Rewarding Summer for Novateur and Its Clients and Portfolio Investment Companies

It has been a rewarding summer for Novateur and its clients and portfolio investment companies! Despite the heat and the vacation season, this summer has seen a flurry of notable activities across the Life Sciences. We are excited to announce new Novateur services as well as to celebrate the success of Novateur clients and our investment portfolio companies in closing deals, partnerships, and investments. Congratulations to IRICoR, Feldan Therapeutics, Navigo Proteins, MetaOptima, Vasomune, Immune BioSolutions and AIT Therapeutics. In industry Review, we discuss a confluence of positive events that have created a perfect storm and the reasons why we encourage our clients to close partnerships and financings as quickly as possible. Confluence of positive events (outlined below) has created a perfect storm currently for our sector: Most active IPO market, as highlighted here by Renaissance Capital Large pharma’s healthy cash position due to Trump’s repatriation tax plan An industry friendly regulatory regime in the US, showcased by a record number of new drug approvals by the FDA A string of good news on a number of large (and often difficult) trials for both pharma and biotech, including successful Alzheimer trial by Biogen and positive Phase 3 trials by Pfizer/Lilly in pain. More than ever, it’s prudent for companies to get deals done or close financing quickly prior to the window closing. Two immediate concerns around the global markets heading to 2019: Upcoming mid-term elections in November and possible loss of the House by Republicans to Democrats may cause turmoil. This switch will likely strengthen the Russian collusion investigations and findings may impact financial markets. New US sanctions on Iran...

Off to a Fabulous Start for 2018

Attending both JP Morgan Conference in January and BIO CEO & Investor Conference in February confirmed several key points:   2018 will see more licensing deals and M&As With the new Trump tax regime there will be significant repatriation of cash by large pharma and biotechs to United States. There is an estimated $250B cash parked off shore by large pharma and biotech companies. This week several major pharmas announced billions of dollars in share buy back. We predict that there will be more licensing and M&A activity by large pharma and biotechs in 2018.   2018 will see more financing & IPOs Several of our clients have been able to raise financing in 2018 in both private and public settings. The general market sentiment, although sometimes choppy, seems positive. We encourage our clients to raise money when they can. It’s a good time now.   Pharma will start coming back to look at large target areas and traditional blockbusters We believe with the repatriation of cash, large pharma and biotechs appetite for larger and somewhat neglected target areas like cardiovascular, women and men’s health and CNS will grow. There will be return to larger trials to develop blockbuster drugs again.   FDA is more industry friendly than before We find FDA to be more open and flexible than ever before. According to a PWC report, there were fewer regulations announced by FDA in 2017. It is predicted that this trend will continue. This trend will encourage biotech and pharma companies to invest more and conduct more trials. We believe there will be more drugs and devices approved this...

Winding Down 2017 With Tremendous Gratitude

As we approach the end of 2017, we look back with tremendous gratitude for the many friends and supporters of Novateur, especially for our valued clients, whom we consider our partners. We had a great year and grew our practice in substantial ways in every possible metric. We worked with over 30 companies and investment groups conducting due diligence and providing product and project development advisory. We completed over 120 projects. Our clients raised over $100 M in capital, including one that successfully became public on a US stock exchange. Several companies also completed partnerships with larger pharma clients. We believe Novateur is the solution for the “talent” challenge in Canada and other geographies where there is dearth of seasoned development and execution expertise and lack of a track record. Novateur has a history of attracting world-class advisors. Only the very best join our team and work diligently to solve our client’s issues. Several of these world-class experts have become full time executives at Novateur and have relocated to Canada from the United States. We are pleased to contribute our part to reverse the Canadian “brain-drain”. With over 120 active advisors and over 1,000 global advisors in our network, we can solve any life science problem effectively and efficiently. Novateur is a very active and global group: Our advisors are part of many new start-ups and serve in active executive roles for our clients and partners. Our advisors attended over 200 conferences and seminars throughout the year and were speakers at several. I attended over 20 conferences and spoke at or chaired 6 conferences. Several of us participated in...

Companion Diagnostics: A Guide to Cure?

There is an obsession by biotechs, pharma, investors and payers to pre-select responders to a therapy before they are treated. How did we end up here and how is this going to impact medicine in the long term? In certain diseases where the biology landscape is understood better, like oncology, there has been tremendous impact. However, in most other target areas we still cannot isolate the responders and use “all comers” to try treatments and hope the safety and efficacy of a drug can be shown to be statistically significant. What happens to target areas where specific responders cannot be identified? What happens to companies that have an effective treatment but cannot get funding because they cannot find their “targeted population”? By “targeted” we mean a sub-population that expresses a specific genetic mutation or biomarker. At Novateur we are often approached by creative scientists that have discovered a biomarker diagnostic or in some cases can analyze hundreds of your markers to show that you may potentially have various disorders. Would the doctors be interested to tell you that you may have early Alzheimer’s when there is no treatment available for it? And would the payers pay for it? In our experience, diagnostics will have a challenging time getting funded and partnered, unless they can be paired with an effective therapeutic. The ultimate goal is to be able to utilize the diagnostic to change the clinical outcome in a meaningful way. In a similar fashion, biotech companies developing treatments need to think how to incorporate potential diagnostics to pre-select responders. After decades of experience at large pharma, our advisors believe...

Entrepreneurial Pharma: Confronting the Adage, “Experience Is Something You Get Just After You Need It.”

During my 23 years working in the entrepreneurial pharma environment I have witnessed many lessons learned and I continue to see many companies focusing primarily on reaching key funding milestones while neglecting good drug development practices. This is a mindset that can cost them dearly and deliver experience after it’s needed! It is crucial for entrepreneurs to focus on creating a strong value proposition for the company, attracting the top investors and scientific advisors and moving quickly to key milestones and the additional funding they provide. It’s the nature of the environment. However, at the same time, pharma development requires early and consistent compliance with regulatory guidelines and quality assurance standards and exemplary collaboration skills to enable critical preclinical and clinical trials. The paradox is the need to move quickly AND carefully comply with regulatory requirements and solve technical challenges. This can create confusion when weighing the “must haves” and the “nice to haves”. Often, many important elements are considered “nice to have”. Many entrepreneurs have trouble discerning which is which. Usually, a lack of time or staff or cash is reason for projects moving ahead without the “must haves” like proper documentation or quality checks. In addition, the outsourcing environment is something that is both art and science, something not fully appreciated by all entrepreneurs. Staffing at outsourcing firms varies in expertise, especially in the areas of regulatory strategy and documentation. This requires experienced oversight by the sponsor company.   Here are some real-world examples of my observations of companies that failed to focus on the fundamentals and paid the price: When I was working as and independent...

How Trump Presidency and BREXIT Are Creating the Perfect Storm for Reversing Canada’s Brain Drain

Historically Canada has faced a significant challenge in attracting top talent compared to the United States and retaining top talent already in Canada. Until recently, top entrepreneurs would often choose to start their next big idea in the US, for several reasons, including: Better access to capital Better access to talent Lower income taxes The results of the 2016 presidential election and BREXIT have changed this. For the first time, some of the top US, UK and international executives and entrepreneurs are considering relocation to Canada. Canada offers the following first class resources: Friendly and easy business regulation Top notch basic science from world class universities Lower corporate income tax Significant government R&D incentives designed for start ups such as SRED, IRAP and Mitacs Provincial incentives for investors (Angels and Venture Capitals) to invest in early stage companies and most importantly, a progressive open minded government that is in tune with the need for change in the 21st century. This January 28, 2017 article from Globe & Mail quoted several global technology leaders including Google, Netflix and Uber CEO expressing concern about top talent leaving US. At Novateur, we have been addressing the shortage of experienced pharma talent by matching the best global advisors to Canadian biotech and pharma Companies. Since the US election, several of our most sought after US based advisors have expressed genuine interest in relocating to Canada. We are delighted to announce that as of April 1, Dr. Gina Stetsko, a world-class biotechnology expert in CMC Manufacturing and process scale up has relocated from San Diego to Vancouver and joined Novateur as a full time...