EP Vantage Interview - Novexel making a name in antibiotics

Analysis

Novexel, which was spun out of Aventis in 2004 with a handful of anti-bacterial and anti-fungal projects, is a name that could become much better known next year if it manages to repeat this year’s achievement and strike a second valuable licensing deal.

The private French company clinched an eye-catching €150m out-licensing agreement with Forest Laboratories in January 2008 over beta lactamase inhibitor, NXL104, €75m of which it pocketed upfront. The deal ranks as one of the most valuable clinical-stage deals struck in the anti-infectives space since the beginning of 2007; the fact that the drug was still in pre-clinical development at the time makes it more impressive (See table below). With the second compound up for grabs being prepared for phase III trials, Novexel would seem to have the potential to better itself next time round.

The product in question is NXL103, an oral streptogramin which has demonstrated strong activity against a range of nasty bacteria including, most importantly, MRSA. The company sees it positioned in the hospital discharge market, when patients with severe infections have already been treated with an intravenous antibiotic such as vancomycin and need to be switched to an oral medicine, so they can return home. This market is currently dominated by oral Zyvox, made by Pfizer.

Zyvox is forecast to become a blockbuster this year, with sales forecasts just tipping over $1bn, however, the drug is also available intravenously and the two products are not split out. However, with few oral options available to treat infections such as community acquired pneumonia (CAP) and certain complicated skin and skin structure infections (cSSSI), the pill could comprise a fairly large proportion of sales.

Could be a contender

Novexel reckons NXL103 can also address that market. Top line phase II results reported in October in mild to moderate CAP found the drug stacked up very well against a very high dose of amoxicillin. Full results will be released next year, and in the meantime the company is conducting further studies to complete a phase II package, with a view to commencing phase III sometime in 2010.

Iain Buchanan, Novexel's chief executive, told EP Vantage that the company is likely to have a partner on board to help with the pivotal trials. Although a deal is not on the immediate horizon, options are currently under consideration, he said in an interview.

“Strategically for us it would be interesting to retain rights to the programme in Europe, but look to partners in the US. In the long term we’d like to build a specialty pharma group,” he said.

With €120m sitting on the balance sheet funding is not an immediate concern, meaning the group is in a fairly strong position. Mr Buchanan admits that there is still a lot of work to do before phase III starts, but said interest has already been shown in the product.

Enhancing spectrum

Other interesting news that should emerge from Novexel next year will be generated by the product in-licensed by Forest, NXL104. The drug is a novel intravenous beta lactamase inhibitor, a class of drug which can be co-administered with certain antibiotics to enhance their spectrum of activity.

The US specialty pharma group is testing the drug in combination with its novel broad spectrum cephalosporin ceftaroline; phase I trials should commence next year.

Novexel meanwhile has a separate programme running with NXL104 in combination with ceftazidime, an off patent cephalosporin. A phase II trial in complicated urinary tract infections started earlier this month, and a trial in intra-abdominal infections will start before the end of the year, Mr Buchanan said.

The phase III development of this project is also likely to be partnered, with Forest owning rights to first negotiation. With Mr Buchanan confident that further fundraisings will not be required, a deal for NXL104 is also clearly on the agenda at some point in the next year or so.

Accurate picture

Further data is required on both NXL103 and NXL104 to guage a more accurate picture of their value, but Forest obviously saw something it liked. One potentially negative aspect to NXL103 is that Sanofi-Aventis cancelled an option over the project earlier this year, although Mr Buchanan points out this was before the phase II data was available.

The need for new powerful antibiotics to fight increasingly resistant infections is clear, and the area was in the spotlight last week with the FDA advisory committee review of three new antibiotics trying to win approval in the first line, severe hospital setting.

If the news from Novexel continues to be as encouraging in 2009 as it was in 2008, the company will certainly be one to watch.

Clinical-stage anti-bacterial deals since 1 Jan 2007    
               Deal values (as disclosed)
Deal Date Company Deal Partner/ Product Source Product Pharmacological Class Status on Deal Date Indication Summary Deal Value ($m) Upfront Payment ($m)
01/10/2008 Wyeth Advance LifeSciences Cethromycin (ABT-773) Ketolide Phase III Community acquired infections [Phase III]  -  -
25/08/2008 Baxter International Innocoll Gentamicin Surgical Implant Aminoglycoside Phase III Wound infection prophylaxis [Phase III]  -  -
04/01/2007 Menarini Oscient Pharmaceuticals Factive Quinolone Phase III Bronchitis, chronic [Filed]; Community acquired infections [Filed]; Sinusitis [Filed]  -  -
06/08/2007 Bayer AG Nektar Therapeutics NKTR-061 (inhaled amikacin) Aminoglycoside Phase II Pneumococcal infections [Phase II]  251  56
07/10/2008 Eli Lilly Microbial Chemistry Research Foundation (MCRF) CPZEN-45 Anti-tuberculosis agent Pre-clinical Tuberculosis (TB) [Pre-clinical]  -  -
22/01/2008 Forest Laboratories Novexel Ceftaroline/NXL 104 combination product
    Deal also included first negotation right in North America to ceftazidime/NXL 104 combination product, in phase I trials being conducted by Novexel.
Cephalosporin & beta-lactamase inhibitor Pre-clinical Broad spectrum bacterial infections [Pre-clinical]  218  109
06/03/2008 Emergent BioSolutions AVANIR Pharmaceuticals AVP-21D9 Anti-anthrax MAb Pre-clinical Anthrax prophylaxis [Pre-clinical]; Anthrax treatment [Pre-clinical]  2  -
08/04/2008 Achillion Pharmaceuticals FOB Synthesis Carbapenem Research Program Carbapenem Research project Staphylococcal infections [Research project]  11  1
07/10/2008 Eli Lilly Summit Tuberculosis Research Programme Anti-tuberculosis agent Research project Tuberculosis (TB) [Research project]  -  -
12/05/2008 Merck & Co Ranbaxy Laboratories Ranbaxy/Merck Anti-bacterial Collaboration Anti-bacterial Research project General bacterial indications [Research project]  100  -
16/06/2008 GlaxoSmithKline Mpex Pharmaceuticals Efflux Pump Inhibitors Research Project Antibiotic Research project General bacterial indications [Research project]  665  8

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