After Beef, India May Ban Gelatin Capsules; GSK, Gilead’s HIV Race Heats Up

After beef, India may ban gelatin capsules; GSK, Gilead’s HIV race heats up

This week in Phispers, we bring you the latest twists in the GSK-Gilead rivalry over HIV drugs. India, which recently banned beef nationwide, plans to now replace gelatin with cellulose-based capsules. A lawsuit in the US says Mylan may have overcharged the government US$ 1.27 billion in the form of rebates on EpiPens. And, there is an update on the opioid crisis. Read on.

After beef, India mulls banning animal-based gelatin capsules

As India deals with the aftermath of the controversial cattle trade ban, the Health Ministry is reviewing a proposal to replace gelatin capsules with cellulose-based capsules which are of plant origin and are “safe for use” as compared to animal-based gelatin capsules. Various stakeholders, NGOs and consumers have 21 days to weigh the pros and cons of this proposal and respond.

India’s ministry of health and family welfare constituted an expert committee on March 20 this year to address all technical issues pertaining to replacement of gelatin capsules with cellulose-based capsules for encapsulation of drugs.

The Indian government's ban on the trade of cattle for slaughter threatens US$ 4 billion in annual beef exports and millions of jobs if the government does not revoke it.

Indian meat traders, under the aegis of the Qureshi Action Committee and other trade and industry associations, plan to petition India's Supreme Court to get the government order revoked.

As Pfizer hikes price of 91 drugs, Maryland enacts law to curb generic drug price gouging

Last week, we had shared our list of drugs with ‘no patents and no competition’.

While our list provides tremendous opportunities for generic companies in the short-term, we also warned that the FDA’s continued focus on accelerating review of these drugs will require companies to rely on strategies less opportunistic than price gouging, to drive their future business growth.

On October 1, 2017 Maryland will become the first state in the United States to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers. The Bill was passed by the Maryland General Assembly on April 20, 2017. On May 26, Maryland Governor Larry Hogan sent a letter to the Speaker of the House stating that he would allow the bill to become law without his signature.

The move coincides with Pfizer hiking the price of 91 drugs by an average of 20 percent so far this year in the United States. This includes price hikes for its erectile dysfunction treatment, Viagra, and its pain drug, Lyrica, on June 1.

There are two essential provisions of the Maryland Bill. First, it prohibits a generic drug manufacturer or wholesale distributor from engaging in price gouging in the sale of an “essential off-patent or generic drug.”

Second, the Bill authorizes the Maryland Medical Assistance Program (MMAP) to notify the Maryland Attorney General of a price increase when the Wholesale Acquisition Cost (WAC) of a prescription drug increases by at least 50 percent from the WAC within the preceding one-year period. Or, when the price paid by MMAP would increase by at least 50 percent from the WAC within the preceding one year period and the WAC for either a 30-day supply or a full course of treatment exceeds US$ 80.

Mylan may have received US$ 1.27 billion more in rebate for EpiPens

In the US, Senate Judiciary Committee Chairman Charles Grassley released a Medicaid investigator's report which highlighted that Mylan’s EpiPen may have received US$ 1.27 billion more from the rebate program from 2006 through 2016 than what the company was entitled to receive.

The amount is nearly three times a proposed settlement that the company had announced in October 2016.

Earlier, Mylan had said it would return US $465 million to the government as part of settlement negotiations with the Department of Justice (DOJ). Talks with the DOJ continue.

Senator Grassley has been involved in a long exchange with Mylan questioning the significant price-hikes which the company had implemented over the years.

The EpiPen auto-injector, used to treat allergic reactions, cost US$ 57 a shot when Mylan purchased it in 2007. However, a series of price increases has raised the cost to more than US$ 600 for a pair of EpiPens.

Before the price hike controversy hit Mylan, the Epipen generated more than US$ 1 billion in sales and contributed about 40 percent to Mylan’s overall profits.

GSK, Gilead’s HIV contest heats up, as GSK goes for priority review

Two of the top 10 fastest growing drugs in 2016 were those used to treat HIV. GlaxoSmithKline’s Triumeq (abacavir, dolutegravir, lamivudine) and Gilead’s Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), both generated a sales growth in excess of US$ 1 billion.

For a long time, Gilead dominated the HIV market. But GSK fought back recently. In an effort to stay ahead in the game, GSK used a priority review voucher, for which it paid US$ 130 million, to shave four months off its application approval process.

ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc and Shionogi Limited as its shareholders, announced regulatory submissions to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for the first HIV maintenance regimen single-tablet, which comprises of only two medicines. The two-drug regimen contains dolutegravir (Tivicay, ViiV Healthcare) and rilpivirine (Edurant, Janssen Sciences Ireland UC).

However, don’t count Gilead out. In four late-stage studies, the US company's new drug bictegravir was found to be as effective as GSK's established dolutegravir, which has been the cornerstone of the British group's growing HIV business in recent years.

This year, Gilead plans to apply for regulatory approval to sell its combination of bictegravir and emtricitabine/tenofovir alafenamide (FTC/TAF), with a submission in the US in the second quarter and in Europe in the third quarter.

If Gilead uses a priority voucher at the US FDA, it could launch in the US market in the first quarter of 2018, industry analysts said.

Mallinckrodt explores divestment of its generics business

Mallinckrodt Plc plans to sell off its generic drug unit in a deal that could fetch the company around US$ 2 billion. The move would also help the specialty pharmaceutical maker shift towards higher-margin branded drugs.

Mallinckrodt's generics unit has seen its sales plummeting, in part because some of its products include opiate-based pain killers, which have fallen out of favor with doctors due to their addictive potential.

The divestment would complete the company’s gradual shift away from its original focus on generic drugs and nuclear imaging towards branded specialty pharmaceuticals, which now make up for bulk of its revenues.

Between 2015 and 2016, Mallinckrodt's generic drug sales declined around 18 percent, to just over US$ 1 billion. During the same period, sales of branded specialty drugs increased by around US$ 2.3 billion.

The England-based Mallinckrodt has reportedly hired investment bank Credit Suisse Group AG to run a sale process for the unit.

Canadian researchers trace the origins of the opioid crisis, as Ohio sues drug makers

Last week, the state of Ohio in the US sued five major drug manufacturers, accusing them of misrepresenting the risks of prescription opioid painkillers that have fueled a skyrocketing drug addiction epidemic.

Opioid drugs, including prescription painkillers and heroin, killed more than 33,000 people in the United States in 2015, more than any year on record, according to the US Centers for Disease Control and Prevention.

Canadian researchers have traced the origins of the current opioid crisis to a letter published in the New England Journal of Medicine (NEJM) in 1980, which stated that opioids were not addictive. The original letter titled ‘Addiction Rare in Patients Treated with Narcotics’, was just a paragraph long.

The lone evidence the letter cited was an anecdote that out of 11,882 hospitalized patients treated with narcotics, only four patients with no history of addiction became addicted.

The journal's prestige helped fuel this misguided belief. The letter was cited over 600 times, usually to argue that opioids were not addictive.

Last week, the NEJM published an unusual warning for readers about the 1980 letter.

The editor's note on the original letter in the NEJM reads, "For reasons of public health, readers should be aware that this letter has been 'heavily and uncritically cited' as evidence that addiction is rare with opioid therapy."

The five companies Ohio sued were Purdue Pharma LP, Johnson & Johnson's Janssen Pharmaceuticals Inc unit, a unit of Endo International Plc, Teva Pharmaceutical Industries Ltd's Cephalon unit and Allergan Plc".

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