Sep 12 Pharma news

Genenta Sciences raises USD 14.54M; GSK announces to buy Sitari Pharmaceuticals; Mallinckrodt to Sell BioVectra for USD 25M; Lexicon to receive USD 260M from terminated diabetes partnership 

Mallinckrodt has announced to sell its Canadian drug manufacturing BioVectra Inc. to a Miami-based private equity firm, an affiliate of H.I.G. Capital for approximately USD 250 Million.

The agreement included a fixed amount of USD 175 Million, with an upfront amount of USD 135 Million, a long term payment of USD 135 Million and further liable payments of USD 75 Million.  The agreement will let Mallinckrodt, a global pharmaceutical company advancing the development and manufacturing of speciality generic drug, to have the full ownership of BioVectra and seize its future potential.

BioVectra, a contract development and manufacturing organization (CDMO), serving pharmaceutical and biotech companies by outsourcing both synthetic and biologic molecules, including human injectable API and final drug product. Our APIs have been used in therapeutics used to treat cancer, kidney disease, cardiovascular disease, multiple sclerosis, and many other serious diseases.

Genenta Science has raised USD 14.54M at the closing of its third funding, totalling up to USD 332.6M from the point of its inception.

The proceeds are intended to fund two ongoing European phases I/II trials. One of the trial is testing the stem cell therapy Temferon in the blood cancer multiple myeloma, and the other in the solid tumour glioblastoma multiforme. The money will also fund preparations for a potential clinical trial of Temferon in the US.

According to the American Brain Tumor Association, Glioblastomas (also called GBM) are malignant Grade IV tumors, where a large portion of tumour cells reproduce and divide at any given time.

The National Cancer Institute estimates that 22,850 adults (12,630 men and 10,280 women) were diagnosed with brain and other nervous system cancer in 2015, out of which 15,320 resulted in the death.

According to DelveInsight, the total Glioblastoma Multiforme market size was calculated to be around USD 957 Million in 2017.

Owing to the positive outcomes of the several drug candidates during the developmental stage by key players such as DelMar Pharmaceuticals, Abbvie, Diffusion Pharmaceuticals, Tocagen, Apogenix, PharmAbcine, etc. they have the potential to create a significant positive shift in the Glioblastoma Multiforme Market Size.

Sanofi has decided to pay Lexicon pharmaceuticals USD 260 Million for the termination of their diabetes pact that came into life in the year 2015.

The collaboration was made to develop and commercialize Zynquista (sotagliflozin), a potential diabetes drug. The drug is a dual inhibitor of sodium-glucose co-transporters (SGLT) 1 and 2 being developed by Lexicon Pharmaceuticals and Sanofi as a treatment for type 1 (T1DM) and type 2 diabetes mellitus (T2DM).

The decision of divestment came following the failure of Zynquista to get approval from the FDA to treat in chronic kidney disease. The decision has cost Sanofi financially, giving all the exclusive worldwide rights of the product to Lexicon.

According to the American Kidney Fund, 30 million people in the United States are living with Chronic Kidney Disease (CKD) and most are undiagnosed. As per the National Kidney Foundation, in people aged 65 through 74 worldwide, it is estimated that one in five men, and one in four women, have CKD.

Approved drugs for the treatment of CKD include- Feraheme (Amag Pharmaceuticals), Auryxia (Keryx Biopharmaceuticals), Omontys (Affymax) & Parsabiv (Amgen). These medications can help to slow the progression of CKD and subsequent loss of kidney function and cardiovascular disease.

Launch of emerging therapies such Roxadustat (Astellas Pharma), Empagliflozin (Boehringer Ingelheim), FG-4592 (FibroGen), HyPoietin (long-acting EPO, GX-E2) (Genexine) will significantly impact the CKD market during the forecast period.

GlaxoSmithKline (GSK) has entered into a definitive agreement with Avalon Ventures for the acquisition of Sitari Pharmaceuticals.

The amount of the deal still remains undisclosed.
In the year 2013, GSK and Avalon jointly found Sitari pharmaceuticals. Till date, Sitari has assured GSK of its successful clinical programs leading GSK to purchase its operations.

Previously incubated at Avalon Ventures’ COI Pharmaceuticals, Sitari is now working on a new therapy for patients with coeliac disease, an autoimmune digestive disorder.

Sitari and GSK’s share a common interest in TG2. By inhibiting TG2, Sitari and GSK are thinking of advancing the Celiac disease pipeline.

Celiac disease (CeD) also known as coeliac disease/Non-tropical sprue or gluten-sensitive enteropathy, is defined as a chronic, multiple-organ small intestinal immune-mediated enteropathy precipitated by exposure to dietary gluten in genetically predisposed people.

An estimated 1 in 133 Americans, or about 1% of the population, has celiac disease. Celiac disease can affect men and women of all ages and races.

The only treatment for celiac disease, at present, is lifelong adherence to a strict gluten-free diet. As per DelveInsight, there are no drugs that treat celiac disease. Owing to the lack of approved drug therapy for the celiac disease, there remains a high unmet need for a therapy that can target the celiac disease and provide relief to the patients.

Key players like Innovate Biopharmaceuticals, ImmunoGenX, Cour Pharmaceutical Development Company, ImmusanT and others are involved in developing therapies for the Celiac Disease.

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