Telix Pharmaceuticals and China Grand Pharma Announce Strategic Licence and Commercial Partnership for Greater China Market

MELBOURNE, Australia and HONG KONG, Nov. 02, 2020 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces it has entered into a strategic licence and commercial partnership with China Grand Pharmaceutical and Healthcare Holdings Limited (‘China Grand Pharma’) for Telix’s portfolio of Molecularly-Targeted Radiation (‘MTR’) products.

Telix has appointed China Grand Pharma as its exclusive partner for the Greater China market (‘Territory’)1 and grants China Grand Pharma exclusive development and commercialisation rights to Telix’s portfolio of prostate, renal and brain (glioblastoma) cancer imaging and therapeutic MTR products in the Territory.

Leveraging off China Grand Pharma’s capabilities and infrastructure in China, Telix will enter a significant oncology market, and by partnering with Telix, China Grand Pharma will build on its pipeline of innovative products for Greater China, as well as its strategy in Nuclear Medicine.

The material terms of the partnership include:

Therapeutic Products

  • US$25M (~AU$35M) up-front non-refundable prepayment to Telix, to be credited against future regulatory and commercial milestone payments.

  • Up to US$225M (~AU$315M) in regulatory and commercial milestone payments to Telix, across Telix’s existing therapeutic products portfolio.

  • Program-related investment estimated at up to US$65M (~AU$90M) for clinical costs associated with the development of the therapeutic products in the Territory, to align with Telix’s global clinical development programs.

  • Royalties on therapeutic product sales in the Territory, in addition to milestone payments.

Imaging Products

  • Exclusive commercial partnership (sales, marketing, distribution) for Telix’s core imaging product portfolio:

    • TLX250-CDx (89Zr-Girentuximab) for renal cancer, and;

    • TLX591-CDx (68Ga-PSMA), TLX599-CDx (99Tc-PSMA) for prostate cancer.

Strategic Equity Investment

Additionally, China Grand Pharma will make a simultaneous one-time strategic equity investment of US$25M (~AU$35M) in Telix. The investment is in the form of a private placement to China Grand Pharma of 20,947,181 fully paid ordinary Telix shares representing a post-issue holding by China Grand Pharma of 7.62%. Shares will be issued at a price of AU$1.69, based on the 10-day volume-weighted average price (‘VWAP’) for Telix shares up to and including 28th October 2020. Shares will be issued no later than November 06 2020, following receipt of the placement proceeds. Shares issued to China Grand Pharma are subject to a holding lock and will not be able to be traded for a period of 12 months from the date of issue. In addition, China Grand Pharma is subject to a standstill provision and is unable to trade in Telix shares for a period of 12 months.

Telix Pharmaceuticals CEO, Dr. Chris Behrenbruch stated, “Telix’s mission is to be a leading global oncology company and China is an important future market for our products. We are pleased to be working with China Grand Pharma to deliver our diagnostic imaging and therapeutic products to cancer patients in China. Considering the successful acquisition of Sirtex Medical Limited with joint venture private equity partner CDH Genetech Limited2 and subsequent approval of a New Drug Application filing for SIR-Spheres® by the National Medical Products Administration (‘NMPA’) of the

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Activists urge ‘Big Pharma’ to be transparent on COVID-19 vaccine costs

By Stephanie Nebehay



FILE PHOTO: A woman holds a small bottle labeled with a "Vaccine COVID-19" sticker and a medical syringe in this illustration


© Reuters/Dado Ruvic
FILE PHOTO: A woman holds a small bottle labeled with a “Vaccine COVID-19” sticker and a medical syringe in this illustration

GENEVA (Reuters) – Activists called on pharmaceutical companies on Thursday to be transparent about the costs and terms of providing COVID-19 vaccines, saying they must be available and affordable for all.

French drugmaker Sanofi and Britain’s GlaxoSmithKline said on Wednesday they would supply 200 million doses of their COVID-19 candidate vaccine to the global COVAX vaccine facility backed by the World Health Organization (WHO) and the GAVI vaccine alliance.

Medecins Sans Frontieres (Doctors Without Borders) demanded the two companies provide details around price, supply and distribution of any vaccine proven safe and effective.

“Pharmaceutical corporations Sanofi and GSK must sell their vaccines at-cost and open their books to show the public exactly how much it costs to make the vaccine,” said Kate Elder, senior vaccines policy adviser at MSF’s Access Campaign.

“There is no room for secrets during a pandemic and past experience tells us that we can’t take pharma at their word without data to back up their claims,” she said in a statement.

Sanofi and GSK could not immediately be reached for comment.

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No company has shared information on research and development, clinical trials or manufacturing costs of potential COVID-19 vaccines, MSF said, adding this was vital for the public to assess prices set.

More than half of the expected volume of doses of leading candidate vaccines has been bought up by 13% of the world, mainly high-income countries, the medical charity said.

Human Rights Watch, in a separate report, said governments funding vaccines with public money should be transparent about terms and conditions attached.

The New York-based group urged states to back a proposal by India and South Africa to wave some aspects of intellectual property (IP) rules on patents to enable large-scale manufacturing and affordability.

A temporary IP waiver was debated this month in the World Trade Organization (WTO), but was opposed by the United States, European Union, Britain, Switzerland and others.

“Since the beginning of the pandemic our priority has been to ensure that all people enjoy the fruits of science … In these difficult times the best health technologies and discoveries cannot be reserved only for a few, they must be available to all,” WHO director-general Tedros Adhanom Ghebreyesus said at a UNESCO event on “Open Science” on Tuesday.

“Sharing data and information that is often kept secret or protected by intellectual property could significantly advance the speed at which technologies are developed,” Tedros added.

(Reporting by Stephanie Nebehay; Editing by Mark Potter)

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As Purdue Pharma Agrees to Settle with the DOJ, Revisit Its Role in the Opioid Crisis | Opioids, Inc. | FRONTLINE | PBS

In the latest chapter of a complex legal battle over who is responsible for the nation’s opioid crisis, Purdue Pharma, the manufacturer of the notorious painkiller OxyContin, has arrived at an $8.3 billion settlement with the federal government, pending court approval.

Announced in an Oct. 21 Department of Justice press conference, the settlement, if approved, resolves the federal government’s civil and criminal probes into Purdue Pharma, which is currently in bankruptcy; an additional settlement resolves a federal civil case against Purdue Pharma’s owners, the Sackler family.

“It’s also important to note that this resolution does not prohibit future criminal or civil penalties against Purdue Pharma’s executives or employees,” Jeffrey A. Rosen, the U.S. deputy attorney general, said at the press conference.

Under the settlement, Purdue Pharma admits guilt on three felony charges involving conspiring to defraud the U.S. and break anti-kickback regulations in how it marketed opioids. The settlement involves a $3.5 billion criminal fine and a $2 billion criminal forfeiture, as well as a civil payment of $2.8 billion, though actual monetary payments could be substantially less, once the company’s value is factored in. Separately, the Sacklers themselves will make a $225 million payment to the U.S.

The settlement “will require that the company be dissolved and no longer exist in its present form,” Rosen said, with the Sacklers barred from any controlling or owning role moving forward. Instead, if the settlement is approved by bankruptcy court, the company’s assets would become “owned by a trust for the benefit of the American public,” Rosen said. The new company would still be able to manufacture opioid drugs but would also be required to produce large quantities of medicines to treat and respond to addiction and overdoses, and would need to offer the latter as donations or “at cost.”

“Purdue deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice in the agreed statement of facts,” Steve Miller, chairman of Purdue Pharma’s board, said in a statement.

In a separate statement, Sackler family members who served on the Purdue Pharma board said they had “acted ethically and lawfully” and that they “reached today’s agreement in order to facilitate a global resolution that directs substantial funding to communities in need, rather than to years of legal proceedings.”

The statement also said, “Regarding the plea agreement between the government and Purdue, no member of the Sackler family was involved in that conduct or served in a management role at Purdue during that time period.”

A number of states’ attorneys general spoke out against the terms of the proposed settlement as inadequate and vowed to continue to pursue cases against the company and the Sacklers, which the federal settlements do not resolve.

Purdue Pharma has long been accused of being a driver of America’s opioid crisis. FRONTLINE’s 2016 documentary Chasing Heroin investigated how that crisis came to be, examining allegations about Purdue Pharma’s role in the early years of what has been called the worst drug epidemic in U.S. history.

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OxyContin maker Purdue Pharma may settle legal claims with a new ‘public trust’ that would still be dedicated to profit

<span class="caption">Deputy Attorney General Jeffrey A. Rosen announced a settlement between the Justice Department and opioid maker Purdue on Oct. 21.</span> <span class="attribution"><a class="link rapid-noclick-resp" href="https://newsroom.ap.org/detail/USOpioidCrisisPurduePharma/d69562dc33ef441d83f32833f91c4d57/photo?boardId=37be9465fcce45d283d5431cccb20a6a&st=boards&mediaType=audio,photo,video,graphic&sortBy=&dateRange=Anytime&totalCount=36&currentItemNo=2" rel="nofollow noopener" target="_blank" data-ylk="slk:Yuri Gripas/Pool via AP">Yuri Gripas/Pool via AP</a></span>
Deputy Attorney General Jeffrey A. Rosen announced a settlement between the Justice Department and opioid maker Purdue on Oct. 21. Yuri Gripas/Pool via AP

Purdue Pharma, the company that makes OxyContin and other potentially addictive prescription opioids, has agreed to plead guilty to three felony counts and reached a settlement potentially worth at least US$8.3 billion with the Justice Department.

The deal could clear the way for Purdue to transform from a profit-seeking privately held company into a public trust that serves the public good, as the company has proposed.

But the settlement is subject to the approval of the federal judge overseeing Purdue’s bankruptcy case. And it may not resolve the thousands of lawsuits Purdue faces for its role in creating the opioid crisis. Notably, the attorneys general from 25 states called on the government a week before the Justice Department announced the deal to simply force the sale of the drugmaker to a new owner instead.

I study the history of prescription drugs (and I have served as a paid consultant and expert witness in opioid litigation). Although there are some recent efforts to establish nonprofit drugmakers to help make certain pharmaceuticals more readily available, I know of no historical precedent for a big drugmaker like Purdue becoming a nonprofit public health provider.

But two similarly ambitious efforts to build alternatives to the profit-driven pharmaceutical model during and immediately after World War II suggest the potential limits of how well this arrangement might work.

Antibiotics

Penicillin was discovered in 1928 but did not come into use until World War II. It was the first antibiotic: a genuinely revolutionary class of drugs that vanquished previously incurable infectious illnesses.

Because of penicillin’s importance for the war effort, the federal government played an active role in its development. Federal scientists developed ways to mass-produce it, federal agencies persuaded reluctant pharmaceutical companies to manufacture it and the government’s “penicillin czar” decided which patients would receive the precious drug.

Despite the high stakes and the faith in centralized planning, no one at that time appears to have even considered the possibility of noncommercial or nonprofit development of antibiotics.

As was the case with wartime goods such as rubber and tanks, private companies with federal contracts made penicillin. As was also the case with other wartime goods, the arrangement was an unqualified success. It dramatically increased production, and allocated the antibiotic so as to best serve the war effort.

For penicillin, as with other goods, federal economic controls quickly faded after the war. As the medical historian Scott Podolsky has observed, drugmakers, freed from government restraints, unleashed an avalanche of brand-name antibiotics whose high-powered marketing campaigns encouraged the overuse and misuse of the new medicines.

Interestingly, the Sackler brothers got their start by selling antibiotics. The Sacklers, future owners of Purdue Pharma, were pioneers of medical advertising who abandoned earlier restraints and advised their sales representatives to see physicians as “prey.”

The Veterans Administration and the Public Health Service sought to keep

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DOJ Reaches $8 Billion Settlement With OxyContin Maker Purdue Pharma | Politics

Purdue Pharma, the manufacturer of the prescription painkiller OxyContin, reached an $8 billion settlement with the Department of Justice and will plead guilty to three federal criminal charges in connection with its role in America’s opioid crisis.

The Justice Department announced on Wednesday that it had reached a resolution in its investigation into individual shareholders from the Sackler family, who own the pharmaceutical company.

Purdue Pharma will plead guilty in a New Jersey federal court to three felony counts, including one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

The deal does not release the company’s executives or owners from criminal liability and a criminal investigation is ongoing.

“The abuse and diversion of prescription opioids has contributed to a national tragedy of addiction and deaths, in addition to those caused by illicit street opioids,” Deputy Attorney General Jeffrey Rosen said in the announcement. “With criminal guilty pleas, a federal settlement of more than $8 billion, and the dissolution of a company and repurposing its assets entirely for the public’s benefit, the resolution in today’s announcement re-affirms that the Department of Justice will not relent in its multi-pronged efforts to combat the opioids crisis.”

According to the Justice Department, the resolution includes the largest penalties ever levied against a pharmaceutical company and includes a criminal fine of $3.544 billion, an additional $2 billion in criminal forfeiture and a $2.8 billion civil settlement.

Separately, the Sackler family has agreed to pay $225 million in damages.

A Rebirth Behind Bars

June 3, 2018 | Colonial Heights, Virginia | Patsy Tucker, 32, center, prays with her family during a weekly Sunday get-together at her mother's house in Colonial Heights, Va. June 3, 2018. 

Patsy started using heroin at 25, after a car accident and a prescription for opioids turned into a full-blown heroin addiction. Patsy was born to Diana McArthur, far left, when she was 16 years old. "We grew up together," Diana said. During Patsy's years of drug abuse, Diana said she couldn't imagine it ever ending. But just over two years ago, it did. Patsy found recovery when she was locked up in the Chesterfield County Jail. As she lay on the jail floor in the throws of heroin withdrawal, Sheriff Karl Leonard told her to get up - she was going to be the first female participant of HARP (Heroin Addiction Recovery Program), an in-jail, Narcotics Anonymous-styled recovery group. "The Sheriff saw in me what I couldn't see in myself," Patsy said.

Steve Miller, who became chairman of the company’s board in 2018, said in a press release that the company “deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice.”

The company filed for bankruptcy last year as it wades through thousands of civil lawsuits. As part of the resolution, Purdue Pharma would cease to operate in its current form and would instead transition to a public benefit company owned by a trust or similar entity. The new company would be operated under different ownership and “will work to provide for free or at cost millions of doses of lifesaving opioid addiction treatment and overdose reversal medicines,” the press release stated.

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Purdue Pharma Pleads Guilty To Criminal Charges Over Opioid Sales

US drugmaker Purdue Pharma pleaded guilty to three criminal charges over its intense drive to push sales of the prescription opioid OxyContin, which stoked a nationwide addiction crisis, the Justice Department announced Wednesday.

Purdue also agreed to $8.3 billion in fines, damages and forfeitures to settle the criminal case against it, the department said.

In a separate agreement, the billionaire Sackler family, which built Purdue to a pharmaceutical giant on the back of lucrative sales of OxyContin, agreed to pay $225 million to resolve civil liability charges filed by the Justice Department.

“Purdue, through greed and violation of the law, prioritized money over the health and well-being of patients,” said FBI assistant director Steven D’Antuono.

Purdue, which filed for bankruptcy protection last year, pleaded guilty to one count of fraud and two counts of violating kickback laws over its marketing and sales of OxyContin and two other hydrocodone-based treatments, which involved encouraging distributors and doctors to aggressively push the highly addictive drugs to consumers.

Headquarters of Purdue Pharma LP, the maker of the painkiller OxyContin, in Stamford, Connecticut Headquarters of Purdue Pharma LP, the maker of the painkiller OxyContin, in Stamford, Connecticut Photo: AFP / TIMOTHY A. CLARY

Even after paying $600 million for falsely marketing the painkiller as “less addictive,” the Justice Department said, Purdue ratched up its sales drive and developed new addictive applications which it marketed through a network of 100,000 prescribing doctors and nurse practitioners.

Among them were thousands of hyper-prescribers that Purdue “knew or should have known were prescribing opioids for uses many of which were not for a medically accepted indication, were unsafe, ineffective, and medically unnecessary,” or which were resold on the black market, the charges said.

To encourage them Purdue had a program dubbed “Evolve to Excellence” which offered financial and other incentives, particularly offering doctors lucrative speaking gigs, which amounted to kickbacks for pumping out more prescriptions of the company’s drugs.

Its activities, combined with those of other prescription opioid producers and distributors, fed an epidemic of addiction. Millions of Americans became dependent on the painkillers while the drugmakers reaped billions of dollars in profits.

According to the Centers for Disease Control and Prevention, more than 500,000 Americans have died of opioid overdoses — both prescription and non-prescription — since 1999.

In a statement, Steven Miller, Purdue’s chairman since 2018, said the company “deeply regrets and accepts responsibility for the misconduct detailed by the Department of Justice.”

Deputy US Attorney General Jeffrey Rosen(C) announces that Purdue Pharma has agreed to plead guilty to criminal charges over its sales of the addictive prescription opioid OxyContin, which fed a national addiction epidemic Deputy US Attorney General Jeffrey Rosen(C) announces that Purdue Pharma has agreed to plead guilty to criminal charges over its sales of the addictive prescription opioid OxyContin, which fed a national addiction epidemic Photo: POOL / YURI GRIPAS

“Purdue today is a very different company. We have made significant changes to our leadership, operations, governance, and oversight,” he added.

Purdue also faces billions of dollars in claims from state and local authorities around the country, and in September 2019 filed for bankruptcy to fend off more legal claims against it.

Because of the bankruptcy and competing claims from litigants and creditors, the Justice Department admitted it might not

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Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference

Biopharma stocks, which started the week on a firm footing, lost momentum mid-way through amid market-wide sell-off triggered by waning stimulus hopes.

The week was a quiet one from the perspective of news flow. Johnson & Johnson (NYSE: JNJ) was in the news for both right and wrong reasons. The company’s Phase 3 trial of its coronavirus vaccine was paused due to a trial participant contracting an unexplained illness. On a positive note, the company reported solid quarterly results and lifted its guidance.

Pfizer Inc. (NYSE: PFE), meanwhile, stayed above political pressure and provided a realistic timeframe for filing for emergency use authorization for its vaccine candidate.

Avenue Therapeutics Inc (NASDAQ: ATXI) shares fell from $11 to just under $4 after FDA rejected its opioid pain drug on safety concerns.

Clinical trial disappointments led to Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) and Cyclerion Therapeutics Inc (NASDAQ: CYCN) shelving alpha-1 antitrypsin deficiency and sickle cell disease studies, respectively.

The week witnessed Nasdaq debuts by six biopharma companies, which collectively raised about $650 million in gross proceeds.

Here are the key catalysts for the unfolding week.

Conferences

American College of Chest Physicians’ CHEST Annual Meeting 2020, being held virtually: Oct. 18-21

The Prostate Cancer Foundation’s 27th Annual Scientific Retreat: Oct. 20-23

IDWeek 2020: Oct. 20-25

American Society of Nephrology, or ASN, Kidney Week 2020 Annual Meeting: Oct. 22-25 (early programs scheduled for Oct. 19-21)

32nd European Organisation for Research and Treatment of Cancer-the National Cancer Institute- the American Association for Cancer Research, or EORTC-NCI-AACR, Symposium: Oct. 24-25

PDUFA Dates

Zosano Pharma Corp’s (NASDAQ: ZSAN) NDA for its migraine drug Qtrypta has a PDUFA action date of Oct. 20. With the company disclosing in late September that it has received a discipline review letter, which raised two concerns about the clinical pharmacology section of the NDA, a decision by the d-day seems unlikely.

The FDA is set to rule on Spectrum Pharmaceuticals, Inc.’s (NASDAQ: SPPI) BLA for SPI-2012 to treat chemotherapy-induced neutropenia. The PDUFA date is Oct. 24.

Clinical Readouts

Pfizer Inc. (NYSE: PFE) is scheduled to present at the ID Week 2020 full results of the pediatric Phase 2 proof-of-concept study of 20vPNC and detailed results from a Phase 2 proof-of-concept study of its potential first-in-class pentavalent meningococcal vaccine candidate.

Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) will present at the ASN meeting results from the ILLUMINATE-B pediatric Phase 3 study of lumasiran in treating primary hyperoxaluria type 1.

Omeros Corporation (NASDAQ: OMER) is due to present final results of its pivotal trial of narsoplimab in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. The presentation, in the form of a webcast, is scheduled for Oct. 22.

Mustang Bio Inc (NASDAQ: MBIO), founded by Fortress Biotech (NASDAQ: FBIO), is scheduled to present at the Prostate Cancer Foundation’s annual scientific retreat initial Phase 1 data on CAR-T cell therapy MB-105 in patients with PSCA-positive metastatic castration-resistant prostate cancer. The presentation is fixed for Oct. 23.

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