Pfizer Allergan end Megamerger, GSK Wants to Make Copying its Drugs Easier & Data Integrity Issue

Phispers: Pfizer-Allergan end megamerger, GSK wants to make copying its drugs easier & more

This week, the biggest news in the world of pharmaceuticals was the termination of the Pfizer-Allergan mega-merger due to new measures taken by the US government. Post that, Allergan signed a US $ 3 billion licensing deal with UK’s Heptares for a portfolio of neurological drugs.

But a lot more happened last week – for instance, Pfizer and Celltrion won approval for a biosimilar of J&J’s Remicade, GSK said it wants to make it easier for manufacturers in least-developed countries to make its drugs and Valeant terminated the salesforce for its female libido pill.

Pharmaceutical Whispers (Phispers) brings you the latest news from across the world.

Pfizer-Allergan terminate merger; Allergan signs licensing deal with Heptares

On Monday, the US Treasury announced new measures to curb tax-inversion deals. The measures seemed to specifically target the Pfizer-Allergan US $ 160 billion mega deal. And, by Wednesday, the US government had achieved its desired objective – Pfizer and Allergan announced their decision to mutually terminate the deal.

Allergan, which is run from New Jersey but has a legal domicile in Dublin, last year agreed to merge with Pfizer. This mega-merger would have moved the Pfizer headquarters from New York to Dublin, saving the pharma behemoth billions of dollars in taxes.

As per news reports, Pfizer will need to pay a US $ 400 million fee to Allergan for expenses relating to the deal. Though the US Treasury decision and the termination of the Pfizer-Allergan deal represents a victory for President Barack Obama, whose administration proposed tougher rules aimed at curbing tax inversions, Allergan is not wasting time.

Just hours after Allergan backed away from the US $ 160 billion-merger with Pfizer, the company bounced back with a US $ 3.3 billion licensing deal for global rights to a portfolio of drugs for neurological disorders from the UK's Heptares. The deal sends a clear signal that Allergan CEO Brent Saunders plans to barrel ahead with new pacts to bolster the company's pipeline.

Pfizer, Celltrion win approval for biosimilar of J&J’s Remicade

Not all news this week was negative for Pfizer as the FDA approved Celltrion’s biosimilar application of Johnson & Johnson’s Remicade. The product will be co-marketed by Pfizer in the United States, a relationship Pfizer accessed through its acquisition of Hospira last year.

Celltrion’s application is only the second biosimilar approved by the FDA. However, unlike generic medicines, biosimilars which have been currently approved are not interchangeable with the reference drug.

The European Medicines Agency also issued a positive opinion to the Bioepis copy of Remicade. Samsung Bioepis, a joint venture between a unit of the Samsung group and Biogen, has become a force in the biosimilar drugs industry. In fact, South Korea too is emerging as a hub for biosimilar production.

Last week, Bioepis filed a lawsuit against AbbVie Inc., makers of the world’s best-selling rheumatoid arthritis drug – Humira – which generated sales of US $ 14 billion last year. In 2015, Johnson & Johnson’s Remicade sales were US $ 6.5 billion .

Glaxo not to patent drugs in poorer countries

In an unusual step, GlaxoSmithKline said it wants to make it easier for manufacturers in the world's 48 least-developed countries to copy its medicines.

The company said it would not file patents in these countries in the hope that by removing the fear of patent litigation and by allowing independent companies to make and sell versions of its drugs in those areas, it would widen public access to these drugs.

In countries classified as lower middle income countries by GSK, it will continue to file patents, but will grant licenses to generic manufacturers in exchange for a “small royalty”. Gilead has adopted a similar model, of granting generic licensing agreements in developing countries, for its blockbuster Hepatitis C treatment, Sovaldi.

The end of the female Viagra?

Valeant Pharmaceutical, still reeling from all its accounting and price-gouging problems, has terminated the sales force for the female libido pill that it acquired last year for US $ 1 billion.

The drug – Addyi (flibanserin) – failed to gain traction in its first six months on the market. Valeant’s stock has plunged 90 percent since its peak in August last year. Valeant plans to relaunch its sales effort for Addyi with an internal team it will build in the coming months, says a Bloomberg news report.

In the meantime, the drug will still be available. Along with the 140 contract workers that make up the Addyi sales force, Valeant is firing about 140 employees across its dermatology, gastrointestinal and women’s health divisions, with dermatology taking the biggest hit. Valeant has about 22,000 employees.

Alkem, Rusan and Anuh Pharma – data-integrity issues raise its ugly head yet again in India

Inspection at Alkem: In July 2015, the European Union banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences. And this year, another laboratory is under the lens of EU regulators.

A routine inspection by the European Medicines Agency in March 2015 of the Department of Bioequivalence of Alkem Laboratories, a major generic drugs manufacturer in India, raised concerns regarding study data used to support the marketing authorization applications of some drugs in the EU.

Rusan Pharma back in news: In an inspection conducted in 2010 at Rusan Pharma’s facility in Gandhidham (India), the UK’s Medicines and Healthcare Regulatory Agency (MHRA) uncovered “evidence of fraudulent presentation of data” and determined that the site did not comply with Good Manufacturing Practices (GMPs).

The same year, another unit of Rusan, located in Ankleshwar (India), did not meet GMP compliance standards during an inspection conducted by Romania’s National Agency for Medicines and Medical Devices.

This week, Rusan was back in news. In January 2016, re-inspection by UK’s MHRA of the Gandhidham site found the Pharmaceutical Quality System “not operating in an adequate manner”. In addition, the inspection report mentions “there was not adequate evidence that the root causes of critical data integrity issues raised at the last inspection had been addressed.”

Non-compliant sourcing of drugs by Anuh Pharma: The French Health Agency’s inspection at Anuh Pharma’s facility in Boisar (India) revealed the firm was sourcing commonly used Azithromycin from a non-EU GMP compliant source (Hebei Dongfeng Pharmaceutical Company Limited , China), micronizing the product and then directly exporting it to Europe under the manufacturer name, Anuh Pharma.

In addition, several documents were found within a pile of rubble which included an original batch repacking record. A large number of active substances were manufactured at the site, such as chloramphenicol, chloramphenicol palmitate, erythromycin, erythromycin ethylsuccinate, roxithromycin, ciprofloxacin HCl etc.

Catalent’s compliance problems delay OPKO’s new drug launch

With more than 40 manufacturing facilities around the world, Catalent is a preferred manufacturing partner for several major pharmaceutical companies across the world.

OPKO Health, Inc., one of Catalent’s customers submitted its application for RAYALDEE^® (calcifediol) to the FDA. In the complete response letter (CRL) issued to the company, the FDA indicated observations of deficiencies at Catalent’s St. Petersberg, Florida, facility as a result of an FDA field inspection initiated on March 14, 2016, and had held up the new drug approval.

According to a news report , OPKO revealed the deficiencies occurred at Catalent’s primary softgel development and manufacturing at St Petersburg, Florida, which was hit with a Form 483 being issued on March 25.

Meanwhile, Catalent began production of essential drugs at its French plant, which had been suspended by France’s health regulator in November last year due to occurrence of out-of-place capsules in several product batches.

Safety warnings for new age diabetes drugs -- saxagliptin and alogliptin

Last year, the FDA had issued safety warnings on new age diabetes drugs called SLGT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) and PharmaCompass had asked the question, “Diabetes: Which new drug is the safest?”.

At the time Merck succeeded in demonstrating the cardiovascular safety of Januvia®, which was not the case for other products in the same categrory such as AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin).

This week the FDA issued a safety warning on Onglyza® (saxagliptin) and Nesina® (alogliptin) as the evaluation of two clinical trials determined that more patients who received saxagliptin or alogliptin-containing medicines were hospitalized for heart failure compared to patients who received an inactive treatment called a placebo.

Blockbuster drug approval expected soon for non-alcoholic fatty liver

The FDA reviewed the application of Intercept Pharmaceuticals Inc's liver drug, Obeticholic Acid (OCA) and did not raise any major red flags indicating a high likelihood that it will get approved.

While the drug is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease, late-stage studies are underway on the same drug to treat non-alcoholic steatohepatitis (NASH), which has no approved treatment.

Obeticholic acid (OCA) is listed as one of the top 10 possible blockbuster drugs by FierceBiotech with an expected sales in 2020 of US $ 1.6 billion.

Gilead is also actively building its liver disease pipeline and this week, the company paid US $ 400 million upfront to acquire an early-stage pipeline of liver disease drugs from privately held Nimbus Therapeutics.

Heart-disease science turns over its head

Science is supposed to be simple – for instance, LDL is bad cholesterol and HDL is good cholesterol.

If a drug lowers the bad cholesterol and increases the good one, the risk of heart disease should reduce significantly.

Specialists were stunned by the results of a study of 12,000 patients, announced on Sunday at the American College of Cardiology’s annual meeting: “There was no benefit from taking the drug, Evacetrapib.”

The drug’s maker, Eli Lilly, stopped the study in October, citing futility, but it was not until Sunday’s meeting that cardiologists first saw the data behind that decision.

As per the study, participants taking the drug saw their LDL levels fall to an average of 55 milligrams per deciliter from 84. Their HDL levels rose to an average of 104 mg per deciliter from 46.

Yet 256 participants had heart attacks, compared with 255 patients in the group who were taking a placebo. Ninety-two patients taking the drug had a stroke, compared with 95 in the placebo group. And 434 people taking the drug died from cardiovascular disease, such as a heart attack or a stroke, compared with 444 participants who were taking a placebo.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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