GENEVA — Pharmaceutical company executives said Thursday that one or several COVID-19 vaccines could begin rolling out before 2021, but warned the challenges would be "daunting" as it was estimated that 15 billion doses would be needed to halt the pandemic.
Well over 100 labs around the world are scrambling to come up with a vaccine against the novel coronavirus, including 10 that have made it to the clinical trial stage.
"The hope of many people is that we will have a vaccine, hopefully several, by the end of this year," Pascal Soriot, head of AstraZeneca, told a virtual briefing.
His company is partnering with the University of Oxford to develop and distribute a vaccine being trialed in Britain.
Albert Bourla, head of Pfizer, meanwhile said that his company, which is conducting clinical trials with German firm Biontech on several possible vaccines in Europe and the United States, also believed one would be ready before the end of the year.
"If things go well, and the stars are aligned, we will have enough evidence of safety and efficacy so that we can... have a vaccine around the end of October," he said.
It can take years for a new vaccine to be licensed for general use, but in the face of the COVID-19 pandemic, experimental vaccines shown to be safe and effective against the novel coronavirus could likely win approval for emergency use.
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which organised Thursday's briefing, highlighted the "daunting" challenges facing the industry in the push for a vaccine.
'RUNNING AGAINST TIME'
One challenge, which may seem counterintuitive, is that transmission rates are rapidly declining in Europe where some of the trials are taking place.
Soon they will be too low to properly conduct clinical vaccine trials in a natural setting, Soriot said, adding that so-called "human challenge" studies in which people are intentionally exposed to the virus to test efficacy, were not considered ethically acceptable with COVID-19.
"We are running against time," he said.
The novel coronavirus has killed more than 355,000 people and infected at least 5.7 million worldwide in a matter of months.
IFPMA director Thomas Cueni pointed to estimates that the world will need some 15 billion doses to stop the virus, posing massive logistical challenges.
He stressed that the industry was committed to ensuring equitable access to a future vaccine, but acknowledged that "we will not have sufficient quantities as from day one, even with the best efforts."
Once a working vaccine is developed, one of the biggest obstacles to putting out the amount needed could surprisingly be that there are not enough glass vials to store the doses in.
"There are not enough vials in the world," Soriot said, adding that AstraZeneca, like a number of other firms, was looking into the possibility of putting multiple doses in each vial.
IP 'FUNDAMENTAL'
Paul Stoffels, vice chairman and chief scientific officer at Johnson and Johnson, meanwhile said that if 15 billion doses were needed, a number of different vaccines would be necessary to satisfy the initial demand.
"Not all vaccine candidates could go all over the world depending on features, so somewhere between five and 10 will definitely be needed to serve the whole world," he said.
One challenge could be that some of the vaccines being worked on require storage at very low temperatures, which could be difficult in places lacking the proper infrastructure.
While stressing the need for solidarity and for ensuring fair and equitable distribution of a COVID-19 vaccine, the pharmaceutical chiefs flatly rejected any suggestion that intellectual property rights should be waived on vaccine research.
"IP is absolutely fundamental to our industry," GSK chief Emma Walmsley said.
Soriot meanwhile pointed out that pharmaceutical companies are currently investing billions of dollars with little chance of recuperating the costs.
"If you don't protect IP, then essentially there is no incentive for anybody to innovate," he said.
Agence France-Presse
MANILA - Pharma giant Unilab Inc said it released P665 million for its COVID-19 response effort and the amount could top the P1 billion mark in the coming weeks.
Unilab said it delivered to its partners P317 million in essential medicines and vitamins, P192 million in personal protective equipment sets consist of coveralls, isolation gowns, face shields, N95 and surgical masks, gloves and shoe covers, P45 million in alcohol, hygiene and basic protective kits, P50 million support for COVID-19 test kit development and P11 million worth of ventilators.
It also supported fundraising drives of civil society groups for the marginalized communities with donations worth P50 million, Unilab said.
The Campos Hess-led firm said it would continue to share its resources tor the country's COVID-19 response.
With "husay and malasakit" as its core values, Unilab said it displayed expertise in responding to crisis situations by determining the kind of support appropriate to the vulnerable sector in collaboration with the Department of Health and the country's coronavirus task force.
Over 400 hospitals nationwide have received support from the firm, it said.
Unilab said it partnered with the Department of Science and Technologu (DOST), University of the Philippines-National Institutes of Health (UP-NIH) and other public and private organizations for the possibility of "significant increase" in the country's testing capacity, which is vital in containing the spread of COVID-19.
Various private firms in the country have also extended millions in support for the government's fight against the coronavirus pandemic.
As of April 19, the Philippines has a total of 6,259 confirmed COVID-19 cases with 572 recoveries and 409 deaths.
news.abs-cbn.com
NEW YORK -- Johnson & Johnson must pay $8 billion in punitive damages to a man who previously won $680,000 over his claims that it failed to warn that young men using its antipsychotic drug Risperdal could grow breasts, a Philadelphia jury said on Tuesday.
The Philadelphia Court of Common Pleas jury's verdict in favor of Nicholas Murray came in the first case in which a Pennsylvania jury had been able to consider awarding punitive damages in one of thousands of Risperdal cases pending in the state.
"This jury, as have other juries in other litigations, once again imposed punitive damages on a corporation that valued profits over safety and profits over patients," Murray's lawyers, Tom Kline and Jason Itkin, said in a joint statement. "Johnson & Johnson and (subsidiary) Janssen chose billions over children."
J&J said the award was "grossly disproportionate with the initial compensatory award in this case, and the company is confident it will be overturned." It added that the jury in the case had not been allowed to hear evidence of Risperdal's benefits.
Professor Carl Tobias of the University of Richmond School of Law said he expects the punitive damages to be lowered on appeal, citing a US Supreme Court decision which found that "few awards exceeding a single-digit ratio between punitive and compensatory damages, to a significant degree, will satisfy due process."
Tobias said the verdict was about sending a message.
"A jury, if it's outrageous enough conduct, will award a big number and let the lawyers and judges work it out," he said.
Tobias added that the verdict could be a sign that J&J will face more large damages awards in other Risperdal cases.
"The kind of evidence in this trial may persuade another jury or judge to do something similar," he said.
Murray, like other male plaintiffs in the mass tort litigation over Risperdal, alleges that he developed breasts after being prescribed the medicine when he was a minor. The US Food and Drug Administration approved the drug in late 1993 for treating schizophrenia and episodes of bipolar mania in adults.
Plaintiffs claim that J&J failed to warn of the risk of gynecomastia, the development of enlarged breasts in males, associated with Risperdal, which they say the company marketed for unapproved uses with children.
In his lawsuit, Murray, now 26, alleged that he developed breasts after his doctors began prescribing him Risperdal off-label in 2003 after a psychologist diagnosed him with autism spectrum disorder. Doctors are allowed to prescribe medicines as they see fit, while companies are only allowed to promote their drugs for approved uses.
A jury in 2015 awarded Murray $1.75 million after finding J&J was negligent in failing to warn of the risk of gynecomastia. A state appeals court upheld the verdict in February 2018 but reduced it to $680,000.
Plaintiffs in the mass tort litigation had been barred from seeking punitive damages since 2014, when a state court judge ruled that the law of New Jersey, which prohibits punitive damages and is J&J's home state, should be applied globally to the cases.
But a Pennsylvania Superior Court ruling in 2018 cleared the way for punitive damages awards, holding that the law of each plaintiff's state should instead apply.
source: news.abs-cbn.com
NEW YORK - Pfizer announced Monday it will merge its off-patent drug business with generic drugmaker Mylan to create a global leader in low-cost treatment, a business that faces significant political pressure in the US.
The new entity, which will be renamed upon the deal's closure, will have a portfolio that includes impotence drug Viagra, cholesterol pills Lipitor, painkiller Lyrica and the life-saving EpiPen treatment for severe allergic reactions.
The merger comes amid rising competition in generic drugs from companies in India and elsewhere, a segment of pharma that is known for having low barriers to entry and commodity-like products.
Joining forces with Pfizer's off-patent division, called Upjohn, will give Mylan access to more international markets. The deal also is expected to result in $1 billion in annual cost savings starting in 2023, the companies said.
"The combined organization will have a presence across nearly every continent and major market, establishing a new leadership position in Asia, and offering products capable of treating all major therapeutic areas," said Mylan chairman Robert Coury, who will serve as executive chairman of the new company.
This marks the latest move by Pfizer, which has grown into one of the world's biggest pharma companies through a string of acquisitions. The new company will be 57 percent owned by Pfizer shareholders, and 43 percent owned by Mylan investors.
Michael Goettler, head of Upjohn, will serve as CEO of the new firm, while Mylan CEO Heather Bresch will leave the company.
Bresch was at the helm when the company was skewered for its massive price increases for the EpiPen emergency treatment, one of several issues that has dogged Mylan in recent years.
Analysts at Morningstar characterized Mylan as "one of the most controversial publicly traded healthcare companies," citing charges of "price gouging" for EpiPen and a high debt load, among other issues.
Mylan also has disclosed US subpoenas looking into the company's sale of opioids and in connection with US antitrust probes of generic companies.
PFIZER EYES BLOCKBUSTERS
Pfizer, meanwhile, has focused extensive investment in research and development with an eye towards developing new blockbuster drugs.
A company earnings release listed about a dozen drugs in various stages of development and introduction, including new treatments for renal cell carcinoma, eczema and muscular dystrophy.
In recent months, Pfizer has announced deals to combine its consumer healthcare business with GlaxoSmithKline's unit, and to spend $11.4 billion to acquire Array BioPharma, which is known for drugs in development focused on oncology and rare disease.
Pfizer chief executive Albert Bourla said the deal with Mylan would sharpen the company's focus on "breakthroughs that change patients' lives."
JPMorgan Chase praised the deal, saying it "makes sense with Pfizer able to focus on its innovative core business and the combined Mylan/Upjohn able to extract synergies" and focus on emerging markets.
However, ratings agency S&P viewed the divestment as "modestly negative to Pfizer's business strength."
S&P lowered the credit score for Pfizer a notch to 'AA-' and put the company on credit watch for another possible downgrade, while affirming Mylan's rating with a positive outlook.
Separately, Pfizer reported that second quarter profit jumped 30.3 percent to $5 billion, due in part to a large one-time boosts from a favorable US tax settlement, and a lower tax rate after the late 2017 US tax cut signed by US President Donald Trump.
Revenues dropped 1.5 percent to $13.3 billion.
Pfizer also cut some of its 2019 financial forecasts, citing the accounting of the GlaxoSmithKline and Array transactions.
Mylan's share price surged 12.6 percent to end the day at $20.78, while Pfizer fell 3.8 percent to $41.45.
source: news.abs-cbn.com
WASHINGTON - Pharmaceutical giant Eli Lilly will acquire cancer treatment specialist Loxo Oncology in a cash deal valued at around $8 billion, the companies said on Monday.
The firms "announced a definitive agreement for Lilly to acquire Loxo Oncology for $235.00 per share in cash, or approximately $8.0 billion," a statement said.
The deal -- which represents a premium of some 68 percent over Loxo Oncology's closing share price on Friday -- is expected to close by the end of the first quarter, the statement said.
The announcement is the latest in a series of major pharmaceutical deals: last week, Bristol-Myers Squibb said it would buy biotech firm Celgene in a $74 billion cash-and-stock agreement, creating a rival to the world's largest drug makers.
Other recent large pharma deals include French company Sanofi's purchase of US hemophilia group Bioverativ for $11.6 billion and Novartis' $8.7 billion acquisition of rare-disease treatment company AveXis.
source: news.abs-cbn.com
NEW YORK - French pharmaceutical giant Sanofi will pay more than $25 million to settle US charges over bribery committed in Kazakhstan and the Middle East, US authorities announced Tuesday.
The US Securities and Exchange Commission said Sanofi employed a kickback system in Kazakhstan to win public contracts and increase prescriptions of its products.
In the Middle East, the company employed "pay-to-prescribe" schemes to induce healthcare providers to increase their prescriptions of Sanofi products, the agency said.
"Bribery in connection with pharmaceutical sales remains as a significant problem despite numerous prior enforcement actions," said Charles Cain an SEC enforcement official who leads the unit on the Foreign Corrupt Practices Act.
"While bribery risk can impact any industry, this matter illustrates that more work needs to be done to address the particular risks posed in the pharmaceutical industry," Cain said.
The probe covered Sanofi and its affiliates in Kazakhstan, Jordan, Lebanon, Bahrein, Kuwait, Qatar, Yemen, Oman and the United Arab Emirates for activities between 2006 and 2015.
Sanofi did not admit or deny any wrongdoing.
source: news.abs-cbn.com
BETHESDA, United States - Christian Hinrichs knew his life had forever changed the day he thought he was pouring milk into a glass, but heard it splashing on the floor instead.
It was 2005, and the young cancer surgeon had just undergone the removal of his right eye because of a rare cancer, called ocular melanoma, which affects 6 in a million people.
Prior to the operation, his doctors had been optimistic that he'd make a full recovery and be able to return to practicing surgery.
"But the reality for me personally was after I lost the eye, it really threw off my depth perception," said Hinrichs.
"I knew I couldn't operate anymore. So I decided not to."
At the time, Hinrichs was 33, and had spent 13 years in training and in the operating theater.
Even before his own diagnosis, he'd decided to focus on cancer surgery.
He also had an interest in cancer research, particularly the burgeoning field of adoptive T-cell therapy, which involved genetically engineering the immune cells to recognize and attack cancer.
But after his eye was removed, he felt like a "square peg" that didn't fit anywhere.
"I was a surgeon who couldn't operate, and I was interested in oncology but I wasn't an internal medicine doctor," he said.
So he went back to school to train as an internal medicine doctor and oncologist, a process that took 4 years.
Going back to being a medical resident -- while married with a one-year-old son at home -- was "a huge drop down the ladder," he recalled.
But he was more driven than ever to find another way to beat cancer, when surgery, chemotherapy and radiation failed.
For Hinrichs, the fight was now personal.
"If the cancer ever came back in me at a site distant from the eye, I would be in that group of incurable patients," he said, explaining that his cancer would then be considered metastatic, and fatal.
The odds of a recurrence, for his type of cancer, were about 50 percent.
'SCANXIETY'
Hinrichs, now 46, is an investigator at the National Cancer Institute, and leads experimental trials aimed at training the body's T-cells to eradicate cancers caused by the human papillomavirus (HPV).
Two women who participated in one of his early clinical trials against cervical cancer have been disease-free for 5 years, and are now considered cured.
Many of the trials he runs at the National Institutes of Health Clinical Center, the nation's top research hospital, are considered "first-in-human," aimed at testing an experimental treatment in people for the first time.
They typically enroll one or 2 dozen patients with advanced cancers that have stopped responding to every other treatment.
Most patients aren't cured. But some see their cancers disappear in months. And that can lead to new treatments which may one day reach the broader public.
Colleagues describe Hinrichs as blunt, honest and direct, traits that may have been sharpened by his cancer ordeal.
"He told me on day one," about his experience with cancer, said NCI researcher Lindsey Draper, who works in Hinrichs' lab and is testing a next-generation T-cell therapy that arose from an earlier HPV trial.
"I think he wanted me to understand his sense of urgency in pushing this research forward."
Hinrichs sometimes tells patients about his back story if they ask how he got into this field, or if he thinks it will help them somehow.
One of them, Aricca Wallace, who has been cancer-free since 2012, said he helps her manage her fear each time she goes for follow-up scans. She even has a word for it: "scanxiety."
"He knows that I am on pins and needles and don't sleep. So he will take a quick look and shoot me a thumbs up," she said, describing their rapport as "more family than doctor-patient."
For his part, Hinrichs decided to stop getting follow-up MRI and CT scans about five years after his eye was removed.
A long-time Presbyterian, he says his faith carries him through times of uncertainty.
When it comes to his particular cancer, "the statistics are really of limited value, anyway," he added.
So he presses on, designing trials that are intended to cure advanced cancer with a single infusion of billions of super-charged T-cells that will take aim at tumors wherever they lie in the body.
Hinrichs thinks pursuing any other work would be unsatisfying.
"Cancer patients don't want researchers to be focused on things that slow down the cancer or may have relatively minor effects," he said.
"What they really want is for their cancers to go away."
source: news.abs-cbn.com
