Monday, March 30, 2015
- The FDA approves Novartis' (NYSE:NVS) Jadenu (deferasirox), a new formulation of Exjade (deferasirox), for the treatment of patients at least two years old with chronic iron overload due to blood transfusions and patients at least 10 years old with chronic iron overload in non-transfusion-dependent thalassemia syndromes.
- Jadenu is a once-daily oral iron chelator (it removes iron from the body) in tablet form that can be swallowed whole with or without a light meal. This simplifies the administration of deferasirox which, in Exjade's case, has to be dissolved in liquid for precisely three minutes (timer needed), then immediately drunk at least 30 minutes prior to food, preferably at the same time each day.
- Exjade, the most prescribed chelator in the U.S., generates almost $1B ($926M the past four quarters) in sales for Novartis.
- The FDA approves a new indication for Medtronic's (NYSE:MDT) CoreValve System, a self-expanding device for aortic value replacement, to treat patients who have had a tissue aortic valve replacement and are in need of a second one, called "valve-in-valve" replacement.
- CoreValve is an artificial heart valve made from the heart of a pig. It is attached to a flexible, self-expanding nickel-titanium alloy frame and is placed in the heart via catheter. Once release by the end of the catheter, it expands automatically, anchoring itself to the old failed valve. Once in place, it expands and closes properly, restoring aortic valve function.
- The original indication was the treatment of patients with aortic stenosis (narrowing) who are considered "high" or "extreme" risk for surgical aortic valve replacement.
- Achaogen (NASDAQ:AKAO) will host a conference call and webcast tomorrow at 4:30 pm ET to update investors on its lead program, plazomicin.
- Fast Track-designated Plazomicin is an antibiotic designed to treat Gram-negative bacterial infections. It is being developed to treat serious infections caused by MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE), bugs the CDC calls "nightmare" bacteria and an immediate public health threat.
- Through a Special Protocol Assessment process, the FDA has agreed that the company's single Phase 3 trial will be sufficient to support a New Drug Application (NDA).
- Insmed (NASDAQ:INSM) commences a public offering of 10M shares of common stock. Net proceeds will fund further clinical development of ARIKAYCE and INS1009, increased third party manufacturing capacity to prepare for the launch of ARIKAYCE in the U.S. and Europe, working capital and general corporate purposes. Price and terms have yet to be announced.
- Coherus BioSciences (NASDAQ:CHRS) commences a $100M public offering of common stock. Underwriters over-allotment is an additional $15M. Net proceeds will fund the development of its biosimilar candidates, its small molecule candidate for multiple sclerosis, working capital and general corporate purposes. Price and terms have yet to be announced.
- Trillium Therapeutics (NASDAQ:TRIL) commences a $50M public offering of common stock and preferred stock. The company is offering the common shares, including an underwriters over-allotment of 15% of the number of common shares offered. The preferred shares are being offering by existing shareholders.
- Net proceeds will fund product development, working capital and general corporate purposes.
- Prices and terms have yet to be announced.
4:07 PM| Comment!
- Nano cap Genetic Technologies (GENE +30.1%) rebounds off its 200-day moving average on turnover of almost 8M. Shares had corrected over 67% from the peak of $11 on February 18. The initial up move was stoked by the company's announcement of emerging market uptake of its breast cancer risk predicting test.
- Previously: Genetic Technologies up on breast cancer test uptake (Jan. 29)
- The latest buzz surrounding Panasonic Healthcare's rumored bid for Bayer's (OTCPK:BAYRY +1%) diabetes device business pegs the price at $830M, down substantially from earlier estimates as high as $2.5B.
- Bayer intends to divest the unit in order to remain focused on its life sciences drugs. Panasonic, interested in Bayer's blood glucose meters, joins a list of Japanese electronics firms that are getting more involved in healthcare and its fatter margins.
- Previously: Bayer mulling sale of diabetes business (Nov. 24, 2014)
- Certain subsidiaries of Abbott Laboratories (ABT +0.7%) commence a public offering of 35M shares of Mylan (MYL -3.6%) N.V. It will also grant underwriters a option to purchase an additional 5.25M shares. Mylan will receive no proceeds from the sale.
- The divestiture represents 31.8% (36.6% of the over-allotment is sold) of Abbott's 110M-share stake.
- According to Bloomberg, privately-held Rome-based drug firm Sigma-Tau Group is attracting interest from prospective bidders for its rare diseases business. The unit, valued as high as $1B, could be nice fit with Jazz Pharmaceuticals (JAZZ -0.3%) or Shire plc (SHPG -1%). Last year, Jazz acquired the rights to Sigma-Tau's defibrotide in the Americas for as much as $250M. No formal negotiations are underway, though, and the Cavazza family that owns the business may choose not to sell.
- Sigma-Tau, founded in 1957, generated sales of €697M ($757M) in 2013, with the rare diseases unit contributing €165M. The 220-employee unit focuses on blood diseases and cancer.
- Previously: Jazz kicks off Fast Track review process for VOD med (Dec. 12, 2014)
- Previously: Jazz secures rights to defibrotide in the Americas (July 2, 2014)
- Last night on CBS' 60 Minutes news show, two segments were dedicated to an experimental treatment for brain cancer being developed at Duke University. The therapy, based on a genetically modified form of the polio virus, was injected directly into the brains of patients with glioblastoma, a type of brain cancer with a poor prognosis. Of the 22 patients treated in a Phase 1 study, 11 died. In the group of 11 survivors, though, all experienced a shrinkage in their tumors with three being cancer-free.
- The polio virus, engineered to render it incapable of harming normal cells, replicates in cancer cells, killing them. Other viruses under investigation as cancer killers are herpes simplex, vaccinia and respiratory viruses.
- Companies working on genetically engineered viruses include Amgen (AMGN +0.6%) and Oncolytics Biotech (ONCY -0.4%). Amgen got into the business via its acquisition of Biovex in 2011. On April 29, a joint meeting of the Cellular, Tissue and Gene Therapies Advisory Committee and the Oncologic Drugs Advisory Committee will review Amgen's Biologics License Application (BLA) for talimogene laherparepvec (T-VEC), based on the herpes virus, for the treatment of metastatic melanoma.
- The unique feature of engineered viruses is that they are designed as a single treatment, rather than a multi-dose regimen. Another benefit is their scalability, a potential problem with personalized CAR-T therapies.
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