalent to Astrazeneca’s Nexium delayed release capsules (20 mg, 40 mg) as listed in reference drug category. With this the company has 253 total ANDA approvals (273 final, including 10 from Aurolife pharma, LLC and 36 tentative from USFDA). According to IMS, it has been estimated that the approved drug has a market size of USD 4.2 billion for the 12 months ended February 2016. As per Bombay Stock Exchange (BSE) Aurobindo Pharma Ltd, currently trading at Rs. 785.15 has raised by Rs. 17.50 or 2.28% from its previous closing of Rs. 767.65.
AbbVie & CytomX Collaboration for Probody drug conjugates against CD71 or transferrin receptor 1 (TfR1)
AbbVie (North Chicago, US) a pharmaceutical company that deals with discovery, manufacturing and marketing of biopharmaceutical and molecular drugs has announced to work in collaboration with CytomX Therapeutics (South San Francisco, US) a biotech company for Probody drug conjugates against CD71 or transferrin receptor 1 (TfR1). CD71 is a kind of glycoproteins that are highly expressed in solid as well as haematological cancers and they work as to transfer cytotoxic material into the tumour cell. Probody therapeutics acts by binding selectively to these receptors leaving behind healthy tissues undisturbed. They remain inactive until and unless they are exposed to proteases present in tumour microenvironment. There tumour cell selectivity has been confirmed by CytomX under preclinical trials. As per the agreement between the two, CytomX will deal with all preclinical and clinical development while AbbVie will look after late stage development and commercialization. However, the benefit will be mutually shared between the two. Also, AbbVie will receive rights to develop and commercialize Probody worldwide while CytomX will receive additional milestone in payments.
AbbVie another Collaboration with Argenx against a Novel Immune-oncology Target GARP
AbbVie and Argenx (Belgium) the two biopharmaceutical companies are planning to work collaboratively on ARGX-115 against a novel immune-oncology target GARP (glycoprotein repetitions A predominant protein). GARP protein is known to produce immunosuppressive effects of T-cells. The basic concept behind ARGX-115 deal is to block immune-suppressive natural pathway with in the body so as to boost natural defence mechanism. According to the deal, Argenx has rights to conduct research and development; commercialization; license the ARGX-115 program. For this Argenx will receive a payment of $40 million to license ARGX-115; $20 million for preclinical development and $625 million as additional development, regulatory and commercial payment upon achievement of pre-determined milestones. Also, it has rights to co-promote ARGX-115 based products in Europe and Swiss Economic areas. With this, Argenx alone has rights to develop ARGX-115. However, AbbVie will fund further GARP research for an initial period of two years and has right to license additional therapeutic programs originated from this research.
Sarepta Therapeutics Receives Duchenne muscular dystrophy Treatment
Sarepta Therapeutics (Cambridge, Massachusetts, US) a medical research and drug development company has faced its shares got crushed on Thursday, then raised on Friday after getting FDA view on Eteplirsen, a Duchenne muscular dystrophy (DMD) treatment that has been waiting for FDA approval. After getting list of questions to be asked by FDA for drug approval the company analysts are in dilemma whether the drug will get approval or not.