Monday 1st July 2019
AstraZeneca’s Imfinzi shows success in clinical trial phase in small cell lung cancer
AZ’s Imfinzi, is the latest inhibitor to show success in the trial phase for small cell lung cancer when used as a first line therapy in the CASPIAN trial. The trial looked at a combination of Imfinzi with the current chemotherapy for previously untreated patients.
SCLC (Small Cell Lung Cancer) is one of the most aggressive types of lung cancer and is notoriously difficult to treat. There are already three approved cancer immunotherapies to treat SCLC, but Imfinzi is the first drug to have results in a first line setting along with current chemotherapy options. MSD’s and BMS currently have two approved treatments by the FDA but only for third line monotherapy. Roche is AstraZeneca’s closest rival, with its Tecentriq getting an FDA approval as a combination first line treatment.
If Imfinzi has further success and secures approval, its positives are further enhanced by the CASPIAN trial where it has been tested with a variety various first line chemotherapy options demonstrating its flexibility.
Imfinzi already has had success with its approval as a second line maintenance therapy for non-small cell lung cancer and for bladder cancer, with sales reaching $295m in the first quarter of the year.
Syncona sells of diagnostic company for $450m to fuel more funding
Syncona has sold of its innovative diagnostic company Blue Earth Imaging to Bracco Imaging for $450m. Syncona was an 89% shareholder in the Oxford based firm and owns rights to its first commercialized product. Blue Earth Imaging first product is an EU and US approved injection of a molecular imaging agent to be used in PET imaging for men with suspected prostate cancer.
Syncona is heavily involved in the setting up a string of cell and gene immunotherapy focused companies and the sale of Blue Earth Imaging only comes five years after it was founded under the guidance of Syncona.
The sale of Blue Earth Imaging represents a ten-fold return from its original investment of $35.3m, a profit in which it will use to fund further life science companies. The sale to Bracco imaging of £354.3m includes an estimated closing judgement of £19.7m. Syncona has already invested £64.1m into its companies including gene therapy companies Freeline, Gyroscope and Achilles.
Tuesday 2nd July 2019
Sanofi and Regeneron’s Libtayo gains its first approval in Europe
Libtayo is an immunotherapy and the sixth PD-1/PD-L1 inhibitor to reach the market. It gained approval for use as a treatment for cutaneous squamous cell carnimona (CSCC), one of the most commonly diagnosed skin cancers globally. It has received approval already in the US in October.
Libtayo is the first treatment approved in the EU for those patients who are not candidates for curative surgery or radiation. Sanofi/Regeneron hope that by getting the first approval in immunotherapy treatment for this condition that it will give them a foothold in this market away from the most contested tumors.
The European approval is based upon data from the phase two trial EMPOWER-CSCC and is also supported by two advanced CSCC expansion cohorts from an additional phase 1 trial. The approval is not definite as is conditional based upon the addition of a new patient group to the EMPOER-CSCC phase two trial. These results will then be reported to the EMA where appropriate action will be taken.
Analysts do not see Sanofi/Regeneron making a large impression on the market, with Evaluate Pharma forecasting the drug reaches revenues of only $600,000 by 2024 far behind MSD leader Keytruda which is expected to hit $14.5bn.
AbbVie’s takeover of Allergan defended by CEO Gonzalez
The $63bn takeover of Allergan by AbbVie has caused division among stakeholders in AbbVie, with some thinking it is a good play with Allergan providing $16bn in annual revenues that will help to preserve AbbVie as it prepares to lose its US patent protection for its $20bn blockbuster drug Humira in 2023. Allergan is struggling to generate growth, but it faces no significant patent deadline anytime soon and stakeholders are confident that AbbVie can help Allergan make the most of its current portfolio.
However, there are those who are under the view that Allergan will just add extra debt to AbbVie, and it will not enhance its current pipeline. With Allergan’s biggest product, Botox, bringing in $3.7bn in revenue last year, is starting to face tougher competition in the medical aesthetic field. AbbVie’s CEO Gonzalez has downplayed the risk to Allergan’s Botox brand saying that Allergan has done well to protect the brand from branded drugs and that for technical reasons it is very unlikely that Botox will face a biosimilar not for a very long time if at all.
After the regulatory issues faced by the takeover of Celgene by BMS, AbbVie has already recognized any cross over drugs between the two companies and has already agreed to divest promptly.
Wednesday 3rd July 2019
ViiV Healthcare secures EU approval for new two-drug HIV therapy
ViiV has now secured both American and EU approval for its two-drug HIV therapy Dovato. Dovato was approved in April in the US as a single tablet, once daily regimen for treatment naïve patients, setting up a rivalry with Gilead Science’s and their product Biktarvy.
Biktarvy has grown quickly since its release last year in the EU and US, already reaching a $1bn plus annual sales rate and predicted to head towards peak sales of $4bn.
ViiV a joint venture majority owned by GSK with Pfizer and Shionogi is hoping that its two-drug regimen will build a market share in the HIV sector. ViiV claims that its two-drug regimen is better than the current three as it reduces drug exposure, side effects and improves adherence to therapy while maintaining the same level of efficacy.
ViiV faces a struggle in proving to patients of these benefits, as previous approved product by ViiV Healthcare, Juluca has failed to make much progress in sales, with revenue of $88m in the first quarter of the year. ViiV sees the treatment naïve patient population as a key area to target with the approval of Dovato opening to a potential HIV patient population of 250,000 each year.
Evaluate Pharma has forecasted that GSK’S two drug regimen will eventually come to lead the market with sales more than $5bn in 2024.
Thursday 4th July , 2019
AstraZeneca is set to appeal NICE rejection of Tagrisso
AZ is too appeal NICE decision to reject Tagrisso as a first line treatment for non-small cell lung cancer. NICE’s decision to reject the drug was based on its cost-effectiveness, with the committee deciding that the treatment does not meet the End of Life (EoL) consideration. This is defined among with other criteria, as a treatment which is given to patients whose life expectancy is normally less than 24 months.
NICE also stated among cost, the extent of benefit of the drug was unclear. NICE concluded from AZ clinical trials that the results produced were not statistically significant. Therefore, NICE judged Tagrisso as not cost effective, since its performance in OS has not surpassed the current treatments in use.
NICE’s decision to reject Tagrisso coincides with its decision to accept Pfizer’s Vizimpro, with its clinical trial results showing that it increased the overall survival rates than those who took AZ’s older drug Iressa. This decision fuels the rivalry between the two treatments, with Vizimpro slowly catching up to Tagrisso.
Friday 5th July 2019
Dutch Biotech firm Citryll raises €15m to back its AutoImmune disease treatment NETS
The company is developing a platform based on antibodies that prevent the formation of neutrophil extracellular traps (NETs), which are thought to play a key role in autoimmunity.
NET’s are part of the bodies natural immune defense system and they are extracellular fibres that bind to pathogens. But in certain autoimmune diseases like lupus and rheumatoid arthritis it is thought that these NETs inadvertently react to host cells releasing autoantigens as well as inflammatory proteins.
This €15m will go into funding Citryll’s leading programme tACPA, which is designed to interfere with the production of NETs. CEO of Citryll Helmuth van E’s says that Citrylls method ‘does not broadly target inflammation or acquired immunity, instead it extinguishes the source of autoantigens in the safest way possible.’
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