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US sues Teva over kickbacks, stock drops; J&J, Sanofi announce big deals
This week, Phispers is packed with news on M&As. Johnson & Johnson acquired Momenta Pharmaceuticals for US$ 6.5 billion to strengthen its autoimmune drug pipeline.
Sanofi acquired Principia Biopharma for US$ 3.7 billion.
BMS signed a US$ 475 million agreement to license Dragonfly Therapeutics’ interleukin-12 (IL-12) immunotherapy program.
And Thermo Fisher Scientific announced that its bid to acquire molecular diagnostics company Qiagen has failed and the planned deal has been terminated.
In Covid vaccine updates, we bring you news that Russia has produced the first batch of its vaccine — Sputnik V; and CanSino has won a patent approval from Beijing for its Covid-19 vaccine candidate.
US Food and Drug Administration approved a saliva test for Covid-19, which does away with the nasal swabs currently in use, and is expected to significantly expand testing capacity.
The US government has sued Teva, accusing the drugmaker of submitting false claims to Medicare by using kickbacks to boost sales of its multiple sclerosis drug —Copaxone.
In new filings, US states have claimed OxyContin maker Purdue Pharma owes them US$ 2.2 trillion to address harm caused due to its alleged role in the opioid epidemic.
And Gilead expanded its tie-up with Tango Therapeutics, even as its rheumatoid arthritis drug failed to get FDA nod.
FDA grants emergency use authorization to saliva test for Covid-19
On August 15, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to a new and inexpensive saliva test for Covid-19 that could significantly expand testing capacity for the disease caused by the novel coronavirus.
The new test — known as SalivaDirect — was developed by researchers at the Yale School of Public Health. It allows saliva samples to be collected in any sterile container.
This is virtually a non-invasive process, as opposed to nasal swabs that are currently being used to test for the virus.
“Providing this type of flexibility for processing saliva samples to test for Covid-19 infection is groundbreaking in terms of efficiency and avoiding shortages of crucial test components like reagents,” FDA Commissioner Stephen M Hahn said.
The test can run approximately 90 samples in fewer than three hours in a lab, although the number can be greater in big labs with automation.
Yale intends to provide its “open source” testing protocol to laboratories around the US. The testing method is available immediately, and researchers say it can be scaled up in the coming weeks.
US government sues Teva over using kickbacks to boost Copaxone sales
The US government sued Israeli generic drug giant Teva Pharmaceutical Industries this week, accusing it of submitting false claims to Medicare by using kickbacks to boost sales of its multiple sclerosis drug — Copaxone.
In a complaint filed in Boston federal court, the US Department of Justice (DOJ) said Teva illegally paid two seemingly independent charitable foundations more than US$ 300 million from 2006 to 2015 to cover co-payments of Copaxone patients, shielding them from a quadrupling of Copaxone’s price to US$ 73,326 a year.
Shares of Teva fell by over 15 percent on Tuesday, after the US revealed this lawsuit.
“The department is committed to stopping pharmaceutical companies from using foundations as conduits to funnel kickbacks to Medicare patients, and to prop up excessive drug costs at the expense of the American taxpayers,” said Acting Assistant Attorney General Ethan P. Davis of the Department of Justice’s Civil Division. “We will continue to root out these unlawful kickback arrangements that undermine the integrity of federal health care programs.”
The government is seeking triple damages for violations of the federal False Claims Act.
Teva said it will defend itself and that the lawsuit “only seeks to further restrict patients’ access to important medicines and healthcare.” Copaxone is one of Teva’s largest selling drugs.
M&A update: J&J buys Momenta; Sanofi buys Principia; BMS signs pact with Dragonfly
Johnson & Johnson (J&J) has entered into a definitive agreement to acquire Momenta Pharmaceuticals, a company that discovers and develops novel therapies for immune-mediated diseases, in an all cash transaction for approximately US$ 6.5 billion.
With this acquisition, J&J has built up the autoimmune section of its pipeline. The transaction will include full global rights to nipocalimab (M281), a clinically validated anti-FcRn antibody.
Momenta got J&J’s attention back in June, with a promising Phase 2 study of nipocalimab for generalized myasthenia gravis. Nipocalimab recently received a rare pediatric disease designation from the US Food and Drug Administration (FDA).
J&J gets more than one drug in the acquisition. There are two other candidates in the clinic and some discovery projects in the works.
Sanofi buys Principia Biopharma: French drugmaker Sanofi is buying US-based Principia Biopharma for US$ 3.7 billion. The acquisition gives Sanofi access to Principia’s pipeline in autoimmune diseases. They include a drug aimed at the rare but painful skin condition — pemphigus — and another against multiple sclerosis. Both the companies have been partnering on these drugs since 2017. The pemphigus drug — rilzabrutinib — is in Phase 3 trials. The multiple sclerosis drug is also in late-stage testing.
Since the two companies had been working under a 2017 agreement, buying Principia will save Sanofi from paying royalties on any future sales.
In May this year, Sanofi CEO Paul Hudson had raised US$ 11.7 billion by selling its stake in Regeneron. He is deploying that cash to buy treatments that command high prices.
Since Hudson became CEO last year, this is the second such purchase — the company had bought Synthorx for US$ 2.5 billion in December 2019.
Thermo Fisher-Qiagen deal gets terminated: Last week, Thermo Fisher Scientific announced that its bid to acquire molecular diagnostics company — Qiagen — has failed and the planned deal has been terminated. As a result, Qiagen will pay Thermo Fisher US$ 95 million in expense reimbursement.
Thermo Fisher had offered €43 (US$ 51.3) per Qiagen share, up from its original offer in March of €39 (US$ 46.56). For the deal to go through, two-thirds of Qiagen shareholders had to tender their shares by August 10. Last week, Thermo Fisher disclosed that only 47.02 percent of Qiagen shares were tendered, thus missing the required threshold.
“We respect the decision of our shareholders and will now continue to execute our strategy to deliver growth and create greater value with our Sample to Insight portfolio,” Qiagen supervisory board chairman Håkan Björklund said in a statement.
BMS to buy Dragonfly: Bristol Myers Squibb (BMS) has signed a US$ 475 million agreement to license Dragonfly Therapeutics’ interleukin-12 (IL-12) immunotherapy program.
This program comprises an early-stage experimental oncology drug DF6002, which is a monovalent IL-12 immunoglobulin Fc fusion protein that works by creating an inflammatory tumor microenvironment to boost anti-tumor responses.
Under the pact, BMS gets to develop and sell this drug once it bags approval, and test it in both solid and blood cancers.
In 2018, BMS had signed a pact with Merck, worth nearly US$ 700 million, also focusing on a series of solid tumor targets. This deal builds on the deals between Dragonfly and Celgene, signed during 2017 and 2018. Last year, BMS had acquired Celgene for US$ 74 billion.
Covid-19 vaccine update: Russia produces first batch of Sputnik V; CanSino bags patent approval
Last week, there was news that Russia had cleared the world’s first Covid-19 vaccine — Sputnik V — for use, even though the clinical trials on the vaccine were far from over. This week, we bring you news that Russia has produced the first batch of this new vaccine for Covid-19.
Moscow’s Gamaleya Institute, which developed the vaccine, had earlier said that Russia would be producing about 5 million doses a month by December or January.
Meanwhile, Vietnam has registered to buy the Russian Covid-19 vaccine. Vietnam has signed up for 50 million-150 million doses of the vaccine, Tuoi Tre newspaper reported. Some will be a “donation” from Russia, with Vietnam paying for the rest.
Vietnam will continue to develop the country’s own Covid-19 vaccine, and will also buy vaccines from Britain. It has a partnership to develop a homegrown vaccine with the University of Bristol.
Israel is also examining Russia’s Covid-19 vaccine. According to a Reuters report, Israel’s health minister has said the country may enter negotiations to buy the Russian vaccine if it is found to be a “serious product”. Israel is also developing its own vaccine candidate and intends to begin human trials in October.
CanSino wins patent approval: China’s vaccine specialist CanSino Biologics Inc has won a patent approval from Beijing for its Covid-19 vaccine candidate Ad5-nCOV, a Reuters news report said.
It is the first Covid-19 vaccine patent granted by China. According to news reports, the patent was issued on August 11. Saudi Arabia plans to begin Phase 3 clinical trials for the CanSino vaccine this month, and CanSino has also said it is in talks with Russia, Brazil and Chile to launch Phase 3 trials in those countries.
Meanwhile, the Hong Kong-listed CanSino made a roaring debut in Shanghai last week. It leapt on its first day of trading on a Nasdaq-style tech board in Shanghai. It fetched US$ 748 million (RMB 5.2 billion) by floating 24.8 million shares, and soared 88 percent on its first day of trading.
US states seek US$ 2.2 trillion from OxyContin maker Purdue Pharma
In new filings of pushing prescription painkillers on to doctors and patients while playing down the risks of abuse and overdose, US states claimed OxyContin maker Purdue Pharma owes them US$ 2.2 trillion to address harm caused due to its alleged role in America’s opioid epidemic.
Purdue Pharma helped inflict more than US$ 2.15 trillion in financial damage on the US economy while pushing highly addictive opioids on Americans for almost two decades, the states said.
Almost every US state and territory will seek to recover a fraction of those alleged losses in Purdue’s Chapter 11 bankruptcy case. New York’s losses alone total more than US$ 165 billion, according to a joint filing made by the states.
The states said Purdue, backed by the wealthy Sackler family, contributed to a public health crisis that has claimed the lives of roughly 450,000 people since 1999 and caused strains on healthcare and criminal justice systems. The filings cited more than 200,000 deaths in the US tied directly to prescription opioids between 1999 and 2016.
Purdue filed for bankruptcy in 2019 under pressure from more than 2,600 lawsuits brought by cities, counties, states, Native American tribes, hospitals and others. The lawsuits said the company, and in some cases the Sacklers, used deceptive marketing and took other improper steps to flood communities with prescription opioids.
Purdue and the Sacklers have denied these allegations and have also pledged to help combat the opioid epidemic by providing addiction treatment drugs and overdose reversal medications.
Gilead expands tie-up with Tango; its rheumatoid arthritis drug fails to get FDA nod
This week, Gilead Sciences announced an expanded strategic collaboration with Tango Therapeutics that will focus on discovery, development and commercialization of targeted immune evasion therapies for cancer patients.
The expanded multi-year collaboration builds on an agreement signed in 2018, wherein Tango will continue to leverage its proprietary, CRISPR-enabled functional genomics target discovery platform to identify novel immune evasion targets.
Gilead and Tango Therapeutics agreed to an estimated US$ 6 billion deal (spread over seven years) that will cover 15 different targets that help cancer cells evade the immune system.
Under the terms of the collaboration, Gilead will make a US$ 125 million upfront payment to Tango and a US$ 20 million equity investment in the company. In addition, Gilead will have the right to option up to 15 programs over the seven-year collaboration for up to US$ 410 million per program in opt-in, extension and milestone payments. Tango will also be eligible to receive royalties on net sales.
Meanwhile, FDA has rejected Gilead’s marketing application for filgotinib, an investigational drug for the treatment of rheumatoid arthritis, ulcerative colitis, psoriatic arthritis and Crohn's disease. Gilead said FDA wanted to see more data from two ongoing safety studies of the drug.
Gilead also said the FDA has “expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.” And that could ultimately force Gilead to scrap one of the biggest development efforts in the industry.
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