Gordon Stein, CFO of CleanTech Lithium, explains why CTL acquired the 23 Laguna Verde licenses. Watch the video here.
One question does arise is what keeps you so busy you cannot multitask ie pursue orphan status in addition to outlicensing. A huge part of the process is due diligence but providing data to be analysed by the counterparts does not create that pressure there are periods of high activity and then awaiting the outcome from activity from the other side of the fence. There may be other requirements that exist but full blown involvement is required looking at alternative results or legal agreements. Wishful thing I know
PWC need to tell AZ
“Biotech acquisitions to fend off patent cliffs: Large-cap pharma companies will continue to face patent cliffs and gaps in their pipelines in the latter half of this decade and will look for M&A opportunities to achieve their growth plans. Small and midsize biotech companies that can fill in pipeline gaps in the back half of the decade will receive significant attention in 2024. However, the threshold rates of return which these acquisition targets must clear are now higher because of higher risk-free interest rates; as such, the competition will be fierce for truly innovative targets whose clinical differentiation is backed by good data.”
https://www.pwc.com/gx/en/services/deals/trends/health-industries.html
Maybe they need to tell the pharmas
EY 2024 Pharma M&A
“M&A targets: oncology and rare diseases
The huge growth potential of the oncology market is reflected in companies’ M&A spending over the past five years, with oncology dominating industry acquisitions in both value and volume terms…..
With legislation such as the IRA unlikely to affect the price point for orphan drugs, companies specializing in rare diseases have become significant M&A targets, “
https://www.ey.com/en_gl/newsroom/2024/01/deals-are-back-surge-in-life-sciences-m-a-fueled-by-sector-s-capital-reserves-and-quest-for-new-revenue-growth
FX that was true however one can only guess that they were advised by pharmas they were talking to, to prove the duration tests as inhalation was a new process for forms of Tranilast and this completed the data set. Of course increasing data sets would have taken time during the process which we have been told is 6 months +
Thought I would check back to see if I could identify when the co thought they were ready to recommence discussions. The first clear notice and the last separate update on NXP002 was 18th May 23. Since then we have had patent updates with notice that discussions are ongoing. Data sets have had to be increased. There would have been some initial foraging before the process started and delays with summer breaks but if things started moving in September it should mean activity is in the final phases possibly
“Following the success achieved in these studies the Company's next steps include:
· Expansion of the current studies to include tissue from further human IPF tissue donors to demonstrate the robustness of NXP002's anti-fibrotic response alone and in SoC combinations in multiple patients; and
· Formally commencing the NXP002 partnering process now that Company has the minimum dataset required to support NXP002's development as an inhaled treatment for IPF, for use alongside SoC's.
Commenting, Dr Dan Gooding, Executive Director of Nuformix, said: "I'm absolutely delighted with the data we've generated over recent months - all the results we've achieved are as good as we could have hoped for and are the first results from advanced 'close to patient' IPF and inflammation human tissue disease models. The inflammation data was perhaps expected given past results but provides further support of NXP002's potential to deliver increased performance on top of existing standards of care. However, the positive duration of action data is a first for the NXP002 programme and allows the Company to discharge one of the programme's last remaining development risks that hasn't previously been addressed.
"The combined data gives us great confidence in NXP002's potential as an inhaled therapy for IPF treatment and allows the Company to tell a more complete pre-clinical story to potential licensing partners for the first time. We will now look for opportunities to share this important new data with key players in the rare disease and respiratory disease sectors as we explore all opportunities to progress the NXP002 programme."
From the 3/1 results RNS -NXP002 is a likely candidate for Orphan Drug Designation, which could provide additional product protection against potential competitors.
The raise on 1/3 was funding to progress NXP002 discussion with partners and progress NXP002 development so was that partly for the fee for the application for Orphan status if so estimated submission date is mid-March.
“These attributes position NXP004 for applications in line-extensions for the currently marketed product, or for possible development in future first-to-generic products. The Company has commenced discussions with potential commercialisation partners.”
There is no current generic version of Lynparza what are AZ options. If they decide not to sign up NXP004 as the new Lynparza patents expire between 2024/2029 with the first having already expired. If they sign up NXP004 to replace the existing formula of Lynparza the patents will run to 2041. Again if a generic product comes to market it will reduce their market share and the risk that a major pharma could be interested the risk of the generic product taking a substantial part of $9bn market grows. The results comparing Lynparza to NXP004 showed NXP004 as having a better formulation for manufacture and bioavailability. So if it is brought to the market as a generic product that will probably prevent AZ adopting it at a later date with the Lynparza brand.
With $1.37 trillion of firepower available for the industry's top 25 companies, expect M&A activity to heat up in 2024 after a surge in activity at the end of last year. EY
https://www.fiercepharma.com/pharma/pharma-firepower-late-ma-surge-23-bode-well-prospects-24-report
Seems the underlying message from the RNS is that discussions re both programs are still progressing “as we progress partnering interactions for these programmes.” Not expecting too much extra cash from patent sale but enough to profess programs
In interviews very difficult to always get the phraseology right but there is a clear reference to partners in this part of the interview
“Therefore, typically what happens is that during these discussion, data is presented to potential partners, sometimes partners like to see an additional experiment repeated or an additional data point collected. A transaction such as these will allow Nuformix to go off and do that, effectively dealing with any objections or questions it receives as part of that partnering process.”
However what is interesting is prospective partners would only ask for repeat tests if there is serious interest
I like this part of the RNS
“enable the Company to progress our core NXP002 and NXP004 programmes and respond to requests for additional data as we continue partnering interactions for these programmes."
This either means they had stopped partnering discussions and can now recommence or that discussions are on-going for both 002 and 004 and it is the exchange of research data which is taking time the latter sounds good to me
A lung duration test is “You'll need to hold your breath for about 10 seconds and then breathe out normally. The level of gas that you breathe out will be measured to see how much oxygen has been carried from your lungs into your blood. The test takes about 10 minutes.”
So no tissue required IPF versus healthy lungs.
“our aim now is to generate datasets from three donors in both human IPF and healthy lung duration of action studies. These data can be generated quickly ” Reckon they already have it, last data from IPF tissue took 6 weeks was not described as quickly and it sounds as though the next info is comparing with healthy tissue.
Clever move, big 4/5 whatever they are as accounting firms do not come cheap, so it helps keep pressure off the cash flow. Despite NFX being straightforward any new firm will do a deep dive and will want reassurance before signing off. Also doesn’t distract from whatever is happening having to hand hold new firm. Are they expecting a windfall in time Dior revised accounts date?