Member Info for Ivyspivey

NDA in late Q1 so presume March Iclaprim can become empiric treatment vs renally impaired ABSSSI Has potential to be blockbuster ie peak sales of $1.2 bn. by 2026.

All and a 2018 that is transformational for the SP as well as MTFB

Mainly in response to using ABs at low therapeutic levels such as growth promoters in animals. Banned in Europe but not in US For pharma like MTFB that can provide one of answers to AMR then is great to have in portfolio and is very attractive to replace other ABs in pharma portfolio

Agree again HM Slightly more comparable is news today from IMM re LPO and SUMM signing a agreement for Latin America vs CDI All bodes very well here fir 2018

Well said HM Many of the biggest gains are made when a seller is out/SP has dropped by 95% and transformation appears to be under way but MTFB is a completely different kettle of fish in terms of its stage of drug development.

Fully concur with what Jimbob has said regarding theses matters and everything remains fully on track. It will be good to see regular updates but only when necessary.If you look at the history of MTFB every time there is a quiet period it does not mean nothing is happening just they are quietly getting on with it. The NDA is a massive document of hundreds of thousands of pages each to be checked and double checked and will be out under close scrutiny. You can’t afford any mistakes so takes a huge effort especially for a small team. It really is a case of no news is good news and as the submission gets confirmed I think there will be a steady rerate up to this point once tgecAMP issue is sorted and post JPM in January

« View All Work | Next Case Study » Objective A publicly traded, specialty pharmaceutical company was preparing for a PDUFA date in anticipation of an FDA decision for this product candidate. The company had previously received a complete response letter from the FDA for this product candidate, and it was essential that the company’s investor relations strategy be understood by Wall Street Program Crafted the press release outlining announcing FDA approval Developed detailed Q&A document of potential questions asked by member of the financial community Organized aggressive non-deal road show with investors following approval to discuss planned commercialization activities Updated the company’s website reflecting the fact that the company is now a commercial organization Updated the company’s IR presentation to include information on the drug approval and outline preliminary commercial strategy and timing Results The product was approved by the FDA and the company’s shares appreciated significantly on news of the approval Following the announcement, the company embarked on an aggressive schedule of calls and in person meetings with members of the financial community to review the company’s commercial launch plans

Look at their case study on FDA Approval. Seems they have been there a few months so missed it earlier.

RNS as IanB says was just housekeeping.Anyone notice new US PR firm +44 (0) 20 7933 8780 / motifbio@walbrookpr.com Paul McManus Mob: +44 (0)7980 541 893 Mike Wort Mob: +44 (0)7900 608 002 MC Services AG (EUROPEAN IR) +49 (0)89 210 2280 Raimund Gabriel raimund.gabriel@mc-services.eu The Trout Group (US IR) +1 (646 )378-2963 Meggie Purcell mpurcell@troutgroup.com Lazar Partners (US PR) motiflp@lazarpartners.com Chantal Beaudry +1 (646) 871-8480 Amy Wheeler +1 (646) 871-8486

Hard to tell. The Tyru approach is in direct contrast to traditional veterinary and pharma so not sure if they would be interested in M&A at this stage. However if the Tyru approach proves very successful and becomes the future of parasite control there will be plenty of interest in buying them out.

No he left Merial a few years ago to join Tyru I am laughing as I used to work for Merial but now work for BI which as you said has just bought Merial.

Hi Los Will be interesting to see which 2 they mean.Could be in poultry as well and totally depends on parasites of concern and of course how market judges Turu technology. The companion animal market has moved on and as well as newer chemistry such as the isoxalyines which are a definite improvement in the flea/tick/mite area the big move forward is combination of products to form endectocides cover both internal and external parasites. Although in some ways cat/dog market is very attractive to Tyru technology as eco friendly and natural most licenced products are very safe wherea the real need is to eliminate some of the OP and DEET based insecticides which Tyru technology is extremely good at. As long as they can prove efficacy vs these parasites of concern which would mainly be mites/flies etc. However it depends how the products work for eg those pRasites which have a GABA central nervous system which include worms and external parasites can be susceptible to one particular chemical product. Once we know which products are in development should be pretty straightforward to predict their impact and that is why Bruno’s confidence is so good as he will know this as well

FYI the definition of blockbuster is those products with the potential to sell more than $1bn.

The first one was a range of products based on Ivermectin so Ivomec in Cattle and Pigs,Sheep and Eqvalan in horses as well as Heartguard in Dogs. Second one is those based on Fipronil which is used in Frontline in Cats/Dogs. There are lots of combination products but these would easily be the 2 best selling animal health products ever. BJ was European head for the Marketing of Fipronil and 2 other SH Alan Reade and current chairman Jose Barella were both global heads of Merial which marketed both drugs.

Know all about Animal Health Blockbusters having helped grow the 2 biggest selling AH products ever both in production and companion animal

E Moyer= enjoyed

Hi Leas, Hope you e Moyer nice rise on IMM and confident this will follow suit shortly. In fairness Kettle may not be fully aware of the changes MTFB made to the 2008 trial protocols to improve both safety and efficacy of Iclaprim as evidenced by the positive R1 and R2. Personally don’t mind these questions unless they are repeated on a continuous basis. Have similar average to you on IMM but bit higher here

Kettle-absolutely not.Why would you be concerned about 2009 when you heave two p3 trials finished this year with big trial protocol differences since 8 years ago and NO deaths in the latest trials in the Iclaprim group but a single death in the Vancomycin group. These are often elderly and ill patients so to have no deaths and/or very few SAEs then the safety of Iclaprim has been totally endorsed

Thanks

As per usual Two main takeouts from me in addition to focus on AH Validating “ clean food” think the deal with the division of kraft is interesting as may use food Company’s to validate their suppliers us8ng Tyratech technology(pesticide free). The mention of the adoption of the technology by main US poultry Company’s as standard of care.