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Sandeep Singh Dhillon
5 Milestones Of 2017 In The War On Cancer – Forbes Healthcare
Pharma Extra
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By Arlene Weintraub,

An impressive 45 novel drugs have been approved by the FDA in 2017 so far — more than doubling last year’s total. A dozen of those new products were in oncology, as the year ushered in new choices for treating a range of cancers, including mantle cell lymphoma, Merkel cell carcinoma and follicular lymphoma.

But what’s notable about the FDA’s list of new chemical entities approved during the year is that it doesn’t include many of the other advances that were seen in the world of oncology research. That’s a separate list, which includes novel combinations of previously approved drugs, and the entry of personalized immune-cell therapies—CAR-T treatments—that have offered hope to thousands of patients who had run out of options for treating their cancers.

The bottom line is that it has been a banner year for cancer research. Here were some of the highlights:

May 23: The FDA approves the first cancer treatment that’s prescribed based on the genetic characteristics of the disease—not the tumour’s location. Merck’s immuno-oncology drug Keytruda won approval to treat patients whose tumors are defined as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). About 5% of colorectal tumors have one of these two characteristics, but the defects are also found in other solid tumors, such as breast cancer, gastrointestinal cancer and prostate cancer. MSI-H and dMMR tumors are unable to properly repair the DNA inside cells. Keytruda works by blocking “checkpoints” that would normally prevent the immune system from recognizing and attacking these defective cells. Merck tested Keytruda in 149 patients with 15 different MSI-H or dMMR cancer types and charted impressive results: More than 39% of patients had at least a partial response to the drug, and 78% of those people responded well for six months or longer.

August 30: The FDA approves the first CAR-T treatment, Novartis’s Kymriah, for some young people with leukaemia. When results from trials of CAR-T treatments first started emerging a few years back, it seemed too good to be true: Cure rates for previously untreatable blood cancers were 70% and higher. But the results held up, and Novartis took home the first FDA approval in this booming area of cancer research.

Kymriah is made by removing immune-boosting T cells from patients, engineering them to be able to recognize and kill their cancers and then re-infusing them. It’s a hugely complex process for a one-time treatment, and it’s priced at a whopping $475,000. But Novartis has proven to be a pioneer not just in the invention of CAR-T but also in its pricing: The company struck a deal with the Centers for Medicare and Medicaid Services (CMS) stipulating that the agency will only have to pay for the treatment when patients respond within the first month.

October 18: Kite Pharma wins approval for its CAR-T, Yescarta, just weeks after cementing its $11.9 billion purchase by Gilead. When Gilead announced its planned purchase of Kite in August—one of the biggest oncology deals of recent years—no one was surprised. Gilead had been under pressure to make a purchase that would boost its pipeline, and Novartis was on the verge of proving that personalized cell therapies can be embraced by regulators.

Yescarta was approved to treat some adult patients with large B-cell lymphoma. There have been some hiccups on the way to market, including reimbursement difficulties that have resulted in long waiting lists for the product. But analysts are optimistic about the $373,000 product, estimating it could bring in as much as $250 million next year.

December 10: Tiny Bluebird Bio stokes optimism for CAR-T in the third type of blood cancer. Shares of gene therapy startup Bluebird Bio shot up 18% to $201.80 in a day after the company announced results from a small trial of its CAR-T in multiple myeloma. The treatment, which is being co-developed by Celgene, is different from the two previously approved CAR-Ts in that it targets a protein on myeloma cells called BCMA. The 18 patients in the trial had failed multiple previous therapies, and 17 of them responded positively to Bluebird’s CAR-T. In 10 of those patients, the cancer seemed to disappear, the companies reported at the annual meeting of the American Society of Hematology (ASH).

Early successes with CAR-T have prompted researchers around the world to see if they can apply T-cell technology to multiple cancer types, including solid tumors. Novartis and Kite are among the companies that have been working on CAR-Ts for solid tumors.

December 20: The FDA approves its 12th cancer combination treatment of the year. The rise of immuno-oncology treatments brought with it a prediction that combining multiple drug modalities might make it possible to conquer previously untreatable cancers. Several companies succeeded this year in persuading the FDA that previously approved products, including immuno-oncology treatments and targeted drugs, work better in groups than do on their own. Hence 12 new cancer combinations were approved in 2017—way up from the five combos approved in 2016.

The most recent of these approvals was awarded to Roche unit Genentech, for its combination of Perjeta, a monoclonal antibody targeted at HER-2 positive breast cancer, with the similarly targeted drug Herceptin and chemotherapy, in patients who face a high risk of recurrence. Earlier in the year, the FDA granted an accelerated approval for Keytruda combined with Eli Lilly’s Alimta and carboplatin for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer.

No doubt 2018 will bring more immuno-oncology advances—and combination treatments designed to outsmart cancer from multiple sides.

This article first appeared at https://www.forbes.com/sites/arleneweintraub/2017/12/21/five-milestones-of-2017-in-the-war-on-cancer/?ss=pharma-healthcare#15a2a7b741de

Sandeep Singh Dhillon
Gilead to Buy Kite Pharma for Roughly $11 Billion — 2nd Update Foxbusiness.com
Pharma News

By Jonathan D. Rockoff Published August 28, 2017

Gilead Sciences Inc. has agreed to pay about $11 billion for Kite Pharma Inc. and its promising new technology for harnessing the body’s immune system to fight cancer, according to people familiar with the matter.

Gilead will pay $180 a share, the people said, representing a 29% premium over Kite’s closing price Friday. The all-cash deal, to be announced Monday, would give Gilead a foothold in a new type of personalized treatment that doctors say could save patients with the most dire cases of cancer and analysts estimate would ring up billions of dollars in sales.

Gilead, of Foster City, Calif., had been looking for an acquisition to diversify its portfolio beyond its leading position in infectious-disease treatments and provide a new revenue stream as sales of the company’s hepatitis C drugs decline.

The deal for Kite would be one of Gilead’s biggest, rivaling the company’s $11 billion purchase of liver-disease drugmaker Pharmasset in 2012. Through that acquisition, Gilead gained hepatitis C therapies that are among the world’s top-selling drugs.

Now Gilead is betting that Kite can provide a similar payoff. Kite, of Santa Monica, Calif., is a leader among several companies that aim to use genetic engineering to weaponize a patient’s own immune T cells and then deploy them to attack lymphoma and other blood cancers.

Kite’s main drug, known as axi-cel, is up for approval in the U.S. and Europe. Analysts predict it would have worldwide sales of $1.7 billion in 2022, according to EvaluatePharma, which ranks the drug among the industry’s top 10 compounds in terms of sales potential. Such expectations have already pushed the company’s shares sharply higher this year.

Axi-cel is likely to face swift, steep competition. Novartis AG, one of the leading cancer-drug makers, beat Kite to be the first company to ask the Food and Drug Administration to approve a bioengineered T-cell drug. Several other companies are developing the drugs too.

Gilead made its name selling treatments for HIV/AIDS. The biotech company surged in value after launching the hepatitis C treatments developed at Pharmasset. The drugs, Sovaldi and Harvoni, helped Gilead double its sales in 2014. It now has a market value of roughly $100 billion.

Last year Gilead had $30 billion in sales, including $9.1 billion from Harvoni and $4 billion from Sovaldi.

Yet the anti-viral drugs’ commercial success has also proved to be an albatross. Gilead faced public criticism and a Senate investigation for listing Sovaldi at $1,000 a day, even though the therapy cured most patients at a cost of less than a liver transplant.

The hepatitis C drugs’ sales were squeezed in recent years when Merck & Co. launched a rival treatment, forcing Gilead to offer steep discounts to health plans. And partly because of the drugs’ success curing the disease, fewer patients needed treatment.

The company’s second-quarter hepatitis C drug sales fell to $2.9 billion worldwide, down from $4 billion during the period a year earlier.

Gilead has faced pressure from investors and analysts to find new revenue sources. Management responded by touting its next generation of HIV/AIDS treatments as well as drugs in development to treat a liver disease known as NASH, for nonalcoholic steatohepatitis.

But Wall Street said Gilead needed to do another deal. Gilead fanned speculation by hiring Alessandro Riva from Novartis to run its hematology and oncology division, as well as its former adviser, investment banker Andrew Dickinson, from Lazard.

After years of surging volume, pharmaceutical deal making has been slow this year, with very few mega-mergers aside from Johnson & Johnson’s roughly $30 billion deal to buy Actelion Ltd. Drug companies have been digesting earlier acquisitions and have also been hampered by uncertainty surrounding tax reform because many of them have large amounts of cash overseas.

The deal is expected to close in the fourth quarter, around the same time as the deadline for U.S. approval of Kite’s main drug, according to the people familiar with the matter.

-Dana Mattioli contributed to this article.

Sandeep Singh Dhillon
Gilead challenges GSK with strong HIV drug data
Pharma News, Pharma Notables
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LONDON, Feb 14 (Reuters) – Gilead Sciences has thrown down a challenge to GlaxoSmithKline with good clinical trial results for an experimental HIV drug that works in the same way as the British group’s successful dolutegravir.

Gilead’s bictegravir, another so-called integrase inhibitor drug, delivered 97 percent virus suppression, making it just as effective as GSK’s product, data presented at a medical meeting in Seattle late on Monday showed.

Importantly, there were no cases of resistance emerging to the new medicine in the 98-patient Phase II study and no patients discontinued treatment due to kidney problems, which can be an issue with HIV treatments.

Potential drug resistance is a key consideration for the new drug because dolutegravir is valued by doctors for its excellent resistance profile.

Berenberg analyst Laura Sutcliffe said the results were good news for Gilead but the data was not yet conclusive, since findings from larger Phase III tests are due later in the year.

Gilead is pinning its hopes on bictegravir to stay competitive with GSK and the U.S. company has been testing the new medicine alongside two older drugs.

GSK, meanwhile, is working on a dolutegravir-based two-drug treatment regimen for controlling the virus behind AIDS, a development that marks a departure from conventional triple drug cocktails.

Detailed findings from two Phase III trials testing the new two-drug combination were presented at the Conference on Retroviruses and Opportunistic Infections in Seattle. GSK already said in December that these studies were successful.

GSK sells its HIV drugs through its majority-owned ViiV Healthcare unit, in which Pfizer and Japan’s Shionogi hold minority stakes.

GSK shares were 0.6 percent lower by 0830 GMT.

Sandeep Singh Dhillon
Merck Wins Record $2.5 Billion Patent Verdict Against Gilead – Bloomberg
Pharma News

Gilead Sciences Inc. was told by a federal jury to pay $2.54 billion to Merck & Co. for using a patented invention as the basis for its blockbuster drugs for the potentially deadly liver disease hepatitis C — the biggest patent-infringement verdict in U.S. history.

The jury in Wilmington, Delaware, deliberated for less than two hours and rejected Gilead’s arguments that Merck’s patent is invalid. The judge in the case had already decided that Merck’s patent was infringed by Gilead’s Sovaldi and Harvoni, which account for more than half the drugmaker’s revenue.

The infringement also was found to be willful, meaning the judge could increase the damage award by as much as three times the amount set by the jury. The jury said on Thursday that Gilead owed 10 percent royalties on $25.4 billion in total sales for the two drugs.

Gilead pledged to appeal.

The patent, issued in 2009, is for a compound that Merck’s Idenix unit contends is the basis for all major treatments for hepatitis C, including ones made by Gilead. Sovaldi was approved by the U.S. Food and Drug Administration in 2013 and Harvoni got regulatory go-ahead a year later. Merck’s drug, Zepatier, was approved this year.

“We were first,” Merck lawyer Stephanie Parker said in closing arguments. “That’s the most important thing. All of the Gilead work comes after ours. Our patent was first. The Gilead story starts years later.”

Merck shares rose 0.9 percent to $62.37 in regular trading and reached as high as $63.40 in after-hours trading. Gilead shares fell 0.2 percent to $75.55 in regular trading and reached a low of $73.20 in after-hours trading.

‘No Contribution’

Gilead argued that Idenix never adequately described what it claimed to have invented, and the patent didn’t cover a new idea.

“We remain steadfast in our opinion that Idenix’s U.S. patent is invalid, and since they made no contribution and assumed none of the risk in the discovery and development of sofosbuvir and its metabolites, do not believe they are entitled to any level of damages,” the company said in a statement following the verdict.

Sovaldi is based on the compound sofosbuvir, while Harvoni combines sofosbuvir with the compound ledipasvir. Gilead, based in Foster City, California, got the compounds as part of its 2012 acquisition of Pharmasset Inc.

Gilead added that the verdict doesn’t affect its ability to sell its products.

This is the second trial between the two companies. The first, over different patents, ended in a disaster for Merck. A jury in California said that Gilead should pay $200 million in royalties, but that was thrown out because the judge said a key Merck witness lied. In that case, Merck may have to pay Gilead’s legal fees.

Hepatitis C is a virus that attacks the liver and can lead to cirrhosis or liver cancer. The disease affects 130 million to 150 million globally, according to the World Health Organization, and the Centers for Disease Control has said as many as 4 million Americans may have chronic hepatitis C infections.

Price Tag

The drugs are effective at curing the virus with fewer side effects than earlier treatments, but they have been controversial because of their costs. A complete treatment with Sovaldi costs $84,000, while Harvoni’s price tag is $94,500, though the drugs are typically discounted. A newer version that can treat more genotypes of the virus, called Epclusa, has a list price of $74,760 for a 12-week treatment.
Harvoni generated $4 billion in U.S. sales in the first nine months of the year, and Sovaldi brought in $1.78 billion. Revenue from the two drugs is falling, however, because Gilead has been forced to offer discounts to insurers due to competition from Merck and AbbVie Inc. Merck sells Zepatier for $54,600.

Gilead and Idenix have been engaged in a global fight since 2012 over who was first to invent certain compounds for treating hepatitis C. Merck had claims demanding patent royalties on sales of Sovaldi and Harvoni even before it bought Idenix in 2014, absorbing this case as part of the deal.

The case in California was Merck’s own suit against Gilead, filed in 2013 by the Whitehouse Station, New Jersey-based drugmaker.

Gilead also had been engaged in a patent fight with AbbVie over ways to treat hepatitis C. The companies resolved their disputes in August.

The previous top verdict was a $1.67 billion judgment Johnson & Johnson won against Abbott Laboratories. It was later thrown out on appeal.

The case is Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., 14-846, U.S. District Court, District of Delaware (Wilmington).

Sanders Asks VA to Break Patents on Gilead and AbbVie Hep C Drugs – Courtesy(Pharmalot)
Intellectual Property Rights, Pharma News
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