Amgen sales decline as biosimilars start to intrude upon established products

Amgen is facing some large losses as its established products are starting to face biosimilar competition, prompting the company to focus on its next list of new products. The drop-in sales of its two stalwart products, Sensipar and Neulasta by 25% and 71% respectively have contributed to a 3% revenue decline to $5.9billion.

These figures make Amgen’s route to profitability much more difficult despite several new medical prescriptions such as Prolia and Repatha making respectable progress. Prolia, an osteoporosis med, jumped by 14% to $698million during Q2.

However, despite the 3% sale decline, Amgen’s revenue haul still came in above analyst predictions by $175m, with the EPS (earnings per share) of $3.57 also exceeding analysts expectation.
Amgen is looking forward to in the future a host of oncology launches plus CGRP migrane med Aimovig. It has also recently launched biosimilars of two of Roche’s cancer blockbusters, with hopes that they will start to chip into Roche’s market share.

Pfizer set to announce Mylan merger and spin-off

It is expected that Pfizer will announce its plan of a $10bn deal to acquire genetics firm Mylan, merge it with its own off-patent operation and then spin the newly formed division.

The buzz around this potential deal arose at the end of last week and these rumours seem further supported by Pfizer announcing its Q2 results a day in advance from its original date with the expected Mylan transaction set to replace the Q2 results presentation.

This deal will help streamline Pfizer, creating a focus of its efforts for profitability and a means of revenue which it can utilize for larger more lucrative deals in the pharma/biotech field.

This sell-off manoevere is a strategy that has already been implemented by newly stated CEO Albert Bourla, with Pfizer already having agreed to a deal with GSK to create a new spin-off consumer health division.

Mylan’s shares prices have risen in the past couple of days by 30%, since the rumours began around this deal. If the deal were to follow through it would create a generics giant that would be set o rival companies like Teva, Perrigo and Sandoz in size.

Biogen’s biosimilar division set to boom

After a mixed Q2 review with new SMA rival’s arrival and end of patent dates looming, Biogen
could use a boost. And that is what is has with its biosimilar division with sales growing by 45% to $184million and that is only with just a few of its products and those only in Europe.

Biogen executives have seen the potential of this division and have poured investment into its biosim joint venture with Samsung last year. Biogen’s Imraldi is a ‘market-leading’ biosimilar to AbbVie’s blockbuster Humira, with the drug generating $47million during the quarter after its October 2018 launch. Imraldi looks promising for Biogen’s future but it still has some way to go before it reaches the heights of Biogen’s most successful biosimilar in Benepali, a similar of Amgen’s Enbrel. Benepali has taken the market share in five European markets and generated $120 million during its 2018 period.

Biogen is looking to offset patent uncertainties, rival products and a failure in its Alzheimer’s pipeline development by boosting its biosimilar focus, with $700m poured into its Samsung Bioepis joint venture.

Biogen grows in Q2, but Sprinraza’s performance raises concerns for investors

Biogen reported an 8% increase in revenue in its Q2 results, with revenues in the second quarter hitting $3.6bn. The majority of the revenue was made up of its multiple sclerosis (MS) division with the MS products pulling in $2.2bn. However this news did not please investors as they are worried about Biogen’s reliance on its MS portfolio, as it is expected in the future that the MS products will face a slew of anticipated rivals.

Investors were also disappointed with the performance of Biogen’s SMA drug Sprinraza, which has been halted in its tracks since the launch of Novartis’s Zolgensma, with Sprinraza posting a dip of 6%. However Biogen’s marketing team were keen to stress that the rival drug is only approved for patients 2 years old and younger and will not intrude into Sprinraza’s market share. 

Biogen CEO Michel Vounatsos said ‘ its premature to make assumptions’ and that it is early days for Sprinraza, with Sprinraza having more room to grow in the US and that the drug prospects outside the US are actually larger than within the US.

Biogen has raised its revenue guidance to between $14bn and $14.2bn up $400m for either side. Market watchers are also looking at Biogen to do M&A or business development to bring in external products.

GSK’s R&D director hopes new riskier R&D approach will pay dividends for the company

R&D president Hal Barron and CEO Emma Walmsley 
Upon Hal Barron's election to R&D director by recent CEO Emma Walmsley, he has swept away GSK’s established approach to product development of consensus led and risk adverse decisions.

Hal Barron was speaking ahead of the announcement of GSK Q2 results later today, as investors await eagerly to see the results of the newly instated leadership team. The company had set itself the goal of doubling its hit rate in drug discovery and development but faces strong opposition in the long withstanding risk-adverse culture that has developed in the pharma company. Other big pharma companies are following suit of R&D upheaval as the industry average is that only 10% of drugs entering the clinical trials reach the market.

The changes that have started to occur in GSK are mainly focused on the decision making process around which molecules will be carried forward, with decisions now in the hands of individuals rather than the team who are then further encouraged to follow the results of the science rather than team members and can even disregard more senior colleagues opinions.

Hal Barron has been key in GSK’s recent decisions towards moving away from its traditional area’s of respiratory medicine towards oncology. With the recent acquisition of Tesaro and licensing partnership with Merck highlighting his strategic moves towards establishing a share of the oncology market. 

Johnson and Johnson submit new formulation of Darzalex to fend off rivals

Darzalex has recorded $775m in the second quarter of this year,
showing no signs of slowdown, four years after its initial approval

J&J has submitted for approval in Europe and the US a subcutaneous injection version of its multiple myeloma drug Darzalex, that would significantly increase ease of dosing for patients and help to defend its franchise from Sanofi rival.

This new formulation, if approved, would result in Darzalex being able to be administered to patients in a few minutes compared to the current intravenous infusion process taking several hours. Not only would this provide an increase in comfort and ease for patients, but it also provides the extra advantage of Darzalex being provided in a community setting rather than the current hospital trip that is necessary.

J&J has submitted phase three trial results that show the subcutaneous formulation is just as effective as the IV Darzalex on myeloma response rates and also shows that seems to cause fewer infusion-related reactions.

J&J hopes that this new formulation will be approved, as it will help to fend off competition from rival Sanofi, which also has recently submitted for approval its candidate isatuximab. Sanofi could take a chunk of the market as it is a treatment that is delivered in a two-hour intravenous fusion. With Sanofi also stating that it is safer to use in patients with inflammatory diseases like asthma, as compared with Darzalex it is not associated with complex activation.

Speculation arises around who will buy Otezla, as it gains new approval for first time treatment

The FDA has approved Celgene’s Otezla as the first and only treatment for patients with Behcet’s disease associated oral ulcers. This recent announcement on Friday fueled discussion about who will buy Otezla off Bristol Myers Squibb hands as part of the requirement from US authorities to allow their merger to gain anti-trust approval. The US federal trade commission demanded Otezla be sold off, as it would give the newly stated BMS/Celgene merger too big of a stake in the psoriasis market With Otezla performing extremely well for Celgene last year, earning $1.6bn in the psoriasis market, making it a lucrative product.

Analysts predict that Gilead Sciences are currently the most likely to acquire Otezla as it fits well into its portfolio plan to increase its competitiveness in the inflammation and immunology area. J&J as well as Amgen are also other names that have been thrown into the ring, as they already are established in the immunology market.

Analysts also predict the sale price of Otezla to be around $5-10bn, with the specific price dependent on the company that eventually buys it.

Rapid approval from NICE for AbbVie’s Skyrizi

AbbVie’s and Boehringer Ingelheims’s new psoriasis treatment, Skyrizi, has gained fast track approval from NICE just three months after EMA approval. This recommendation will result in the NHS offering it as a treatment for those with severe psoriasis in adults where current treatment have failed to improve conditions from August onwards.

Skyrizi is a new entrant to the IL-23 inhibitor class, a class that presents the advantage of being administered once every 12 weeks compared to once every four weeks for established treatments. In NICE’s final appraisal it noted that Skyrizi is more effected than AbbVie’s now off patent blockbuster Humira and J&J’s Tremfya.
This comes as great news for AbbVie, as it looks to make up lost millions in revenue to biosimilars of Humira, which arrived in Europe in late 2018. Analysts predict peak sales of $3bn for Skyrizi, with success also dependent not in only how it performs in the psoriasis market but also in the hotly contested inflammation and immunology area’s such as Crohn’s and ulcerative colitis.

UnaCom Pharma News

1st July – 6th July

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.’

Coranavirus and its relationship with IP exclusivity

With the global shutdown that has occurred due to COVID-19, its presence has caused long-lasting effects in all aspects of our lives and t...