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By PharmaCompass
2021-01-07
Impressions: 1631
The New Year opened with ample news from the world of pharmaceuticals.
Drug behemoth Pfizer unveiled a new brand identity which signifies Pfizer’s shift from commerce to science.
There was news that both EMA and FDA will take time to grant conditional nod to the AstraZeneca-Oxford jab, and will wait for results from late-stage trials being carried out in the US.
Like every year, drugmakers rang in the new year with drug price hikes in the US.
This year, the average hike was 3.3 percent. China approved its first Covid-19 vaccine for the general public.
The vaccine is developed by an affiliate of Sinopharm, and claims 79 percent efficacy.
Celgene investors lost out on a US$ 6 billion payout they stood to receive from Bristol Myers Squibb had FDA approved a key drug by December 31.
And 2021 saw its first M&A deal as Italian drugmaker Angelini Pharma announced it would acquire Swiss biopharma Arvelle Therapeutics for US$ 960 million.
Pfizer unveils new brand identity that focuses on science
After Pfizer Inc and its partner BioNTech announced positive data from the phase 3 trials on the efficacy of its Covid-19 vaccine, the American drug behemoth has rebranded itself. Pfizer says after 170 years of preventing and curing diseases, it has arrived at a new era.
“By uniting transformational technology, cutting-edge science and indomitable human spirit, Pfizer is pioneering biopharmaceutical innovations to do more than just treat difficult diseases – we’re curing and preventing them,” Albert Bourla, chairman and CEO, Pfizer Inc, said in a tweet.
The new logo resembles the DNA helix, signifying Pfizer’s “shift from commerce to science”. The company says the DNA helix is the code and engine of human potential.
It’s the first significant visual redesign for Pfizer in 70 years since the company began using the blue oval background. The company has changed the historic Pfizer blue to a vibrant, two-tone palette. It has also gone in for a new typeface and a font family that accommodates more than 800 languages across the globe.
Bourla says Pfizer is now a first-in-class scientific powerhouse. From a diversified enterprise, it has now emerged as a focused and innovative biopharma company, he added.
The new logo is a result of 18 months of work. The process included surveying patients and doctors globally. “The company whittled 200 designs down to four and eventually selected the winning logo,” a report published in the Wall Street Journal said.
EMA, FDA signal delays in conditional nod to AstraZeneca’s Covid-19 vaccine
Even as the UK opened the new year by vaccinating its people with AstraZeneca’s Covid-19 vaccine, the European Union has said it is unlikely to give a conditional marketing authorization (CMA) to AstraZeneca and Oxford University’s Covid-19 vaccine in January 2021.
Similarly, in the US, Operation Warp Speed chief adviser, Moncef Slaoui said the emergency use authorization (EUA) for the AstraZeneca vaccine is likely to come by April. The recruitment for Astra’s late-stage US trial is almost complete with over 29,000 enrolled participants.
The UK government has already procured 100 million doses of AstraZeneca’s Covid-19 jab and more than half a million doses were ready for administering on January 4. The UK MHRA granted a temporary authorization of supply in emergency use setting to the AstraZeneca vaccine, which is distinct from a CMA, on December 30.
European Medicines Agency’s deputy executive director Noel Wathion had told a Belgian newspaper that AstraZeneca “has not even filed an application” with the European drug regulators. The company, however, clarified in a statement that it has submitted a substantial data package to support a possible application for a CMA for its Covid-19 vaccine to the EMA. The company “has been submitting data on a rolling basis and will continue to work closely with the EMA to support the start of a formal CMA application process,” it added.
The EMA said in a statement that its assessment of the AstraZeneca-Oxford vaccine has been progressing over the past weeks, and that it has sought additional scientific information on issues related to the quality, safety and efficacy of the vaccine from the company. This information is required for a CMA. “Further information from the ongoing clinical trials is also expected from January. Interim data from a large trial ongoing in the USA are expected in Q1 2021,” it said.
There has been skepticism over the efficacy of the AstraZeneca vaccine due to different results received from trials due to a dosing error.
“We project, if everything goes well with readout and emergency use authorization may be granted somewhere in April,” Slaoui said. It would ultimately be up to the FDA to evaluate the vaccine for US authorization, he added.
Several countries delay booster shot: In Europe, several countries are delaying the booster shot (or the second dose of the vaccine), or plan to do so. This way, they hope to protect more people with one shot.
Last week, Britain announced a plan to separate doses by up to 12 weeks. Britain has authorized vaccines made by Pfizer and AstraZeneca. Similarly, Denmark recently approved a lag of up to six weeks between the first and second shots of the Pfizer-BioNTech vaccine, while Germany and Ireland are said to be considering similar moves.
The US, on the other hand, is opposed to the idea. “The approach some countries are taking of delaying the booster shot could backfire and could decrease confidence in the vaccines,” Moncef Slaoui, chief adviser, Operation Warp Speed, said.
The FDA said in a statement that it is important to receive the Covid vaccines according to “how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness.”
BMS saves US$ 6 billion in payout to Celgene investors as key drug misses milestone deadline
The US Food and Drug Administration (FDA) did not approve a closely watched cancer cell therapy — liso-cel — owned by Bristol Myers Squibb by December 31, 2020. This was a crucial milestone deadline for investors holding a tradable security issued by Bristol Myers as part of its US$ 74 billion buyout of Celgene two years ago.
The security, known as contingent value right (CVR), was a deal sweetener for Celgene investors. It promised payouts from Bristol Myers, if liso-cel and two other drugs formerly owned by Celgene won FDA approval by certain dates. Had all the three drugs secured FDA nods on time, Bristol Myers would have paid those shareholders roughly US$ 6 billion more.
The Biologics License Application (BLA) “for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies remains under review” by the FDA, Bristol Myers Squibb said in a statement.
Since the FDA approval of liso-cel did not occur by December 31, 2020, one of the three required milestones for payment of the Bristol Myers Squibb CVR was not met. As a result, on January 1, 2021, the CVR agreement got terminated automatically. And the trading of those CVRs on the New York Stock Exchange was halted, the statement added.
The FDA has not provided a new action date for the BLA. Liso-cel is a CAR-T cell therapy, a personalized type of cancer treatment that consists of a patient’s own immune cells, which are extracted and then genetically engineered to target tumors.
70 drugmakers ring in New Year with price hikes in US; AbbVie, Biogen lead pack
Every year, the drug industry in the US chooses to usher in the new year with a hike in the list prices of its drugs, and 2021 was no exception. This year, 70 drugmakers opened 2021 with higher prices of drugs. The average price hike was 3.3 percent — which was lower than the average price hike of 5.8 percent implemented by drugmakers in the beginning of 2020 (according to an analysis done by RX Savings Solutions).
Notable amongst them was AbbVie, as it raised the price of its anti-inflammatory drug Humira by 7.4 percent. AbbVie also hiked list prices of its newer autoimmune medicines Skyrizi and Rinvoq and cancer treatment Imbruvica by 7.4 percent. The company raised the price of its eye drug Restasis and gastrointestinal drug Linzess by 5 percent.
Biogen increased the list price of its multiple sclerosis drug Tysabri by 5.3 percent, following two separate 3.5 percent hikes in 2020.
As the new administration begins work this month, these price hikes could create a renewed urgency for drug pricing legislation. President-elect Joe Biden has endorsed controlling drug prices by allowing Medicare to negotiate directly with drug companies. As of today, Medicare is barred from doing that.
Though drug list price increases are watched closely, they are not a true gauge of how much more insurers or consumers will pay, due to the rebates and discounts that insurers ask from drugmakers in exchange for coverage. In recent years, the gap between the list price and the net price (what insurers pay) has grown. The net price increase is usually about half as big.
Pfizer, Sanofi, and GlaxoSmithKline are increasing prices between 0.5 and 8.6 percent. Pfizer is increasing prices of its blockbuster cancer drug Ibrance and its anti-inflammatory drug Xeljanz.
A Pfizer spokesperson said the company’s list price increases for about 200 products were in line with overall inflation rates of 1.3 percent, and that net prices were flat or declining because of rebates and discounts.
Sanofi said it pegged its list price increases to the US government’s national health expenditures forecast of 5.1 percent, and that the average net prices have decreased every year since 2016.
China approves Sinopharm’s vaccine for public use; efficacy data not publicly released
Last week, China approved its first Covid-19 vaccine for the general public — a jab developed by an affiliate of state-backed drug behemoth Sinopharm. While, no detailed efficacy data of the vaccine has been released publicly, its developer — Beijing Biological Products Institute (a unit of Sinopharm subsidiary China National Biotec Group), said its vaccine was 79.34 percent effective in preventing people from developing the disease based on interim data. Earlier, the company had said the vaccine was around 86 percent effective, but gave no detailed evidence.
The approval of the vaccine comes after the United Arab Emirates became the first country to roll out the vaccine to the public, and Pakistan announced a 1.2 million dose purchase deal with Sinopharm.
Sinopharm’s vaccine uses an inactivated version of the SARS-CoV-02 virus to spark an immune response. It is being seen as a vaccine of choice for developing countries, as they have little access to the mRNA jabs being developed by Pfizer and Moderna. The mRNA vaccines also pose a logistical challenge as they need to be transported and kept under very low temperatures.
China has been giving the vaccine to some of its citizens for months, even though the country has been late in approving the vaccine. China launched an emergency use program in July aimed at essential workers and others at high risk of infection. The country had administered more than 4.5 million doses as of December 15. China has at least five vaccines, developed by Sinovac, CNBG units, CanSino Biologics and the Chinese Academy of Sciences, in late stage trials.
A Chinese newspaper report said the country would vaccinate as many as 50 million people from high-priority groups before the Lunar New Year holiday in February.
Italian drugmaker Angelini Pharma buys Arvelle Therapeutics for US$ 960 million
The year 2021 opened with an M&A deal. Angelini Pharma, the pharmaceutical division of Italy’s Angelini Group, and Swiss biopharma Arvelle Therapeutics announced a definitive merger agreement. Angelini Pharma will acquire Arvelle Therapeutics in an all cash transaction of up to US$ 960 million.
The deal revolves around cenobamate, Arvelle’s epilepsy drug. Cenobamate bagged US Food and Drug Administration (FDA) approval in late 2019 as an anti-seizure drug for the treatment of partial-onset (focal-onset) seizures in adults.
Angelini Pharma plans to launch cenobamate after receiving approval from the European Medicines Agency (EMA), which is expected in 2021.
Once the buyout deal bags regulatory approval, Angelini Pharma will pay Arvelle US$ 610 million. Subsequently, and subject to cenobamate reaching certain revenue targets, Angelini will make a further payment of US$ 350 million to Arvelle.
Angelini Pharma will have the exclusive license to commercialize cenobamate in the European Union and other countries in the European Economic Area (Switzerland and the United Kingdom).
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