iBio Pharmaceutical Technology Embraced by the Government of Brazil
NEWARK, Del., June 24, 2013 /PRNewswire/ -- iBio, Inc. (NYSE MKT: IBIO) today released the following information, which was contained in the Portuguese language report published on June 18, 2013 in the official Journal of the Government of Brazil under the heading, "Brazil Expands Production of Biological Medicines." This information is being released in this translated form by iBio to assure uniform distribution to the public of material information regarding iBio. References to the "factory" refer to the facility described in iBio's press release dated April 9, 2013 and to the "first vaccine in the world from a plant," to the vaccine described in iBio's release dated January 18, 2011.
"The ministry will invest U.S. $ 170 million in the construction of the first national factory of organic products made from plant cell technology unprecedented in the country, in Ceara."
"The first technology platform for the production of biological medicines from plant cells, such as carrot and tobacco, involves partnerships between Fiocruz and the Israeli company Protalix, the American Fraunhofer USA Center for Molecular Biotechnology, and iBio Inc. This was also the first plant-based biotechnological which was registered in the Food and Drug Administration (FDA) and the National Agency for Sanitary Surveillance (ANVISA), worldwide. Operations should start at full steam in 2016. The new Fiocruz center will be installed in the city of Eusebio near Fortaleza (Ceara) and construction starts from 2014. A factory will initially produce drugs for rare diseases as Taliglucerase Alfa Recombinant Human, for Gaucher disease, and the first vaccine in the world from a plant, against yellow fever."
"The production process from the extraction plant is a novelty in the country. The technology ensures higher security than the biological produced from viruses and bacteria. It produces fewer side effects and less resistance facing the human body which receives the treatment. Moreover, it requires less investment."
"Ceara is very happy to help correct regional inequalities. It is the country's time to celebrate because we see investing in Brazil and seeing possibilities," said state governor Cid Gomes.
"Organic products are more effective compared to traditional medicines from chemical synthesis, increasing the chances of successful treatment especially for chronic diseases. They are made from living material and manufactured from processes involving personalized medicine and molecular biology."
"Currently biological resources represent 43% of the medicines used by the Ministry of Health, or about U.S. $ 4 billion per year."
• 1-Aug-2013: MNTA’s 2Q13 financial results and conference call.
Copaxone program
• 2H13: Ruling on Copaxone patent case by Appellate Court. (See #msg-85870008 for musings on why a reversal by the Appellate Court is more doable than some investors probably think.) All but one of the patents in the Copaxone litigation expire on 5/24/14, and the other one (a process patent) expires on 9/1/15; hence, if MNTA/NVS succeed in overturning the process patent, the potential launch date will be advanced by 15 months.
• Timing uncertain: FDA action on MNTA’s Copaxone ANDA. Although the FDA is now barred by court order from issuing a final approval of the ANDA before May 2014 (unless there’s a settlement or reversal of the District Court ruling), the FDA can issue a tentative approval, which will allow NVS/MNTA to launch their product upon the expiration of Teva’s patents. FDA tentative approval is highly consequential for MNTA investors because it will: i) re-validate MNTA’s technical prowess in replicating complex drugs; and ii) guarantee that generic Copaxone can be launched at the expiration of Teva’s patents (or sooner if there’s a settlement or reversal of the District Court on appeal).
• Timing uncertain: FDA action on Mylan’s Copaxone ANDA. The same restrictions on a final FDA approval described in the bullet item above apply to MYL’s Copaxone ANDA. (Note: MYL’s Copaxone ANDA was accepted for FDA review about 14 months after NVS/MNTA’s ANDA.)
FoB program
• Early 2014: Start of clinical trial for M923, the first compound in the BAX-MNTA FoB collaboration (which I think is Orencia). This will trigger two milestone payments from BAX (#msg-81498217). Note: MNTA has already established proof of concept on this compound.
• Early 2014: BAX decision whether to license M511, the third compound in the BAX-MNTA collaboration (which I think is Erbitux). If BAX licenses M511, MNTA will receive an up-front license fee and be eligible for additional milestone payments on this compound (#msg-81498217).
• Timing uncertain: Pre-IND progress on M834, the second compound in the BAX-MNTA collaboration (which I think is Humira). BAX has already licensed this product for further development.
• Timing uncertain: Selection of the fourth, fifth, and sixth FoB compounds to be developed in the BAX-MNTA collaboration (if any).
Other programs
• 1H14: M402 data (safety, tolerability, efficacy to determine dose(s) for further study) from first portion of phase-1/2 trial in pancreatic cancer. The revised trial design (adding Abraxane as a comparator) is listed at http://www.clinicaltrials.gov/ct2/show/NCT01621243 . Data from the second (randomized) portion of the trial is expected in Jan 2015.
• Timing uncertain: Progress on IVIG program based on the sialic switch technology.
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