NEWS VGTI Florida opens new facility at The Tradition Center for Innovation
The Tradition Center for Innovation (TCI) and the Vaccine & Gene Therapy Institute (VGTI) Florida have opened a new, 100,000 sq ft facility within TCI’s 150-acre research park located in Tradition in Port St. Lucie, Florida, USA. Since breaking ground in 2006, TCI has become the location of a number of research institutes and health care facilities, and it is now one of the fastest-growing immunology
research hubs in the USA. VGTI Florida is a pioneer in translating scientific discoveries into the clinic. The new facility, mainly composed of scientific space, is located next to the Torrey Pines Institute for Molecular Studies. The two institutes have collaborated their efforts to take discoveries from the bench to bedside with the help of fellow TCI anchor member, Martin Health System, which operates a
nationally recognised clinical programme.
“Each and every one of TCI’s anchor members have played a pivotal role in the development of this park,” said Andrew Favata, VP of Mann Research Center. “The opening of VGTI’s Florida facility further demonstrates TCI’s position as one of the only bioclusters focused on translating immunology and cancer research.”
Marina Biotech and ProNAi Therapeutics to develop new DNAi-based therapeutics
Nucleic acid-based drug discovery and development company Marina Biotech, Inc and ProNAi Therapeutics, Inc, a biotechnology company developing DNA interference (DNAi) therapies for cancer, have entered into an exclusive license agreement regarding the development and
commercialisation of DNAi-based therapeutics utilising Marina Biotech’s SMARTICLES liposomal delivery technology. ProNAi will have full responsibility for the development and commercialisation of any products from the agreement. Marina Biotech could receive up to $14 million for each gene target in total upfront, clinical and commercialisation milestone payments, as well as royalties on
sales, with ProNAi having the option to select any number of additional gene targets. DNAi are short single-strand unmodified oligonucleotides designed to silence genes by interfering with DNA. The DNAi silencing approach is
differentiated from that of RNAi, antisense or miRNA in that it targets genomic sequences within the non-coding region of DNA, disrupting transcription. ProNAi’s first drug candidate from the DNAi drug platform is PNT2258, and the company is conducting an open-label, single- arm, Phase 1 dose-escalation study of PNT2258 in patients with advanced solid tumours for which no standard therapy exists. ProNAi plans to report the results of this study at oncology
conferences later this year and initiate the next Phase 1/2 safety and efficacy studies in select cancer patients based upon the safety and dose findings from this Phase 1 study. Marina Biotech is a
biotechnology company focused on the development and commercialisation of oligonucleotide-based therapeutics utilising multiple mechanisms of action including RNA interference (RNAi) and messenger RNA translational blocking. The company’s pipeline currently includes a clinical programme in familial adenomatous polyposis (a precancerous syndrome) and two preclinical programmes, one in bladder cancer and one in malignant ascites.
NicOx enters into option agreement to acquire Altacor
NicOx SA has agreed to acquire 11.8 per cent of the shares of UK ophthalmology company Altacor, and has also entered an exclusive option agreement to acquire the remaining shares. The company said the
agreements are the first step in its strategic plan to become a late-stage development and commercial ophthalmology company.
Altacor supplies prescription and over-the-counter (OTC) products for the treatment of dry eye in the UK and Ireland and has a diversified late-stage pipeline including ALT-005, a
surgical antiseptic, and SOLO, a device for the insertion of intra- ocular lenses. Under the terms of the agreement, NicOx is investing £2 million to acquire the initial 11.8 per cent stake in Altacor. The company may acquire the remaining shares of Altacor for an additional consideration of £9 million to be paid in NicOx shares, cash or a combination of cash and shares at NicOx’s discretion. This option may be exercised by NicOx up to the end of May of this year. If agreed milestones are met, the
consideration will be increased by up to £8.5 million.
The ophthalmology market is experiencing significant growth and NicOx believes this therapeutic area offers potential to create a mid-sized international specialist pharmaceutical company. NicOx has already gained significant expertise in ophthalmology through its collaborations with Bausch + Lomb, Pfizer, and a network of other organisations and advisors.
NicOx is currently evaluating a number of additional ophthalmic acquisition and in-licensing opportunities both in the USA and Europe.
FDA News
FDA issues guidance limiting use of DBP and DEHP excipients
The FDA has issued a new document ‘Guidance for Industry: Limiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products’ which decribes the CDER’s current thinking on the potential human health risks associated with exposure to dibutyl phthalate (DBP) and di(2-ethylhexyl) phthalate (DEHP). The draft guidance recommends that the avoidance of the use of these phthalates as excipients in CDER-regulated drug and biologic products, including prescription and non-prescription products. The FDA says while it is recognised that drug products may carry inherent risks, there are safer alternatives available to these phthalates as excipients. It recommends avoiding the use of DBP and DEHP in CDER- regulated drug and biologic products. The recommendations apply to CDER-regulated drug and biologic products that are under development (INDs), non- application products (for example OTC products), and both marketed approved products and those currently under review for marketing consideration (NDAs, ANDAs, and BLAs). The FDA says manufacturers with products that contain DBP or DEHP should consider alternative excipients and determine if the alternative excipient they plan to use has been used in similar CDER- approved products and at what level. Manufacturers of currently marketed products approved under an NDA or ANDA are referred to the FDA’s guidance for industry, Changes to an Approved NDA or ANDA, regarding the reporting category associated with a change in excipient. Questions on non-application drug products should be directed to the relevant CDER review division.
March/April 2012 sp2 Inter-Active 7
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