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Patients with neurofibromatosis type 1 (NF1) carry approximately a 10% lifetime risk of developing a malignant peripheral nerve sheath tumor (MPNST). Although the molecular mechanisms underlying NF1 to MPNST malignant transformation remain unclear, alterations of both the RAS/RAF/MAPK and PI3K/AKT/mTOR signaling pathways have been implicated.
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October 2009
October 28, 2009
AstraZeneca withdraws Zactima from EMEA and FDA in lung cancer
Earlier this year I posted about the interim results in non-small cell lung cancer (NSCLC) for AstraZeneca's Zactima (vandetanib) at the ASCO meeting, as part of a review about VEGF inhibitors. Of the 3 trials available for review, one showed some responses and the other two 'had not yet reached significance'.
Unfortunately, it now seems that the final survival data was indifferent at best and AstraZeneca announced the sudden withdrawal of the marketing applications to the regulatory authorities this morning:
"The decision to withdraw these submissions was based on an updated analysis that demonstrated no overall survival advantage when vandetanib was added to chemotherapy as well as preliminary feedback from regulatory agencies that the current package with progression-free survival (PFS) as the primary endpoint may not be sufficient for approval."
Granted that oncology is a difficult area to develop new drugs, but the woes in this category have made for a sad and sorry 2009 for R&D this year so far.
With 2 months to go, perhaps we might see a stunning winner yet...
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October 27, 2009
Medivation and Astellas ink deal for MDV3100 in prostate cancer
Wow, that was the Pharma headline news this morning, after the excitement of last night's announcement that Medivation are hosting a conference call at 8.30am to announce a partnership deal.
I was expecting a big Pharma oncology company to have bitten, not a Japanese company known for it's cardiology and immunology franchise. Granted they have urology products such as Flomax, but this is a cancer drug for late stage prostate cancer. It will likely compete with Cougar Biotech/J&J's abiraterone, if both make it to the market. Interesting. That shakes up the prostate cancer landscape a little bit.
More details will follow at the 8.30am conference call, so I'll update this post with more information then.
{Update}
The details of the deal can be found on Medivation's website here.
Basically, $MDVN gets $110m in up front payment, followed by $655m in milestones. The two companies will the share costs and profits in US. I should add a big caveat here - MDV3100 is currently being evaluated in the Phase 3 AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. The results are as yet unknown.
Medivation announced this morning that they made a competitive decision to choose Astellas as a partner for MDV3100 based on 5 key factors:
1) Global reach in development and commercialisation: Astellas has over $10B in sales globally
2) Expanding use into early stage prostate cancer through urologists: Astellas has a urology franchise (via Flomax)
3) Expand the clinical development program: earlier stage trials after hormone (and possibly before) therapies
4) High priority product: Astellas wants to build an oncology franchise around MDV3100
5) Terms offer compelling value to MDVN and shareholders: ($110M up front, $655M milestone payments, co-development and commercialisation in the US, Astellas exclusivity ex-US with royalty payments to Medivation.
Astellas management declined to provide any details of the proposed clinical development plan, were a little defensive about the market size of the initial indication after failure of docetaxel, which is also treated by medical oncologists not urologists, there were vague mumblings about 'we intend to fast track to the drug market and then develop and expand into earlier opportunities' kind of approach.
Note, it's an oral drug so yes, it would be attractive to urologists but only with data and that will be a long time coming in even the hormone refractory setting. There are no guarantees that MDV3100 in the chemo refractory trial that started accruing in September will work in that late stage setting (we should all remember the ghost of GPC's satraplatin there), although it might be effective in the hormone sensitive- early refractoriness setting before metastases sets in. There are some early preclinical data showing it was superior to bicalutamide (Casodex) based on my preliminary search.
All in all - it's a very big leap of faith and a long term strategic play that is very risky indeed. My suspicion is that Astellas won't want to be outdone by Takeda in the Japanese and Asian markets, so their new strategic focus looks like it will be building an oncology franchise from scratch while possibly leveraging their expertise in urology in the medium term.
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October 26, 2009
A leap of faith - AB Science and masitinib in pancreatic cancer
As announced last week, this is the first in a series of interviews with people who make a difference in the Pharma, Biotechnology and medical world.
Alain Moussy is CEO of AB Science, an emerging French biotechnology company. As previously reported on this blog, AB Science gained EMEA approval in 2008 for its novel tyrosine kinase, masitinib, in dog mast cell cancer. This product was launched to vets throughout Europe earlier this year and is awaiting FDA approval. Masitinib is also in phase 3 human clinical trials in GIST, mastocytosis and pancreatic cancer for which the EMEA has granted orphan drug status.
Pharma Strategy Blog: Could you tell us about yourself and how you came to start AB Science in 2001?
Alain Moussy: I met a great team of researchers and physicians, and we decided to build a company around tyrosine kinase inhibitors for oncology and other diseases. Compared to big pharmaceutical companies, our goal has been to come up with the safest tyrosine kinase inhibitors, and the first one we have is now available in dogs and we hope will go all the way in humans both in oncology and outside oncology.
Pharma Strategy Blog: Why did you start off with a drug for dogs?
Alain Moussy: We think that that dog is a fantastic scientific platform for humans and is also a shorter time to develop, so you can go to the market earlier, which is good when you don’t have any revenues.
Pharma Strategy Blog: What is your vision for AB Science?
Alain Moussy: This business is about making drugs that really make a difference for patients. Pharmaceutical companies, however, have the constraints of having to make a return for the benefit of their shareholders, and so 90% of the time they develop a drug that is not that effective but is safe. This generates revenue that sustains their sales force and high cost structure. We at AB Science are here to make new drugs that radically change the life of patients by surviving more in cancer, or reducing symptoms in chronic inflammatory disorders. Our vision is to make new drugs that make a difference.
Pharma Strategy Blog: Many biotechs have pursued alliances or partnerships with large pharma companies, why has AB Science publicly said it has no interest in this?
Alain Moussy: Biotechs are owned by venture capitalists, who have a 5 to 7 year cycle to make money, but the cycle of drug development is 10-12 years, so in the middle of the cycle they have to sell where the risk is not too high. Typically, venture capitalists do not care whether the product ends up being approved or not. Most biotechs end up following this strategy because they are owned by VC firms. AB Science is owned by entrepreneurs, and we have chosen to dedicate our life to developing products that make a difference. We have to stay independent, because if we try to make money in the middle of the drug development cycle, then we will just select drugs that we can sell to a big pharma, and this is not what we want. What we want is stability for the long-term to have time to take the necessary risks to make the right products. We take a lot of risks everyday because it is the only way to find the right drug. We don’t think we need to partner with anybody because we know how to develop our drugs and that is what we did in dogs.
Pharma Strategy Blog: How do you feel about going up against large companies such as Pfizer?
Alain Moussy: In dogs, we obtained the first approval in Europe for a drug to treat cancer in animals, ahead of Pfizer Animal Health. We are competing against them, and we will see who has the best product. Pfizer based their regulatory submission on a clinical trial with only a 6-week end point, while we have follow-up data after 150 weeks showing a significant increase in survival. We think our product is very specific and safer and that based on the data, it offers a greater benefit/risk.
The other important thing to note is that last year Pfizer spent $10 billion in R&D with no new chemical entity registered, and AB Science had one. It does not cost $1B to develop a new drug, as that is the cost of failure integrated into debt. If you go to a very severe disease with the right product, you can do it even if you are small.
Pharma Strategy Blog: How have sales of masitinib for dogs gone in Europe?
Alain Moussy: Sales are picking up and because they like the drug, orders are repeating. That is the sign of a good drug. The profit generated by the veterinary business, although limited, will be invested back in R&D.
Pharma Strategy Blog: Where do you hope to go after Europe?
Alain Moussy: The United States is the next target for dogs and we are very close to registration. Besides that there is Canada, Australia, South Africa, South America and Japan. There are a dozen or so countries that are of interest for dogs.
Pharma Strategy Blog: When is approval likely in humans?
Alain Moussy: In humans, we don’t expect approval before end of 2011, with sales in early 2012. If our phase 3 trials are positive, we will register in the US and Europe at the same time. The earliest approval will be in pancreatic cancer. GIST is a long-term play because it is difficult to recruit.
Pharma Strategy Blog: Where do you see masitinib being used in humans, will it compete against existing products?
Alain Moussy: In pancreatic cancer, the positioning of our product is in addition to gemcitabine. In vitro masitinib has been shown to reverse resistance of pancreatic tumor cell lines to gemcitabine. Our product is unique in its ability to resensitize the pancreatic cell line that has become resistant to gemcitabine.
In phase 2, the survival rate at 18 months was 28% with no difference between metastatic tumors and locally advanced. From an analysis of 45 other studies, the current survival rate at 18 months is 6-8% in metastatic, non-resectable tumors. In our study, 28% survived. This is a major difference, but sometimes phase 2 data is not replicated in phase 3, but that is the magnitude of the hope we are carrying. Many large companies have failed in pancreatic cancer, so if we succeed this will be big news for us and for pancreatic cancer patients who, unfortunately, die rapidly.
Masitinib is able to resensitize other cell lines with other chemotherapies, so it has a generalist mechanism of action that can be used in many cancers, so we are doing clinical trials in e.g. prostate, CRC, NSCLC, breast, and multiple myeloma. We get very good results in-vitro, which we hope to replicate in-vivo in humans and dogs. This is why masitinib is fascinating in oncology.
In the GIST indication, we will not compete against sunitinib since our product is not positioned in resistance to imatinib, but we will compete directly against imatinib. Our phase 3 trial is head to head against Glivec/Gleevec. We will see what results we have at the end.
Pharma Strategy Blog: Les Echos published a report earlier this year that you planned an IPO in early 2010, is that still planned?
Alain Moussy: The market for IPOs was closed, but is re-opening. AB Science is a candidate for an IPO next year and we will do that in Europe, not in America. We plan to use the money we gain from an IPO to invest in clinical trials. The IPO will take place before we know the results of our phase 3 trials, so I hope that people will in invest in the hope of what masitinib may be able to do.
Pharma Strategy Blog: What are your plans post IPO?
We hope post IPO to deliver positive results in one of our phase 3 trials, which would allow us to register the drug in humans. If that happens then since it is a specialty business product sold to hospitals and not general physicians, it is likely we will keep ownership and distribute the product ourselves, which means we will make high margins in markets that are worth billions. In that case, it is likely AB Science will become big, which we are not today.
Pharma Strategy Blog: Does AB Science have other products in the pipeline other than masitinib?
Alain Moussy: We have a platform of new products, which have not been developed yet. In order to keep control of the company, we have limited the amount of money we have raised so far. After the IPO we will invest in developing these new products.
Our approach is to invest in one compound at a time, because if you have multiple indications with one compound you have economies of scale. If our development cost for one compound in multiple indications is roughly €200M in man, this would be €800M if instead we had one compound per indication. So our strategy of one compound for multiple indications, which some people think is risky, saves us €600M.
Pharma Strategy Blog: Do you have to spend a lot of time with your institutional investors explaining your strategy?
Alain Moussy: We have refused many venture capitalists because they did not share our strategy. We selected the shareholders of AB Science on the basis of sharing the long-term strategy of the company. There is no conflict with them because they agreed at the beginning to give us the time and independence to develop drugs that change the lives of people.
Pharma Strategy Blog: Finally, looking back on your experiences over the past eight years, what advice would you give to other biotech entrepreneurs who wish to follow you?
Alain Moussy: Coming from the retail industry at Carrefour, I was totally ignorant of the difficulties. Bringing a drug to market is an incredibly challenging, difficult and positive job helping save people’s lives and there is nothing better that I could have done in my life. Science needs entrepreneurs because science needs to take risks. The lesson of entrepreneurship is when you do believe in something, you should not try to measure the effort but just do it and that is what we are doing.
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October 23, 2009
The real heroes of the Pharma industry are the patients
This morning, I was planning on writing a scientific and technical post about the EML4-ALK mutation in response to several requests for information about it. It occurs in some lung cancers and effectively prevents drugs from working. Pfizer have a compound in development for targeting this mutation, it is currently in phase II trials and soon to begin phase III.
During my researches, however, I came across some dialogue between patients on the excellent Lung Cancer Alliance support site, Inspire. The goal of this online patient group is:
"Inspire is a place where you can connect with people who share your health concerns and find information and advice in groups sponsored by organizations you know and trust."
Patient conversations both intrique and fascinate me, reminding me vividly of my days following the hopes, fears and progress of chronic myeloid leukemia (CML) patients in the Gleevec trials. You learn about their struggles, how they manage the practicalities and logistics of doing a clinical trial, what side effects they experience and how they cope with them. You also hear the good news and the bad news, warts and all. It's very uplifting to follow these stories, you can feel the strength, resolve and determination to succeed in many of them. The words of advice and support clearly matter a great deal to those going through the experience.
Here is one post about the EML4-ALK trial that particularly caught my eye:
"In August of 2007, I was diagnosed with stage IIIa/b Non-Small Cell Lung Cancer at the age of 29. As it always is when being diagnosed with any form of cancer, I was shocked. I was especially concerned because of the lack of information that exists surrounding lung cancer and the extremely poor survival statistics. I am a lifelong non-smoker and I have always remained active in sports and athletics. I'm writing today because I want every single patient who has been diagnosed with non-small cell lung cancer to tell your doctors that you want to have your tumors biopsied and tested for every type of genetic mutation that they know of, especially the EML4-ALK mutation. I had been on six cycles of Cisplatin/Alimta with minimal results. I then had two months off before taking Tarceva with negative results. I then went on two more cycles of Alimta. As I was on Alimta the last time, my oncologists and pathologists discovered that the EML4-ALK mutation exists in the tumors in my body. It is very weird to think about it now, but the timing of this was impeccable because a clinical trial was open through the Harvard medical system up here in Boston, MA for a study of a inhibitor drug that targets the EML4-ALK mutation. I started the drug on June 5th. I went over the scan results yesterday with my clinical trial team to compare with the baseline scans taken before beginning the clinical trial. To say that the drug is working...is an understatement. The tumor is dead from the inside out, which is called necrotic cell death. The left side of my lung, which was shrouded in a cloud when viewing the baseline CT scan, is now showing more signs of it becoming clear. Substantial response. I hope that the drug continues to destroy these tumors that are located in my left lung and pleura. The lymphatic activity has also decreased significantly as well. If any of you have biopsies, I urge you to tell your doctors that you want them tested for genetic mutations such as EGFR, K-RAS, EML4-ALK and every other known mutation. The drug's side effects are minimal with diarrhea once a week and some nausea at the beginning but your body gets used to it. The side-effects are MUCH more tolerable than platinum based chemotherapies."
Source: Lung Cancer Alliance
What followed was various other patients and caregivers asking questions, offering support etc. Throughout, the gentleman remained patient and upbeat, helping others where he could and being equally thoughtful in spades and replying to as many comments as he could. I was impressed and felt my own spirits lifted by his energy and heart.
After scrolling to the end, I noticed there were no comments from him, surely not! The original comment was posted on July 31st, 2008. Then on June 26th, 2009 I found a post from one of his fellow trialists:
"This is difficult to post--but I feel it is necessary to let people know that Kevin passed away on 5/28/09. I was enrolled in the same trial as Kevin, and I told him once that he was like my beacon in a storm--he was always so brave and positive. Kevin fought as hard as a person could fight--and it would be impossible to have a sunnier outlook than Kevin had. It is not only terribly sad, but it makes all of us feel uneasy when one of our own, someone who fought so valiantly, passes. There is a terrible randomness to all of this--and it is important to not lose personal hope. I miss my friend Kevin, but feel compelled to fight even harder in his memory."
Source: Lung Cancer Alliance
From the time of diagnosis to his death was a mere two years. Remember, he was a youngish non-smoker in good health and fitness who happened to get lung cancer. It could be any of us reading this in that boat and that's what makes the story all the more surreal and terrifying.
For me, the real heroes of the Pharma industry are the patients who volunteer to participate in clinical trials with often nothing more than a leap of faith and hope that things might work out. It's the biggest risk anyone will ever face - roll the dice on your life and hope for a positive outcome.
When Pharma and Biotech people get bogged down in petty office politics, bureaucracy and turf wars, perhaps they might actually stop and think about something bigger and more important in the wider scheme of things:
"What's the right thing to do for the patient?"
Or how about:
"Are we doing the best we can to improve the lives of patients today?"
If you focus on either of those aspirational thoughts as the single most important thing you do all day, the rest really doesn't matter anymore. After all, you could be diagnosed with lung cancer tomorrow.
We are all on the earth for just a smidgeon of time, we might as well spend it making a difference.
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October 22, 2009
Making a difference
Next week we're launching a new series of vignettes that are part podcastlet and part interview on this blog.
The theme is centred around people in pharma, biotech, academic institutions and patient advocacy groups who make a difference to patients lives. We will begin with the CEO of a biotech company who believes that the product they have will be a real game changer. If you know any one who has a real passion and excitement, we'd love to hear about them. Feel free to make your suggestions in the comments below.
Sent from my iPhone
October 21, 2009
The future of the Pharma business (Part 2)
Thank you every one for the incredible response to the recent post about the strategic direction of the Pharma industry, I enjoyed all of the emails and debates that followed on from that. I'm glad it stimulated many of you to think about the environment we work in.
Several interesting questions and ideas have evolved from those discussions, which I will lay out here for further debate.
Firstly, a number of you wanted to know what I thought about consolidation (the Pfizer-Wyeth merger in particular) and secondly, several asked about the future of biotech.
Many of you know that I'm not a big fan of huge behemoths because they encourage bureaucracy, CYA and lack of innovation. It was interesting listening to the interviews the Pfizer CEO Jeff Kindler did yesterday after their 3Q earnings call to the analysts. He seemed to be hedging his bets a little arguing that on one hand you need economies of scale in order to compete and grow in new, emerging markets such as China yet on the other, you need smaller business units in R&D to try and foster innovation.
It made me wonder if Pfizer have been listening to too many big management consultants and doing those grand (and very expensive) corporate organisation reviews, yet people forget that the consultants who do the project work are often kids out of college with plenty of business school theory and little industry knowledge.
Bigger does not always mean better. The Pfizer story reminded me of interviews with GSK's Andrew Witty a year or so ago arguing with reporters that they needed to get smaller in R&D to foster and encourage innovation. Hmmmm, sounds like management consultancy redux - if you persuade enough companies to try it, it justifies the huge costs (not).
The problem with this approach is that just downsizing or rearranging the constituent parts into smaller groups doesn't minimise the bureaucracy because Pharma likes control so they still have hundreds of VP's managing these units, all competing for capital and fiefdoms. If anything, the approach increases the bureaucracy and power fighting. That's not innovation, it's torpor.
Take a look at this quick and useful video from my SCIP buddy August Jackson. It's short, pithy, humourous and to the point (hat tip to Eric Garland for bringing it to my attention). While August has a background in Telecoms, his perspective on bureaucracy is also remarkably apt for big Pharma:
So, no I'm not a big fan of merger and acquisition consolidation, especially when they involve biotechnology, such as the recent Roche - Genentech merger. Will the Roche big Pharma bureaucracy stifle the entrepreneurial spirit at Genentech? What about Medarex now that BMS has acquired them?
In the long run, yes it will, especially as many of the top key people have left at Genentech. In the short to medium term, however, Roche will reap the benefits of a massive pipeline of over a 100 compounds in development, mostly through creative licensing deals with even smaller biotechnology companies. BMS will ride the Medarex pipeline for all it's worth and then what? Time to look for another 'strategic' acquisition probably. Still, these deals beg the question - why kill the golden goose? Why not keep them as separately run business units or companies as J&J tend to do and continue to keep the scientists creating new compounds for the future in a small lean operation? Perhaps the fear of losing out is over-ridden by the drive to have it all now. Whether that is a viable long term strategy remains to be seen.
Real innovation in the future will most likely continue to come from baby biotechs taking risks on one or two products they passionately believe in and get a whole organisation focused behind it with the ability to think and act fast. They're largely free from the big management consultants who tend to complicate things. A small nimble biotech is full of scientists and entrepreneurs and not too many managers. Big pharma is full of managers who outnumber the scientists and entrepreneurs are few and far between. In fact, they are probably most unwelcome as they tend to upset the applecart a bit.
Of course, the other big trend yet to emerge is whether some of the pharma companies will start spinning off chunks of their business, as they struggle to cut costs and maintain margins in these recessionary times. But hey, that's a whole different ballgame.
Thoughts and comments?
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October 19, 2009
Biotech and Pharma news - Genentech, Amgen, GSK and Merck
This week is going to be a busy one in the Icarus office with several client strategy reports to finish and many Pharma companies reporting 3Q earnings and plans for making year end targets.
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Meanwhile, on the Biotech front, Genentech and Amgen are reviewing their letters from the FDA on rituximab in moderate to severe rheumatoid arthritis (RA) who no longer respond to methotrexate (and other DMARDs) and denosumab for the treatment and prevention of postmenopausal osteoporosis, respectively.
Neither letters are a big surprise. The FDA has declined to support the approval of rituximab in rheumatoid arthritis owing to the incidence of a rare, but fatal adverse event, known as progessive multifocal leukeoencephalopathy (PML). According to Genentech:
"PML is a usually fatal brain disease caused by the reactivation of a common virus called the JC virus. Although the incidence of PML in RA patients treated with Rituxan is rare (as of today, three reports out of approximately 100,000 patients), there are no known reliable PML treatments."
Amgen have an entirely different kettle of fish on their hands, however. The FDA were expected to get back to the company this month and last week there were rumours circulating about potential delays in the approval due to the FDA's backlog and other reasons. However, they have indeed sent a complete response letter, requesting further information be provided, including:
"The Complete Response Letter related to the Prolia applications requested several items, including further information on the design of Amgen's previously submitted post-marketing surveillance program. This letter does not require additional pre-marketing clinical trials to complete the review of the treatment indication. The FDA has requested a new clinical program to support approval of Prolia for the prevention of postmenopausal osteoporosis indication.
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for Prolia and must include a medication guide, a communication plan, and a timetable for submission of assessments of the REMS. The FDA acknowledged receipt of Amgen's previously submitted proposed REMS materials. The FDA has also requested all updated safety data related to Prolia."
Amgen had clearly anticipated the need for a REMS in pre-submitting some materials, so this application will likely lead to full approval in the near future. Whether the company has the sales muscle to compete in a highly competitive mass market segment with primary care doctors instead of specialists such as medical oncologists is a whole different ball game though.
At the other end of the spectrum, GSK have received approval to market their HPV vaccine for prevention of cervical cancer, Cervarix, a competitor to Merck's Gardasil, which ironically, just received approval for the treatment of genital warts in boys, a new indication in addition to the one already held for the prevention of cervical cancer in girls. The Merck vaccine inhibits several additional HPV types compared to the GSK one, but whether this is significant or not is unclear. Either way, physicians and patients now have a choice and this can only be a good thing, although there will likely not be any difference in the manufacturer's prices of the two vaccines.
{UPDATE:}
Amgen announced that they have also received a complete response letter for the BLA for Prolia in the treatment and prevention of bone loss due to hormone ablation therapy (HALT) in breast and prostate cancer patients. In a press release, the company stated:
"The Complete Response Letter on the Prolia HALT applications requested additional information regarding the safety of Prolia in patients with breast cancer receiving aromatase inhibitor therapy and patients with prostate cancer receiving androgen deprivation therapy. Specifically, the
FDA has requested results from additional adequate and well-controlled clinical trials demonstrating that Prolia has no detrimental effects on either time-to-disease progression or overall survival."
This second letter requesting data from additional clinical trials will likely significantly delay approval for the cancer indication.
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