We spoke to research and consulting firm MP Advisors for this week’s Analyst Q&A. The firm focuses on the pharmaceutical and biotechnology sectors and discussed a wide variety of topics with us, including the biggest challenges currently facing the pharmaceutical industry and the FDA’s drive to create an “Abuse deterrent Era”.
Here’s the interview in full:
Q. In your opinion, what are the three biggest challenges facing the pharmaceutical industry in 2017? How will these changes influence the industry and how will market players respond?
MP: The biggest challenge facing the pharma industry in 2017 is the same as it has been for many years. The problem is that biology is still not nearly as developed and understood as a science compared to something like physics, because there are large gaps in our knowledge, inventing new drugs is both risky and expensive.
I don’t think you can point to a single other industry that has such high development costs and low probability of success (and of course the two are related). Pretty much all other difficulties the industry faces, from regulatory barriers to pricing pressure to IP issues, stem from this basic fact. Drug trials are long and expensive because we don’t know another way to tell if they really work and are safe other than giving them to patients to see what happens. Expensive trials mean that the few successful drugs need to be priced relatively high in order to make up for the failures. High priced drugs leads to push back from patients, insurance companies, regulators, and politicians. Reform that focuses on the symptom of the problem (high drug prices) is likely to lead to less overall investment in the sector if nothing else changes fundamentally.
On the positive side, there seems to be signs that technology can help improve R&D productivity, and if developing new drugs becomes even a little less risky, then lots of positive changes to the pharma business model would be possible (for both pharma and patients).
Q. How are new drug formulations helping to create the Abuse Deterrent Era? What steps have the US Food and Drug Administration (FDA) taken to encourage pharmaceutical companies to design abuse-deterrent formulations?
MP: A recent announcement by the new FDA commissioner to form a special steering committee to examine additional regulatory and policy action for abuse deterrent formulation confirms the FDA’s strong stance to create an “Abuse deterrent Era”. To better practically understand the meaningful impact of these formulations to deter abuse, the FDA is asking companies to conduct studies in a way that provides meaningful data and gives priority review to the filings for early approval to combat the opioid abuse epidemic.
Q. What are the key trends influencing the Prostate Cancer market in 2017? How will these developments guide the industry in the coming years and what can we expect to see?
MP: Recent amendments in the protocol of the PROSPER study of Xtandi targeting nmCRPC population reported positive data of Zytiga in early stage Prostate cancer at ASCO-17. They’re awaiting PhIII results of ARN-509 in nmCRPC, which will make 2017 eventful to decide the role of newer antiandrogens in treating early stage prostate cancer - mainly nmCRPC.
Other than antiandrogens, proof of concept data using Anti-PD1 or Anti-PD1 combining PARP inhibitor to treat the nmCRPC & Xtandi/Zytiga resistance population will decide the role of more a targeted approach to cater to these new markets.
Q. How many drugs are currently in development for Prostate cancer treatment? How would the success of these drugs impact the market in the coming years?
MP: Around 8 plus drugs are in Ph III development for Prostate cancer and 26 plus drugs are in PhII development (21 small molecules) - success of a few (ARN-509, ODM-201, AZD 5363, GX301, TYME-88) in the coming years will expand the untapped prostate cancer drug market – nmCRPC ($3.5be), mHSPC market ($1be) and Xtandi/Zytiga resistant population ($1be) by 2023. Longer duration of therapy and high prevalence makes earlier setting market more beneficial and bigger for newer options than the late stage if they succeed.
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