U.K. court invalidates Gilead’s Truvada patent extension, allowing PrEP generics

Activists in the U.S. are asking authorities to break Gilead’s patents on Truvada in an effort to help end the HIV epidemic. Now, a court in the U.K. has done just that, potentially allowing for widespread use of generics as a pre-exposure prophylaxis.

The U.K.’s High Court overturned a patent extension for Truvada, meaning “that unbranded versions of the drug can be legally prescribed,” National AIDS Trust chief executive Deborah Gold said in a statement.

She added that the development “represents a huge cost saving to buying a drug that would save public money, even at full price.” National AIDS Trust is calling on NHS England to fund the medicine by April 2019, arguing that a current trial program isn’t reaching everyone at need.

A Gilead spokesperson told pharmaphorum that the company is disappointed with the decision and will appeal. Teva, Accord, Lupin and Mylan brought the patent challenge.

Truvada’s EU patent expired last year, according to the company’s annual SEC filing. Gilead secured supplementary protection certificates in several countries, which have come under legal challenges. The company’s U.S. patent expires in 2021, according to the filing. Gilead also has a patent settlement with Teva, allowing that company to launch a U.S. generic at an undisclosed date.

Gilead’s Truvada can be taken regularly as an HIV prevention tool, and activists in the U.S. recently penned a New York Times op-ed calling on the government to break Gilead’s patents to ensure equal access. Part of the activists’ “national strategy” to end the HIV epidemic includes “insisting that federal agencies use their statutory authority to break Gilead’s undeserved monopoly,” they wrote.

Less than 10% of people in the U.S. who could benefit from the drug in the PrEP setting are getting it, according to the authors.

At the time, a Gilead representative said the company is “committed to ensuring that people who are at high risk for HIV infection have access to Truvada for PrEP.” He noted that the company supports “comprehensive payer coverage” and maintains an access program for “qualified uninsured and underinsured people” in the U.S. The company also supports education programs, according to the spokesman.

Gilead this year launched a TV advertising campaign recommending viewers talk to their doctors about HIV prevention options.

Truvada brought in about $3.1 billion in sales around the world last year.

https://www.fiercepharma.com/pharma/u-k-court-invalidates-gilead-s-truvada-patent-extension-allowing-prep-generics

UK rejects adult Novartis CAR-T therapy, after ‘yes’ in kids

Health authorities in England have rejected a pricey CAR-T cell therapy from Novartis for adults with blood cancer, two weeks after endorsing its use in children and young people.

The National Institute for Health and Care Excellence (NICE) said Kymriah was not cost-effective for adult lymphoma. That contrasts with a green light for youngsters with aggressive leukaemia when other drugs have failed.

NICE said the Swiss drugmaker had offered a confidential discount on the list price of 282,000 pounds per patient, but this was still above the level considered to be an acceptable use of resources.

Despite the preliminary rebuttal, NICE said it welcomed “further discussions” around the cost-effectiveness of Kymriah. NICE is the body that decides if new treatments are worth using on the state health service in England and Wales.

The decision on Kymriah in adults is in line with the rejection of a rival CAR-T treatment for adult lymphoma from Gilead Sciences.

Still, Novartis said it was surprised and disappointed, adding it would work with NICE to find a way to make Kymriah available to adults.

“This relates to individuals who have already failed two previous therapies, and for the vast majority of this population, life expectancy can be counted in months rather than years,” the company said.

Kymriah and Gilead’s Yescarta are chimeric antigen receptor T-cell therapies, or CAR-Ts, which reprogramme the body’s own immune cells to attack malignant cells.

The treatments represents a new approach to fighting cancer, since the therapy involves extraction of infection-fighting cells from a patient. These cells are then genetically engineered to recognise cancer cells and infused back.

The process is complex and expensive but it offers hope for people with certain kinds of blood cancer who have exhausted all other treatment options.

https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-Sciences-UK-rejects-adult-Novartis-CAR-T-therapy-after-yes-in-kids-27282069/

SEC sues U.S. breast-implant company Sientra’s ex-CEO after stock dive

The U.S. Securities and Exchange Commission on Wednesday sued the founder and former chief executive of Sientra Inc for fraudulently concealing problems with his company’s breast and other implants as it was raising $61.4 million in a public stock offering.

Hani Zeini, 54, was accused of letting the offering close on Sept. 23, 2015, despite having learned three days earlier from the chief executive of the company’s sole supplier that European implant sales would be suspended because contamination had been detected in an audit of manufacturing procedures.

Sientra’s share price sank 52.9 percent on Sept. 24, 2015, to $9.70 from $20.58, after it disclosed that the U.K. Medicines and Healthcare Products Regulatory Agency had suspended the certificate needed for the supplier, Brazil’s Silimed, to sell the implants.

Zeini could not immediately be reached for comment, and a lawyer for him could not immediately be identified.

The SEC said Zeini had hid “damaging” details from “every other professional” working on his Santa Barbara, California-based company’s 3 million share offering, including its chief financial officer, directors, lawyers, auditors and bankers, and tried to cover his tracks after it was done.

“Zeini acted knowingly, recklessly and without reasonable care,” the complaint said.

The SEC is seeking a civil fine and an officer and director ban for Zeini. It filed its lawsuit with the U.S. District Court in Los Angeles.

Sientra settled related charges, but was not fined after providing “extensive” cooperation, the SEC said. The company did not admit or deny wrongdoing. Silimed was not charged.

The SEC did not respond to a request for comment.

According to his LinkedIn profile, Zeini is now the owner of Elissar Advisors & Investment Co in Santa Barbara. He stepped down as Sientra’s chief executive in November 2015.

Sientra announced in January 2016 that independent testing showed that its implants were safe.

Its shares traded down 39 cents at $23.76 in Wednesday afternoon trading on the Nasdaq.

The case is SEC v Zeini, U.S. District Court, Central District of California, No. 18-08103.

https://www.marketscreener.com/SIENTRA-INC-18397158/news/Sientra-SEC-sues-U-S-breast-implant-company-s-ex-CEO-after-stock-dive-27285595/

Mars aims to tackle ‘broken’ cocoa model with new sustainability scheme

Mars Wrigley Confectionery launched a new sustainability strategy on Wednesday with the aim of combating deforestation, child labor and poverty in what it called the “broken” cocoa supply chain.

U.S.-based Mars, the maker of M&Ms and Snickers, said it had revamped its cocoa strategy in an effort to tackle problems that the company and wider industry had so far failed to address.

“The cocoa supply chain as it works today is broken,” John Ament, global vice president of cocoa at the privately owned company, told Reuters in an interview.

“It’s time to recognize this and to build a new model and a new approach that focuses on putting the smallholder at the center.”

The cocoa industry’s current approach to sustainability has drawn criticism in recent months, as years of scattered actions have done little to improve the lives of farmers and prevent environmental degradation.

Under the new sustainability scheme – which will cost the company $1 billion over 10 years – all the cocoa it buys will be responsibly sourced by 2025, Mars said.

This means the cocoa will fit the company’s internal criteria – including full traceability to ensure it doesn’t contribute to deforestation – and carry a stamp of approval from a third-party verifier.

Mars had previously committed to buying 100 percent certified cocoa by 2020. However, the company is now looking to move “beyond certification”, which has not delivered the impact the company had hoped for, according to Ament.

“Certification isn’t enough,” he said. “Our belief is that we need to set more demanding standards than certification sets today.”

Currently, 50 percent of the cocoa that Mars buys is certified by schemes such as Rainforest Alliance and Fairtrade. Mars said it will maintain these volumes and potentially increase them if it sees improvements in the schemes’ standards.

Certification – designed to ensure more ethical practices and better earnings – has also been widely criticized as doing little to improve the lives of farmers, as the premiums they receive under the biggest of these schemes have been falling.

HIGHER PREMIUMS, GPS MAPPING

As part of its new scheme, Mars said it will work with certifiers and suppliers to “overhaul” its premium model, ensuring it pays more for responsibly sourced cocoa.

“We’ll see a combination of increased premiums overall and a bigger share of those premiums going to the farmers,” Ament said.

The scheme will also use GPS mapping to ensure none of the cocoa it sources is coming from protected forests. Much of the surge in production in West Africa has come from the encroachment of cocoa into protected areas.

Mars also plans to work with certifiers and suppliers to tackle hazardous child labor on plantations through community monitoring and intervention schemes.

However, the company said it recognizes that the voluntary nature of such program – coupled with limited access to schooling – poses a challenge. It aims to work with governments to drive investments in infrastructure and to provide communities with an alternative to child labor.

The company’s new strategy also involves measures aimed at ensuring long-term sustainability, which will be rolled out across 75,000 farming families and suppliers. These will aim to boost productivity, help producers diversify crops and improve access to finance.

“We’re convinced that these farmers need a broader source of income to ensure that they have a resilient model, with income spread throughout the year rather than just two peak seasons of cocoa,” Ament said.

Some critics have accused productivity schemes of contributing to overproduction, with Ivory Coast this year halting the distribution of higher-yielding seed varieties and other advanced tools.

However, Ament said Mars is seeking to collaborate with governments and stakeholders to ensure productivity increases do not have a negative impact on supply and price.

https://www.marketscreener.com/COCOA-16214/news/Mars-aims-to-tackle-broken-cocoa-model-with-new-sustainability-scheme-27285915/

Delcath up 57% as end of subscription rights period approaches

Thinly traded nano cap Delcath Systems (DCTH +56.6%) is up on a 15x surge in volume, albeit on turnover of only 242K shares. The stock has doubled since last week.

The company’s subscription rights will be exercisable until 5:00 pm ET on September 26. Under the terms of the rights offering, stockholders will be entitled to purchase 500 common shares at $1.75 for each share owned. Holders who fully exercise their subscription rights will be have an oversubscription privilege subject to conditions.

https://seekingalpha.com/news/3391236-delcath-57-percent-end-subscription-rights-period-approaches

Galera Therapeutics Nabs $150 Million to Drive Lead Therapeutic Into Phase 3

Privately-held Galera Therapeutics secured $150 million in a Series C funding round that will be used to drive its experimental head and neck cancer treatment GC4419 into Phase III trials, as well as support pre-commercialization activities.

In a Phase IIb clinical trial, GC4419 demonstrated significant reductions in the incidence and duration of radiation-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer. Data showed that GC4419 was able to reduce the duration of SOM from 19 days to 1.5 days, a reduction of 92 percent. SOM is one of the most debilitating side effects of radiotherapy, and there are currently no effective therapies to prevent or mitigate it, the company said this morning.

GC4419 is a “highly selective and potent small molecule dismutase mimetic” that closely imitates the activity of human superoxide dismutase enzymes, according to company data. The experimental drug works to reduce elevated levels of superoxide caused by radiation therapy by rapidly converting superoxide to hydrogen peroxide and oxygen. Phase III is expected to be initiated in the fourth quarter of this year, the company noted.

The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to GC4419 for the reduction of the duration, incidence and severity of SOM induced by radiation therapy with or without systemic therapy. It was also granted Fast Track designation to GC4419 for the reduction of the severity and incidence of radiation and chemotherapy-induced oral mucositis.

Mel Sorensen, president and chief executive officer of Galera, said the $150 million Series C validates the “dramatic and meaningful results” of the Phase IIb trial.

“The funds provide Galera with ample financial resources to complete the Phase III clinical trial, begin commercial planning activities and further explore the potential of GC4419 beyond SOM. We look forward to initiating a supportive care trial of GC4419 in radiation-induced esophagitis and a therapeutic trial in a second cancer indication, as well as continuing to evaluate the safety and anti-tumor effect of GC4419 in our ongoing Phase I/II pancreatic cancer clinical trial,” Sorensen said in a statement.

Galera dosed the first patient in the pancreatic cancer trial in February.

The Series C funding round included a $70 million equity raise and an $80 million royalty financing payable from future sales. The round was supported by new investor Clarus, with participation from additional new investors Adage Capital Management, HBM Healthcare Investments, Nan Fung Life Sciences, RA Capital, Rock Springs Capital and Tekla Capital Management LLC. Existing investors Correlation Ventures, Galera Angels, New Enterprise Associates, Novartis Venture Fund, Novo Ventures and Sofinnova Ventures.

Under terms of the financing agreement, Emmett T. Cunningham, managing director of Clarus, will assume a seat on the Galera board of directors. Additionally, Clarus will receive single-digit future commercial royalties from the sales of GC4419 and a related pipeline asset until the total royalty amount achieves an undisclosed multiple of the initial $80 million, upon which the royalty terminates.

“With its highly differentiated scientific approach and its potential in a number of indications, GC4419 is well-positioned to address serious unmet medical needs. We’re pleased to support Galera as the company moves closer to potentially bringing GC4419 to head and neck cancer patients with SOM who need a new treatment option,” Cunningham said in a statement.

https://www.biospace.com/article/ip3o-galera-therapeutics-nabs-150-million-to-drive-lead-therapeutic-into-phase-iii/

Centene initiated at MUFG

Centene initiated with an Overweight at MUFG. MUFG analyst Jason Twizell started Centene with an Overweight rating and $170 price target. The analyst sees an attractive risk/reward profile given the stock’s discount to peers. He believes Centene’s “significant” Medicaid and Medicare growth opportunities make the discount unwarranted.

https://thefly.com/landingPageNews.php?id=2792361