More Global Health Business News (No. 6)

Auritec Pharmaceuticals is a very-low-profile drug delivery company in Pasadena, CA, and is part of a group of academic institutions that recently received a $20 million NIH grant to develop a vaginal ring for microbicide and anti-viral drug delivery (FierceDrugDelivery article). Auritec did not issue a press release on the grant, to be given over five years, but it is co-located with the grant’s lead institution, the Oak Crest Institute of Science, whose press release noted the program will test the delivery of up to five drugs in combination, an important goal for achieving compliance-independent HIV control and treatment (Oak Crest press release).

As I noted in a previous newsletter, GlaxoSmithKline (GSK) is leading a crash program to develop an Ebola vaccine.   Earlier this month, GSK published the results of a study in primates that showed the candidate vaccine was effective in preventing infection but that a booster shot was needed for longer (greater than ten months) protection (FierceVaccines article). It is expected that the NIH will start trials of the experimental vaccine, acquired by GSK when it purchased the biotech company, Okairos, for $325 million, this month.

Also on the Ebola front, the Bill and Melinda Gates Foundation is putting $50 million into immediate efforts to control the outbreak and into grants for drug, vaccine, and diagnostic development. The Foundation’s press release noted that $12 million was being distributed to the WHO, CDC, and UNICEF and the remainder was to-be-granted.

In the “still-not-getting-any-good-press” category, Gilead Sciences, Inc., reported completion of the licensing of rights to manufacture and sell its blockbuster anti-hepatitis C drug, Solvadi (sofosbuvir), to seven Indian generic drug manufacturers (Gilead press release in FiercePharma).   Gilead anticipates these agreements will bring low-cost sofosbuvir to 100 million patients (54% of the world’s total) in 91 countries (Gilead HCV Fact Sheet). As I noted in my blog posts, Gilead’s generic licensing program could be an effective model for other pharma companies wanting (needing) to increase access to their products.

I first wrote about Vaxxas, a Cambridge, MA-based vaccine delivery company, when it started back in November 2012 (“Vax Patch”) and have occasionally checked for progress, of which there has been none, at least made public. That changed last week when the company announced it had received funding from WHO for a pre-clinical and pre-manufacturing project aimed at applying its Nanopatch delivery technology to the polio vaccine (Vaxxas press release). Vaxxas has one commercial partner, Merck, and I expect/hope its BD team’s efforts pay off soon.

Also, I wrote about the Japanese Global Health Innovative Technology Fund in May 2013 (“GHIT Ready”) and posited that its award criteria were biased against smaller, more innovative companies, its awards were too small to have a real impact, and its bureaucracy extensive and inexperienced in product development. The Fund announced its second round of grants last week; $15+ million will go to seven preclinical or early clinical projects for drugs or vaccines for dengue, malaria, or Chagas. The recipients were the usual suspects- established academic and research groups with the occasional corporate partner- but no innovative, low-overhead, and hungry start-ups.

 

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Global Health Business Weekly (No. 5)

What does it cost in time and money to run a crash vaccine program against a deadly but infrequent disease that occurs in uninsured and underserved people outside the US? The disease, of course, is Ebola, and the program was announced two weeks ago (GSK press release in FierceVaccines). The program’s goal is to complete safety and efficacy tests in about three months, and its costs will be met in part by a $4 million grant from private and government (UK) sources, GSK, and the US NIH. GSK will also receive funding to manufacture 10,000 doses of the candidate vaccine in parallel to be deployed by WHO if the trials are successful. Such success will not only save lives but may provide a model for crash vaccine development programs against other infectious diseases in the rest of the world which have no or limited vaccines like hepatitis C, malaria, and TB.

An effective drug for treating Ebola is also needed, and recently the US Biomedical Advanced Research and Development Authority announced commitment of up to $42 million (10x what is going into the vaccine program) to tiny Mapp Biopharmaceuticals, Inc. for further testing and manufacture of its candidate drug, ZMapp (FierceBiotech article).

At the other end of the funding spectrum, OncoSynergy, Inc. recently announced the start of a crowd-funding campaign to raise $5,000 to test an antibody it is developing to treat cancer against Ebola (FierceBiotech article FierceBiotech article, OncoSynergy press release, and Experiment.com funding page ). My skeptical side says “PR stunt” but I hope I’m wrong and the company has positive results in its in vitro demo.

In the “Nature doesn’t take a day off” category, FierceVaccines reported that an academic study of the polio virus associated with a 2010 outbreak in central Africa found a new, mutated form (FierceVaccines article). The scary part is that the mutated form was not neutralized in vitro by antibodies generated by the current vaccine. Even more scary was that the outbreak had a 50% mortality rate and it was estimated that half of those affected had been vaccinated. Of course, everyone knows that polio was common in the US with 35,000 cases per year in the 1950s and about 1% resulting in limb paralysis until almost universal vaccination was introduced (CDC Polio FAQ).

In the “lost in the noise” category, Gilead mentioned last week that it is in discussion with six generic drug companies about licensing its anti-hepatitis-C drug, Sovaldi (FiercePharma article and Bloomberg article). According to Gilead’s EVP Gregg Alton, the agreements will bring the drug to about 80 developing countries, and the licensing is in addition to Gilead’s plans to sell Sovaldi in India and other countries for $900 per treatment course. The noise, of course, is that Gilead has priced the same treatment in the US at $84,000 which has generated approbation by some payers and members of Congress. Alton noted, however, that this price is the same as that paid by the payers for the older, less effective regime. So I guess the payers are upset not by the cost of treating (and curing) a patient but by the potential demand for the drug. So the overall cost of the drug is the fault of patients and their doctors.

In the “emerging start-up opportunity” category, MIT reported that researchers of the Singapore-MIT Alliance for Research and Technology had built an MRI-like prototype device for detecting the malaria waste product, hemozoin, in blood (Fierce Diagnostics article and MIT press release). The team is starting a company to develop and test a cheaper, portable version that may be faster and more reliable than the current microscopy-based detection. Not mentioned was another diagnostics company founded by an MIT alum, Disease Diagnostics Group, that is using a simpler technology to detect hemozoin and that its prototype is in field testing (Boston Globe article).

The Business of Global Health (No. 3)

Thanks to the broad and deep coverage of the biotech and medtech industries by the editors and reporters of the Fierce newsletters, I noted the following recent stories relevant to global health.

Last week an article in Fierce Medical Devices reported that a not-for-profit organization, Engineering World Health (EWH) recently received a $1.5 million grant from the GE Foundation to expand its program of training technicians in the repair of medical devices into Nigeria, in addition to previous GE support (Fiercemedicaldevices article). EWH was started in 2001, became an independent, volunteer organization in 2008, and runs 3-4 year programs in Cambodia, Rwanda, Ghana, and Honduras, with about 50 students enrolled each year. Also two recent studies found marked improvement in equipment “up-time” in the hospitals with EWH-trained technicians and improved technician productivity (another FMD article). It looks to me as if EWH is a good funding and good works opportunity for a medtech company looking to enter developing world markets. It also runs a small product design competition (EWH Competition).

As some readers may remember, I have written about the need and potential for therapeutics to treat Sickle Cell Disease (SCD), especially in Africa where it is a major cofactor in mortality (“Still Neglected”). So I was pleased to learn of another company, Global Blood Therapeutics (GBT) with a promising preclinical SCD drug candidate. San Francisco-based GBT was launched in 2012 with a $41 million Series A funding by Third Rock Ventures, so its likely first market will be the US (about 100,000 patients out of a world total of 15 million).

Also some readers may remember that earlier this year I wrote about Knight Therapeutics receiving FDA approval for a drug that is effective against leishmaniasis, a protozoan infection that occurs annually in about 1.3 million people and causes 20-30,000 deaths (“GUD Knight”). In addition and since the disease is neglected and without any good treatments, Knight also received a Priority Review Voucher, which confers to the holder expedited regulatory review for a product and therefore 6-10 month sooner market access.   Fiercebiotech recently reported Knight is offering the voucher for sale but also that, because the FDA is expediting approvals in other ways, its value is uncertain (Fiercebiotech article). To his credit, Knight’s CEO, Jonathan Goodman, is also quoted as saying the company’s goal (in addition to getting funds) is to “set the bar high to encourage others to invest in R&D for neglected tropical diseases.”

Finally, Fierce also reported that PanVax, a vaccine company “committed to providing both attractive financial returns and social returns,” has expanded its marketing team with the addition of vice presidents for North American and global sales and marketing and five U.S. sales people (another FBT article). This personnel is added to that obtained when the company acquired an approved oral typhoid vaccine last month (“More Bits and Bytes”).

 

Rxs for Vxs Replay

August is a good month to be on vacation so here is a repost from November 2013.

The international and multilateral effort to deploy vaccines against the infectious diseases of childhood and poverty has resulted in millions of lives saved and illnesses averted, contributing substantially to personal and national health and well-being. But at the same time, there are scientific and political challenges that are limiting the extension the benefits of vaccination. To overcome these challenges, the experts of the vaccine community have identified a set of goals. In the technical/scientific category these include:

  • Vaccines that confer long-lasting immunity with a single dose (e.g., through new adjuvants);
  • Vaccines that do not require refrigeration;
  • Alternatives to delivery via injection;
  • Antigen design especially for parasitic diseases; and
  • Curative vaccines (see Gates Grand Challenges 1-6 and 12).

Under policy goals there are:

  • Expansion of funding options, especially for the low- and middle-income countries;
  • Strengthening immunization delivery and monitoring systems;
  • Improving public acceptance of vaccination; and
  • Utilization of evidence-based vaccination programs (Cochi 2011).

Often overlooked by the experts though is the role the biopharmaceutical industry can have by improving existing vaccines, inventing new ones, and increasing access and affordability through competition. Thanks to the Bill & Melinda Gates Foundation, progress was announced on three efforts involving industry in the past month.

In early October, PATH’s program to help Chinese vaccine manufacturers enter the global health vaccine market reached a milestone (PATH is a Seattle-based product development program largely funded by the Gates Foundation). WHO announced that it had added a vaccine for Japanese encephalitis made by China National Biotec Group (CNBG) to its list of prequalified vaccines, meaning UN agencies like UNICEF can purchase the vaccine for their immunization programs and purchases by eligible countries may be subsidized by the GAVI Alliance (WHO press release). PATH has spent a substantial sum (I’m not sure how much) and has provided expertise over the past ten years to Chinese companies and the Chinese drug regulatory authority to meet the stringent requirements of manufacturing quality and processes of prequalification program (see the 2011 interview with PATH’s China program leader). Japanese encephalitis is an important vaccine target since the mosquito-borne disease is endemic in much of south Asia and causes 10-15,000 deaths per year and the other available vaccine is expensive and requires multiple doses (WHO JE vaccine). To achieve prequalification status, PATH provided CNBG $39 million since 2004, and CNBG invested about $131 million (China Daily article). According to the Financial Times, the CNBG vaccine costs $.30 per dose, eight times lower than the retail price of a competing vaccine (FT blog and FierceVaccines article).

Also, last week at the 9th annual Grand Challenges Meeting held in Rio de Janeiro, two steps were announced to involve industry and increase competition. In the first, Trevor Mundel, president of global health for the Gates Foundation, said that the foundation is starting a Vaccine Discovery Partnership program (VxDP) through which it will be funding research at companies from preclinical to Phase II trials to “reduce the risks associated with early-stage vaccine research, and increase the likelihood that the most promising new vaccines are developed quickly, and at lower cost” (Mundel blog post). Also announced were the first two company participants, GlaxoSmithKline (GSK) and Sanofi. According to its press release, GSK and the VxDP will devote a combined $1.8 million to explore how to make adjuvants, compounds that are co-administered with vaccine antigens to stimulate a robust immune response, more heat stable and thus improving he heat-stability required for vaccines to be used in under-resourced environments where refrigeration is lacking (GSK press release). Specifically, the work will focus on the adjuvant, AS01, that is a component of GSK’s malaria vaccine candidate, RTS,S. RTS,S is in Phase III testing in partnership with the Gates-backed PATH Malaria Vaccine Initiative. Also given in the release were the details that VxDP projects may include multiple partners including academic and not-for-profit organizations, that companies will agree to match foundation funding and to provide global access, and that projects may also address nontechnical problems like the affordability and delivery of vaccines. Sanofi Pasteur, the vaccine group of Sanofi, also announced its participation in the VxDP in a press release but did not specify its projects or funding (Sanofi press release). While the VxDP’s emphasis on funding early-stage and higher risk projects is good, as I have noted in the past, the Gates Foundation often shies away from providing meaningful funding for highly speculative research, such as may be found at small biotech companies, and the requirement for matching funding will likely exclude them. But then until the VxDP puts up a website with information on how to apply for participation, the amounts and commitment of funds, and its coordination and management functions, the potential of the program to help vaccine development broadly is not clear.

Also announced at the conference was the Gates Foundation’s first grant, as far as I know, to a government to make a vaccine, and hence possibly improving the competitive landscape and resulting in lower prices cost and increased availability. As was reported by Reuters (Reuters article), Brazil’s minister for health, Alexandre Padilha, said that Bio-Manguinhos, a unit of the government’s Oswaldo Cruz Foundation (Fiocruz), will make a new measles/rubella vaccine specifically for export to developing countries in Africa, Asia, and Latin America. The Gates is providing a grant of $1.1 million and possibly additional funds for development. The goal will be to produce 30 million doses per year starting in 2017. Measles is a potentially fatal viral disease for children and rubella, while mild in children can be spread to pregnant women causing miscarriage and defects. Combined vaccines now reach 80% of the world’s children before the age of one year, but an estimated 158,000 children still die of measles annually (WHO Fact Sheet). This is a small, but possibly meaningful, step given that Fiocruz will need at least tens of millions of dollars more to get the vaccine to market, the vaccine will not be on the market for 4-5 years, and its market share will be small, 10-20% (according to the WHO 225 million doses of combined measles vaccines were given in 2011). But Fiocruz is a unique government entity having extensive experience in vaccine development and production, including being the recipient of the transfer of the technology for the measles vaccine production from GSK (for more about Fiocruz, see the Fiocruz website and my 2010 posting, “Fio-Cruise”). I’m guessing that the Gates grant is a one-time deal, but if it is part of a wider plan to improve the ability of vaccine manufacturing programs of governments to meet their and other countries’ needs for basic vaccines, it could be a significant move.

More Bits and Bytes (No. 2)

Continuing the theme I started last week, here are a few stories I noted relating to the global health business and my comments.

Unlike the subtle pressure being put on drug prices in the US by insurers that I mentioned last week, the National Pharmaceutical Pricing Authority of India announced recently that it was reducing the allowed retail price of 50 generic cardiovascular and diabetes drugs so no brand is priced at more than 25% above the average price of that category (FiercePharma article and Wall Street Journal blog). The immediate effect was a decrease in the share price of foreign and domestic pharma companies, and the longer term effect may be an increase of Indian companies increasing efforts to sell outside of India, especially in countries with third-party payers (the US and Europe) and growing middle classes (developing world).

Speaking of which, the Indian pharma company, Glenmark, will be selecting a site for a new factory in Canada or Mexico to serve the North American generic drug market. The company, which already has more that a dozen non-Indian plants, said it is planning a $100 million investment over five years (FiercePharmaManufacturing article). I’m glad to see a company intending to help bring US health care costs down.

In big news for ROW vaccines, GlaxoSmithKline (GSK) submitted its malaria vaccine (called “RTS,S”) for approval by the European Medicines Agency last week (FierceVaccines article). GSK noted in a press release that it has expended $350 million and expects to spend another $260 million to complete development and that the Bill & Melinda Gates Foundation, through the PATH Malaria Vaccine Initiative, kicked in $200 million (GSK press release). GSK also stated it that “the eventual price of RTS,S will cover the cost of manufacturing the vaccine together with a small return of around 5 per cent that will be reinvested in research and development for second-generation malaria vaccines, or vaccines against other neglected tropical diseases.” I am hoping that buyers, primarily health ministers in Sub-Saharan African countries subsidized by the Global Fund, will find this acceptable.

And in other vaccine news, PanVax, a California-based company that I have posted on previously (“Knick-Knacks”), obtained an additional $50 million in debt financing and $12 million in a Series B venture funding and will use the funds to complete acquisition of an approved oral typhoid vaccine (Crucell’s Vivotif) and for its ongoing Phase III study of a cholera vaccine candidate (PanVax press release).   PanVax’s mission: “We are committed to providing both attractive financial returns and social returns, without a significant trade-off between the two. As a double bottom line business, we will measure our financial success in terms of return on equity and we will assess our social returns by access to our vaccines globally, particularly to the poor and otherwise disenfranchised. We strive to develop and deliver vaccines that are affordable and deliverable anywhere in the world regardless of the state of medical infrastructure or supply chains.” (PanVax About).

Vakzine Projekt Replay

Vaccines are important in global health and I’ve written a number of posts on the development of new, possibly game-changing vaccines. Here is a post I wrote in August 2013 on TB vaccine candidate VPM1002, now licensed to the Serum Institute of India (SII). I checked clinicaltrials.gov and SII for an update of the Phase II trial, but no results have been released.

A major goal in achieving better global health is the development of a vaccine for tuberculosis, a latent bacterial infection found in about 27% of the world’s population. When the infection becomes active, e.g., when one’s immune system is weak (currently about 20% of all cases) and if it is untreated with antibiotics, it is fatal and about 1.4 million people die of TB annually (Global Health Primer TB). A vaccine is needed to replace the current, partially effective vaccine, called bacille Calmette-Guérin or BCG, that was invented in the early 1900s and of which more than 100 million doses are now administered each year, primarily in countries where TB is endemic like India, Pakistan, Russia, and Brazil. While BCG will prevent TB infection of infants, but with an efficacy of 50-80% (Wikipedia article), it does not prevent primary infection or conversion from the latent to active state in adolescents and adults. In addition, immune-compromised patients (e.g., as in HIV/AIDS) do not respond well to treatment with antibiotics and strains of TB resistant to some or all antibiotics are emerging (WHO TB Fact Sheet).

The global health community, academic institutions, and the biotech/pharma industry have responded to this need over the past years and in 2001 a modest $100 million was spent to develop a new vaccine (the total TB R and D spending was about $500 million, WHO TB background paper). This effort has resulted in about two dozen vaccine candidates in the pipeline with one in Phase III and seven in Phase II trials that are aimed at either preventing infection, stopping conversion, or eliminating infection (Global Health Primer TB). One candidate, VPM1002, achieved a major business milestone in its development last week when it was licensed to the Serum Institute of India (SII), a major manufacturer of vaccines for the developing/emerging market countries (Fiercevaccines press release). VPM1002 is based on an approach invented at the Max Planck Institute for Infection Biology of Berlin, in which the BCG vaccine (which is actually a weakened form of a mycobacteria related to the TB bug that infects cows) is made more effective by the addition of two genetic modifications to make the vaccine more “visible” to the immune system (for more on the technology, see Velmurugan t al. 2013).

The deal was clearly a major commitment by SII which will still need to scale up and get approved a GMP manufacturing process in parallel with conducting several Phase III-level trials, at a cost tens of millions of dollars at least. SII may also need to secure country-by-country regulatory approval for adult use. SII is a WHO prequalified vendor for sale to the WHO’s Expanded Programme on Immunization which promotes and subsidizes childhood vaccinations and already is a supplier of its version of BCG called Tubervac. The parties did not provide any information on the terms of the deal, so it is not clear what SII’s upfront financial commitment was. Nor it is clear how SII valued the candidate; the Phase II study was completed last October, but the results have not been reported according to the NIH trial tracking system (VPM1002 status). SII must have ranked VPM1002 highly since five of the other candidate vaccines at Phase II/III have no major manufacturing partners. One detail of the license was suggested in that the licensor’s CEO implied that SII is committed to the accessibility and affordability of the final product: “Only an experienced and specialized developer and global player like Serum is able to ensure that the vaccine will be made available to people everywhere at a fair price.”

I was also interested in how VPM1002 progressed to Phase II since the preclinical and early clinical studies likely required millions of dollars and substantial product development experience. According to the press release, Vakzine Projekt Management GmbH, a private company in Hannover, Germany (VPM) granted the license to SII after having obtained the rights from the Max Plank Institute’s tech transfer group. But my poking about the VPM website and the web did not yield useful information. VPM, founded in 2002 as a spin-out from another German research institute, the Helmholtz Centre for Infection Research, calls itself a fee-for-service consultancy and a speculative product developer: “VPM offers tailor-made consultancy and services based on in-depth experience in development of biopharmaceutical candidates. In addition, VPM acquires promising candidates from academic research and develops them in cooperation with a pool of partners to products with a high value potential” (VPM Company), but I wondered how the cash flow from the former could support the latter and doubted that the customers or licensees provided substantial capital. Three “shareholders” are listed by VPM, one a tech transfer company for German academic life sciences institutions, one the donor group for the Helmholtz Center, and the last, an individual. It is possible that VPM funds itself through license fees, and it claims that three of its five products have been licensed, but I could find substantiation for only one. The “CMV dense body technology project” was licensed to small German company earlier this year (Cvec press release). I suspected VPM receives a government or foundation subsidy, but found none. I was also mystified by VPM’s relative lack of product development experience; other than the CEO, none of the management seemed to have taken a product through to launch. But perhaps if I had kept up my study of German, I could be better informed. In any case, congrats to VPM and I look forward to learning more about their business model and the progress of VPM1002.

Readers with good memories may recall that I wrote a post on my favored TB vaccine candidate in June, 2010 (“Una Sorpresa Prometedora”). RUTI, a therapeutic vaccine being developed by Archivel Farma of Spain, has the potential to reduce the time of therapy from months to days and had completed a Phase I trial in 2010. Since then, however, news has been sparse. According to Clinicaltrials.gov, the Phase II trial was completed in January, 2012, but no results were reported (RUTI status). In general, no news on a candidate’s progress is not good news.

 

Vector Vax

Malaria is a nasty disease resulting from an infection by the Plasmodium parasite that occurs via injection by an infected mosquito, and that, according the WHO, happened to about 200 million people in 2012 (WHO Malaria Facts).  Fever and chills ensue and, if untreated, death, and this happened to about 600,000 people, mostly children in Africa, in 2012.  While drug treatment exists and is being improved by newer drugs, combinations, and better distribution and measures like preventing bites with netting and killing mosquitoes and destroying their habitat are helping reduce mortality, a malaria vaccine has been a long-sought goal of the global health community.  A vaccine is a major challenge though.  The parasite goes through a number of stages in the human host and the insect vector (see a nice graphic at Malaria Vaccine Initiative) and how, when, and where the human immune system mounts a successful response are not known.

Vaccine developers have taken three vaccine approaches (also at Malaria Vaccine Initiative).  The first is to aim at the early stage of an infection when the parasite is infecting the host liver; the most advanced vaccine, GlaxoSmithKline’s (GSK) RTS,S AS01 in Phase 3 clinical trials, is of this type.  The second is to generate an immune response to the parasite while it is rapidly reproducing in the host red blood cells, reducing the severity of the disease and allowing time for the innate immune response to occur.  The third, using a transmission-blocking vaccine (TBV), is my favorite because it targets the parasite while it is reproducing in the mosquito using antibodies obtained from the host.  Essentially the vaccine turns a human into a system to deliver antibodies to treat the vector’s malaria.  The idea for a TBV has been around at least since 1987 when studies confirmed that the blood of malaria sufferers contained antibodies that reduced the number of parasites in mosquitoes (e.g., Mendis et al. 1987 in which the researchers dissected out the mosquito gut to look for parasites), but it has only been in the last three years that candidates have advanced into clinical trials.  The primary sponsors of the trials have been the Malaria Vaccine Initiate (MVI is run by the Seattle-based global health product developer, PATH, and funded by the Gates Foundation) and the NIH’s National Institute for Allergy and Infectious Diseases.

MVI’s lead TBV candidate was Psf25-EPA, so named because it consists of  antigens to a Plasmodium surface protein and a detoxified version of an immune-stimulating bacterial protein.  Unfortunately, it failed to generate a strong enough response in a Phase I trial in 2012 (MVI Call for Letters of Intent).  While a number of companies and academic groups have expressed a variety of the parasite’s surface proteins in a range of expression systems (I noted one in yeast and another in algae), the Fraunhofer Center for Molecular Biotechnology (FCMB) evidently had the best proposal and was selected by MVI to fill the gap left by the failure of Psf25-EPA.  Also apparently FCMB was able to move its candidate, Psf25-CP, into trials quickly.  Recruiting for Phase I started last November (Clinicaltrials.gov entry), and the trial got under way this past month (FierceVaccines iBio press release, FierceVaccines iBio press release).  Since I’m interested in how multiple parties collaborate to develop global health products, I looked into the background of this project and found not all the players on the same page.

The FCMB is part of the globe-spanning Fraunhofer Gesellschaft, a German-based research and development non-profit that has 67 institutes in Germany and offices and centers around the world including 11 in the US (Fraunhofer).  The Fraunhofer has 23,000 employees and $2 billion plus budget, 30% from the government and 70% from government and industry contracts (Fraunhofer Wikipedia article).  The FCMB is in Newark, DE, and has 90 employees focused on recombinant protein expression in a proprietary plant-based expression system (FCMB).  It has a GMP-compliant pilot plant and projects for vaccines and antibodies for influenza, Trypanosomiasis (sleeping sickness), yellow fever, hookworm, HPV, and malaria, the last supported by a Gates grant of $9.85 million received in 2009 (FCMB press release).

As noted in the above-cited press release, apparently FCMB has a commercial partner in the development of the expression system and in the malaria TBV project, a company called iBio, Inc.  iBio has a 2011-dated website (iBio Inc.), that seemed to be light on details, but since it is a public company listed on the NYSE, I looked at its SEC filings and analysts’ reports.  iBio appears to be struggling financially, facing delisting (see Middle Market article) and floating stock with the aim of raising $10 million but securing only $500K in 2013 (but had $5 million cash on hand at year’s end; see the latest iBio 10Q).  I looked at the US patents assigned to iBio and the three key ones are either co-assigned to Fraunhofer or have Fraunhofer employees as inventors.  I am guessing this co-ownership resulted from iBio’s sponsoring of the expression system’s development at FCMB (with FCMB scientists being the actual inventors).  Such an agreement and its recent modification to less expensive terms for iBio are mentioned in the company 10Q filing (iBio is committed to $1.5 million in payments to FCMB through 2015).  I also noted the company is co-located with the FCMB.

All this suggests to me that iBio is a shell company whose main assets are patents on the expression system and future revenues are dependent on FCMB’s success in using the system to develop products with partners like MVI and FioCruz (a Brazilian governmental institute with whom FCMB has a contract to build a plant for a yellow fever vaccine; see my post, “Procurement Power”) and those products being licensed to a commercial entity to conduct full-scale trials, registration, distribution, and sales.  If the FCMB wrote its contract with iBio correctly, or used the recent renegotiation opportunity correctly, it may have the right to pursue commercial partners independent of iBio, just owing a royalty.  I hope this is the case so that FCMB can find partners for the malaria TBV and other products that are committed to global access.  I assume that the FCMB management and  board has thought through its product development strategy perhaps with help from the Gates and/or PATH (the latter have successfully launched one global vaccine, MenAfriVac®).  There is no statement of a strategy on the FCMB website, and I noted its management team is all scientists (FCMB Leadership ) and its advisory committee is all solid citizens of Delaware with no pharma/biotech/medical experience (FCMB Committee).